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Pharmaceutics
Special Issues
Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications
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Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications

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

Deadline for manuscript submissions: 31 August 2025 | Viewed by 3397

Special Issue Editor

Dr. Emma Adriana Ozon

E-Mail Website
Guest Editor
Department of Pharmaceutical Technology and Biopharmacy, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, 020956 Bucharest, Romania
Interests: pharmaceutical technology; cyclodextrin inclusion complexes; drug delivery systems; biopharmaceuticals; pharmaceutical processes; drug release profiles; drug design; development, optimization and manufacturing of pharmaceutical products; pre- and post-compression parameters for solid dosage forms; preformulation studies on pharmaceuticals; physico-chemical characterization of materials; quality of pharmaceutical forms
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues, 

It is our great pleasure to invite you to submit a manuscript to this Special Issue of Pharmaceutics entitled Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications.

This special issue is focused on an in-depth exploration of advancement in solid dosage forms, such as tablets, powders, solid dispersion, cocrystals, and capsules. This issue explores the newest research and developments in manufacturing techniques, design principles, and characterization methods. The practical insights on formulation design, process optimization, quality control, and stability testing are also explored, focusing on bioavailability and manufacturing efficiency. The issue also highlights the newest developing technologies, such as 3D printing. Additionally, the special issue covers the biomedical applications of solid dosage forms, highlighting their role in treating diseases, enhancing therapeutic efficacy, and reducing side effects. Providing state-of-the-art developments in the field and biomedical applications, this special issue will help researchers and industry professionals who work on the development of new solid dosage formulations and improve the quality of pharmaceutical products.

Theoretical and experimental contributions in the form of full-length research articles review manuscripts, and short communications are welcome.

We welcome and look forward to your submissions.

Prof. Dr. Emma Adriana Ozon
Guest Editor

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

  • pharmaceutical solid dosage forms
  • pharmaceutical manufacturing
  • hot-melt extrusion
  • formulation development
  • 3D printing
  • film coating
  • biomaterials
  • polymers
  • drug delivery systems

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Published Papers (5 papers)

