Drug Polymorphism and Dosage Form Design, 2nd Edition

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 26 December 2025 | Viewed by 1476

Special Issue Editors


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Guest Editor
Área Análisis de Medicamentos, Departamento Química Orgánica, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 531, S2002LRK, Rosario, Argentina
Interests: principal component analysis; bioactive compounds; functional properties

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Guest Editor
Área Técnica Farmacéutica, Departamento Farmacia, Facultad de Ciencias Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, Suipacha 570, Rosario 2000, Argentina
Interests: polymeric films; microparticles; drug delivery; controlled release; antifungal agents
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Special Issue Information

Dear Colleagues,

We are pleased to announce a new Special Issue for the journal Pharmaceutics titled, ‘Drug Polymorphism and Dosage Form Design, 2nd Edition’.

Crystalline polymorphism, a solid-state phenomenon present in most active pharmaceutical ingredients (APIs), significantly impacts various drug properties such as dissolution rate, solubility, tabletability, flowability, and stability. Polymorphism is crucial for Class II BCS drugs, as even slight variations in solubility can significantly influence the bioavailability and efficacy of these drugs. The success of the first volume of this Special Issue, led by Dr. Roberta Censi and Prof. Dr. Piera Di Martino, as well as the growing interest in this research area in both the scientific community and the pharmaceutical industry, has prompted the launch of Volume II.

This Special Issue aims to delve into the latest advancements in pharmaceutical polymorphism. We welcome submissions of original research articles and reviews covering all facets of drug polymorphism and dosage form design. Particular emphasis will be placed on the influence of polymorphism on physicochemical properties, which may compromise the safety or effectiveness of formulated products. Additionally, we seek to highlight the developments in quality by design (QbD) for both formulation and processes, along with the advancement of process analytical tools (PATs). Analytical methods employing cutting-edge technologies, such as vibrational spectroscopies (MIR, NIR, and RAMAN), will take the centre stage in this Special Issue.

We look forward to receiving your contributions.

Dr. Rubén M. Maggio
Prof. Dr. Darío Leonardi
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

  • polymorphism
  • solid state
  • dissolution
  • dosage form design
  • stability
  • mechanical properties
  • vibrational spectroscopy
  • quality by design
  • process analytical technologies
  • active pharmaceutical ingredient

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Published Papers (1 paper)

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12 pages, 2663 KiB  
Article
A QbD Approach for the Formulation and Control of Triclabendazole in Uncoated Tablets: From Polymorphs to Drug Formulation
by Lucas P. Muzi, Marina Antonio and Rubén M. Maggio
Pharmaceutics 2024, 16(12), 1594; https://doi.org/10.3390/pharmaceutics16121594 - 13 Dec 2024
Viewed by 968
Abstract
Triclabendazole (TCB) is a well-established anthelmintic effective in treating fascioliasis, a neglected tropical disease. This study employs quality by design (QbD) to investigate the impact of TCB polymorphism and pharmacotechnical variables, from the development of immediate-release tablets to process optimization and green analysis. [...] Read more.
Triclabendazole (TCB) is a well-established anthelmintic effective in treating fascioliasis, a neglected tropical disease. This study employs quality by design (QbD) to investigate the impact of TCB polymorphism and pharmacotechnical variables, from the development of immediate-release tablets to process optimization and green analysis. Critical process parameters (CPPs) and critical material attributes (CMAs), characterized by type of polymorph, composition of excipients (talc, lactose, cornstarch, and magnesium stearate), and compression force, were screened using a Plackett–Burman design (n = 24), identifying polymorphic purity and cornstarch as a CPP. To establish a mathematical model linking CPP to dissolution behaviour, a multiple linear regression (MLR) was applied to the training design (central composite design, n = 18). Simultaneously, a near-infrared spectroscopy coupled to partial least squares (NIR-PLSs) method was developed to analyze CPPs. An independent set of samples was prepared and analyzed using the NIR-PLSs model, and their dissolution profiles were also obtained. The PLSs model successfully predicted the CPPs in the new samples, yielding almost quantitative results (100 ± 3%), and MLR dissolution predictions mirrored the actual dissolution profiles (f2 = 85). In conclusion, the developed model could serve as a comprehensive tool for the development and control of pharmaceutical formulations, starting from the polymorphic composition and extending to achieve targeted dissolution outcomes. Full article
(This article belongs to the Special Issue Drug Polymorphism and Dosage Form Design, 2nd Edition)
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