Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies

Journal of Pharmaceutical Sciences
Filippos KesisoglouTycho Heimbach

Abstract

In recent years, there has been a significant increase in use of physiologically based pharmacokinetic models in drug development and regulatory applications. Although most of the published examples have focused on aspects such as first-in-human (FIH) dose predictions or drug-drug interactions, several publications have highlighted the application of these models in the biopharmaceutics field and their use to inform formulation development. In this report, we present 5 case studies of use of such models in this biopharmaceutics/formulation space across different pharmaceutical companies. The case studies cover different aspects of biopharmaceutics or formulation questions including (1) prediction of absorption prior to FIH studies; (2) optimization of formulation and dissolution method post-FIH data; (3) early exploration of a modified-release formulation; (4) addressing bridging questions for late-stage formulation changes; and (5) prediction of pharmacokinetics in the fed state for a Biopharmaceutics Classification System class I drug with fasted state data. The discussion of the case studies focuses on how such models can facilitate decisions and biopharmaceutic understanding of drug candidates and the opportunities for incr...Continue Reading

References

Sep 29, 2001·Advanced Drug Delivery Reviews·B AgoramM B Bolger
Jun 20, 2006·Pharmaceutical Research·Steven C SuttonKathy Sweeney
Nov 13, 2008·The AAPS Journal·Filippos Kesisoglou, Yunhui Wu
Apr 22, 2009·The AAPS Journal·Masoud JameiGeoffrey Tucker
Jun 2, 2009·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·C R GibsonE Mulrooney
Aug 2, 2011·International Journal of Pharmaceutics·Wenlei JiangLawrence X Yu
Aug 31, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Edmund S KostewiczPatrick Augustijns
Sep 26, 2013·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Edmund S KostewiczJennifer Dressman
Jan 21, 2014·AAPS PharmSciTech·Preetanshu PandeyChandra Vemavarapu
Apr 22, 2014·Clinical Pharmacology and Therapeutics·X Zhang, R A Lionberger
Sep 25, 2014·The Journal of Pharmacy and Pharmacology·Orestis PetrakisChristos Reppas
Feb 19, 2015·Journal of Pharmaceutical Sciences·Tao ZhangHandan He

❮ Previous
Next ❯

Citations

Jul 22, 2016·Molecular Pharmaceutics·Amitava MitraFilippos Kesisoglou
Apr 18, 2018·Expert Opinion on Drug Discovery·Miguel Ángel Cabrera-Pérez, Hai Pham-The
Aug 1, 2018·The Journal of Pharmacy and Pharmacology·Chara LitouJennifer B Dressman
Jan 24, 2019·The AAPS Journal·Cordula StillhartFilippos Kesisoglou
Sep 21, 2016·Journal of Pharmacokinetics and Pharmacodynamics·Clara HartmanshennIoannis P Androulakis
Feb 5, 2019·Technology·Paulina KrzyszczykMartin L Yarmush
Mar 10, 2020·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·R Díaz de León-OrtegaN Fotaki
Oct 31, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Takao Komasaka, Jennifer Dressman
Nov 19, 2020·Journal of Clinical Pharmacology·Filippos Kesisoglou
Aug 24, 2021·Annales pharmaceutiques françaises·D TodeschiniM Dutra Duque
Oct 9, 2021·Drug Development and Industrial Pharmacy·Thalita Martins da SilvaHelvécio Vinícius Antunes Rocha

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.