Purdue Pharma L.p.

Purdue Pharmaceuticals L.p.

Other

Richard O Mannion

Haiyong Hugh Huang

Edward P O'Donnell

William H McKenna

Ozgur Akcan

Stephen C Harris

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.

Tamper resistant dosage forms

The invention relates to a solid dosage form comprising a core-shell structure comprising two or more different active agents, wherein the core-shell structure comprises (1) a core comprising a first matrix formulation, the first matrix formulation comprising at least one active agent selected from the group of an active agent (A) and an active agent (B); and (2) a shell encasing the core and comprising a second matrix formulation, wherein the weight ratio of the first matrix formulation to the second matrix formulation is from about 1:10 to about 4:1. In certain embodiments, the solid dosage forms of the invention are in oral solid extended release dosage forms, which provide an extended release of at least a portion of at least one active agent included therein.

Pharmaceutical dosage forms

The invention relates to a solid oral extended release pharmaceutical dosage form comprising an extended release matrix formulation. The extended release matrix formulation comprises (1) at least one active agent, (2) at least one anionic surfactant, and (3) at least about 40% by weight (based on the weight of the extended release matrix formulation) of at least one polyethylene oxide. In certain embodiments, the molar ratio of the at least one anionic surfactant to the at least one active agent is from about 1:2 to about 10:1.

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Furlong, PA, United States of America

Richard O Mannion