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Sutar, Shubhangi V.
- Stability Indicating Forced Degradation Studies
Abstract Views :165 |
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Authors
Affiliations
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 1 (2019), Pagination: 429-433Abstract
Forced degradation study (FD) studies (stress testing) are an intrinsic part of pharmaceutical product development. It is procedure whereby the natural degradation rate of a product or material is increased by the application of additional stress condition. It manifests chemical behaviour of the molecule which helps in the development of formulation and packaging of pharmaceutical development. It is necessary to specify the specificity of the stability indication methods and provide insight into degradation pathways and degradation products of the drug substance and aid in an elucidation of the structure of the degradation products. This review discusses the regulatory aspects of force degradation and the study of stability and also the analytical hyphenated methods used for the development of the forced degradation study.Keywords
Forced Degradation, Regulatory Aspects, Degradation Products.
References
- ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2), International Conference on Harmonization.
- FDA Guidance for Industry, INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology Derived Products, Draft Guidance, Food and Drug Administration.
- Alsante KM, Hatajik TD, Lohr LL, Santafianos D Sharp TR. Solving impurity/degradation problems: case studies. pp: 380, In; handbook of Isolation and Characterization of impurities in Pharmaceutical, Ahuja S, Alsante K, editors, Academics Press, New York. 2003.
- Boccardi G. Oxidative susceptibility testing,:220. In; pharmaceutical Stress Testing-Predicting Drug Degradation; Baertschi SW, editors, Taylor and Francis, New York. 2005.
- Alan RO, Brigitte ES, Yanqiu SA, Polshyna NM, Dunphy R, Barbara LM, et al. Forced degradation studies of rapamycin: Identification of autoxidation products. J Pharmaceut Biomed 59, 2012: 194-200.
- Trabelsi H, Hassen IE, Bouabdallah S, Bouzouita K, Safta F. Stability indicating LC method for determination of Pipamperone. J Pharmaceut Biomed 39, 2005: 914-919.
- Dorman DE, Lornez LJ, Occolowitz JL, Spangle LA, Collins, MW, Bashore FN, Baertschi SW. Isolation and structure elucidation of the major degaradtion products of cefaclor in the solid state. J Pharm. Sci 86, 1997: 526-539.
- Bojana P, Markus D, Kappe CO. Microwave-assisted forced degradation using high-throughput microtiter platforms. J Pharmaceut Biomed 56, 2011:867-873.
- Baertschi SW, Thatcher SR. Sample presentation for photostability studies: problems and solutions, pp: 445, In; Pharmaceutical Photostability and Stabilization Technology. Piechocki J, Editor, Taylor & Francis, New York. 2006.
- Baertschi SW, Alsante KM. Stress testing: the chemistry of the drug degradation, pp: 99, In Pharmaceutical Stress Testing, Baertschi SW, editors, Taylor & Francis, New York. 2005.
- D.W. Reynolds, K.L.Facchine, J.F. Mullaney, et al., Available guidance and best practices for conducting forced degradation studies, Pharm. Technol. 26(2), (2002): 48–56.
- Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech. 24, 2000: 1-14.
- H. Brummer, How to approach a forced degradation study, Life Sci. Technol. Bull.31, (2011):1–4.
- Blessy M., Ruchi D.Patel,Prajesh M. Prajapati, Y.K.Agarwal. Development of Forced degradation and stability indicating studies of drugs-A Review.Journal of Pharmaceutical Analysis.4 (3); 2014:159-165.
- Smita Shinde.S.A.Nirmal .A Review on Force Degradation Study for Pharmaceutical Product Development. International journal of Pharmaceutical and chemical sciences .5(2), 2016: 163-166.
- A Review:Stability Indicating Forced Degradation Studies
Abstract Views :156 |
PDF Views:0
Authors
Affiliations
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 885-890Abstract
Forced degradation study (FD) studies (stress testing) are an intrinsic part of pharmaceutical product development. It is procedure whereby the natural degradation rate of a product or material is increased by the application of additional stress condition. It manifests chemical behaviour of the molecule which helps in the development of formulation and packaging of pharmaceutical development. It is necessary to specify the specificity of the stability indication methods and provide insight into degradation pathways and degradation products of the drug substance and aid in an elucidation of the structure of the degradation products. This review discusses the regulatory aspects of force degradation and the study of stability and also the analytical hyphenated methods used for the development of the forced degradation study.Keywords
Forced Degradation, Regulatory Aspects, Degradation Products.References
- ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2), International Conference on Harmonization.
- FDA Guidance for Industry, INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology Derived Products, Draft Guidance, Food and Drug Administration.
- Alsante KM, Hatajik TD, Lohr LL, Santafianos D Sharp TR. Solving impurity/degradation problems: case studies. pp: 380, In; handbook of Isolation and Characterization of impurities in Pharmaceutical, Ahuja S, Alsante K, editors, Academics Press, New York. 2003.
- Boccardi G. Oxidative susceptibility testing,:220. In; pharmaceutical Stress Testing-Predicting Drug Degradation; Baertschi SW, editors, Taylor and Francis, New York. 2005.
- Alan RO, Brigitte ES, Yanqiu SA, Polshyna NM, Dunphy R, Barbara LM, et al. Forced degradation studies of rapamycin: Identification of autoxidation products. J Pharmaceut Biomed 59;2012: 194-200.
- Trabelsi H, Hassen IE, Bouabdallah S, Bouzouita K, Safta F. Stability indicating LC method for determination of Pipamperone. J Pharmaceut Biomed 39;2005: 914-919.
- Dorman DE, Lornez LJ, Occolowitz JL, Spangle LA, Collins, MW, Bashore FN, Baertschi SW. Isolation and structure elucidation of the major degaradtion products of cefaclor in the solid state. J Pharm. Sci 86;1997: 526-539.
- Bojana P, Markus D, Kappe CO. Microwave-assisted forced degradation using high-throughput microtiter platforms. J Pharmaceut Biomed 56;2011:867-873.
- Baertschi SW, Thatcher SR. Sample presentation for photostability studies: problems and solutions, pp: 445, In; Pharmaceutical Photostability and Stabilization Technology. Piechocki J, Editor, Taylor & Francis, New York. 2006.
- Baertschi SW, Alsante KM. Stress testing: the chemistry of the drug degradation, pp: 99, In Pharmaceutical Stress Testing, Baertschi SW, editors, Taylor & Francis, New York. 2005.
- D.W. Reynolds, K.L.Facchine, J.F. Mullaney, et al., Available guidance and best practices for conducting forced degradation studies, Pharm. Technol.26(2);(2002):48–56.
- Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech. 24; 2000: 1-14.
- H. Brummer, How to approach a forced degradation study, Life Sci. Technol. Bull.31; (2011):1–4.
- Blessy M., Ruchi D.Patel,Prajesh M. Prajapati, Y.K.Agarwal. Development of Forced degradation and stability indicating studies of drugs-A Review.Journal of Pharmaceutical Analysis.4 (3); 2014:159-165.
- Smita Shinde.S.A.Nirmal .A Review on Force Degradation Study for Pharmaceutical Product Development. International journal of Pharmaceutical and chemical sciences .5(2); 2016: 163-166.