Stability Studies of Pyron Tablets During Storage in Natural Conditions

Puchnina S. V.
PhD (Pharmacy), Associate Professor, Chair for Pharmacology and Pharmacy¹
ORCID 0000-0002-8591-4615

Suldin A. S.
PhD (Pharmacy), Associate Professor, Chair for Pharmacology and Pharmacy¹, Chair for Industrial Technology of Medicinal Drugs with a Biotechnology course²
ORCID 0000-0003-4366-7772

Suldin A. V.
Doctor of Pharmaceutical Sciences, Professor, Pharmaceutical Technology²

Kalikina I. Yu.
Postgraduate Student²
ORCID 0000-0002-4495-0118

1 - Perm State University, Perm, Russian Federation
2 - Perm State Pharmaceutical Academy, Perm, Russian Federation

Kalikina Irina; e-mail: kalikinaira@yandex.ru.

None declared.

The study had no sponsorship.

Objective. Determination of the stability of different series of the drug «Piron film-coated tablets, 50 mg», when stored in natural conditions. Materials and methods. Three experimental series of new anti-inflammatory drug Piron tablets were analyzed. The stability study was carried out in accordance with the requirements of the State Pharmacopoeia of the XIV edition, GOST Р 57129-2016 and ICH Q1A: 2003 «Study of the stability of new pharmaceutical substances and drugs.» During storage in natural conditions (temperature not higher than 25 ºС, in a dry place protected from light), in accordance with the current regulatory documentation and draft specification all three series of the drug were analyzed by indicators: description, authenticity, mass uniformity, dissolution, dosage uniformity, impurities, microbiological purity, quantitative determination. Results. As a result of stability analysis of the finished dosage form «Piron film-coated tablets, 50 mg», we can conclude that during the storage period in natural conditions (temperature not higher than 25 ºС, in a dry place protected from light) quality parameters met specification requirements. Conclusion. The stability of tablets of the new modern non-steroidal anti-inflammatory drug «Piron film-coated tablets, 50 mg» during storage was investigated and confirmed, when stored under natural conditions. The shelf life is at least two years.

osteoarthritis, tablets, non-steroidal anti-inflammatory drugs (NSAIDs), stability

10.29234/2308-9113-2022-10-2-65-72

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