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Pharmaceutics
Special Issues
Site-Specific Drug Delivery: Formulation Strategies and Regulatory Challenges
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Site-Specific Drug Delivery: Formulation Strategies and Regulatory Challenges

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Drug Delivery and Controlled Release".

Deadline for manuscript submissions: closed (31 March 2025) | Viewed by 8510

Special Issue Editors

Prof. Dr. Maria Begoña Delgado-Charro

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Guest Editor
Department of Life Sciences, University of Bath, Claverton Down, Bath BA2 7AY, UK
Interests: topical drug delivery; transdermal drug delivery; nail drug delivery; bioequivalence; regulatory science; onychomychosis
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Leila Bastos Leal

E-Mail Website
Guest Editor
Departamento de Ciências Farmacêuticas, Núcleo de Desenvolvimento Farmacêutico e Cosmético (NUDFAC), Universidade Federal de Pernambuco (UFPE), Recife 50740-521, PE, Brazil
Interests: bioequivalence; vasoconstrictor assay; topical drug delivery; new approach methodologies; pesticide exposition; regulatory science

Special Issue Information

Dear Colleagues,

Site-specific, local drug delivery is valuable as drug exposure is optimized at the target site and minimized systemically, reducing risks for systemic drug interactions and side effects. Depending on the specific site targeted, parenteral, topical, oral, and mucosal drug delivery systems can be used, so a broad range of technologies, dosage forms, excipients, and drug development strategies are employed. Despite recent advances, methods to measure, simulate, and predict local bioavailability and bioequivalence and approaches to establish effective in vitro–in vivo correlations are less developed than for systemic drug delivery methods. In addition, regulatory guidelines regarding the development of these systems and their characterization, including quality tests and new approaches and methodologies, are not as comprehensive as drug developers might wish. This Special Issue aims to support the development of site-specific drug delivery systems by bringing together the latest innovations in the field and providing comprehensive and critical state-of-the-art reviews.

Prof. Dr. Maria Begoña Delgado-Charro
Prof. Dr. Leila Bastos Leal
Guest Editors

Manuscript Submission Information

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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

  • site-specific drug delivery
  • targeted drug delivery
  • topical drug delivery
  • mucosal drug delivery
  • parenteral drug delivery
  • ocular drug delivery
  • nail drug delivery
  • new methodologies

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Published Papers (3 papers)

