Application of surface in physics methods in pharmaceutical development of the medicine on the basis of essential phospholipids
Abstract
The main issues addressed in the process of pharmaceutical medicine’s development include the choice of substance, excipients; development of technological and analytical methods of control; definition of critical points, etc. Objective – the application of surface in physics methods in pharmaceutical development of the medicine on the basis of essential phospholipids.
The application of surface in physics methods in pharmaceutical development of the medicine on the basis of essential phospholipids (dynamic light scattering, calorimetry, osmolality), which allow to control the technology of obtaining a medicine and to justify basic technological parameters of receipt of the product at all stages of the process, is grounded.
It is shown that the critical parameters of the process of obtaining the medicine Lesfal are contents of impurities and ethyl alcohol. It is proposed for the rapid analysis of ethanol to use in the medicine a method of osmolality and to control impurities of lysophosphatidylcholine – calorimetry method.
References
2. Uspensky Yu.P. Essential phospholipids: old natural substances - new technologies for the production of medicines // RZHGGK. - 2009. - No. 5. - P. 24-28.
3. Sidorova I. The market of medicines and supplements on the basis of essential phospholipids // Remedium. - 2014. - No. 4. - P. 32-33.
4. Barshchevsky G.I., Yarnykh T.G. Technological aspects of creation of an injection drug on the basis of essential phospholipids / Mat. 9 intern. scientific practice. conf. "Novelty for the science of science", 2013 - Sofia. - p. 28-30.
5. Pat. for invention No. 97742. Injection preparation based on phosphatidylcholine and method of its obtaining / Zhebrovskaya F.I., Barshchevsky G.I., Borschevskaya M.I., Kostyuk G.V. - Submitted. 10. 11. 2010; Pubwished 03. 03. 2012, Bull. No. 5
6. Georgievsky V. P., et al. Analytical chemistry in the creation, standardization and control of the quality of medicinal products. - Kharkov: "NTMT", 2011. - T. 3. - 520 p.
7. Leontiev N. E. Fundamentals of the theory of filtration. - Moscow: Publishing house of the CPI at the mechanics of mathematics. Faculty of MSU, 2009. - 88 p.
8. Barshchevsky G.I., Komarov IV, Kulinich AV, Factors Affecting the Stability of the Lesfal Drug // Management, Economics and Quality Assurance in Pharmacy. - 2013. - No. 6 (32). - P. 10-14.
9. Barshchevsky G. I., Yarniy T. G. Physicochemical substantiation of the method of obtaining a multicomponent liposomal preparation // Vysn. Pharmacy - 2013. - No. 3 (75). - S. 5-7.
10. Lebed VI Physical chemistry. - Kharkiv: Folio, 2005. - 478 p.
11. Barshchevsky G.I. Application of the method of differential scanning calorimetry to determine the quality of filtration on the example of the drug Lesfal // Pharmac. journ - 2013. - No. 4. - P. 72-80.
This work is licensed under a Creative Commons Attribution 4.0 International License.
