Food for thought: formulating away the food effect - a PEARRL review
| Autor: | Joseph P. O'Shea, Caitriona M. O'Driscoll, Brendan T. Griffin, René Holm |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Chemistry
Pharmaceutical Administration Oral Biological Availability Pharmaceutical Science Clinical settings 030226 pharmacology & pharmacy Food-Drug Interactions 03 medical and health sciences 0302 clinical medicine Drug Development Animals Humans Medicine Formulation screening Pharmacology Food-drug interactions FOOD EFFECT business.industry Fasting Food effect 3. Good health Bioavailability Pharmaceutical Preparations Fasted state Drug development Risk analysis (engineering) 030220 oncology & carcinogenesis Gastrointestinal physiology business Bio-enabling formulations |
| Zdroj: | Journal of Pharmacy and Pharmacology |
| Popis: | Objectives Co-ingestion of oral dosage forms with meals can cause substantial changes in bioavailability relative to the fasted state. Food-mediated effects on bioavailability can have significant consequences in drug development, regulatory and clinical settings. To date, the primary focus of research has focused on the ability to mechanistically understand the causes and predict the occurrence of these effects. Key findings The current review describes the mechanisms underpinning the occurrence of food effects, sheds new insights on the relative frequency for newly licensed medicines and describes the various methods by which they can be overcome. Analysis of oral medicines licensed by either the EMA or FDA since 2010 revealed that over 40% display significant food effects. Due to altered bioavailability, these medicines are often required to be dosed, rather restrictively, in either the fed or the fasted state, which can hinder clinical usefulness. Summary There are clinical and commercial advantages to predicting the presence of food effects early in the drug development process, in order to mitigate this risk of variable food effect bioavailability. Formulation approaches aimed at reducing variable food-dependent bioavailability, through the use of bio-enabling formulations, are an essential tool in addressing this challenge and the latest state of the art in this field are summarised here. |
| Databáze: | OpenAIRE |
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