Studying of stability of tablets on the basis of the substance ademetionine 1,4-butandisulfonate
DOI:
https://doi.org/10.24959/ubphj.16.54Keywords:
ademetionine 1, 4-butandisulfonate, shelf life, optimum conditionsAbstract
The essential part of development of composition and technology of medicines is research of its stability. It allows to assert and to overbear accuracy of choosing of adjuncts, ways and conditions of getting a medicinal drug, to lay down definitive parameters and expiry date. By using the Karl Fischer method (SPhU* 2.5.12) and liquid chromatography (SPhU* 2.2.29) it was found that the optimal environment for production of tablets on the basis of ademetionine 1,4-butandisulfonate is 20° C and the humidity must be no more than 20%. These very conditions make possible to save the stability of medicinal drug according to such parameters as water content, determination of accompanying impurities, quantitative determination and content of S,S-isomere within 12 months.
References
Георгиевский В. П. Руководство по качеству 42-3.3:2004. Лекарственные средства. Испытания стабильности. / В. П. Георгиевский, Н. А. Ляпунов. – Киев: Морион, 2004.
Державна фармакопея України. – Харків: РІРЕГ, 2001. – 532 с. – (Вид.1).
Спектральные методы для контроля качества фармацевтических производств // Фармацевтическая отрасль. – 2011. – №3 (26). – С. 72-76
Bajajh S. Stability Testing of Pharmaceutical Products / S. Bajajh, D. Singla, N. Sakhuja. // Journal of Applied Pharmaceutical Science. – 2012. – №2. – С. 129–138.
Khan W. Characterization, thermal stability studies, and analytical method development of Paromomyc in for formulation development / W. Khan, K. Neeraj. // Drug Test Analysis. – 2011. – №3. – С. 363–372.
Perumal, O. Role of Preformulation in Development of Solid Dosage Forms [Електронний ресурс] / O. Perumal,, S. Podaralla // John Wiley & Sons, Inc. All rights reserved.. – 2010. – Режим доступу до ресурсу: http://onlinelibrary.wiley.com/doi/10.1002/9780470571224.pse363/abstract.
Stability testing of active substances and pharmaceutical products [Електронний ресурс] // World health organization. – 2006. – Режим доступу до ресурсу: http://www.who.int/medicines/services/expertcommittees/pharmprep/QAS06_179_StabilityGuidelineSept06.pdf.
World Intellectual Property Organization International Bureau A61K 9/28 Рrocess for the preparation of tablets comprising s-adenosylmethionine / Mancini, Vicenzo et al.; International Filing Date: 18.10.2002, International Publication Date: 30.05.2003
Zanowiak P. Pharmaceutical Dosage Forms [Електронний ресурс] / P. Zanowiak, V. Loyd // Wiley-VCH. – 2014. – Режим доступу до ресурсу: http://onlinelibrary.wiley.com/doi/10.1002/14356007.a19_241.pub2/abstract.
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