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Pharmaceutics
Special Issues
Dosage Form Design for Oral Administration
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Dosage Form Design for Oral Administration

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

Deadline for manuscript submissions: 10 May 2025 | Viewed by 11552

Special Issue Editors

Dr. Atheer Awad

E-Mail Website
Guest Editor
Department of Clinical, Pharmaceutical and Biological Sciences, School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield AL10 9AB, UK
Interests: 3D printing; drug delivery; pharmaceutical formulation; digital health
Dr. Hend Abdelhakim

E-Mail Website
Guest Editor
Global Business School for Health, UCL East, 7 Sidings Street, London E20 2AE, UK
Interests: taste masking; electrospinning; nanofabrication; age-appropriate; QbD; taste assessment

Special Issue Information

Dear Colleagues,

We extend a warm invitation to you to contribute to our forthcoming Special Issue entitled "Dosage Form Design for Oral Administration" in the esteemed journal Pharmaceutics. This Special Issue represents a significant opportunity to explore the latest developments in the design of oral medications and their impact on the field of pharmaceutical sciences.

Our Special Issue seeks to showcase recent advancements in the field of oral medication design. Aligned with the core focus of Pharmaceutics, spanning the topics of pharmaceutical formulation, drug design, and manufacturing processes, we welcome the submission of original research articles and reviews. Potential research areas include, but are not limited to:

  • Novel age-appropriate dosage forms, particularly designed for special populations, such as mini-tablets and orally disintegrating dosage forms;
  • Controlled drug delivery systems tailored for site-specific administration within the gastrointestinal tract;
  • Leveraging nanotechnology in the design and manufacturing of oral dosage forms, with a focus on enhancing dissolution profiles;
  • Innovations in the oral delivery of therapeutic proteins and peptides, including via buccal and sublingual routes;
  • Advancements in oral vaccine delivery with the aim of expanding global healthcare accessibility;
  • Research focused on taste-masking strategies for the oral delivery of bitter pharmaceuticals;
  • Specialized packaging solutions for unique oral dosage forms;
  • Implementation of Quality by Design methodologies for the design of oral dosage forms;
  • Progress in the design and manufacturing of oral delivery systems for veterinary medicines;
  • Advanced manufacturing technologies for oral drug administration.

This Special Issue offers an exceptional platform for researchers, scientists, and practitioners to share their findings and enrich our collective understanding of oral dosage form design. We eagerly anticipate your valuable contributions and active participation.

Dr. Atheer Awad
Dr. Hend Abdelhakim
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

  • controlled release
  • nanotechnology
  • peptide and protein
  • buccal
  • age-appropriate
  • taste
  • packaging
  • mini-tablets
  • quality by design
  • veterinary medicine

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Published Papers (5 papers)

