Forced Degradation Studies: Practical Approach - Overview of Regulatory Guidance and Literature for the Drug Products and Drug Substances (original) (raw)
Related papers
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.
2002
orced degradation or stress testing is undertaken to demonstrate specificity when developing stability-indicating methods, particularly when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products that could form during storage. Forced degradation studies may help facilitate pharmaceutical development as well in areas such as formulation development, manufacturing, and packaging, in which knowledge of chemical behavior can be used to improve a drug product.
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...
2018
This review discusses forced degradation methodology and validation as per regulatory aspects of investigations of degradation of active pharmaceutical ingredients. It also highlights the prediction of degradants of drug substances and degradation pathways and development of stability indicating analytical methods. Furthermore, review discusses analytical methodology of various conventional and hyphenated techniques for degradant separation and characterizations are summarized in detail. Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways of degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Forced degradation studies show the chemical behavior of the molecule which in turn helps in the development of formulation and ...
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.
Journal of Drug Delivery and Therapeutics, 2018
Forced degradation studies of new drug substances and drug product are important to help develop and demonstrate specificity of stability indicating methods and provide knowledge about possible degradation pathways and degradation products of the active ingredients and help elucidate the structure of the degradants. They were also useful in the investigation of chemical and physical stability of crystal forms. It is better to start degradation studies earlier in the drug development process to have sufficient time to gain more information about the stability of the molecule. This information will in turn help improve the formulation manufacturing process and determine the storage conditions. As no specific set of conditions is applicable to all drug products and drug substances and the regulatory guidance does not specify the conditions to be used, this study requires the experimenter to use common sense. The aim of any strategy used for forced degradation is to produce the desired amount of degradation i.e., 5-20%. Adequate degradation required to understand the probable degradants for the evaluation of stability indicating method. It has become mandatory to perform stability studies of new drug moiety before filing in registration dossier. The stability studies include long term studies (12 months) and accelerated stability studies (6 months).
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.