A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development

MN Martinez, F Wu, B Sinko, DJ Brayden, M Grass… - The AAPS Journal, 2022 - Springer
It is now recognized that a number of excipients previously considered to be “inert” have the
capacity to alter drug oral bioavailability through a range of in vivo effects. The various …

A critical overview of the biological effects of excipients (Part I): impact on gastrointestinal absorption

MN Martinez, B Sinko, F Wu, T Flanagan, E Borbás… - The AAPS Journal, 2022 - Springer
Traditionally, excipients have been considered in drug development from the perspective of
their influence on drug solubility, manufacturability, and ability to control in vitro and in vivo …

Considerations and recommendations on traditional and non-traditional uses of excipients in oral drug products

PP Constantinides, S Chakraborty, D Shukla - AAPS Open, 2016 - Springer
Excipients represent diverse classes of molecules, small molecules or macromolecules, with
versatile structures within a given class and are from natural, semi-synthetic and synthetic …

Potential for pharmaceutical excipients to impact absorption: A mechanistic review for BCS Class 1 and 3 drugs

T Flanagan - European Journal of Pharmaceutics and …, 2019 - Elsevier
The potential for certain excipients to impact drug absorption is the subject of numerous
publications. Reflecting this, current Biopharmaceutics Classification System (BCS) …

Excipient knowledgebase: Development of a comprehensive tool for understanding the disposition and interaction potential of common excipients

SJ McFeely, J Yu, Y Wang, C Wu… - CPT …, 2021 - Wiley Online Library
Although the use of excipients is widespread, a thorough understanding of the drug
interaction potential of these compounds remains a frequent topic of current research. Not …

Impact of osmotically active excipients on bioavailability and bioequivalence of BCS class III drugs

ML Chen, N Sadrieh, L Yu - The AAPS journal, 2013 - Springer
The Biopharmaceutics Classification System (BCS), based on aqueous solubility and
intestinal permeability, has been widely used to predict drug absorption during …

The biopharmaceutical classification system of excipients

T Vasconcelos, S Marques, B Sarmento - Therapeutic Delivery, 2017 - Future Science
The increasing number of new chemical entities is bringing new challenges to the field of
drug delivery. These drugs present bioavailability issues that are frequently associated with …

Considerations for determining direct versus indirect functional effects of solubilizing excipients on drug transporters for enhancing bioavailability

M Lavan, G Knipp - Journal of pharmaceutical sciences, 2020 - Elsevier
Excipients used in drug formulations at clinically safe levels have been considered to be
pharmacologically inert; however, numerous studies have suggested that many solubilizing …

Effect of excipients on oral absorption process according to the different gastrointestinal segments

A Ruiz-Picazo, I Lozoya-Agullo… - Expert Opinion on …, 2021 - Taylor & Francis
Introduction Excipients are necessary to develop oral dosage forms of any Active
Pharmaceutical Ingredient (API). Traditionally, excipients have been considered inactive …

Evaluation of excipient risk in BCS class I and III biowaivers

M Metry, JE Polli - The AAPS journal, 2022 - Springer
The objective of this review article is to summarize literature data pertinent to potential
excipient effects on intestinal drug permeability and transit. Despite the use of excipients in …