In silicoprediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen

Author:

Tsume Yasuhiro1,Langguth Peter2,Garcia-Arieta Alfredo3,Amidon Gordon L.1

Affiliation:

1. College of Pharmacy; University of Michigan; Ann Arbor; Michigan; 48109-1065; USA

2. Department of Pharmaceutical Technology and Biopharmaceutics; Johannes Gutenberg-University of Mainz; Staudinger Weg 5; Mainz; D-55099; Germany

3. Division de Farmacologia y Evaluacion Clinica, Subdireccion General de Medicamentos de Uso Humano; Agencia Espanola de Medicamentos y Productos Sanitarios; C/ Campezo 1, Edifico 8; 28022; Madrid; Spain

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science,Pharmacology,General Medicine

Reference50 articles.

1. U.S. FDA Department of Health and Human Services Food and Drug Administration Center for Evaluation and Research Guidances for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System 2000

2. EMA Guideline on the Investigation of Bioequivalence 2010

3. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability;Amidon;Pharm Res,1995

4. The ‘high solubility’ definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs;Yazdanian;Pharm Res,2004

5. Review of global regulations concerning biowaivers for immediate release solid oral dosage forms;Gupta;Eur J Pharm Sci,2006

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