Abstract: The present invention relates to novel tablet dosage forms and methods of preparing these forms, which can be used for different classes of pharmaceutical active ingredients posing stability issues in a single unit system. The dosage form includes a first layer, which includes a tablet of one or more active pharmaceutical ingredients, which is inlayed in the first layer along with other pharmaceutically acceptable excipients, and a second layer that includes one or more active pharmaceutical ingredients optionally with other pharmaceutically acceptable excipients.

Abstract: The present invention relates to stable pharmaceutical compositions comprising entacapone, levodopa and carbidopa, or pharmaceutically acceptable salts or hydrates thereof. The invention also relates to processes for the preparation of such compositions.

Abstract: The present invention relates to pharmaceutical compositions of duloxetine or pharmaceutically acceptable salts thereof, and processes for their preparation.

Abstract: Chiral 1-(4-methylphenylmethyl)-5-oxo-{N-[(3-t-butoxycarbonyl-aminomethyl)]-piperidin-1-yl}-pyrrolidine-2-carboxamides as inhibitors of collagen induced platelet activation and adhesion. The present invention provides chiral (2S)-1-(4-methyl-phenylmethyl)-5-oxo-(3S)-{N-[(3-t-butoxycarbonyl aminomethyl)]-piperidin-1-yl}-pyrrolidine-2-carboxamide, and (2S)-1-(4-methylphenylmethyl)-5-oxo-(3R)-{N-[(3-t-butoxycarbonyl amino methyl)]-piperidin-1-yl}-pyrrolidine-2-carboxamide of formula 6 and 7 respectively. The present invention also relates to use of these moieties as inhibitors of collagen induced platelet adhesion and aggregation mediated through collagen receptors. The present invention provides a process for preparation of chiral carboxamides of formula 6 and 7 using the process which has advantage to avoid any racemization at the a-carboxylic center, during N-alkylation. The reagent LiHMDS is used at low temperatures to furnish methyl N-(p-methylphenylmethyl)1pyroglutamate in good chiral purity.

Abstract: There is provided an extended release pharmaceutical composition comprising from about 200 mg to about 1000 mg of entacapone or salts thereof, optionally with other pharmaceutically acceptable excipients. The invention also provides an extended release pharmaceutical composition comprising triple combination of from about 30 mg to about 300 mg of levodopa, 10 mg to about 100 mg of carbidopa and 200 mg to about 1000 mg of entacapone or salts thereof, optionally with other pharmaceutically acceptable excipients. The invention also relates to process of preparation of such compositions.

Abstract: The present invention relates to pharmaceutical compositions of tamsulosin or salts thereof. In particular, the invention relates to pharmaceutical compositions comprising a core of tamsulosin or salts, hydrates thereof and at least one specialized coating over the core. Such compositions of tamsulosin may exhibit desired release kinetics with excellent storage stability and particularly, levels of degradants in the formulation during storage can be effectively controlled. The invention also includes a process of preparing such compositions and additionally combination with other pharmaceutical ingredient.

Abstract: There is provided an extended release pharmaceutical composition comprising from about 200 mg to about 1000 mg of entacapone or salts thereof, optionally with other pharmaceutically acceptable excipients. The invention also provides an extended release pharmaceutical composition comprising triple combination of from about 30 mg to about 300 mg of levodopa, 10 mg to about 100 mg of carbidopa and 200 mg to about 1000 mg of entacapone or salts thereof, optionally with other pharmaceutically acceptable excipients. The invention also relates to process of preparation of such compositions.

Abstract: The present invention provides solid oral pharmaceutical compositions comprising combination of metformin and sitagliptin or salts thereof. In particular, the present invention relates to a multilayered coated pharmaceutical composition comprising at least two compartments of metformin or salts thereof exhibiting immediate and extended release and at least one compartment of sitagliptin and metformin or salts thereof exhibiting immediate release. The invention also includes process of preparing such compositions and method of use of such compositions for treating type II diabetes.

Abstract: The present invention relates to a stable pharmaceutical composition of amiodipine and benazepril or salts thereof. In particular, the invention relates to a stable pharmaceutical composition comprising at least one amiodipine component and at least two benazepril components in which physical contact between amiodipine and benazepril components is limited. The invention also includes a process of preparing such compositions and method of treating hypertension by administering the composition to a patient in need thereof.

Abstract: The present invention relates to an oral pharmaceutical composition of aliphatic amine polymer or salts thereof comprising mixture of water and organic solvent(s) and/or less than of about 10% of plasticizing agent in the coating composition. In particular, present invention relates to a coated pharmaceutical composition of aliphatic amine polymer or salt thereof which comprises mixture of water and organic solvent(s) and less than of about 10% of plasticizing agent in coating. The invention also includes process of preparing such composition.

