Fabrication and Optimization of Glibenclamide Drug Delivery System Using Pulsatile Approach for Hyperglycemia

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dc.contributor.authorDesai, Sen_US
dc.contributor.authorThakkar, Ven_US
dc.contributor.authorGandhi, Ten_US
dc.contributor.authorGandhi, Aen_US
dc.contributor.authorParekh, Ken_US
dc.contributor.authorJoshi, A.en_US
dc.date.accessioned2025-05-12T07:23:53Z
dc.date.available2025-05-12T07:23:53Z
dc.date.issued2024-12
dc.description.abstractDiabetes mellitus is characterized by persistently high blood sugar levels, and Glibenclamide is commonly used to manage these levels. Pulsatile formulations of Glibenclamide offer controlled timed release to address early morning hyperglycemia, enhancing glucose management and reducing complications. Incorporating Aloe barbadensis miller spray-dried powder as a solid plug in the pulsatile capsule design may help control morning glucose spikes and reduce elevated triglyceride levels in diabetic patients. The present study utilized the Pulsincap® system, which incorporates ethyl cellulose (EC)--coated capsules containing optimized glibenclamide tablets and a swellable plug. Solid dispersions (SDs) were developed using Soluplus® to enhance the poor aqueous solubility of glibenclamide, with compatibility confirmed via Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC). Capsules (size ‘000’), coated with 10% w/v ethyl cellulose in methanol and dibutyl phthalate solution, achieved sustained release over 12 hrs. Immediate-release (IR) tablets, formulated via wet granulation, exhibited rapid disintegration within 2 mins. Sustained-release (SR) tablets, optimized using a 3² full factorial design with varying concentrations of HPMC K4M and HPMC K100M CR, demonstrated release profiles of 16-37% at 1 hr, 33-74% at 4 hrs, and 44-100% at 8 hrs. The erodible plug, composed of HPMC K15M, guar gum, and aloe vera, provided swelling and controlled lag times ranging from 7 to 12 hrs. The pulsatile delivery system effectively enhanced glibenclamide bioavailability and modulated its release, offering potential improvements in glycemic management for diabetic patients.en_US
dc.identifier.affiliationsGujarat Technological University, Anand Pharmacy College, Department of Pharmaceutics, Anand, Gujarat, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmacology, Anand Pharmacy College, Anand, Gujarat, Indiaen_US
dc.identifier.affiliationsZydus Life sciences Ltd., Ahmedabad, Gujarat, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, Indiaen_US
dc.identifier.affiliationsDepartment of Pharmaceutics, Anand Pharmacy College, Anand, Gujarat, Indiaen_US
dc.identifier.citationDesai S, Thakkar V, Gandhi T, Gandhi A, Parekh K, Joshi A. Fabrication and Optimization of Glibenclamide Drug Delivery System Using Pulsatile Approach for Hyperglycemia . International Journal of Pharmaceutical Sciences and Drug Research . 2024 Dec; 16(6): 922-930en_US
dc.identifier.issn0975–248X
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/246524
dc.languageenen_US
dc.publisherMRI Publication Pvt. Ltd.en_US
dc.relation.issuenumber6en_US
dc.relation.volume16en_US
dc.source.urihttps://doi.org/10.25004/IJPSDR.2024.160601en_US
dc.subjectGlibenclamideen_US
dc.subjectPulsatile deliveryen_US
dc.subjectSolid dispersionen_US
dc.subjectSoluplus®en_US
dc.subjectAloe barbadensis millersen_US
dc.titleFabrication and Optimization of Glibenclamide Drug Delivery System Using Pulsatile Approach for Hyperglycemiaen_US
dc.typeJournal Articleen_US
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