Title:
OPIOID SUSTAINED-RELEASED FORMULATION
Document Type and Number:
WIPO Patent Application WO/2001/008661
Kind Code:
A2
Abstract:
A solid, oral, controlled release dosage form comprising a therapeutically effective amount of an opioid compound, or a salt thereof, a matrix-forming polymer and an ionic exchange resin.
Inventors:
MALONEY ANN M
Application Number:
PCT/US2000/020413
Publication Date:
February 08, 2001
Filing Date:
July 27, 2000
Export Citation:
Assignee:
ROXANE LAB INC (US)
International Classes:
A61K9/20; C07D489/08; A61K9/22; A61K9/26; A61K9/28; A61K31/135; A61K31/216; A61K31/439; A61K31/451; A61K31/485; A61K47/30; A61K47/32; A61K47/34; A61K47/38; A61K47/48; A61P25/04; (IPC1-7): A61K9/00
Foreign References:
| US4859461A | 1989-08-22 | |||
| GB2176999A | 1987-01-14 | |||
| US5709882A | 1998-01-20 |
Other References:
SRIWONGJANYA M ET AL: "EFFECT OF ION EXCHANGE RESINS ON THE DRUG RELEASE FROM MATRIX TABLETS" EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS,NL,ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM, vol. 46, no. 3, 1 November 1998 (1998-11-01), pages 321-327, XP000787137 ISSN: 0939-6411
Attorney, Agent or Firm:
Raymond, Robert P. (900 Ridgebury Road P.O. Box 36, Ridgefield CT, US)
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Claims:
WHAT IS CLAIMED IS:
| 1. | A solid, oral, controlled release dosage form comprising a therapeutically effective amount of oxycodone, or a salt thereof, a matrixforming polymer and an ionic exchange resin. |
| 2. | The dosage form of claim 1 wherein the matrixforming polymer is an alkylcellulose. |
| 3. | The dosage form of claim 2 wherein the alkylcellulose is a C,C6 alkylcellulose. |
| 4. | The dosage form of claim 1 wherein the matrixforming polymer is a hydroxyalkylcellulose. |
| 5. | The dosage form of claim 4 wherein the hydroxyalkylcellulose is a ClC6 hydroxyalkylcellulose. |
| 6. | The dosage form of claim 5 wherein the hydroxyalkylcellulose is selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethyl cellulose and hydroxyethylcellulose. |
| 7. | The dosage form of claim 1 wherein the ionic exchange resin comprises a cationic exchange resin. |
| 8. | The dosage form of claim 7 wherein the cationic exchange resin comprises a sulfonated polymer. |
| 9. | The dosage form of claim 8 wherein the cationic exchange resin comprises a copolymer of divinylbenzene and styrene. |
| 10. | The dosage form of claim 8 wherein the cationic exchange resin comprises a copolymer of divinylbenzene and methacrylic acid. |
| 11. | The dosage form of claim 1 wherein the ionic exchange resin is a phenolic polyamine. |
| 12. | The dosage form of claim 1 where the dosage form contains between about 1 and 20% ionic exchange resin. |
| 13. | The dosage form of claim 12 wherein the dosage form contains between about 7 and 10% ionic exchange resin. |
| 14. | The dosage form of claim 12 wherein the dosage form further contains between about 30 and 65% matrixforming polymer. |
| 15. | The dosage form of claim 14 wherein the dosage form contains between about 50 and 60% matrixforming polymer. |
| 16. | A solid, oral, controlled release dosage form comprising a therapeutically effective amount of opioid compound, or a salt thereof, between about 30 and 65% of a matrixforming polymer and between about 1 and 20% ionic exchange resin. |
| 17. | The dosage form of claim 16 wherein the opioid compound is selected from the group consisting of butorphanol, codeine, dihydrocodeine, hydrocodone bitartrate, hydromorphone, meperidine, methadone, morphine, oxycodone hydrochloride, oxymorphone, pentazocine, propxyphene hydrochloride and propoxyphene napsylate. |
| 18. | The dosage form of claim 16 wherein the opioid compound is oxycodone. |
| 19. | The dosage form of claim 16 wherein the matrixforming polymer is an alkylcellulose. |
| 20. | The dosage form of claim 19 wherein the alkylcellulose is a ClC6 alkylcellulose. |
| 21. | The dosage form of claim 16 wherein the matrixforming polymer is a hydroxyalkylcellulose. |
| 22. | The dosage form of claim 21 wherein the hydroxyalkylcellulose is a ClC6 hydroxyalkylcellulose. |
| 23. | The dosage form of claim 22 wherein the hydroxyalkylcellulose is selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethyl cellulose and hydroxyethylcellulose. |
| 24. | The dosage form of claim 16 wherein the ionic exchange resin comprises a cationic exchange resin. |
