23 results about "Tonicity" patented technology

Disclosed herein is a stable oxytocin composition having between about 0.04 and 0.08 IU / mL of oxytocin and / or a pharmaceutically acceptable salt thereof, a buffer comprising sodium acetate trihydrate and acetic acid, a tonicity adjusting agent comprising sodium chloride, a pH adjusting agent comprising acetic acid, sodium hydroxide, or a combination thereof, and water, the composition having a total impurities concentration of equal to or less than 16% after storage of at least six months at 25° C. Also disclosed herein is a pharmaceutical product having a single-use container containing the sterile and storage-stable liquid composition of the present disclosure.

An aqueous solution composition having a pH in the range of 4.0 to 8.5, comprising: an antibody construct comprising an Fc domain; optionally, one or more buffering agents which are a substance having at least one ionizable group, have a pKa in the range of 3.0 to 9.5, and have a pKa within 2 pH units of the pH of the composition; optionally, one or more neutral amino acids; and an uncharged tension regulator; wherein the total concentration of the buffer in the composition is 0-5 mM; and wherein the composition has a total ionic strength of less than 20 mM, excluding the contribution of engineered protein constructs.

An aqueous pharmaceutical composition suitable for parenteral administration and having enhanced storage stability includes between about 0.1 mg / mL and about 40 mg / mL micafungin; (ii) between about 0.1 mM and 400 mM buffering agent; and (iii) between about 0 mg / mL and about 500 mg / mL tonicity adjusting agent, wherein the pH of the composition is between about 3.0 and 7.0, for example, between about 3.5 and 7.0.

Disclosed herein is a stable oxytocin composition having between about 0.01 and 0.07 IU / mL of oxytocin and / or a pharmaceutically acceptable salt thereof, one or more tonicity adjusting agents, a buffer, one or more pH adjusting agents, and water, the composition having a total impurities concentration of equal to or less than 16% after storage of at least six months at 25° C. Also disclosed herein is a pharmaceutical product having a single-use container containing the sterile and storage-stable liquid composition of the present disclosure.

The present invention relates to the use of a liquid aqueous composition comprising a tonicity agent, a buffering agent, a non-ionic surfactant and a polysaccharide, and having a pH of from 5 to 7, for solubilization and stabilization of an antibody-drug conjugate during a period T equal or greater than 3 months at a temperature Θ of from 2° C. to 8° C.

A stable pharmaceutical formulation comprising: an antibody comprising a polypeptide having a canine CH2, CH3, IgG Fc region variant, or a canine FcRn-binding region thereof; a buffering agent at a pH in the range of from 4.5 to 7. 0; a tonicity and / or stabilizing agent; a chelating agent; and a surfactant; wherein the formulation retains stability for up to twenty-four months in solution and is suitable for oral, rectal, transmucosal, intestinal, or parenteral administration.

An aqueous solution composition of pH in the range 4.0-8.5 comprising:an antibody construct comprising an Fc domain;optionally one or more buffers being substances having at least one ionisable group with a pKa in the range 3.0 to 9.5 and which pKa is within 2 pH units of the pH of the composition;optionally one or more neutral amino acids; andan uncharged tonicity modifier;wherein the buffers are present in the composition at a total concentration of 0-5 mM; andwherein the total ionic strength of the composition excluding the contribution of the engineered protein construct is less than 20 mM.

An aqueous formulation includes a PEDF-derived short peptide (PDSP) having the sequence of one of SEQ ID NO: 1, 2, 3, 5, 6, 8, or 9; histidine having a concentration of 1 mM – 100 mM; and an antioxidant and optionally a non-ionic tonicity agent. The pH value is around 5–9. The antioxidant is nicotinamide, which is at a concentration of 50 mM – 1000 mM. The non-ionic tonicity agent is sorbitol, which is at a concentration of 0 mM – 500 mM. A concentration of the PDSP is 0.01% - 1% w / v.

The present invention provides a formulation that includes a therapeutically effective amount of phenylephrine or a pharmaceutically acceptable salt thereof, and a method for preparing the formulation. In some embodiments, the formulation includes a tonicity agent, a citrate buffer, water, and has an initial pH of from 5.6 to 6.0. In other embodiments, the formulation includes a tonicity agent, a citrate buffer, an antioxidant, water, and has an initial pH of from 3.6 to 4.8. The formulation of the invention is sterile, stable, ready-to-administer and packaged into a polymeric syringe.

The present invention relates to a liquid formulation comprising (i) botulinum toxin, (ii) human serum albumin (HSA), and optionally (iii) a tonicity agent and / or (iv) a buffering agent. In one aspect, the liquid formulation is characterized by a very low iron ion concentration. In another aspect, liquid formulation is characterized by the absence or very low concentration of tryptophan and / or N-acetyl-tryptophan. According to the present invention, the liquid formulation can be prepared by a method comprising the steps of contacting human serum albumin with a chelating agent to obtain a mixture and removing the chelating agent from the mixture. Furthermore, the present invention relates to the use of the liquid formulation in the treatment of therapeutic indications and cosmetic conditions.

Aspects of the invention can include a composition including an N,N-Dimethyltryptamine base in the range of 0.5-5 mg / mL, a buffer component with acidic acid in the range of 2-15 mM, a cyclodextrin component in the range of 5-15 mM, and a solubilizer component in the range of 1-5 mM; The composition can also include a tonicity agent, wherein the tonicity agent causes an osmolarity of the composition to be in the range of 250-600 mOsm / kg, wherein the composition has a pH in the range of 3-6.

