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Polymeric Thin Films as an Emerging Formulation Approach for Biomedical...
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Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmaceutical Technology, Manufacturing and Devices".

Deadline for manuscript submissions: closed (20 April 2021) | Viewed by 17822

Special Issue Editors

Prof. Dr. Alessandra Adrover

E-Mail Website
Guest Editor
Dipartimento di Ingegneria Chimica, Materiali e Ambiente, Sapienza Università di Roma, Rome, Italy
Interests: transport phenomena in porous media; modeling and optimization of biotechnological separation processes; laminar mixing theory; transport phenomena in microfluidic systems; drug release modeling and optimization
Dr. Stefania Petralito

E-Mail Website
Guest Editor
Department of Chemistry and Technology of Drugs, University of Rome Sapienza, Rome, Italy
Interests: on demand (AMF or PEMF and nsPEF as trigger) controlled release from responsive liposomes; hybrid gel-in-liposomes as a new tool for drug delivery; cyclodextrins; controlled release from polymeric materials for pharmaceutical use
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

In recent years, a great amount of focus has been placed upon polymeric thin films as versatile technological tools for pharmaceutical applications ranging from functional coatings to novel drug delivery systems. 

As coating materials, they have been used first as tools to control the release of therapeutic molecules. More recently, the deposition of polymeric thin films on solid surfaces of biomaterials has been proposed as a novel strategy to modulate surface properties in order to influence/control their bio-interaction.

Moreover, polymeric thin films have also been identified as an alternative and convenient dosage form to conventional approaches, because of their ability to safely load drugs and release them in a controlled manner.

Thin films are considered to be convenient as a swallowable, self-administrable, usually fast-dissolving dosage form. Film-form systems can also act as a matrix for the sustained release of drugs. All of these features make thin films a versatile platform for drug delivery via several routes such as oral, buccal, sublingual, ocular, and transdermal.

The design of an efficient thin film, used as a polymer coating or a solid dosage form, requires the investigation of the physical and chemical properties of the film-forming polymers as well as physical, chemical, and pharmacological characteristics of the drug substances to be used. Manufacturing aspects of films and the characterization of critical properties such as film thickness, mechanical characteristics, adhesive strength, drug content uniformity, and permeation rate represent the major research areas in the design of thin films for biomedical and pharmaceutical applications.

This Special Issue aims to provide an overview of the critical factors affecting the formulation or deposition of thin films and the more recent trends in their characterization methods and quality specifications. We invite research scientists from academia and the pharmaceutical industry to submit original research articles or review articles.

Prof. Dr. Alessandra Adrover
Dr. Stefania Petralito
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

  • polymeric thin films
  • coatings
  • fast-dissolving dosage form
  • matrix for sustained release of drug
  • manufacturing aspects

Published Papers (6 papers)

