Details

Titel

An overview of lyophilization: troubleshooting the challenges and pharmaceutical applications

Ist Teil von

• Letters in Applied NanoBioScience, 2019-12, Vol.8 (4), p.723-731

Erscheinungsjahr

2019

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• 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.