The PEARRL reviews–innovative drug development strategies tailored to facilitate earlier access to new oral medicines

BT Griffin, JB Dressman - Journal of Pharmacy and …, 2019 - academic.oup.com
A major bottleneck to development of new oral medicines is the poor solubility of many drug
candidates. The need to develop bio-enabling formulations for poorly soluble drug …

The effects of excipients on transporter mediated absorption

J Goole, DJ Lindley, W Roth, SM Carl, K Amighi… - International journal of …, 2010 - Elsevier
Traditionally most pharmaceutical excipients used for peroral dosage forms have been
considered to be inert, although they have been known to play an important role in …

Assessment of food effects during clinical development

Z Vinarov, J Butler, F Kesisoglou, M Koziolek… - International Journal of …, 2023 - Elsevier
Food-drug interactions frequently hamper oral drug development due to various
physicochemical, physiological and formulation-dependent mechanisms. This has …

Formulation strategies to improve the bioavailability of poorly absorbed drugs

FJO Espinar, CB Lavilla, GB Fernández… - Dosage Forms …, 2024 - Elsevier
One of the most frequent causes for discarding new drug molecules in the first phases of
early drug discovery is their poor bioavailability. The pharmaceutical R&D researcher must …

Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination

MVS Varma, RS Obach, C Rotter… - Journal of medicinal …, 2010 - ACS Publications
Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall
elimination (Fg), and fraction escaping hepatic elimination (Fh). In this study, using a …

Biopharmaceutical aspects and implications of excipient variability in drug product performance

P Zarmpi, T Flanagan, E Meehan, J Mann… - European Journal of …, 2017 - Elsevier
Abstract Implementation of Quality by Design approaches in pharmaceutical industry
requires a sound understanding of the parameters triggering final product variability …

[PDF][PDF] Emerging excipients in parenteral medications

SP Apte, SO Ugwu - Pharmaceutical Technology, 2003 - academia.edu
48 Pharmaceutical Technology MARCH 2003 www. pharmtech. com are not entirely devoid
of pharmacological activity. As parenteral drug delivery becomes more complex and …

[HTML][HTML] In vitro models for the prediction of in vivo performance of oral dosage forms: recent progress from partnership through the IMI OrBiTo collaboration

J Butler, B Hens, M Vertzoni, J Brouwers… - European Journal of …, 2019 - Elsevier
The availability of in vitro tools that are constructed on the basis of a detailed knowledge of
key aspects of gastrointestinal (GI) physiology and their impact on formulation performance …

Reply to “Comment on 'In Silico Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically Based Absorption Models'”

E Sjögren, H Thörn, C Tannergren - Molecular Pharmaceutics, 2017 - ACS Publications
This is a reply to the comment on “In Silico Modeling of Gastrointestinal Drug Absorption:
Predictive Performance of Three Physiologically Based Absorption Models” by Turner and …

[HTML][HTML] Leveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary

C Reppas, M Kuentz, A Bauer-Brandl, S Carlert… - European Journal of …, 2023 - Elsevier
Due to the strong tendency towards poorly soluble drugs in modern development pipelines,
enabling drug formulations such as amorphous solid dispersions, cyclodextrins, co-crystals …