Immediate release, abuse deterrent pharmaceutical compositions
AssigneeMallinckrodt Inc.
InventorsSiva N. Raman, Jae Han Park, Thomas A. Diezi, Clifford J. Herman, Sunil K. Battu, Eric A. Burge
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Abstract
The present disclosure provides pharmaceutical compositions and processes for making solid dosage form pharmaceutical compositions that provide immediate release of active ingredients and have abuse deterrent properties. The pharmaceutical compositions provided herein comprise at least one pharmaceutically active ingredient, at least one low molecular weight hydrophilic polymer, at least one high molecular weight hydrophilic polymer, and an effervescent system.
Claims20
A solid dosage form comprising at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, at least one low molecular weight hydrophilic polymer, at least one high molecular weight hydrophilic polymer, and an effervescent system, wherein the at least one low molecular weight hydrophilic polymer has an average molecular weight of no more than 200,000 Daltons, the at least one high molecular weight hydrophilic polymer has an average molecular weight of at least 400,000 Daltons, and the solid dosage form has been heated at a temperature from about 50° C. to about 80° C. to plasticize and/or cure at least one of the low or high molecular weight hydrophilic polymers.
A process for preparing a solid dosage form, the process comprising:
- a. forming a mixture comprising at least one active pharmaceutical ingredient (API) or a pharmaceutically acceptable salt thereof, at least one low molecular weight hydrophilic polymer, at least one high molecular weight hydrophilic polymer, and an effervescent system, wherein the at least one low molecular weight hydrophilic polymer has an average molecular weight of no more than 200,000 Daltons, and the at least one high molecular weight hydrophilic polymer has an average molecular weight of at least 400,000 Daltons;
- b. forming the mixture into a solid dosage unit;
- and
- c. heating the solid dosage unit at a temperature of less than about 90° C. to yield the solid dosage form.
Dependencies are inferred from the claim text.