Taxane composition and use thereof

Abstract

A taxane composition and use thereof. The taxane composition is a taxane aqueous composition comprising a taxane. The taxane aqueous composition is used for treating an individual with bladder cancer by means of intravesical instillation, and has at least one of the following characteristics: (1) at least about 5% of the taxane is free taxane; and (2) the concentration of the free taxane is about 0.01 mg / ml to about 0.8 mg / ml. Alternatively, the taxane aqueous composition is used for treating a bladder cancer patient by means of intravesical instillation; after the taxane aqueous composition is administrated to the bladder cancer patient, the taxane in the plasma of the bladder cancer patient has at least one of the following characteristics: (1) the concentration of the taxane in the plasma of the bladder cancer patient is at least about 0.02 ng / ml; and (2) the AUC of the taxane in the plasma of the bladder cancer patient is at least about 0.02 h*ng / mL.

Description

Taxane compositions and uses thereof

[0001] Priority claim

[0002] This application claims priority to Chinese Patent Application No. 202411419008.1, filed on October 11, 2024, Chinese Patent Application No. 202510110408.2, filed on January 23, 2025, and Chinese Patent Application No. 202510175740.7, filed on February 18, 2025. The entire contents of the foregoing Chinese Patent Applications are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application belongs to the technical field of anti-tumor, in particular, relates to a taxane composition and uses thereof. BACKGROUND

[0004] Bladder cancer is the seventh most common cancer in the male population and the eleventh most common cancer in women worldwide. It is estimated that there were approximately 81,000 new cases of bladder cancer in the United States in 2019, of which >70% presented as non-muscle invasive bladder cancer (NMIBC). During the course of NMIBC, up to 50-70% of cases will recur and approximately 10-20% will progress to muscle invasive bladder cancer (MIBC). For detailed information, see Sylvester RJ, et al. Eur Urol. 2006;49:466-477. The cornerstone of diagnosis and treatment of NMIBC is transurethral resection of bladder tumours (TURBt). To prevent recurrence, adjuvant intravesical Bacillus Calmette-Guerin (BCG) immunotherapy or chemotherapy should be administered following surgical resection for intermediate to high risk NMIBC. See, e.g., Babjuk, M, et al. Eur Urol. 2017;71:447-61, Chang SS, et al. J Urol. 2016;196:1021-9, Brausi M, et al. J Urol. 2011;186:2158-67. For bladder cancer, intravesical therapy is attractive because direct delivery of the therapeutic agent to the bladder allows high concentrations of drug at the site of the tumour while limiting systemic drug absorption. Currently, BCG is the most successful drug for adjuvant intravesical therapy of NMIBC. BCG is considered the standard of care for high risk NMIBC. However, intravesical BCG therapy can sometimes cause local or systemic side effects. Despite being the gold standard treatment, up to 40% of NMIBC patients do not respond to intravesical BCG therapy and 20% will progress to muscle invasive disease within 5 years. In the case of BCG failure, the preferred treatment for high risk patients is to undergo radical cystectomy. However, not all patients are suitable for radical cystectomy. Radical cystectomy is associated with significant short and long term complications and many patients prefer to retain their bladder or are medically unfit for this procedure.

[0005] Docetaxel has very poor aqueous solubility. Currently marketed clinical use of docetaxel injection (e.g. ) is formulated with polysorbate 80. Polysorbate 80 is a hydrophilic non-ionic surfactant that forms micelles in aqueous solution. In the currently marketed docetaxel injection, the hydrophobic docetaxel is encapsulated in polysorbate 80 micelles to solubilize docetaxel in the infusion solution. Therefore, after reconstitution of the docetaxel injection, about 98-99% of the docetaxel is encapsulated in the micelles. The concentration of free (in solution) docetaxel in the currently marketed docetaxel injection reconstituted solution is very low. The low free docetaxel concentration limits the therapeutic effect of intravesical therapy for the treatment of bladder cancer. Literature Chen Jingwen et al., Chinese Journal of Hospital Pharmacy, 2020, 40(10): 1122-1125. reported that the average encapsulation efficiency of paclitaxel for injection (albumin-bound type) was 93.6%. Literature Su Z et al., Int J Pharm. 2023 Mar 25; 635: 122711. reported that the encapsulation efficiency of docetaxel (albumin-bound type) was 95.43%. Barlow LJ et al., World J Urol. 2009 Jun; 27(3): 331-5. reported the results of intravesical treatment of docetaxel injection (containing polysorbate 80) for refractory NMIBC, and the results showed that after the 6-week induction period, the complete remission rate (CR) of 33 patients (3 mg-75 mg) was 61%, and the CR of 18 patients receiving a dose of 75 mg was 67%.

[0006] To date, none of the intravesical chemotherapy drugs has shown superiority over BCG in treating patients with NMIBC for the first time. The adverse reactions of intravesical chemotherapy are partly due to insufficient absorption of the drug in the bladder tissue during the short indwelling time. Therefore, there is an urgent need for new drugs that can be more effectively delivered to the cancer tissue in the bladder. SUMMARY

[0007] The present application provides a taxane composition and its use, more specifically, a taxane aqueous composition for treating bladder cancer individuals by bladder instillation. The docetaxel composition or cabazitaxel composition containing albumin described in documents WO2017123760A1, WO2019204738A1, WO2022056396A1, WO2016187147A1, WO2018081520A1, WO2018204386A1, WO2019200084A1, WO2021158632A1, the entire contents of the above documents are incorporated herein by reference as part of the contents herein.

[0008] One aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of individuals with bladder cancer, wherein at least about 5% of the taxane in the aqueous taxane composition is free taxane.

[0009] In some embodiments, at least about 5% of the taxane in the aqueous taxane composition is free taxane, for example, at least about 7%, at least about 10%, at least about 15%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, or at least about 90% is free taxane. In some embodiments, about 10% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 55% to about 65% of the taxane in the aqueous taxane composition is free taxane. The concentration of free taxane is determined by 30 kDa membrane ultrafiltration.

[0010] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0011] In some embodiments, the taxane composition further includes albumin. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 20%, from about 0.005% to about 10%, from about 0.01% to about 20%, from about 0.1% to about 15%, from about 0.5% to about 12%, from about 1% to about 10%, from about 2% to about 8%, from about 3% to about 7%, from about 4% to about 6%, from about 4.5% to about 5.5%, or about 5%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 4% to about 6%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is about 5%.

[0012] In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 300:1, from about 1:5 to about 900:1, from about 1:1 to about 800:1, from about 5:1 to about 700:1, from about 10:1 to about 600:1, from about 20:1 to about 500:1, from about 30:1 to about 400:1. The weight ratios of albumin to taxane in the taxane composition are approximately 40:1 to approximately 300:1, approximately 50:1 to approximately 200:1, approximately 60:1 to approximately 150:1, approximately 70:1 to approximately 150:1, approximately 80:1 to approximately 150:1, approximately 90:1 to approximately 150:1, approximately 100:1 to approximately 160:1, approximately 120:1 to approximately 150:1, approximately 130:1 to approximately 155:1, approximately 135:1 to approximately 150:1, and approximately 140:1 to approximately 145:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 130:1 to approximately 155:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 140:1 to approximately 145:1.

[0013] In some embodiments, the albumin is serum albumin. In some embodiments, the albumin is human serum albumin (HSA). In some embodiments, the human serum albumin is natural human serum albumin or recombinant human serum albumin.

[0014] In some embodiments, the human serum albumin is derived from lyophilized human serum albumin powder or human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the concentration (w / v%) of the infusion-grade human serum albumin solution is 5%, 10%, 20%, or 25%.

[0015] In some embodiments, the taxane aqueous composition is a dispersion. In some embodiments, the taxane aqueous composition is a suspension. In some embodiments, the taxane aqueous composition is a solution.

[0016] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 2 mg to about 150 mg, from about 3 mg to about 120 mg, from about 4 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 15 mg to about 20 mg, from about 12.5 mg to about 22.5 mg, from about 10 mg to about 25 mg, from about 7.5 mg to about 37.5 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg.

[0017] In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.02 mg / mL to about 9 mg / mL, from about 0.05 mg / mL to about 8 mg / mL, from about 0.1 mg / mL to about 7 mg / mL, from about 0.15 mg / mL to about 6 mg / mL, from about 0.2 mg / mL to about 5 mg / mL, from about 0.25 mg / mL to about 4 mg / mL, from about 0.3 mg / mL to about 3 mg / mL, from about 0.32 mg / mL to about 2 mg / mL, from about 0.33 mg / mL to about 1 mg / mL, or from about 0.34 mg / mL to about 0.5 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.33 mg / mL to about 0.37 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is about 0.35 mg / mL.

[0018] In some embodiments, the pH value of the taxane aqueous composition is from about 2 to about 9, for example, from about 2 to about 8.5, from about 2 to about 7, from about 2 to about 6, from about 2.5 to about 8, from about 3 to about 7.5, from about 3.5 to about 7, from about 5 to about 7, from about 6 to about 8, or from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is about 7.

[0019] In some embodiments, the taxane composition is a docetaxel composition. In some embodiments, the docetaxel composition comprises docetaxel, the docetaxel composition is an aqueous docetaxel composition, the aqueous docetaxel composition is used for the treatment of bladder cancer individuals via bladder instillation, and at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0020] In some embodiments, the docetaxel aqueous composition is a dispersion. In some embodiments, the docetaxel aqueous composition is a suspension. In some embodiments, the docetaxel aqueous composition is a solution. In some embodiments, the docetaxel aqueous composition is a clear aqueous solution.

[0021] In some embodiments, the docetaxel composition further includes one or more of a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, and a sugar or sugar alcohol. In some embodiments, the docetaxel composition further includes a water-soluble organic solvent. In some embodiments, the docetaxel composition further includes a pharmaceutically acceptable carrier. In some embodiments, the docetaxel composition further includes a pH adjuster.

[0022] In some embodiments, the pharmaceutically acceptable carrier is a parenteral acceptable carrier. In some embodiments, the parenteral acceptable carrier is an aqueous carrier. In some embodiments, the aqueous carrier is water for injection, physiological saline, and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline (e.g., 0.9% sodium chloride solution). In some embodiments, the aqueous carrier is a glucose solution (e.g., 5% glucose solution).

[0023] In some implementations, the pH adjuster is citric acid.

[0024] Another aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of individuals with bladder cancer, wherein the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.8 mg / ml.

[0025] In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.01 mg / ml to about 0.75 mg / ml, for example, from about 0.02 mg / ml to about 0.7 mg / ml, from about 0.03 mg / ml to about 0.65 mg / ml, from about 0.04 mg / ml to about 0.6 mg / ml, from about 0.05 mg / ml to about 0.55 mg / ml, from about 0.06 mg / ml to about 0.5 mg / ml, from about 0.07 mg / ml to about 0.45 mg / ml, or from about 0.08 mg / ml. / ml to about 0.4 mg / ml, about 0.09 mg / ml to about 0.35 mg / ml, about 0.1 mg / ml to about 0.3 mg / ml, about 0.2 mg / ml to about 0.25 mg / ml, about 0.05 mg / ml, about 0.1 mg / ml, about 0.15 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.5 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml, about 0.55 mg / ml.

[0026] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0027] In some embodiments, the taxane composition further includes albumin. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 20%, from about 0.005% to about 10%, from about 0.01% to about 20%, from about 0.1% to about 15%, from about 0.5% to about 12%, from about 1% to about 10%, from about 2% to about 8%, from about 3% to about 7%, from about 4% to about 6%, from about 4.5% to about 5.5%, or about 5%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 4% to about 6%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is about 5%.

[0028] In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 300:1, from about 1:5 to about 900:1, from about 1:1 to about 800:1, from about 5:1 to about 700:1, from about 10:1 to about 600:1, from about 20:1 to about 500:1, from about 30:1 to about 400:1. The weight ratios of albumin to taxane in the taxane composition are approximately 40:1 to approximately 300:1, approximately 50:1 to approximately 200:1, approximately 60:1 to approximately 150:1, approximately 70:1 to approximately 150:1, approximately 80:1 to approximately 150:1, approximately 90:1 to approximately 150:1, approximately 100:1 to approximately 160:1, approximately 120:1 to approximately 150:1, approximately 130:1 to approximately 155:1, approximately 135:1 to approximately 150:1, and approximately 140:1 to approximately 145:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 130:1 to approximately 155:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 140:1 to approximately 145:1.

[0029] In some embodiments, the albumin is serum albumin. In some embodiments, the albumin is human serum albumin. In some embodiments, the human serum albumin is natural human serum albumin or recombinant human serum albumin.

[0030] In some embodiments, the human serum albumin is derived from lyophilized human serum albumin powder or a human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the concentration (w / v%) of the infusion-grade human serum albumin solution is 5%, 10%, 20%, or 25%.

[0031] In some embodiments, the taxane aqueous composition is a dispersion. In some embodiments, the taxane aqueous composition is a suspension. In some embodiments, the taxane aqueous composition is a solution.

[0032] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 2 mg to about 150 mg, from about 3 mg to about 120 mg, from about 4 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 15 mg to about 20 mg, from about 12.5 mg to about 22.5 mg, from about 10 mg to about 25 mg, from about 7.5 mg to about 37.5 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg.

[0033] In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.02 mg / mL to about 9 mg / mL, from about 0.05 mg / mL to about 8 mg / mL, from about 0.1 mg / mL to about 7 mg / mL, from about 0.15 mg / mL to about 6 mg / mL, from about 0.2 mg / mL to about 5 mg / mL, from about 0.25 mg / mL to about 4 mg / mL, from about 0.3 mg / mL to about 3 mg / mL, from about 0.32 mg / mL to about 2 mg / mL, from about 0.33 mg / mL to about 1 mg / mL, or from about 0.34 mg / mL to about 0.5 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.33 mg / mL to about 0.37 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is about 0.35 mg / mL.

[0034] In some embodiments, the pH value of the taxane aqueous composition is from about 2 to about 9, for example, from about 2 to about 8.5, from about 2 to about 7, from about 2 to about 6, from about 2.5 to about 8, from about 3 to about 7.5, from about 3.5 to about 7, from about 5 to about 7, from about 6 to about 8, or from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is about 7.

[0035] In some embodiments, the taxane composition is a docetaxel composition. In some embodiments, the docetaxel composition includes docetaxel, the docetaxel composition is an aqueous docetaxel composition, the aqueous docetaxel composition is used by bladder instillation to treat individuals with bladder cancer, and the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml.

[0036] In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml, and at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.05 mg / ml to about 0.75 mg / ml, and at least 10% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.7 mg / ml, and at least 20% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.6 mg / ml, and at least 30% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.5 mg / ml, and at least 40% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.4 mg / ml, and at least 50% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.3 mg / ml, and about 10% to about 90% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.15 mg / ml to about 0.25 mg / ml, and about 20% to about 80% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 30% to about 70% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 55% to about 65% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0037] In some embodiments, the docetaxel aqueous composition is a dispersion. In some embodiments, the docetaxel aqueous composition is a suspension. In some embodiments, the docetaxel aqueous composition is a solution. In some embodiments, the docetaxel aqueous composition is a clear aqueous solution.

[0038] In some embodiments, the docetaxel composition further includes one or more of a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, and a sugar or sugar alcohol. In some embodiments, the docetaxel composition further includes a water-soluble organic solvent. In some embodiments, the docetaxel composition further includes a pharmaceutically acceptable carrier. In some embodiments, the docetaxel composition further includes a pH adjuster.

[0039] In some embodiments, the pharmaceutically acceptable carrier is a parenteral acceptable carrier. In some embodiments, the parenteral acceptable carrier is an aqueous carrier. In some embodiments, the aqueous carrier is water for injection, physiological saline, and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline (e.g., 0.9% sodium chloride solution). In some embodiments, the aqueous carrier is a glucose solution (e.g., 5% glucose solution).

[0040] In some implementations, the pH adjuster is citric acid.

[0041] Another aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of bladder cancer patients, wherein after administration of the aqueous taxane composition to the bladder cancer patients, the concentration of taxane in the plasma of the bladder cancer patients is at least about 0.02 ng / ml.

[0042] In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.03 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.05 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.15 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.25 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.25 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.3 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.35 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.45 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.54 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.55 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.65 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.65 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.75 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 10 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 100 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 200 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 300 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 500 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 400 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 300 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 200 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 100 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.03 ng / ml to about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 20 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.05 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.04 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.12 ng / ml to about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.14 ng / ml to about 0.3 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.16 ng / ml to about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.5 ng / ml to about 1 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.7 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.09 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.8 ng / ml.

[0043] In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.02 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.04 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.06 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.08 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.1 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.2 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.3 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.35 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.4 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.45 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.5 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.75 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 1 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 10 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... maxAt least approximately 15 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 20 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 50 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 100 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least approximately 150 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 200 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 300 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... maxFrom about 0.02 ng / ml to about 500 ng / ml (e.g., about 0.02 ng / ml to about 400 ng / ml, about 0.02 ng / ml to about 300 ng / ml, about 0.02 ng / ml to about 200 ng / ml, about 0.02 ng / ml to about 100 ng / ml, about 0.02 ng / ml to about 50 ng / ml, about 0.02 ng / ml to about 40 ng / ml, about 0.02 ng / ml to about 30 ng / ml, about 0.02 ng / ml to about 20 ng / ml, about 0. 0.02 ng / ml to about 10 ng / ml, about 0.02 ng / ml to about 5 ng / ml, about 0.02 ng / ml to about 0.8 ng / ml, about 0.05 ng / ml to about 0.9 ng / ml, about 0.1 ng / ml to about 0.8 ng / ml, about 0.15 ng / ml to about 0.75 ng / ml, about 0.2 ng / ml to about 0.7 ng / ml, about 0.25 ng / ml to about 0.65 ng / ml, about 0.3 ng / ml to about 0.6 ng / ml, about 0.3 ng / ml From about 0.55 ng / ml, from about 0.3 ng / ml to about 0.5 ng / ml, from about 0.3 ng / ml to about 0.45 ng / ml, from about 0.3 ng / ml to about 0.4 ng / ml, from about 0.25 ng / ml to about 0.6 ng / ml, from about 0.25 ng / ml to about 0.55 ng / ml, from about 0.25 ng / ml to about 0.5 ng / ml, from about 0.25 ng / ml to about 0.45 ng / ml, from about 0.25 ng / ml to about 0.4 ng / ml, from about 0.2 ng / ml to about The concentrations of taxane in the plasma of bladder cancer patients range from 80% to 125% of the concentrations of 0.65 ng / ml, about 0.2 ng / ml to about 0.6 ng / ml, about 0.2 ng / ml to about 0.55 ng / ml, about 0.2 ng / ml to about 0.5 ng / ml, about 0.2 ng / ml to about 0.45 ng / ml, about 0.2 ng / ml to about 0.4 ng / ml, about 0.15 ng / ml to about 0.45 ng / ml, about 0.15 ng / ml to about 0.35 ng / ml, and about 0.15 ng / ml to about 0.3 ng / ml. In some embodiments, the C60 of taxane in the plasma of bladder cancer patients is... max Within the range of 80% to 125% of about 0.02 ng / ml to about 50 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max Within the range of 80% to 125% of about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... maxWithin the range of 80% to 125% of about 0.05 ng / ml to about 0.8 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max Within the range of 80% to 125% of about 0.3 ng / ml to about 0.4 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max In the range of 80% to 125% of about 0.15 ng / ml to about 0.3 ng / ml.

[0044] In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... max From approximately 0.05 hours to approximately 10 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.1 hours to approximately 5 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.2 hours to approximately 4 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.3 hours to approximately 3 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.4 hours to approximately 2.1 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From about 0.5 hours to about 2 hours, for example from about 0.6 hours to about 1.8 hours, from about 0.7 hours to about 1.6 hours, from about 0.8 hours to about 1.4 hours, from about 0.9 hours to about 1.2 hours, and from about 0.9 hours to about 1.1 hours.