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Research

17 pages, 2898 KiB  
Article
Selective Laser Sintering of Atomoxetine Tablets: An Innovative Approach for Small-Scale, Personalized Production
by Gordana Stanojević, Ivana Adamov, Snežana Mugoša, Veselinka Vukićević and Svetlana Ibrić
Pharmaceutics 2025, 17(6), 794; https://doi.org/10.3390/pharmaceutics17060794 - 18 Jun 2025
Viewed by 494
Abstract
Background/Objectives: The growing interest in personalized medicine has accelerated the exploration of three-dimensional (3D) printing technologies in pharmaceutical applications. This study investigates the potential of selective laser sintering (SLS) as a flexible, small-scale manufacturing method for atomoxetine tablets tailored for individualized therapy, comparing [...] Read more.
Background/Objectives: The growing interest in personalized medicine has accelerated the exploration of three-dimensional (3D) printing technologies in pharmaceutical applications. This study investigates the potential of selective laser sintering (SLS) as a flexible, small-scale manufacturing method for atomoxetine tablets tailored for individualized therapy, comparing it with conventional direct compression. Methods: Atomoxetine tablets were produced using SLS 3D printing with varying laser scanning speeds and compared to tablets made via a compaction simulator. Formulations were based on hydroxypropyl methylcellulose (HPMC) as the primary matrix former. The physical properties, drug content, disintegration time, and dissolution profiles were evaluated. The structural and chemical integrity were assessed using SEM, FTIR, DSC, and XRPD. Results: The SLS tablets exhibited comparable mechanical properties and drug content to those made by compaction. Lower laser speeds produced harder tablets with slower disintegration, while higher speeds yielded more porous tablets with ultra-rapid drug release (>85% in 15 min). All tablets met the European Pharmacopoeia dissolution criteria. No significant drug–excipient interactions or changes in crystallinity were detected. Conclusions: SLS printing is a viable alternative to traditional tablet manufacturing, offering control over drug release profiles through parameter adjustment. The technique supports the development of high-quality, patient-specific dosage forms and shows promise for broader implementation in personalized pharmaceutical therapy. Full article
(This article belongs to the Special Issue Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications)
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14 pages, 1586 KiB  
Article
Stability-Guided Formulation of a Light-Sensitive D-LSD Capsule for Clinical Investigation
by Bernard Do, Luc Mallet, Maxime Annereau, Danielle Libong, Audrey Solgadi, Florence Vorspan, Muriel Paul and Philippe-Henri Secretan
Pharmaceutics 2025, 17(6), 767; https://doi.org/10.3390/pharmaceutics17060767 - 11 Jun 2025
Viewed by 573
Abstract
Background/Objectives: D-lysergic acid diethylamide (D-LSD) is under investigation as a potential therapeutic strategy for alcohol use disorder (AUD). However, the extreme light sensitivity of D-LSD presents a significant challenge in developing suitable pharmaceutical forms, particularly for clinical trial settings. This study proposes a [...] Read more.
Background/Objectives: D-lysergic acid diethylamide (D-LSD) is under investigation as a potential therapeutic strategy for alcohol use disorder (AUD). However, the extreme light sensitivity of D-LSD presents a significant challenge in developing suitable pharmaceutical forms, particularly for clinical trial settings. This study proposes a liquid-filled capsule formulation designed to provide accurate dosing while protecting D-LSD from photodegradation. Methods: To support formulation development and ensure its suitability as an investigational medicinal product, a multi-tiered analytical strategy was employed. This included liquid chromatography coupled with ion mobility spectrometry and mass spectrometry (LC-IM-MS), along with quantum chemical calculations (density functional theory (DFT) and time dependent-DFT (TD-DFT)), to ensure robust and orthogonal structural characterization of degradation products. Results: Photostress studies demonstrated that while D-LSD in solution rapidly degrades into photoisomers and photooxidative byproducts, the capsule formulation markedly mitigates these transformations under ICH-compliant conditions. Conclusions: These findings highlight the essential role of orthogonal stability profiling in guiding formulation development and demonstrate that this approach may offer a viable, photostable platform for future clinical investigation of D-LSD in the treatment of AUD. Full article
(This article belongs to the Special Issue Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications)
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19 pages, 2738 KiB  
Article
Formulation and Bioequivalence Evaluation of a Miniaturized Fexofenadine Hydrochloride Tablet
by Woo-Yul Song, Chang-Soo Han, Won-Sang Yu, Jae-Won Jang, Gyoung-Won Kim, Yoo-Shin Jeon, Young-Jin Kim, So-Jeong Jeong, Ji-Hyun Kang, Dong-Wook Kim, Yun-Sang Park and Chun-Woong Park
Pharmaceutics 2025, 17(6), 756; https://doi.org/10.3390/pharmaceutics17060756 - 8 Jun 2025
Viewed by 697
Abstract
Background: Fexofenadine hydrochloride (FEX) is widely used to treat allergic rhinitis. However, poor solubility, high cohesiveness, and risk of polymorphic transformation present significant formulation challenges. Conventional FEX tablet formulations are large and may pose swallowing difficulties for patients with dysphagia. Therefore, a miniaturized [...] Read more.
