Open AccessAn overview of lyophilization: troubleshooting the challenges and pharmaceutical applications
Author(s) -
Hetal Pandya,
Shital Butani,
Maharshi Pandya,
Milan Pandya,
V.P. Pandya
Publication year - 2019
Publication title -
letters in applied nanobioscience
Language(s) - English
Resource type - Journals
ISSN - 2284-6808
DOI - 10.33263/lianbs84.723731
Subject(s) - process engineering , sublimation (psychology) , troubleshooting , shrinkage , moisture , freeze drying , materials science , solubility , yield (engineering) , nanotechnology , pulp and paper industry , biochemical engineering , computer science , chemistry , chromatography , composite material , engineering , psychology , organic chemistry , psychotherapist , operating system
Although, lyophilization is well known technique for drying, recently its applications in pharmaceutical field is tremendously increased. The quality product with low moisture content, higher solubility and easy reconstitution lead to wide spread applications of the process. The formulation is frozen, followed by sublimation and desorption to yield dry powder ready for reconstitution. This technique is critical, therefore optimization of many parameters is mandatory to get quality product. The improper insight of parameters like freezing temperature, drying temperature, vacuum, fill volume, etc. may result into collapse, melt back, blow out, shrinkage of the cake which directly affects product reconstitution time, moisture content, assay, and ultimately the stability of the final product. In this review, the challenges experienced in development of freeze drying cycle and its appropriate remedies are discussed at a length. Additionally pharmaceutical applications with the regulatory concerns are also reviewed.