Recent Advances in Pharmaceutical Dosage Forms

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

Deadline for manuscript submissions: closed (20 July 2024) | Viewed by 9140

Special Issue Editors


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Guest Editor
Pharmaceutics and Food Technology, School of Pharmacy, Complutense University of Madrid, Madrid, Spain
Interests: conventional pharmaceutical dosage forms (tablets, capsules, semisolid and liquid formulations); new controlled release systems (pellets, nanoparticles, microcapsules, microspheres and liposomes) including production and quality control
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Special Issue Information

Dear Colleagues,

Active pharmaceutical ingredients have to be formulated in the most suitable dosage form according to the administration route. Suitable drug delivery is obtained through careful excipient selection and fabrication. Current advances in the development of novel drug dosage forms focus on the use of new excipients, innovative technologies, and better knowledge and control of pharmaceutical manufacturing processes. This Special Issue deals with the following items related to pharmaceutical dosage forms:

  • Dosage form optimization design based on DOE and multivariable analysis.
  • Use and application of novel excipients.
  • Innovation in drug formulation and characterization techniques.
  • Improvements in process quality control.
  • Continuous manufacturing.
  • Process analytical technology applied to drug manufacturing.
  • 2D and 3D printing technologies.

Prof. Dr. Juan José Torrado Durán
Dr. Dolores R. Serrano
Guest Editors

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Keywords

  • excipient
  • formulation
  • drug
  • quality
  • design
  • dosage form
  • drug delivery
  • 3D printing

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Published Papers (4 papers)

