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US4529589A
Expired / Lapsed
US
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Pharmaceutical composition for the treatment of diabetes mellitus
Assignee: VSESOJUZNY KARDIOLOGICHESKY NAUCHNY TSENTR AMN SSSR
•
Filing: 1983-09-29
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Granted: 1985-07-16
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Expires: 2003-09-29
Abstract
Abstract A pharmaceutical preparation for the treatment of diabetes mellitus comprising the following components, in percent by weight: crystalline insulin with a conventional 1 to 25.0 activity of 1 mg = 20 units additives inhibiting deactivation of insulin, 0.02 to 10.0 viz. 5-(para-[N-(3-methoxypyridazinyl-6)- sulphamido]-phenylazo)-salicylic acid, calcium gluconate or a mixture thereof preservatives 0.1 to 15.0 additives adjusting solubility of 0.01 to 10.0 insulin water-soluble polymeric base the balance.
Inventors
- 👤 Anatoly B. Davydov
- 👤 Eduard A. Babaian
- 👤 Vladimir I. Metelitsa
- 👤 Tamara P. Ostrovskaya
- 👤 Rustam I. Utyamyshev
- 👤 Gennady L. Khromov
- 👤 Evgeny I. Chazov
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 05:51
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K9/2022; A61K9/2027; A61K38/00; A61K38/16; A61K38/17; A61K38/22; A61K38/28; A61K9/0012; A61K9/0053; A61K9/006
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
143 words
A pharmaceutical composition which provides a smooth hypoglycemic effect for treatment of diabetes comprising a self-adhesive shaped object for administration by adhesion to the mucous membrane of the mouth cavity, which is capable of resorption, which is of a sufficient size to provide an effective dose, and which comprises the following components in percent by weight: crystalline insulin; 1 to 25.0 at least one additive for inhibiting deactivation of insulin by saliva selected from the group consisting of (a) 5-(para-[N-(3-methoxypyridazinyl-6)-sulphamido]-phenylazo)-salicyclic acid of the formula: ##STR2## and ______________________________________
(b) mixtures of (a) and calcium gluconate
0.02 to 10.0
a preservative for said insulin;
0.1 to 15.0
an additive for adjusting insulin solubility; and
0.01 to 10.0
a coploymer of N--vinylpyrrolidone, acrylamide,
and ethylacrylate, in the following
proportions in percent by weight:
N--vinylpyrrolidone with acrylamide;
70 to 99%
Ethylacrylate 1 to 30%
______________________________________ the balance.
Claim 2
Dependent Claim
143 words
A pharmaceutical composition which provides a smooth hypoglycemic effect for treatment of diabetes comprising a self-adhesive shaped object for administration by adhesion to the mucous membrane of the mouth cavity, which is capable of resorption, which is of a sufficient size to provide an effective dose, and which comprises the following components in percent by weight: crystalline insulin; 1 to 25.0 at least one additive for inhibiting deactivation of insulin by saliva selected from the group consisting of (a) 5-(para-[N-(3-methoxypyridazinyl-6)-sulphamido]-phenylazo)-salicyclic acid of the formula: ##STR2## and ______________________________________
(b) mixtures of (a) and calcium gluconate
0.02 to 10.0
a preservative for said insulin;
0.1 to 15.0
an additive for adjusting insulin solubility; and
0.01 to 10.0
a coploymer of N--vinylpyrrolidone, acrylamide,
and ethylacrylate, in the following
proportions in percent by weight:
N--vinylpyrrolidone with acrylamide;
70 to 99%
Ethylacrylate 1 to 30%
______________________________________ the balance.
Claim 3
Dependent Claim
21 words
The pharmaceutical composition as claimed in claim 1, wherein the preservative is phenol in an amount of from 0.1 to 1%.
Claim 4
Dependent Claim
21 words
The pharmaceutical composition as claimed in claim 1, wherein the preservative is albumin in an amount of from 1 to 15%.
Claim 5
Dependent Claim
28 words
The pharmaceutical composition as claimed in claim 1, wherein the preservative a is mixture of phenol and albumin is used in an amount of from 0.1 to 15%.
Claim 6
Dependent Claim
44 words
The pharmaceutical composition as claimed in claim 1, wherein the additive adjusting insulin solubility is selected from the group consisting of 0.5N hydrochloric acid and acetic acid in an amount ensuring a pH of the mixture within the range of from 2.0 to 4.0.
Claim 7
Dependent Claim
24 words
The pharmaceutical composition as claimed in claim 1, wherein the additive adjusting insulin solubility is glycine in an amount of from 1 to 10%.
Claim 8
Dependent Claim
24 words
The pharmaceutical composition as claimed in claim 1, further comprising glucose in an amount of from 2 to 20% by weight of the copolymer.
Claim 9
Dependent Claim
42 words
The pharmaceutical composition as claimed in claim 1, further comprising a polyester derived from polyethylene glycol and a dibasic acid with a molecular mass of from 2,000 to 5,000 in an amount of from 2 to 20% by weight of the copolymer.
Claim 10
Dependent Claim
24 words
The pharmaceutical composition as claimed in claim 1, further comprising polyvinylpyrrolidone in an amount of from 2 to 20% by weight of the copolymer.
Claim 11
Dependent Claim
34 words
The pharmaceutical composition as claimed in claim 1 shaped as a plate, said plate having a thickness of from 0.1 to 1.5 mm with a content of insulin ranging from 20 to 150 units.
Claim 12
Dependent Claim
30 words
A method of treating diabetes mellitus in a warm blooded animal comprising administering to said warm blooded animal, a therapeutically effective amount of the composition of claim 1 or 11.
Claim 13
Dependent Claim
18 words
The method of claim 11 further comprising contacting said composition with the mucous membrane of the oral cavity.
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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) | 1988-07-15 | 1989-01-14 | 1989-07-16 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-07-15 | 1993-01-14 | 1993-07-16 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-07-15 | 1997-01-14 | 1997-07-16 | $7700.00 | Window Closed / Lapsed |