[0045] In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24hAt least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 1 h*ng / mL, at least about 1.5 h*ng / mL, at least about 1.8 h*ng / mL, at least about 2 h*ng / mL, at least about 2.5 h*ng / mL, at least about 3 h*ng / mL, at least about 5 h*ng / mL, at least about 6.5 h*ng / mL. At least about 10 h*ng / mL, at least about 15 h*ng / mL, at least about 20 h*ng / mL, at least about 25 h*ng / mL, at least about 30 h*ng / mL, at least about 40 h*ng / mL, at least about 50 h*ng / mL, at least about 100 h*ng / mL, at least about 250 h*ng / mL, at least about 500 h*ng / mL, at least about 1000 h*ng / mL, at least about 1500 h*ng / mL, at least about 2000 h*ng / mL, at least about 3000 h*ng / mL, at least about 4500 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-24hFrom approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL (e.g., approximately 0.02 h*ng / mL to approximately 5000 h*ng / mL, approximately 0.02 h*ng / mL to approximately 2500 h*ng / mL, approximately 0.02 h*ng / mL to approximately 1000 h*ng / mL, approximately 0.02 h*ng / mL to approximately 500 h*ng / mL, approximately 0.03 h*ng / mL to approximately 400 h*ng / mL, approximately 0.04 h*ng / mL to approximately 300 h*ng / mL, approximately 0.04 h*ng / mL to approximately 100 h*ng / mL, approximately 0.04 h*ng / mL From approximately 50 h*ng / mL, approximately 0.04 h*ng / mL to approximately 40 h*ng / mL, approximately 0.04 h*ng / mL to approximately 30 h*ng / mL, approximately 0.04 h*ng / mL to approximately 20 h*ng / mL, approximately 0.04 h*ng / mL to approximately 10 h*ng / mL, approximately 0.1 h*ng / mL to approximately 50 h*ng / mL, approximately 0.1 h*ng / mL to approximately 40 h*ng / mL, approximately 0.1 h*ng / mL to approximately 30 h*ng / mL, approximately 0.1 h*ng / mL to approximately 20 h*ng / mL, approximately 0.1 h*ng / mL to approximately 10 h*ng / mL / mL, about 0.1h*ng / mL to about 9.5h*ng / mL, about 0.1h*ng / mL to about 9h*ng / mL, about 0.5h*ng / mL to about 8.5h*ng / mL, about 0.6h*ng / mL to about 8h*ng / mL, about 0.7h*ng / mL to about 7h*ng / mL, about 0.8h*ng / mL to about 6.5h*ng / mL, about 1h*ng / mL to about 6h*ng / mL, about 1.5h*ng / mL to about 5.5h*ng / mL, about 1.6h*ng / mL to about 5h*ng / mL, about 1.7h*ng / mL The concentrations of taxane in plasma from bladder cancer patients are within the range of 80% to 125% of the concentrations of approximately 4.5 h*ng / mL, approximately 1.8 h*ng / mL to approximately 4 h*ng / mL, approximately 1.9 h*ng / mL to approximately 3.5 h*ng / mL, approximately 2 h*ng / mL to approximately 3 h*ng / mL, approximately 2.5 h*ng / mL to approximately 3 h*ng / mL, approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL, approximately 1 h*ng / mL to approximately 5 h*ng / mL, approximately 1 h*ng / mL to approximately 4 h*ng / mL, approximately 1 h*ng / mL to approximately 3 h*ng / mL, and approximately 1 h*ng / mL to approximately 2 h*ng / mL. In some embodiments, the AUC of taxane in plasma from bladder cancer patients is... 0-24h Within the range of approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL, the AUC of taxane in the plasma of the bladder cancer patient is [not specified]. 0-24hWithin the range of 80% to 125% of approximately 0.2 h*ng / mL to approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 2.5 h*ng / mL to approximately 3 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 1.2 h*ng / mL to approximately 1.7 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h In the range of 80% to 125% of approximately 1.2 h*ng / mL to approximately 3.5 h*ng / mL.

[0046] In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ At least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 0.7 h*ng / mL, at least about 1 h*ng / mL, at least about 1.5 h*ng / mL, at least about 1.8 h*ng / mL, at least about 2 h*ng / mL, at least about 2.5 h*ng / mL, at least about 3 h*ng / mL, at least about 5 h*ng / mL, at least about 7. 5 h*ng / mL, at least about 10 h*ng / mL, at least about 15 h*ng / mL, at least about 20 h*ng / mL, at least about 25 h*ng / mL, at least about 30 h*ng / mL, at least about 40 h*ng / mL, at least about 50 h*ng / mL, at least about 100 h*ng / mL, at least about 250 h*ng / mL, at least about 500 h*ng / mL, at least about 1000 h*ng / mL, at least about 1500 h*ng / mL, at least about 2000 h*ng / mL, at least about 3000 h*ng / mL, at least about 4500 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-∞From approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL (e.g., approximately 0.02 h*ng / mL to approximately 5000 h*ng / mL, approximately 0.02 h*ng / mL to approximately 2500 h*ng / mL, approximately 0.1 h*ng / mL to approximately 1000 h*ng / mL, approximately 0.2 h*ng / mL to approximately 500 h*ng / mL, approximately 0.3 h*ng / mL to approximately 400 h*ng / mL, approximately 0.4 h*ng / mL to approximately 300 h*ng / mL, approximately 0.5 h*ng / mL to approximately 100 h*ng / mL, approximately 0.6 h*ng / mL to approximately 50 h*ng / mL, approximately 0.65 h *ng / mL to about 40h*ng / mL, about 0.65h*ng / mL to about 30h*ng / mL, about 0.65h*ng / mL to about 20h*ng / mL, about 0.65h*ng / mL to about 10h*ng / mL, about 0.65h*ng / mL to about 0.85h*ng / mL, about 0.1h*ng / mL to about 40h*ng / mL, about 0.1h*ng / mL to about 30h*ng / mL, about 0.1h*ng / mL to about 20h*ng / mL, about 0.1h*ng / mL to about 10h*ng / mL, about 0.1h*ng / mL to about 9.5h*ng / mL Approximately 0.1 h*ng / mL to approximately 9 h*ng / mL, approximately 0.5 h*ng / mL to approximately 8.5 h*ng / mL, approximately 0.6 h*ng / mL to approximately 8 h*ng / mL, approximately 0.7 h*ng / mL to approximately 7 h*ng / mL, approximately 0.8 h*ng / mL to approximately 6.5 h*ng / mL, approximately 1 h*ng / mL to approximately 6 h*ng / mL, approximately 1.5 h*ng / mL to approximately 5.5 h*ng / mL, approximately 1.6 h*ng / mL to approximately 5 h*ng / mL, approximately 1.7 h*ng / mL to approximately 4.5 h*ng / mL, approximately 1.8 h*ng / mL to approximately 4 h*ng / mL, approximately 1.9 h*ng / mL. The AUC of taxane in the plasma of bladder cancer patients is in the range of 80% to 125% of the values ​​of approximately 2 h*ng / mL to approximately 3.5 h*ng / mL, approximately 2 h*ng / mL to approximately 3.5 h*ng / mL, approximately 2 h*ng / mL to approximately 4 h*ng / mL, approximately 1 h*ng / mL to approximately 5 h*ng / mL, approximately 1 h*ng / mL to approximately 4.5 h*ng / mL, approximately 1 h*ng / mL to approximately 4 h*ng / mL, approximately 1.5 h*ng / mL to approximately 3.5 h*ng / mL, approximately 1.5 h*ng / mL to approximately 3 h*ng / mL, and approximately 2 h*ng / mL to approximately 2.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-∞Within the range of 80% to 125% of approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 0.2 h*ng / mL to approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 0.65 h*ng / mL to approximately 8.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 2 h*ng / mL to approximately 4 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ In the range of 80% to 125% of about 2 h*ng / mL to about 2.5 h*ng / mL.

[0047] In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... 1 / 2 From about 0.1 hours to about 50 hours, for example, from about 0.5 hours to about 40 hours, from about 0.7 hours to about 30 hours, from about 0.8 hours to about 20 hours, from about 1 hour to about 15 hours, from about 1.2 hours to about 13 hours, from about 1.5 hours to about 10 hours, from about 2 hours to about 9.5 hours, from about 2.5 hours to about 8.5 hours, from about 3 hours to about 8 hours, from about 2.5 hours to about 7.5 hours, from about 3 hours to about 7 hours, from about 3.5 hours to about 6.5 hours, from about 4 hours to about 6 hours, from about 4.5 hours to about 6 hours, from about 5 hours to about 6 hours, from about 5.5 hours to about 6 hours, from about 5 hours to about 6.5 hours, from about 5.5 hours to about 6.5 hours, from about 4 hours to about 6.5 hours, from about 4.5 hours to about 6.5 hours. In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 2 hours to approximately 9 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 2.2 hours to approximately 8.8 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5.5 hours to approximately 6 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5 hours to approximately 6.5 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2From approximately 5.5 hours to approximately 6.5 hours.

[0048] In some implementations, the bladder cancer patient is a single individual. In some implementations, the bladder cancer patient is multiple individuals (e.g., 2-1000, 2-500, 2-400, 2-300, 2-150, 2-100, 2-50, 25, 20, 6, etc.). When the bladder cancer patient is multiple individuals, the C described in this application... max AUC 0-24h AUC 0-∞ T 1 / 2 The T is the average value. max This is the median value.

[0049] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0050] In some embodiments, at least about 5% of the taxane in the aqueous taxane composition is free taxane, for example, at least about 7%, at least about 10%, at least about 15%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, or at least about 90% is free taxane. In some embodiments, about 10% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 55% to about 65% of the taxane in the aqueous taxane composition is free taxane.

[0051] In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.01 mg / ml to about 0.8 mg / ml, for example, from about 0.01 mg / ml to about 0.75 mg / ml, from about 0.02 mg / ml to about 0.7 mg / ml, from about 0.03 mg / ml to about 0.65 mg / ml, from about 0.04 mg / ml to about 0.6 mg / ml, from about 0.05 mg / ml to about 0.55 mg / ml, from about 0.06 mg / ml to about 0.5 mg / ml, from about 0.07 mg / ml to about 0.45 mg / ml. ml, about 0.08 mg / ml to about 0.4 mg / ml, about 0.09 mg / ml to about 0.35 mg / ml, about 0.1 mg / ml to about 0.3 mg / ml, about 0.2 mg / ml to about 0.25 mg / ml, about 0.05 mg / ml, about 0.1 mg / ml, about 0.15 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.5 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml, about 0.55 mg / ml.

[0052] In some embodiments, the taxane composition further includes albumin. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 20%, from about 0.005% to about 10%, from about 0.01% to about 20%, from about 0.1% to about 15%, from about 0.5% to about 12%, from about 1% to about 10%, from about 2% to about 8%, from about 3% to about 7%, from about 4% to about 6%, from about 4.5% to about 5.5%, or about 5%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 4% to about 6%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is about 5%.

[0053] In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 300:1, from about 1:5 to about 900:1, from about 1:1 to about 800:1, from about 5:1 to about 700:1, from about 10:1 to about 600:1, from about 20:1 to about 500:1, from about 30:1 to about 400:1. The weight ratios of albumin to taxane in the taxane composition are approximately 40:1 to approximately 300:1, approximately 50:1 to approximately 200:1, approximately 60:1 to approximately 150:1, approximately 70:1 to approximately 150:1, approximately 80:1 to approximately 150:1, approximately 90:1 to approximately 150:1, approximately 100:1 to approximately 160:1, approximately 120:1 to approximately 150:1, approximately 130:1 to approximately 155:1, approximately 135:1 to approximately 150:1, and approximately 140:1 to approximately 145:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 130:1 to approximately 155:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 140:1 to approximately 145:1.

[0054] In some embodiments, the albumin is serum albumin. In some embodiments, the albumin is human serum albumin. In some embodiments, the human serum albumin is natural human serum albumin or recombinant human serum albumin.

[0055] In some embodiments, the human serum albumin is derived from lyophilized human serum albumin powder or a human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the concentration (w / v%) of the human serum albumin solution is 5%, 10%, 20%, or 25%.

[0056] In some embodiments, the taxane aqueous composition is a dispersion. In some embodiments, the taxane aqueous composition is a suspension. In some embodiments, the taxane aqueous composition is a solution.

[0057] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 2 mg to about 150 mg, from about 3 mg to about 120 mg, from about 4 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 15 mg to about 20 mg, from about 12.5 mg to about 22.5 mg, from about 10 mg to about 25 mg, from about 7.5 mg to about 37.5 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg.

[0058] In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.02 mg / mL to about 9 mg / mL, from about 0.05 mg / mL to about 8 mg / mL, from about 0.1 mg / mL to about 7 mg / mL, from about 0.15 mg / mL to about 6 mg / mL, from about 0.2 mg / mL to about 5 mg / mL, from about 0.25 mg / mL to about 4 mg / mL, from about 0.3 mg / mL to about 3 mg / mL, from about 0.32 mg / mL to about 2 mg / mL, from about 0.33 mg / mL to about 1 mg / mL, or from about 0.34 mg / mL to about 0.5 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.33 mg / mL to about 0.37 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is about 0.35 mg / mL.

[0059] In some embodiments, the pH value of the taxane aqueous composition is from about 2 to about 9, for example, from about 2 to about 8.5, from about 2 to about 7, from about 2 to about 6, from about 2.5 to about 8, from about 3 to about 7.5, from about 3.5 to about 7, from about 5 to about 7, from about 6 to about 8, or from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is about 7.

[0060] In some embodiments, the taxane composition is a docetaxel composition. In some embodiments, the docetaxel composition comprises docetaxel, the docetaxel composition is an aqueous docetaxel composition, the aqueous docetaxel composition is used for the treatment of bladder cancer patients by bladder instillation, and after administration of the aqueous docetaxel composition to the bladder cancer patient, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.02 ng / ml.

[0061] In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.02 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.05 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.1 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.2 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.3 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.4 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.5 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.6 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.7 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.05 ng / ml to about 0.7 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 0.6 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.2 ng / ml to about 0.5 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.25 ng / ml to about 0.45 ng / ml.

[0062] In some embodiments, the C-level of docetaxel in the plasma of the bladder cancer patient is... max At least approximately 0.02 ng / ml. In some embodiments, the C-level of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.05 ng / ml. In some embodiments, the C-level of docetaxel in the plasma of the bladder cancer patient is [not specified].max At least approximately 0.1 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.2 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.25 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.3 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.35 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.5 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.7 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max The concentration is approximately 0.02 ng / ml to approximately 0.8 ng / ml. In some embodiments, the C-level concentration of docetaxel in the plasma of the bladder cancer patient is [not specified]. max The concentration is approximately 0.2 ng / ml to approximately 0.5 ng / ml. In some embodiments, the C60 of docetaxel in the plasma of the bladder cancer patient is [not specified]. max The concentration is approximately 0.2 ng / ml to approximately 0.4 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max Within the range of 80% to 125% of approximately 0.3 ng / ml to approximately 0.4 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max In the range of 80% to 125% of about 0.15 ng / ml to about 0.3 ng / ml.

[0063] In some implementations, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From approximately 0.05 hours to approximately 10 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From approximately 0.3 hours to approximately 3 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From approximately 0.4 hours to approximately 2.5 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From about 0.5 hours to about 2 hours, for example from about 0.6 hours to about 1.8 hours, from about 0.7 hours to about 1.6 hours, from about 0.8 hours to about 1.4 hours, from about 0.9 hours to about 1.2 hours, and from about 0.9 hours to about 1.1 hours.

[0064] In some implementations, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-24h At least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 1 h*ng / mL, at least about 1.1 h*ng / mL, at least about 1.3 h*ng / mL, at least about 1.4 h*ng / mL, at least about 1.8 h*ng / mL, at least about 2.0 h*ng / mL, at least about 2.2 h*ng / mL, at least about 2.4 h*ng / mL, at least about 2.6 h*ng / mL, at least about 2.7 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-24h Within the range of approximately 0.04 h*ng / mL to approximately 10 h*ng / mL, the AUC of docetaxel in the plasma of the bladder cancer patient is [not specified]. 0-24h Within the range of approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL, the AUC of docetaxel in the plasma of the bladder cancer patient is [not specified]. 0-24h The concentration is in the range of 80% to 125% of approximately 1.2 h*ng / mL to approximately 1.7 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-24h In the range of 80% to 125% of about 2 h*ng / mL to about 2.5 h*ng / mL.

[0065] In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞At least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 0.7 h*ng / mL, at least about 1 h*ng / mL, at least about 1.5 h*ng / mL, at least about 1.8 h *ng / mL, at least about 2h*ng / mL, at least about 2.1h*ng / mL, at least about 2.6h*ng / mL, at least about 2.3h*ng / mL, at least about 2.5h*ng / mL, at least about 2.8h*ng / mL, at least about 3h*ng / mL, at least about 3.1h*ng / mL, at least about 4h*ng / mL, at least about 5h*ng / mL, at least about 7.5h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞ The concentration is in the range of 80% to 125% of approximately 0.65 h*ng / mL to approximately 8.5 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 2 h*ng / mL to approximately 4 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞ In the range of 80% to 125% of about 2 h*ng / mL to about 2.5 h*ng / mL.

[0066] In some implementations, the T-cell docetaxel in the plasma of the bladder cancer patient is... 1 / 2 From approximately 2 hours to approximately 15 hours, for example, from approximately 3 hours to approximately 11 hours, from approximately 5 hours to approximately 6.5 hours, from approximately 5 hours to approximately 6 hours, from approximately 5.5 hours to approximately 7 hours, and from approximately 5.5 hours to approximately 6.5 hours. In some embodiments, the T-value of docetaxel in the plasma of the bladder cancer patient is... 1 / 2 From approximately 3 hours to approximately 11 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... 1 / 2 Within approximately 5 to 6.5 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5.5 hours to approximately 6.5 hours.

[0067] In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml, and at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.05 mg / ml to about 0.75 mg / ml, and at least 10% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.7 mg / ml, and at least 20% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.6 mg / ml, and at least 30% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.5 mg / ml, and at least 40% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.4 mg / ml, and at least 50% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.3 mg / ml, and about 10% to about 90% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.15 mg / ml to about 0.25 mg / ml, and about 20% to about 80% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 30% to about 70% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 55% to about 65% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0068] In some embodiments, the docetaxel aqueous composition is a dispersion. In some embodiments, the docetaxel aqueous composition is a suspension. In some embodiments, the docetaxel aqueous composition is a solution. In some embodiments, the docetaxel aqueous composition is a clear aqueous solution.

[0069] In some embodiments, the docetaxel composition further includes one or more of a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, and a sugar or sugar alcohol. In some embodiments, the docetaxel composition further includes a water-soluble organic solvent. In some embodiments, the docetaxel composition further includes a pharmaceutically acceptable carrier. In some embodiments, the docetaxel composition further includes a pH adjuster.

[0070] In some embodiments, the pharmaceutically acceptable carrier is a parenteral acceptable carrier. In some embodiments, the parenteral acceptable carrier is an aqueous carrier. In some embodiments, the aqueous carrier is water for injection, physiological saline, and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline (e.g., 0.9% sodium chloride solution). In some embodiments, the aqueous carrier is a glucose solution (e.g., 5% glucose solution).

[0071] In some implementations, the pH adjuster is citric acid.

[0072] Another aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of bladder cancer patients, wherein after administration of the aqueous taxane composition to the bladder cancer patients, the AUC of taxane in the plasma of the bladder cancer patients is at least about 0.01 h*ng / mL.

[0073] In some implementations, the AUC is AUC 0-24h In some implementations, the AUC is AUC. 0-∞ .

[0074] In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24hAt least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 1 h*ng / mL, at least about 1.5 h*ng / mL, at least about 1.8 h*ng / mL, at least about 2 h*ng / mL, at least about 2.5 h*ng / mL, at least about 3 h*ng / mL, at least about 5 h*ng / mL, at least about 6.5 h*ng / mL. At least about 10 h*ng / mL, at least about 15 h*ng / mL, at least about 20 h*ng / mL, at least about 25 h*ng / mL, at least about 30 h*ng / mL, at least about 40 h*ng / mL, at least about 50 h*ng / mL, at least about 100 h*ng / mL, at least about 250 h*ng / mL, at least about 500 h*ng / mL, at least about 1000 h*ng / mL, at least about 1500 h*ng / mL, at least about 2000 h*ng / mL, at least about 3000 h*ng / mL, at least about 4500 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-24hFrom approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL (e.g., approximately 0.02 h*ng / mL to approximately 5000 h*ng / mL, approximately 0.02 h*ng / mL to approximately 2500 h*ng / mL, approximately 0.02 h*ng / mL to approximately 1000 h*ng / mL, approximately 0.02 h*ng / mL to approximately 500 h*ng / mL, approximately 0.03 h*ng / mL to approximately 400 h*ng / mL, approximately 0.04 h*ng / mL to approximately 300 h*ng / mL, approximately 0.04 h*ng / mL to approximately 100 h*ng / mL, approximately 0.04 h*ng / mL From approximately 50 h*ng / mL, approximately 0.04 h*ng / mL to approximately 40 h*ng / mL, approximately 0.04 h*ng / mL to approximately 30 h*ng / mL, approximately 0.04 h*ng / mL to approximately 20 h*ng / mL, approximately 0.04 h*ng / mL to approximately 10 h*ng / mL, approximately 0.1 h*ng / mL to approximately 50 h*ng / mL, approximately 0.1 h*ng / mL to approximately 40 h*ng / mL, approximately 0.1 h*ng / mL to approximately 30 h*ng / mL, approximately 0.1 h*ng / mL to approximately 20 h*ng / mL, approximately 0.1 h*ng / mL to approximately 10 h*ng / mL / mL, about 0.1h*ng / mL to about 9.5h*ng / mL, about 0.1h*ng / mL to about 9h*ng / mL, about 0.5h*ng / mL to about 8.5h*ng / mL, about 0.6h*ng / mL to about 8h*ng / mL, about 0.7h*ng / mL to about 7h*ng / mL, about 0.8h*ng / mL to about 6.5h*ng / mL, about 1h*ng / mL to about 6h*ng / mL, about 1.5h*ng / mL to about 5.5h*ng / mL, about 1.6h*ng / mL to about 5h*ng / mL, about 1.7h*ng / mL The concentrations of taxane in plasma from bladder cancer patients are within the range of 80% to 125% of the concentrations of approximately 4.5 h*ng / mL, approximately 1.8 h*ng / mL to approximately 4 h*ng / mL, approximately 1.9 h*ng / mL to approximately 3.5 h*ng / mL, approximately 2 h*ng / mL to approximately 3 h*ng / mL, approximately 2.5 h*ng / mL to approximately 3 h*ng / mL, approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL, approximately 1 h*ng / mL to approximately 5 h*ng / mL, approximately 1 h*ng / mL to approximately 4 h*ng / mL, approximately 1 h*ng / mL to approximately 3 h*ng / mL, and approximately 1 h*ng / mL to approximately 2 h*ng / mL. In some embodiments, the AUC of taxane in plasma from bladder cancer patients is... 0-24h Within the range of 80% to 125% of approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24hWithin the range of 80% to 125% of approximately 0.2 h*ng / mL to approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 2.5 h*ng / mL to approximately 3 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 1.2 h*ng / mL to approximately 1.7 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h In the range of 80% to 125% of approximately 1.2 h*ng / mL to approximately 3.5 h*ng / mL.

