Abstract: Liquid polymer pharmaceutical compositions with a biodegradable liquid polymer, a biocompatible solvent or combination or mixture of solvents and/or co-solvents, and an active pharmaceutical agent comprising a peptide are useful to provide extended long-term release of the drug to a subject and/or to improve the stability of the active pharmaceutical agent. In embodiments, the polymer may be initiated with a low-molecular weight polyethylene glycol and/or may be a block copolymer comprising a low-molecular weight polyethylene glycol block. In further embodiments, the liquid polymer pharmaceutical composition may include a divalent cation, which may be provided in the form of a metal salt.

Abstract: An extended release formulation is provided for use in a method for the treatment of Central Precocious Puberty (CPP) in pediatric patients 2 years of age or older. The extended release formulation comprises leuprolide or a pharmaceutically acceptable salt thereof, a biodegradable polymer, and a biocompatible organic solvent. The biodegradable polymer is comprised of poly(lactide-co-glycolide) (PLG) copolymer segments, poly(lactic acid-co-glycolic acid) (PLGA) copolymer segments, poly(lactide) (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, or a combination thereof. The extended release formulation is administered as a subcutaneous injection of a flowable composition that forms a solid in situ depot. The extended release formulation releases leuprolide for a period of about 6 months for the effective treatment of CPP within a pediatric patient.

Abstract: Compositions and methods for suppressing ovarian function in subjects with hormone receptor-positive breast cancer.

Abstract: Liquid polymer pharmaceutical compositions comprising a biodegradable liquid polymer, a biocompatible solvent system, and an active pharmaceutical ingredient (API) are disclosed. The compositions of the invention are useful for providing extended, long-term release of the API.

Abstract: A kit including topical pharmaceutical composition of corticosteroid(s) and metered-dose dispenser with an actuator which delivers precise amount of corticosteroid(s) per actuation for the treatment of various skin disorders is disclosed. Also disclosed is a process for preparation of such compositions.

Abstract: An extended release formulation is provided for use in a method for the treatment of Central Precocious Puberty (CPP) in pediatric patients 2 years of age or older. The extended release formulation comprises leuprolide or a pharmaceutically acceptable salt thereof, a biodegradable polymer, and a biocompatible organic solvent. The biodegradable polymer is comprised of poly(lactide-co-glycolide) (PLG) copolymer segments, poly(lactic acid-co-glycolic acid) (PLGA) copolymer segments, poly(lactide) (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, or a combination thereof. The extended release formulation is administered as a subcutaneous injection of a flowable composition that forms a solid in situ depot. The extended release formulation releases leuprolide for a period of about 6 months for the effective treatment of CPP within a pediatric patient.

Abstract: A kit including topical pharmaceutical composition of corticosteroid(s) and metered-dose dispenser with an actuator which delivers precise amount of corticosteroid(s) per actuation for the treatment of various skin disorders is disclosed. Also disclosed is a process for preparation of such compositions.

Abstract: The present invention is directed to pharmaceutical compositions that allow for once-daily or alternate day dosage forms of topiramate. The proposed delayed/extended release single dosage form is equivalent to the immediate-release multiple dose daily regimen, and upon administration, provides steady state blood levels of topiramate. Formulations with increased bioavailability and improved pharmacokinetics are disclosed. A once-a-day administration of topiramate is advantageous over the multiple dose regimen both in terms of patient compliance and reduced adverse events, thus providing better treatment of the conditions for which the topiramate is indicated.

Abstract: An oral modified release pharmaceutical composition of methylergonovine suitable for oral once daily administration is provided. The composition includes at least about 0.6 mg dose of methylergonovine or a pharmaceutically acceptable salt thereof and is particularly useful for treating migraine or refractory migraine.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.

Abstract: A once a day bupropion salt formulation is disclosed.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.

Abstract: A controlled release dosage form of venlafaxine that comprises an immediate release pellet and an extended release pellet.

Abstract: The invention is directed to controlled release formulations containing drugs which are preferably considered sparingly soluble to insoluble and which are suitable for administration to a patient in need of treatment related thereto, and methods of manufacturing the same.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.

Abstract: A once a day bupropion hydrochloride formulation is disclosed.

Abstract: The invention relates to a rapidly disintegrating oral antihistamine dosage formulation and method of preparing the rapidly disintegrating formulation wherein the formulation is designed to dissolve in the buccal cavity of the patient.

Abstract: Polymers and compositions, collectively “bioadhesive materials”, with improved bioadhesive properties have been developed. One or more compounds comprising: a) an aromatic moiety comprising two or more hydroxyl substituents, methoxy substituents, substituents hydrolyzable to hydroxyl substituents, or a combination thereof, and b) a primary or secondary amino moiety are either covalently attached to a polymer or are physically mixed with a polymer to form a bioadhesive material. These bioadhesive materials can be used, for example, to fabricate new drug delivery or diagnostic systems with increased residence time at tissue surfaces, and consequently increase the bioavailability of a drug or a diagnostic agent.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.