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Details for Patent: 4,664,256

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Details for Patent: 4,664,256

Title: Packaged stable enema solution or suspension containing 5-aminosalicyclic acid
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.
Inventor(s): Halskov; Soren (Helsinge, DK)
Assignee: Farmaceutisk Laboratorium Ferring A/S (Vanlose, DK)
Filing Date:Oct 02, 1985
Application Number:06/782,159
Claims:1. 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.

2. 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.

3. A packaged enema solution or suspension according to claim 1, wherein the buffer is sodium bicarbonate and hydrochloric acid.

4. 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.

5. A packaged enema solution or suspension according to claim 1, wherein the inert gas is argon, nitrogen or carbon dioxide.

6. 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.

7. A packaged enema solution or suspension according to claim 1, wherein the plastic bottle is polyethylene.

8. 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.

9. 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.

10. 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.

11. A packaged enema solution or suspension according to claim 10, wherein the aroma-tight bag is a plastic aluminum laminate.

12. 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.

13. 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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