US4664256A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Packaged stable enema solution or suspension containing 5-aminosalicyclic acid
Assignee: AbbVie Products LLC
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Filing: 1985-10-02
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Granted: 1987-05-12
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Expires: 2005-10-02
Abstract
Abstract A packaged enema solution or suspension consisting essentially of an effective amount of 5-ASA or a pharmaceutically acceptable salt or ester thereof, a chelating agent, an antioxidant and a buffer, the solution or suspension having a pH value of from 4 to 7 and being contained in a plastic bottle under an inert gas, the plastic bottle being packaged in a diffusion-tight light-impervious package in the same inert gas as is present in the bottle.
Inventors
- 👤 Soren Halskov
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-28 11:17
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0031; A61K31/00; A61K31/60; B; B65; B65D; B65D2565/00; B65D2565/38; B65D2565/381; B65D2565/387; Y; Y02; Y02W; Y02W30/00; Y02W30/50; Y02W30/80
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
73 words
A packaged enema solution or suspension consisting essentially of an effective amount of 5-ASA or a pharmaceutically acceptable salt or ester thereof, a chelating agent, an antioxidant and a buffer, said solution or suspension having a pH value of about 4.8 and being contained in a plastic bottle under an inert gas, said plastic bottle being packaged in a diffusion-tight light-impervious package in the same inert gas as is present in the bottle.
Claim 2
Dependent Claim
73 words
A packaged enema solution or suspension consisting essentially of an effective amount of 5-ASA or a pharmaceutically acceptable salt or ester thereof, a chelating agent, an antioxidant and a buffer, said solution or suspension having a pH value of about 4.8 and being contained in a plastic bottle under an inert gas, said plastic bottle being packaged in a diffusion-tight light-impervious package in the same inert gas as is present in the bottle.
Claim 3
Dependent Claim
30 words
A packaged enema solution or suspension according to claim 1, wherein the chelating agent comprises EDTA, the antioxidant comprises sodium pyrosulfite and the buffer comprises citric acid and sodium hydroxide.
Claim 4
Dependent Claim
19 words
A packaged enema solution or suspension according to claim 1, wherein the buffer is sodium bicarbonate and hydrochloric acid.
Claim 5
Dependent Claim
27 words
An enema solution or suspension according to claim 1, wherein the 5-aminosalicyclic acid is sufficiently pure to avoid autooxidation, having no additional HPLC fluospectrophotometric and spectrophotometric peaks.
Claim 6
Dependent Claim
20 words
A packaged enema solution or suspension according to claim 1, wherein the inert gas is argon, nitrogen or carbon dioxide.
Claim 7
Dependent Claim
36 words
A packaged enema solution or suspension according to claim 1 consisting essentially of substantially pure 5-aminosalicyclic acid or a pharmaceutically acceptable salt or ester thereof, ethylenediaminetetraacetic acid, sodium pyrosulfite, citric acid, sodium hydroxide and purified water.
Claim 8
Dependent Claim
16 words
A packaged enema solution or suspension according to claim 1, wherein the plastic bottle is polyethylene.
Claim 9
Dependent Claim
34 words
A packaged enema solution or suspension according to claim 7, wherein a polyethylene granulate used for producing the polyethylene bottle is deoxidized by alternately evacuating the granulate and flooding the granulate with nitrogen gas.
Claim 10
Dependent Claim
35 words
A package enema solution or suspension according to claim 8, wherein the deoxidized granulate is extruded, formed into a bottle by means of an inert gas, and the bottle is filled with said enema solution.
Claim 11
Dependent Claim
44 words
A package enema solution or suspension according to claim 9, the filled bottle is conveyed directly to a packing chamber wherein the bottle is packed into an aroma-tight bag under an inert gas, said bag being sealed by welding before being contacted with air.
Claim 12
Dependent Claim
19 words
A packaged enema solution or suspension according to claim 10, wherein the aroma-tight bag is a plastic aluminum laminate.
Claim 13
Dependent Claim
56 words
A packaged enema solution or suspension according to claim 11, containing per 100 ml of solution about 0.2 to 4.0 g 5-aminosalicyclic acid, about 50 mg to 200 mg of sodium pyrosulfite, about 0.5 to 1.5 g citric acid, about 0.5 to 2 g sodium hydroxide, about 5 to 30 mg sodium EDTA, and purified water.
Claim 14
Dependent Claim
51 words
A packaged enema solution or suspension according to claim 12, containing per 100 ml of solution about 1 g of 5-aminosalicyclic acid, about 200 mg of sodium pyrosulfite, about 1 g citric acid, about 20 mg sodium EDTA, and sufficient sodium hydroxide and purified water to maintain said pH of 4.8.
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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) | 1990-05-11 | 1990-11-10 | 1991-05-12 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1994-05-11 | 1994-11-10 | 1995-05-12 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1998-05-11 | 1998-11-10 | 1999-05-12 | $7700.00 | Window Closed / Lapsed |