[0075] In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ At least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 0.7 h*ng / mL, at least about 1 h*ng / mL, at least about 1.5 h*ng / mL, at least about 1.8 h*ng / mL, at least about 2 h*ng / mL, at least about 2.5 h*ng / mL, at least about 3 h*ng / mL, at least about 5 h*ng / mL, at least about 7. 5 h*ng / mL, at least about 10 h*ng / mL, at least about 15 h*ng / mL, at least about 20 h*ng / mL, at least about 25 h*ng / mL, at least about 30 h*ng / mL, at least about 40 h*ng / mL, at least about 50 h*ng / mL, at least about 100 h*ng / mL, at least about 250 h*ng / mL, at least about 500 h*ng / mL, at least about 1000 h*ng / mL, at least about 1500 h*ng / mL, at least about 2000 h*ng / mL, at least about 3000 h*ng / mL, at least about 4500 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-∞From approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL (e.g., approximately 0.02 h*ng / mL to approximately 5000 h*ng / mL, approximately 0.02 h*ng / mL to approximately 2500 h*ng / mL, approximately 0.1 h*ng / mL to approximately 1000 h*ng / mL, approximately 0.2 h*ng / mL to approximately 500 h*ng / mL, approximately 0.3 h*ng / mL to approximately 400 h*ng / mL, approximately 0.4 h*ng / mL to approximately 300 h*ng / mL, approximately 0.5 h*ng / mL to approximately 100 h*ng / mL, approximately 0.6 h*ng / mL to approximately 50 h*ng / mL, approximately 0.65 h *ng / mL to about 40h*ng / mL, about 0.65h*ng / mL to about 30h*ng / mL, about 0.65h*ng / mL to about 20h*ng / mL, about 0.65h*ng / mL to about 10h*ng / mL, about 0.65h*ng / mL to about 0.85h*ng / mL, about 0.1h*ng / mL to about 40h*ng / mL, about 0.1h*ng / mL to about 30h*ng / mL, about 0.1h*ng / mL to about 20h*ng / mL, about 0.1h*ng / mL to about 10h*ng / mL, about 0.1h*ng / mL to about 9.5h*ng / mL Approximately 0.1 h*ng / mL to approximately 9 h*ng / mL, approximately 0.5 h*ng / mL to approximately 8.5 h*ng / mL, approximately 0.6 h*ng / mL to approximately 8 h*ng / mL, approximately 0.7 h*ng / mL to approximately 7 h*ng / mL, approximately 0.8 h*ng / mL to approximately 6.5 h*ng / mL, approximately 1 h*ng / mL to approximately 6 h*ng / mL, approximately 1.5 h*ng / mL to approximately 5.5 h*ng / mL, approximately 1.6 h*ng / mL to approximately 5 h*ng / mL, approximately 1.7 h*ng / mL to approximately 4.5 h*ng / mL, approximately 1.8 h*ng / mL to approximately 4 h*ng / mL, approximately 1.9 h*ng / mL. The AUC of taxane in the plasma of bladder cancer patients is in the range of 80% to 125% of the values ​​of approximately 2 h*ng / mL to approximately 3.5 h*ng / mL, approximately 2 h*ng / mL to approximately 3.5 h*ng / mL, approximately 2 h*ng / mL to approximately 4 h*ng / mL, approximately 1 h*ng / mL to approximately 5 h*ng / mL, approximately 1 h*ng / mL to approximately 4.5 h*ng / mL, approximately 1 h*ng / mL to approximately 4 h*ng / mL, approximately 1.5 h*ng / mL to approximately 3.5 h*ng / mL, approximately 1.5 h*ng / mL to approximately 3 h*ng / mL, and approximately 2 h*ng / mL to approximately 2.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-∞Within the range of 80% to 125% of approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 0.2 h*ng / mL to approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 0.65 h*ng / mL to approximately 8.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 2 h*ng / mL to approximately 4 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ In the range of 80% to 125% of about 2 h*ng / mL to about 2.5 h*ng / mL.

[0076] In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.02 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.03 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.05 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.15 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.25 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.3 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.35 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.45 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.54 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.55 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.65 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.75 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 10 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 100 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 200 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 300 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 500 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 400 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 300 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 200 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 100 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.03 ng / ml to about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 20 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.05 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.04 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.12 ng / ml to about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.14 ng / ml to about 0.3 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.16 ng / ml to about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 1 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.5 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.7 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.09 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.8 ng / ml.

[0077] In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.02 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.04 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.06 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.08 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.1 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.2 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.3 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.35 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.4 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.45 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.5 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.75 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 1 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... maxAt least approximately 10 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 15 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 20 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 50 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 100 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least approximately 150 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 200 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 300 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... maxFrom about 0.02 ng / ml to about 500 ng / ml (e.g., about 0.02 ng / ml to about 400 ng / ml, about 0.02 ng / ml to about 300 ng / ml, about 0.02 ng / ml to about 200 ng / ml, about 0.02 ng / ml to about 100 ng / ml, about 0.02 ng / ml to about 50 ng / ml, about 0.02 ng / ml to about 40 ng / ml, about 0.02 ng / ml to about 30 ng / ml, about 0.02 ng / ml to about 20 ng / ml, about 0. 0.02 ng / ml to about 10 ng / ml, about 0.02 ng / ml to about 5 ng / ml, about 0.02 ng / ml to about 0.8 ng / ml, about 0.05 ng / ml to about 0.9 ng / ml, about 0.1 ng / ml to about 0.8 ng / ml, about 0.15 ng / ml to about 0.75 ng / ml, about 0.2 ng / ml to about 0.7 ng / ml, about 0.25 ng / ml to about 0.65 ng / ml, about 0.3 ng / ml to about 0.6 ng / ml, about 0.3 ng / ml From about 0.55 ng / ml, from about 0.3 ng / ml to about 0.5 ng / ml, from about 0.3 ng / ml to about 0.45 ng / ml, from about 0.3 ng / ml to about 0.4 ng / ml, from about 0.25 ng / ml to about 0.6 ng / ml, from about 0.25 ng / ml to about 0.55 ng / ml, from about 0.25 ng / ml to about 0.5 ng / ml, from about 0.25 ng / ml to about 0.45 ng / ml, from about 0.25 ng / ml to about 0.4 ng / ml, from about 0.2 ng / ml to about The concentrations of taxane in the plasma of bladder cancer patients range from 80% to 125% of the concentrations of 0.65 ng / ml, about 0.2 ng / ml to about 0.6 ng / ml, about 0.2 ng / ml to about 0.55 ng / ml, about 0.2 ng / ml to about 0.5 ng / ml, about 0.2 ng / ml to about 0.45 ng / ml, about 0.2 ng / ml to about 0.4 ng / ml, about 0.15 ng / ml to about 0.45 ng / ml, about 0.15 ng / ml to about 0.35 ng / ml, and about 0.15 ng / ml to about 0.3 ng / ml. In some embodiments, the C60 of taxane in the plasma of bladder cancer patients is... max Within the range of 80% to 125% of about 0.02 ng / ml to about 50 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max Within the range of 80% to 125% of about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... maxWithin the range of 80% to 125% of about 0.05 ng / ml to about 0.8 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max Within the range of 80% to 125% of about 0.3 ng / ml to about 0.4 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max In the range of 80% to 125% of about 0.15 ng / ml to about 0.3 ng / ml.

[0078] In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... max From approximately 0.05 hours to approximately 10 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.1 hours to approximately 5 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.2 hours to approximately 4 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.3 hours to approximately 3 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.4 hours to approximately 2.1 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From about 0.5 hours to about 2 hours, for example from about 0.6 hours to about 1.8 hours, from about 0.7 hours to about 1.6 hours, from about 0.8 hours to about 1.4 hours, from about 0.9 hours to about 1.2 hours, and from about 0.9 hours to about 1.1 hours.

[0079] In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... 1 / 2 From about 0.1 hours to about 50 hours, for example, from about 0.5 hours to about 40 hours, from about 0.7 hours to about 30 hours, from about 0.8 hours to about 20 hours, from about 1 hour to about 15 hours, from about 1.2 hours to about 13 hours, from about 1.5 hours to about 10 hours, from about 2 hours to about 9.5 hours, from about 2.5 hours to about 8.5 hours, from about 3 hours to about 8 hours, from about 2.5 hours to about 7.5 hours, from about 3 hours to about 7 hours, from about 3.5 hours to about 6.5 hours, from about 4 hours to about 6 hours, from about 4.5 hours to about 6 hours, from about 5 hours to about 6 hours, from about 5.5 hours to about 6 hours, from about 5 hours to about 6.5 hours, from about 5.5 hours to about 6.5 hours, from about 4 hours to about 6.5 hours, from about 4.5 hours to about 6.5 hours. In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 2 hours to approximately 9 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2From approximately 2.2 hours to approximately 8.8 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5.5 hours to approximately 6 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5 hours to approximately 6.5 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5.5 hours to approximately 6.5 hours.

[0080] In some implementations, the bladder cancer patient is a single individual. In some implementations, the bladder cancer patient is multiple individuals (e.g., 2-1000, 2-500, 2-400, 2-300, 2-150, 2-100, 2-50, 25, 20, 6, etc.). When the bladder cancer patient is multiple individuals, the C described in this application... max AUC 0-24h AUC 0-∞ T 1 / 2 The T is the average value. max This is the median value.

[0081] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0082] In some embodiments, at least about 5% of the taxane in the aqueous taxane composition is free taxane, for example, at least about 7%, at least about 10%, at least about 15%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, or at least about 90% is free taxane. In some embodiments, about 10% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 55% to about 65% of the taxane in the aqueous taxane composition is free taxane.

[0083] In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.01 mg / ml to about 0.8 mg / ml, for example, from about 0.01 mg / ml to about 0.75 mg / ml, from about 0.02 mg / ml to about 0.7 mg / ml, from about 0.03 mg / ml to about 0.65 mg / ml, from about 0.04 mg / ml to about 0.6 mg / ml, from about 0.05 mg / ml to about 0.55 mg / ml, from about 0.06 mg / ml to about 0.5 mg / ml, from about 0.07 mg / ml to about 0.45 mg / ml. ml, about 0.08 mg / ml to about 0.4 mg / ml, about 0.09 mg / ml to about 0.35 mg / ml, about 0.1 mg / ml to about 0.3 mg / ml, about 0.2 mg / ml to about 0.25 mg / ml, about 0.05 mg / ml, about 0.1 mg / ml, about 0.15 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.5 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml, about 0.55 mg / ml.

[0084] In some embodiments, the taxane composition further includes albumin. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 20%, from about 0.005% to about 10%, from about 0.01% to about 20%, from about 0.1% to about 15%, from about 0.5% to about 12%, from about 1% to about 10%, from about 2% to about 8%, from about 3% to about 7%, from about 4% to about 6%, from about 4.5% to about 5.5%, or about 5%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is from about 4% to about 6%. In some embodiments, the concentration (w / v%) of albumin in the aqueous taxane composition is about 5%.

[0085] In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 300:1, from about 1:5 to about 900:1, from about 1:1 to about 800:1, from about 5:1 to about 700:1, from about 10:1 to about 600:1, from about 20:1 to about 500:1, from about 30:1 to about 400:1. The weight ratios of albumin to taxane in the taxane composition are approximately 40:1 to approximately 300:1, approximately 50:1 to approximately 200:1, approximately 60:1 to approximately 150:1, approximately 70:1 to approximately 150:1, approximately 80:1 to approximately 150:1, approximately 90:1 to approximately 150:1, approximately 100:1 to approximately 160:1, approximately 120:1 to approximately 150:1, approximately 130:1 to approximately 155:1, approximately 135:1 to approximately 150:1, and approximately 140:1 to approximately 145:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 130:1 to approximately 155:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is approximately 140:1 to approximately 145:1.

[0086] In some embodiments, the albumin is serum albumin. In some embodiments, the albumin is human serum albumin. In some embodiments, the human serum albumin is natural human serum albumin or recombinant human serum albumin.

[0087] In some embodiments, the human serum albumin is derived from lyophilized human serum albumin powder or a human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the concentration (w / v%) of the human serum albumin solution is 5%, 10%, 20%, or 25%.

[0088] In some embodiments, the taxane aqueous composition is a dispersion. In some embodiments, the taxane aqueous composition is a suspension. In some embodiments, the taxane aqueous composition is a solution.

[0089] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 2 mg to about 150 mg, from about 3 mg to about 120 mg, from about 4 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 15 mg to about 20 mg, from about 12.5 mg to about 22.5 mg, from about 10 mg to about 25 mg, from about 7.5 mg to about 37.5 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg.

[0090] In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.02 mg / mL to about 9 mg / mL, from about 0.05 mg / mL to about 8 mg / mL, from about 0.1 mg / mL to about 7 mg / mL, from about 0.15 mg / mL to about 6 mg / mL, from about 0.2 mg / mL to about 5 mg / mL, from about 0.25 mg / mL to about 4 mg / mL, from about 0.3 mg / mL to about 3 mg / mL, from about 0.32 mg / mL to about 2 mg / mL, from about 0.33 mg / mL to about 1 mg / mL, or from about 0.34 mg / mL to about 0.5 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is from about 0.33 mg / mL to about 0.37 mg / mL. In some embodiments, the concentration of taxane in the aqueous taxane composition is about 0.35 mg / mL.

[0091] In some embodiments, the pH value of the taxane aqueous composition is from about 2 to about 9, for example, from about 2 to about 8.5, from about 2 to about 7, from about 2 to about 6, from about 2.5 to about 8, from about 3 to about 7.5, from about 3.5 to about 7, from about 5 to about 7, from about 6 to about 8, or from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is from about 6.5 to about 7.5. In some embodiments, the pH value of the taxane aqueous composition is about 7.

[0092] In some embodiments, the taxane composition is a docetaxel composition. In some embodiments, the docetaxel composition comprises docetaxel, the docetaxel composition is an aqueous docetaxel composition, the aqueous docetaxel composition is used for the treatment of bladder cancer patients by bladder instillation, and after administration of the aqueous docetaxel composition to the bladder cancer patients, the AUC of docetaxel in the plasma of the bladder cancer patients is at least about 0.01 h*ng / mL.

[0093] In some implementations, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-24h At least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 1 h*ng / mL, at least about 1.1 h*ng / mL, at least about 1.3 h*ng / mL, at least about 1.4 h*ng / mL, at least about 1.8 h*ng / mL, at least about 2.0 h*ng / mL, at least about 2.2 h*ng / mL, at least about 2.4 h*ng / mL, at least about 2.6 h*ng / mL, at least about 2.7 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-24h Within the range of approximately 0.04 h*ng / mL to approximately 10 h*ng / mL, the AUC of docetaxel in the plasma of the bladder cancer patient is [not specified]. 0-24h Within the range of approximately 2.5 h*ng / mL to approximately 3.5 h*ng / mL, the AUC of docetaxel in the plasma of the bladder cancer patient is [not specified]. 0-24h The concentration is in the range of 80% to 125% of approximately 1.2 h*ng / mL to approximately 1.7 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-24h In the range of 80% to 125% of about 2 h*ng / mL to about 2.5 h*ng / mL.

[0094] In some implementations, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞At least about 0.01 h*ng / mL, for example, at least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.05 h*ng / mL, at least about 0.08 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 0.7 h*ng / mL, at least about 1 h*ng / mL, at least about 1.5 h*ng / mL, at least about 1.8 h *ng / mL, at least about 2h*ng / mL, at least about 2.1h*ng / mL, at least about 2.6h*ng / mL, at least about 2.3h*ng / mL, at least about 2.5h*ng / mL, at least about 2.8h*ng / mL, at least about 3h*ng / mL, at least about 3.1h*ng / mL, at least about 4h*ng / mL, at least about 5h*ng / mL, at least about 7.5h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞ The concentration is in the range of 80% to 125% of approximately 0.65 h*ng / mL to approximately 8.5 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞ Within the range of 80% to 125% of approximately 2 h*ng / mL to approximately 4 h*ng / mL. In some embodiments, the AUC of docetaxel in the plasma of the bladder cancer patient is... 0-∞ In the range of 80% to 125% of about 2 h*ng / mL to about 2.5 h*ng / mL.

[0095] In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.02 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.05 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.1 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.2 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.3 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.4 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.5 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.6 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is at least about 0.7 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.05 ng / ml to about 0.7 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 0.6 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.2 ng / ml to about 0.5 ng / ml. In some embodiments, the concentration of docetaxel in the plasma of the bladder cancer patient is from about 0.25 ng / ml to about 0.45 ng / ml.

[0096] In some embodiments, the C-level of docetaxel in the plasma of the bladder cancer patient is... max At least approximately 0.02 ng / ml. In some embodiments, the C-level of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.05 ng / ml. In some embodiments, the C-level of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.1 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.2 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.25 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. maxAt least approximately 0.3 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.35 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.5 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max At least approximately 0.7 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max The concentration is approximately 0.02 ng / ml to approximately 0.8 ng / ml. In some embodiments, the C-level concentration of docetaxel in the plasma of the bladder cancer patient is [not specified]. max The concentration is approximately 0.2 ng / ml to approximately 0.5 ng / ml. In some embodiments, the C60 of docetaxel in the plasma of the bladder cancer patient is [not specified]. max The concentration is approximately 0.2 ng / ml to approximately 0.4 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max Within the range of 80% to 125% of approximately 0.3 ng / ml to approximately 0.4 ng / ml. In some embodiments, the C-value of docetaxel in the plasma of the bladder cancer patient is [not specified]. max In the range of 80% to 125% of about 0.15 ng / ml to about 0.3 ng / ml.

[0097] In some implementations, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From approximately 0.05 hours to approximately 10 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From approximately 0.3 hours to approximately 3 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From approximately 0.4 hours to approximately 2.5 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... max From about 0.5 hours to about 2 hours, for example from about 0.6 hours to about 1.8 hours, from about 0.7 hours to about 1.6 hours, from about 0.8 hours to about 1.4 hours, from about 0.9 hours to about 1.2 hours, and from about 0.9 hours to about 1.1 hours.

[0098] In some implementations, the T-cell docetaxel in the plasma of the bladder cancer patient is... 1 / 2 From approximately 2 hours to approximately 15 hours, for example, from approximately 3 hours to approximately 11 hours, from approximately 5 hours to approximately 6.5 hours, from approximately 5 hours to approximately 6 hours, from approximately 5.5 hours to approximately 7 hours, and from approximately 5.5 hours to approximately 6.5 hours. In some embodiments, the T-value of docetaxel in the plasma of the bladder cancer patient is... 1 / 2From approximately 3 hours to approximately 11 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... 1 / 2 Within approximately 5 to 6.5 hours. In some embodiments, the T-cell docetaxel in the plasma of the bladder cancer patient is... 1 / 2 From approximately 5.5 hours to approximately 6.5 hours.

[0099] In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml, and at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.05 mg / ml to about 0.75 mg / ml, and at least 10% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.7 mg / ml, and at least 20% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.6 mg / ml, and at least 30% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.5 mg / ml, and at least 40% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.4 mg / ml, and at least 50% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.3 mg / ml, and about 10% to about 90% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.15 mg / ml to about 0.25 mg / ml, and about 20% to about 80% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 30% to about 70% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 55% to about 65% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0100] In some embodiments, the docetaxel aqueous composition is a dispersion. In some embodiments, the docetaxel aqueous composition is a suspension. In some embodiments, the docetaxel aqueous composition is a solution. In some embodiments, the docetaxel aqueous composition is a clear aqueous solution.

