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The Provisional No-Effect Threshold of Sugar Alcohols on Oral Drug Absorption Estimated by Physiologically Based Biopharmaceutics Model.
J Pharm Sci
January 2021
Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.
Sugar alcohols reduce oral drug bioavailability by osmotic effects, but the magnitude of these effects differs among different drugs. This study aimed to identify the drug-related critical attributes of osmotic effects and estimate the impact of a "practical" sugar alcohol dose on the pharmacokinetics of various molecules using modeling and simulation approaches. We developed a physiologically based biopharmaceutics model that considers the dose-dependent effects of sugar alcohols on the gastrointestinal physiology.
View Article and Find Full Text PDFUse of sorbitol as pharmaceutical excipient in the present day formulations - issues and challenges for drug absorption and bioavailability.
Drug Dev Ind Pharm
September 2019
a Department of Drug Discovery and Development , Harrison School of Pharmacy, Auburn University, AL , USA.
Sorbitol is a popular sugar alcohol which has been used as an excipient in formulations of various drugs. Although from a safety perspective the presence of sorbitol in drug formulations does not raise a concern, reports have emerged and these suggest that sorbitol in drug formulations may alter oral absorption and bioavailability of certain drugs. The focus of this article was to review the published literature of various drugs where pharmacokinetic data has been reported for the drug alone drug administered with sorbitol and provide perspectives on the pharmacokinetic findings.
View Article and Find Full Text PDFHuman in vivo regional intestinal permeability: quantitation using site-specific drug absorption data.
Mol Pharm
June 2015
Department of Pharmacy, Biopharmaceutic Research Group, Uppsala University, SE-751 23 Uppsala, Sweden.
Application of information on regional intestinal permeability has been identified as a key aspect of successful pharmaceutical product development. This study presents the results and evaluation of an approach for the indirect estimation of site-specific in vivo intestinal effective permeability (Peff) in humans. Plasma concentration-time profiles from 15 clinical studies that administered drug solutions to specific intestinal regions were collected and analyzed.
View Article and Find Full Text PDFA Sensitive Medium-Throughput Method to Predict Intestinal Absorption in Humans Using Rat Intestinal Tissue Segments.
J Pharm Sci
September 2015
Laboratory of Biopharmacy and Pharmacokinetics, School of Pharmacy, Federal University of Goiás, Goiânia, Brazil.
A range of in vitro, ex vivo, and in vivo approaches are currently used for drug development. Highly predictive human intestinal absorption models remain lagging behind the times because of numerous variables concerning permeability through gastrointestinal tract in humans. However, there is a clear need for a drug permeability model early in the drug development process that can balance the requirements for high throughput and effective predictive potential.
View Article and Find Full Text PDFStudy on biopharmaceutics classification and oral bioavailability of a novel multikinase inhibitor NCE for cancer therapy.
Int J Mol Sci
April 2014
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.
Specific biopharmaceutics classification investigation and study on phamacokinetic profile of a novel drug candidate (2-methylcarbamoyl-4-{4-[3- (trifluoromethyl) benzamido] phenoxy} pyridinium 4-methylbenzenesulfonate monohydrate, NCE) were carried out. Equilibrium solubility and intrinsic dissolution rate (IDR) of NCE were estimated in different phosphate buffers. Effective intestinal permeability (P(eff)) of NCE was determined using single-pass intestinal perfusion technique in rat duodenum, jejunum and ileum at three concentrations.
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