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THE PHARMA REVIEW (JANUARY - FEBRUARY 2012)

Optimization of Freeze Drying By Identifying Eutectic Point Theoritically

P. Kartheeswaran

Abstract: The objective of this effort is to systematically evaluate the freeze drying process in pharmaceutical industries. Freezing temperature and eutectic temperature of the product is identified theoretically to verify/modify the freeze drying process. Molality and mass balance equation are used to construct phase diagram to find out the eutectic point region for the required product. Theoretically obtained eutectic point was confirmed with DSC (Differential Scanning Calorimetry).

 
Introduction: From manufacturing and marketing of sterile indictable, a liquid product is generally more desirable than a lyophilized product. The lyophilized product must be reconstituted prior to administration, requires a complex and lengthy unit operation to the manufacturing process, resulting in higher costs and larger capital investment. However, a liquid formulation is generally less stable than a Lyophilized formulation, leading to more product loss during storage and distribution. In pharmaceutical industry we have two types of drugs manufacturing technique namely non sterile API and Sterile API. In case of Non sterile API the medicines available in the form of capsules and tablets. In sterile API (Active Pharmaceutical Ingredients) medicines are in the form of injectable liquid. The sterile and non sterile drug products are dried by various methods. We need to focus the sterile drug product manufacturing process. Two types of drying methods are available in pharmaceutical industries. One is Crystallization and another is Freeze drying or Lyophilization. For crystallization we can use various solvents, in case of Lyophilization we can use only water for Injection. In Lyophilization we are using various stages Freezing, Primary Drying, Secondary Drying. Some of the Pharmaceutical products and organic molecules could not be manufactured by applying crystallization technique. For this we can choose the Freeze drying process only. In various drug products MSDS we are not having the sufficient data of boiling point, Eutectic point and freezing point. Based on this Eutectic theoretical value we can simplify our Lyophilization technique.

 

 

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