Preparation of solid oral dosage forms of alendronic acid (4-amino-1-hydroxybutylidene-1, 1-bisphosphonic acid)

摘要

Described is a process for preparing solid oral dosage forms, for example tablets, capsules, and coated tablets/capsules, comprising as active ingredient 4-amino-1-hydroxybutylidene-1,1-biphosphonic acid or one of its pharmaceutical acceptable salts ("Alendronic acid"). It comprises the free acid or one of its pharmaceutically acceptable salts. The process is characterized by granulating pharmaceutical carriers with an aqueous solution of Alendronic acid which is solubilized with the aid of alkaline hydroxides or alkaline salts. The oral dosage forms obtained by this process are less irritating the digestive system than oral dosage forms obtained by conventional processes. Also described are tablets and capsules prepared by the process.