Development of lyophilization cycle and effect of excipients on the stability of catalase during lyophilization (original) (raw)

2011, International Journal of Pharmaceutical Investigation

Development of lyophilization cycle and effect of excipients on the stability of catalase during lyophilization drying, vacuum drying, film drying, and supercritical fluid drying. Out of all these methods, freeze-drying, also called as lyophilization, is widely used due to its advantages over other drying methods. [3] There is minimal thermal damage of protein during lyophilization, since the entire process is carried out at temperature below 30°C. [3-5] This method also offers better accuracy of dose because the drug is filled in final containers in the solution form. Many protein pharmaceuticals are potent drugs having very low dose and hence microgram quantities of such potent drugs are required to be filled precisely. [6,7] Although the lyophilization possesses numerous advantages over other drying processes, it also has certain challenges. [8] The process involves inherent destabilization forces that can denature proteins e.g. cold shock, ice-water interfaces, pH changes during freezing, dehydration stress, etc. [9-11] Also, if lyophilization cycle is not optimized, the process can be highly energy demanding and time consuming. [12,13] Development of optimized lyophilization cycle and use of stabilizing excipients are adopted to overcome these challenges of lyophilization process. [14] Excipients giving protection to protein against freezing stress are called as cryoprotectants, whereas those giving protection against drying stress are called as lyoprotectants. [15] Various excipients like sugars/polyols, polymers, surfactants, amino acids, Original Research Article INTRODUCTION Liquid protein formulations are economic and easy to manufacture but are susceptible to physical and chemical degradation. [1] Solid formulations can help in addressing these problems, as chemical reactions occurring in liquid state get drastically reduced in solid form. [1,2] Various methods for manufacturing solid protein pharmaceuticals include freeze-drying, spray drying, spray coating, spray freeze