[0101] In some embodiments, the docetaxel composition further includes one or more of a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, and a sugar or sugar alcohol. In some embodiments, the docetaxel composition further includes a water-soluble organic solvent. In some embodiments, the docetaxel composition further includes a pharmaceutically acceptable carrier. In some embodiments, the docetaxel composition further includes a pH adjuster.

[0102] In some embodiments, the pharmaceutically acceptable carrier is a parenteral acceptable carrier. In some embodiments, the parenteral acceptable carrier is an aqueous carrier. In some embodiments, the aqueous carrier is water for injection, physiological saline, and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline (e.g., 0.9% sodium chloride solution). In some embodiments, the aqueous carrier is a glucose solution (e.g., 5% glucose solution).

[0103] In some implementations, the pH adjuster is citric acid.

[0104] Another aspect of this application provides a method for preparing any taxane aqueous composition (such as a docetaxel aqueous composition) described in this application.

[0105] In some embodiments, the preparation method includes mixing a first liquid composition containing taxane (such as docetaxel) and a second liquid composition containing albumin to obtain an aqueous taxane composition (such as an aqueous docetaxel composition).

[0106] In some embodiments, the first liquid composition further includes ethanol. In some embodiments, the ethanol is anhydrous ethanol.

[0107] In some embodiments, the preparation method includes the following steps:

[0108] (i) Obtaining a first liquid composition comprising taxane (such as docetaxel) and ethanol;

[0109] (ii) Obtaining a second aqueous composition comprising human serum albumin in a pharmaceutically acceptable carrier;

[0110] (iii) The first liquid composition and the second aqueous composition are mixed to obtain an aqueous taxane composition (such as a docetaxel aqueous composition) comprising taxane (such as docetaxel), human serum albumin and ethanol.

[0111] In some embodiments, the docetaxel aqueous composition described in this application can be prepared according to the method described in WO2021158632A1.

[0112] In some embodiments, the amount of taxane (such as docetaxel) in the first liquid composition is from about 1 mg to about 500 mg, for example, from about 5 mg to about 400 mg, from about 5 mg to about 350 mg, from about 10 mg to about 300 mg, from about 15 mg to about 250 mg, from about 20 mg to about 200 mg, from about 20 mg to about 150 mg, from about 20 mg to about 100 mg, from about 20 mg to about 50 mg, from about 20 mg to about 30 mg, or from about 25 mg. In some embodiments, the amount of taxane (such as docetaxel) in the first liquid composition is from about 20 mg to about 30 mg. In some embodiments, the amount of taxane (such as docetaxel) in the first liquid composition is about 25 mg.

[0113] In some embodiments, the concentration of taxane (such as docetaxel) in the first liquid composition is from about 0.01 mg / ml to about 500 mg / ml, for example, from about 0.05 mg / ml to about 450 mg / ml, from about 0.1 mg / ml to about 400 mg / ml, from about 0.3 mg / ml to about 300 mg / ml, from about 0.5 mg / ml to about 200 mg / ml, from about 0.5 mg / ml to about 250 mg / ml, from about 1 mg / ml to about 100 mg / ml, from about 1 mg / ml to about 90 mg / ml, from about 2 mg / ml to about 80 mg / ml, from about 3 mg / ml to about 70 mg / ml, from about 5 mg / ml to about 60 mg / ml, from about 7 mg / ml to about 50 mg / ml, from about 8 mg / ml to about 40 mg / ml, from about 9 mg / ml to about 30 mg / ml, from about 5 mg / ml to about 15 mg / ml. In some embodiments, the concentration of taxane (such as docetaxel) in the first liquid composition is from about 5 mg / ml to about 15 mg / ml. In some embodiments, the concentration of taxane (such as docetaxel) in the first liquid composition is about 10 mg / ml.

[0114] In some embodiments, the first liquid composition further includes an acid. In some embodiments, the acid is an organic acid. In some embodiments, the organic acid is one or more selected from citric acid, acetic acid, formic acid, ascorbic acid, benzoic acid, tartaric acid, lactic acid, maleic acid, and succinic acid. In some embodiments, the organic acid is citric acid. In some embodiments, the citric acid is anhydrous citric acid.

[0115] In some embodiments, the pH value of the first liquid composition is from about 2 to about 9, for example, from about 2 to about 8, from about 2.5 to about 7.5, from about 3 to about 7, from about 3.5 to about 6.5, from about 3.5 to about 5, or from about 3.5 to about 4.5. In some embodiments, the pH value of the first liquid composition is from about 3.5 to about 4.5. To determine the pH value of the first liquid composition, the first liquid composition is mixed with water at a ratio of 3:2 (v / v) to obtain an aqueous solution, and then the pH value of the aqueous solution is measured.

[0116] In some embodiments, the concentration (w / v%) of albumin in the second liquid composition is from about 0.001% to about 25%, for example, from about 0.01% to about 20%, from about 0.1% to about 15%, from about 0.5% to about 10%, from about 1% to about 8%, from about 2% to about 7%, from about 3% to about 6.5%, from about 3.5% to about 6%, or from about 4% to about 6%. In some embodiments, the concentration (w / v%) of albumin in the second liquid composition is from about 4% to about 6%.

[0117] In some embodiments, the second liquid composition is a second aqueous composition.

[0118] In some embodiments, the second liquid composition is a human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the concentration (w / v%) of human serum albumin in the human serum albumin solution is from 1% to about 40%, for example, about 5%, about 10%, about 15%, about 20%, or about 25%.

[0119] In some embodiments, the second aqueous composition is obtained by mixing a human serum albumin solution with a pharmaceutically acceptable carrier.

[0120] In some embodiments, the pharmaceutically acceptable carrier is one or more of water for injection, physiological saline, or glucose solution. In some embodiments, the pharmaceutically acceptable carrier is physiological saline or glucose solution. In some embodiments, the pharmaceutically acceptable carrier is physiological saline. In some embodiments, the pharmaceutically acceptable carrier is glucose solution.

[0121] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0122] In some embodiments, prior to infusing or administering the drug to an individual, a first liquid composition comprising taxane (such as docetaxel) and ethanol is mixed with a second aqueous composition comprising human serum albumin to prepare an aqueous taxane composition (such as an aqueous docetaxel composition).

[0123] In some embodiments, the preparation method includes reconstructing a taxane solid composition (such as a docetaxel solid composition) in a pharmaceutically acceptable carrier.

[0124] In some embodiments, the taxane solid composition is a taxane lyophilized powder. In some embodiments, the docetaxel solid composition is a docetaxel lyophilized powder.

[0125] In some embodiments, the preparation of the taxane lyophilized powder (such as docetaxel lyophilized powder) includes the following steps: (i) obtaining an organic solution of taxane (such as docetaxel) in a polar water-miscible organic solvent; (ii) obtaining an aqueous solution 1 of human serum albumin; (iii) mixing the organic solution of taxane with the aqueous solution 1 of human serum albumin to obtain an aqueous solution 2; and (iv) removing the solvent to obtain a lyophilized powder containing taxane (such as docetaxel) and human serum albumin.

[0126] In some embodiments, the docetaxel lyophilized powder can be prepared according to the method described in WO2016187147A1.

[0127] In some embodiments, the taxane aqueous composition (such as docetaxel aqueous composition) is prepared within 24 hours prior to administration to the patient.

[0128] In some embodiments, the taxane aqueous composition is a docetaxel aqueous composition. In some embodiments, the taxane lyophilized powder is a docetaxel lyophilized powder. In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0129] Another aspect of this application provides the use of any of the compositions described herein in the preparation of a medicament for the treatment of bladder cancer via bladder instillation.

[0130] In some embodiments, the use of any of the docetaxel compositions described in this application is provided in the preparation of a medicament for the treatment of bladder cancer via bladder instillation.

[0131] In some embodiments, use is provided in the preparation of a medicament for the treatment of bladder cancer by bladder instillation, in combination with other antitumor drugs, of any docetaxel composition described in this application.

[0132] In some embodiments, the bladder cancer is non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is low-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is intermediate-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is low-grade (LG). In some embodiments, the bladder cancer is high-grade (HG). In some embodiments, the bladder cancer is G1. In some embodiments, the bladder cancer is G2. In some embodiments, the bladder cancer is G3. In some embodiments, the bladder cancer is stage CIS. In some embodiments, the bladder cancer is stage Ta. In some embodiments, the bladder cancer is stage T1. In some embodiments, the bladder cancer is non-muscle-invasive bladder cancer that has failed BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that has failed BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is refractory to BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is resistant to BCG. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that has recurred after BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is unresponsive to BCG. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is intolerant to BCG. In some embodiments, the bladder cancer is high-grade non-muscle-invasive bladder cancer that has failed standard intravesical instillation (intravesical) therapy. In some embodiments, the bladder cancer is carcinoma in situ. In some embodiments, the bladder cancer is bladder urothelial carcinoma.

[0133] In some embodiments, the other antitumor drugs are one or more of gemcitabine, mitomycin, epirubicin, BCG, and pembrolizumab. In some embodiments, the other antitumor drugs are administered via bladder instillation or intravenous administration. In some embodiments, gemcitabine, mitomycin, epirubicin, or BCG are administered via bladder instillation. In some embodiments, pembrolizumab is administered intravenously. In some embodiments, the intravenous administration is an intravenous infusion.

[0134] In some embodiments, the combined administration includes administration separately, sequentially, or simultaneously. In some embodiments, the combined administration is simultaneous administration. In some embodiments, the combined administration is administration separately. In some embodiments, the combined administration is administration sequentially.

[0135] In some implementations, the other antitumor drug mentioned is gemcitabine.

[0136] In some embodiments, the individual with said bladder cancer (bladder cancer individual) is a person. In some embodiments, said individual has undergone tumor resection surgery. In some embodiments, said individual has not undergone tumor resection surgery. In some embodiments, said individual is in the clinical stage of Ta, Tis, or T1 bladder cancer.

[0137] In some embodiments, the medicament for treating bladder cancer via bladder instillation comprises the taxane composition described in this application (such as the docetaxel composition), wherein the unit dose of taxane (such as docetaxel) is about 1 mg to about 500 mg, for example, about 1 mg to about 450 mg, about 1 mg to about 400 mg, about 1 mg to about 350 mg, about 1 mg to about 300 mg, about 1 mg to about 200 mg, about 1 mg to about 100 mg, about 1 mg to about 80 mg, about 3.5 mg to about 60 mg, about 7 mg to about 40 mg, about 8.5 mg to about 30 mg, about 10.5 mg to about 25 mg, about 14 mg to about 20 mg, or about 17.5 mg. In some embodiments, the medicament for treating bladder cancer via bladder instillation comprises the taxane composition described in this application (such as the docetaxel composition), wherein the unit dose of taxane (such as docetaxel) is about 17.5 mg.

[0138] In some implementations, the bladder instillation is intravesical administration.

[0139] In some implementations, the administration is performed via injection into the upper urinary tract.

[0140] In some embodiments, the administration is performed after tumor resection is visible in the bladder.

[0141] In some embodiments, the intravesical administration is an immediate single bladder instillation within 24 hours after transurethral resection of bladder tumor (TURBt) (e.g., within 20 hours, 16 hours, 14 hours, 12 hours, 10 hours, 8 hours, or 6 hours). In some embodiments, the intravesical administration is a maintenance bladder instillation after TURBt.

[0142] In some embodiments, each administration cycle of the taxane composition is at least 1-180 days or 1 month, for example, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days, 21 days, 28 days, 29 days, 30 days, 31 days, 1 month, 35 days, 42 days, at least 1 day, at least 7 days, or at least 1 month. In some embodiments, the taxane composition is repeated for the patient in a new cycle every 1 to 6 weeks (e.g., 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). In some embodiments, the bladder instillation includes an induction therapy period and a maintenance therapy period. In some embodiments, after the completion of the induction therapy period, patients with bladder cancer who achieve complete remission or no recurrence based on efficacy evaluation enter the maintenance therapy period. In some embodiments, the induction therapy period is administered 4-8 times (e.g., 4, 5, 6, 7, 8 times), repeated in a new cycle every 1 week. In some implementations, the maintenance treatment is administered 6 to 25 times (e.g., 6, 8, 10, 12, 14, 16, 18, 20, 22, 25 times), repeated monthly or in a new cycle of 3 to 6 weeks (e.g., 3, 4, 5, 6 weeks).

[0143] In some embodiments, the dosage of the taxane (such as docetaxel) is about 1 to about 500 mg per dose, for example, about 1 to about 400 mg per dose, about 1 to about 300 mg per dose, about 1 to about 200 mg per dose, about 1 to about 100 mg per dose, about 5 to about 90 mg per dose, about 7.5 to about 80 mg per dose, about 10 to about 75 mg per dose, about 12.5 to about 70 mg per dose, about 15.5 to about 65 mg per dose, about 17.5 to about 60 mg per dose, about 20 to about 55 mg per dose, about 22.5 to about 50 mg per dose, about 25 to about 45 mg per dose, about 27.5 to about 40 mg per dose, about 10 mg per dose, about 12.5 mg per dose, about 15 mg per dose, about 17.5 mg per dose, and about 20 mg per dose. In some implementations, the dosage of the taxane (such as docetaxel) is approximately 17.5 mg per dose.

[0144] In some embodiments, the unit dose of docetaxel is from about 1 mg to about 500 mg, for example, from about 1 mg to about 450 mg, from about 1 mg to about 400 mg, from about 1 mg to about 350 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 1 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 20 mg to about 55 mg, from about 22.5 mg to about 50 mg, from about 25 mg to about 45 mg, from about 27.5 mg to about 40 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg. In some embodiments, the unit dose of docetaxel is about 17.5 mg.

[0145] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0146] Another aspect of this application provides the use of any of the compositions described herein for the treatment of bladder cancer via bladder instillation.

[0147] In some embodiments, the use of any docetaxel composition described in this application for the treatment of bladder cancer via bladder instillation is provided.

[0148] In some embodiments, the use of any docetaxel composition described in this application, administered in combination with other antitumor drugs, for the treatment of bladder cancer via bladder instillation is provided.

[0149] In some embodiments, the bladder cancer is non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is low-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is intermediate-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is low-grade (LG). In some embodiments, the bladder cancer is high-grade (HG). In some embodiments, the bladder cancer is G1. In some embodiments, the bladder cancer is G2. In some embodiments, the bladder cancer is G3. In some embodiments, the bladder cancer is stage CIS. In some embodiments, the bladder cancer is stage Ta. In some embodiments, the bladder cancer is stage T1. In some embodiments, the bladder cancer is non-muscle-invasive bladder cancer that has failed BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that has failed BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is refractory to BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is resistant to BCG. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that has recurred after BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is unresponsive to BCG. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is intolerant to BCG. In some embodiments, the bladder cancer is high-grade non-muscle-invasive bladder cancer that has failed standard intravesical instillation (intravesical) therapy. In some embodiments, the bladder cancer is carcinoma in situ. In some embodiments, the bladder cancer is bladder urothelial carcinoma.

[0150] In some embodiments, the other antitumor drugs are one or more of gemcitabine, mitomycin, epirubicin, BCG, and pembrolizumab. In some embodiments, the other antitumor drugs are administered via bladder instillation or intravenous administration. In some embodiments, gemcitabine, mitomycin, epirubicin, or BCG are administered via bladder instillation. In some embodiments, pembrolizumab is administered intravenously. In some embodiments, the intravenous administration is an intravenous infusion.

[0151] In some embodiments, the combined administration includes administration separately, sequentially, or simultaneously. In some embodiments, the combined administration is simultaneous administration. In some embodiments, the combined administration is administration separately. In some embodiments, the combined administration is administration sequentially.

[0152] In some implementations, the other antitumor drug mentioned is gemcitabine.

[0153] In some embodiments, the individual with said bladder cancer (bladder cancer individual) is a person. In some embodiments, said individual has undergone tumor resection surgery. In some embodiments, said individual has not undergone tumor resection surgery. In some embodiments, said individual is in the clinical stage of Ta, Tis, or T1 bladder cancer.

[0154] In some embodiments, the composition comprises the taxane composition (such as the docetaxel composition) described in this application, wherein the unit dose of taxane (such as docetaxel) is about 1 mg to about 500 mg, for example, about 1 mg to about 450 mg, about 1 mg to about 400 mg, about 1 mg to about 350 mg, about 1 mg to about 300 mg, about 1 mg to about 200 mg, about 1 mg to about 100 mg, about 1 mg to about 80 mg, about 3.5 mg to about 60 mg, about 7 mg to about 40 mg, about 8.5 mg to about 30 mg, about 10.5 mg to about 25 mg, about 14 mg to about 20 mg, or about 17.5 mg. In some embodiments, the composition comprises the taxane composition (such as the docetaxel composition) described in this application, wherein the unit dose of taxane (such as docetaxel) is about 17.5 mg.

[0155] In some implementations, the bladder instillation is intravesical administration.

[0156] In some implementations, the administration is performed via injection into the upper urinary tract.

[0157] In some embodiments, the administration is performed after tumor resection is visible in the bladder.

[0158] In some embodiments, the intravesical administration is an immediate single bladder instillation within 24 hours after transurethral resection of bladder tumor (TURBt) (e.g., within 20 hours, 16 hours, 14 hours, 12 hours, 10 hours, 8 hours, or 6 hours). In some embodiments, the intravesical administration is a maintenance bladder instillation after TURBt.

[0159] In some embodiments, each administration cycle of the taxane composition is at least 1-180 days or 1 month, for example, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days, 21 days, 28 days, 29 days, 30 days, 31 days, 1 month, 35 days, 42 days, at least 1 day, at least 7 days, or at least 1 month. In some embodiments, the taxane composition is repeated for the patient in a new cycle every 1 to 6 weeks (e.g., 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). In some embodiments, the bladder instillation includes an induction therapy period and a maintenance therapy period. In some embodiments, after the completion of the induction therapy period, patients with bladder cancer who achieve complete remission or no recurrence based on efficacy evaluation enter the maintenance therapy period. In some embodiments, the induction therapy period is administered 4-8 times (e.g., 4, 5, 6, 7, 8 times), repeated in a new cycle every 1 week. In some implementations, the maintenance treatment is administered 6 to 25 times (e.g., 6, 8, 10, 12, 14, 16, 18, 20, 22, 25 times), repeated monthly or in a new cycle of 3 to 6 weeks (e.g., 3, 4, 5, 6 weeks).

[0160] In some embodiments, the dosage of the taxane (such as docetaxel) is about 1 to about 500 mg per dose, for example, about 1 to about 400 mg per dose, about 1 to about 300 mg per dose, about 1 to about 200 mg per dose, about 1 to about 100 mg per dose, about 5 to about 90 mg per dose, about 7.5 to about 80 mg per dose, about 10 to about 75 mg per dose, about 12.5 to about 70 mg per dose, about 15.5 to about 65 mg per dose, about 17.5 to about 60 mg per dose, about 20 to about 55 mg per dose, about 22.5 to about 50 mg per dose, about 25 to about 45 mg per dose, about 27.5 to about 40 mg per dose, about 10 mg per dose, about 12.5 mg per dose, about 15 mg per dose, about 17.5 mg per dose, and about 20 mg per dose. In some implementations, the dosage of the taxane (such as docetaxel) is approximately 17.5 mg per dose.

[0161] In some embodiments, the unit dose of docetaxel is from about 1 mg to about 500 mg, for example, from about 1 mg to about 450 mg, from about 1 mg to about 400 mg, from about 1 mg to about 350 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 1 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 20 mg to about 55 mg, from about 22.5 mg to about 50 mg, from about 25 mg to about 45 mg, from about 27.5 mg to about 40 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg. In some embodiments, the unit dose of docetaxel is about 17.5 mg.

[0162] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0163] Another aspect of this application provides a method for treating an individual (e.g., a person) with bladder cancer via bladder instillation, the method comprising administering a therapeutic amount of any of the compositions described in this application to the individual with bladder cancer.

[0164] In some embodiments, the composition is a taxane composition or a docetaxel composition. In some embodiments, the docetaxel composition is an aqueous docetaxel composition.

[0165] In some embodiments, the bladder cancer is non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is low-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is intermediate-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer. In some embodiments, the bladder cancer is low-grade (LG). In some embodiments, the bladder cancer is high-grade (HG). In some embodiments, the bladder cancer is G1. In some embodiments, the bladder cancer is G2. In some embodiments, the bladder cancer is G3. In some embodiments, the bladder cancer is stage CIS. In some embodiments, the bladder cancer is stage Ta. In some embodiments, the bladder cancer is stage T1. In some embodiments, the bladder cancer is non-muscle-invasive bladder cancer that has failed BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that has failed BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is refractory to BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is resistant to BCG. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that has recurred after BCG treatment. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is unresponsive to BCG. In some embodiments, the bladder cancer is high-risk non-muscle-invasive bladder cancer that is intolerant to BCG. In some embodiments, the bladder cancer is high-grade non-muscle-invasive bladder cancer that has failed standard intravesical instillation (intravesical) therapy. In some embodiments, the bladder cancer is carcinoma in situ. In some embodiments, the bladder cancer is bladder urothelial carcinoma.