A test method determines at least one status parameter of an individual undergoing peritoneal dialysis. The status parameter(s) may include a transport property of the peritoneum, a tonicity, or a residual volume. The test method includes receiving first data indicative of a flow rate as a function of time of a treatment fluid into and out of a peritoneal cavity during a test procedure, and second data comprising measured data samples representing a concentration of one or more solutes in the treatment fluid at time points during the test procedure. The test method also includes computing, based on the first data and by use of a transport model for a peritoneal membrane, estimated data samples representing the concentration of the one or more solutes in the treatment fluid at the time points and determining the status parameter(s) as a function of the measured data samples and the estimated data samples.

A triamcinolone acetonide pharmaceutical composition and a preparation method therefor. The pharmaceutical composition contains the following ingredients: (i) a triamcinolone acetonide active ingredient, (ii) hyaluronic acid or a salt thereof. (iii) a buffering agent; and (iv) a tonicity adjustment agent. The pharmaceutical composition has a suitable viscosity, osmotic pressure and particle size range and is easily injected, especially administrated by means of a suprachoroidal space injection.

A nuclear magnetic resonance (NMR) system measures an effective osmolarity or tonicity and characterizes the effective osmolarity or tonicity's effect on water exchange in a specimen. The NMR system includes a magnetic resonance (MR) device, which has: a magnetic field generator; a magnetic field gradient generator; a radio frequency (RF) transmitter; and a RF receiver. The NMR system also includes a processing system coupled to the MR device. The processing system is configured to: receive sample NMR data from the MR device, the sample NMR data corresponding to the specimen; estimate an exchange rate from the NMR data, the exchange rate corresponding to the water exchange through a semipermeable membrane of the specimen; and estimate the effective osmolarity or tonicity based on the estimated exchange rate.

Slurries comprise liquid water, about 2% to about 70% ice by volume, and one or more additives affecting flowability and / or tonicity of the slurry. Solutions for making a slurry comprise liquid water and one or more additives affecting flowability of the slurry. Flowability of the slurry relates to ice particles capable of flowing through a cannula, such as a needle. The slurry is suitable for injection into subcutaneous fat of a human subject for removal of adipose tissue.

The present invention relates to Human Immunodeficiency Virus (HIV) prevention and treatment. In particular, the invention relates to a pharmaceutical composition comprising: cabotegravir, a wetting agent; a stabilizer, and a tonicity adjuster, wherein cabotegravir is present in the form of particles having a mass median diameter (X50) of between (and including) 2.5 μm and 10 μm.

The present invention relates to a liquid formulation comprising (i) a botulinum toxin, (ii) human serum albumin (HSA), (iii) hyaluronic acid, (iv) a sugar alcohol, and optionally (v) a tonicity agent and / or (vi) a buffer. In a preferred embodiment, the HSA has been treated with a chelating agent. Furthermore, the present invention relates to the use of said liquid formulation in the treatment of therapeutic and cosmetic indications.

Disclosed herein are compositions comprising a CD38-binding fusion protein, a buffer (e.g., a histidine / histidine-HCl buffer), a tonicity agent (e.g., arginine-HCl), a stabilizer (e.g., sucrose), and a surfactant (e.g., polysorbate such as polysorbate 80). In some aspects, the compositions described herein provide for stable storage of the CD38-binding fusion protein when lyophilized. Methods of treating cancer (e.g., CD38 positive cancer) using the composition described herein are also provided.

The invention provides a stable, pharmaceutical formulation comprising epinephrine or a pharmaceutically acceptable salt thereof. The formulation includes an organic acid, a tonicity agent, and water, has a pH of about 3.0 to about 3.6, and is substantially free of a conjugate base of the organic acid.

Disclosed herein are pharmaceutical compositions comprising (a) a fluorescein labeled nerve targeting peptide of formula (I) or a pharmaceutically acceptable salt, solvate, hydrate, isomer, tautomer, racemate or isotope thereof: (I) (b) an additive comprising a pH regulator, a buffer, a filler, a tonicity regulator, a preservative, or any combination thereof; and (c) an aqueous vehicle wherein the pH of the composition is from about 7 to about 9 and the concentration of the peptide in the aqueous composition is from about 25 mg / mL to about 200 mg / mL based on the total volume of the aqueous composition. Also disclosed are methods for making and using the pharmaceutical compositions described herein.

An aqueous pharmaceutical composition suitable for parenteral administration and having enhanced storage stability includes between about 0.1 mg / mL and about 40 mg / mL micafungin; (ii) between about 0.1 mM and 400 mM buffering agent; and (iii) between about 0 mg / mL and about 500 mg / mL tonicity adjusting agent, wherein the pH of the composition is between about 3.0 and 7.0, for example, between about 3.5 and 7.0.

Disclosed herein is a method for the preparation of a pharmaceutical composition comprising a GLP-1 agonist, a tonicity modifier, a buffering agent and a preservative which comprises the following steps: preparing a final solution comprising the tonicity modifier, the buffering agent, the preservative, the GLP-1 agonist and water for injection; and adjusting the pH of the final solution between 7.5-8.5 with a pH adjuster; wherein the final solution is prepared at a temperature between 2-15° C.

Disclosed herein are pharmaceutical compositions containing (a) a fluorescein-labeled nerve targeting peptide of formula (I): or pharmaceutically acceptable salt, solvate, hydrate, isomer, tautomer, racemate, or isotope thereof; (b) an additive comprising a pH-adjusting agent, a buffering agent, a bulking agent, a tonicity-adjusting agent, a preservative, or any combination thereof; and (c) an aqueous vehicle, wherein a pH of the composition ranges from about 7 to about 9, and a concentration of the peptide in the aqueous composition ranges from about 25 mg / mL to about 200 mg / mL, based on a total volume of the aqueous composition. Also disclosed are methods for preparing and using the pharmaceutical compositions described herein.