Special Issue "Methodology, Design and Regulatory Considerations for the Bioequivalence of Oral Inhaled Products"
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".
Deadline for manuscript submissions: closed (20 May 2021).
Interests: controlled release; solid state properties; organic and inorganic nano- microparticles; inhaled dry powders; drug physical modification; cell microencapsulation and engineering
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Special Issue in Pharmaceutics: Advances in Nanostructured Materials between Pharmaceutics and Biomedicine 2.0
Interests: aerosol technology; drug delivery to the lung; lung deposition and disposition models; inhalation pharmacokinetics; inhalation biopharmaceutics
Interests: repurposing drugs; poorly water soluble drugs; personalized medicine; pulmonary medicine; nasal drug delivery
2. Centro de Investigacion Farmacopea Chilena, Universidad de Valparaíso, 2340000 Valparaíso, Chile
Interests: inhalation; bioequivalence of OIDPs; powder flow characterization
While there are long standing methods for determining the bioequivalence of systemically delivered drugs such as injectables and oral solid dosage forms, assessing the bioequivalence of orally inhaled products requires special attention to various unique aspects, such as formulation properties and device design, to ensure equivalent therapeutic efficacy between products in patients. As many inhaled products are intended for a local therapeutic effect, pharmacokinetic studies, if even possible, fail to support equivalent performance between products. In order to provide generic products at reduced cost to patients, methods for determining bioequivalence without clinical testing are needed. Methods and updates to current regulatory guidelines for bioequivalence, for accurately assessing and predicting drug deposition placement in the lungs, and for delivery devices and drug solubility at the site of action, among others, that can be standardized and reproducible are needed in order to meet this need.
This Special Issue highlights the research that has taken place regarding the methodology, regulatory and device design space for inhaled products.
Prof. Dr. Stefano Giovagnoli
Dr. Bo Olsson
Dr. Zachary Warnken
Dr. Daniel Moraga-Espinoza
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 papers will be 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 2200 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.
- inhaled drug delivery
- dry powder inhalers
- regulatory agencies
- analytical methodology