[0166] In some embodiments, the treatment method involves administering only taxanes (such as docetaxel) without other antitumor drugs. In some embodiments, the method further includes administering a therapeutic dose of other antitumor drugs to the individual. In some embodiments, the other antitumor drugs are one or more of gemcitabine, mitomycin, epirubicin, BCG, and pembrolizumab. In some embodiments, the other antitumor drug is gemcitabine. In some embodiments, the other antitumor drugs are administered via bladder instillation or intravenously. In some embodiments, gemcitabine, mitomycin, epirubicin, or BCG are administered via bladder instillation. In some embodiments, pembrolizumab is administered intravenously. In some embodiments, the intravenous administration is an intravenous infusion. In some embodiments, the method involves administering the taxane composition (such as an aqueous docetaxel composition) and the other antitumor drugs separately, sequentially, or simultaneously. In some embodiments, the method involves administering the taxane composition (such as an aqueous docetaxel composition) and the other antitumor drugs simultaneously. In some embodiments, the method involves administering the taxane composition (such as an aqueous docetaxel composition) and the gemcitabine sequentially or simultaneously.

[0167] In some implementations, the bladder instillation is intravesical administration.

[0168] In some implementations, the administration is performed via injection into the upper urinary tract.

[0169] In some embodiments, the administration is performed after tumor resection is visible in the bladder. In some embodiments, the intravesical administration is an immediate single bladder instillation within 24 hours after transurethral resection of bladder tumor (TURBt) (e.g., within 20 hours, 16 hours, 14 hours, 12 hours, 10 hours, 8 hours, or 6 hours). In some embodiments, the intravesical administration is a maintenance bladder instillation after TURBt.

[0170] In some embodiments, each administration cycle of the taxane composition is at least 1-180 days or 1 month, for example, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 14 days, 21 days, 28 days, 29 days, 30 days, 31 days, 1 month, 35 days, 42 days, at least 1 day, at least 7 days, or at least 1 month. In some embodiments, the taxane composition is repeated for the patient in a new cycle every 1 to 6 weeks (e.g., 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). In some embodiments, the bladder instillation includes an induction therapy period and a maintenance therapy period. In some embodiments, after the completion of the induction therapy period, patients with bladder cancer who achieve complete remission or no recurrence based on efficacy evaluation enter the maintenance therapy period. In some embodiments, the induction therapy period is administered 4-8 times (e.g., 4, 5, 6, 7, 8 times), repeated in a new cycle every 1 week. In some implementations, the maintenance treatment is administered 6 to 25 times (e.g., 6, 8, 10, 12, 14, 16, 18, 20, 22, 25 times), repeated monthly or in a new cycle of 3 to 6 weeks (e.g., 3, 4, 5, 6 weeks).

[0171] In some embodiments, the dosage of the taxane (such as docetaxel) is about 1 to about 500 mg per dose, for example, about 1 to about 400 mg per dose, about 1 to about 300 mg per dose, about 1 to about 200 mg per dose, about 1 to about 100 mg per dose, about 5 to about 90 mg per dose, about 7.5 to about 80 mg per dose, about 10 to about 75 mg per dose, about 12.5 to about 70 mg per dose, about 15.5 to about 65 mg per dose, about 17.5 to about 60 mg per dose, about 20 to about 55 mg per dose, about 22.5 to about 50 mg per dose, about 25 to about 45 mg per dose, about 27.5 to about 40 mg per dose, about 10 mg per dose, about 12.5 mg per dose, about 15 mg per dose, about 17.5 mg per dose, and about 20 mg per dose. In some implementations, the dosage of the taxane (such as docetaxel) is approximately 17.5 mg per dose.

[0172] In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel. Attached Figure Description

[0173] Figure 1. Individual and mean concentration-time curves of docetaxel in plasma of female SD rats after a single intravesical administration of composition D in Example 7.

[0174] Figure 2. Mean blood drug concentration-time curve after the first dose in patients in stage I of Example 9.

[0175] Figure 3. Mean blood drug concentration-time curve after the 6th dose in patients in stage I of Example 9. Detailed Implementation

[0176] One aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of individuals with bladder cancer, wherein at least about 5% of the taxane in the aqueous taxane composition is free taxane.

[0177] In some embodiments, at least about 5% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 7% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 10% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 15% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 20% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 25% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 30% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 65% of the taxane in the aqueous taxane composition is free taxane.In some embodiments, about 10% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 30% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 25% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 20% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 30% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 25% of the taxane in the aqueous taxane composition is free taxane.In some embodiments, about 30% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 90% of the taxane in the aqueous taxane composition is free taxane.In some embodiments, about 50% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 80% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 80% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 55% to about 65% of the taxane in the aqueous taxane composition is free taxane. The concentration of free taxane is determined by 30 kDa membrane ultrafiltration.

[0178] In some embodiments, the taxane is paclitaxel, docetaxel, or cabazitaxel. In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0179] In some embodiments, the taxane composition further includes albumin.

[0180] In some embodiments, the concentration (w / v%) of albumin in the taxane aqueous composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 20%, from about 0.005% to about 10%, from about 0.05% to about 25%, from about 0.05% to about 20%, from about 0.1% to about 20%, from about 0.1% to about 8%, from about 0.1% to about 6%, from about 0.5% to about 15%, from about 0.5% to about 10%. About 1% to about 10%, about 1% to about 8%, about 1% to about 6%, about 2% to about 10%, about 2% to about 8%, about 2% to about 6%, about 4% to about 8%, about 0.1% to about 15%, about 0.1% to about 10%, about 0.5% to about 15%, about 0.5% to about 10%, about 1% to about 15%, about 1% to about 10%, about 2% to about 15%, about 2% to about 10%, about 4% to about 10%, about 0.1% to about 20%, about 0.2% to about 20%. 0.5% to about 20%, about 0.5% to about 15%, about 0.5% to about 10%, about 0.25% to about 10%, about 1% to about 10%, about 0.3% to about 8%, about 0.3% to about 5%, about 0.5% to about 5%, about 0.3% to about 2.5%, about 0.3% to about 1.5%, about 0.5% to about 1.2%, about 0.5% to about 1%, 0.2% to about 1.5%, about 0.1% to about 5%, about 0.2% to about 5%, about 5% to about 10%. About 1% to about 10%, about 1% to about 5%, about 0.3% to about 3%, about 2% to about 6%, about 0.5% to about 4%, 0.5% to about 5%, about 5% to about 10%, about 1% to about 5%, about 0.5% to about 3%, about 0.3% to about 3%, about 0.2% to about 6%, about 2% to about 6%, about 0.3% to about 20%, about 0.5% to about 15%, about 1% to about 10%, about 2% to about 8%, about 4% to about 6%, about 4%, about 5%, about 6%. In some embodiments, the albumin concentration (w / v%) in the docetaxel aqueous composition is about 5%.

[0181] In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 300:1, from about 1:5 to about 900:1, from about 1:1 to about 800:1, from about 5:1 to about 700:1, from about 10:1 to about 500:1, from about 20:1 to about 200:1, from about 50:1 to about 150:1, from about 150:1, from about 120:1, from about 100:1, from about 80:1, from about 60:1, or from about 50:1, from about 50:1 to about 1000:1, from about 50:1 to about 600:1, from about 100:1 to about 1000:1, from about 1 00:1 to about 600:1, about 50:1 to about 300:1, about 100:1 to about 200:1, about 100:1 to about 300:1, about 200:1 to about 600:1, about 300:1 to about 800:1, about 50:1 to about 300:1, about 60:1 to about 150:1, about 80:1 to about 150:1, about 100:1 to about 150:1, about 120:1 to about 150:1, about 135:1 to about 150:1, about 140:1 to about 145:1, about 140:1, about 150:1, about 120:1, about 100:1, about 100:1 to about 600:1, about 100:1 to about 300:1. In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 140:1 to about 145:1.

[0182] In some embodiments, the albumin is serum albumin. In some embodiments, the albumin is human serum albumin. In some embodiments, the human serum albumin is natural human serum albumin or recombinant human serum albumin.

[0183] In some embodiments, the human serum albumin is substantially free of fatty acids. In some embodiments, the human serum albumin is derived from lyophilized human serum albumin powder or a human serum albumin solution. In some embodiments, the human serum albumin is derived from a human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the human serum albumin solution is commercially available or prepared in-house. In some embodiments, the human serum albumin solution can be prepared by mixing water-soluble human serum albumin powder with other pharmaceutically acceptable stabilizers found in commercially available albumin products.In some embodiments, the concentration (w / v%) of the human serum albumin solution can be 0.01% to 60%, including but not limited to: 0.01% to 60%, 0.01% to 50%, 0.01% to 40%, 0.01% to 30%, 0.01% to 25%, 0.01% to 20%, 0.01% to 15%, 0.01% to 10%, 0.01% to 5%, 0.01% to 2%, 0.01% to 1%, 0.01% to 0.1%, 0.1% to 60%, 0.1% to 50%, 0.1% to 40%, 0.1% to 30%, 0.1% to 25%, 0. 0.1%–20%, 0.1%–15%, 0.1%–10%, 0.1%–5%, 0.1%–2%, 0.1%–1%, 0.5%–60%, 0.5%–50%, 0.5%–40%, 0.5%–30%, 0.5%–25%, 0.5%–20%, 0.5%–15%, 0.5%–10%, 0.5%–5%, 0.5%–2%, 0.5%–1%, 1%–60%, 1%–50%, 1%–40%, 1%–30%, 1%–25%, 1%–20%, 1%–15%, 1%–10%, 1%–5%, 1%– 2%, 2%–60%, 2%–50%, 2%–40%, 2%–30%, 2%–25%, 2%–20%, 2%–15%, 2%–10%, 2%–5%, 5%–60%, 5%–50%, 5%–40%, 5%–30%, 5%–25%, 5%–20%, 5%–15%, 5%–10%, 10%–60%, 10%–50%, 10%–40%, 10%–30%, 10%–25%, 10%–20%, 10%–15%, 15%–60%, 15%–50%, 15%–40%, 15%–30 ... %–25%, 15%–20%, 20%–60%, 20%–50%, 20%–40%, 20%–30%, 20%–25%, 25%–60%, 25%–50%, 25%–40%, 25%–30%, 30%–60%, 30%–50%, 30%–40%, 40%–60%, 40%–50%, 45%–60%, 45%–50%, 50%–60%, 0.01%, 0.1%, 0.5%, 1%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 45%, 50%, 60%. In some embodiments, the human serum albumin solution concentration (w / v%) is 5%, 10%, 20%, or 25%. In some embodiments, the concentration (w / v%) of human serum albumin in the human serum albumin solution is 5%. In some embodiments, the concentration (w / v%) of human serum albumin in the human serum albumin solution is 10%. In some embodiments, the concentration (w / v%) of the human serum albumin solution is 20%.In some implementations, the concentration (w / v%) of the human serum albumin solution is 25%.

[0184] In some embodiments, the taxane aqueous composition is a dispersion. In some embodiments, the taxane aqueous composition is a suspension. In some embodiments, the taxane aqueous composition is a solution. In some embodiments, the taxane aqueous composition is a sterile solution. In some embodiments, the taxane aqueous composition is an infusion solution. In some embodiments, the taxane aqueous composition is a bladder infusion solution. In some embodiments, the taxane aqueous composition is a clear solution. In some embodiments, the taxane aqueous composition is a clear sterile infusion solution.

[0185] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 2 mg to about 150 mg, from about 3 mg to about 120 mg, from about 4 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 15 mg to about 20 mg, from about 12.5 mg to about 22.5 mg, from about 10 mg to about 25 mg, from about 7.5 mg to about 37.5 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg.

[0186] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 450 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 400 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 350 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 300 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 200 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 90 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 60 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 40 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 35 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 30 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 80 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 50 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 45 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 15 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 12.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 10 mg.In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 9.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 9 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 8.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 8 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 7.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 6.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 5.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 90 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 80 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 70 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 60 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 55 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 50 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 45 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 40 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 35 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 30 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 90 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 80 mg.In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 70 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 60 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 55 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 50 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 45 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 40 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 35 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 30 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 17.5 mg. In some embodiments, the amount of taxane in the taxane composition is about 17.5 mg.

[0187] In some embodiments, the concentration of taxane in the said taxane aqueous composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.02 mg / mL to about 8 mg / mL, from about 0.04 mg / mL to about 8 mg / mL, from about 0.05 mg / mL to about 8 mg / mL, from about 0.08 mg / mL to about 8 mg / mL, from about 0.1 mg / mL to about 8 mg / mL, from about 0.5 mg / mL to about 8 mg / mL, from about 1 mg / mL to about 8 mg / mL, from about 2 mg / mL to about 8 mg / mL, from about 3 mg / mL to about 8 mg / mL, from about 4 mg / mL to about 8 mg / mL, from about 5 mg / mL to about 8 mg / mL, from about 0.5 mg / mL to about 8 mg / mL. / ml to about 7.5mg / ml, about 0.8mg / ml to about 7mg / ml, about 1mg / ml to about 6.5mg / ml, about 1.2mg / ml to about 6mg / ml, about 1.5mg / ml to about 5.5mg / ml, about 2.5mg / ml to about 5mg / ml, about 3mg / ml to about 5mg / ml, about 4mg / ml to about 6mg / ml, about 0.02mg / ml to about 0.8mg / ml, about 0.03mg / ml to about 0.8mg / ml, about 0.04mg / ml to about 0.8mg / ml, about 0.05mg / ml to about 0.8mg / ml, about 0.06mg / ml to about 0.8mg / ml, about 0.07mg / ml to about 0.8 mg / ml, about 0.08 mg / ml to about 0.8 mg / ml, about 0.09 mg / ml to about 0.8 mg / ml, about 0.1 mg / ml to about 0.8 mg / ml, about 0.1 mg / ml to about 0.75 mg / ml, about 0.1 mg / ml to about 0.7 mg / ml, about 0.1 mg / ml to about 0.65 mg / ml, about 0.1 mg / ml to about 0.6 mg / ml, about 0.1 mg / ml to about 0.55 mg / ml, about 0.1 mg / ml to about 0.5 mg / ml, about 0.1 mg / ml to about 0.45 mg / ml, about 0.1 mg / ml to about 0.4 mg / ml, about 0.1 mg / ml From about 0.35 mg / ml, from about 0.1 mg / ml to about 0.3 mg / ml, from about 0.1 mg / ml to about 0.25 mg / ml, from about 0.1 mg / ml to about 0.2 mg / ml, from about 0.1 mg / ml to about 0.15 mg / ml, from about 0.2 mg / ml to about 0.8 mg / ml, from about 0.2 mg / ml to about 0.75 mg / ml, from about 0.2 mg / ml to about 0.7 mg / ml, from about 0.2 mg / ml to about 0.65 mg / ml, from about 0.2 mg / ml to about 0.6 mg / ml, from about 0.2 mg / ml to about 0.55 mg / ml, from about 0.2 mg / ml to about 0.5 mg / ml, from about 0.2 mg / ml to about 0.45 mg / ml, about 0.2 mg / ml to about 0.4 mg / ml, about 0.2 mg / ml to about 0.35 mg / ml, about 0.2 mg / ml to about 0.3 mg / ml, about 0.2 mg / ml to about 0.25 mg / ml, about 0.3 mg / ml to about 0.8 mg / ml, about 0.3 mg / ml to about 0.75 mg / ml, about 0.3 mg / ml to about 0.7 mg / ml, about 0.3 mg / ml to about 0.65 mg / ml, about 0.3 mg / ml to about 0.6 mg / ml, Approximately 0.3 mg / ml to approximately 0.55 mg / ml, approximately 0.3 mg / ml to approximately 0.5 mg / ml, approximately 0.3 mg / ml to approximately 0.45 mg / ml, approximately 0.3 mg / ml to approximately 0.4 mg / ml, approximately 0.3 mg / ml to approximately 0.35 mg / ml, approximately 0.4 mg / ml to approximately 0.8 mg / ml, approximately 0.4 mg / ml to approximately 0.75 mg / ml, approximately 0.4 mg / ml to approximately 0.7 mg / ml, approximately 0.4 mg / ml to approximately 0.65 mg / ml, approximately 0.4 mg / ml Approximately 0.6 mg / ml, approximately 0.4 mg / ml to approximately 0.55 mg / ml, approximately 0.4 mg / ml to approximately 0.5 mg / ml, approximately 0.4 mg / ml to approximately 0.45 mg / ml, approximately 0.5 mg / ml to approximately 0.8 mg / ml, approximately 0.5 mg / ml to approximately 0.75 mg / ml, approximately 0.5 mg / ml to approximately 0.7 mg / ml, approximately 0.5 mg / ml to approximately 0.65 mg / ml, approximately 0.5 mg / ml to approximately 0.6 mg / ml, approximately 0.5 mg / ml to approximately 0.55 mg / ml. mg / ml, about 0.6 mg / ml to about 0.8 mg / ml, about 0.6 mg / ml to about 0.75 mg / ml, about 0.6 mg / ml to about 0.7 mg / ml, about 0.6 mg / ml to about 0.65 mg / ml, about 0.7 mg / ml to about 0.8 mg / ml, about 0.7 mg / ml to about 0.75 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.35 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml. In some embodiments, the concentration of taxane in the said taxane aqueous composition is about 0.35 mg / ml.

[0188] In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 9. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 9. In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 8.5. In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 7. In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 6. In some embodiments, the pH of the taxane aqueous composition is from about 2.5 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 3 to about 7.5. In some embodiments, the pH of the taxane aqueous composition is from about 3.5 to about 7. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 7. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 6 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 6.5 to about 7.5. In some embodiments, the pH of the taxane aqueous composition is from about 4 to about 9. In some embodiments, the pH of the taxane aqueous composition is from about 4 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 8.5. In some embodiments, the pH of the taxane aqueous composition is from about 6 to about 7.5.

[0189] In some embodiments, the taxane composition is surfactant-free. In some embodiments, the taxane composition is polysorbate 80-free.

[0190] In some embodiments, the taxane composition is a docetaxel composition. In some embodiments, the docetaxel composition comprises docetaxel, the docetaxel composition is an aqueous docetaxel composition, the aqueous docetaxel composition is used for the treatment of bladder cancer individuals via bladder instillation, and at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0191] In some embodiments, at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 7% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 10% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 20% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 30% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 40% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 50% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 10% to about 90% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 20% to about 80% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 30% to about 70% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 55% to about 65% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0192] In some embodiments, the docetaxel aqueous composition is a dispersion. In some embodiments, the docetaxel aqueous composition is a suspension. In some embodiments, the docetaxel aqueous composition is a solution. In some embodiments, the docetaxel aqueous composition is a sterile solution. In some embodiments, the docetaxel aqueous composition is an infusion solution. In some embodiments, the docetaxel aqueous composition is a bladder infusion solution. In some embodiments, the docetaxel aqueous composition is a clear solution. In some embodiments, the docetaxel aqueous composition is a clear sterile infusion solution.

[0193] In some embodiments, the amount of docetaxel in the docetaxel composition is about 1 to about 500 mg, for example, about 1 to about 400 mg, about 1 to about 300 mg, about 1 to about 200 mg, about 1 to about 100 mg, about 5 to about 90 mg, about 7.5 to about 80 mg, about 10 to about 75 mg, about 12.5 to about 70 mg, about 15.5 to about 65 mg, about 17.5 to about 60 mg, about 20 to about 55 mg, about 22.5 to about 50 mg, about 25 to about 45 mg, about 27.5 to about 40 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg. In some embodiments, the amount of docetaxel in the docetaxel composition is about 17.5 mg.

[0194] In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel composition is from about 1:10 to about 1000:1, for example, from about 10:1 to about 500:1, from about 20:1 to about 200:1, from about 50:1 to about 300:1, from about 50:1 to about 150:1, from about 60:1 to about 150:1, from about 80:1 to about 150:1, from about 100:1 to about 150:1, from about 120:1 to about 150:1, from about 135:1 to about 150:1, from about 140:1 to about 145:1, from about 140:1, from about 150:1, from about 120:1, from about 100:1, from about 100:1 to about 600:1, from about 100:1 to about 300:1. In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel composition is from about 140:1 to about 145:1.

[0195] In some embodiments, the amount of docetaxel in the docetaxel aqueous composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 1 mg to about 100 mg, from about 5 mg to about 180 mg, from about 5 mg to about 150 mg, from about 5 mg to about 120 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 20 mg to about 55 mg, from about 22.5 mg to about 50 mg, from about 25 mg to about 45 mg, from about 27.5 mg to about 40 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg. In some embodiments, the amount of docetaxel in the docetaxel aqueous composition is about 17.5 mg.