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Research

15 pages, 2853 KiB  
Article
The Formulation and Evaluation of Customized Prednisolone Gel Tablets Prepared by an Automated Extrusion-Based Material Deposition Method
by Marina Tihhonova, Andres Meos, Sari Airaksinen, Jaan Aruväli, Niklas Sandler Topelius, Jyrki Heinämäki and Urve Paaver
Pharmaceutics 2024, 16(12), 1532; https://doi.org/10.3390/pharmaceutics16121532 - 29 Nov 2024
Viewed by 1220
Abstract
Background/Objectives: An automated extrusion-based material deposition is a contemporary and rapid method for pharmaceutical dose-dispensing and preparing (printing) individualized solid dosage forms. The aim of this study was to investigate and gain knowledge of the feasibility of automated extrusion-based material deposition technology [...] Read more.
Background/Objectives: An automated extrusion-based material deposition is a contemporary and rapid method for pharmaceutical dose-dispensing and preparing (printing) individualized solid dosage forms. The aim of this study was to investigate and gain knowledge of the feasibility of automated extrusion-based material deposition technology in preparing customized prednisolone (PRD)-loaded gel tablets for veterinary applications (primarily for dogs and cats). Methods: The PRD loads of the extrusion-based deposited gel tablets were 0.5% and 1.0%, and the target weights of tablets were 0.250 g, 0.500 g, and 1.000 g. The effects of the material deposition processes on the physical solid state, in vitro dissolution, and the physicochemical stability of PRD gel tablets were investigated. Results: The small-sized gel tablets presented a uniform round shape with an exceptionally smooth outer surface texture. The actual average weight of the tablets (n = 10) was very close to the target weight, showing the precision of the process. We found that PRD was in a pseudopolymorphic sesquihydrate form (instead of an initial PRD crystalline form II) in the gel tablets. In all the immediate-release gel tablets studied, more than 70% of the drug load was released within 30 min. The soft texture and dimensions of gel tablets affected the dissolution behaviour in vitro, suggesting the need for further development and standardization of a dissolution test method for such gel tablets. A short-term storage stability study revealed that the content of PRD did not decrease within 3 months. Conclusions: Automated extrusion-based material deposition is a feasible method for the rapid preparation of gel tablets intended for veterinary applications. In addition, the present technology and gel tablets could be used in pediatric and personalized medicine where precise dosing is crucial. Full article
(This article belongs to the Special Issue Dosage Form Design for Oral Administration)
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22 pages, 11648 KiB  
Article
Electrospraying as a Means of Loading Itraconazole into Mesoporous Silica for Enhanced Dissolution
by Charitini Volitaki, Andrew Lewis, Duncan Q. M. Craig and Asma Buanz
Pharmaceutics 2024, 16(8), 1102; https://doi.org/10.3390/pharmaceutics16081102 - 22 Aug 2024
Viewed by 1022
Abstract
Mesoporous silica particles (MSPs) have been investigated as potential carriers to increase the apparent solubility and dissolution rate of poorly water-soluble drugs by physically stabilising the amorphous nature of the loaded drug. In preparing such systems, it is recognized that the loading method [...] Read more.
Mesoporous silica particles (MSPs) have been investigated as potential carriers to increase the apparent solubility and dissolution rate of poorly water-soluble drugs by physically stabilising the amorphous nature of the loaded drug. In preparing such systems, it is recognized that the loading method has a critical impact on the physical state and performance of the drug. To date, there has been very limited investigation into the use of electrospraying for loading drugs into mesoporous silica. In this study, we further explore the use of this approach, in particular as a means of producing amorphous and high drug-loaded MSPs; the study includes an investigation of the effect of drug loading and MSP concentration on the formulation performance and process. A comparison with rotary evaporation, a more widely utilised loading technique, was conducted to assess the relative effectiveness of electrospraying. The physical state of the drug in the formulations was assessed using powder X-ray diffraction (PXRD) and differential scanning calorimetry (DSC). The drug release profiles were determined by a comparative in vitro drug release test. Electrospraying successfully produced formulations containing amorphous drug even at a high drug loading. In contrast, while itraconazole was present in amorphous form at the lower drug-loaded formulations produced by rotary evaporation, the drug was in the crystalline state at the higher loadings. The percentage of drug released was enhanced up to ten times compared to that of pure itraconazole for all the formulations apart from the highest loaded (crystalline) formulation prepared by rotary evaporation. Supersaturation for at least six hours was maintained by the formulations loaded with up to 30 mg/mL itraconazole produced by electrospraying. Overall, the results of this study demonstrate that electrospraying is capable of producing amorphous drug-loaded MSPs at high loadings, with associated favourable release characteristics. A comparison with the standard rotary evaporation approach indicates that electrospraying may be more effective for the production of higher loadings of amorphous material. Full article
(This article belongs to the Special Issue Dosage Form Design for Oral Administration)
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13 pages, 2800 KiB  
Article
Enhanced Oral Efficacy of Semaglutide via an Ionic Nanocomplex with Organometallic Phyllosilicate in Type 2 Diabetic Rats
by Gyu Lin Kim, Jae Geun Song and Hyo-Kyung Han
Pharmaceutics 2024, 16(7), 886; https://doi.org/10.3390/pharmaceutics16070886 - 30 Jun 2024
Cited by 3 | Viewed by 3748
Abstract
This study aimed to develop an effective oral formulation of semaglutide, a glucagon-like peptide-1 receptor agonist, using an organometallic phyllosilicate-based colonic delivery system. The core nanocomplex (AMP-Sema) of 3-aminopropyl-functionalized magnesium phyllosilicate (AMP) and semaglutide was prepared via electrostatic interactions. Subsequently, AMP-Sema was coated [...] Read more.
