0000000000359566

AUTHOR

I. E. Shohin

showing 2 related works from this author

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

2014

ABSTRACT Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing piroxicam in the free acid form are reviewed. Piroxicam solubility and permeability, its therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA), and corresponding dissolution data are taken into consideration. The available data suggest that according to the current biopharmaceutics classification system (BCS) and all current guidances, piroxicam would be assigned to BCS Class II. The ex…

DrugChemistry Pharmaceuticalmedia_common.quotation_subjectBiological AvailabilityPharmaceutical ScienceExcipientBioequivalencePharmacologyPiroxicamDosage formBiopharmaceuticsArthritis RheumatoidExcipientsFood-Drug InteractionsPiroxicamPharmacokineticsmedicineAnimalsHumansTissue Distributionmedia_commonChemistryAnti-Inflammatory Agents Non-SteroidalStereoisomerismBiopharmaceutics Classification SystemRatsBioavailabilityIntestinal AbsorptionSolubilityTherapeutic EquivalencyCaco-2 CellsHalf-Lifemedicine.drugJournal of Pharmaceutical Sciences
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Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Ketoprofen

2012

Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing ketoprofen are reviewed. Ketoprofen's solubility and permeability, its therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA)/dissolution data were taken into consideration. The available data suggest that according to the current Biopharmaceutics Classification System (BCS) and all current guidances, ketoprofen is a weak acid that would be assigned to BCS Class II. The extent of ketoprofen abso…

Dosage FormsKetoprofenChromatographyChemistryChemistry PharmaceuticalAdministration OralBiological AvailabilityPharmaceutical ScienceExcipientBioequivalenceBiopharmaceutics Classification SystemPermeabilityDosage formAbsorptionBioavailabilityExcipientsstomatognathic diseasesSolubilityTherapeutic EquivalencyPharmacokineticsKetoprofenmedicineHumansSolubilitymedicine.drugJournal of Pharmaceutical Sciences
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