Claims
- 1. An oral pharmaceutical preparation containing a therapeutically effective amount of a salt of morphine for administration once daily which consists of at least 50 particles, each particle having a core containing a salt of morphine coated with a barrier layer, said barrier layer being formed from a coating liquid containing at least one water insoluble barrier forming component selected from the group consisting of ethyl cellulose, copolymers of acrylic and methacrylic esters and natural or synthetic waxes, and a plasticizer, wherein said coating liquid is a solution, dispersion, suspension, emulsion or melt and wherein the mean serum concentration of morphine obtained is at least 50% of the maximum serum concentration during at least 12 hours after the administration of a single dose of said preparation.
- 2. A preparation according to claim 1 wherein the mean serum concentration of morphine obtained is at least 50% of the maximum serum concentration during at least 18 hours after the administration of a single dose of said preparation.
- 3. A preparation according to claim 1 wherein in that the drug release through the coating barrier layer is substantially independent of pH within the range of 1.0 to 7.0.
- 4. A preparation according to claim 1 wherein the size of the particles is in the range of 0.2 to 3 mm.
- 5. A preparation according to claim 1 wherein the size of the particles is between 0.7 and 1.4 mm.
- 6. A preparation according to claim 1 wherein the coating barrier layer also contains at least one water soluble component selected from the group consisting of hydroxypropylmethyl cellulose, hydroxypropyl cellulose, copolymers of acrylic and methacrylic acid esters, and optionally pigments.
- 7. A preparation according to claim 1 wherein the coating barrier layer contains ethyl cellulose, hydroxypropylmethyl cellulose and triethyl citrate as a plasticizer.
- 8. A preparation according to claim 7 wherein the relation between ethyl cellulose, hydroxypropylmethyl cellulose and triethyl citrate lies in the range from 55:35:10% to 80:10:10%.
- 9. A preparation according to claim 8 wherein said relation is 80:5:15%.
- 10. A preparation according to claim 1 wherein the viscosity of the ethyl cellulose lies in the range of from 5 to 15 cps.
- 11. A preparation according to claim 1 wherein the salt of morphine is chosen among morphine hydrochloride, morphine sulphate and morphine salts of organic carboxylic acids.
- 12. A preparation according to claim 1 wherein it is in the form of a tablet, a capsule or a sachet.
- 13. A preparation according to claim 2 wherein the drug release through the coating barrier layer is substantially independent of pH within the range of 1.0 to 7.0.
- 14. A preparation according to claim 2 wherein the size of the particles is in the range of 0.2 to 3 mm.
Parent Case Info
This application is a continuation of U.S. patent application Ser. No. 08/426,906, filed Apr. 21, 1995, now U.S. Pat. No. 5,656,291, which in turn is a divisional application of U.S. patent application Ser. No. 08/213,518 filed Mar. 16, 1994, now U.S. Pat. No. 5,614,218.
US Referenced Citations (1)
Number |
Name |
Date |
Kind |
4557925 |
Lindahl et al. |
Dec 1985 |
|
Foreign Referenced Citations (2)
Number |
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Country |
0 097 523 |
Jan 1984 |
EPX |
03161 |
Feb 1994 |
WOX |
Non-Patent Literature Citations (2)
Entry |
Olsson et al. (1991). Proc. Int. Symp. Cont. Rel. Biact. Mater., vol. 18, pp. 433-434. |
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Divisions (1)
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Number |
Date |
Country |
Parent |
213518 |
Mar 1994 |
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Continuations (1)
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Number |
Date |
Country |
Parent |
426906 |
Apr 1995 |
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