Abstract: The present invention relates to multilayered modified release formulation comprising amoxicillin and clavulanate, process of preparation thereof and method of treating bacterial infection using these formulations. The multilayered modified release formulation comprises: an immediate release layer comprising amoxicillin and clavulanate; and a slow release layer comprising amoxicillin and one or more release retarding agents; and one or more non-release controlling inert barrier layers placed in between the immediate release layer and the slow release layer and comprising one or more pharmaceutically acceptable excipients.

Abstract: The present invention discloses modified-release oral dosage forms of an azabicyclo derivative or its pharmaceutically acceptable salts, solvates, esters, enantiomers, diastereomers, N-oxides and polymorphs; and processes for the preparation thereof. The modified release formulation comprises an azabicyclo derivative, at least one rate-controlling polymer and at least one pharmaceutically acceptable excipient which provides therapeutically effective plasma levels of the active ingredient for a period of up to 24 hours.

Abstract: The present invention relates to controlled release oral dosage forms of galantamine or acceptable salts thereof and processes for the preparation thereof.

Abstract: The present invention provides extended-release matrix formulations comprising a therapeutically effective amount of morphine or salt thereof, one or more hydrophilic controlled release polymers and one or more pharmaceutically acceptable excipients. The formulations provide extended release of morphine or salt thereof over a specified period of time after oral administration in humans or animals.

Abstract: The present invention relates to multiple-unit modified release carbamazepine compositions for oral administration which include: (i) at least one extended release unit, and (ii) at least one enteric release unit. Also provided are processes for the preparation of multiple-unit modified release compositions of carbamazepine.

Abstract: This invention relates to a once a day sustained release dosage form suitable for oral administration of oxcarbazepine. The once a day sustained release dosage form of oxcarbazepine includes oxcarbazepine and hydroxypropyl methylcellulose (HPMC) having a viscosity of 11,000 to 25,000 cps.

Abstract: The invention relates to novel modified release multiple unit systems, and methods of preparing these systems, which can be easily compressed into tablets or filled into capsules or sachets without affecting the desired release characteristics of the pharmaceutical active ingredients incorporated within the systems. The multiple unit tablet includes multiple units. Each unit includes at least one core having an outer surface, a first coating layer surrounding at least a portion of the outer surface of the core and having an outer surface, one or more rate controlling polymers, and one or more one active pharmaceutical ingredients. The coating layer includes one or both of the one or more active pharmaceutical ingredients and the one or more rate controlling polymers. The tablet may further include an outer layer on the outer surface of the unit which includes a material that is one or both of elastic and compressible. The material may be a wax materials, such as polyethylene glycol's (PEGS).

Abstract: The present invention relates to a stable bupropion hydrochloride tablet and a method of stabilizing bupropion hydrochloride tablets, which also serves as an improved tabletting process for the preparation of sustained release bupropion hydrochloride tablets.

Abstract: The present invention relates to extended release matrix tablets for oral administration that include a cationic polymer, a water-swellable polymer, and an alginic acid derivative to cause the release rate of the active ingredient of the tablets to be independent of pH and gastric residence time. The active pharmaceutical ingredient may be one or more of antibiotics, sympathomimetics, sympatholytic agents, cholinergic agents, antimuscarinics, gastro-intestinal drugs, gentio-urinary smooth muscle relaxants, cardiac drugs, anticonvulsants, tranquilizers and sedatives, and in particular may be an antibiotic, such as cefaclor, or may be a sympatholytic agent, such as carvedilol.

Abstract: The present invention relates to pharmaceutical compositions of alfuzosin or pharmaceutically acceptable salt, solvate, enantiomers or mixtures thereof, that release the active ingredient over an extended period of time. The pharmaceutical composition can be a sustained release oral dosage form that includes a single functional layer and, optionally, one or more nonfunctional layers adjacent to the single functional layer. The single functional layer includes alfuzosin or pharmaceutically acceptable salt, solvate, enantiomers or mixtures thereof and one or more release retarding ingredients.

Abstract: The present invention relates to an oral drug delivery system with biphasic release characteristics comprising a porous matrix comprising at least one drug substance, sugar(s), a release retarding polymer, gas generating components and optionally, pharma-ceuti-cally acceptable auxiliary components wherein the pharmaceutical composition further comprises a coating of said drug substance. The pharmaceutical composi-tion, either in the form of pellets (multiparticulate or single unit dosage form), beads, granules, capsules or tablets, is retained in the stomach while selectively delivering the drug(s) at gastrointestinal levels and upper parts of the small intestine over an extended period of time. The release of the drug from the said pharmaceutical composition is characterized by a biphasic release profile of the drug substance, which exhibits both immediate and controlled release characteristics.

Abstract: The present invention relates to solid dosage forms that contain bupropion hydrochloride and glucono delta lactone or its corresponding open chain hydroxy acid derivative. The bupropion hydrochloride retains at least 80% of the bupropion hydrochloride potency after storage for three months at 40° C. and 75% relative humidity. The solid dosage form may be in the form of a tablet, a capsule, or a granulate with or without an immediate release profile, a modified release profile, or an extended release profile.

Abstract: The present invention relates to a monocompartment osmotic controlled drug delivery system comprising a poorly soluble drug and at least one alginic acid derivative.

Abstract: A pharmaceutical composition includes micronized clarithromycin and exhibits improved dissolution characteristics relative to a pharmaceutical composition that includes unmicronized clarithromycin. The clarithromycin may have a particle size less than approximately 35 microns. One process for preparing an extended release tablet of the clarithromycin includes micronizing the clarithromycin; blending the micronized clarithromycin with one or more rate controlling polymers and pharmaceutically acceptable excipients; granulating the blend; and compressing to form a tablet. To treat a bacterial infection in a mammal in need of treatment, a patient may be administered a pharmaceutical composition that includes micronized clarithromycin.

Abstract: The present invention relates to sustained release oral dosage forms of gabapentin and at least one rate controlling polymer, and a process for the preparation of the sustained release oral dosage forms, and a process for the preparation thereof. The sustained release tablet includes gabapentin or a pharmaceutically acceptable salt or hydrates thereof and at least one rate-controlling polymer such that the tablet provides therapeutically effective plasma levels of gabapentin for a period of up to about 12 hours.

Abstract: The present invention relates to an oral drug delivery system comprising pravastatin or its pharmaceutically acceptable salts such that the system provides enhanced stability in the acidic environment of the stomach and exhibits controlled release of the drug.

Abstract: The present invention relates to a controlled release pharmaceutical composition comprising amounts ranging from about 0.1 to about 4.5% w/w, of one or more of rate controlling cellulosic ether polymers.

Abstract: The present invention relates to an extended release pharmaceutical composition comprising valproic acid, a pharmaceutically acceptable salt, ester, or amide thereof or divalproex sodium.

Abstract: The present invention relates to a controlled release pharmaceutical composition comprising amounts ranging from about 0.1 to about 4.5% w/w, of one or more of rate controlling cellulosic ether polymers.

Abstract: The present invention relates to a controlled release pharmaceutical composition comprising amounts ranging from about 0.1 to about 4.5% w/w, of one or more of rate controlling cellulosic ether polymers.