The study of pharmaco-technological parameters for the standardization of hard gelatin capsules on the base of the substance phenibut

E. S. Shakin, N. M. Asmolova, T. G. Yarnykh

Abstract


Within the pharmaceutical development is necessary to determine the volume and the order of operations aimed at standardizing of a medicine. In this aspect is important the achieving of standardization conditions at appropriate stages of the production process and conducting the quality control procedures at the release of a medicine.

Aim. To study the pharmaco-technological parameters of a medicine in the form of hard gelatin capsules on the base of the substance phenibut.

Results. It has been built the control strategy of Bifren medicine, capsules of 250 mg. Taking into account the recommendations of the leadership ICH Q8 there were conducted the works on determination the medicine’s quality target profile. Obtained results was formed the basis of the concept of documentation development for standardization of medicines, particularly, specifications for quality control of the products. The study of pharmaco-technological parameters was consisted in the study of the uniformity content of active ingredient per unit dosage of the medicine, the average weight of the capsule content, the uniformity of the mass of the capsule content, and the disintegration and dissolution of capsules. When carried out the works of assessment of the stability of a medicine there were studied conditions and developed eligibility criteria to include pharmaco-technological parameters in the specification on the stability studying.

Conclusions. The results of experimental studies were used in the development of quality control methods for the medicine Phenibut, capsules of 250 mg and specifications for a series of a medicine and to specifications on corresponding intermediate products. A result of conducted complex works were defined permissible limits of pharmaco-technological indicators which characterized more rigid approach to the requirements for intermediate products compared with the standards for the finished product, which is one of the provable elements of the system ensure the quality of medicines in the company “Pharma Start”.


Keywords


nootropic medicines; hard gelatin capsules; control strategy; standardization; specification; stability; risk assessment

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DOI: https://doi.org/10.24959/uekj.17.9

Abbreviated key title: Upr. ekon. zabezp. âkostì farm.

ISSN 2519-8807 (Online), ISSN 2311-1127 (Print)