QbD-Enabled Development of Novel Stimuli-Responsive Gastroretentive Systems of Acyclovir for Improved Patient Compliance and Biopharmaceutical Performance.
作者： Bhupinder Singh , Anterpreet Kaur , Shashi Dhiman , Babita Garg , Rajneet Kaur Khurana
DOI: 10.1208/S12249-015-0367-0
关键词:
摘要: The current studies entail systematic quality by design (QbD)-based development of stimuli-responsive gastroretentive drug delivery systems (GRDDS) acyclovir using polysaccharide blends for attaining controlled release profile and improved patient compliance. patient-centric target product was defined critical attributes (CQAs) earmarked. Risk assessment studies, carried out through Ishikawa fish bone diagram failure mode, effect, criticality analysis, helped in identifying the plausible risks or modes affecting product. A face-centered cubic employed optimization concentration sodium alginate (X 1) gellan 2) as material (CMAs) formulations, which were evaluated CQAs viz. viscosity, gel strength, onset floatation, characteristics. Mathematical modeling generation space, optimum formulation embarked upon, exhibiting characteristics marked excellent floatation bioadhesion along with promising control up to 24 h. Drug-excipient compatibility FTIR DSC revealed absence any interaction(s) among excipients. In vivo pharmacokinetic Wistar rats corroborated extension absorption from optimized GR formulations vis-a-vis marketed suspension (ZOVIRAX®). Establishment vitro/in correlation (IVIVC) a high degree between vitro data. nutshell, present investigations report successful GRDDS acyclovir, can be applicable platform approach other drugs too.
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