Stability studying of antral film-coated tablets
Stability studying is very important in process of development of finished drug products. Stability of drugs provides saving of theirs therapeutical properties during several years of shelf life. Stability should be under close attention of the developer, as this parameter is not checked by state control and only is on responsibility of the manufacturer.
The aim of the article is a scientific justification of Antral film-coated tablet’s stability during storage and setting the expiration date of the drug.
The object of the study was Antral, film-coated tablets 0,2 g.
For this research there were used such methods: UV spectrophotometry, TLC and HPTLC. The preparation was evaluated in accordance with the methods of quality control procedures and specifications of the intermediate and finished products, as well as the State Pharmacopoeia of Ukraine.
The results of the drug stability studies during stress tests, accelerated and long-term storage tests, were performed. The study was carried out at two temperature conditions: 25 °C and 60% relative humidity and 40 °C and 75% relative humidity and also stress studies to examine the effect of oxidizing agents, acids, alkalis, metals on the impurities formation process in active substance and drug .
Based on the forecast by extrapolation of experimental data and long-term stability studies of the drug of pilot scale batches has been established for 2 years, and then the registration expiration date has been confirmed on the basis of long-term stability studies of pilot scale batches. The results of long-term stability studies of production batches allowed to establish the shelf life of the drug for 3 years.
2. Georgiyevsky V., Lyapunov M., Bezugla O. and others. Guidance on quality. Medicines. Stability test. Instruction March 42-3, 2004 - K .: Ministry of Health of Ukraine. - 2004 - 60 s.
3. State Pharmacopoeia of Ukraine / State Enterprise "Ukrainian Scientific Pharmacopoeial Center for the Quality of Drugs". - 2nd kind. - Kharkiv: State Enterprise "Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicines", 2015 - T. 1. - 1128 p.
4. ICH Topic Q1E Evaluation of Stability Data. August 2003 CPMP / ICH / 420/02. - EMA - 2006 - 17 c.
5. World Health Organization WHO Technical Report Series, N 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products. - 2009 - 130 p.
This work is licensed under a Creative Commons Attribution 4.0 International License.