Treatment of bladder cancer by local administration of taxane particles
A taxane and bladder cancer technology, applied in medical preparations with non-active ingredients, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as inability to obtain survival rates
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Embodiment 1
[0295] The preparation of embodiment 1 paclitaxel granules and docetaxel granules
[0296] Materials and methods
[0297] Raw material paclitaxel and docetaxel were purchased from Phyton Biotech (British Columbia, Canada) with lot numbers FP2-15004 and DT7-14025, respectively. Both are in their original form. Milling of both drugs was done using a Deco-PBM-V-0.41 mill (Deco). The milling conditions for the two compounds were as follows:
[0298] Ball diameter = 5mm;
[0299] RPM = 600;
[0300] Processing time = 60min;
[0301] room temperature.
[0302] Preparation of Paclitaxel Granules
[0303] A 65 mg / ml solution of paclitaxel was prepared in acetone. Will BETE The spray nozzle (produced by BETE FogNozzle, Inc) and the acoustic wave probe (Qsonica, model number Q700) were placed in the crystallization chamber with a distance of about 8 mm. A stainless steel mesh filter with pores of about 100 nm was installed on the crystallization chamber to collect the precipi...
Embodiment 2
[0337] Example 2. Pilot Evaluation Study of Direct Injection of Dye into Rabbit Bladder Wall
[0338] A study was performed to evaluate the injection of blue tissue dye in a vehicle formulation directly into the bladder wall of rabbits (intratumoral injection). Injection into the bladder wall is the administration of nDoce (docetaxel nanoparticles as disclosed herein, the purity of the docetaxel used in this example is about 99%, the average particle size (number) is 1.078 μm, and the SSA is 37.2 μm in the human body. 2 / g, the bulk density (uncompacted) is 0.0723g / cm 3 ) expected route of the suspension. Due to the similarity in bladder wall musculature and bladder size, rabbits are a suitable species for research. The vehicle formulation contained 0.4% w / w polysorbate 80NF, 3.2% w / w ethanol (200 proof), prepared in sterile saline solution (0.9% sodium chloride injection, USP). Add 10 mg / ml Evans blue tissue dye to the vehicle, which is sufficient for visualization.
[03...
Embodiment 3
[0341] Example 3. nDoce single-dose intratumoral toxicity ranging and toxicokinetic study in mice
[0342] Non-GLP studies were performed to evaluate and characterize the experimental sample nDoce (docetaxel nanoparticles as disclosed herein, the purity of docetaxel used in this example was about 99%, the average particle size (number) was 1.078 μm, and the SSA was 37.2m 2 / g, the bulk density is 0.0723g / cm 3 ) toxicity and toxicokinetics, and intratumoral administration to [Contrast: (SD)] Retrovesical assessment of maximum tolerated dose (MTD) in female mice. The intratumoral route is the intended route of administration of nDoce suspension in humans. Mice are a commonly used rodent model for assessing the toxicity of various chemicals, and there are extensive historical databases. Female mice were chosen for this study considering the ease of urethral catheterization in female versus male mice. Animals were maintained in a post-dose recovery period of 72 hours or 14...
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