Determination of shelf life, storage conditions and packaging materials for suppositories Altabor
Abstract
Stable is a fixture in the quality of pharmaceutical products. At the organization of studies on the stability is important to understand that drugs – is mostly multi-active system, which occur simultaneously different physic-chemical, biochemical and microbiological reactions. Particular attention is paid to the creation of drug choice of primary packaging material which is in direct contact with the dosage form. Important is not only the stability of the packaging material but also its ability to protect the drug from the effect of temperature, light and humidity.Therefore, the stability of samples of drugs tested in packages that will be used in mass production of drugs.
The aim of the work was to study the shelf life, storage conditions and type of packaging materials for suppositories Altabor based substance derived from the stems of alder and gray adhesive on the «Borschagovsky Chemical-Pharmaceutical Plant».
The experimental data obtained in the study of the stability of the drug during storage showed that all indicators of quality, regardless of the form of suppositories PVC film in which they were stored, and the storage conditions comply with the requirements of State Pharmacopoeia of Ukraine and specifications. However, such indicators as the disintegration of suppositories and their melting temperature were slightly higher when stored at room temperature, which may be due to structural and mechanical changes during storage. A quantitative content elagotanins contrary, at room temperature decreased slightly, which may be caused by the action altabor decomposition temperature and time.
The studies led to the conclusion about the stability of the drug developed within 30 months of storage and shelf-life of the drug set – 2 years at a temperature of 8–15 °C, as a packaging material is advisable to use PVC film brand ZNSJ.01 PET Clear sheet (Zibo Zhongnan Plastics Co., Ltd) made in China.
References
2. Pertsev, I. M., Dmitrievsky D. I., Gudzenko O. P. and others. Auxiliary substances in drug technology: influence on technological, consumer, economic characteristics and therapeutic effectiveness / Ed. I. M. Perceva. - Kharkiv: Golden Pages, 2010. - 600 p.
3. Instruction "Medicines. Pharmaceutical Development "(42-3.1: 2004). - K .: Morion. - 2004 - 15 p.
4. Instruction "Medicines. Testing for stability "(Guidance 42-3.3: 2004). - K .: Morion. - 2004 - 60 s.
5. Chudeshov V.I., Gladuk E.V., Saiko I.V. and others. Technology of medicines for industrial production: Handrail. in 2 hours, 2nd kind. processing. and add - Kharkiv: NFaU, Original, 2012. - Ch.1. - 694 p., - Ch. 2. - 638 p.
6. Demyanenko V.G., Afanasyeva VA, Проскочило Л.В., Бресова С.В. Medical and Pharmaceutical Chemistry Studies / Ed. V.G. Demyanenko. - K .: VSI "Medicine", 2010. - 296 p.
7. State Pharmacopoeia of Ukraine / State Enterprise "Scientific Expert Pharmacopoeia Center". 1st kind. - Kharkov: RIREG, 2001. 556 p.
This work is licensed under a Creative Commons Attribution 4.0 International License.
