Abstract

TECHNOLOGY TRANSFER PROCESS OF LYOPHILIZED INJECTION

Lallu Rachel Mathai*, Siva.P

Department of Pharmaceutics, Grace College of pharmacy, Palakkad, Kerala 678004

ABSTRACT

This study is focussed on the technology transfer process of the parenteral product which is made into a compact cake by the process of lyophilization.The drug which is unstable in liquid form or has poor oral bioavailability is lyophilized by optimising the lyo-cycle ,based on the trials taken.Thus the optimised process is subjected to scale up ,transferred to commercial scale production.The product is evaluated for its characteristics which should be in line to the specifications of the innovator product. Development of stable injectable dosage form was possible as the moisture content of the formulation is greatly reduced thus enhancing the stability of the product, ease of handling, rapid dissolution because of porous nature of the cake and easier transport of the material during shipping.

Keywords: Technology transfer,lyophilisation,lyo-cycle,eutectic temperature.