Compressible mixture, compressed pharmaceutical compositions, and method of preparation thereof
First Claim
Patent Images
1. A compressed pharmaceutical composition, comprising:
- a plurality of coated pellets, wherein the coated pellets comprise a pharmaceutically active agent or salt, solvate, hydrate, or polymorph thereof; and
a compressible mixture, wherein the compressible mixture comprises i) a non-water soluble waxy filler and ii) a disintegrant, and wherein the compressible mixture is in powder form, with the proviso that the compressible mixture is not prepared by extrusion, spheronization, high shear mixing, melt blending, melt pelletization, freeze-drying, or a combination thereof, and wherein the compressed composition exhibits an in vitro dissolution profile according to a USP compendia method that is substantially the same as the dissolution of the coated pellets in the absence of the compressible mixture.
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Abstract
A compressible mixture prepared from a waxy filler, cellulose filler, or a mixture thereof and a disintegrant is disclosed for the preparation of compressed pharmaceutical compositions containing coated pellets. The resulting compressed compositions exhibit substantially the same dissolution profiles as the pellets in the absence of the compressible mixture.
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Citations
21 Claims
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1. A compressed pharmaceutical composition, comprising:
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a plurality of coated pellets, wherein the coated pellets comprise a pharmaceutically active agent or salt, solvate, hydrate, or polymorph thereof; and
a compressible mixture, wherein the compressible mixture comprises i) a non-water soluble waxy filler and ii) a disintegrant, and wherein the compressible mixture is in powder form, with the proviso that the compressible mixture is not prepared by extrusion, spheronization, high shear mixing, melt blending, melt pelletization, freeze-drying, or a combination thereof, and wherein the compressed composition exhibits an in vitro dissolution profile according to a USP compendia method that is substantially the same as the dissolution of the coated pellets in the absence of the compressible mixture. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A process of making a compressed pharmaceutical composition, comprising:
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mixing a powdered, waxy filler and a disintegrant to form a compressible mixture, wherein the waxy filler is non-water soluble;
mixing the compressible mixture with a plurality of coated pellets to form a pellet mixture, wherein the coated pellets comprise a pharmaceutically active agent or salt, solvate, hydrate, or polymorph thereof; and
compressing the pellet mixture with conventional direct compression equipment, wherein the compression force is not more than about 25 kiloNewtons.
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20. A direct compression compressible mixture for forming compressed pharmaceutical compositions, comprising:
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a mixture of a powdered waxy filler and a disintegrant, optionally further comprising a cellulose filler, a binder, a lubricant, a glidant, a compression aid, a colorant, a preservative, a flavor, or combinations thereof, wherein the mixture has an average particle diameter of about 0.1 to about 125 micrometers, with the proviso that the compressible mixture is not prepared by extrusion, spheronization, high shear mixing, melt blending, melt pelletization, freeze-drying, or a combination thereof; and
wherein the compressible mixture is suitable for directly compressing mixtures of the compressible mixture and coated drug pellets with substantially no damage to the coated drug pellets. - View Dependent Claims (21)
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Specification