☆ 4.5 Article

Dissolution-Hollow Fiber Membrane (D-HFM) System to Anticipate Biopharmaceutics Risk of Tablets and Capsules

JOURNAL OF PHARMACEUTICAL SCIENCES (2023)

相关参考文献

注意：仅列出部分参考文献，下载原文获取全部文献信息。

Article Chemistry, Medicinal

Dissolution/Permeation of Albendazole in the Presence of Cyclodextrin and Bile Salts: A Mechanistic In Vitro Study into Factors Governing Oral Bioavailability

Jonas Borregaard Eriksen et al.

Summary: This study aimed to investigate the impact of the interaction between bile salts and cyclodextrins on the dissolution-permeation of poorly soluble drug compounds. The results showed that the interplay between bile salts and cyclodextrins can enhance the free fraction of the drug in solution to a greater extent than using either component alone.

JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

添加到收藏夹

Review Pharmacology & Pharmacy

Best practices in current models mimicking drug permeability in the gastrointestinal tract - An UNGAP review

Joseph P. O'Shea et al.

Summary: This article discusses the complexity of oral drug absorption and the importance of evaluating intestinal permeability. It provides a critique of in vivo, in vitro, and ex vivo approaches for assessing drug permeability. Continued improvement and validation of in silico models will enhance early characterization of permeability and facilitate absorption modeling.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

添加到收藏夹

Article Pharmacology & Pharmacy

An Artificial Gut/Absorption Simulator: Description, Modeling, and Validation Using Caffeine

Krutika Meena Harish Jain et al.

Summary: The purpose of this study was to develop and validate a tool for simultaneous dissolution and absorption testing of oral drug formulations, called the artificial gut simulator (AGS). The AGS was optimized to simulate physiological gastric emptying and drug absorption using a high aqueous solubility model compound, caffeine. This study provides a framework for establishing in vitro/in vivo correlation for high-permeability supersaturating drug formulations.

AAPS JOURNAL (2022)

添加到收藏夹

Article Pharmacology & Pharmacy

Prediction of in vitro drug dissolution into fasted-state biorelevant media: Contributions of solubility enhancement and relatively low colloid diffusivity

Raqeeb Jamil et al.

Summary: This study evaluated the contributions of fasted biorelevant media-mediated solubility and diffusivity on enhanced drug dissolution in FaSSGF and FaSSIF-V2. The results showed that the media mainly affected drug solubility rather than diffusion, resulting in slower dissolution rates for drug-loaded micelles. Therefore, FaSSGF and FaSSIF-V2 had minimal enhancement on drug dissolution.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

添加到收藏夹

Article Chemistry, Medicinal

Characterization of Dissolution-Permeation System using Hollow Fiber Membrane Module and Utility to Predict in Vivo Drug Permeation Across BCS Classes

Asmita Adhikari et al.

Summary: The dissolution-permeation system provides valuable insights into drug absorption by examining the contributions of dissolution and permeation. This study characterizes a dissolution-hollow fiber membrane (D-HFM) system and compares its in vitro drug permeation constants to clinical permeation constants for four drugs. The results demonstrate the potential of the D-HFM system as a dissolution-permeation tool, with close agreement between predicted and observed drug permeation profiles. Furthermore, the D-HFM system shows higher drug permeation compared to other in vitro models.

JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

添加到收藏夹

Article Pharmacology & Pharmacy

Biopredictive capability assessment of two dissolution/permeation assays, μFLUX™ and PermeaLoop™, using supersaturating formulations of Posaconazole

Florentin Lukas Holzem et al.

Summary: The majority of new drugs have poor water solubility, which requires the development of enabling formulations for sufficient bioavailability upon oral administration. This study compared the biopredictive abilities of two in vitro tools for predicting intestinal supersaturation and systemic absorption of drug formulations. The PermeaLoop™ apparatus showed better predictive ability compared to the mu FLUX™ setup. The study confirms the usefulness of these tools for formulation ranking of weakly basic compounds and supersaturating formulations.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

添加到收藏夹

Article Pharmacology & Pharmacy

Predicting in vivo performance of fenofibrate amorphous solid dispersions using in vitro non-sink dissolution and dissolution permeation setup

Karoline Aagaard Lentz et al.

Summary: This study compared the predictive performance of two different in vitro study setups for oral exposure of ASDs, and found that predictions based on in vitro Cmax were more accurate than those based on in vitro AUC. Both in vitro studies resulted in the same rank order based on Cmax and AUC.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2021)

添加到收藏夹

Article Chemistry, Medicinal

Absorptive Dissolution Testing: An Improved Approach to Study the Impact of Residual Crystallinity on the Performance of Amorphous Formulations

Siddhi S. Hate et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

添加到收藏夹

Article Pharmacology & Pharmacy

In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When-Workshop Summary Report

Sandra Suarez-Sharp et al.

