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Pharmaceutical Forced Degradation Studies with Regulatory Consideration


Affiliations
1 Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415004, (MS), India
2 Satara College of Pharmacy, Degaon, Satara-415004, (MS), India
     

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Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stabilityindicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. These experiments generally expose the material to an external stress to assess the stability of the constituents or formulation. External Stress mainly includes temperature, pH, light, moisture, and even exposure to other materials within the product formulation, and their degradation products. Conventionally, degradation tests can take very long periods of time, because standard test methods require the materials to be exposed to stress factors for periods of weeks or longer, and then tested using standard analytical methods. Accelerated testing is of clear benefit, as use of elevated temperature to increase the rate of interactions is the most powerful factor to shorten the length of time required for these tests. Forced degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development.

Keywords

Forced Degradation Study, Active Pharmaceutical Ingredient (API), and International Conference on Harmonization (ICH).
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  • Pharmaceutical Forced Degradation Studies with Regulatory Consideration

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Authors

Namdeo G. Shinde
Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415004, (MS), India
Bhaskar N. Bangar
Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415004, (MS), India
Sunil M. Deshmukh
Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415004, (MS), India
Suyog P. Sulake
Department of Pharmaceutics, Satara College of Pharmacy, Degaon, Satara-415004, (MS), India
Dipak P. Sherekar
Satara College of Pharmacy, Degaon, Satara-415004, (MS), India

Abstract


Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stabilityindicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. These experiments generally expose the material to an external stress to assess the stability of the constituents or formulation. External Stress mainly includes temperature, pH, light, moisture, and even exposure to other materials within the product formulation, and their degradation products. Conventionally, degradation tests can take very long periods of time, because standard test methods require the materials to be exposed to stress factors for periods of weeks or longer, and then tested using standard analytical methods. Accelerated testing is of clear benefit, as use of elevated temperature to increase the rate of interactions is the most powerful factor to shorten the length of time required for these tests. Forced degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development.

Keywords


Forced Degradation Study, Active Pharmaceutical Ingredient (API), and International Conference on Harmonization (ICH).