47 results about "Polysorbate 20" patented technology

The present disclosure provides an IL-6 formulation, comprising about 40 μg / mL to about 2 mg / ml IL-6, about 5 to about 15 mM histidine, about 5 to about 15 mg / mL glycine, about 40 to about 60 mg / mL trehalose, about 0.1 to about 0.3 mg / mL polysorbate 20, and about 1 to about 1000 μM DTPA, wherein the formulation has a pH of about 6.0 to about 8.0. Such formulations may be useful to treat and / or prevent a disease or disorder in a subject in need thereof.

The present disclosure relates to formulations comprising a protein comprising an Fc region (e.g., an antibody) and a surfactant such as a polysorbate (e.g., Polysorbate 20), and methods of purifying such proteins that improve stability of the surfactant such as a polysorbate in such formulations.

Pharmaceutical aerosol formulations containing pre-micronized albuterol sulfate, high amount of green propellant trans-1,3,3,3-tetrafluoropropene (HFO-1234ze(E)), and a surfactant (polysorbate 80 (polyoxyethylene (20) sorbitan monooleate), polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate), polyethylene glycol 1000, span 85 (sorbitan trioleate), polyvinylpyrrolidone K25, or their combination) in a pressurized metered dose inhaler are described. The formulations do not use any co-solvent, i.e., they are co-solvent-free (e.g., free of ethanol, glycerol, propylene glycol, and a combination thereof). The formulations provide highly efficient delivery, through metered dose inhaler (MDI), of pre-micronized albuterol particles into the patients' respiratory tracts and have the advantages of high efficacy, improved safety, and a low global warming potential (GWP) for environmental impact.

The invention relates to a detection method, in particular to a method for detecting aldehyde impurities in polysorbate 20. According to the method, interference caused by the purity of 2, 4-dinitrophenylhydrazine is avoided, derivatization of a reference substance is performed by adopting a method synchronously operating with a test sample, eight aldehyde ketone substances can be detected at the same time, and compared with literature methods, the method is high in specificity, good in precision, high in accuracy, simple and easy to implement and high in operability.

The application belongs to the technical field of biological medicine, and particularly relates to a freeze-dried preparation based on synergistic effect of trehalose and arginine for optimizing the performance of omalizumab reconstitution and a preparation method thereof. The preparation method comprises the following steps: preparing a histidine-hydrochloric acid buffer, dissolving omalizumab, trehalose, arginine and polysorbate 20 in the histidine-hydrochloric acid buffer to prepare a solution preparation; and freeze-drying the solution preparation to obtain the freeze-dried preparation; wherein the molar concentration ratio of trehalose to arginine in the solution preparation is 10-90:15-55. The freeze-dried preparation obtained by using the preparation method has a fast reconstitution speed and a fast bubble disappearance speed during reconstitution, can save time, meets the clinical emergency drug demand, and is more convenient to use.

The present invention relates to a liquid composition for stabilizing botulinum toxin, and it was confirmed that a stabilizer comprising a non-ionic surfactant, an amino acid, and disaccharides as active ingredients can significantly increase the stability of botulinum toxin. Specifically, in the present invention, polysorbate 20, histidine, and disaccharides are combined, and the concentration conditions of each ingredient were established to prepare the optimal stabilizer through the combination. Thus, it is possible to prepare a botulinum toxin liquid formulation with low cytotoxicity and increased stability without containing animal-derived substances, and therefore the present invention can be used in various fields using botulinum toxin.

The present invention provides stable, pure and potent compositions optimized for administration to neonates and / or preterm infants, and use of the same in methods for treating intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), and / or chronic lung disease of prematurity (CLD), comprising administering to a subject in need of treatment a pharmaceutical composition comprising insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3), and a polysorbate 20 surfactant at high effective doses in low volumes in an infant resulting high serum IGF-1 exposure and treatment of IVH, BPD and / or CLD. In some aspects, provided herein are methods for manufacturing the compositions comprising a single-use bag, wherein the compositions have improved stability, reduced oxidation and increased potency. In some aspects, the methods provided result in reduced incidence of symptoms and features of intraventricular hemorrhage, bronchopulmonary dysplasia, right ventricular hypertrophy (RVH), pulmonary hypertension (PH), necrotizing enterocolitis, or chronic lung disease of prematurity.

This invention provides an improved formulation and administration method of an FcRn inhibitor for use in the treatment of autoimmune diseases. [Solution] An aqueous formulation containing approximately 100-300 mg / mL of an FcRn antagonist, 20-60 mM histidine / histidine HCl, 0-70 mM sucrose, 0-150 mM NaCl, 0-250 mM arginine HCl, 0%-0.05% (w / v) polysorbate 20 or polysorbate 80, and 0-15 mM L-methionine. The aqueous formulation has a pH of 6.0-6.5, and the FcRn antagonist consists of a variant Fc region, which consists of two Fc domains that form a homodimer.

