US4867970A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Moistureless oral drug delivery formulation and method for preparing same
Assignee: ER Squibb and Sons LLC
•
Filing: 1987-05-21
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Granted: 1989-09-19
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Expires: 2007-05-21
Abstract
Abstract Oral drug delivery systems are provided formed of compositions which include one or more hydrocolloids solids, such as gelatin, pectin, and sodium carboxymethyl cellulose, and preferably mixtures thereof, which solids contain less than about 5% by weight moisture and preferably comprise less than about 50% by weight of the total formulation; and an ointment base such as mineral oil containing dispersed polyethylene (Plastibase). Such oral drug delivery compositions may be used to deliver to the oral mucosa active ingredients such as steroids, anti-fungal agents, anti-bacterial agents and the like and do not harden even upon prolonged storage or upon filling into containers.
Inventors
- 👤 E. A. Newsham
- 👤 Jeffrey W. Forrester
- 👤 Duncan J. Rowley
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 20:50
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0053; A61K9/006
Claims Analysis
Total Claims: 20
Claim 1
Independent Claim
107 words
An oral drug delivery system, in the form of an oral ointment formulation, comprising one or more hydrocolloids solids in an amount within the range of from about 0.5 to about 60% by weight of the formulation, containing less than about 5% by weight moisture, and an ointment base therefor, said formulation having resistance to hardening even upon prolonged storage or filling into containers, whereupon application of said formulation at the desired site of action in the oral cavity, moisture in said oral cavity causes said hydrocolloid to swell and medicament to be released and to adhere to and be retained at the desired site of action.
Claim 2
Dependent Claim
107 words
An oral drug delivery system, in the form of an oral ointment formulation, comprising one or more hydrocolloids solids in an amount within the range of from about 0.5 to about 60% by weight of the formulation, containing less than about 5% by weight moisture, and an ointment base therefor, said formulation having resistance to hardening even upon prolonged storage or filling into containers, whereupon application of said formulation at the desired site of action in the oral cavity, moisture in said oral cavity causes said hydrocolloid to swell and medicament to be released and to adhere to and be retained at the desired site of action.
Claim 3
Dependent Claim
30 words
The formulation as defined in Claim 1 further including a medicament in an amount within the range of from about 0.01 to about 25% by weight of the total formulation.
Claim 4
Dependent Claim
14 words
The formulation as defined in claim 2 wherein the medicament is an antifungal agent.
Claim 5
Dependent Claim
20 words
The formulation as defined in claim 3 wherein the antifungal agent is nystatin, clotrimazole, amphotericin B, miconazole, ketoconazole or griseofulvin.
Claim 6
Dependent Claim
13 words
The formulation as defined in claim 2 wherein the medicament is a steroid.
Claim 7
Dependent Claim
13 words
The formulation as defined in claim 5 wherein said steroid is triamcinolone acetonide.
Claim 8
Dependent Claim
47 words
The formulation as defined in claim 1 wherein said hydrocolloid is gelatin, pectin, cellulose ether, a cellulose alkyl hydroxylate, a cellulose alkyl carboxylate, an alkali metal salt of a cellulose alkyl carboxylate, an acrylic acid homo- or copolymer or salt thereof, sodium alginate, carrageenan or mixtures thereof.
Claim 9
Dependent Claim
20 words
The formulation as defined in claim 1 wherein said hydrocolloid is a mixture of gelatin, pectin and sodium carboxymethyl cellulose.
Claim 10
Dependent Claim
18 words
The formulation as defined in claim 2 wherein said ointment base is mineral oil containing a thickening agent.
Claim 11
Dependent Claim
16 words
The formulation as defined in claim 9 wherein said ointment base is mineral oil containing polyethylene.
Claim 12
Dependent Claim
18 words
The formulation as defined claim 2 including one or more antifungal agent and/or antibacterial agents as the medicament.
Claim 13
Dependent Claim
18 words
The formulation as defined in claim 1 wherein the hydrocolloids solids contain less than 1% by weight moisture.
Claim 14
Dependent Claim
32 words
The formulation as defined in claim 1 wherein the hydrocolloids solids are present in an amount within the range of from about 30 to about 50% by weight of the total formulation.
Claim 15
Dependent Claim
54 words
The formulation as defined in claim 13 wherein the hydrocolloid is comprised of from about 0.5 to about 60% by weight gelatin, from about 0.5 to about 60% by weight pectin, and from about 0.5 to about 60% by weight sodium carboxymethyl cellulose, said % being based on the weight of the hydrocolloid mixture.
Claim 16
Dependent Claim
68 words
The formulation as defined in claim 10 wherein the medicament is triamcinolone acetonide, the ointment base is mineral oil thickened with polyethylene and said hydrocolloids solids is a mixture of gelatin, pectin and sodium carboxymethyl cellulose, said solids containing less than about 1% by weight moisture and being present in a weight ratio to said ointment base of within the range of from about 0.43:1 to about 1:1.
Claim 17
Dependent Claim
21 words
The formulation as defined in claim 1 wherein said hydrocolloids have an average particle size of less than about 100 micrometers.
Claim 18
Dependent Claim
66 words
A method for preparing an oral drug delivery system in the form of an oral ointment formulation having improved resistance to hardening during storage, as defined in claim 1, which comprises drying the hydrocolloids solids to a moisture content of less than about 5% by weight of said hydrocolloids solids, and mixing the so-dried hydrocolloids solids with said ointment base to form said oral ointment formulation.
Claim 19
Dependent Claim
18 words
The method as defined in claim 17 wherein said hydrocolloids solids are dried to about 0% moisture content.
Claim 20
Dependent Claim
29 words
The method as defined in claim 17 wherein said hydrocolloids solids are comprised of sodium carboxymethyl cellulose, pectin and gelatin and said ointment base is mineral oil containing polyethylene.
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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) | 1992-09-18 | 1993-03-20 | 1993-09-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-09-18 | 1997-03-20 | 1997-09-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-09-18 | 2001-03-20 | 2001-09-19 | $7700.00 | Window Closed / Lapsed |