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FDA and EMA Oversight of Disruptive Science on Application of Finite Absorption Time (F.A.T.) Concept in Oral Drug Absorption: Time for Scientific and Regulatory Changes.
Pharmaceutics
November 2024
Faculty of Pharmacy, National and Kapodistrian University of Athens, 15784 Athens, Greece.
It has been demonstrated that the concept of infinite absorption time, associated with the absorption rate constant, which drives a drug's gastrointestinal absorption rate, is not physiologically sound. The recent analysis of oral drug absorption data based on the finite absorption time (F.A.
View Article and Find Full Text PDFHarnessing spectrophotometry resolution power for determining ternary mixture for respiratory disorders treatment in their pharmaceutical formulation.
PLoS One
October 2024
Faculty of Pharmacy, Pharmaceutical Analytical Chemistry Department, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, Egypt.
A ternary mixture incorporating Hydroxyzine hydrochloride (HYX), Ephedrine hydrochloride (EPH) and Theophylline (THP) frequently prescribed for the treatment of respiratory diseases. Herein, two spectrophotometric methods are designated and applied to resolve these three components in their mixture. Method A is ratio-subtraction combined with derivative spectrophotometry, where THP can be determined directly at its λmax 271 nm (neither HYX or EPH interfere), then for determination of HYX and EPH, the ternary mixture was divided by 22 μg/mL of THP and after subtraction of the plateau region, HYX can be determined directly at its λmax 234.
View Article and Find Full Text PDFAssessment of polymeric mucin-drug interactions.
PLoS One
June 2024
Wellcome Centre for Cell-Matrix Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, United Kingdom.
Mucosal-delivered drugs have to pass through the mucus layer before absorption through the epithelial cell membrane. Although there has been increasing interest in polymeric mucins, a major structural component of mucus, potentially acting as important physiological regulators of mucosal drug absorption, there are no reports that have systematically evaluated the interaction between mucins and drugs. In this study, we assessed the potential interaction between human polymeric mucins (MUC2, MUC5B, and MUC5AC) and various drugs with different chemical profiles by simple centrifugal method and fluorescence analysis.
View Article and Find Full Text PDFN-Hydroxyalkanamide Based Organo/hydrogels as Novel Scaffolds for pH-Dependent Metronidazole and Theophylline Release.
Chem Biodivers
July 2024
Department of Chemistry, School of Basic Sciences, Central University of Haryana, Mahendergarh, Haryana, 123031, India.
The traditional delivery of metronidazole and theophylline presents challenges like bitter taste, variable absorption, and side effects. However, gel-based systems offer advantages including enhanced targeted drug delivery, minimized side effects, and improved patient compliance, effectively addressing these challenges. Consequently, a cost-effective synthesis of N-hydroxyalkanamide gelators with varying alkyl chain lengths was achieved in a single-step reaction procedure.
View Article and Find Full Text PDFIVIVC Revised.
Pharm Res
February 2024
Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
Purpose: To revise the IVIVC considering the physiologically sound Finite Absorption Time (F.A.T.
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