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Pharmaceutics
Special Issues
Physiologically-Based Pharmacokinetics (PBPK) and Biopharmaceutics (PBBM) Modeling for Formulation Development
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Physiologically-Based Pharmacokinetics (PBPK) and Biopharmaceutics (PBBM) Modeling for Formulation Development

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmacokinetics and Pharmacodynamics".

Deadline for manuscript submissions: 31 May 2024 | Viewed by 1078

Special Issue Editors

Dr. Marcelo Dutra Duque

E-Mail Website
Guest Editor
Department of Pharmaceutical Sciences, Federal University of Sao Paulo–UNIFESP, São Paulo 04021-001, Brazil
Interests: solid oral dosage forms; dissolution; modeling & simulation; PBPK; PBBM; dissolution/bioequivalence safe space
Dr. Michele Georges Issa

E-Mail Website
Guest Editor
Department of Pharmaceutical Sciences, University of Sao Paulo–USP, São Paulo 05508-070, Brazil
Interests: preformulation; formulation; solid oral dosage forms; multiparticulate systems; dissolution; design of experiments; PBBM; dissolution/bioequivalence safe space
Dr. Humberto Gomes Ferraz

E-Mail Website
Guest Editor
Department of Pharmaceutical Sciences, University of Sao Paulo–USP, São Paulo 05508-070, Brazil
Interests: preformulation; formulation; solid oral dosage forms; multiparticulate systems; dissolutio; PBBM; dissolution/bioequivalence safe space

Special Issue Information

Dear Colleagues,

Physiologically-Based Pharmacokinetics (PBPK) modeling represents advancements in mathematical models based on information from animal and human physiology that can be integrated with the physicochemical information of a drug to predict its concentration in any tissue. Physiologically-Based Biopharmaceutics (PBBM) modeling establishes a link between the performance of a formulation, such as in vitro drug dissolution, and a PBPK model. In this context, PBPK and PBBM approaches are of great interest to pharmaceutical companies for various applications, particularly in the development of formulations with desirable drug release, the evaluation of the bio-predictive and clinical relevance of dissolution methods, support for formulation changes, assessment of the impact on bioequivalence (BE) due to any formulation modifications, and to run virtual BE studies. PBPK and PBBM can also be employed for predicting drug disposition from other routes of administration, such as injectable, nasal–pulmonary, dermal, transdermal, ocular, and buccal.

This Special Issue aims to gather recent advances in the use of PBBK and PBBM for formulation development, encompassing all aspects that can contribute to supporting drug product development. We are pleased to invite you to submit original research articles or reviews utilizing PBPK and/or PBBM for drug product development (across all dosage forms). Topics of interest may include, but are not limited to, biopharmaceutics applications, the evaluation of dissolution methods, regulatory applications, post-approval changes, virtual bioequivalence studies, and in vitro–in vivo correlation.

We look forward to receiving your contributions.

Dr. Marcelo Dutra Duque
Dr. Michele Georges Issa
Dr. Humberto Gomes Ferraz
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • PBPK
  • PBBM
  • formulation development
  • dissolution
  • IVIVC
  • IVIVR
  • particle size distribution
  • bioequivalence
  • virtual bioequivalence
  • drug release

Published Papers (1 paper)

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Research

13 pages, 2609 KiB  
Article
Development of Mechanistic In Vitro–In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables
by Daniela Amaral Silva, Maxime Le Merdy, Khondoker Dedarul Alam, Yan Wang, Quanying Bao, Nilesh Malavia, Diane Burgess and Viera Lukacova
Pharmaceutics 2024, 16(4), 552; https://doi.org/10.3390/pharmaceutics16040552 - 19 Apr 2024
Viewed by 755
Abstract
Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance. Nevertheless, many challenges arise in the development and regulatory assessment of LAI drug products due to a limited understanding [...] Read more.
Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance. Nevertheless, many challenges arise in the development and regulatory assessment of LAI drug products due to a limited understanding of the tissue response to injected particles (e.g., inflammation) impacting in vivo performance. Mechanism-based in silico methods may support the understanding of LAI–physiology interactions. The objectives of this study were as follows: (1) to use a mechanistic modeling approach to delineate the in vivo performance of DepoSubQ Provera® and formulation variants in preclinical species; (2) to predict human exposure based on the knowledge gained from the animal model. The PBPK model evaluated different elements involved in LAI administration and showed that (1) the effective in vivo particle size is potentially larger than the measured in vitro particle size, which could be due to particle aggregation at the injection site, and (2) local inflammation is a key process at the injection site that results in a transient increase in depot volume. This work highlights how a mechanistic modeling approach can identify critical physiological events and product attributes that may affect the in vivo performance of LAIs. Full article
(This article belongs to the Special Issue Physiologically-Based Pharmacokinetics (PBPK) and Biopharmaceutics (PBBM) Modeling for Formulation Development)
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