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US 4,540,685 AGranted
Process for the production of readily soluble 5-aminosalicylic acid preparations, compositions and methods of use
OwnerKurt H. Bauerinventor
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OwnerKurt H. Bauerinventor
Estimating the term…
The invention relates to a process for the production of pharmaceutical preparations based on 5-aminosalicylic acid in which the 5-aminosalicylic acid is mixed with physiologically and toxicologically acceptable, basic auxiliaries and/or buffer mixtures, which in a 1% aqueous solution give pH-values in the range from 8 to 12, and the mixture obtained is processed in known manner to form tablets, film tablets, dragees, capsules or suppositories, or in which the 5-aminosalicylic acid is mixed with a concentrated aqueous solution of the above-mentioned basic auxiliaries and/or buffer mixtures, the 5-aminosalicylic acid salt formed is precipitated, separated off from the aqueous solution and dried and the salt obtained is processed in known manner to form tablets, film tablets, dragees, capsules or suppositories.
A process for preparing a stable and readily soluble pharmaceutical preparation for oral or rectal application based on 5-aminosalicylic acid for use in the treatment of Crohn's disease and ulcerative colitus which comprises mixing a pharmaceutically acceptable solid or liquid carrier and either a dry mixture of 5-aminosalicylic acid and a pharmaceutically acceptable alkaline material, or a dry salt of 5-aminosalicylic acid and a pharmaceutically acceptable organic alkaline material, said pharmaceutically acceptable alkaline material or organic alkaline material giving a pH of 8-12 in a 1.0% aqueous solution and the concentration of acceptable alkaline material in the dry mixture being 0.5-3.0 mols per mol of 5-aminosalicylic acid.
A stable and readily soluble pharmaceutical preparation for oral or rectal application based on 5-aminosalicylic acid for use in the treatment of Crohn's Disease and ulcerative colitus which comprises a pharmaceutically acceptable solid or liquid carrier and either a dry mixture of 5-aminosalicylic acid and a pharmaceutically acceptable alkaline material, or a dry salt of 5-aminosalicylic acid and a pharmaceutically acceptable organic alkaline material, said pharmaceutically acceptable alkaline material or organic alkaline material giving a pH of 8-12 in a 1.0 percent aqueous solution and the concentration of acceptable alkaline material in the dry mixture being 0.5-3.0 mols per mol of 5-aminosalicylic acid.
Dependencies are inferred from the claim text.