Orodispersible and Innovative Dosage Forms: Advances in Preparation Technologies, Direct Compression, and Co-Processed Excipients

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmaceutical Technology".

Deadline for manuscript submissions: closed (25 July 2025) | Viewed by 2398

Special Issue Editors


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Guest Editor
Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Medyczna 9, 30-688 Krakow, Poland
Interests: orodispersible tablets; minitablets; pediatric formulations; parenteral nutrition

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Guest Editor
Department of Pharmaceutical Technology and Biopharmaceutics, Jagiellonian University Medical College, Medyczna 9, 30-688 Krakow, Poland
Interests: pharmaceutical technology; biopharmaceutics; artificial intelligence; machine learning; data science
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Special Issue Information

Dear Colleagues,

Although orodispersible tablets (ODTs) were introduced to the pharmaceutical market more than 25 years ago, this dosage form still remains a subject of interest for many pharmaceutical technologists as well as innovators from pharma companies. ODTs are gaining more and more popularity in the pharmacotherapy of many diseases, including both acute and chronic kinds.

Initially produced via freeze-drying, ODT manufacturing now predominantly utilizes direct compression or post-granulation tableting. This shift is largely attributed to the development of superdisintegrants and the advent of co-processed excipients exhibiting superior compression properties. These advancements significantly reduce disintegration time and enhance the mechanical properties of compressed ODTs, streamlining production.

Current trends highlight the emergence of third-generation ODTs, incorporating modified-release formulations such as microcapsules, coated micropellets, and sustained-release granules. These formulations greatly simplify administration for pediatric patients and individuals with swallowing difficulties. Furthermore, the development of orodispersible minitablets (ODMTs and MODTs) and the exploration of alternative manufacturing technologies like 3D printing represent significant areas of ongoing research.

This Special Issue welcomes review articles and original research encompassing all aspects of fast-dissolving oral dosage forms. We welcome submissions covering a broad spectrum of topics, from the conceptualization and formulation of innovative orodispersible systems—including orodispersible films, granules, and buccal films—to their pharmacokinetic profiles and clinical trial data. This issue also welcomes studies on chewable tablets, buccal dosage forms, mucoadhesive dosage forms, and the broader application of co-processed excipients in improving the tabletability of various tablet formulations, including modified-release tablets. The enhanced tabletability afforded by co-processed excipients is especially relevant for direct compression methods. We encourage submissions exploring all aspects of these advanced dosage forms and their impact on patient care.

Dr. Witold Brniak
Prof. Dr. Aleksander Mendyk
Guest Editors

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Keywords

  • orodispersible films
  • buccal films
  • chewable tablets
  • orodispersible granules
  • buccal dosage forms
  • mucoadhesive dosage forms
  • tabletability
  • modified release tablets
  • minitablets

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Published Papers (1 paper)

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29 pages, 6884 KiB  
Article
Orodispersible Dosage Forms with Rhinacanthin-Rich Extract as a Convenient Formulation Dedicated to Pediatric Patients
by Thongtham Suksawat, Witold Brniak, Ewelina Łyszczarz, Małgorzata Wesoły, Patrycja Ciosek-Skibińska and Aleksander Mendyk
Pharmaceuticals 2024, 17(8), 994; https://doi.org/10.3390/ph17080994 - 27 Jul 2024
Viewed by 1291
Abstract
Rhinacanthins, derived from Rhinacanthus nasutus, widely used in traditional medicine, exhibit antifungal, anticancer, antiviral, antibacterial, and antiplatelet aggregation effects. Recently, their anti-diabetic activity was confirmed, which makes them an interesting natural alternative in the therapy of the early stage of diabetes mellitus. [...] Read more.
Rhinacanthins, derived from Rhinacanthus nasutus, widely used in traditional medicine, exhibit antifungal, anticancer, antiviral, antibacterial, and antiplatelet aggregation effects. Recently, their anti-diabetic activity was confirmed, which makes them an interesting natural alternative in the therapy of the early stage of diabetes mellitus. The aim of this study was to demonstrate the possibility of formulating orodispersible tablets (ODTs) and orodispersible films (ODFs) containing rhinacanthin-rich extract (RRE). Tablets with 50 mg or 100 mg of RRE were produced by direct compression. ODFs were manufactured by casting of Lycoat RS 720 or polyvinyl alcohol solution with RRE and additional excipients. The mechanical properties and disintegration times of the prepared formulations were studied. The effectiveness of taste masking was analyzed with an electronic tongue system. Six months simplified stability studies were performed in conditions complying to ICH guidelines. Appropriate friability of ODTs was achieved, despite low tensile strength (0.45–0.62 MPa). All prepared ODFs successfully met the acceptance criteria regarding Young’s modulus, tensile strength, and elongation at break. The observed variations in their mechanical properties were dependent on the type and quantity of polymers and plasticizers used. Disintegration time of ODTs ranged from 38.7 s to 54.2 s, while for ODFs from 24.2 to 40 s in the pharmacopoeial apparatus. Analyses made with the electronic tongue showed the significant taste-masking effect in both formulations. The addition of sucralose as a sweetener and menthol with mint flavor as a taste-masking agent was sufficient to mask an RRE’s taste in the case of ODTs and ODFs. Stability studies of ODTs packed in the PVC/Alu blisters showed a decrease in the RRE content below 90% after 6 months. However, ODFs with PVA were physicochemically stable for 6 months while being stored in Alu/Alu sachets. Our study proved for the first time the possibility of the formulation of orodispersible dosage forms with RRE, characterized by good mechanical properties, disintegration time, and appropriate taste masking. Full article
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