Abstract: Long term storage stable budesonide-containing solutions are disclosed. The solutions can include budesonide or a pharmaceutically acceptable salt thereof, cromolyn sodium, antioxidizing agent, benzoic acid, and a pharmaceutically acceptable fluid including propylene glycol and water. Kits including the long term storage stable budesonide-containing solutions and methods of treating ulcerative colitis are also disclosed.

Abstract: Long term storage stable budesonide-containing solutions are disclosed. The solutions can include budesonide or a pharmaceutically acceptable salt thereof, cromolyn sodium, antioxidizing agent, benzoic acid, and a pharmaceutically acceptable fluid including propylene glycol and water. Kits including the long term storage stable budesonide-containing solutions and methods of treating ulcerative colitis are also disclosed.

Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30° C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.

Abstract: Long term storage stable fulvestrant-containing compositions are disclosed. The compositions can include fulvestrant; a solvent selected from dimethyl sulfoxide (DMSO), glycofurol, N-methyl pyrrolidone, and mixtures thereof; an oil mixture selected from a mixture of caprylic and capric triglycerides, a mixture of caprylic, capric and linoleic triglycerides, a mixture of caprylic, capric and succinic triglycerides, and a mixture of propylene glycol dicaprylate and propylene glycol dicaprate; and a sustained release member selected from benzyl benzoate, dihydrolipoic acid, benzyl alcohol and lipoic acid. The fulvestrant-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 24 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: Long term storage stable pemetrexed-containing liquid pharmaceutical compositions are disclosed. The compositions can include pemetrexed or pharmaceutically acceptable salts thereof; an antioxidant selected from lipoic acid, dihydrolipoic acid, methionine and mixtures thereof; a chelating agent selected from lactobionic acid, sodium citrate, tribasic and mixtures thereof; and a pharmaceutically acceptable fluid. The pH of the compositions is in a range of about 8 to about 9.5. The pemetrexed-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 227 nm, after at least about 18 months of storage at a temperature of from about 5° C. to about 25° C. Methods of preparing the formulation as well as methods of treatment of pemetrexed-susceptible diseases using the same are also disclosed.

Abstract: Long term storage stable daptomycin-containing compositions are disclosed. The compositions include daptomycin or a pharmaceutically acceptable salt thereof at a concentration of less than or equal to about 25 mg/mL, a buffer having an acidic functional group and have a pH of from about 6.0 to about 7. The formulations are surprisingly free of degradation products such as the hydrolysis product of daptomycin and the ?-isomer of daptomycin after storage periods of at least about 18 months.

Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.

Abstract: Long term storage stable daptomycin-containing compositions are disclosed. The compositions include daptomycin or a pharmaceutically acceptable salt thereof at a concentration of less than or equal to about 25 mg/mL, a buffer having an acidic functional group and have a pH of from about 6.0 to about 7. The formulations are surprisingly free of degradation products such as the hydrolysis product of daptomycin and the ?-isomer of daptomycin after storage periods of at least about 18 months.

Abstract: Long term storage stable daptomycin-containing compositions are disclosed. The compositions include a pharmacologically acceptable fluid including daptomycin or a pharmaceutically acceptable salt thereof at a concentration of less than or equal to about 25 mg/mL, and a calcium source. The formulations are surprisingly free of degradation products such as the hydrolysis product of daptomycin, the ?-isomer of daptomycin and anhydro daptomycin after storage periods of at least about 18 months under refrigerated conditions.

Abstract: The present invention relates to the method of increasing the bioavailability of Angiotensin II Receptor Blockers (ARBs) by preparing a composition of an ARB with at least one solubility enhancing agent. The invention is particularly focused to provide a novel or modified dissolution profile where the release of ARB in the GI tract is independent of physiological pH conditions.

Abstract: Aqueous-based, ready to use topotecan-containing formulations for parenteral use having extended stability are disclosed. The formulations are surprisingly free of precipitated degradation products such as 10-hydroxycamptothecin (10-HCPT) after periods of up to 1 year or greater.

Abstract: This invention relates to a stable epoprostenol composition that can be combined with commercially available IV fluids and can be administered in its reconstituted and/or diluted form under ambient conditions of about 15-30° C. for greater than 24 hours. The composition preferably contains (a) epoprostenol or a salt thereof; (b) a alkalinization agent; and (c) a base, such that when reconstituted or in solution, the solution has a pH>11. Methods for making the lyophilized composition are also disclosed.

Abstract: The present invention is generally related to alcohol free, liquid ranitidine formulations for oral administration. In particular, the present invention is related to stable, syrup formulations having ranitidine as an active ingredient for oral administration, processes for making the same, and methods of their use. The ranitidine of the present invention is stable in non-polar media or media having a relatively low polarity such that the dielectric constant is less than about 60, and is achieved by using certain saccharides, certain relatively high molecular weight starches, and/or certain celluloses instead of alcohol.

Abstract: The present invention is directed to a stable, rapidly soluble lyophilized injectable composition containing up to about 6% moisture and capable of being stored at room temperature comprising the hydrochloric or sulfate salt of a compound selected from the group consisting of (S)-(+)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione and (R)-(-)-bis-4,4'-(1-methyl-1,2-ethanediyl)2,6-piperazinedione; wherein said lyophilized composition is prepared from a bulk solution comprising from about 25 mg/mL to about 40 mg/mL of said compound dissolved in a hydrochloric acid or sulfuric acid; wherein the pH of said bulk solution is from about 1.0 to about 2.0. The invention is further directed to an isotonic solution which is formed upon reconstitution of the lyophilizate of the invention with a pharmaceutically acceptable diluent.