Abstract: Stable pharmaceutical compositions for oral administration are provided comprising an anti-allergic effective amount of descarbonylethoxy-loratadine or a pharmaceutically acceptable salt thereof, a lactose-based excipient and a pharmaceutically acceptable filler wherein the composition is substantially free of a pharmaceutically acceptable basic salt and wherein the composition contains less than about 1% by weight of N-formyl descarbonylethoxyloratadine after storage at a temperature of from about 25° C. to about 40° C. and a relative humidity of about 60% to about 75% for at least 1 month.

Abstract: A sustained release pharmaceutical composition in solid dosage form is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical agents; (b) a first high viscosity release retarding cellulose ether; and (c) a second high viscosity release retarding cellulose ether, wherein the first and second high viscosity release retarding cellulose ethers are of the same material.

Abstract: Dosage forms of oxcarbazepine or a pharmaceutically acceptable salt thereof and a pH modifying agent for use in oral administration are provided.

Abstract: Pharmaceutical composition comprising a therapeutically effective amount of micronized particles of cilostazol or pharmaceutically acceptable salts or esters thereof, wherein at least about 50% of the micronized cilostazol particles have an effective average particle size of less than about 10 microns is provided.

Abstract: A sustained release, mucoadhesive vaginal pharmaceutical composition is provided comprising (a) an effective amount of at least one active pharmaceutical ingredient and (b) a hydrophilic matrix having mucoadhesive properties and capable of providing a sustained release of the active pharmaceutical ingredient, the hydrophilic matrix comprising a hydrophilic polymer having a weight average molecular weight of at least about 100,000. Also provided are solid oral dosage forms comprising the sustained release, mucoadhesive vaginal pharmaceutical compositions.

Abstract: A pharmaceutical cream composition is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical ingredients comprising one or more macrolide related immunosuppressants or pharmaceutically acceptable salts or esters thereof; (b) one or more cream forming agents; and (c) an effective amount of one or more skin penetration enhancers capable of percutaneous delivery of the macrolide related immunosuppressant through the skin. Also provided is a process for its preparation and methods for delivering a macrolide related immunosuppressant through the skin of a mammal in order to treat conditions situated on and beneath the skin.

Abstract: A pharmaceutical gel composition is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical ingredients comprising one or more macrolide related immunosuppressants or pharmaceutically acceptable salts or esters thereof; (b) one or more gel forming agents; and (c) an effective amount of one or more skin penetration enhancers capable of percutaneous delivery of the macrolide related immunosuppressant through the skin. Also provided is a process for its preparation and methods for delivering a macrolide related immunosuppressant through the skin of a mammal in order to treat conditions situated on and beneath the skin.

Abstract: A pharmaceutical ointment composition is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical ingredients comprising one or more macrolide related immunosuppressants or pharmaceutically acceptable salts or esters thereof; (b) an ointment base; and (c) an effective amount of one or more skin penetration enhancers capable of percutaneous delivery of the macrolide related immunosuppressant through the skin. Also provided is a process for its preparation and methods for delivering a macrolide related immunosuppressant or a pharmaceutically acceptable salt or ester thereof through the skin of a mammal in order to treat conditions situated on and beneath the skin.

Abstract: The present invention relates to a pharmaceutical composition including an active pharmaceutical ingredient for the treatment of iron-deficiency anemia and related disorders. The active pharmaceutical ingredient is preferably carbonyl iron. The formulation of the pharmaceutical composition of the present invention ensures enhanced absorption of iron in its ferrous form. Also contemplated by the present invention are the methods of making the pharmaceutical composition.

Abstract: Disclosed is an extended release pharmaceutical formulation containing at least an alpha-2 adrenergic agonist, such as tizanidine, for the treatment and prevention of spasticity in a subject, e.g., painful inflammatory conditions associated with skeletal muscle spasms.

Abstract: The present invention relates to pharmaceutical dosage forms which include an antifungal having poor solubility. The pharmaceutical dosage forms of the present invention further comprise non-spherical granules, which do not contain a coated core region and may be formed into pharmaceutically acceptable dosage forms. The antifungal active pharmaceutical ingredients include itraconazole, saperconazole, ketoconazole, voriconazole and fluconazole.

Abstract: Disclosed is an extended release pharmaceutical formulation comprising a muscle relaxant drug, such as tizanidine, in combination with a cyclooxygenase-2 inhibitor, such as valdecoxib. The formulations are useful in the treatment and management of painful inflammatory conditions associated with, for example, skeletal muscle spasms.

Abstract: A hydroalcoholic topical pharmaceutical composition is provided comprising a therapeutically effective amount of a therapeutic agent comprising one or more selective cyclooxygenase-2 (COX-2) inhibitors or pharmaceutically acceptable salts or esters thereof solubilized in a solubilizing amount of a penetration vehicle system comprising a skin penetration enhancing effective amount of at least one monohydric alcohol and at least two non-volatile organic compounds selected from the group consisting of pyrrolidones, polyol ethers, polyols and mixtures thereof. Also provided is a process for its preparation.

Abstract: A taste-masking, pharmaceutical composition is provided which comprises (a) a core comprising an active pharmaceutical ingredient having a taste for which masking is desired and (b) a taste-masking film coating layer on the core, the taste-masking film coating layer comprising (i) a film-forming, water insoluble polymer and (ii) a pH dependent, water-insoluble polymer which dissolves at a pH level of about 5 or below.

Abstract: Disclosed is a controlled release modifying complex for solid oral controlled release pharmaceutical compositions suitable for once-a-day administration. The composition comprises an active pharmaceutical ingredient, a release modifying complex and other required pharmaceutically acceptable excipients. The release modifying complex comprises a primary release modifying agent, a secondary release modifying agent and an auxiliary release modifying agent or varying combinations thereof, wherein said primary, secondary and auxiliary release modifying agents are present in amounts that synergistically effect and extend the release of active pharmaceutical ingredient.