[0196] In some embodiments, the concentration of docetaxel in the aqueous docetaxel composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.05 mg / mL to about 9.5 mg / mL, from about 0.1 mg / mL to about 9 mg / mL, from about 0.5 mg / mL to about 8.5 mg / mL, from about 1 mg / mL to about 8 mg / mL, from about 2 mg / mL to about 7.5 mg / mL, from about 2.5 mg / mL to about 7 mg / mL, from about 3 mg / mL to about 6.5 mg / mL, from about 3.5 mg / mL to about 6 mg / mL, from about 4 mg / mL to about 5.5 mg / mL, from about 4.5 mg / mL to about 6 mg / mL, and from about 0.01 mg / mL to about 0.5 mg / mL. mg / ml, about 0.01 mg / ml to about 0.3 mg / ml, about 0.01 mg / ml to about 0.2 mg / ml, about 0.02 mg / ml to about 0.25 mg / ml, about 0.02 mg / ml to about 0.2 mg / ml, about 0.03 mg / ml to about 1 mg / ml, about 0.03 mg / ml to about 0.5 mg / ml, about 0.03 mg / ml to about 0.3 mg / ml, about 0.03 mg / ml to about 0.2 mg / ml, about 0.03 mg / ml to about 0.15 mg / ml, about 0.03 mg / ml to about 0.1 mg / ml, about 0.05 mg / ml to about 0.15 mg / ml, about 0.08 mg / ml to About 0.1 mg / ml, 0.05 mg / ml to about 1 mg / ml, about 0.05 mg / ml to about 0.5 mg / ml, about 0.05 mg / ml to about 0.3 mg / ml, about 0.05 mg / ml to about 0.2 mg / ml, about 0.07 mg / ml to about 1 mg / ml, about 0.07 mg / ml to about 0.5 mg / ml, about 0.07 mg / ml to about 0.3 mg / ml, about 0.07 mg / ml to about 0.2 mg / ml, about 0.1 mg / ml to about 1 mg / ml, about 0.1 mg / ml to about 0.5 mg / ml, about 0.1 mg / ml to about 0.3 mg / ml, about 0.1 mg / ml to about 0.2 mg / ml l, about 0.05 mg / ml, about 0.06 mg / ml, about 0.01 mg / ml to about 0.8 mg / ml, about 0.1 mg / ml to about 0.8 mg / ml, about 0.2 mg / ml to about 0.7 mg / ml, about 0.3 mg / ml to about 0.5 mg / ml, about 0.3 mg / ml to about 0.4 mg / ml, about 0.07 mg / ml, about 0.08 mg / ml, about 0.09 mg / ml, about 0.10 mg / ml, about 0.11 mg / ml, about 0.12 mg / ml, about 0.13 mg / ml, about 0.14 mg / ml, about 0.15 mg / ml, about 0.16 mg / ml, about 0.17 mg / ml, about 0.18 mg / ml, about 0.19 mg / ml, about 0.20 mg / ml, about 0.25 mg / ml, about 0.30 mg / ml, about 0.35 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml. In some embodiments, the concentration of docetaxel in the aqueous docetaxel composition is about 0.35 mg / ml.

[0197] In some embodiments, the albumin concentration (w / v%) in the docetaxel aqueous composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 15%, from about 0.005% to about 8%, from about 0.05% to about 25%, from about 0.05% to about 20%, from about 0.1% to about 20%, from about 0.1% to about 8%, from about 0.1% to about 6%, from about 0.5% to about 15%, from about 0.5% to about 10%, from about 1% to about 10%, about 1% to about 8%, about 1% to about 6%, about 2% to about 10%, about 2% to about 8%, about 2% to about 6%, about 4% to about 8%, about 0.1% to about 15%, about 0.1% to about 10%, about 0.5% to about 15%, about 0.5% to about 10%, about 1% to about 15%, about 1% to about 10%, about 2% to about 15%, about 2% to about 10%, about 4% to about 10%, about 0.1% to about 20%, about 0.2% to about 20%. 0.5% to about 20%, about 0.5% to about 15%, about 0.5% to about 10%, about 0.25% to about 10%, about 1% to about 10%, about 0.3% to about 8%, about 0.3% to about 5%, about 0.5% to about 5%, about 0.3% to about 2.5%, about 0.3% to about 1.5%, about 0.5% to about 1.2%, about 0.5% to about 1%, 0.2% to about 1.5%, about 0.1% to about 5%, about 0.2% to about 5%, about 5% to about 10%. About 1% to about 10%, about 1% to about 5%, about 0.3% to about 3%, about 2% to about 6%, about 0.5% to about 4%, 0.5% to about 5%, about 5% to about 10%, about 1% to about 5%, about 0.5% to about 3%, about 0.3% to about 3%, about 0.2% to about 6%, about 2% to about 6%, about 0.3% to about 20%, about 0.5% to about 15%, about 1% to about 10%, about 2% to about 8%, about 4% to about 6%, about 4%, about 5%, about 6%. In some embodiments, the albumin concentration (w / v%) in the docetaxel aqueous composition is about 5%.

[0198] In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel aqueous composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 200:1, from about 10:1 to about 500:1, from about 20:1 to about 200:1, from about 50:1 to about 150:1, from about 150:1, from about 120:1, from about 100:1, from about 80:1, from about 60:1, or from about 50:1, from about 50:1 to about 1000:1, from about 50:1 to about 600:1, from about 100:1 to about 1000:1, from about 100:1 to about 600:1, from about 50:1... The ratios are approximately 1 to 300:1, approximately 100:1 to 200:1, approximately 100:1 to 300:1, approximately 200:1 to 600:1, approximately 300:1 to 800:1, approximately 50:1 to 300:1, approximately 60:1 to 150:1, approximately 80:1 to 150:1, approximately 100:1 to 150:1, approximately 120:1 to 150:1, approximately 135:1 to 150:1, approximately 140:1 to 145:1, approximately 140:1, approximately 150:1, approximately 120:1, approximately 100:1, approximately 100:1 to 600:1, and approximately 100:1 to 300:1. In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel aqueous composition is approximately 140:1 to approximately 145:1.

[0199] In some embodiments, at least 80% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 90% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 92% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 94% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 95% of the albumin in the docetaxel aqueous composition is a monomer.

[0200] In some embodiments, most or all of the albumin in the docetaxel aqueous composition is dissolved in the aqueous composition. In some embodiments, at least 90% of the albumin in the docetaxel aqueous composition is dissolved in the aqueous composition. In some embodiments, at least 95% of the albumin in the docetaxel aqueous composition is dissolved in the aqueous composition.

[0201] In some embodiments, the docetaxel aqueous composition is a clear aqueous solution. In some embodiments, the clear aqueous solution remains clear for at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 6 hours, at least 8 hours, at least 24 hours, and at least 7 days. In some embodiments, when the clear aqueous solution is maintained at about 20–25°C, the clear aqueous solution remains clear for at least 1 hour and at least 7 days. In some embodiments, when the clear aqueous solution is maintained at about 2–8°C, the clear aqueous solution remains clear for at least 1 hour and at least 7 days. In some embodiments, when the clear aqueous solution is maintained at about 35–40°C, the clear aqueous solution remains clear for at least 1 hour and at least 24 hours.

[0202] In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 10, no more than 20, no more than 30, no more than 50, no more than 100, no more than 150, or no more than 2000 particles larger than 10 μm. In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 5 to no more than 10 particles larger than 25 μm. In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 5 particles larger than 15 μm. In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 20 particles larger than 25 μm.

[0203] In some embodiments, the docetaxel composition further includes one or more of a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, and a sugar or sugar alcohol. In some embodiments, the docetaxel composition further includes a water-soluble organic solvent. In some embodiments, the docetaxel composition further includes a pharmaceutically acceptable carrier. In some embodiments, the docetaxel composition further includes a pH adjuster. For example, the docetaxel composition includes docetaxel, human serum albumin, and an amino acid; the docetaxel composition includes docetaxel, human serum albumin, a pharmaceutically acceptable carrier, and a water-soluble organic solvent; the docetaxel composition includes docetaxel, human serum albumin, a water-soluble organic solvent, a pH adjuster, and a pharmaceutically acceptable carrier.

[0204] In some embodiments, the water-soluble organic solvent is selected from at least one of ethanol, acetone, and polyethylene glycol (PEG) (such as PEG 300, PEG 400). In some embodiments, the water-soluble organic solvent is ethanol.

[0205] In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition does not exceed 15%, for example, not more than 10%, not more than 5%, not more than 3%, not more than 2%, not more than 1.5%, not more than 1%, not more than 0.8%, not more than 0.7%, about 0.1% to about 15%, about 0.2% to about 10%, about 0.1% to about 10%, about 0.5% to about 3%, about 0.1% to about 3%, about 1% to about 5%, about 0.1% to about 5%, about 0.5% to about 5%, about 0.5% to about 10%, about 0.5% to about 3%, about 2% to about 8%, about 0.2% to about 4%, about 0.1% to about 3%, about 0.5% to about 2%, or about 0.7% to about 1.5%, about 0.5%, about 0.7%, about 0.8%, about 1%, or about 2%. In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition is about 1% to 8%. In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition is about 1% to 6%. In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition is about 3% to 4%.

[0206] In some embodiments, the volume of ethanol in the docetaxel aqueous composition does not exceed 30 ml, for example, not exceeding 25 ml, not exceeding 20 ml, not exceeding 15 ml, not exceeding 10 ml, not exceeding 7.5 ml, not exceeding 5 ml, or not exceeding 2.5 ml. In some embodiments, the volume of ethanol in the docetaxel aqueous composition does not exceed 2.5 ml.

[0207] In some embodiments, the stabilizer is selected from at least one of caprylic acid, sodium caprylate, sodium N-acetyltryptophan, and N-acetyltryptophan.

[0208] In some embodiments, the amino acid is selected from at least one of aspartic acid, glutamic acid, and cysteine.

[0209] In some embodiments, the pharmaceutically acceptable carrier is a parenteral acceptable carrier. In some embodiments, the parenteral acceptable carrier is an aqueous carrier. In some embodiments, the aqueous carrier is water for injection, physiological saline, and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline (e.g., 0.9% sodium chloride solution). In some embodiments, the aqueous carrier is a glucose solution (e.g., 5% glucose solution).

[0210] In some embodiments, the pH adjuster includes, but is not limited to, diethanolamine, triethanolamine, sodium hydroxide, hydrochloric acid, citric acid, and sodium dihydrogen phosphate, or mixtures thereof. In some embodiments, the pH adjuster is citric acid. In some embodiments, the pH of the docetaxel aqueous composition is about 2 to about 9. In some embodiments, the pH of the docetaxel aqueous composition is about 5 to about 9. In some embodiments, the pH of the docetaxel aqueous composition is about 5 to about 8. In some embodiments, the pH of the docetaxel aqueous composition is about 6 to about 8. In some embodiments, the pH of the docetaxel aqueous composition is about 6.5 to about 7.5. In some embodiments, the pH of the docetaxel aqueous composition is about 4 to about 9. In some embodiments, the pH of the docetaxel aqueous composition is about 4 to about 8. In some embodiments, the pH of the docetaxel aqueous composition is about 5 to about 8.5. In some embodiments, the pH of the docetaxel aqueous composition is about 6 to about 7.5.

[0211] In some embodiments, the sugar alcohol is selected from at least one of mannitol, sorbitol, inositol, and xylitol. In some embodiments, the sugar is selected from at least one of glucose, sucrose, lactose, maltose, trehalose, fructose, hexose, and raffinose.

[0212] Another aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of individuals with bladder cancer, wherein the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.8 mg / ml.

[0213] In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.07 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.01 mg / ml to about 0.06 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.05 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.04 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.03 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.01 mg / ml to about 0.02 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.02 mg / ml to about 0.1 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.07 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.06 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.05 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.04 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.02 mg / ml to about 0.03 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.03 mg / ml to about 0.25 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.07 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.06 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.05 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.03 mg / ml to about 0.04 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.04 mg / ml to about 0.35 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.07 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.06 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.04 mg / ml to about 0.05 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.05 mg / ml to about 0.4 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.07 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.05 mg / ml to about 0.06 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.06 mg / ml to about 0.4 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.06 mg / ml to about 0.07 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.07 mg / ml to about 0.35 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.07 mg / ml to about 0.08 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.08 mg / ml to about 0.25 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.1 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.08 mg / ml to about 0.09 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.09 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.09 mg / ml to about 0.1 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.2 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.1 mg / ml to about 0.15 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.2 mg / ml to about 0.6 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.2 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.3 mg / ml to about 0.35 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.4 mg / ml to about 0.75 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.4 mg / ml to about 0.45 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.5 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.5 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.5 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.5 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.5 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.5 mg / ml to about 0.55 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.6 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.6 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.6 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.6 mg / ml to about 0.65 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.7 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.7 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free taxane in the said taxane aqueous composition is from about 0.15 mg / ml to about 0.25 mg / ml.In some embodiments, the concentration of free taxane in the aqueous taxane composition is from about 0.18 mg / ml to about 0.24 mg / ml. In some embodiments, the concentration of free taxane in the aqueous taxane composition is about 0.05 mg / ml, about 0.1 mg / ml, about 0.15 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.35 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml, or about 0.55 mg / ml.

[0214] In some embodiments, the taxane is paclitaxel, docetaxel, or cabazitaxel. In some embodiments, the taxane is paclitaxel. In some embodiments, the taxane is docetaxel. In some embodiments, the taxane is cabazitaxel.

[0215] In some embodiments, the taxane composition further includes albumin.

[0216] In some embodiments, the concentration (w / v%) of albumin in the taxane aqueous composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 20%, from about 0.005% to about 10%, from about 0.05% to about 25%, from about 0.05% to about 20%, from about 0.1% to about 20%, from about 0.1% to about 8%, from about 0.1% to about 6%, from about 0.5% to about 15%, from about 0.5% to about 10%. About 1% to about 10%, about 1% to about 8%, about 1% to about 6%, about 2% to about 10%, about 2% to about 8%, about 2% to about 6%, about 4% to about 8%, about 0.1% to about 15%, about 0.1% to about 10%, about 0.5% to about 15%, about 0.5% to about 10%, about 1% to about 15%, about 1% to about 10%, about 2% to about 15%, about 2% to about 10%, about 4% to about 10%, about 0.1% to about 20%, about 0.2% to about 20%. 0.5% to about 20%, about 0.5% to about 15%, about 0.5% to about 10%, about 0.25% to about 10%, about 1% to about 10%, about 0.3% to about 8%, about 0.3% to about 5%, about 0.5% to about 5%, about 0.3% to about 2.5%, about 0.3% to about 1.5%, about 0.5% to about 1.2%, about 0.5% to about 1%, 0.2% to about 1.5%, about 0.1% to about 5%, about 0.2% to about 5%, about 5% to about 10%. About 1% to about 10%, about 1% to about 5%, about 0.3% to about 3%, about 2% to about 6%, about 0.5% to about 4%, 0.5% to about 5%, about 5% to about 10%, about 1% to about 5%, about 0.5% to about 3%, about 0.3% to about 3%, about 0.2% to about 6%, about 2% to about 6%, about 0.3% to about 20%, about 0.5% to about 15%, about 1% to about 10%, about 2% to about 8%, about 4% to about 6%, about 4%, about 5%, about 6%. In some embodiments, the albumin concentration (w / v%) in the docetaxel aqueous composition is about 5%.

[0217] In some embodiments, the weight ratio of albumin to taxane in the taxane composition is from about 1:10 to about 1000:1, for example, from about 1:10 to about 800:1, from about 1:10 to about 300:1, from about 1:5 to about 900:1, from about 1:1 to about 800:1, from about 5:1 to about 700:1, from about 10:1 to about 500:1, from about 20:1 to about 200:1, from about 50:1 to about 150:1, from about 150:1, from about 120:1, from about 100:1, from about 80:1, from about 60:1, or from about 50:1, from about 50:1 to about 1000:1, from about 50:1 to about 600:1, from about 100:1 to about 1000:1, from about 1 00:1 to about 600:1, about 50:1 to about 300:1, about 100:1 to about 200:1, about 100:1 to about 300:1, about 200:1 to about 600:1, about 300:1 to about 800:1, about 50:1 to about 300:1, about 60:1 to about 150:1, about 80:1 to about 150:1, about 100:1 to about 150:1, about 120:1 to about 150:1, about 135:1 to about 150:1, about 140:1 to about 145:1, about 140:1, about 150:1, about 120:1, about 100:1, about 100:1 to about 600:1, about 100:1 to about 300:1.

[0218] In some embodiments, the albumin is serum albumin. In some embodiments, the albumin is human serum albumin. In some embodiments, the human serum albumin is natural human serum albumin or recombinant human serum albumin.

[0219] In some embodiments, the human serum albumin is substantially free of fatty acids. In some embodiments, the human serum albumin is derived from lyophilized human serum albumin powder or a human serum albumin solution. In some embodiments, the human serum albumin is derived from a human serum albumin solution. In some embodiments, the human serum albumin solution is an infusion-grade human serum albumin solution. In some embodiments, the human serum albumin solution is commercially available or prepared in-house. In some embodiments, the human serum albumin solution can be prepared by mixing water-soluble human serum albumin powder with other pharmaceutically acceptable stabilizers found in commercially available albumin products.In some embodiments, the concentration (w / v%) of the human serum albumin solution can be 0.01% to 60%, including but not limited to: 0.01% to 60%, 0.01% to 50%, 0.01% to 40%, 0.01% to 30%, 0.01% to 25%, 0.01% to 20%, 0.01% to 15%, 0.01% to 10%, 0.01% to 5%, 0.01% to 2%, 0.01% to 1%, 0.01% to 0.1%, 0.1% to 60%, 0.1% to 50%, 0.1% to 40%, 0.1% to 30%, 0.1% to 25%, 0. 0.1%–20%, 0.1%–15%, 0.1%–10%, 0.1%–5%, 0.1%–2%, 0.1%–1%, 0.5%–60%, 0.5%–50%, 0.5%–40%, 0.5%–30%, 0.5%–25%, 0.5%–20%, 0.5%–15%, 0.5%–10%, 0.5%–5%, 0.5%–2%, 0.5%–1%, 1%–60%, 1%–50%, 1%–40%, 1%–30%, 1%–25%, 1%–20%, 1%–15%, 1%–10%, 1%–5%, 1%– 2%, 2%–60%, 2%–50%, 2%–40%, 2%–30%, 2%–25%, 2%–20%, 2%–15%, 2%–10%, 2%–5%, 5%–60%, 5%–50%, 5%–40%, 5%–30%, 5%–25%, 5%–20%, 5%–15%, 5%–10%, 10%–60%, 10%–50%, 10%–40%, 10%–30%, 10%–25%, 10%–20%, 10%–15%, 15%–60%, 15%–50%, 15%–40%, 15%–30 ... %–25%, 15%–20%, 20%–60%, 20%–50%, 20%–40%, 20%–30%, 20%–25%, 25%–60%, 25%–50%, 25%–40%, 25%–30%, 30%–60%, 30%–50%, 30%–40%, 40%–60%, 40%–50%, 45%–60%, 45%–50%, 50%–60%, 0.01%, 0.1%, 0.5%, 1%, 2%, 5%, 10%, 15%, 20%, 25%, 30%, 40%, 45%, 50%, 60%. In some embodiments, the human serum albumin solution concentration (w / v%) is 5%, 10%, 20%, or 25%. In some embodiments, the concentration (w / v%) of human serum albumin in the human serum albumin solution is 5%. In some embodiments, the concentration (w / v%) of human serum albumin in the human serum albumin solution is 10%. In some embodiments, the concentration (w / v%) of the human serum albumin solution is 20%.In some implementations, the concentration (w / v%) of the human serum albumin solution is 25%.

[0220] In some embodiments, the taxane aqueous composition is a dispersion. In some embodiments, the taxane aqueous composition is a suspension. In some embodiments, the taxane aqueous composition is a solution. In some embodiments, the taxane aqueous composition is a sterile solution. In some embodiments, the taxane aqueous composition is an infusion solution. In some embodiments, the taxane aqueous composition is a bladder infusion solution. In some embodiments, the taxane aqueous composition is a clear solution. In some embodiments, the taxane aqueous composition is a clear sterile infusion solution.

[0221] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 2 mg to about 150 mg, from about 3 mg to about 120 mg, from about 4 mg to about 100 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 15 mg to about 20 mg, from about 12.5 mg to about 22.5 mg, from about 10 mg to about 25 mg, from about 7.5 mg to about 37.5 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg.

[0222] In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 500 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 450 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 400 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 350 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 300 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 200 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 90 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 60 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 40 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 35 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 30 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 1 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 80 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 50 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 45 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 15 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 12.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 10 mg.In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 9.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 9 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 8.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 8 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 7.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 6.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 5 mg to about 5.5 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 90 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 80 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 70 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 60 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 55 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 50 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 45 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 40 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 35 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 30 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 10 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 150 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 120 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 100 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 90 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 80 mg.In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 70 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 60 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 55 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 50 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 45 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 40 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 35 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 30 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 25 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 20 mg. In some embodiments, the amount of taxane in the taxane composition is from about 15 mg to about 17.5 mg. In some embodiments, the amount of taxane in the taxane composition is about 17.5 mg.

