High dose oral formulation of bisphosphonate and a process for making thereof

A process for the preparation of a tablet comprising ibandronic acid or a pharmaceutically acceptable salt thereof and a disintegrant, wherein the disintegrant is selected from the group consisting of crosslinked polyvinylpyrrolidone and croscarmellose, comprising

• a) spray-granulating ibandronic acid or a pharmaceutically acceptable salt thereof, filler and the entire amount of the disintegrant to be used in the preparation of the tablet with a solution of a binder in purified water at a temperature of about 70° C. to yield a spray granulated material;
• b) drying the spray granulated material at a temperature of about 70° C. and subsequently screening the dried spray granulated material through a fine sieve;
• c) mixing the dried spray granulated material with a mixture consisting of additional filler, a lubricant, and a flow regulator wherein said mixture was previously passed through a fine sieve, to yield a final blend;
• and
• d) compressing the final blend into tablet kernels.