This study aimed to develop an effective oral formulation of semaglutide, a glucagon-like peptide-1 receptor agonist, using an organometallic phyllosilicate-based colonic delivery system. The core nanocomplex (AMP-Sema) of 3-aminopropyl-functionalized magnesium phyllosilicate (AMP) and semaglutide was prepared via electrostatic interactions. Subsequently, AMP-Sema was coated with a polymer showing pH-dependent solubility (Eudragit® S100) for preferential colonic delivery. The surface-coated nanoparticles (EAMP-Sema) showed a narrow size distribution, and the encapsulated semaglutide maintained its conformational stability. The pH-dependent drug release property of EAMP-Sema yielded around 20% and 62% drug release at pH 1.2 and 7.4, respectively. The nanoparticles exhibited significantly decreased size and surface charge at pH 7.4, which indicated the pH-dependent dissolution of the coating layer. Furthermore, EAMP-Sema effectively improved the membrane permeability and metabolic stability of semaglutide in the gastrointestinal tract. It protected the encapsulated drugs from proteolysis in simulated intestinal fluids and increased drug transport by 2.5-fold in Caco-2 cells. Consequently, orally administered EAMP-Sema (equivalent to 8 mg/kg of semaglutide) showed significant therapeutic benefits, yielding effective glycemic control and weight loss in high-fat diet/streptozotocin (40 mg/kg)-induced type 2 diabetic rats. These results demonstrate that EAMP-Sema could improve the efficacy of orally administered semaglutide by enhancing the GI stability and cellular uptake of protein drugs. Full article
(This article belongs to the Special Issue Dosage Form Design for Oral Administration)
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21 pages, 7797 KiB  
Article
Simultaneous Delivery of Curcumin and Resveratrol via In Situ Gelling, Raft-Forming, Gastroretentive Formulations
by Worrawee Siripruekpong, Rachanida Praparatana, Ousanee Issarachot and Ruedeekorn Wiwattanapatapee
Pharmaceutics 2024, 16(5), 641; https://doi.org/10.3390/pharmaceutics16050641 - 10 May 2024
Cited by 5 | Viewed by 2107
Abstract
Curcumin and resveratrol are polyphenolic compounds that have been shown to exhibit synergistic therapeutic properties including anti-inflammatory, anticancer, and antiulcer activities, which may be exploited for the treatment of gastric diseases. However, both compounds have poor aqueous solubility and rapid metabolism, resulting in [...] Read more.
Curcumin and resveratrol are polyphenolic compounds that have been shown to exhibit synergistic therapeutic properties including anti-inflammatory, anticancer, and antiulcer activities, which may be exploited for the treatment of gastric diseases. However, both compounds have poor aqueous solubility and rapid metabolism, resulting in a low oral bioavailability. In situ gelling, liquid formulations were developed to produce a gastroretentive, raft-forming delivery vehicle to improve bioavailability. Solid dispersions containing a mixture of curcumin and resveratrol with Eudragit® EPO (Cur/Res-SD) were first prepared using solvent evaporation, to improve the solubility and dissolution of the compounds. Solid dispersions of a weight ratio of 1:10 curcumin/resveratrol to Eudragit® EPO were subsequently incorporated into in situ gelling, liquid formulations based on the gelling polymers, sodium alginate (low viscosity and medium viscosity), pectin, and gellan gum, respectively. Calcium carbonate and sodium bicarbonate were included to produce carbon dioxide bubbles in the gel matrix, on exposure to gastric fluid, and to achieve flotation. Moreover, the calcium ions acted as a crosslinking agent for the hydrogels. Optimized formulations floated rapidly (<60 s) in simulated gastric fluid (pH = 1.2) and remained buoyant, resulting in the gradual release of more than 80% of the curcumin and resveratrol content within 8 h. The optimized formulation based on medium-viscosity sodium alginate exhibited enhanced cytotoxic activity toward human gastric adenocarcinoma cell lines (AGS), compared with unformulated curcumin and resveratrol compounds, and increased anti-inflammatory activity against RAW 264.7 macrophage cells compared with the NSAID, indomethacin. These findings demonstrate that in situ gelling, liquid formulations, loaded with a combination of curcumin and resveratrol in the form of solid dispersions, show potential as gastroretentive delivery systems for local and systemic effects. Full article
(This article belongs to the Special Issue Dosage Form Design for Oral Administration)
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17 pages, 13528 KiB  
Article
Taste-Masked Pellets of Warfarin Sodium: Formulation towards the Dose Personalisation
by Lakija Kovalenko, Kirils Kukuls, Marta Berga and Valentyn Mohylyuk
Pharmaceutics 2024, 16(5), 586; https://doi.org/10.3390/pharmaceutics16050586 - 26 Apr 2024
Viewed by 2188
Abstract
The bitter drug, warfarin, has a narrow therapeutic index (NTI) and is used in paediatrics and geriatrics. The aim of this feasibility study was to formulate the taste-masked warfarin-containing pellets to be applicable for dose personalisation and to improve patient compliance, as well [...] Read more.
The bitter drug, warfarin, has a narrow therapeutic index (NTI) and is used in paediatrics and geriatrics. The aim of this feasibility study was to formulate the taste-masked warfarin-containing pellets to be applicable for dose personalisation and to improve patient compliance, as well as to investigate the effect of the core type (PharSQ® Spheres M, CELPHERE™ CP-507, and NaCl) on the warfarin release from the Kollicoat® Smartseal taste-masking-coated pellets. The cores were successfully drug-loaded and coated in a fluid-bed coater with a Wurster insert. An increase in particle size and particle size distribution was observed by optical microscopy. In saliva-simulated pH, at the Kollicoat® Smartseal level of 2 mg/cm2, none of the pellets demonstrated drug release, confirming their efficient taste-masking. However, in a stomach-simulated pH, a faster drug release was observed from PharSQ® Spheres M- and CELPHERE™ CP-507-coated pellets in comparison with NaCl cores. Additional experiments allowed us to explain the slower drug release from NaCl-containing pellets because of the salting-out effect. Despite the successful taste masking, the drug release from pellets was relatively slow (not more than 91% per 60 min), allowing for further formulation improvements. Full article
(This article belongs to the Special Issue Dosage Form Design for Oral Administration)
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