[0223] In some embodiments, the concentration of taxane in the said taxane aqueous composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.02 mg / mL to about 8 mg / mL, from about 0.04 mg / mL to about 8 mg / mL, from about 0.05 mg / mL to about 8 mg / mL, from about 0.08 mg / mL to about 8 mg / mL, from about 0.1 mg / mL to about 8 mg / mL, from about 0.5 mg / mL to about 8 mg / mL, from about 1 mg / mL to about 8 mg / mL, from about 2 mg / mL to about 8 mg / mL, from about 3 mg / mL to about 8 mg / mL, from about 4 mg / mL to about 8 mg / mL, from about 5 mg / mL to about 8 mg / mL, from about 0.5 mg / mL to about 8 mg / mL. / ml to about 7.5mg / ml, about 0.8mg / ml to about 7mg / ml, about 1mg / ml to about 6.5mg / ml, about 1.2mg / ml to about 6mg / ml, about 1.5mg / ml to about 5.5mg / ml, about 2.5mg / ml to about 5mg / ml, about 3mg / ml to about 5mg / ml, about 4mg / ml to about 6mg / ml, about 0.02mg / ml to about 0.8mg / ml, about 0.03mg / ml to about 0.8mg / ml, about 0.04mg / ml to about 0.8mg / ml, about 0.05mg / ml to about 0.8mg / ml, about 0.06mg / ml to about 0.8mg / ml, about 0.07mg / ml to about 0.8 mg / ml, about 0.08 mg / ml to about 0.8 mg / ml, about 0.09 mg / ml to about 0.8 mg / ml, about 0.1 mg / ml to about 0.8 mg / ml, about 0.1 mg / ml to about 0.75 mg / ml, about 0.1 mg / ml to about 0.7 mg / ml, about 0.1 mg / ml to about 0.65 mg / ml, about 0.1 mg / ml to about 0.6 mg / ml, about 0.1 mg / ml to about 0.55 mg / ml, about 0.1 mg / ml to about 0.5 mg / ml, about 0.1 mg / ml to about 0.45 mg / ml, about 0.1 mg / ml to about 0.4 mg / ml, about 0.1 mg / ml From about 0.35 mg / ml, from about 0.1 mg / ml to about 0.3 mg / ml, from about 0.1 mg / ml to about 0.25 mg / ml, from about 0.1 mg / ml to about 0.2 mg / ml, from about 0.1 mg / ml to about 0.15 mg / ml, from about 0.2 mg / ml to about 0.8 mg / ml, from about 0.2 mg / ml to about 0.75 mg / ml, from about 0.2 mg / ml to about 0.7 mg / ml, from about 0.2 mg / ml to about 0.65 mg / ml, from about 0.2 mg / ml to about 0.6 mg / ml, from about 0.2 mg / ml to about 0.55 mg / ml, from about 0.2 mg / ml to about 0.5 mg / ml, from about 0.2 mg / ml to about 0.45 mg / ml, about 0.2 mg / ml to about 0.4 mg / ml, about 0.2 mg / ml to about 0.35 mg / ml, about 0.2 mg / ml to about 0.3 mg / ml, about 0.2 mg / ml to about 0.25 mg / ml, about 0.3 mg / ml to about 0.8 mg / ml, about 0.3 mg / ml to about 0.75 mg / ml, about 0.3 mg / ml to about 0.7 mg / ml, about 0.3 mg / ml to about 0.65 mg / ml, about 0.3 mg / ml to about 0.6 mg / ml, Approximately 0.3 mg / ml to approximately 0.55 mg / ml, approximately 0.3 mg / ml to approximately 0.5 mg / ml, approximately 0.3 mg / ml to approximately 0.45 mg / ml, approximately 0.3 mg / ml to approximately 0.4 mg / ml, approximately 0.3 mg / ml to approximately 0.35 mg / ml, approximately 0.4 mg / ml to approximately 0.8 mg / ml, approximately 0.4 mg / ml to approximately 0.75 mg / ml, approximately 0.4 mg / ml to approximately 0.7 mg / ml, approximately 0.4 mg / ml to approximately 0.65 mg / ml, approximately 0.4 mg / ml Approximately 0.6 mg / ml, approximately 0.4 mg / ml to approximately 0.55 mg / ml, approximately 0.4 mg / ml to approximately 0.5 mg / ml, approximately 0.4 mg / ml to approximately 0.45 mg / ml, approximately 0.5 mg / ml to approximately 0.8 mg / ml, approximately 0.5 mg / ml to approximately 0.75 mg / ml, approximately 0.5 mg / ml to approximately 0.7 mg / ml, approximately 0.5 mg / ml to approximately 0.65 mg / ml, approximately 0.5 mg / ml to approximately 0.6 mg / ml, approximately 0.5 mg / ml to approximately 0.55 mg / ml. mg / ml, about 0.6 mg / ml to about 0.8 mg / ml, about 0.6 mg / ml to about 0.75 mg / ml, about 0.6 mg / ml to about 0.7 mg / ml, about 0.6 mg / ml to about 0.65 mg / ml, about 0.7 mg / ml to about 0.8 mg / ml, about 0.7 mg / ml to about 0.75 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.35 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml. In some embodiments, the concentration of taxane in the said taxane aqueous composition is about 0.35 mg / ml.

[0224] In some embodiments, at least about 5% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 7% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 10% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 15% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 20% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 25% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 30% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, at least about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 65% of the taxane in the aqueous taxane composition is free taxane.In some embodiments, about 10% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 30% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 25% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 10% to about 20% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 30% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 20% to about 25% of the taxane in the aqueous taxane composition is free taxane.In some embodiments, about 30% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 40% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 30% to about 35% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 50% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 40% to about 45% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 90% of the taxane in the aqueous taxane composition is free taxane.In some embodiments, about 50% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 60% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 50% to about 55% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 70% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 60% to about 65% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 80% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 70% to about 75% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 80% to about 90% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 80% to about 85% of the taxane in the aqueous taxane composition is free taxane. In some embodiments, about 55% to about 65% of the taxane in the aqueous taxane composition is free taxane.

[0225] In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 9. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 9. In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 8.5. In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 7. In some embodiments, the pH of the taxane aqueous composition is from about 2 to about 6. In some embodiments, the pH of the taxane aqueous composition is from about 2.5 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 3 to about 7.5. In some embodiments, the pH of the taxane aqueous composition is from about 3.5 to about 7. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 7. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 6 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 6.5 to about 7.5. In some embodiments, the pH of the taxane aqueous composition is from about 4 to about 9. In some embodiments, the pH of the taxane aqueous composition is from about 4 to about 8. In some embodiments, the pH of the taxane aqueous composition is from about 5 to about 8.5. In some embodiments, the pH of the taxane aqueous composition is from about 6 to about 7.5.

[0226] In some embodiments, the taxane composition is surfactant-free. In some embodiments, the taxane composition is polysorbate 80-free.

[0227] In some embodiments, the taxane composition is a docetaxel composition. In some embodiments, the docetaxel composition includes docetaxel, the docetaxel composition is an aqueous docetaxel composition, the aqueous docetaxel composition is used by bladder instillation to treat individuals with bladder cancer, and the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml.

[0228] In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.05 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.05 mg / ml to about 0.75 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.7 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.6 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.5 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.4 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.3 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.15 mg / ml to about 0.25 mg / ml. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml. In some embodiments, the concentration of free docetaxel in the docetaxel aqueous composition is about 0.05 mg / ml, about 0.1 mg / ml, about 0.15 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.5 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml, or about 0.55 mg / ml.

[0229] In some embodiments, at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 7% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 10% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 20% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 30% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 40% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, at least 50% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 10% to about 90% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 20% to about 80% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 30% to about 70% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, about 55% to about 65% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0230] In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.01 mg / ml to about 0.8 mg / ml, and at least 5% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.05 mg / ml to about 0.75 mg / ml, and at least 10% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.7 mg / ml, and at least 20% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.6 mg / ml, and at least 30% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.5 mg / ml, and at least 40% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.4 mg / ml, and at least 50% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.1 mg / ml to about 0.3 mg / ml, and about 10% to about 90% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.15 mg / ml to about 0.25 mg / ml, and about 20% to about 80% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 30% to about 70% of the docetaxel in the aqueous docetaxel composition is free docetaxel. In some embodiments, the concentration of free docetaxel in the aqueous docetaxel composition is from about 0.18 mg / ml to about 0.24 mg / ml, and about 55% to about 65% of the docetaxel in the aqueous docetaxel composition is free docetaxel.

[0231] In some embodiments, the docetaxel aqueous composition is a dispersion. In some embodiments, the docetaxel aqueous composition is a suspension. In some embodiments, the docetaxel aqueous composition is a solution. In some embodiments, the docetaxel aqueous composition is a sterile solution. In some embodiments, the docetaxel aqueous composition is an infusion solution. In some embodiments, the docetaxel aqueous composition is a bladder infusion solution. In some embodiments, the docetaxel aqueous composition is a clear solution. In some embodiments, the docetaxel aqueous composition is a clear sterile infusion solution.

[0232] In some embodiments, the amount of docetaxel in the docetaxel composition is about 1 to about 500 mg, for example, about 1 to about 400 mg, about 1 to about 300 mg, about 1 to about 200 mg, about 1 to about 100 mg, about 5 to about 90 mg, about 7.5 to about 80 mg, about 10 to about 75 mg, about 12.5 to about 70 mg, about 15.5 to about 65 mg, about 17.5 to about 60 mg, about 20 to about 55 mg, about 22.5 to about 50 mg, about 25 to about 45 mg, about 27.5 to about 40 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg. In some embodiments, the amount of docetaxel in the docetaxel composition is about 17.5 mg.

[0233] In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel composition is from about 1:10 to about 1000:1, for example, from about 10:1 to about 500:1, from about 20:1 to about 200:1, from about 50:1 to about 300:1, from about 50:1 to about 150:1, from about 60:1 to about 150:1, from about 80:1 to about 150:1, from about 100:1 to about 150:1, from about 120:1 to about 150:1, from about 135:1 to about 150:1, from about 140:1 to about 145:1, from about 140:1, from about 150:1, from about 120:1, from about 100:1, from about 100:1 to about 600:1, from about 100:1 to about 300:1. In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel composition is from about 140:1 to about 145:1.

[0234] In some embodiments, the amount of docetaxel in the docetaxel aqueous composition is from about 1 mg to about 500 mg, for example, from about 1 mg to about 400 mg, from about 1 mg to about 300 mg, from about 1 mg to about 200 mg, from about 1 mg to about 100 mg, from about 5 mg to about 180 mg, from about 5 mg to about 150 mg, from about 5 mg to about 120 mg, from about 5 mg to about 90 mg, from about 7.5 mg to about 80 mg, from about 10 mg to about 75 mg, from about 12.5 mg to about 70 mg, from about 15.5 mg to about 65 mg, from about 17.5 mg to about 60 mg, from about 20 mg to about 55 mg, from about 22.5 mg to about 50 mg, from about 25 mg to about 45 mg, from about 27.5 mg to about 40 mg, from about 10 mg, from about 12.5 mg, from about 15 mg, from about 17.5 mg, from about 20 mg. In some embodiments, the amount of docetaxel in the docetaxel aqueous composition is about 17.5 mg.

[0235] In some embodiments, the concentration of docetaxel in the aqueous docetaxel composition is from about 0.01 mg / mL to about 10 mg / mL, for example, from about 0.05 mg / mL to about 9.5 mg / mL, from about 0.1 mg / mL to about 9 mg / mL, from about 0.5 mg / mL to about 8.5 mg / mL, from about 1 mg / mL to about 8 mg / mL, from about 2 mg / mL to about 7.5 mg / mL, from about 2.5 mg / mL to about 7 mg / mL, from about 3 mg / mL to about 6.5 mg / mL, from about 3.5 mg / mL to about 6 mg / mL, from about 4 mg / mL to about 5.5 mg / mL, from about 4.5 mg / mL to about 6 mg / mL, and from about 0.01 mg / mL to about 0.5 mg / mL. mg / ml, about 0.01 mg / ml to about 0.3 mg / ml, about 0.01 mg / ml to about 0.2 mg / ml, about 0.02 mg / ml to about 0.25 mg / ml, about 0.02 mg / ml to about 0.2 mg / ml, about 0.03 mg / ml to about 1 mg / ml, about 0.03 mg / ml to about 0.5 mg / ml, about 0.03 mg / ml to about 0.3 mg / ml, about 0.03 mg / ml to about 0.2 mg / ml, about 0.03 mg / ml to about 0.15 mg / ml, about 0.03 mg / ml to about 0.1 mg / ml, about 0.05 mg / ml to about 0.15 mg / ml, about 0.08 mg / ml to About 0.1 mg / ml, 0.05 mg / ml to about 1 mg / ml, about 0.05 mg / ml to about 0.5 mg / ml, about 0.05 mg / ml to about 0.3 mg / ml, about 0.05 mg / ml to about 0.2 mg / ml, about 0.07 mg / ml to about 1 mg / ml, about 0.07 mg / ml to about 0.5 mg / ml, about 0.07 mg / ml to about 0.3 mg / ml, about 0.07 mg / ml to about 0.2 mg / ml, about 0.1 mg / ml to about 1 mg / ml, about 0.1 mg / ml to about 0.5 mg / ml, about 0.1 mg / ml to about 0.3 mg / ml, about 0.1 mg / ml to about 0.2 mg / ml l, about 0.05 mg / ml, about 0.06 mg / ml, about 0.01 mg / ml to about 0.8 mg / ml, about 0.1 mg / ml to about 0.8 mg / ml, about 0.2 mg / ml to about 0.7 mg / ml, about 0.3 mg / ml to about 0.5 mg / ml, about 0.3 mg / ml to about 0.4 mg / ml, about 0.07 mg / ml, about 0.08 mg / ml, about 0.09 mg / ml, about 0.10 mg / ml, about 0.11 mg / ml, about 0.12 mg / ml, about 0.13 mg / ml, about 0.14 mg / ml, about 0.15 mg / ml, about 0.16 mg / ml, about 0.17 mg / ml, about 0.18 mg / ml, about 0.19 mg / ml, about 0.20 mg / ml, about 0.25 mg / ml, about 0.30 mg / ml, about 0.35 mg / ml, about 0.4 mg / ml, about 0.45 mg / ml, about 0.5 mg / ml. In some embodiments, the concentration of docetaxel in the aqueous docetaxel composition is about 0.35 mg / ml.

[0236] In some embodiments, the albumin concentration (w / v%) in the docetaxel aqueous composition is from about 0.001% to about 25%, for example, from about 0.005% to about 25%, from about 0.005% to about 15%, from about 0.005% to about 8%, from about 0.05% to about 25%, from about 0.05% to about 20%, from about 0.1% to about 20%, from about 0.1% to about 8%, from about 0.1% to about 6%, from about 0.5% to about 15%, from about 0.5% to about 10%, from about 1% to about 10%, about 1% to about 8%, about 1% to about 6%, about 2% to about 10%, about 2% to about 8%, about 2% to about 6%, about 4% to about 8%, about 0.1% to about 15%, about 0.1% to about 10%, about 0.5% to about 15%, about 0.5% to about 10%, about 1% to about 15%, about 1% to about 10%, about 2% to about 15%, about 2% to about 10%, about 4% to about 10%, about 0.1% to about 20%, about 0.2% to about 20%. 0.5% to about 20%, about 0.5% to about 15%, about 0.5% to about 10%, about 0.25% to about 10%, about 1% to about 10%, about 0.3% to about 8%, about 0.3% to about 5%, about 0.5% to about 5%, about 0.3% to about 2.5%, about 0.3% to about 1.5%, about 0.5% to about 1.2%, about 0.5% to about 1%, 0.2% to about 1.5%, about 0.1% to about 5%, about 0.2% to about 5%, about 5% to about 10%. About 1% to about 10%, about 1% to about 5%, about 0.3% to about 3%, about 2% to about 6%, about 0.5% to about 4%, 0.5% to about 5%, about 5% to about 10%, about 1% to about 5%, about 0.5% to about 3%, about 0.3% to about 3%, about 0.2% to about 6%, about 2% to about 6%, about 0.3% to about 20%, about 0.5% to about 15%, about 1% to about 10%, about 2% to about 8%, about 4% to about 6%, about 4%, about 5%, about 6%. In some embodiments, the albumin concentration (w / v%) in the docetaxel aqueous composition is about 5%.

[0237] In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel aqueous composition is from about 1:10 to about 1000:1, for example, from about 10:1 to about 500:1, from about 20:1 to about 200:1, from about 50:1 to about 150:1, from about 150:1, from about 120:1, from about 100:1, from about 80:1, from about 60:1, or from about 50:1, from about 50:1 to about 1000:1, from about 50:1 to about 600:1, from about 100:1 to about 1000:1, from about 100:1 to about 600:1, from about 50:1 to about 300:1, from about 100:1, or from about 100:1 to about 1000:1. The ratios are approximately 1 to 200:1, approximately 100:1 to 300:1, approximately 200:1 to 600:1, approximately 300:1 to 800:1, approximately 50:1 to 300:1, approximately 60:1 to 150:1, approximately 80:1 to 150:1, approximately 100:1 to 150:1, approximately 120:1 to 150:1, approximately 135:1 to 150:1, approximately 140:1 to 145:1, approximately 140:1, approximately 150:1, approximately 120:1, approximately 100:1, approximately 100:1 to 600:1, and approximately 100:1 to 300:1. In some embodiments, the weight ratio of albumin to docetaxel in the docetaxel aqueous composition is approximately 140:1 to approximately 145:1.

[0238] In some embodiments, at least 80% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 90% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 92% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 94% of the albumin in the docetaxel aqueous composition is a monomer. In some embodiments, at least 95% of the albumin in the docetaxel aqueous composition is a monomer.

[0239] In some embodiments, most or all of the albumin in the docetaxel aqueous composition is dissolved in the aqueous composition. In some embodiments, at least 90% of the albumin in the docetaxel aqueous composition is dissolved in the aqueous composition. In some embodiments, at least 95% of the albumin in the docetaxel aqueous composition is dissolved in the aqueous composition.

[0240] In some embodiments, the docetaxel aqueous composition is a clear aqueous solution. In some embodiments, the clear aqueous solution remains clear for at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 6 hours, at least 8 hours, at least 24 hours, and at least 7 days. In some embodiments, when the clear aqueous solution is maintained at about 20–25°C, the clear aqueous solution remains clear for at least 1 hour and at least 7 days. In some embodiments, when the clear aqueous solution is maintained at about 2–8°C, the clear aqueous solution remains clear for at least 1 hour and at least 7 days. In some embodiments, when the clear aqueous solution is maintained at about 35–40°C, the clear aqueous solution remains clear for at least 1 hour and at least 24 hours.

[0241] In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 10, no more than 20, no more than 30, no more than 50, no more than 100, no more than 150, or no more than 2000 particles larger than 10 μm. In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 5 to no more than 10 particles larger than 25 μm. In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 5 particles larger than 15 μm. In some embodiments, 1 ml of the docetaxel aqueous composition contains no more than 20 particles larger than 25 μm.

[0242] In some embodiments, the docetaxel composition further includes one or more of a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, and a sugar or sugar alcohol. In some embodiments, the docetaxel composition further includes a water-soluble organic solvent. In some embodiments, the docetaxel composition further includes a pharmaceutically acceptable carrier. In some embodiments, the docetaxel composition further includes a pH adjuster. For example, the docetaxel composition includes docetaxel, human serum albumin, and an amino acid; the docetaxel composition includes docetaxel, human serum albumin, a pharmaceutically acceptable carrier, and a water-soluble organic solvent; the docetaxel composition includes docetaxel, human serum albumin, a water-soluble organic solvent, a pH adjuster, and a pharmaceutically acceptable carrier.

[0243] In some embodiments, the water-soluble organic solvent is selected from at least one of ethanol, acetone, and PEG (such as PEG 300, PEG 400). In some embodiments, the water-soluble organic solvent is ethanol.

[0244] In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition does not exceed 15%, for example, not more than 10%, not more than 5%, not more than 3%, not more than 2%, not more than 1.5%, not more than 1%, not more than 0.8%, not more than 0.7%, about 0.1% to about 15%, about 0.2% to about 10%, about 0.1% to about 10%, about 0.5% to about 3%, about 0.1% to about 3%, about 1% to about 5%, about 0.1% to about 5%, about 0.5% to about 5%, about 0.5% to about 10%, about 0.5% to about 3%, about 2% to about 8%, about 0.2% to about 4%, about 0.1% to about 3%, about 0.5% to about 2%, or about 0.7% to about 1.5%, about 0.5%, about 0.7%, about 0.8%, about 1%, or about 2%. In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition is about 1% to 8%. In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition is about 1% to 6%. In some embodiments, the concentration (v / v%) of ethanol in the docetaxel aqueous composition is about 3% to 4%.

