Claims
- 1. A process for production of easy-to-swallow tablets comprising the steps of
- a) drying raw cholestyramine to a moisture content of about 9 to 12% by weight;
- b) blending the dried cholestyramine of step a) with about 0.01 to 0.5% of a lubricant to prevent internal tablet stress and directly compressing elongated, cylindrically-shaped tablets to a desired thickness; and
- c) applying a protective film coating to the uncoated tablet using aqueous film coating comprising simultaneous spray-drying without preheating the inner tablet during the coating process.
- 2. The process of claim 1 wherein about 0.1 to 0.2% of magnesium stearate is the lubricant used in step b).
- 3. The process of claim 1 wherein the elongated, cylindrically-shaped tablets are compressed to a thickness of about 0.70 to 0.83 inches.
- 4. The process of claim 1 wherein the aqueous film coating process comprises the use of an aqueous solution or suspension of a coating polymer selected from an aqueous cellulosic or acrylic polymer.
- 5. The process of claim 4 wherein the coating polymer is a hydroxyalkylcellulose.
- 6. The process of claim 5 wherein the coating polymer is hydroxypropylmethylcellulose.
- 7. The process of claim 4 wherein the aqueous film coating process also uses a suitable plasticizer selected from polyethylene glycols.
- 8. The process of claim 4 wherein the aqueous film coating process also uses an antifoam emulsion.
- 9. The process of claim 6 wherein the aqueous coating process uses a solution or suspension of about 5 to 15% of solid contents comprised of hydroxypropylmethylcellulose, polyethylene glycol 6000, polyethylene glycol 400 and antifoam C emulsion.
- 10. The film-coated cholestyramine tablets produced by the process of one of claims 1 through 9.
- 11. An easy-to-swallow tablet comprised of
- an inner tablet comprising a cholesterol-lowering ion exchange resin having about 9 to 12% moisture and about 0.01 to 0.5% by weight of lubricant directly compressed to the desired thickness; and
- an outer aqueous film coat providing about 6 to 12% by weight of the easy-to-swallow tablet, the film coat comprising an aqueous cellulosic polymer with optional added amounts of a plasticizer and an antifoam emulsion.
- 12. The tablet of claim 1 wherein the ion exchange resin is cholestyramine.
- 13. The tablet of claim 2 wherein the lubricant is magnesium stearate and the cellulosic polymer is hydroxypropylmethylcellulose.
- 14. The tablet of claim 3 wherein the film coat also contains about one part of an antifoam agent per 10 parts hydroxypropylmethylcellulose.
- 15. The tablet of claim 3 wherein the inner tablet contains from about 0.1 to 0.2% of magnesium stearate.
- 16. The tablet of claim 1 wherein the film coat is comprised of hydroxypropylmethylcellulose, polyethylene glycol and an antifoam agent.
CROSS REFERENCE TO RALATED APPLICATION
This non-provisional application claims the benefit of U.S. provisional application 60/060,357 filed Sep. 29, 1997.
US Referenced Citations (8)