The choice of optimal filtration and freezing modes for frozen-dried medicine on the basis of bee venom
Lately there is heightened interestin creation of medicines from bee venom, especially for parenteral application. Application of freeze-drying technology is one of the waysforobtaining the medicine of high quality. The process of freeze-dryingis prolongedand power-consuming. Therefore development of economic process of freeze-dryingwith the ground of choice of optimal parameters at all stages of medicine obtaining is the extremely important element in pharmaceutical development.
The aim of our work was study of compatibility of the solution on the basis of bee venom with materials of filters from caprone, nylon, polyestersulphone, and also choosing the optimal mode of filtration and determination of conditions of the product freezing whenfreeze-drying. The objects of our investigations were the substance of bee venom(batch № 250 B) produced by Ariadna Ltd Co. andthe solution on its basis. Freeze-dryingwas conducted using freeze-drying devices of ТG-50 type.
The researches on creation of the new frozen-dried medicinefor injections on the basis of bee venomhave been conducted. The modes of filtration of the solution on the basis of bee venom have been studied. Filter materials, which are compatible with the solution and can be used for filtration when medicine producing, have been determinedfor realization of the filtration process. For establishment of interferenceof the solution and filter materials used in producing the injection solutions we have studied the membrane filters made from caprone («MIFIL» type, Belarus), nylon («Ultipor N 66» type, Pall, Germany), polyestersulphone («ProporPes» type, Dominic hanter, England). The membranes with the pore size of 0.8 μm (previous filtration) and 0.2 μm (final filtration) have been studied. The compatibility of the solution on the basis of bee venom with filters materials from caprone, nylon and polyestersulphonehave been established. The optimal filtration mode has beenchosen for themedicine: it is recommended to carry out filtration by compressed airwith the pressure of not less than 0,06 МPa that provides the optimal duration of filtration and obtaining intermediate product of high quality that satisfies the requirements of absence of the mechanical inclusions.
The freeze-dryingmode forthe medicine on the basis of bee venom has been developed by us. Such actions as determination of freezing temperature for the solution; choosing the method of the solutionfreezing; studyingthe influence of freezing duration on the quality of finalproducthave been conductedsequentially. The eutectic temperature has beendetermined for establishing the necessary temperature of the solution freezing. It has been set that the freezing speed of the product does not influence substantially on the quality offrozen-driedmedicine on the basis of bee venom.
2. State Pharmacopoeia of Ukraine / State Enterprise "Scientific Expert Pharmacopoeia Center". 1st kind. - Kharkiv: Rigor Ltd., 2001. - 531 pp.
3. Medicines. Pharmaceutical Development (ICH Q8). Instruction ST-N MOHU 42-3.0: 2011. - K .: Ministry of Health of Ukraine, 2011. - 33 p.
4. Patent for Utility Model No. 61039 (Ukraine). IPC 2006.01 A 61 K 9/08, A 61 K 35/64, A 61 K 37/04. Drug "Injectable agent with immunostimulant and general-fixing properties" / Tikhonov O.I., Emelyanov AV, Almakaeva L.G., Skrypnyk-Tikhonov R.I., Murtishchev A. M., Chehuta O.O. - No. 61039; Declared 19. 11. 2010; Pubwished Jul 07, 2011, Bul. No. 3
5. Technology and standardization of medicines. T. 2. / Ed. V.P. Georgievskii, F. A. Koneva. - Kharkiv: IG RIREG, 2000. - 784 pp.
6. Tikhonov OI, Bodnya KI, Tikhonova S.O. etc. Innovative Approaches to Apitherapy: Method. recommendations (Approved by the Department of Medical Assistance of the Ministry of Health of Ukraine dated 25.03.2015) / Ed. OI Tikhonova. - K., 2015. - 32 p.
7. Barres A. A., Velardi S. A., Pisano R. et al. // Inter J. refrigeration. - 2009. - P. 32. - P. 1003-1014.
8. Kamath L. // Genetic Engineering & Biotechnology News. - 2006 - Vol. 26, N 20. - P. 1-4.
9. Kasper J. C., Friess W. // Europ. J. Pharmaceutics and Biopharmaceutics. - 2011. - P. 78. - P. 248-263.
10. Tichonov A. I., Bondarczuk L. I., Tichonova S. A. et al. You have to go to the pharmacy and meditate. Theory, technology, dissertation, lectures: Monographs / Pod Editorial Academy of Ukrainian Academy of Sciences, AI Tichonov; Editor-in-Chief of Polski K. Sodzawiczny, prof. dr hab. B. Kedzia / Apipol-Farma. - Myslenice. - 2011 - 274 s.
11. Fetisova E. G., Andryukova L. N. Study of compatibility of filter materials with eye drops of cromoglycate of sodium 2% // Farmakom. - 2007. - No. 3. - P. 93-97.
12. Sadikoglu H., Ozdemir M., Seker M. // Drying Technology. - 2006. - V 24, N 7. - P. 849-861.
13. Almakaeva L.G., Dolya V.G., Budnikova T. M. The problem of the presence of mechanical inclusions in preparations for parenteral application and their normalization // Pharmacist. journ - 2006. - No. 5. - P. 67-72.
14. Tikhonov A.I., Kovalenko SN, Gusarov V.I., Skrypnik-Tikhonov R. I. Development of the method of analysis of bee venom by high-performance liquid chromatography // Med. almanac. - 2011. - No. 4 (17). - S. 263-266.
15. Pat. to utility model 97105 Ukraine, МПК51 (2015.01), А61К 9/14 (2006.01), А61К 35/00, А61К 35/56 (2015.01). Freeze-dried preparation for injections / Tikhonov O. I., Almakaeva L. G., Skrypnik-Tikhonov R. I. .; patent holders: Tikhonov O.I., Almakaeva L.G. - No. u 201411347; Declared 17.10.2014; Pubwished Feb. 25, 2015, Bul. No. 4. - 4 s.
This work is licensed under a Creative Commons Attribution 4.0 International License.