ABSTRACT:
As lyophilization technique exalts the efficiency of the product to a culminative point, it is important to understand the concept in detail as well as to gather the information about recent advancements related to it. This review aims at collecting all the information at one platform. Lyophilization/Freeze-drying process is an advanced drying method which is used now a days. This technique basically involves the sublimation process and is more efficient than normal drying process.This review mainly focus on cumulating the basics of lyophilisation(i.e. advantages, disadvantages, basic steps for lyophilzation, evaluation parameters) as well as the technical and instrumental advancements made to enhance the productivity of the process to multiple times. This review also includes recent advancements in pharmaceutical application of freeze-drying technique. It will be an effective tool for the researchers to select appropriate lyophilization technique for enhancement of their product’s stability.
Cite this article:
Mishra Sandhya, Kesharwani Disha. Expension in the field of Freeze-drying: An Advanced Review. Research J. Pharm. and Tech 2020; 13(5): 2468-2474. doi: 10.5958/0974-360X.2020.00441.2
Cite(Electronic):
Mishra Sandhya, Kesharwani Disha. Expension in the field of Freeze-drying: An Advanced Review. Research J. Pharm. and Tech 2020; 13(5): 2468-2474. doi: 10.5958/0974-360X.2020.00441.2 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2020-13-5-71
REFERENCE:
1. Liu Y., Zhao Y., Feng X., Exergy analysis for a freeze-drying process, Appl Thermal Eng, 2008, 28, 675–690.
2. Khairnar S, Kini R, Harwalkar M, Chaudhari SR., A Review on Freeze Drying Process of Pharmaceuticals, International Journal of Research in Pharmacy and Science, 2014 Jan 1;4(1).
3. Louis Rey PhD et al.,” Sage of freeze drying” CH-1010. 5-8.
4. Shukla S. Freeze Drying Process: a Review, International Journal of Pharmaceutical Sciences and Research, 2011 Dec 1; 2(12):3061-8.
5. Nail SL. et al. Fundamentals of freeze-drying, Development and Manufacture of Protein Pharmaceuticals. Marcel Dekker, 2002; 281–360.
6. Nireesha GR, Divya L, Sowmya C, Venkateshan NN, Babu MN, Lavakumar V. Lyophilization/freeze drying-an review. International Journal of Novel Trends in Pharmaceutical Sciences, 2013 Oct 4; 3(4):87-98.
7. Chien and Yiew W. Pharmaceutical Dosageforms: Parenteral Medications. Indian Journal of Pharmaceutical Science and Technology, 1981, 35, 106-118.
8. Khandagale P.M., Bhairav B., Saudagar R.B., Lyophilization Technique: A Review, Asian Journal of Research in Pharmaceutical Science. 2016 6(4) 269-76.
9. Shivanand A., Mukhopadhayaya S., A Review on Lyophilization: A Technique to Improve Stability of Hygroscopic, Thermolabile Substances. PharmaTutor,2017, 5(11) 28-39.
10. Gaidhani K.A., Harwalkar M., Bhambere D., Nirgude P.S., Lyophilization/ freeze drying–a review. World Journal of Pharmaceutical Research, 2015, 4(8) 516-543.
11. Tang X.C., Pikal M.J., Design of freeze-drying processes for pharmaceuticals: practical advice. Pharmaceutical Research. 2004, 21(2) 191-200.
12. Shah R., Mehta P., Freeze dried injectable drug product development selection of non-functional additives, 2014, International Journal of Pharmacy and Pharmaceutical Sciences, 6(9)3-7.
13. Schwegman J.J., Hardwick L.M., Akers M.J., Practical formulation and process development of freeze-dried products, Pharmaceutical Development and Technology, 2005, 10(2)151-73.
14. Franks F., Freeze-drying of bioproducts: putting principles into practice, European Journal of Pharmaceutics and Biopharmaceutics. 1998, 45 (3) 221–229.
15. J. Li, T. Viverette, M. Virgin, M. Anderson, and P. Dalal, A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill-depth, Pharmaceutical Development and Technology. 2005, 10(2), 261– 272.
16. Goldman J. M., More H. T., Yee O.,Optimization of primary drying in lyophilization during early-phase drug development using a definitive screening design with formulation and process factors, Journal of Pharmaceutical Sciences. 2018, 107(10), 2592–2600.
17. Pikal M. J., Use of laboratory data in freeze drying process design: heat and mass transfer coefficients and the computer simulation of freeze drying, Journal of Parenteral Science and Technology. 1985, 39 115–139.
18. Kawasaki H, Shimanouchi T, Kimura Y. Recent Development of Optimization of Lyophilization Process, Journal of Chemistry. 2019.
19. https://www.spscientific.com/freeze-drying-lyophilization-basics/
20. Patel S.M., Nail S.L., Pikal M.J., Geidobler R., Winter G., Hawe A., Davagnino J. and Gupta S.R., Lyophilized drug product cake appearance: what is acceptable? Journal of Pharmaceutical Sciences. 2017, 106(7) 1706-1721.
21. Mikkilineni R., Srinivasa P.B., Mandava V.B., Formulation and evaluation of stable lyophilized bendamustine hydrochloride injection, Int. J. Pharm. Sci. Rev. Res., 2013, 23(2) 89-93.
22. May J.C., Wheeler R.M., Elz N., Del G., A Measurement of final container residual moisture in freeze dried biological products, Dev. Biol. Standard., 1992, 74:153–164.
