US5021241A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Long-term sustained-release preparation
Assignee: Sumitomo Pharma Co Ltd
•
Filing: 1988-04-28
•
Granted: 1991-06-04
•
Expires: 2008-04-28
Abstract
Abstract A solid sustained-release preparation in the form of a needle-like or bar-like shape, which consists essentially of an active ingredient and a pharmaceutically acceptable biodegradable carrier (e.g. proteins, preferably collagen, gelatin, and a mixture thereof). The sustained release preparation can be administered to the body or implanted into the body by injection or an injection-like method and can release the active ingredient at an effective level for a long period of time when administered.
Inventors
- 👤 Yoshiya Yamahira
- 👤 Keiji Fujioka
- 👤 Shigeji Sato
- 👤 Yoshihiro Takada
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 10:25
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61K31/00; A61K31/33; A61K31/395; A61K31/40; A61K31/403; A61K31/404; A61K31/405; A61K31/41; A61K31/415; A61K38/00; A61K38/16; A61K38/17; A61K38/19; A61K38/21; A61K38/212; A61K9/20; A61K9/2004; A61K9/2022; A61K9/2063
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
88 words
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.
Claim 2
Dependent Claim
88 words
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.
Claim 3
Dependent Claim
33 words
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.
Claim 4
Dependent Claim
42 words
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.
Claim 5
Dependent Claim
12 words
The preparation according to claim 1, wherein the biodegradable carrier contains collagen.
Claim 6
Dependent Claim
12 words
The preparation according to claim 4, wherein the biodegradable carrier contains atelocollagen.
Claim 7
Dependent Claim
12 words
The preparation according to claim 1, wherein the biodegradable carrier contains gelatin.
Claim 8
Dependent Claim
23 words
The preparation according to claim 1, wherein the drying of the mixture is carried out by the mixture to stand at room temperature.
Claim 9
Dependent Claim
19 words
The preparation according to claim 1, wherein the drying of the mixture is carried out by spray-drying or lyophilizing.
Claim 10
Dependent Claim
17 words
The preparation according to claim 8, wherein the drying of the mixture is carried out by lyophilizing.
Claim 11
Dependent Claim
20 words
The preparation according to claim 1, wherein the forming is carried out by compressing a powder of the carrier matrix.
Claim 12
Dependent Claim
20 words
The preparation according to claim 1, wherein the forming is carried out by pouring the resulting mixture into a mold.
Claim 13
Dependent Claim
20 words
The preparation according to claim 1, wherein said mixing is conducted at a temperature of from 5° to 30° C.
Claim 14
Dependent Claim
19 words
The preparation according to claim 1, wherein said drying is conducted at a temperature from 15° to 30° C.
Claim 15
Dependent Claim
19 words
The preparation according to claim 12, wherein said drying is conducted at a temperature from 15° to 30° C.
Claim 16
Dependent Claim
19 words
The preparation according to claim 1, wherein said drying is performed by lyophilization at -50° C. to 0° C.
Claim 17
Dependent Claim
22 words
The preparation according to claim 1, wherein said preparation provides sustained release of said active ingredient for at least about 48 hours.
Claim 18
Dependent Claim
87 words
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.
Claim 19
Dependent Claim
87 words
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.
Claim 20
Dependent Claim
14 words
The preparation according to claim 17, wherein said form is suitable for intramuscular administration.
Claim 21
Dependent Claim
33 words
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.
Claim 22
Dependent Claim
42 words
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.
Claim 23
Dependent Claim
12 words
The preparation according to claim 17, wherein the biodegradable carrier is collagen.
Claim 24
Dependent Claim
12 words
The preparation according to claim 21, wherein the biodegradable carrier is atelocollagen.
Claim 25
Dependent Claim
12 words
The preparation according to claim 17, wherein the biodegradable carrier is gelatin.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1994-06-03 | 1994-12-03 | 1995-06-04 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1998-06-03 | 1998-12-03 | 1999-06-04 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2002-06-03 | 2002-12-03 | 2003-06-04 | $7700.00 | Window Closed / Lapsed |