The invention provides a rivastigmine new-form salt compound and a preparation method of a rivastigmine new-form salt compound preparation. The rivastigmine new-form salt compound is prepared from the following rivastigmine salt and auxiliary materials in percentage by mass: 1.5%-3% of rivastigmine salt, 5%-10% of polysorbate 20, 1%-8% of polyethylene glycol-4000, 0.15%-1.5% of citric acid, 0.5%-1.0% of anhydrous disodium hydrogen phosphate, 0.1%-0.5% of sodium hydroxide and 80%-90% of water for injection. The invention also discloses a method for preparing a preparation by using the compound. The preparation process of the preparation disclosed by the invention is simple, is suitable for large-scale production of enterprises, and has great market development prospects. The preparation disclosed by the invention adopts a new administration mode, and the characteristics of the preparation are utilized, so that the medicine is slowly dissolved out subcutaneously; therefore, the purpose of reducing side effects of intestinal tracts is achieved. The preparation disclosed by the invention is stable in blood concentration and good in tolerance.

The invention discloses an ellagic acid composite solid dispersion and a preparation method thereof. The preparation method comprises the following steps: S1, respectively preparing a fucoidin aqueous solution and an ellagic acid ethanol suspension; s2, mixing the two solutions to obtain a mixed solution; s3, adding the modified polysorbate 20 and the chitosan-CPP compound, and performing ultrasonic stirring; s4, ball milling; and S5, carrying out reduced pressure rotary evaporation to remove the solvent, drying, crushing, and sieving with a 100-mesh sieve to obtain the product. Ternary synergistic compounding is formed through the fucoidin-modified polysorbate 20-chitosan-CPP compound, a multi-dimensional molecular interaction network is constructed, and the effect of remarkably improving the water solubility and dispersion stability of ellagic acid is achieved; wherein xylooligosaccharide branched chains of the modified polysorbate 20, hydroxyl groups of the fucoidin and phosphate groups of the chitosan-CPP compound form a multi-point hydrogen bond cross-linked structure through hydrogen bonds, and the hydrophobic association effect and lattice stacking among ellagic acid molecules are broken through the steric hindrance effect.

The present invention provides pneumococcal conjugate vaccine formulations comprising surfactant systems incorporating polysorbate 20 or a combination of a poloxamer and a polyol.

Provided are the compositions (e.g., pharmaceutical compositions) of coagulation factor X activator (FX activator, e.g., RVV-X) comprising sucrose, histidine, polysorbate 20, and mannitol, and uses of FX activators (e.g., RVV-X) or compositions (e.g., pharmaceutical compositions) thereof for treating a bleeding disorder (e.g., hemophilia) in an individual (e.g., human).

The present disclosure relates to formulations comprising a protein having an Fc region (e.g., an antibody) and a surfactant such as polysorbate (e.g., polysorbate 20), and methods of purifying the protein that improve the stability of the surfactant such as polysorbate in the formulation.

The present invention relates to the field of pharmacy and medicine, i.e. To compositions of quick-acting, injectable insulin formulations. More specifically, the present invention relates to a composition comprising insulin aspart, a nicotinic acid compound, a surfactant selected from poloxamer 188, polysorbate 20, polysorbate 80, or a combination thereof, and an amino acid selected from lysine, arginine, and / or a salt thereof, and / or a combination thereof. The compositions of the present invention are useful for reducing blood glucose levels in subjects, particularly suitable for insulin formulations requiring high stability against thermal and / or physical and mechanical stresses.

The invention discloses a ketotifen fumarate nasal spray. The ketotifen fumarate nasal spray comprises ketotifen fumarate, water, a stabilizer ergothioneine and isopropanol, and an absorption enhancer polysorbate 20. According to the ketotifen fumarate nasal spray, ergothioneine and isopropanol are used as stability, so that the problem that the drug stability is reduced after an absorption enhancer is added can be solved, the ketotifen fumarate nasal spray enters the brain after passing through the nasal cavity and can quickly take effect, and the sleep promoting effect is remarkably improved.

The present invention provides a stable high-concentration anti-PD-1 antibody pharmaceutical formulation, which comprises an anti-PD-1 antibody, histidine-histidine hydrochloric acid, proline, methionine, polysorbate 20 or polysorbate 80, and optional arginine or arginine hydrochloric acid, with a pH value of 5.0-6.0. The present invention further provides use of the anti-PD-1 antibody pharmaceutical formulation in preparing a drug for treating cancers.

