Special Issue "Drug Polymorphism and Dosage Form Design"

A special issue of Pharmaceutics (ISSN 1999-4923).

Deadline for manuscript submissions: 20 March 2020.

Special Issue Editors

Dr. Roberta Censi
E-Mail Website
Guest Editor
School of Pharmacy, Department of Pharmaceutical Technology, University of Camerino, 62032 Camerino (MC), Italy
Interests: pharmaceutical technology; formulation; biomaterials; hydrogels; nanoparticles; polymorphism
Prof. Piera Di Martino
E-Mail Website1 Website2
Guest Editor
School of Pharmacy, Department of Pharmaceutical Technology, University of Camerino, 62032 Camerino (MC), Italy
Tel. +393207985643
Interests: physical pharmacy, pharmaceutical technology, formulation, polymorphism, solid dosage forms, dermatological formulation
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Special Issue Information

Dear Colleagues,

We are pleased to announce the new Special Issue for Pharmaceutics entitled “Drug Polymorphism and Dosage Form Design”.

Extensive academic and industrial research demonstrated that more than 50% of the currently used APIs  shows multiple physical arrangement of the constituents in the crystal lattice. This polymorphism significantly influences a variety of drug properties, including dissolution rate, solubility, tabletability, flowability, stability and even bioavailability, efficacy and toxicity. Pioneered by Aguiar et al in the ‘60s, surprisingly, after many decades, this research area is still attracting much attention by the scientific community and motivated the edition of this Special Issue, that is aimed at gathering the most recent advances in the field of polymorphism, highlighting its relevance in the Pharmaceutical Sciences and in the Design of Dosage Forms.

Original research articles and review articles dealing with all the aspects of drug polymorphism are considered. Particularly, the discovery of new crystal forms, methods for their preparation, influence of the polymorphism on the physicochemical properties, analytical methods for the study of crystal forms, API stability during processing and storage, biological effects of polymorphism, preformulation studies, design of dosage forms and  regulatory implications are all included in this Special Issue.

Dr. Roberta Censi
Prof. Dr. Piera Di Martino
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 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 1800 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

  • Amorphism
  • Dissolution
  • Polymorphism
  • Dosage form
  • Bioavailability
  • Stability
  • Mechanical properties
  • Tabletability
  • Flowability
  • Analytical methods

Published Papers (2 papers)

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Research

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Open AccessArticle
Stabilisation and Growth of Metastable Form II of Fluconazole in Amorphous Solid Dispersions
Pharmaceutics 2020, 12(1), 12; https://doi.org/10.3390/pharmaceutics12010012 - 20 Dec 2019
Abstract
The crystallisation of metastable drug polymorphs in polymer matrices has been reported as a successful approach to enhance the solubility of poorly water-soluble drug molecules. This can be achieved using different polymers, drug to polymer ratios and formulation techniques enabling the formation of [...] Read more.
The crystallisation of metastable drug polymorphs in polymer matrices has been reported as a successful approach to enhance the solubility of poorly water-soluble drug molecules. This can be achieved using different polymers, drug to polymer ratios and formulation techniques enabling the formation of stable nuclei and subsequent growth of new or metastable drug polymorphs. In this work we elucidated the polymorphism behaviour of a model compound fluconazole (FLU) embedded in solid dispersions with amorphous Soluplus® (SOL) obtained using spray drying and fusion methods. The effect of humidity on the stability of FLU in the obtained dispersions was also evaluated. FLU at a drug content below 40 wt. % stayed amorphous in the dispersions prepared using the fusion method and crystallised exclusively into metastable form II at a drug content above 40 wt. % and 70% relative humidity (RH) conditions. In contrast, a mixture of forms I, II and hydrate of FLU was detected in the spray dried formulations after 14 days of storage at 40 °C/40% RH, with preferential growth of thermodynamically stable form I of FLU. This study highlights the importance of preparation techniques and the drug:polymer ratio in the formulation of amorphous solid dispersions and provides further understanding of the complex crystallisation behaviour of amorphous pharmaceuticals encapsulated in the polymer matrixes. Full article
(This article belongs to the Special Issue Drug Polymorphism and Dosage Form Design)
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Review

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Open AccessReview
The Polymorphism of Drugs: New Approaches to the Synthesis of Nanostructured Polymorphs
Pharmaceutics 2020, 12(1), 34; https://doi.org/10.3390/pharmaceutics12010034 - 01 Jan 2020
Abstract
Among the significant problems of modern pharmacology are the low solubility and bioavailability of drugs. One way to resolve this problem is to obtain new polymorphic forms of drugs with improved physicochemical properties. Various approaches have been developed with this aim, including the [...] Read more.
Among the significant problems of modern pharmacology are the low solubility and bioavailability of drugs. One way to resolve this problem is to obtain new polymorphic forms of drugs with improved physicochemical properties. Various approaches have been developed with this aim, including the preparation of co-crystals, the use of nanoparticles, or the use of compounds in the form of a salt. A promising direction in pharmacology concerns the production of new stable polymorphic structures. In this mini-review, we consider certain aspects of drug polymorphism, methods for the synthesis of polymorphs, and the stability, size, and transformation of crystalline polymorphs. Moreover, we summarize our results from several studies demonstrating the problems associated with the synthesis of new polymorphous modifications based on inert gases and cryotemperatures. The results indicate that the problems specific to drug polymorphisms have only been partly resolved, are of current interest, and require further development. Full article
(This article belongs to the Special Issue Drug Polymorphism and Dosage Form Design)
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