Background: Fexofenadine hydrochloride (FEX) is widely used to treat allergic rhinitis. However, poor solubility, high cohesiveness, and risk of polymorphic transformation present significant formulation challenges. Conventional FEX tablet formulations are large and may pose swallowing difficulties for patients with dysphagia. Therefore, a miniaturized FEX tablet that maintained bioequivalence with the marketed product was developed. Methods: An organic solvent-based binder and porous carrier enhanced solubility, flowability, and process efficiency. The formulation was optimized using a design of experiments approach to assess the effects of tablet size and porous carrier incorporation on dissolution and residual solvent content. Scale-up feasibility was evaluated using Froude number-based process optimization, and stability studies were conducted under accelerated conditions (40 °C and 75% relative humidity) to ensure long-term formulation robustness. Results: The miniaturized tablet exhibited dissolution at pH 4.0 and pH 6.8 equivalent to that of the reference product, whereas a faster dissolution rate was observed at pH 1.2. No significant changes were observed in the dissolution rate, crystalline structure, or impurity levels over six months. An in vivo bioequivalence study demonstrated that the test formulation met the bioequivalence criteria, with 90% confidence intervals for the area under the curve and the Cmax falling within the regulatory acceptance range. Conclusions: A miniaturized and commercially viable fexofenadine hydrochloride tablet was developed (44% weight reduction and 50% volume reduction compared to the marketed product). The organic solvent-based binder and porous carrier system improved manufacturing efficiency, stability, and solubility, thereby ensuring compliance with regulatory standards. These findings provide valuable insights into size reduction, solubility enhancement, and large-scale production strategies for the development of future pharmaceutical formulations. Full article
(This article belongs to the Special Issue Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications)
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19 pages, 1541 KiB  
Article
Advanced QbD-Based Process Optimization of Clopidogrel Tablets with Insights into Industrial Manufacturing Design
by Young Woo Bak, Mi Ran Woo, Hyuk Jun Cho, Taek Kwan Kwon, Ho Teak Im, Jung Hyun Cho and Han-Gon Choi
Pharmaceutics 2025, 17(5), 659; https://doi.org/10.3390/pharmaceutics17050659 - 17 May 2025
Viewed by 557
Abstract
Background/Objectives: Traditional Quality by Testing (QbT) strategies rely heavily on end-product testing and offer limited insight into how critical process parameters (CPPs) influence product quality. This increases the risk of variability and inconsistent outcomes. To overcome these limitations, this study aimed to [...] Read more.
Background/Objectives: Traditional Quality by Testing (QbT) strategies rely heavily on end-product testing and offer limited insight into how critical process parameters (CPPs) influence product quality. This increases the risk of variability and inconsistent outcomes. To overcome these limitations, this study aimed to implement a Quality by Design (QbD) approach to optimize the manufacturing process of clopidogrel tablets. Methods: A science- and risk-based QbD framework was applied to identify and prioritize key CPPs, intermediate critical quality attributes (iCQAs), and final product CQAs across key unit operations—pre-blending, dry granulation, post-blending, lubrication, and compression. Risk assessment tools and statistical design of experiments (DoE) were used to define proven acceptable ranges (PARs). Results: The study revealed strong correlations between CPPs and CQAs, allowing the definition of PARs and development of a robust control strategy. This led to improved manufacturing consistency, reduced variability, and enhanced process understanding. Conclusions: The QbD approach minimized reliance on end-product testing while ensuring high-quality outcomes. This study offers a novel QbD implementation tailored to the manufacturing challenges of clopidogrel tablets, providing a validated approach that integrates dry granulation CPPs with process-specific CQAs. These results demonstrate the value of QbD in achieving robust pharmaceutical manufacturing and meeting regulatory expectations. Full article
(This article belongs to the Special Issue Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications)
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22 pages, 1786 KiB  
Article
Preformulation Study of Carbamazepine Orally Disintegrating Tablets for Pediatric Patients Using Direct Compression and the SeDeM Diagram Tool: A Quality by Design Approach
by Ricard Canadell-Heredia, Khadija Rouaz-El-Hajoui, Natalia Franco-Piedrahita, Pilar Pérez-Lozano, Marc Suñé-Pou, Josep María Suñé-Negre and Encarna García-Montoya
Pharmaceutics 2025, 17(5), 624; https://doi.org/10.3390/pharmaceutics17050624 - 8 May 2025
Viewed by 630
Abstract
Background/Objectives: Carbamazepine is widely used as a first-line treatment for pediatric patients with benign epilepsy. However, most commercial formulations have doses of 100 mg or higher, limiting their suitability for pediatric use. The aim of this study was to develop mini orally disintegrating [...] Read more.
Background/Objectives: Carbamazepine is widely used as a first-line treatment for pediatric patients with benign epilepsy. However, most commercial formulations have doses of 100 mg or higher, limiting their suitability for pediatric use. The aim of this study was to develop mini orally disintegrating tablets (ODTs) containing 50 mg of carbamazepine, utilizing direct compression technology, specifically tailored to meet the unique needs of pediatric patients. Methods: The development was carried out following a Quality by Design (QbD) approach, beginning with preformulation studies using the SeDeM expert system. Various co-processed excipients (PROSOLV® ODT and PARTECK® ODT) and non-co-processed excipients (L-HPC LH11 and L-HPC NBD-022) were evaluated. Additionally, modifications to the radius parameter of the SeDeM expert system were investigated to improve formulation design. Results: Optimized Formulations 13 and 14 achieved disintegration times below 1 min, hardness values between 25 and 60 N, and friability under 1%, fulfilling the predefined Critical Quality Attributes (CQAs). Tablets were successfully produced with a diameter of 5 mm and a weight below 100 mg. Moreover, reducing the SeDeM incidence radius from 5.0 to values between 4.0 and 3.5 proved viable, enabling the inclusion of excipients previously considered unsuitable and broadening formulation options without compromising quality. Conclusions: This study demonstrates the feasibility of producing small, fast-disintegrating, and mechanically robust 50 mg carbamazepine ODTs tailored for pediatric patients. It also validates the adjustment of SeDeM parameters as an effective strategy to expand excipient selection and enhance formulation flexibility in pediatric drug development. Full article
(This article belongs to the Special Issue Pharmaceutical Solid Dosage Forms: Manufacturing, Design, Development, and Biomedical Applications)
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