Claims
- 1. A solid sustained-release preparation for injection or implantation into the body consisting essentially of a pharmaceutically active ingredient and a pharmaceutically acceptable protein carrier in the form of a needle-like or bar-like shape, which is prepared by a process comprising the steps of: mixing under aqueous conditions a physiologically active ingredient that is unstable to heat and a pharmaceutically acceptable biodegradable protein carrier to incorporate the active ingredient in a carrier matrix to a degree sufficient to provide sustained-release properties, and subjecting the mixture to drying and forming.
- 2. The preparation according to claim 1, wherein the active ingredient is a member selected from the group consisting of tissue plasminogen activator, prostaglandins, prostacyclines, biohormones, interferons, interleukins, tumor necrosis factor, and other cytokines.
- 3. The preparation according to claim 1, wherein the active ingredient is a member selected from the group consisting of interferons, interleukins, tumor necrosis factor, growth hormone, growth hormone releasing factor, somatomedines, calcitonin, macrophage activating factor, migration inhibitory factor, and colony stimulating factor.
- 4. The preparation according to claim 1, wherein the biodegradable carrier contains collagen.
- 5. The preparation according to claim 4, wherein the biodegradable carrier contains atelocollagen.
- 6. The preparation according to claim 1, wherein the biodegradable carrier contains gelatin.
- 7. The preparation according to claim 1, wherein the drying of the mixture is carried out by the mixture to stand at room temperature.
- 8. The preparation according to claim 1, wherein the drying of the mixture is carried out by spray-drying or lyophilizing.
- 9. The preparation according to claim 8, wherein the drying of the mixture is carried out by lyophilizing.
- 10. The preparation according to claim 1, wherein the forming is carried out by compressing a powder of the carrier matrix.
- 11. The preparation according to claim 1, wherein the forming is carried out by pouring the resulting mixture into a mold.
- 12. The preparation according to claim 1, wherein said mixing is conducted at a temperature of from 5.degree. to 30.degree. C.
- 13. The preparation according to claim 1, wherein said drying is conducted at a temperature from 15.degree. to 30.degree. C.
- 14. The preparation according to claim 12, wherein said drying is conducted at a temperature from 15.degree. to 30.degree. C.
- 15. The preparation according to claim 1, wherein said drying is performed by lyophilization at -50.degree. C. to 0.degree. C.
- 16. The preparation according to claim 1, wherein said preparation provides sustained release of said active ingredient for at least about 48 hours.
- 17. A solid sustained-release preparation consisting essentially of a pharmaceutically active ingredient and a pharmaceutically acceptable protein carrier in the form of a needle-like or bar-like shape suitable for injection into the body, which is prepared by a process comprising the steps of: mixing under aqueous conditions a physiologically active ingredient that is unstable to heat and a pharmaceutically acceptable biodegradable protein carrier to incorporate the active ingredient in a carrier matrix to a degree sufficient to provide sustained-release properties, and subjecting the mixture to drying and forming.
- 18. The preparation according to claim 17, wherein said form is suitable for intramuscular administration.
- 19. The preparation according to claim 17, wherein the active ingredient is a member selected from the group consisting of tissue plasminogen activator, prostaglandins, prostacyclines, biohormones, interferons, interleukins, tumor necrosis factor, and other cytokines.
- 20. The preparation according to claim 17, wherein the active ingredient is a member selected from the group consisting of interferons, interleukins, tumor necrosis factor, growth hormone, growth hormone releasing factor, somatomedines, calcitonin, macrophage activating factor, migration inhibitory factor, and colony stimulating factor.
- 21. The preparation according to claim 17, wherein the biodegradable carrier is collagen.
- 22. The preparation according to claim 21, wherein the biodegradable carrier is atelocollagen.
- 23. The preparation according to claim 17, wherein the biodegradable carrier is gelatin.
Priority Claims (6)
Number |
Date |
Country |
Kind |
58-193064 |
Oct 1983 |
JPX |
|
58-206226 |
Nov 1983 |
JPX |
|
58-236994 |
Dec 1983 |
JPX |
|
58-236995 |
Dec 1983 |
JPX |
|
58-236996 |
Dec 1983 |
JPX |
|
60-77250 |
Apr 1985 |
JPX |
|
Parent Case Info
This application is a divisional of copending Application Ser. No. 06/846,193, filed on Mar. 31, 1986, now U.S. Pat. No. 4,774,091, which is a continuation-in-part of Application Ser. No. 06/660,052, filed on Oct. 12, 1984, now abandoned.
US Referenced Citations (29)
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Divisions (1)
|
Number |
Date |
Country |
Parent |
846193 |
Mar 1986 |
|
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
660052 |
Oct 1984 |
|