23. May J.C., Grim E., Wheeler R.M., West J., Determination of residual moisture in freeze dried viral vaccines: Karl Fischer, gravimetric and thermogravimetric methodologies. Journal of Biological Standerdization. 1982, 10 249-59.
24. Kamat M.S., Lodder R.A., DeLuca P.P., Near infra red spectroscopic determination of residual moisture in lyophilized sucrose through intact glass vials. Pharmaceutical Research. 1989, 6(11) 961–965.
25. Savage M., Torres J., Franks L., Determination of adequate moisture content for efficient dry-heat viral inactivation in lyophilised factor VIII by loss on drying and by near infra red spectroscopy. Biologicals.1998,26(2) 119–124
26. do Vale Morais A.R., do Nascimento Alencar É., Júnior FH, De Oliveira CM, Marcelino HR, Barratt G, Fessi H, Do Egito ES, Elaissari A. Freeze-drying of emulsified systems: A review, International Journal of Pharmaceutics. 2016 Apr 30; 503(1-2):102-14.
27. Mohammed A.R., Bramwell V.W., Coombes A.G., Perrie Y., Lyophilisation and sterilisation of liposomal vaccines to produce stable and sterile products. Methods. 2006, 40(1)30-38.
28. Franks F., Freeze-drying of bioproducts: putting principles into practice. European Journal of Pharmaceutics and BioPharmaceutics. 1998, 45(3) 221-229.
29. Tsuka H., Mori H., Okada K., Matsukawa S., Utilization of the freeze-drying method in the preparation of biologically active, intact RNA from hard frozen tissues of human prostate. Analytical Biochemistry. 1997, 247(2) 458-461.
30. Kreilgaard L., Frokjaer S., Flink J.M., Randolph T.W., Carpenter J.F., Effects of additives on the stability of recombinant human factor XIII during freeze-drying and storage in the dried solid. Archives of Biochemistry and Biophysics. 1998, 360(1) 121-134.
31. Kommawar S.S., Bakal R.L., Dewani A., Chandewar A.V., Research Journal of Pharmaceutical, Biological and Chemical Sciences.
32. Ratti C., Hot air and freeze-drying of high-value foods: a review, Journal of food engineering, 2001, 49(4)311-319.
33. https://nutrineat.com/freeze-drying-food-advantages-disadvantages
34. Konan Y.N., Gurny R. and Allémann E., Preparation and characterization of sterile and freeze-dried sub-200 nm nanoparticles. International Journal of Pharmaceutics. 2002, 233(1-2) 239-252.
35. Ohsawa T., Miura H. and Harada K., A novel method for preparing liposome with a high capacity to encapsulate proteinous drugs: freeze-drying method, Chemical and Pharmaceutical Bulletin.1984, 32(6) 2442-2445.
36. Corveleyn S. and Remon J.P., Formulation of a lyophilized dry emulsion tablet for the delivery of poorly soluble drugs. International Journal of Pharmaceutics, 1998, 166(1) 65-74.
37. Da KH, Sa AI, Na PC, Va CH. Formulation and Evaluation of Amphotericin-B as a Lyophilized Product.
38. Dani B.A., Lyophilised antibody formulations, US Patent US20100226928A1, 2019.
39. http://www.biotechnologynotes.com/food-biotechnology/food-technology/industrial-freeze-drying-process-applications-advantages-disadvantages-food-technology/14221
40. Reckless., Na W., Chaobin Z., Juan W., Plant extract vacuum freeze drying device, China Patent CN208244130U, 2018.
41. Ahmed I.S., Nafadi M.M and Fatahalla F.A., Formulation of a fast-dissolving ketoprofen tablet using freeze-drying in blisters technique, Drug Development and Industrial Pharmacy. 2006., 32(4) 437-442.
42. Risbud M.V., Hardikar A.A., Bhat S.V., Bhonde R.R., pH-sensitive freeze-dried chitosan–polyvinyl pyrrolidone hydrogels as controlled release system for antibiotic delivery. Journal of Controlled Release, 2000, 68(1) 23-30.
43. Jing W., Xuanyu S., A kind of bendamustine hydrochloride freeze-dried powder needle and preparation method thereof, China Patent CN108078931B, 2019.
44. Fan P., Na L., Zhenya D., Xiang H., Jinli C., Xinbing P., Jingxia H., A kind of process units of Loratidine freeze-drying tablets, China Patent CN208469125U, 2019.
45. Hamamoto, Y., Method for producing freeze-dried rice, Japan Patent JP6469906B1, 2019.
46. Jiao Z., Guoquan L., Contains freeze-drying strawberry grain granules, China Patent CN207444208U, 2018.
47. Zhaojian L., Xiaogiu S., Ying l., Qingguo S., The energy-saving fresh freeze drying system of low dew point air supply, China Patent CN208901523U, 2019.
48. Chuansheng W., Jin L., A kind of medicinal material freeze drying plant, China Patent CN208620706U, 2019.
49. Wei Y., A kind of bigger surface continuous discharge freeze-drying apparatus, China Patent CN208720639U, 2019.
50. Xianglin., Liang T., A kind of freeze dryer with automatic feeder, China Patent CN208952541U, 2019.
51. Xiaobo C., Peibin W., Yanlong L., A kind of low energy consumption freeze dryer, China Patent CN208382727U, 2019.
52. Maobin S., Xingbo L., Bi Z., Kuan W., Freeze -drying box, China Patent CN207610462U, 2018.
53. Kuan, W., Cooling system of freeze -drying box body, China Patent CN207335290U, 2018.