Pharmaceutical composition containing a pyrrolidone anticonvulsant agent and method for the preparation thereof

A process for the preparation of a solid dosage form for oral administration, such as a tablet, a capsule or a sachet, containing a pyrrolidone anticonvulsant agent such as Levetiracetam or a pharmaceutical acceptable salt or derivative thereof as an active ingredient is provided, which comprises:

• Forming a granulating solution by agitating purified water with the total quantity of a binder, such as HPC;
• Forming a homogenous mixture by mixing the total quantity of said active ingredient with the total quantity of an effective quantity of Dibasic Calcium Phosphate as an agent to improve friability, hardness and flow properties of the composition, and optionally at least a diluent, such as MCC and a portion of the total quantity of a disintegrant, such as Cross Povidone;
• Kneading the above mixture with the granulating solution;
• Sieving the wetted mass through a sieve and forming granules
• Drying the granules;
• Sieving the dried granules through a sieve to achieve the desired granule size;
• forming a second blend by mixing the remaining amount of the disintegrant, such as Cross Povidone and the total quantity of any other optional excipient such as a binder, lubricant, a colorant, and/or a glidant until uniform,
• blending the above formed granules with the second blend, and
• Formulating the resulting mixture in a solid dosage form either by compressing it into a desired tablet form or by filling capsules or sachets.