Claims
- 1. An oral medicament having a smooth, uniform and substantially bubble-free gelatinous outer coating comprising a swallowable solid core containing a pharmaceutical active which has an exterior surface that is coated with a subcoating composed of a mixture of a water-soluble film-forming polymer selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, mixtures of hydroxypropyl cellulose and hydroxypropylmethyl cellulose, mixtures of hydroxypropyl cellulose and methyl cellulose wherein the hydroxypropyl cellulose constitutes greater than 50 weight percent but less than 100 weight percent of the mixture of hydroxypropyl cellulose and methyl cellulose, mixtures of hydroxypropyl cellulose and hydroxyethyl cellulose wherein the hydroxypropyl cellulose constitutes greater than 80 weight percent but less than 100 weight percent of the mixture of hydroxypropyl cellulose and hydroxyethyl cellulose, mixtures of hydroxypropylmethyl cellulose and methyl cellulose wherein the hydroxypropylmethyl cellulose constitutes greater than 50 weight percent but less than 100 weight percent of the mixture of hydroxypropylmethyl cellulose and methyl cellulose, mixtures of hydroxypropylmethyl cellulose and hydroxyethyl cellulose wherein the hydroxypropylmethyl cellulose constitutes more than 80 weight percent but less than 100 weight percent of the mixture of hydroxypropylmethyl cellulose and hydroxyethyl cellulose and combinations of two or more thereof; and castor oil, wherein the subcoating provides an outer subsurface which is coated with a gelatinous coating, wherein the subcoating is provided in an amount which is effective to promote a smooth, uniform and substantially bubble-free outer coating appearance to the oral medicament.
- 2. The oral medicament of claim 1 wherein the solid core has a capsule-like shape which is slight bowed in shape.
- 3. The capsule-like medicament of claim 2 wherein the bowed shape is convex and represents a variance of about 1 to 5 degrees about a longitudinal axis of the caplet core.
- 4. The capsule-like medicament of claim 2 wherein the subcoating on the solid core comprises a mixture of hydroxypropylmethyl cellulose and castor oil.
- 5. The capsule-like medicament of claim 2 wherein the subcoating composition comprises from about 2 to about 8% by weight of the total weight of the subcoated caplet core.
- 6. The capsule-like medicament of claim 2 wherein the subcoating composition comprises from about 4 to about 6% by weight of the total weight of the subcoated caplet core.
- 7. The capsule-like medicament according to claim 5 wherein the castor oil comprises from about 0.1 to about 1.0% by weight of the total weight of the subcoated caplet core.
- 8. The capsule-like medicament according to claim 4 wherein the medicament is acetaminophen.
- 9. The capsule-like medicament according to claim 4 wherein the medicament is ibuprofen.
- 10. The capsule-like medicament according to claim 4 wherein the medicament is naproxen.
- 11. The capsule-like medicament according to claim 4 wherein the medicament is loperamide.
- 12. The capsule-like medicament according to claim 4 wherein the medicament comprises a combination of acetaminophen, pseudoephedrine, dextromethorphan and chlorphenarimine.
- 13. The capsule-like medicament according to claim 4 wherein the medicament comprises a combination of acetaminophen and pseudoephedrine.
- 14. The capsule-like medicament according to claim 4 wherein the medicament comprises a combination of ibuprofen and pseudoephedrine.
- 15. An oral medicament having a smooth, uniform and substantially bubble-free gelatinous outer coating comprising a capsule shaped solid core containing a pharmaceutical active which has an exterior surface that is coated with in the range of from about 2 weight percent to about 8 weight percent by weight of the total weight of a subcoating composed of a mixture of hydroxypropylmethyl cellulose and castor oil, wherein the subcoating provide an outer subsurface which is coated with a gelatinous coating thereby providing a capsule-like medicament.
- 16. The capsule-like medicament according to claim 15 wherein the medicament is selected from the group consisting of acetaminophen, ibuprofen, loperamide, naproxen, pseudoephedrine, dextromethorphan, chlorphenarimine, and mixtures thereof.
- 17. The capsule-like medicament according to claim 15 wherein the medicament is acetaminophen.
