Technical Considerations of Forced Degradation Studies of New Drug Substances and Product: Regulatory Perspectives (original) (raw)
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The objective of the review article is to give detailed description and guidance of the forced degradation studies as per regulatory guidelines. Forced degradation study provide information about the degradation pathways and degradation products of the drug substance and helps in the elucidation of the structure of the degradation products. forced degradation study provide the chemical behaviour and chemical nature of the molecule which ultimately helps in the development of formulation during manufacturing and packaging specification, thus this review article provide knowledge of the current trends in performance of forced degradation study and establishing the analytical methods that helpful for development of stability indicating method. The stability of drug product and or drug substance is a critical parameter which may affect purity, potency and safety.
Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s
Journal of Drug Delivery and Therapeutics
The stability of a new drug substances and new drug products is a vital parameter which may affect purity, safety & potency. Changes in drug stability can threat patient safety by formation of toxic degradation products or deliver to lower dose than expected. Therefore it is to know the purity profile & behaviour of a drug substances under the various environmental condition. Forced Degradation studies show the chemical behavior of the molecule which in turn helps in the development of new formulation & package . Degradation study is required to the design of a regulatory compliant stability program for the both drug substances & products, and formalized as a regulatory requirement in ICH Guideline Q1A in 1993. Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug product which is required to develop and demonstrate the specificity i.e stability indicating method. Forced degradation studies used to determination of the degradation pat...
An Introduction to Forced degradation studies for drug substances and drug products
Journal of emerging technologies and innovative research, 2021
Forced degradation is basically degradation studies of may drug substances and drug products which are generally available in pharmaceutical industry. Forced degradation studies also known as stress testing studies, carried out to demonstrate developed stability indicating method by using high performance liquid chromatography i.e. HPLC. Forced degradation is a powerful tool used routinely in pharmaceutical development in order to develop stability indicating methods that lead to quality stability data and to understand the degradation pathways of the drug substances and drug products. This review discuss the trends in forced degradation studies. Forced degradation studies ensure appropriate stability of final pharmaceutical products in very early stages of pharmaceutical development.
Forced degradation is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify potential degradation products. They are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. It is particularly useful when little information is available about potential degradation products. In addition to develop stability-indicating analytical methods, these studies also provide information about the degradation pathways and degradation products that could form during storage, transportation. Forced degradation studies may help facilitate pharmaceutical development in areas such as formulation development, manufacturing, and packaging, in which knowledge of chemical behavior can be used to improve a drug product. This publication provides information about regulatory needs and scientific guidance to perform forced degradation.
Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. The objective of the review article is to furnish comprehensive portrayal of the forced degradation studies as per the regulatory guidelines that are associated with various regulatory agencies. This article recapitulates the collective views of industry practices on the topic of forced degradation studies. This article reiterates a practical interpretation and summary of the available guidance and some suggestions for best practices for conducting forced degradation studies.
International Research Journal of Pharmacy, 2013
The Objective of the review article is to give a detailed description of the forced degradation studies as per the regulatory guidelines that are associated with various regulatory agencies. This article summarizes the collective views of industry practices on the topic of forced degradation studies. The article includes an overview of existing guidance's and literature for best practices. . Forced degradation studies: Practical approach: Overview of regulatory guidance and literature for the drug products and drug substances. Int. Res. J.