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This book deals with predicting behavior of poorly soluble weakly basic drugs in the human body, particularly in the gastrointestinal tract. Under fasting conditions weak bases usually show good solubility in the human stomach and poor solubility in the intestine. This solubility discrepancy can lead to unusual drug dissolution behavior during the process of gastric emptying, such as supersaturation and precipitation. The current thesis investigates dissolution, supersaturation and precipitation behavior of weak bases in the human stomach and intestine using biorelevant media. These media…mehr

Produktbeschreibung
This book deals with predicting behavior of poorly soluble weakly basic drugs in the human body, particularly in the gastrointestinal tract. Under fasting conditions weak bases usually show good solubility in the human stomach and poor solubility in the intestine. This solubility discrepancy can lead to unusual drug dissolution behavior during the process of gastric emptying, such as supersaturation and precipitation. The current thesis investigates dissolution, supersaturation and precipitation behavior of weak bases in the human stomach and intestine using biorelevant media. These media simulate fluids of the gastrointestinal tract and can be utilized in different in vitro experiments mimicking the human gastric and intestinal physiology. The experimental outcomes can then be coupled with physiologically based pharmacokinetic (PBPK) models, which simulate drug uptake into the human blood flow and finally enable the prediction of drug plasma concentration profiles in humans. This work shows that combining biorelevant in vitro investigation with PBPK modeling is essential for predicting in vivo performance of poorly soluble weakly basic drugs.
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Autorenporträt
Mark Berlin was born in Vilnius, Lithuania in 1984. At an age of 10 he moved to Germany where he went to school and university. He owns a double degree in Pharmacy and Business from Goethe University Frankfurt. During his studies he worked in a pharmaceutical company (Eli Lilly & Company) and at an international pharmacy (Ludwigs-Apotheke, Munich), as well as a scientist at the Institute of Pharmaceutical Technology, Frankfurt University. After finishing his studies in 2012 he started his PhD work under the supervision of Prof.Dr. Jennifer B. Dressman in the Institute of Pharmaceutical Technology, Goethe University Frankfurt. In 2015 Mark Berlin accomplished his thesis titled ¿Predicting oral absorption of poorly soluble weakly basic drugs¿ with a magna cum laude. His PhD work contributes theoretically and practically to development of drugs and drug formulations. He introduced a ¿Decision Tree for Assessing Behavior of Poorly Soluble, Weakly Basic Drugs¿ which was presented at several conferences such as Gordon Conference on Preclinical Form & Formulation Development in Waterville Valey, USA or OrBito meeting in Paris, France (both in 2015). Mark Berlin¿s focus on predicting behavior of weak bases in the human gastrointestinal tract was also published in several scientific papers and presented at various international conferences in USA, Australia and Germany. Mark Berlin currently works at the innovative company Biorelevant.com Ltd., which develops biorelevant products for the simulation of fluids of the human and animal gastrointestinal tracts.