Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms
AssigneeSPI Pharma, Inc.
InventorsGary T. Norman, Kalyan S. Nuguru, Arun F. Amin, Sarath Chandar
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Abstract
The present invention comprises a co-processed carbohydrate system, and formulations produced therefrom, which formulations are directly compressible into solid dosage forms, some of which rapidly and completely dissolve or disintegrate in the oral cavity within 60 seconds. The invention also comprises the solid dosage forms produced by directly compressing the co-processed carbohydrate system, some of which, when placed in the oral cavity, shall dissolve or disintegrate, preferably within about 60 seconds.
Claims20
A method for producing a directly compressible and highly compactible composition, said method comprising:
- dissolving mannitol powder and sorbitol powder into a solution;
- seeding the solution with a blend of co-spray-dried particles consisting essentially of mannitol and sorbitol, wherein the ratio of mannitol powder to sorbitol powder in the solution is the same as the ratio of mannitol to sorbitol in the blend of dry particles;
- drying the solution in an air stream;
- and
- forming particles having a nonfilamentous microstructure from the solution.
A quick-dissolving composition comprising:
- particles having a surface with a nonfilamentous microstructure, the particles comprising (i) co-spray-dried polyols consisting essentially of sorbitol and mannitol, wherein the particles are produced by seeding a solution comprising the polyols selected in (i) with a blend of dry particles of the polyols selected in (i), wherein the ratio of the polyols in the solution is the same as the ratio of the polyols in the blend of dry particles;
- and
- a disintegrant,
- wherein said composition dissolves in the oral cavity in less than 60 seconds.
A composition comprising:
- (a) particles including co-spray dried mannitol and sorbitol, wherein the particles are produced by seeding a solution comprising mannitol and sorbitol with a blend of dry particles consisting essentially of mannitol and sorbitol, wherein the ratio of the mannitol to the sorbitol in the solution is the same as the ratio of the mannitol to the sorbitol in the blend of dry particles;
- wherein the particles have a nonfilamentous microstructure;
- (b) a disintegrant selected from the group consisting of crospovidone, croscarmellose, sodium starch glycolate, and combinations thereof;
- (c) a glidant selected from the group consisting of silica gel, colloidal silica, precipitated silica, and combinations thereof;
- and
- (d) an active ingredient.
Dependencies are inferred from the claim text.