Asian Journal of Pharmaceutical Research

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Stability testing: An Essential study for Vaccine Formulation Development


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1 B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
     

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Forced degradation studies are carried out at a more severe condition than accelerated conditions. Stress studies for vaccines are carried out in the early stage of development. By conducting stress studies, we can know the chemical behavior of our molecule which is important while developing formulation, packaging, transportation, storage, etc. there are general regulatory guidelines are available for conducting forced degradation studies but there is no sufficient information provided about how to perform forced degradation studies. Thus, this review discussed stress testing studies of vaccines, mechanisms of vaccine degradation, also analytical methods which are helpful to develop a method for forced degradation.


Keywords

Vaccine, Stability testing of the vaccine, Forced degradation, Analytical Methods, Degradation Mechanism
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  • Stability testing: An Essential study for Vaccine Formulation Development

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Authors

Amitkumar J. Vyas
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Sinchan M. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Ashok B. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Ajay I. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Nilesh K. Patel
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Suuny Shah
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India
Devang Sheth
B. K. Mody Government Pharmacy College, Rajkot-360003, Gujarat, India

Abstract


Forced degradation studies are carried out at a more severe condition than accelerated conditions. Stress studies for vaccines are carried out in the early stage of development. By conducting stress studies, we can know the chemical behavior of our molecule which is important while developing formulation, packaging, transportation, storage, etc. there are general regulatory guidelines are available for conducting forced degradation studies but there is no sufficient information provided about how to perform forced degradation studies. Thus, this review discussed stress testing studies of vaccines, mechanisms of vaccine degradation, also analytical methods which are helpful to develop a method for forced degradation.


Keywords


Vaccine, Stability testing of the vaccine, Forced degradation, Analytical Methods, Degradation Mechanism

References