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Research

10 pages, 2173 KiB  
Article
Evaluation of Dutasteride-Loaded Liposomes and Transfersomes for Follicular-Targeting for Androgenic Alopecia Topical Treatment
by Jayanaraian F. M. Andrade, Breno N. Matos, Rafael V. Rocho, Geisa N. Barbalho, Marcilio Cunha-Filho, Guilherme M. Gelfuso and Taís Gratieri
Pharmaceutics 2024, 16(12), 1524; https://doi.org/10.3390/pharmaceutics16121524 - 27 Nov 2024
Viewed by 2181
Abstract
Background/Objectives: Although androgenic alopecia is the most prevalent among non-cicatricial alopecia, it still lacks an effective and safe treatment. Dutasteride (DUT) shows promising results in hair regrowth; however, oral DUT intake causes serious sexual adverse events. Hence, we produced liposomes with different bilayer [...] Read more.
Background/Objectives: Although androgenic alopecia is the most prevalent among non-cicatricial alopecia, it still lacks an effective and safe treatment. Dutasteride (DUT) shows promising results in hair regrowth; however, oral DUT intake causes serious sexual adverse events. Hence, we produced liposomes with different bilayer structures and evaluated the capability of such systems in increasing DUT accumulation in the hair follicles. Methods: In vitro skin penetration tests were performed with porcine ear skin, and the follicular targeting factor (Tf) was calculated as the ratio between DUT amount in HFs and DUT recovered from the sum of all skin layers. Results: While the stiffer DUT-loaded liposome was not able to target the hair follicles in 12 h (Tf = 0.15), a DUT-loaded liposome with an edge activator in its composition, i.e., transfersomes, promoted better control over DUT release and a higher Tf (0.32) (p < 0.005). Conclusions: Transfersomes present higher affinity with DUT providing a better controlled release; hence, they are a better option for DUT follicle targeting compared to liposomes. Further formulation optimizations are needed aiming to prolong such targeting effect. Full article
(This article belongs to the Special Issue Site-Specific Drug Delivery: Formulation Strategies and Regulatory Challenges)
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19 pages, 4062 KiB  
Article
Molded Round Window Niche Implant as a Dexamethasone Delivery System in a Cochlear Implant-Trauma Animal Model
by Chunjiang Wei, Ziwen Gao, Robert Mau, Thomas Eickner, Gabor Jüttner, Nicklas Fiedler, Hermann Seitz, Thomas Lenarz and Verena Scheper
Pharmaceutics 2024, 16(9), 1236; https://doi.org/10.3390/pharmaceutics16091236 - 23 Sep 2024
Cited by 1 | Viewed by 4164
Abstract
Background: Preserving residual hearing after cochlear implant (CI) surgery remains a crucial challenge. The application of dexamethasone (DEX) has been proven to positively affect residual hearing. To deliver DEX in a localized and controlled way, a round window niche implant (RNI), allowing drug [...] Read more.
Background: Preserving residual hearing after cochlear implant (CI) surgery remains a crucial challenge. The application of dexamethasone (DEX) has been proven to positively affect residual hearing. To deliver DEX in a localized and controlled way, a round window niche implant (RNI), allowing drug diffusion via the round window membrane into the cochlea, may be used. To prove this concept, an RNI for guinea pigs as a CI-trauma model was manufactured by molding and tested for its drug release in vitro and biological effects in vivo. Methods: The RNIs were molded using silicone containing 10% DEX. Release was analyzed over time using high-performance liquid chromatography (HPLC). Fourteen adult guinea pigs were randomly assigned to two groups (CI or CI + RNI group). All animals received a unilateral CI electrode insertion trauma followed by CI insertion. The CI + RNI group was additionally implanted with an RNI containing 10% DEX. Animals were followed up for 4 weeks. Acoustically evoked auditory brainstem response and impedance measurement, micro-computed tomography (µCT) imaging, and histology were performed for evaluation. Results: DEX was released for more than 250 days in vitro, with an initial burst followed by a slower release over time. Comparing the hearing threshold shift (from day 0 to day 28) of the CI and CI + RNI groups, significant differences were observed at 32 and 40 kHz. The impedance shift at basal contacts was lower in the CI + RNI group than in the CI group. Moreover, the fibrosis in the lower basal turn was reduced in the CI + RNI group in contrast to the CI group. Conclusions: The RNI containing 10% DEX has anti-inflammatory potential concerning fibrosis inhibition and has beneficial effects on hearing preservation at high frequencies. Full article
(This article belongs to the Special Issue Site-Specific Drug Delivery: Formulation Strategies and Regulatory Challenges)
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13 pages, 1958 KiB  
Article
Assessing α-Bisabolol as a Transmucosal Permeation Enhancer of Buccal Local Anesthetics
by Renê Oliveira do Couto, Douglas Vieira Thomaz, Maira Perez Ferreira Duarte, Renata Fonseca Vianna Lopez, Vinícius Pedrazzi, Osvaldo de Freitas and Gianluca Martino Tartaglia
Pharmaceutics 2024, 16(9), 1198; https://doi.org/10.3390/pharmaceutics16091198 - 12 Sep 2024
Viewed by 1531
Abstract
Needle-free buccal anesthesia improves dental treatment outcomes for both patients and dentists. In this study, we report on an assessment of the enhancement effects of α-bisabolol on the in vitro transmucosal permeation of prilocaine hydrochloride (PCl) and lidocaine hydrochloride (LCl) from needleless buccal [...] Read more.
Needle-free buccal anesthesia improves dental treatment outcomes for both patients and dentists. In this study, we report on an assessment of the enhancement effects of α-bisabolol on the in vitro transmucosal permeation of prilocaine hydrochloride (PCl) and lidocaine hydrochloride (LCl) from needleless buccal films. We also evaluated the mechanical properties of the film, which consisted of Methocel™ K100 LV as the film-forming polymer (3% m·m−1), PEG 400 as a cosolvent (15% m·m−1 based on drug loading), α-bisabolol (15 and 30% m·m−1 based on drug loading), and the drugs combined at a 1:1 ratio (15 mg·unit−1). The porcine esophageal epithelium was used as a membrane barrier, and artificial saliva was the release medium. After a 1 h experiment at 25 ± 2 °C, α-bisabolol significantly decreased, rather than enhanced, the permeation fluxes (five-fold), permeability coefficients (seven-fold), and retentions (two-fold) of both PCl and LCl through the epithelium, regardless of the concentration. Moreover, the resistance and flexibility of the films markedly decreased compared to those without α-bisabolol. Therefore, under the experimental conditions, using α-bisabolol as a buccal permeation enhancer for the hydrophilic local anesthetics PCl and LCl from buccal films is not feasible. Full article
(This article belongs to the Special Issue Site-Specific Drug Delivery: Formulation Strategies and Regulatory Challenges)
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