Drug Delivery and Penetration through Skin and Its Formulations, 2nd Edition

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

Deadline for manuscript submissions: 20 September 2024 | Viewed by 5765

Special Issue Editors

Laboratory Reig Jofre, Avda. Del Flors s/n, 08970 Sant Joan Despi, Barcelona, Spain
Interests: nanotechnology; topical administration; skin permeation; drug release; colloidal systems; skin delivery; vaginal delivery; oral delivery; ocular delivery; drug delivery
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Special Issue Information

Dear Colleagues,

Drugs exert their effects at the site of action, and depending on the pathology, it might be convenient to reach either different skin layers or a specific one. Formulations have an important role in modulating the diffusion of the drugs through the skin. Thus, it is important to fully characterize these formulations and to study the permeation of the drug through the skin and the drug’s biodistribution within the skin. The distribution of the drug can be associated with its efficacy; thus, these studies are essential for the development and optimization of drug products to improve the therapeutic index.

Authors are invited to contribute to this Special Issue entitled ‘Drug Delivery and Penetration through Skin and Its Formulations (Volume II)’. We encourage you to submit your eminent research as reviews, research papers and communications.

Dr. Mireia Mallandrich
Dr. Francisco Fernandez-Campos
Guest Editors

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Keywords

  • topical drug delivery
  • topical formulations
  • transdermal drug delivery
  • skin penetration
  • cutaneous
  • biodistribution
  • in vitro and ex vivo permeation assays

Published Papers (3 papers)

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Research

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22 pages, 2292 KiB  
Article
Cutaneous Delivery and Biodistribution of Cannabidiol in Human Skin after Topical Application of Colloidal Formulations
by Maria Lapteva, Jonathan Faro Barros and Yogeshvar N. Kalia
Pharmaceutics 2024, 16(2), 202; https://doi.org/10.3390/pharmaceutics16020202 - 30 Jan 2024
Viewed by 823
Abstract
The objective of this study was to investigate the cutaneous delivery of cannabidiol (CBD) from aqueous formulations developed for the targeted local treatment of dermatological conditions. CBD was formulated using a proprietary colloidal drug delivery system (VESIsorb®) into an aqueous colloidal [...] Read more.
The objective of this study was to investigate the cutaneous delivery of cannabidiol (CBD) from aqueous formulations developed for the targeted local treatment of dermatological conditions. CBD was formulated using a proprietary colloidal drug delivery system (VESIsorb®) into an aqueous colloidal solution at 2% (ACS 2%) and two colloidal gels (CG 1% and CG 2%, which contained 1% and 2% CBD, respectively). Two basic formulations containing CBD (5% in propylene glycol (PG 5%) and a 6.6% oil solution (OS 6.6%)) and two marketed CBD products (RP1 and RP2, containing 1% CBD) were used as comparators. Cutaneous delivery and cutaneous biodistribution experiments were performed using human abdominal skin (500–700 µm) under infinite- and finite-dose conditions with 0.5% Tween 80 in the PBS receiver phase. The quantification of CBD in the skin samples was performed using a validated UHPLC-MS/MS method and an internal standard (CBD-d3). The cutaneous deposition of CBD under finite-dose conditions demonstrated the superiority of CG 1%, CG 2%, and ACS 2% over the marketed products; CG 1% had the highest delivery efficiency (5.25%). Cutaneous biodistribution studies showed the superiority of the colloidal systems in delivering CBD to the viable epidermis, and the upper and lower papillary dermis, which are the target sites for the treatment of several dermatological conditions. Full article
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15 pages, 1380 KiB  
Article
In Vitro Approaches to Explore the Anticancer Potential of One Natural Flavanone and Four Derivatives Loaded in Biopolymeric Nanoparticles for Application in Topical Delivery Treatments
by Paola Bustos-Salgado, Berenice Andrade-Carrera, Valeri Domínguez-Villegas, Véronique Noé, Mireia Mallandrich, Helena Colom, Ana Calpena-Campmany and María Luisa Garduño-Ramírez
Pharmaceutics 2023, 15(6), 1632; https://doi.org/10.3390/pharmaceutics15061632 - 31 May 2023
Cited by 2 | Viewed by 1783
Abstract
The increasing number of skin cancer cases worldwide and the adverse side effects of current treatments have led to the search for new anticancer agents. In this present work, the anticancer potential of the natural flavanone 1, extracted from Eysenhardtia platycarpa, and [...] Read more.
The increasing number of skin cancer cases worldwide and the adverse side effects of current treatments have led to the search for new anticancer agents. In this present work, the anticancer potential of the natural flavanone 1, extracted from Eysenhardtia platycarpa, and four flavanone derivatives 1a–d obtained by different reactions from 1 was investigated by an in silico study and through cytotoxicity assays in melanoma (M21), cervical cancer (HeLa) cell lines and in a non-tumor cell line (HEK-293). The free compounds and compounds loaded in biopolymeric nanoparticles (PLGA NPs 1, 1a–d) were assayed. A structure–activity study (SAR) was performed to establish the main physicochemical characteristics that most contribute to cytotoxicity. Finally, ex vivo permeation studies were performed to assess the suitability of the flavanones for topical administration. Results revealed that most of the studied flavanones and their respective PLGA NPs inhibited cell growth depending on the concentration; 1b should be highlighted. The descriptors of the energetic factor were those that played a more important role in cellular activity. PLGA NPs demonstrated their ability to penetrate (Qp of 17.84−118.29 µg) and be retained (Qr of 0.01−1.44 g/gskin/cm2) in the skin and to exert their action for longer. The results of the study suggest that flavanones could offer many opportunities as a future anticancer topical adjuvant treatment. Full article
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Review

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29 pages, 842 KiB  
Review
Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union
by Alfredo García-Arieta, John Gordon, Luther Gwaza, Virginia Merino and Víctor Mangas-Sanjuan
Pharmaceutics 2023, 15(2), 601; https://doi.org/10.3390/pharmaceutics15020601 - 10 Feb 2023
Cited by 2 | Viewed by 2677
Abstract
The development of second-entry topical products is hampered by several factors. The excipient composition should be similar to the reference product because excipients may also contribute to efficacy. Conventional pharmacokinetic bioequivalence studies were not considered acceptable because drug concentrations are measured downstream after [...] Read more.
The development of second-entry topical products is hampered by several factors. The excipient composition should be similar to the reference product because excipients may also contribute to efficacy. Conventional pharmacokinetic bioequivalence studies were not considered acceptable because drug concentrations are measured downstream after the site of action. There was no agreed methodology to characterize the microstructure of semisolids, and waivers of therapeutic equivalence studies with clinical endpoints were not possible. Only the vasoconstrictor assay for corticosteroids was accepted as a surrogate. This paper describes the implementation of the European Union’s stepwise approach for locally acting products to cutaneous products, discusses the equivalence requirements of the EMA Draft Guideline on the Quality and Equivalence of Topical Products, and compares them with the US Food and Drug Administration recommendations. Step 1 includes the possibility of waivers for simple formulations based on in vitro data only (Q1 + Q2 + Q3 + IVRT). Step 2 includes step 1 requirements plus a kinetic study (TS/IVPT/PKBE) to compare the local availability of complex formulations. Step 3 refers to clinical studies with pharmacodynamic/clinical endpoints. As excipients may affect the local tolerability and efficacy of the products, the similarity of excipient composition is required in all steps, except where clinical endpoints are compared. Full article
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