AAPS JOURNAL (2020)

添加到收藏夹

Article Pharmacology & Pharmacy

On the Usefulness of Two Small-Scale In Vitro Setups in the Evaluation of Luminal Precipitation of Lipophilic Weak Bases in Early Formulation Development

Patrick J. O'Dwyer et al.

PHARMACEUTICS (2020)

添加到收藏夹

Article Pharmacology & Pharmacy

The tangential flow absorption model (TFAM) - A novel dissolution method for evaluating the performance of amorphous solid dispersions of poorly water-soluble actives

Bastian Haering et al.

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2020)

添加到收藏夹

Article Chemistry, Medicinal

Simultaneous Analysis of Dissolution and Permeation Profiles of Nanosized and Microsized Formulations of Indomethacin Using the In Vitro Dissolution Absorption System 2

Jibin Li et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2019)

添加到收藏夹

Article Pharmacology & Pharmacy

A Physiologically Based Pharmacokinetic Model for Optimally Profiling Lamotrigine Disposition and Drug-Drug Interactions

Todd M. Conner et al.

EUROPEAN JOURNAL OF DRUG METABOLISM AND PHARMACOKINETICS (2019)

添加到收藏夹

Article Pharmacology & Pharmacy

First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing

Nikolay Zaborenko et al.

AAPS JOURNAL (2019)

添加到收藏夹

Article Chemistry, Medicinal

The Combination of GIS and Biphasic to Better Predict In Vivo Dissolution of BCS Class IIb Drugs, Ketoconazole and Raloxifene

Yasuhiro Tsume et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2018)

添加到收藏夹

Article Pharmacology & Pharmacy

Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report

Sandra Suarez-Sharp et al.

AAPS JOURNAL (2018)

添加到收藏夹

Review Pharmacology & Pharmacy

In vitro biphasic dissolution tests and their suitability for establishing in vitro-in vivo correlations: A historical review

Aude Pestieau et al.

EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES (2017)

添加到收藏夹

Article Pharmacology & Pharmacy

Evaluation of a dynamic dissolution/permeation model: Mutual influence of dissolution and barrier-flux under non-steady state conditions

Daniel Sironi et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2017)

添加到收藏夹

Article Medicine, Research & Experimental

Absorptive Dissolution Testing of Supersaturating Systems: Impact of Absorptive Sink Conditions on Solution Phase Behavior and Mass Transport

Siddhi S. Hate et al.

MOLECULAR PHARMACEUTICS (2017)

添加到收藏夹

Article Clinical Neurology

Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy The EQUIGEN Randomized Clinical Trial

Michel Berg et al.

JAMA NEUROLOGY (2017)

添加到收藏夹

Review Pharmacology & Pharmacy

Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications

Sandra Suarez-Sharp et al.

AAPS JOURNAL (2016)

添加到收藏夹

Article Clinical Neurology

Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial

Michael D. Privitera et al.

LANCET NEUROLOGY (2016)

添加到收藏夹

Editorial Material Clinical Neurology

Generic Substitution of AEDs: Is it Time to Put This Issue to Rest?

Barry E. Gidal

EPILEPSY CURRENTS (2016)

添加到收藏夹

Editorial Material Clinical Neurology

AES Position Statement on Generic Substitution of Antiepileptic Drugs

David G. Vossler et al.

EPILEPSY CURRENTS (2016)

添加到收藏夹

Article Clinical Neurology

Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard

Tricia Y. Ting et al.

EPILEPSIA (2015)

添加到收藏夹

Article Medicine, Research & Experimental

Biopharmaceutic Risk Assessment of Brand and Generic Lamotrigine Tablets

Soundarya Vaithianathan et al.

MOLECULAR PHARMACEUTICS (2015)

添加到收藏夹

Review Pharmacology & Pharmacy

Understanding Pharmaceutical Quality by Design

Lawrence X. Yu et al.

AAPS JOURNAL (2014)

添加到收藏夹

Article Chemistry, Medicinal

Biowaiver monographs for immediate-release solid oral dosage forms: Ketoprofen

Igor E. Shohin et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2012)

添加到收藏夹

Article Medicine, Research & Experimental

Biopharmaceutics classification of selected β-blockers:: Solubility and permeability class membership

Yongsheng Yang et al.

MOLECULAR PHARMACEUTICS (2007)

添加到收藏夹

Article Chemistry, Medicinal

Biowaiver monographs for immediate release solid oral dosage forms:: Ranitidine hydrochloride

H Kortejärvi et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2005)

添加到收藏夹

© Peeref 2019-2024. All rights reserved.