US4572832A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Soft buccal
Assignee: Takeda Pharmaceutical Co Ltd
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Filing: 1983-10-07
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Granted: 1986-02-25
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Expires: 2003-10-07
Abstract
Abstract A soft buccal containing (1) a medicament to be absorbed through the oral mucosa, (2) a water-soluble protein, (3) a polyhydric alcohol, and (4) a fatty acid ester or/and a carboxyvinyl polymer, has various advantages such as good feeling in use, good retainability within the mouth, slow release, improved absorbability of drug through the mucosa, improved bioavailability, etc., and therefore can be used an excellent pharmaceutical preparation for administration to the mucous membrane of the mouth.
Inventors
- 👤 Kazuo Kigasawa
- 👤 Hiroaki Shimizu
- 👤 Toshihiro Hayashi
- 👤 Kazuo Watabe
- 👤 Akira Tanizaki
- 👤 Osamu Koyama
- 👤 Kikuo Wakisaka
- 👤 Yasuaki Ogawa
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-26 17:24
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/0012; A61K9/0053; A61K9/006
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
117 words
A soft buccal suitable for retention in the cavity of the mouth particularly suitable for prolonged residence in said cavity due to the softness thereof, said soft buccal containing (1) a pharmaceutically effective amount of a medicament to be absorbed through the oral mucosa and to be delivered over the desired residence period of said soft buccal in said cavity; (2) a water-soluble protein in an amount of from 0.5 to 150 parts by weight per part of drug (1); (3) 0.01 to 3 parts by weight of a polyhydric alcohol per part of protein (2); and (4) 0.01 to 10 parts by weight of fatty acid ester or a carboxyvinyl polymer, per part of protein (2).
Claim 2
Dependent Claim
117 words
A soft buccal suitable for retention in the cavity of the mouth particularly suitable for prolonged residence in said cavity due to the softness thereof, said soft buccal containing (1) a pharmaceutically effective amount of a medicament to be absorbed through the oral mucosa and to be delivered over the desired residence period of said soft buccal in said cavity; (2) a water-soluble protein in an amount of from 0.5 to 150 parts by weight per part of drug (1); (3) 0.01 to 3 parts by weight of a polyhydric alcohol per part of protein (2); and (4) 0.01 to 10 parts by weight of fatty acid ester or a carboxyvinyl polymer, per part of protein (2).
Claim 3
Dependent Claim
22 words
A soft buccal of claim 1 wherein the component (4) comprises a mixture of said fatty acid ester and said carboxyvinyl polymer.
Claim 4
Dependent Claim
92 words
A soft buccal base material suitable for accepting a drug, whereby upon incorporation of said drug to form a soft buccal which is capable of retention in the cavity of the mouth, particularly suitable for prolonged residence in said cavity due to the softness thereof, said soft buccal base material comprising (a) a water-soluble protein; (b) 0.01 to 3 parts by weight of a polyhydric alcohol per part of protein (a); and (c) 0.01 to 10 parts by weight of fatty acid ester or a carboxyvinyl polymer, per part of protein (a).
Claim 5
Dependent Claim
92 words
A soft buccal base material suitable for accepting a drug, whereby upon incorporation of said drug to form a soft buccal which is capable of retention in the cavity of the mouth, particularly suitable for prolonged residence in said cavity due to the softness thereof, said soft buccal base material comprising (a) a water-soluble protein; (b) 0.01 to 3 parts by weight of a polyhydric alcohol per part of protein (a); and (c) 0.01 to 10 parts by weight of fatty acid ester or a carboxyvinyl polymer, per part of protein (a).
Claim 6
Dependent Claim
22 words
A base material of claim 3 wherein the component (c) comprises a mixture of said fatty acid ester and said carboxyvinyl polymer.
Claim 7
Dependent Claim
41 words
A method of providing a sustained release of a medicament to a subject which comprises placing a soft buccal of claim 1 in the mouth cavity of said subject, whereby a sustained release of said medicament is delivered to said subject.
Claim 8
Dependent Claim
35 words
A soft buccal as claimed in claim 1, wherein the water-soluble protein is at least one selected from gelatin; solubilized collagen; casein; glue; hydrolysates from gelatin, solubilized collagen, casein or glue; polyalanine; polylysine and polyglutamine.
Claim 9
Dependent Claim
14 words
A soft buccal as claimed in claim 1, wherein the water-soluble protein is gelatin.
Claim 10
Dependent Claim
22 words
A soft buccal as claimed in claim 1, wherein the polyhydric alcohol is at least one selected from glycol, triol and polyol.
Claim 11
Dependent Claim
65 words
A soft buccal as claimed in claim 1, wherein the polyhydric alcohol is at least one selected from ethylene glycol; propylene glycol; butylene glycol; polyethylene glycol; glycerin; trimethylolpropane; polyvinyl alcohol; methylcellulose; ethylcellulose; propylcellulose; hydroxymethylcellulose; hydroxyethylcellulose; carboxymethylcellulose or an alkali metal salt thereof; glucose; galactose; fructose; mannose; mannitol; sorbitol; maltose; lactose; sucrose; carboxymethyl-starch; hydroxypropyl-starch; dextrin; dextran; chitin; alginic acid; glycogen; Purlan®; mannan; pectin; and gum arabic.
Claim 12
Dependent Claim
17 words
A soft buccal as claimed in claim 1, wherein the polyhydric alcohol is glycerin or propylene glycol.
Claim 13
Dependent Claim
26 words
A soft buccal as claimed in claim 1, wherein the fatty acid ester is a monoalcohol or polyalcohol ester of a saturated or unsaturated fatty acid.
Claim 14
Dependent Claim
19 words
A soft buccal as claimed in claim 1, wherein the fatty acid ester is a sucrose fatty acid ester.
Claim 15
Dependent Claim
21 words
A soft buccal as claimed in claim 1, wherein the carboxyvinyl polymer is polyacrylic acid, polymethacrylic acid or a salt thereof.
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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) | 1989-02-24 | 1989-08-26 | 1990-02-25 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-02-24 | 1993-08-26 | 1994-02-25 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1997-02-24 | 1997-08-26 | 1998-02-25 | $7700.00 | Window Closed / Lapsed |