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AssigneeBoard of Regents, The University of Texas System
InventorsJames W. MCGINITY, Sandra U. SCHILLING
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The present invention includes compositions and methods of making a modified release pharmaceutical formulation and a method of preparation for the embedding of modified release multi-particulates into a polymeric or wax-like matrix. The modified release multi-particulates comprise an effective amount of a therapeutic compound having a known or desired drug-release profile. Modified release multi-particulates may include a polymeric coat or may be incorporated into particle or core material. The polymer matrix comprises a thermoplastic polymer or lipophilic carrier or a mixture thereof that softens or melts at elevated temperature and allows the distribution of the modified release multi-particulates in the polymer matrix during thermal processing. Formulation compounds and processing conditions are selected in a manner to preserve the controlled release characteristics and/or drug-protective properties of the original modified release multi-particulates.
-55. (canceled)
A modified release pharmaceutical composition comprising an extruded thermoplastic polymer matrix comprised of a poly(ethylene oxide) or a poly(ethylene oxide)-polypropylene oxide) copolymer in which modified release multi-particulate pellets are uniformly disposed, wherein the modified release multi-particulate pellets have a particle size of from 300 to 800 μm or an average particle size of from 300 to 3000 μm, and further wherein individual multi-particulate pellets comprise a modified release polymer matrix or a modified release polymer coating, and also further comprise an effective amount of one or more therapeutic compounds.
Dependencies are inferred from the claim text.