The present disclosure provides polysorbate 20 compositions with particular fatty acid ester concentrations. In some embodiments, they may be used in pharmaceutical formulations, for example, to improve stability.

To provide pharmaceutical compositions of ANTI-191P4D12 antibody drug conjugates.SOLUTION: A pharmaceutical composition comprises an antibody drug conjugate comprising an antibody or antigen binding fragment thereof that binds to 191P4D12 conjugated to one or more units of monomethyl auristatin E (MMAE) and a pharmaceutically acceptable excipient comprising L-histidine, polysorbate-20 (TWEEN-20(R)), and at least one of trehalose dihydrate and sucrose.SELECTED DRAWING: Figure 1A

The application discloses an anti-EGFR antibody eye injection, which comprises an anti-EGFR antibody with a final concentration of 1-100 mg / mL, 0.25-1 mg / mL polysorbate 20, 1-5 mg / mL buffer, 0.1-1 mg / mL isotonicity regulator, 30.0-40 mg / mL sucrose and 5-10 mg / mL glycine; and the pH value of the eye injection is 5.3-5.7. The application has good storage stability, and has few insoluble particles, which meets the requirement of USP789 eye injection, and provides a new preparation selection for the application of the anti-EGFR antibody in ophthalmology.

The invention relates to the technical field of pharmaceutical preparations, in particular to an ipratropium bromide solution for inhalation and a preparation method of the ipratropium bromide solution. The preparation method of the ipratropium bromide solution for inhalation comprises the following steps: dissolving sodium chloride in water for injection, regulating the pH value to 3.1-3.5 by adopting a citric acid-sodium citrate buffer system, then adding a composite surfactant, finally adding ipratropium bromide, stirring, dissolving, fixing the volume, filtering and sterilizing, thereby obtaining the ipratropium bromide solution for inhalation. The composite surfactant is a mixture of polysorbate 20, polysorbate 60 and polysorbate 80. The ipratropium bromide solution for inhalation has excellent stability, can be stored for a long time without deterioration, has relatively excellent atomization performance, and can meet the requirements of various patients.

The utility model relates to a multi-application composition, having a core oil which consists of gumamela oil, calamansi peel oil, guava leaf oil, and avocado seed oil. In one embodiment of the utility model, the composition is in the form of a spray comprising the core oil, ethanol, distilled water, polysorbate 20, and glycerin. In another embodiment, the composition is in the form of a gel comprising the core oil, carbomer, ethanol, distilled water, glycerin, and triethanolamine. In yet another embodiment, the composition is in the form of a liquid cleanser comprising the core oil, coco-glucoside, cocamidopropyl betaine, glycerin, sodium chloride, and distilled water. In yet another embodiment, the composition is in the form of a cream comprising the core oil, emulsifying wax, cetyl alcohol, glycerin, and distilled water. The utility model provides a practical and sustainable spray, gel, cream, and cleanser derived from renewable plant resources.

Anti-SIRPa antibody formulation, suitable for parenteral administration, comprising: an anti-SIRPα antibody that inhibits signaling via the SIRPα-CD47 axis at a concentration between approximately 20 mg / ml and approximately 100 mg / ml; a buffer component selected from the group consisting of approximately 20 mM L-histidine and 20 mM sodium phosphate; a disaccharide comprising an α-glycosidic bond and present at a concentration of approximately 8 wt. / vol.%; approximately 0.01 wt% polysorbate 20; and a pH value of approximately 5.7 to approximately 6.3; which is free of glycine, arginine, carbonate, HEPES, citrate and acetate.

An anti-B7H3 antibody-eribulin conjugate formulation, a preparation method therefor, and use thereof. The formulation contains trehalose, polysorbate 20, histidine, histidine hydrochloride, and an anti-B7H3 antibody-eribulin conjugate or a pharmaceutically acceptable salt or solvate thereof. A specific formulation formula is designed for the anti-B7H3 antibody-eribulin conjugate. By means of using the synergistic cooperation of specific component excipients and a buffer system, the stability of the formulation is significantly improved. Moreover, the preparation process is further verified scientifically and systematically, which proves that the well-developed anti-B7H3 antibody-eribulin conjugate formulation and the preparation process thereof maintain the purity, coupling rate, and free drug of the finished product stable, reduce molecular degradation and aggregates, have strong process stability, and can be applied on a large scale, thereby promoting the application of the anti-B7H3 antibody-eribulin conjugate.

