Biyolojik Maddelerin Kurutularak Saklanması: Liyofilizasyon

Öz Organik maddelerden suyun uzaklaştırılması sürecini tanımlayan liyofilizasyon, günümüzde tüm dünyada gerek sağlık endüstrisinde ve gerekse gıda endüstrisinde çok fazla kullanım alanı bulan bir tekniktir. Bu teknikte azaltılmış basınç (vakum) altında, dondurulmuş haldeki solüsyonlardan suyun uzaklaştırılması ile biyolojik maddeler ve gıdalar, bozulma meydana gelmeden uzun süre saklanabilmektedir. Liyofilizasyonun, uzun bir süreç olması, sıcaklık ve basıncın içinde bulunduğu hassas dengeler üzerine kurulmuş olması gibi dezavantajları bulunmasına rağmen halen dünyada sıklıkla kullanılan bir yöntemdir. Bu teknik, aslen eski bir yöntem olmasına karşın biyolojik ve organik maddelerin saklanmasına ilişkin daha etkin bir teknik geliştirilemediğinden günümüzde tüm dünyada halen etkinliğini ve önemini korumaktadır. Bununla birlikte prensipte aynı olmakla birlikte liyofilizasyon teknolojisi sürekli geliştirilmektedir.

Kaynakça

1. Abdelwahed W, Thomas and David E, (2002). The Importance of Freezing on Lyophilization Cycle Development. Biopharm. 16-21.

2. Adams GDJ, (1994). Freeze-drying of biohazardous products, in Biosafety in Industrial Biotechnology. Blackie Academic and Professional, London. 178–212.

3. Adams GDJ, (1996). Lyophilization of vaccines. In: Vaccine Protocols. Humana Press, Totowa, NJ. 167-185.

4. Anonim, (2013). A Guide to Freeze Drying for the Laboratory. Erişim: http://www.pharmaceuticalonline. com/doc/a-guide-to-freeze-drying-for-the laboratory-0002. Son erişim tarihi: 05.01.2014.

5. Arshinova OY, Sanarova EV, Lantsova AV, Oborotova NA, (2012). Lyophilization of liposomal drug forms (Review). Pharmaceutical Chemistry Journal .46(4), 228- 233.

6. Bahetia A, Kumarb L, Bansal AK, (2010). Excipients used in lyophilization of small molecules. IPEC-Americas Inc J Excip Food Chem. 1(1), 46.

7. Beale PT, (1983). Water in biological systems. Cryobiology. 20, 528–531.

8. Bindschaedler C, (1999). Lyophilization process validation. In: Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products. Marcel Dekker, New York. 373-408.

9. Charles P, Detke HC, Pyne A, (2005). Post injection delirium/ sedation syndrome in patients with schizophrenia treated with Olanzapine longacting injection: analysis of cases. BMC psychiatry.

10. Greiff D, ve Rightsel, WA, (1969). Stabilities of freezedried suspensions of influenza virus sealed in vacuum or under different gases. Appl. Microbiol. 17, 830–835.

11. Griffin CW, Cook FC, ve Mehaffrey MA, (1981). Predicting the stability of freze dried Fusobacterium montiferum. Proficiency testing samples by accelerated storage tests. Cryobiology. 18, 420–425.

12. Kasper JC, Friess W, (2011). The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm. 78(2), 248-63.

13. Khairnar S, Kini R, Harwalkar M, Salunkhe K, Chaudhari SR, (2013). A Review on Freeze Drying Process of Pharmaceuticals. Int J Res Pharma Sc . 4(1),76-94.

14. Kumar GP, Prashanth N, Kumari BC, (2011). Fundamentals and Applications of Lyophilization. Journal of Advanced Pharmaceutical Research. 2(4), 157-169.

15. Kuu WY, Hardwick LM, Akers MJ, (2006). Rapid determination of dry layer mass transfer resistance for various pharmaceutical formulations during primary drying using product temperature profiles. Int J Pharm. 313(1-2), 99- 113.

16. Lam T, Strickly RG ve Visor GC, (2004). An unexpected pH effect on stability of moexipril lyophilized powder. Pharm Res. 6, 971-975.

17. Mackenzie AP, (1966). Basic principles of freeze-drying for pharmaceuticals. Bull. Parenteral Drug Assoc. 26, 101- 129.

18. Nireesha GR, Divya L, Sowmya C, Venkateshan N, Niranjan Babu M, Lavakumar V, (2013). Lyophilization/ Freeze Drying - An Review. Int J Nov Trends Pharma Sci. 87-98.

19. Patel SM, Pikal MJ, (2013). Lyophilization process design space. J Pharm Sci. 102(11):3883-7.

20. Pikal MJ, (2002). Heat and Mass Transfer in Low Pressure Gases: Applications to Freeze Drying., 610-680.

21. Pikal T, Cannor AJ, Trappier EH, (2004). Optimization of lyo cyles and production of mathematical models. Eur J Pharm. 54, 132-154.

22. Przc DS, Ruzic NLJ, Petrovic SD, (2004). Lyophilization –The process and ındustrial use. Chem Ind. 58(12), 552- 562.

23. Remmele RL, Krishnan S, Callahan WJ, (2012). Development of stable lyophilized protein drug products. Curr Pharm Biotechnol. 13(3):471-96.

24. Rey S, Xialoin T, ve Michael J. (2004). Study of optimization of the freeze dried product: practical advice pharmaceutical research. Eur J Pharm. 78- 94.

25. Rightsel WA ve Grieff D, (1967). Freezing and freezedrying of viruses. Cryobiology. 3, 423–431.

26. Rudge RH, (1984). Maintenance of bacteria by freeze-drying, in Maintenance of Microorganisms. Academic Press, London. 23–35.

27. Serigo A, Rambhatla S, ve Pikal MJ, (2003). Heat and mass transfer scale-up issues during freeze drying, I: Atypical radiation and the edge vial effect. AAPS Pharm Sci Tech. 4(2), 114-127.

28. Tang XC ve Pikal MJ, (2004). Design of freeze-drying processes for pharmaceuticals: Practical advic. (Review). Pharmaceutical research. 21(2), 191-200.

29. Wong JP, Yang H, Nagata L, Kende M, Levy H, Schnell G, Blasetti K, (1999). Liposome-mediated immunotherapy against respiratory influenza virus infection using doublestranded RNA poly ICLC. Vaccine. 1788–1795.

30. Yoshioka S, Aso Y ve Kojima S, (1999). The effect of excipients on the molecular mobility of lyopihilized formulations, as measured by glass transition temperature and NMR relaxationbased critical mobility temperature. Pharm Res. 135-140.

Kaynak Göster

APA Ergün, Z . (2015). Biyolojik Maddelerin Kurutularak Saklanması: Liyofilizasyon . Etlik Veteriner Mikrobiyoloji Dergisi , 26 (1) , 35-40 . DOI: 10.35864/evmd.513369