Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: A pharmaceutical composition may include a granulate which may include at least one active pharmaceutical ingredient susceptible to abuse by an individual mixed with at least two materials, a first material that is substantially water insoluble and at least partially alcohol soluble and a second material that is substantially alcohol insoluble and at least partially water soluble, wherein the active pharmaceutical ingredient and the two materials are granulated in the presence of water and alcohol. The composition may also include a coating on the granulate exhibiting crush resistance which may have a material that is deposited on the granulate using an alcohol based solvent. The composition further comprises a second particle comprising a fat/wax. The present invention also includes a coated granulate, various dosage forms of the composition, as well as methods of production and tableting.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.

Abstract: The disclosure relates to a sustained-release oral dosage form for once-a-day administration comprising a matrix containing a viscosity modifier and coated granules containing hydromorphone. The dosage form can have a release profile such that 16 hours following administration, less than about 85 percent of the hydromorphone is released. In addition, the dosage form may have alcohol and/or crush resistance.

Abstract: A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.

Abstract: This disclosure relates to an extended release oral dosage form comprising a matrix containing a viscosity modifier (but no lipid) and coated granules containing metoprolol or a pharmaceutically acceptable salt or solvate thereof. The dosage form has alcohol resistance and may also have crush resistance.

Abstract: The present invention relates to tablets containing prednisolone salts and in particular prednisolone sodium phosphates. The dosage forms include ODTs and non-ODTs, effervescent tablets and noneffervescent tablets and tablets meeting certain performance criteria.

Abstract: This disclosure relates to an extended release oral dosage form comprising a matrix containing a viscosity modifier (but no lipid) and coated granules containing metoprolol or a pharmaceutically acceptable salt or solvate thereof. The dosage form has alcohol resistance and may also have crush resistance.

Abstract: This disclosure relates to a sustained-release oral dosage form suitable for twice-a-day administration comprising a matrix containing a viscosity modifier and coated granules containing hydrocodone. The dosage form can have a release profile such that 6 hours following administration, less than about 80 percent of the hydrocodone is released. In addition, the dosage form may have alcohol and/or crush resistance.

Abstract: This disclosure relates to an extended release oral dosage form comprising a matrix containing a viscosity modifier (but no lipid) and coated granules containing a high water-soluble, high dose drug. The dosage form has alcohol resistance and may also have crush resistance.

Abstract: This disclosure relates to an extended release oral dosage form comprising a matrix containing a viscosity modifier (but no lipid) and coated granules containing venlafaxine or a pharmaceutically acceptable salt or solvate thereof. The dosage form has alcohol resistance and may also have crush resistance.

Abstract: A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.

Abstract: A pharmaceutical composition may include a granulate which may include at least one active pharmaceutical ingredient susceptible to abuse by an individual mixed with at least two materials, a first material that is substantially water insoluble and at least partially alcohol soluble and a second material that is substantially alcohol insoluble and at least partially water soluble, wherein the active pharmaceutical ingredient and the two materials are granulated in the presence of water and alcohol. The composition may also include a coating on the granulate exhibiting crush resistance which may have a material that is deposited on the granulate using an alcohol based solvent. The composition further comprises a second particle comprising a fat/wax. The present invention also includes a coated granulate, various dosage forms of the composition, as well as methods of production and tableting.

Abstract: A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.

Abstract: This disclosure relates to a sustained-release oral dosage form for once-a-day administration comprising a matrix containing a viscosity modifier and coated granules containing hydromorphone. The dosage form can have a release profile such that 16 hours following administration, less than about 85 percent of the hydromorphone is released. In addition, the dosage form may have alcohol and/or crush resistance.

Abstract: This disclosure relates to dosage forms (e.g., solid dosage forms) comprising a drug-containing emulsion, a drug-containing microemulsion, a self-emulsifying oil composition, or a self-microemulsifying oil composition, wherein each comprises a weakly ionizable drug and a pH modifier. Also provided are pharmaceutical dosage forms (e.g., solid dosage forms) and methods of preparing the same.

Abstract: A blister package and method of removing a dosage form from a blister package are disclosed. In one embodiment, the blister package includes a unitary blister sheet and a unitary sheet of lidding material. The lidding sheet is peelably sealed to the blister sheet, and includes unsealed areas for facilitating the peeling of the lidding material from the blister sheet. The unsealed areas are preferably only accessible upon a bending of the blister package.