Study of compatibility of filter materials with solution of meloksmkama for injections

  • M. S. Almakaev National University of Pharmacy, Kharkiv
Keywords: filtration, filter materials, solution of meloksikama, mechanical including

Abstract

One of pharmaceutical design of parenterally solutions times is establishment of influence of filter materials on quality of preparation and choice of optimum filter membranes on the basis of these researches, establishment of optimum size of pores, and sequence of filtration of solution through filters with the different size of pores, that provides the necessary cleaning of injection solution from the mechanical including and microorganisms. The purpose of work was a leadthrough of pharmaceutical development of solution of meloksikama for injections, some aspects of which are lighted up in this article. A research object were «Meloksikam, solution for injection 10 mgs/ml for 1,5 ml in ampoules» and filter membranes, made from a kapron (type of «MIFIL», Byelorussia), nylon (type of «Ultipor N 66», Pall, Germany), poliefirsul'fona (type of «PROPOR PES», Domnik Khanter, England). Control of standards was conducted on methods, to described in DFU and normative document on preparation.

Compatibility of solution of meloksikama is well-proven 10 mgs/ml with materials of filters from a kapron (type of «MIFIL», Byelorussia), from a nylon (type of «Ultipor N 66», Pall, Germanу), poliefirsul'fona (type of «PROPOR PES», Domnick Hunter, England). The optimum mode of filtration and assortment of suitable to the use filter materials is chosen taking into account the cross-coupling of components of solution, рН environment and material of filter.

For determination of efficiency of filtration, there was a certain index of filtrated of FI (Filtrability Index) and maximal volume of the filtered solution of Vmax. It is set that for achievement of greater efficiency of filtration it is necessary to combine preliminary filtration through membranes with the threshold of detention of 0,6 mkm and steralizing – through membranes with the threshold of detention of 0,2 mkm.

References

1. State Pharmacopoeia of Ukraine / State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicinal Products". 1st kind. - Kharkov, 2001. - 556 p. (Extras. 1. - 2004. - 520 p .; Extras. 2. - 2008. - 620 p .; Extras. 3. - 2009. - 280 p .; Extras. 4. - 2011. - 540 p.).
2. Medicines. Pharmaceutical Development (ICH Q8). Instruction ST-N MOHU 42-3.0: 2011. - K .: Ministry of Health of Ukraine, 2011. - 33 p.
3. Technology and standardization of medicines: Sb. scientific of labor. T. 2. - Kharkov: IG "RIREG", 2000. - P. 369-373.
4. Brock T. Membrane filtration. - M .: Mir, 1987. - 464 p.
5. FA horse, Rypko AE, AA Bolotov et al. Membrane technology in the production of drugs / Membrane processes in biotechnology, medicine and the food industry: Tez. doc. All Union. scientific conf. - Moscow, 1991. - P. 96-97.
6. Travin L.A., Seletsky M. A. Filtration of solutions for injections / Chem.-pharmac. production: Review info. - 1984. - No. 3. - 39 p.
7. Pharmazeutische Technologie / hrsg. von Sucher M., Fuchs P., Speiser P. Bearb. von W. Becher. - 1. Aufl. - Stuttgorts, Thieme, 1978. - S. 706.
8. Domnick Hunter. Process Filtration Catalog. - UK - 167 p.
9. Pat. 2465892 Russia, IPC A61K9 / 14, A61K9 / 16, A61K31 / 5415, A61K31 / 427, V82V3 / 00. Method of obtaining vыsokodyspersnoho meloksykama / Mыz SA, King James Version AG, Boldyreva EV, Boldyreva VV, Manakova AY et al. - № 2011138761/15. Declared 21.09.2011; Pubwished 10.11.2012, Bull. No. 31. - 13 p.
Published
2019-02-12
How to Cite
Almakaev, M. S. (2019). Study of compatibility of filter materials with solution of meloksmkama for injections. Farmatsevtychnyi Zhurnal, (2), 75-79. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/247
Section
Production, quality control, standardization of medicines