[0245] In some embodiments, the volume of ethanol in the docetaxel aqueous composition does not exceed 30 ml, for example, not exceeding 25 ml, not exceeding 20 ml, not exceeding 15 ml, not exceeding 10 ml, not exceeding 7.5 ml, not exceeding 5 ml, or not exceeding 2.5 ml. In some embodiments, the volume of ethanol in the docetaxel aqueous composition does not exceed 2.5 ml.

[0246] In some embodiments, the stabilizer is selected from at least one of caprylic acid, sodium caprylate, sodium N-acetyltryptophan, and N-acetyltryptophan.

[0247] In some embodiments, the amino acid is selected from at least one of aspartic acid, glutamic acid, and cysteine.

[0248] In some embodiments, the pharmaceutically acceptable carrier is a parenteral acceptable carrier. In some embodiments, the parenteral acceptable carrier is an aqueous carrier. In some embodiments, the aqueous carrier is water for injection, physiological saline, and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline and / or glucose solution. In some embodiments, the aqueous carrier is physiological saline (e.g., 0.9% sodium chloride solution). In some embodiments, the aqueous carrier is a glucose solution (e.g., 5% glucose solution).

[0249] In some embodiments, the pH adjuster includes, but is not limited to, diethanolamine, triethanolamine, sodium hydroxide, hydrochloric acid, citric acid, and sodium dihydrogen phosphate, or mixtures thereof. In some embodiments, the pH adjuster is citric acid. In some embodiments, the pH of the docetaxel aqueous composition is about 2 to about 9. In some embodiments, the pH of the docetaxel aqueous composition is about 5 to about 9. In some embodiments, the pH of the docetaxel aqueous composition is about 5 to about 8. In some embodiments, the pH of the docetaxel aqueous composition is about 6 to about 8. In some embodiments, the pH of the docetaxel aqueous composition is about 6.5 to about 7.5. In some embodiments, the pH of the docetaxel aqueous composition is about 4 to about 9. In some embodiments, the pH of the docetaxel aqueous composition is about 4 to about 8. In some embodiments, the pH of the docetaxel aqueous composition is about 5 to about 8.5. In some embodiments, the pH of the docetaxel aqueous composition is about 6 to about 7.5.

[0250] In some embodiments, the sugar alcohol is selected from at least one of mannitol, sorbitol, inositol, and xylitol. In some embodiments, the sugar is selected from at least one of glucose, sucrose, lactose, maltose, trehalose, fructose, hexose, and raffinose.

[0251] Another aspect of this application provides a taxane composition comprising taxane, wherein the taxane composition is an aqueous taxane composition, the aqueous taxane composition being used by bladder instillation for the treatment of bladder cancer patients, wherein after administration of the aqueous taxane composition to the bladder cancer patients, the concentration of taxane in the plasma of the bladder cancer patients is at least about 0.02 ng / ml.

[0252] In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.03 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.05 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.08 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.12 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.14 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.16 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.18 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.22 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.24 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.26 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.28 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.3 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.32 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.34 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.36 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.38 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.42 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.44 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.46 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.48 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.52 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.54 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.56 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.58 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.62 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.64 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.66 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.68 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.72 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.74 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.76 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.78 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.82 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.84 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.86 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.88 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.92 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.94 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.96 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 0.98 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 5 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 10 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 20 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 25 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 30 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 40 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 100 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 200 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is at least about 300 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 500 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 400 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 300 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 200 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 100 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.03 ng / ml to about 50 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.04 ng / ml to about 40 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 30 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 20 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 10 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.12 ng / ml to about 8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.14 ng / ml to about 6 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.16 ng / ml to about 4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.18 ng / ml to about 2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.2 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.04 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.12 ng / ml to about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.14 ng / ml to about 0.3 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.16 ng / ml to about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.14 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.18 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.22 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.26 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.3 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.34 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.38 ng / ml to about 1 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.42 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.46 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.5 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.54 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.58 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.62 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.66 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.7 ng / ml to about 1 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.9 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.03 ng / ml to about 0.85 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.04 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.05 ng / ml to about 0.75 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.06 ng / ml to about 0.7 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.07 ng / ml to about 0.65 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.08 ng / ml to about 0.6 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.09 ng / ml to about 0.55 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.1 ng / ml to about 0.5 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.11 ng / ml to about 0.45 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.12 ng / ml to about 0.4 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.13 ng / ml to about 0.35 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.14 ng / ml to about 0.3 ng / ml.In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.15 ng / ml to about 0.25 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.16 ng / ml to about 0.2 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.09 ng / ml to about 0.8 ng / ml. In some embodiments, the concentration of taxane in the plasma of the bladder cancer patient is from about 0.02 ng / ml to about 0.8 ng / ml.

[0253] In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.02 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.04 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.05 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.06 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.08 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.1 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.15 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.18 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least about 0.2 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.25 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.3 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.35 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.4 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.45 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... maxAt least about 0.5 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 0.55 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.6 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.65 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.7 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.75 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.8 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.85 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 0.9 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least about 1 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 2 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 3 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 4 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 5 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 10 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 15 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 20 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 30 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 40 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 50 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is...max At least approximately 100 ng / ml. In some embodiments, the C6 of taxane in the plasma of the bladder cancer patient is... max At least approximately 150 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 200 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... max At least approximately 300 ng / ml. In some embodiments, the C60 of taxane in the plasma of the bladder cancer patient is... maxFrom about 0.02 ng / ml to about 500 ng / ml (e.g., about 0.02 ng / ml to about 400 ng / ml, about 0.02 ng / ml to about 300 ng / ml, about 0.02 ng / ml to about 200 ng / ml, about 0.02 ng / ml to about 100 ng / ml, about 0.02 ng / ml to about 50 ng / ml, about 0.02 ng / ml to about 40 ng / ml, about 0.02 ng / ml to about 30 ng / ml, about 0.02 ng / ml to about 20 ng / ml, about 0. 0.02 ng / ml to about 10 ng / ml, about 0.02 ng / ml to about 5 ng / ml, about 0.02 ng / ml to about 0.8 ng / ml, about 0.05 ng / ml to about 0.9 ng / ml, about 0.1 ng / ml to about 0.8 ng / ml, about 0.15 ng / ml to about 0.75 ng / ml, about 0.2 ng / ml to about 0.7 ng / ml, about 0.25 ng / ml to about 0.65 ng / ml, about 0.3 ng / ml to about 0.6 ng / ml, about 0.3 ng / ml From about 0.55 ng / ml, from about 0.3 ng / ml to about 0.5 ng / ml, from about 0.3 ng / ml to about 0.45 ng / ml, from about 0.3 ng / ml to about 0.4 ng / ml, from about 0.25 ng / ml to about 0.6 ng / ml, from about 0.25 ng / ml to about 0.55 ng / ml, from about 0.25 ng / ml to about 0.5 ng / ml, from about 0.25 ng / ml to about 0.45 ng / ml, from about 0.25 ng / ml to about 0.4 ng / ml, from about 0.2 ng / ml to about The concentrations of taxane in the plasma of bladder cancer patients range from 80% to 125% of the concentrations of 0.65 ng / ml, about 0.2 ng / ml to about 0.6 ng / ml, about 0.2 ng / ml to about 0.55 ng / ml, about 0.2 ng / ml to about 0.5 ng / ml, about 0.2 ng / ml to about 0.45 ng / ml, about 0.2 ng / ml to about 0.4 ng / ml, about 0.15 ng / ml to about 0.45 ng / ml, about 0.15 ng / ml to about 0.35 ng / ml, and about 0.15 ng / ml to about 0.3 ng / ml. In some embodiments, the C60 of taxane in the plasma of bladder cancer patients is... max Within the range of 80% to 125% of about 0.02 ng / ml to about 50 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max Within the range of 80% to 125% of about 0.02 ng / ml to about 1 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... maxWithin the range of 80% to 125% of about 0.05 ng / ml to about 0.8 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max Within the range of 80% to 125% of about 0.3 ng / ml to about 0.4 ng / ml. In some embodiments, the C of taxane in the plasma of the bladder cancer patient is... max In the range of 80% to 125% of about 0.15 ng / ml to about 0.3 ng / ml.

[0254] In some embodiments, the T of taxane in the plasma of the bladder cancer patient is... max From approximately 0.05 hours to approximately 10 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.1 hours to approximately 5 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.2 hours to approximately 4 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.3 hours to approximately 3 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From approximately 0.4 hours to approximately 2.1 hours. In some embodiments, the T value of taxane in the plasma of the bladder cancer patient is... max From about 0.5 hours to about 2 hours, for example from about 0.6 hours to about 1.8 hours, from about 0.7 hours to about 1.6 hours, from about 0.8 hours to about 1.4 hours, from about 0.9 hours to about 1.2 hours, and from about 0.9 hours to about 1.1 hours.

[0255] In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 0.01 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 0.02 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 0.04 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 0.05 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 0.08 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 0.1 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24hAt least approximately 0.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 1 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 1.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 1.8 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 2 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 2.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 3 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 6.5 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 10 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 15 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 20 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 25 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 30 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 40 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least approximately 50 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 0.01 h*ng / mL to approximately 5000 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24hWithin the range of approximately 0.02 h*ng / mL to approximately 2500 h*ng / mL, the AUC of taxane in the plasma of the bladder cancer patient is [not specified]. 0-24h Within the range of 80% to 125% of approximately 0.02 h*ng / mL to approximately 1000 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of approximately 0.02 h*ng / mL to approximately 500 h*ng / mL, the AUC of taxane in the plasma of the bladder cancer patient is [not specified]. 0-24h Within the range of approximately 0.03 h*ng / mL to approximately 400 h*ng / mL, the AUC of taxane in the plasma of the bladder cancer patient is [not specified]. 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 300 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of approximately 0.04 h*ng / mL to approximately 100 h*ng / mL, the AUC of taxane in the plasma of bladder cancer patients is between 80% and 125%. In some embodiments, the AUC of taxane in the plasma of bladder cancer patients is... 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 50 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 40 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 30 h*ng / mL. In some embodiments, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h Within the range of 80% to 125% of approximately 0.04 h*ng / mL to approximately 20 h*ng / mL. In some embodiments, the AUC of taxane in the plasm...

Claims

1. A taxane composition, wherein, The taxane composition comprises taxane, the taxane composition is an aqueous taxane composition, the aqueous taxane composition is used for the treatment of bladder cancer patients via bladder instillation, and the aqueous taxane composition has at least one of the following characteristics: In the aqueous taxane composition, at least about 5%, at least about 10%, at least about 20%, at least about 40%, at least about 50%, about 10% to about 90%, about 20% to about 75%, about 30% to about 70%, about 40% to about 65%, or about 55% to about 65% of the taxane is free taxane; The concentration of free taxane in the aqueous taxane composition is about 0.01 mg / ml to about 0.8 mg / ml, about 0.05 mg / ml to about 0.55 mg / ml, about 0.1 mg / ml to about 0.4 mg / ml, about 0.2 mg / ml to about 0.25 mg / ml, about 0.2 mg / ml, about 0.25 mg / ml, about 0.3 mg / ml, about 0.35 mg / ml, about 0.4 mg / ml, about 0.5 mg / ml, or about 0.55 mg / ml.

2. A taxane composition, wherein, The taxane composition comprises taxane, the taxane composition is an aqueous taxane composition, the aqueous taxane composition is used for the treatment of bladder cancer patients by bladder instillation, and after administration of the aqueous taxane composition to the bladder cancer patient, the taxane in the plasma of the bladder cancer patient has at least one of the following characteristics: The concentration of taxane in the plasma of the bladder cancer patient is at least about 0.02 ng / ml, at least about 0.1 ng / ml, at least about 0.5 ng / ml, at least about 5 ng / ml, at least about 10 ng / ml, about 0.02 ng / ml to about 100 ng / ml, about 0.08 ng / ml to about 20 ng / ml, about 0.05 ng / ml to about 1 ng / ml, about 0.02 ng / ml to about 1 ng / ml, or about 0.02 ng / ml to about 0.8 ng / ml; The AUC of taxane in the plasma of the bladder cancer patients was at least about 0.02 h*ng / mL.

3. The taxane composition according to claim 1 or 2, wherein, The taxane composition also includes albumin; Optionally, the amount of taxane in the taxane composition is about 1 mg to about 500 mg, about 1 mg to about 200 mg, about 10 mg to about 75 mg, about 15 mg to about 20 mg, about 12.5 mg to about 22.5 mg, about 10 mg to about 25 mg, about 7.5 mg to about 37.5 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg; Optionally, the concentration of taxane in the aqueous taxane composition is about 0.01 mg / mL to about 10 mg / mL, about 0.05 mg / mL to about 8 mg / mL, about 0.2 mg / mL to about 5 mg / mL, about 0.3 mg / mL to about 3 mg / mL, about 0.33 mg / mL to about 1 mg / mL, about 0.34 mg / mL to about 0.5 mg / mL, or about 0.33 mg / mL to about 0.37 mg / mL; Optionally, the concentration (w / v%) of albumin in the taxane aqueous composition is about 0.001% to about 25%, about 0.01% to about 20%, about 0.1% to about 15%, about 1% to about 10%, about 2% to about 8%, about 4% to about 6%, about 4.5% to about 5.5%, or about 5%. Optionally, the weight ratio of albumin to taxane in the taxane composition is about 1:10 to about 1000:1, about 10:1 to about 600:1, about 50:1 to about 200:1, about 100:1 to about 160:1, about 120:1 to about 150:1, about 130:1 to about 155:1, about 135:1 to about 150:1, or about 140:1 to about 145:

1. Optionally, the taxane composition further includes one or more of the following: a water-soluble organic solvent, a stabilizer, an amino acid, a pharmaceutically acceptable carrier, a pH adjuster, a sugar, and a sugar alcohol. Optionally, the pH value of the taxane aqueous composition is about 2 to about 9, about 2 to about 8.5, about 2 to about 7, about 2 to about 6, about 5 to about 7, or about 6.5 to about 7.5; Optionally, the taxane aqueous composition is a dispersion, suspension, or solution, such as a clear aqueous solution.

4. The taxane composition according to claim 3, wherein, The taxane is paclitaxel, docetaxel, or cabazitaxel, and the taxane is further described as docetaxel; Optionally, the taxane composition further includes a water-soluble organic solvent, a pharmaceutically acceptable carrier, and a pH adjuster; Optionally, the water-soluble organic solvent is selected from at least one of ethanol, acetone, and polyethylene glycol; Optionally, the pharmaceutically acceptable carrier is a parenteral acceptable carrier; Optionally, the parenteral carrier is an aqueous carrier; Optionally, the aqueous carrier is one or more of water for injection, physiological saline, and glucose solution; Optionally, the pH adjuster is citric acid.

5. The taxane composition according to any one of claims 1-4, wherein, The taxane composition may be administered alone or in combination with other antitumor drugs. Optionally, the other antitumor drugs mentioned are one or more of gemcitabine, mitomycin, epirubicin, BCG, and pembrolizumab; Optionally, the administration is by injection into the upper urinary tract; Optionally, the administration is performed after tumor resection in the bladder; Optionally, each application cycle of the taxane composition is at least 1-180 days, at least 2 days, at least 3 days, at least 5 days, at least 7 days, at least 14 days, at least 21 days, at least 28 days, at least 1 month, at least 35 days, or at least 42 days; Optionally, the unit dose of taxane in the taxane composition is about 1 mg to about 500 mg, about 5 mg to about 90 mg, about 12.5 mg to about 70 mg, about 15.5 mg to about 65 mg, about 17.5 mg to about 60 mg, about 20 mg to about 55 mg, about 22.5 mg to about 50 mg, about 25 mg to about 45 mg, about 27.5 mg to about 40 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, or about 20 mg; Optionally, the dosage of taxane in the taxane composition is about 1 to about 500 mg / dose, about 10 to about 75 mg / dose, about 12.5 to about 70 mg / dose, about 15.5 to about 65 mg / dose, about 20 to about 55 mg / dose, about 22.5 to about 50 mg / dose, about 25 to about 45 mg / dose, about 27.5 to about 40 mg / dose, about 10 mg / dose, about 12.5 mg / dose, about 15 mg / dose, about 17.5 mg / dose, or about 20 mg / dose; Optionally, after administration of the taxane aqueous composition to the bladder cancer patient, the C60 of taxane in the plasma of the bladder cancer patient is reduced. max At least about 0.02 ng / ml, at least about 0.05 ng / ml, at least about 0.1 ng / ml, at least about 0.15 ng / ml, at least about 0.3 ng / ml, at least about 0.5 ng / ml, about 0.05 ng / ml to about 0.8 ng / ml, about 0.3 ng / ml to about 0.4 ng / ml, or about 0.15 ng / ml to about 0.3 ng / ml; Optionally, after administration of the taxane aqueous composition to the bladder cancer patient, the T value of taxane in the plasma of the bladder cancer patient is [not specified]. max The durations are approximately 0.05 hours to approximately 10 hours, approximately 0.5 hours to approximately 2 hours, approximately 0.8 hours to approximately 1.4 hours, approximately 0.9 hours to approximately 1.2 hours, and approximately 0.9 hours to approximately 1.1 hours. Optionally, after administration of the taxane aqueous composition to the bladder cancer patient, the AUC of taxane in the plasma of the bladder cancer patient is... 0-24h At least about 0.02 h*ng / mL, at least about 0.04 h*ng / mL, at least about 0.1 h*ng / mL, at least about 0.5 h*ng / mL, at least about 1 h*ng / mL, at least about 2 h*ng / mL, at least about 3 h*ng / mL, about 0.04 h*ng / mL to about 10 h*ng / mL, about 0.1 h*ng / mL to about 9 h*ng / mL, about 1 h*ng / mL to about 6 h*ng / mL, about 2 h*ng / mL to about 3 h*ng / mL, about 1.2 h*ng / mL to about 1.7 h*ng / mL, about 1.2 h*ng / mL to about 3.5 h*ng / mL; Optionally, after administration of the taxane aqueous composition to the bladder cancer patient, the AUC of taxane in the plasma of the bladder cancer patient is... 0-∞ At least about 0.02 h*ng / mL, at least about 0.1 h*ng / mL, at least about 1 h*ng / mL, at least about 2 h*ng / mL, about 0.1 h*ng / mL to about 10 h*ng / mL, about 1 h*ng / mL to about 6 h*ng / mL, about 2.5 h*ng / mL to about 3.5 h*ng / mL, about 2 h*ng / mL to about 4 h*ng / mL, about 2 h*ng / mL to about 2.5 h*ng / mL; Optionally, after administration of the taxane aqueous composition to the bladder cancer patient, the T value of taxane in the plasma of the bladder cancer patient is [not specified]. 1 / 2 From about 0.1 hours to about 50 hours, from about 2 hours to about 9.5 hours, from about 3 hours to about 7 hours, from about 4 hours to about 6 hours, from about 5 hours to about 6 hours, from about 5 hours to about 6.5 hours, from about 5.5 hours to about 6.5 hours, from about 4 hours to about 6.5 hours, and from about 4.5 hours to about 6.5 hours.

6. A method for preparing the taxane aqueous composition according to any one of claims 1-5, comprising the following steps: A first liquid composition containing taxane and a second liquid composition are mixed to obtain the taxane composition; wherein the second liquid composition comprises water; Optionally, the second liquid composition further includes albumin.

7. Use of the taxane composition according to any one of claims 1-5 or the taxane composition prepared by the method according to claim 6 in the preparation of a medicament for the treatment of bladder cancer by bladder instillation.

8. Use of the taxane composition according to any one of claims 1-5 or the taxane composition prepared by the method according to claim 6 in the treatment of bladder cancer by bladder instillation.

9. A method for treating an individual with bladder cancer via bladder instillation, the method comprising administering to the individual with a therapeutic amount of the taxane composition as described in any one of claims 1-5 or the taxane composition prepared by the method of claim 6.

10. The taxane composition according to any one of claims 1-5, the taxane composition prepared by the method according to claim 6, the use according to claim 7 or 8, or the method according to claim 9, wherein, The bladder cancer described is non-muscle-invasive bladder cancer; Optionally, the non-muscle-invasive bladder cancer includes low-risk non-muscle-invasive bladder cancer, intermediate-risk non-muscle-invasive bladder cancer, high-risk non-muscle-invasive bladder cancer, non-muscle-invasive bladder cancer that has failed standard intravesical instillation (intravesical) therapy, and non-muscle-invasive bladder cancer that has failed BCG therapy, such as high-risk non-muscle-invasive bladder cancer that has failed BCG therapy, high-risk non-muscle-invasive bladder cancer that is BCG refractory, high-risk non-muscle-invasive bladder cancer that is BCG resistant, high-risk non-muscle-invasive bladder cancer that has relapsed after BCG therapy, high-risk non-muscle-invasive bladder cancer that is not responsive to BCG, and high-risk non-muscle-invasive bladder cancer that is intolerant to BCG.

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