A controlled extended release composition comprising at least one unit dosage form having at least one active pharmaceutical ingredient (API), wherein said at least one API comprises at least one of pregabalin, a base thereof, a pharmaceutically acceptable prodrug thereof, a pharmaceutically acceptable derivative thereof, a pharmaceutically acceptable complex thereof, a pharmaceutically acceptable salt thereof, a pharmaceutically acceptable polymorph thereof, a pharmaceutically acceptable hydrate thereof, a pharmaceutically acceptable solvate thereof, an enantiomer thereof and a racemate thereof. Methods and uses of the composition are provided.

Pharmaceutical compositions comprising at least one active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof, at least one hydrophilic plastomer, at least one hydrophilic elastomer, and at least one deliquescent plasticizer, wherein the pharmaceutical compositions provide extended release of the API and have abuse deterrent properties. Methods for preparing the pharmaceutical compositions in which the components of the composition are humidified such that the deliquescent plasticizer deliquesces, thereby plasticizing the hydrophilic polymers.

The present invention relates to an abuse-proofed, oral dosage form with controlled opioid-release for once daily administration, characterised in that it comprises at least one opioid with potential for abuse (A), at least one synthetic or natural polymer (C), optionally delayed-release matrix auxiliary substances, physiologically acceptable auxiliary substances (B), optionally a wax (D) and optionally at least one delayed-release coating, component (C) or (D) in each case exhibiting a breaking strength of at least 500 N, preferably of at least 1000 N.

The present invention provides for novel sustained release silk-based delivery systems. The invention further provides methods for producing such formulations. In general, a silk fibroin solution is combined with a therapeutic agent to form a silk fibroin article. The article is then treated in such a way as to alter its conformation. The change in conformation increases its crystallinity or liquid crystallinity, thus controlling the release of a therapeutic agent from the formulation. This can be accomplished as single material carriers or in a layer-by-layer fashion to load different therapeutic agents or different concentrations of these agents in each layer.

The disclosure provides a novel polymorph of Compound (I):

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2-((1-(2-(4-Fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one monohydrochloride dihydrate, i.e., Form (A) of Compound (I).HCl.2H.sub.2O. Pharmaceutical compositions comprising Form (A) of Compound (I).HCl.2H.sub.2O and related methods of treatment are also disclosed.

Carvedilol parenteral sustained release systems by IV infusion, injection, or subcutaneous routes are disclosed. Preparation of carvedilol disperse systems such as liposomes, biodegradable microparticles or nanoparticles, and polymeric microparticles or nanoparticles have been presented in the present invention. Compositions containing carvedilol encapsulated in liposomes showed higher bioavailability and lower clearance rate than that of the free solution after intravenous administration. In vitro release of those liposomes in buffer solutions shows drug extended release over 48 hours, and correspondingly the in vivo animal data shows that parenteral administration of carvedilol encapsulated in liposomal materials has sustained release PK profile.

The present application relates to pharmaceutical compositions comprising retinoic acid or its derivatives such as isotretinoin and processes for preparing thereof. It also provides methods for treating acne by administering such pharmaceutical composition to a patient in need thereof.

The present invention provides a new use for cannabinoids in the prevention of pre-cachexia or cachexia in a patient suffering from cancer, wherein said cannabinoid is administered at low dosage and wherein administration is started prior to chemotherapy and is maintained for at least the duration of the chemotherapy.

The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.