| 25. | The dosage form of claim 24 wherein the cationic exchange resin comprises a sulfonated polymer. |
| 26. | The dosage form of claim 24 wherein the cationic exchange resin comprises a copolymer of divinylbenzene and styrene. |
| 27. | The dosage form of claim 24 wherein the cationic exchange resin comprises a copolymer of divinylbenzene and methacrylic acid. |
| 28. | The dosage form of claim 24 wherein the cationic exchange resin comprises phenolicbased polyamine condensates. |
| 29. | The dosage form of claim 16 wherein each of the opioid compound, matrixforming polymer and cationic exchange resin are admixed with one another in dry form. |
| 30. | A solid, oral, controlled release dosage form comprising a therapeutically effective amount of an opioid compound, or a salt thereof, between about 30 and 65% of a matrixforming polymer and between about 1 and 20% ionic exchange resin having a mean particle size of less than about 50 ; j. m and a particle size distribution such that not less than 90% of the particles pass through a 325 mesh sieve, US. Standard Sieve Size. |
| 31. | The dosage form of claim 30 wherein the opioid compound is selected from the group consisting of : butorphanol, codeine, dihydrocodeine, hydrocodone bitartrate, hydromorphone, meperidine, methadone, morphine, oxycodone hydrochloride, oxymorphone, pentazocine, propxyphene hydrochloride and propoxyphene napsylate. |
| 32. | The dosage form of claim 30 wherein the opioid compound is oxycodone. |
| 33. | The dosage form of claim 30 wherein the matrixforming polymer is an alkylcellulose. |
| 34. | The dosage form of claim 30 wherein the alkylcellulose is a CiC6 alkylcellulose. |
| 35. | The dosage form of claim 30 wherein the matrixforming polymer is a hydroxyalkylcellulose. |
| 36. | The dosage form of claim 35 wherein the hydroxyalkylcellulose is a C IC6 hydroxyalkylcellulose. |
| 37. | The dosage form of claim 36 wherein the hydroxyalkylcellulose is selected from the group consisting of : hydroxypropylcellulose, hydroxypropylmethyl cellulose and hydroxyethylcellulose. |
| 38. | The dosage form of claim 30 wherein the ionic exchange resin is a cationic exchange resin. |
| 39. | The dosage form of claim 38 wherein the cationic exchange resin comprises a sulfonated polymer. |
| 40. | The dosage form of claim 38 wherein the cationic exchange resin comprises a copolymer of divinylbenzene and styrene. |
| 41. | The dosage form of claim 38 wherein the cationic exchange resin comprises a copolymer of divinylbenzene and methacrylic acid. |
| 42. | The dosage form of claim 38 wherein the cationic exchange resin comprises phenolicbased polyamine condensates. |
| 43. | The dosage form of claim 30 wherein each of the opioid compound, matrixforming polymer and cationic exchange resin are admixed with one another in dry form. |
Description:
INTERNATIONALSEARCHREPORT j-------------------) Interr nal ApplicationNo PCT/US00/20413 C.(Continuation)DOCUMENTSCONSIDEREDTOBERELEVANT Category ° Citationofdocument,withindication,whereappropriate,oftherele
vantpassagesRelevanttoclaimNo. ASRIWONGJANYAMETAL:"EFFECTOFION1-43 EXCHANGERESINSONTHEDRUGRELEASEFROM MATRIXTABLETS" EUROPEANJOURNALOFPHARMACEUTICSAND BIOPHARMACEUTICS,NL,ELSEVIERSCIENCE PUBLISHERSB.V.,AMSTERDAM, vol.46,no.3, 1November1998(1998-11-01),pages 321-327,XP000787137 ISSN:0939-6411 thewholedocument 1 INTERNATIONALSEARCHREPORT InterrialApplicationNo ..ormation on patent family members PCT/US00/20413 PatentdocumentPublication Patent family Publication citedinsearchreportdate member(s)date US4859461A22-08-1989AT 93164 T 15-09-1993 AU 582302 B 16-03-1989 AU 7098987 A 04-02-1988 CA 1283998 A 07-05-1991 DE 3787060 A 23-09-1993 DE 3787060 T 02-12-1993 DK 394787 A 02-05-1988 EP 0254811 A 03-02-1988 FI 872582 A 31-01-1988 IE 62100 B 14-12-1994 JP 2670777 B 29-10-1997 JP 63035527 A 16-02-1988 KR 9612067 B 12-09-1996 NO 873031 A 01-02-1988 NZ 219816 A 06-01-1989 GB2176999A14-01-1987NONE US5709882A20-01-1998AU 656346 B 02-02-1995 AU 8930591 A 08-07-1992 CA 2097176 A 08-06-1992 EP 0560816 A 22-09-1993 FI 932553 A 04-06-1993 HU 64213 A 28-12-1993 JP 6503311 T 14-04-1994 NO 305536 B 21-06-1999 PT 99720 A 30-10-1992 WO 9210171 A 25-06-1992 SI 9111867 A 31-08-1998 US 5707656 A 13-01-1998
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