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Journal of Siberian Medical Sciences

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Choice and justification of the method of bacterial purification of hormonal substances at production of medicinal preparations in suspension form for injections in rheumatology

Аннотация

The aim of our research is to choose and justify the method of bacterial purification of hormonal substances of active ingredients of betamethasone dipropionate and hydrocortisoni acetas at developing of the most acceptable ways of receiving sterile prepared parenteral suspensions of «Hydrocortisoni Acetas + Lidocaine Hydrochloride» and «Betamethasone» is conducted. We developed two technological methods for obtaining these medicinal preparations which are characterized by identical final quality. They correspond the requirements of the State pharmacopoeia of Ukraine and the European regulatory requirements concerning the choice of a method of bacterial purification of the readymade dosage forms.

Об авторе

A. Kachaput
Central Laboratory of Pharmaceutical Development Farmak JointStock Company, Kiev, Ukraine
Россия


Список литературы

1. Rheumatoid arthritis. Adapted management based on proofs. (2014).

2. Malej M. (2010). Sovremennye podhody k lecheniju revmtatoidnogo artrita [Electron. Resource] Medicinskie aspekty zdorov’ja zhenshhiny, 8, 57-66. From https://mazg.com.ua/enissuearticle389#Suchasnipidhodidolikuvannyarevmatoyidnogoartritu.

3. Kulshreshtha A.K., Singh O.N., Wall G.M. (Eds.). (2010). Pharmaceutical suspensions. Formulation development to manufacturing. New York: Springer. 327.

4. Gosudarstvennaja Farmakopeja Ukrainy (2001). Gos. predprijatie “Nauchnojekspertnyj farmakopejnyj centr”. 1st ed. Har’kov.

5. Gosudarstvennaja Farmakopeja Ukrainy (2004). Gos. predprijatie “Nauchnojekspertnyj farmakopejnyj centr”. 1st ed., suppl. 1. Har’kov.

6. European Pharmacopoeia. 8th ed. (2013). Strasbourg: European Directorate for the Quality of medicines & HealthCare.

7. Joseph L. O’Neill (the USA), Lafayette Hill, Pa (the USA), Merck & Co. Inc., Rahway N. J. Sterilization of solid nonalectrolyte medicinal agents employing sodium chloride. Patent the USA, No. 3962430; 1975.

8. ShivajiPurwar, Monroe, Conn (the USA); Bayer Corporation, Pittsburgh, Pa (the USA). Sterilization process for pharmaceutical suspensions. Patent the USA No. 6066293,1997

9. Decision trees for the selection of sterilisation methods. Annex to note for guidance on development pharmaceutics [Electron. Resource]. From htts:www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500003520.


Рецензия

Для цитирования:


  . Journal of Siberian Medical Sciences. 2017;(2):36-41.

For citation:


Kachaput A.I. Choice and justification of the method of bacterial purification of hormonal substances at production of medicinal preparations in suspension form for injections in rheumatology. Journal of Siberian Medical Sciences. 2017;(2):36-41.

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ISSN 2542-1174 (Print)