Pharmaceutical development of the anti-epileptic tablets on the basis of levetiracetam substance. the specificity of pharmaco-technological studies at standardization of the remedy

Abstract

Remedies containing Levetiracetam are widely used in medical practice for treatment of different forms of epilepsy. In result of pharmaceutical development, manufacturing formulation for the tablets on the basis of Levetiracetam substance was obtained, and the new technology for its production was developed.

The aim of research within the pharmaceutical development of the remedy was to determine the necessity of the complex of operations related to the standardization of the remedies Levetiracetam 250, film coated tablets 250 mg and Levetiracetam 500, film coated tablets 500 mg. Experimental studies should be devoted to determination of quality target product profile (QTPP), according to ICH Q8 recommendations. Concerning the specificity of the mentioned drugs production, the amount of work was determined to develop pharmaco-technological indexes for their implementation to the relevant specifications for the finished drug product, as well as for the intermediate products obtained at different stages of the technological process.

Methods. By results of tests, which were carried out in accordance to pharmacopoeia requirements, the eligibility criteria of pharmaco-technological parameters for the corresponding control objects were determined.

Results. Results of quality target product profile (QTPP) studies were used for development of specifications for the remedies Levetiracetam 250, film coated tablets 250 mg and Levetiracetam 500, film coated tablets 500 mg, which were completed in the form of quality control methods and specifications for the finished drug product series.

Experimental research of the samples of products, which were obtained at appropriate stages of the technological process, were carried out; pharmaco-technological indexes, which were implemented into the specifications for the finished drug product, as well as the specifications for the intermediate products, were developed. According to the given data estimation, it was displayed, that pharmaco-technological indexes are rather important both for the quality of drug assesment, and for evidence base formation to confirm the reproducibility of the technological process.

Conclusion. The results of research within standardization of the remedies Levetiracetam 250, film coated tablets 250 mg and Levetiracetam 500, film coated tablets 500 mg show processability of obtaining drugs, which LLC "Pharma Start" carries out, as well as guarantee of the drugs quality from batch to batch