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ABSTRACT:
Freeze-drying is effective technique used in pharmaceutical industry to increase the efficacy, shelf-life of formulations and makes easier to transport and storage. Freeze-drying applies to the product that is thermolabile and unstable in solution form, because of utilization of low temperature and pressure. Nowadays freeze-drying gained so much attention in the development of parenteral formulation especially vaccines. The selection of excipients plays a key role in development of freeze-dried product and used to improve the shelf life and makes the product cost effective. The structure of cake not only focuses on appearance of product and also provide information about issues on drying stage that impact quality of product. Tray style freeze dryer helps in development of long-term storage vaccines and labile drugs. It performs freeze drying in containers or in vials on large quantities. This makes tray style freeze dryer become most common for developing lyophilized product. The need for improve the shelf-life of protein-based drug and antibiotics formulations makes tremendous growth of freeze-dried product market. This review focuses on the lyophilization process, design of freeze dryer, role of excipients in lyophilization process, decision of selecting the excipients, importance of cake structure helps to develop stable lyophilized drug product for long-term usage and applications of lyophilization technology.
KEYWORDS: Freezing, Primary drying, Secondary drying, Excipients, Freezing, Vacuum, Cake structure.
INTRODUCTION:
Lyophilization is a popularly used technique in Pharmaceuticals to improve the stability of drug and make them use for long-time1. The term lyophilization means a "product that loves the dry state". In lyophilization or freeze-drying, water is frozen first and then eliminated from the product by primary drying (Sublimation) and then through secondary drying (Desorption). It is applied to those products that are heatsensitive and aqueous-sensitive, but in the dry state it looks stable. Other than freeze-drying, several methods for manufacturing sterile dry powder drug products include spray-drying, powder-filling and sterile crystallization2. The process can also be used to stabilize living materials like microbial cultures, animal specimen preservation and concentrate and recover reaction synthesized products3.
HISTORY:
Arsened Arsonval and his assistant Frederic Bordas invented the freeze-drying process in 1906 at the College de France's laboratory of biophysics in Paris. Downey Harris and Shackle introduced the lyophilization method for maintaining live rabies virus in 1911,...