2016
DOI: 10.1002/ptr.5618
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Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives

Abstract: Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can … Show more

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Cited by 30 publications
(23 citation statements)
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“…12 Other study conducted in Jordan among pharmacists documented that the majority of pharmacists believed that advanced educational courses about pharmacological and toxic effects of herbal medicine products were essential. 13 In 2010, other study conducted among the pharmacists in Abu Dhabi reported that the use of herbal medicine is more prevalent, and they were aware of the uses of these products, but they had similar results regarding herbal side effects and herbal-drug interactions. 14 Another study that opposed our study finding had previously evaluated the prevalence of using herbal medicine among pharmacist was at Kuwait in 2007 recorded that most pharmacists preferred herbal products instead of conventional pharmaceuticals.…”
Section: Discussionmentioning
confidence: 99%
“…12 Other study conducted in Jordan among pharmacists documented that the majority of pharmacists believed that advanced educational courses about pharmacological and toxic effects of herbal medicine products were essential. 13 In 2010, other study conducted among the pharmacists in Abu Dhabi reported that the use of herbal medicine is more prevalent, and they were aware of the uses of these products, but they had similar results regarding herbal side effects and herbal-drug interactions. 14 Another study that opposed our study finding had previously evaluated the prevalence of using herbal medicine among pharmacist was at Kuwait in 2007 recorded that most pharmacists preferred herbal products instead of conventional pharmaceuticals.…”
Section: Discussionmentioning
confidence: 99%
“…After a few months, the sample analyzed associated clarity, pH, viscosity, drug content, rheological, and in vitro dissolution. The storage conditions and the length of the study chosen should be sufficient to cover the storage, shipment, and subsequent use [121,122].…”
Section: Stability Studiesmentioning
confidence: 99%
“…The WHO (2006) has also recommended for stability studies on herbal drugs and finished herbal formulations. The stability testing of herbal drugs, challenges, regulatory compliance and perspectives has been recently reviewed (Bansal, Suthar, Kaur, et al, 2016). In India, for a phytopharmaceutical drug, there is a provision in Drugs and Cosmetics Rules, 1945 (notified vide GSR 918(E) (2015), Ministry of Health and Family Welfare) for requirement of stability data.…”
Section: Stability Testing Of Herbal Drugsmentioning
confidence: 99%