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Research

18 pages, 3175 KiB  
Article
Application of a Novel Dissolution Medium with Lipids for In Vitro Simulation of the Postprandial Gastric Content
by Tjaša Felicijan, Iva Rakoše, Manca Prislan, Igor Locatelli, Marija Bogataj and Jurij Trontelj
Pharmaceutics 2024, 16(8), 1040; https://doi.org/10.3390/pharmaceutics16081040 - 3 Aug 2024
Viewed by 1449
Abstract
Food can change various physiological parameters along the gastrointestinal tract, potentially impacting postprandial drug absorption. It is thus important to consider different in vivo conditions during in vitro studies. Therefore, a novel dissolution medium simulating variable postprandial pH values and lipid concentrations was [...] Read more.
Food can change various physiological parameters along the gastrointestinal tract, potentially impacting postprandial drug absorption. It is thus important to consider different in vivo conditions during in vitro studies. Therefore, a novel dissolution medium simulating variable postprandial pH values and lipid concentrations was developed and used in this study. Additionally, by establishing and validating a suitable analytical method, the effects of these parameters on the dissolution of a model drug, cinnarizine, and on its distribution between the lipid and aqueous phases of the medium were studied. Both parameters, pH value and lipid concentration, were shown to influence cinnarizine behavior in the in vitro dissolution studies. The amount of dissolved drug decreased with increasing pH due to cinnarizine’s decreasing solubility. At pH values 5 and 7, the higher concentration of lipids in the medium increased drug dissolution, and most of the dissolved drug was distributed in the lipid phase. In all media with a lower pH of 3, dissolution was fast and complete, with a significant amount of drug distributed in the lipid phase. These results are in accordance with the in vivo observed positive food effect on cinnarizine bioavailability described in the literature. The developed medium, with its ability to easily adjust the pH level and lipid concentration, thus offers a promising tool for assessing the effect of co-ingested food on the dissolution kinetics of poorly soluble drugs. Full article
(This article belongs to the Special Issue Recent Advances in Pharmaceutical Dosage Forms)
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12 pages, 2653 KiB  
Article
Influence of Light Irradiation on the Degradation of Dezocine in Injections
by Li Zhu, Xu Teng, Yu Duan, Xia Zhang, Jingxin Xie, Mingzhe Xu and Lihui Yin
Pharmaceutics 2024, 16(7), 858; https://doi.org/10.3390/pharmaceutics16070858 - 25 Jun 2024
Viewed by 1283
Abstract
Dezocine, which is well-known as an analgesic, had about 45% share of the Chinese opioid analgesic market. Since drug products containing impurities could bring serious health consequences, it was important to control the generation of impurities and degradation products in the dezocine product. [...] Read more.
Dezocine, which is well-known as an analgesic, had about 45% share of the Chinese opioid analgesic market. Since drug products containing impurities could bring serious health consequences, it was important to control the generation of impurities and degradation products in the dezocine product. In this study, two kinds of photodegradation products (i.e., degradation product 1 and degradation product 2) in the dezocine injection were isolated using high-performance liquid chromatography. The possible structures of the photodegradation products were identified using both high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy. In addition, the possible generation mechanism showed that degradation product 1 was the oxidation product of dezocine, and degradation product 2 was the coupled dimer of dezocine. Finally, we found that the degradation rate of dezocine increased with the increase in light intensity. Moreover, the degradation of dezocine easily occurred under ultraviolet light in comparison with visible light. A deeper insight into the generation of the photodegradation products in the dezocine injection would directly contribute to the safety of drug therapy based on the dezocine injection by minimizing the degradant/impurity-related adverse effects of drug preparations. Full article
(This article belongs to the Special Issue Recent Advances in Pharmaceutical Dosage Forms)
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25 pages, 7465 KiB  
Article
Design and Characterization of Ocular Inserts Loaded with Dexamethasone for the Treatment of Inflammatory Ophthalmic Disease
by Omar Rodrigo Guadarrama-Escobar, Cassandra Araceli Valdés-Alvarez, Karla Stella Constantino-Gonzalez, Pablo Serrano-Castañeda, Ma. Concepción Peña-Juárez, Miriam Isabel Morales-Florido, Mariana Salgado-Machuca, Betsabe Rodríguez-Pérez, Isabel Marlen Rodriguez-Cruz, Dinorah Vargas-Estrada, Crisóforo Mercado-Márquez, Alma Vázquez-Durán, Abraham Méndez-Albores, Ericka Anguíano-Almazán and José Juan Escobar-Chavez
Pharmaceutics 2024, 16(2), 294; https://doi.org/10.3390/pharmaceutics16020294 - 19 Feb 2024
Cited by 2 | Viewed by 2639
Abstract
The short precorneal residence time of ophthalmic drops is associated with their low absorption; therefore, the development of ocular inserts capable of prolonging and controlling the ophthalmic release of drugs is an interesting option in the design and development of these drugs. A [...] Read more.
The short precorneal residence time of ophthalmic drops is associated with their low absorption; therefore, the development of ocular inserts capable of prolonging and controlling the ophthalmic release of drugs is an interesting option in the design and development of these drugs. A surface response design was developed, specifically the Central Composite Design (CCD), to produce ophthalmic films loaded with Dexamethasone (DEX) by the solvent evaporation method having experimental levels of different concentrations of previously selected polymers (PVP K-30 and Eudragit RS100.). Once optimization of the formulation was obtained, the in vivo test was continued. The optimal formulation obtained a thickness of 0.265 ± 0.095 mm, pH of 7.11 ± 0.04, tensile strength of 15.50 ± 3.94 gF, humidity (%) of 22.54 ± 1.7, mucoadhesion strength of 16.89 ± 3.46 gF, chemical content (%) of 98.19 ± 1.124, release of (%) 13,510.71, and swelling of 0.0403 ± 0.023 g; furthermore, in the in vivo testing the number and residence time of PMN cells were lower compared to the Ophthalmic Drops. The present study confirms the potential use of polymeric systems using PVPK30 and ERS100 as a new strategy of controlled release of ophthalmic drugs by controlling and prolonging the release of DEX at the affected site by decreasing the systemic effects of the drug. Full article
(This article belongs to the Special Issue Recent Advances in Pharmaceutical Dosage Forms)
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17 pages, 12694 KiB  
Article
Co-Delivery of a High Dose of Amphotericin B and Itraconazole by Means of a Dry Powder Inhaler Formulation for the Treatment of Severe Fungal Pulmonary Infections
by Salomé S. Celi, Raquel Fernández-García, Andreina I. Afonso-Urich, M. Paloma Ballesteros, Anne Marie Healy and Dolores R. Serrano
Pharmaceutics 2023, 15(11), 2601; https://doi.org/10.3390/pharmaceutics15112601 - 8 Nov 2023
Cited by 6 | Viewed by 1859
Abstract
Over the past few decades, there has been a considerable rise in the incidence and prevalence of pulmonary fungal infections, creating a global health problem due to a lack of antifungal therapies specifically designed for pulmonary administration. Amphotericin B (AmB) and itraconazole (ITR) [...] Read more.
Over the past few decades, there has been a considerable rise in the incidence and prevalence of pulmonary fungal infections, creating a global health problem due to a lack of antifungal therapies specifically designed for pulmonary administration. Amphotericin B (AmB) and itraconazole (ITR) are two antifungal drugs with different mechanisms of action that have been widely employed in antimycotic therapy. In this work, microparticles containing a high dose of AmB and ITR (20, 30, and 40% total antifungal drug loading) were engineered for use in dry powder inhalers (DPIs) with an aim to improve the pharmacological effect, thereby enhancing the existing off-label choices for pulmonary administration. A Design of Experiment (DoE) approach was employed to prepare DPI formulations consisting of AmB-ITR encapsulated within γ-cyclodextrin (γ-CD) alongside functional excipients, such as mannitol and leucine. In vitro deposition indicated a favourable lung deposition pattern characterised by an upper ITR distribution (mass median aerodynamic diameter (MMAD) ~ 6 µm) along with a lower AmB deposition (MMAD ~ 3 µm). This offers significant advantages for treating fungal infections, not only in the lung parenchyma but also in the upper respiratory tract, considering that Aspergillus spp. can cause upper and lower airway disorders. The in vitro deposition profile of ITR and larger MMAD was related to the higher unencapsulated crystalline fraction of the drug, which may be altered using a higher concentration of γ-CD. Full article
(This article belongs to the Special Issue Recent Advances in Pharmaceutical Dosage Forms)
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