- 18. A process for preparing an oral gelatin coated medicament comprising the steps of: compressing a mixture of a pharmaceutical active and excipients to form a solid core; applying a subcoating composition comprising a mixture of a water-soluble film-forming polymer selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, mixtures of hydroxypropyl cellulose and hydroxypropylmethyl cellulose, mixtures of hydroxypropyl cellulose and methyl cellulose wherein the hydroxypropyl cellulose constitutes greater than 50 weight percent but less than 100 weight percent of the mixture of hydroxypropyl cellulose and methyl cellulose, mixtures of hydroxypropyl cellulose and hydroxyethyl cellulose wherein the hydroxypropyl cellulose constitutes greater than 80 weight percent but less than 100 weight percent of the mixture of hydroxypropyl cellulose and hydroxyethyl cellulose, mixtures of hydroxypropylmethyl cellulose and methyl cellulose wherein the hydroxypropylmethyl cellulose constitutes greater than 50 weight percent but less than 100 weight percent of the mixture of hydroxypropylmethyl cellulose and methyl cellulose, mixtures of hydroxypropylmethyl cellulose and hydroxyethyl cellulose wherein the hydroxypropylmethyl cellulose constitutes more than 80 weight percent but less than 100 weight percent of the mixture of hydroxypropylmethyl cellulose and hydroxyethyl cellulose and combinations of two or more thereof; and castor oil, and applying a smooth outer gelatinous coating to the subcoated solid core to provide a smooth, uniform and substantially bubble free outer coating appearance to the oral medicament.
- 19. The process of claim 18 wherein the film forming polymer is hydroxypropylmethyl cellulose.
- 20. The process of claim 18 wherein the medicament is selected from the group consisting of acetaminophen, ibuprofen, loperamide, naproxen, pseudoephedrine, dextromethorphan, chlorphenarimine and mixtures thereof.
- 21. The process of claim 18 wherein the smooth outer coating comprises a gelatin which is a mixture of bone gelatin and pork gelatin.
- 22. The process of claim 20 wherein the gelatin outer coating is applied at temperatures in the range of about 35 to 55° C.
- 23. The process of claim 22 wherein the medicament is acetaminophen and the gelatin outer coating is applied at a temperature of about 40° C.
- 24. The process of claim 20 wherein the gelatin outer coating is applied at temperatures in the range of about 40 to 50° C.
- 25. The process of claim 18 wherein the subcoating comprises in the range of from about 2 weight percent to about 8 weight percent of the total weight of the oral gelatin coated medicament.
- 26. The process of claim 20 wherein the subcoating comprises in the range of from about 6 weight percent to about 8 weight percent of the total weight of the oral gelatin coated medicament.
- 27. The process of claim 20 wherein the solid caplet core is compressed and formed into a slight convex bowed shape.
- 28. The process of claim 20 wherein the gelatin outer-coating is applied by dipping the subcoated capsule-like medicament into one or more gelatin solutions.
- 29. A capsule-like medicament comprising a solid caplet core which has a slight bowed shape.
- 30. The capsule-like medicament of claim 29 wherein the bowed shape is convex and represents a variance of about 1 to 5 degrees about a longitudinal axis of the caplet core.
Parent Case Info
[0001] This invention is a continuation-in-part of Ser. No. 07/345,599 filed on Apr. 28, 1989 entitled “Subcoated Simulated Capsule-Like Medicament” the text of which is incorporated herein by reference.
Divisions (3)
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Number |
Date |
Country |
Parent |
09389793 |
Sep 1999 |
US |
Child |
09484173 |
Jan 2000 |
US |
Parent |
09292211 |
Apr 1999 |
US |
Child |
09389793 |
Sep 1999 |
US |
Parent |
08802185 |
Feb 1997 |
US |
Child |
09292211 |
Apr 1999 |
US |
Continuations (2)
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Number |
Date |
Country |
Parent |
09484173 |
Jan 2000 |
US |
Child |
09970436 |
Oct 2001 |
US |
Parent |
07784623 |
Oct 1991 |
US |
Child |
08802185 |
Feb 1997 |
US |
Continuation in Parts (1)
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Number |
Date |
Country |
Parent |
07345599 |
Apr 1989 |
US |
Child |
07784623 |
Oct 1991 |
US |