Abstract: The present invention provides solid oral pharmaceutical compositions comprising combination of metformin and sitagliptin or salts thereof. In particular, the present invention relates to a pharmaceutical composition comprising metformin and sitagliptin or salts thereof which is glidant and/or surface active agent. The invention also includes process of preparing such compositions and method of use of such compositions for treating type II diabetes.

Abstract: The present invention relates to a modified release pharmaceutical composition of dexmethylphenidate or salts thereof. In particular, the present invention relates to a modified release pharmaceutical composition comprising plurality of components exhibiting both immediate and extended release of dexmethylphenidate or salts thereof. The composition may provide therapeutically effective plasma concentration over a period of 24 hours to treat attention deficit hyperactivity disorder when administered to a patient in need thereof. The invention also includes process of preparing such composition.

Abstract: Chiral 1-(4-methylphenylmethyl)-5-oxo-{N-[(3-t-butoxycarbonyl-aminomethyl)]-piperidin-1-yl}-pyrrolidine-2-carboxamides as inhibitors of collagen induced platelet activation and adhesion The present invention provides chiral (2S)-1-(4-methyl-phenylmethyl)-5-oxo-(3S)—{N-[(3-t-butoxycarbonyl aminomethyl)]-piperidin-1-yl}-pyrrolidine-2-carboxamide, and (2S)-1-(4-methylphenylmethyl)-5-oxo-(3R)—{N-[(3-t-butoxycarbonyl amino methyl)]-piperidin-1-yl}-pyrrolidine-2-carboxamide of formula 6 and 7 respectively. The present invention also relates to use of these moieties as inhibitors of collagen induced platelet adhesion and aggregation mediated through collagen receptors. The present invention provides a process for preparation of chiral carboxamides of formula 6 and 7 using the process which has advantage to avoid any racemization at the a-carboxylic center, during N-alkylation. The reagent LiHMDS is used at low temperatures to furnish methyl N-(p methylphenylmethyl)lpyroglutamate in good chiral purity.

Abstract: The invention relates to self emulsifying drug delivery system based compositions of rhein or diacerein, or salts or esters or prodrugs thereof which are bioequivalent to a 50 mg diacerein formulation marketed under the trade name Art 50®. The compositions exhibit no variability in fed and fasted state conditions. The compositions also result in significant reduction in side effects such as, soft stools effects as compared to Art 50®. The invention also relates to methods for preparing such compositions.

Abstract: The invention relates to pharmaceutical compositions comprising unmicronized fenofibrate in admixture with a wetting agent and one or more pharmaceutically acceptable excipients, wherein the admixture is not comicronized before processing. The invention also relates to processes for the preparation of such compositions.

Abstract: The present invention refers to pharmaceutical microparticulate compositions of biologically active polypeptides and methods of forming and using such compositions. More particularly, microparticle compositions for sustained release of biologically active polypeptides are provided. By using particular pharmaceutical excipients or their specific quantity, compositions of biologically active polypeptides with desired release profile can be prepared. The microparticle compositions of this invention comprise a biocompatible polymer, a biologically active polypeptide, and pharmaceutical excipients.

Abstract: The present invention refers to an improved pharmaceutical composition of diclofenac or pharmaceutically acceptable salt comprising dispersing agent and pharmaceutically acceptable excipients. The invention relates to pharmaceutical composition of diclofenac or pharmaceutically acceptable salt and lower amount of dispersing agents. By administering such composition, rapid and uniform gastrointestinal absorption of diclofenac can be achieved. The invention also includes process of preparing such composition.

Abstract: The present invention refers to a stable pharmaceutical composition of saxagliptin or salts thereof. In particular, the invention relates to stable comprises a core and two or more layers coated on the core, wherein the composition or the inner first coat is free of polyvinyl alcohol. Such composition of saxagliptin may exhibit relatively improved storage stability and particularly, levels of degradants in the formulation during storage can be effectively controlled. The invention also includes a process of preparing such compositions and method of treating type-II diabetes mellitus by administering the composition to a patient in need thereof.

Abstract: The present invention refers to an improved pharmaceutical composition of diclofenac or pharmaceutically acceptable salt and pharmaceutically acceptable excipients wherein the composition is substantially free of dispersing agents. By judicially using pharmaceutical excipients other than dispersing agent, pharmaceutical composition of diclofenac or its salts with rapid and uniform gastrointestinal absorption of diclofenac can be achieved. The composition of the invention can also minimize the controllable side effects of diclofenac.

Abstract: The present invention refers to a stabilized injectable pharmaceutical composition of epinephrine or salts thereof comprising sodium metabisulfite, wherein the ratio of the amount of epinephrine or salt thereof to sodium metabisulfite in the composition ranges from about 1:0.005 to about 1:1.5 by weight. It has been observed that stable injectable epinephrine compositions with excellent storage stability and substantially free of overages can be prepared using sodium metabisulfite in said ratios. Particularly, it was found that using sodium metabisulfite in said ratios controls levels of adrenaline sulfonate impurity in said pharmaceutical compositions.