The present invention generally relates to the transdermal delivery of various compounds. In some aspects, transdermal delivery may be facilitated by the use of a hostile biophysical environment. One set of embodiments provides a composition for topical delivery comprising a phosphodiesterase type 5 inhibitor and / or a salt thereof, and optionally, a hostile biophysical environment and / or a nitric oxide donor. In some cases, the composition may be stabilized using a combination of a stabilization polymer (such as xanthan gum, KELTROL® BT and / or KELTROL® RD), propylene glycol, and a polysorbate surfactant such as Polysorbate 20, which combination unexpectedly provides temperature stability to the composition, e.g., at elevated temperatures such as at least 40° C. (at least about 104° F.), as compared to compositions lacking one or more of these.

The invention discloses a rucotinib cream and a preparation method thereof, and relates to the technical field of pharmaceutical preparations. The cream comprises a therapeutic agent, an oil component, an emulsifier component, a solubilizer component and water, wherein the therapeutic agent is rucotinib or a pharmaceutically acceptable salt of rucotinib; polysorbate 20 is adopted as a solubilizer component, so that the solubility and the stability of the active components are effectively improved. The preparation method mainly comprises the following steps: dissolving the chelating agent, the polysorbate 20 and the antibacterial agent in water, heating for dissolving, and adding the rucotinib phosphate and the stabilizer to form a water phase; heating and melting the oil component and the emulsifier to form an oil phase; and finally, carrying out high-shear mixing emulsification on the two phases at a high temperature, adding phenoxyethanol, and cooling under a low-shear condition to obtain a finished product. Through optimized components and a specific preparation process, the physical stability and medication uniformity of the cream are remarkably improved, the product quality is controllable, and the cream is suitable for industrial production.

The present invention relates to a dry cleansing tissue and a manufacturing method therefor, the dry cleansing tissue having cleansing power for cosmetics when contacted with water in a dried state. The dry cleansing tissue manufactured according to the manufacturing method of the present invention is manufactured by applying, to a fabric, a mixed solution obtained by mixing a first solution comprising olive oil, jojoba oil, and vitamin E with a second solution comprising butylene glycol, glycerin, polysorbate 20, hyaluronic acid, castor oil, and rose oil, and has the effects of excellent cleansing power and improved moisturization and skin elasticity after use of the cleansing tissue.

This invention belongs to the field of pharmaceutical analysis technology and discloses a method for determining the dissolution curve of phenelzine tablets. The method uses a pH 4.5 acetate buffer containing 0.05%-0.2% polysorbate 20 as the dissolution medium, with a volume of 800-1000 ml, and dissolution is performed using a paddle method at a speed of 70-80 rpm and a temperature of 36.5℃-37.5℃. The dissolution solution is collected at multiple time points, filtered, and analyzed by high-performance liquid chromatography (HPLC). The chromatographic conditions are: an octadecylsilane-bonded silica gel column; a mobile phase of potassium dihydrogen phosphate buffer (pH 2.8-3.2) mixed with acetonitrile at a volume ratio of 65:35-75:25; and a detection wavelength of 245-255 nm. The cumulative dissolution amount is calculated using the external standard method. This method is highly specific, accurate, and robust, and can effectively determine the dissolution curve of phenelzine tablets, making it suitable for their quality control and evaluation.

This invention belongs to the field of biomedical technology, specifically relating to a freeze-dried formulation of omalizumab that reduces viscosity based on the synergistic effect of trehalose and arginine, and its preparation method. The freeze-dried formulation of this invention comprises: omalizumab, trehalose, arginine, polysorbate 20, and histidine-hydrochloric acid. The freeze-dried formulation of this invention exhibits good stability, and when reconstituted with water to prepare a high-concentration omalizumab solution, the solution viscosity is low, thereby effectively reducing injection pain.

The invention relates to the technical field of pharmaceutical preparations, and discloses a formoterol fumarate inhalation solution and a preparation method thereof. The formoterol fumarate inhalation solution provided by the invention is prepared from the following components in mass concentration: 0.05 percent to 0.2 percent of sodium hydroxide, 0.6 percent to 1.0 percent of tartaric acid, 0.1 percent to 0.3 percent of aminocaproic acid, 0.001 percent to 0.1 percent of polysorbate 20, 0.0009 percent to 0.0011 percent of formoterol fumarate, 0.7 percent to 0.9 percent of sodium chloride and the balance of water for injection. By adjusting the pH value of the solution, adding the polysorbate 20 and the aminocaproic acid, controlling the raw materials and the dissolving temperature thereof, filling nitrogen in the dissolving process and the filling process, and combining filtration and sterilization, the invention provides a method for improving the stability of the product under the condition of controlling the impurity level of the product. And the preparation method can be used for industrially producing the formoterol fumarate inhalation solution.