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Research

15 pages, 1076 KiB  
Article
Transdermal Film Loaded with Garlic Oil-Acyclovir Nanoemulsion to Overcome Barriers for Its Use in Alleviating Cold Sore Conditions
by Alshaimaa M. Almehmady and Sarah A. Ali
Pharmaceutics 2021, 13(5), 669; https://doi.org/10.3390/pharmaceutics13050669 - 07 May 2021
Cited by 9 | Viewed by 2461
Abstract
The exponentially mounting cases of herpes simplex virus infection or cold sores have become a serious global concern. Acyclovir (ACV) and garlic oil (GO)-loaded lipid nanocarrier could be a promising therapeutic approach in alleviating cold sores, as well as limiting the biopharmaceutical constraints [...] Read more.
The exponentially mounting cases of herpes simplex virus infection or cold sores have become a serious global concern. Acyclovir (ACV) and garlic oil (GO)-loaded lipid nanocarrier could be a promising therapeutic approach in alleviating cold sores, as well as limiting the biopharmaceutical constraints associated with ACV absorption and therapeutic efficacy. Therefore, the objective of the current research study was to formulate an ACV-GO self-nanoemulsifying drug delivery system (ACV-GO-SNEDDS) as transdermal films. The prepared SNEDDS was optimized using an experimental mixture design. The optimized ACV-GO SNEDDS was loaded in transdermal film and was evaluated for ex vivo skin permeation and in vivo pharmacokinetic prospects. An optimized ACV-GO SNEDDs formulation constituted of 10.4% (w/w) of GO, 64.8% (w/w) of surfactant mixture (Tween 20®-Span 20®); 24.8%(w/w) of co-surfactant (Propylene glycol®), and 200mg of ACV, respectively, were prepared and characterized for particle size (Y). The observed globule size of the optimized ACV-GO SNEDDS is 170 ± 13.45 nm. The results of stability studies indicated that the stability index of optimized ACV-GO-SNEDDS was more than 92 ± 3%. This optimized ACV-GO SNEDDS was loaded in hydroxypropyl cellulose transdermal film. The outcome of the ex vivo skin permeation study demonstrated a 2.3-fold augmented permeation of ACV from the optimized ACV-GO SNEDDS HPC transdermal film in comparison to the raw ACV transdermal film. There was a 3-fold increase in the relative bioavailability of the optimized ACV-GO SNEDDS transdermal film compared to the raw ACV-HPC film. The study findings confirmed that the ACV-GO SNEDDS transdermal film exhibited excellent potential to enhance the bioavailability of ACV. Full article
(This article belongs to the Special Issue Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications)
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20 pages, 40816 KiB  
Article
Dexamethasone-Loaded Bioactive Coatings on Medical Grade Stainless Steel Promote Osteointegration
by Jan Rožanc, Marko Žižek, Marko Milojević, Uroš Maver and Matjaž Finšgar
Pharmaceutics 2021, 13(4), 568; https://doi.org/10.3390/pharmaceutics13040568 - 16 Apr 2021
Cited by 11 | Viewed by 2409
Abstract
In this study, a multilayer bioactive coating based on carboxymethyl cellulose (CMC) and dexamethasone (DEX) was prepared on medical-grade stainless steel (AISI 316LVM). Its aim was the controlled drug delivery of the incorporated anti‑inflammatory drug, which at the same time promotes osteogenic differentiation [...] Read more.
In this study, a multilayer bioactive coating based on carboxymethyl cellulose (CMC) and dexamethasone (DEX) was prepared on medical-grade stainless steel (AISI 316LVM). Its aim was the controlled drug delivery of the incorporated anti‑inflammatory drug, which at the same time promotes osteogenic differentiation of mesenchymal stem cells. Due to DEX’s limited solubility in physiological fluids, which limits the loading capacity of coatings, it was further combined with β-cyclodextrin to increase its concentration in the bioactive coating. Controlled release of DEX from the multilayer coating was achieved in four steps: a “burst”, i.e., very fast, release step (in an immersion interval of 0–10 min), a fast release step (10–30 min), a slow-release step (60–360 min), and a plateau step (360–4320 min), following a zero-order release or Higuchi model release mechanism. Successful layer-by-layer coating formation was confirmed using attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR). It was shown that the application of the coating significantly increases the hydrophilic character of AISI 316LVM, and also significantly increases the surface roughness, which is known to promote cell growth. In addition, electrochemical measurements demonstrated that the coating application does not increase the susceptibility of medical-grade stainless steel to corrosion. In vitro cell testing using all cell types with which such coatings come into contact in the body (osteoblasts, chondrocytes, and mesenchymal stem cells (MSCs)) showed very good biocompatibility towards all of the mentioned cells. It further confirmed that the coatings promoted MSCs osteogenic differentiation, which is the desired mode of action for orthopedic implants. Full article
(This article belongs to the Special Issue Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications)
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13 pages, 2738 KiB  
Article
Physicochemical and Biological Performance of Aloe Vera-Incorporated Native Collagen Films
by Mireia Andonegi, Ainhoa Irastorza, Ander Izeta, Koro de la Caba and Pedro Guerrero
Pharmaceutics 2020, 12(12), 1173; https://doi.org/10.3390/pharmaceutics12121173 - 02 Dec 2020
Cited by 27 | Viewed by 2447
Abstract
Collagen was obtained from porcine skin by mechanical pretreatments with the aim of preserving the triple helix structure of native collagen, which was indirectly corroborated by differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) results. Moreover, aloe vera (AV), with inherent [...] Read more.
Collagen was obtained from porcine skin by mechanical pretreatments with the aim of preserving the triple helix structure of native collagen, which was indirectly corroborated by differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) results. Moreover, aloe vera (AV), with inherent biological properties, was incorporated into collagen film formulations, and films were prepared by compression and characterized to assess their suitability for biomedical applications. SEM images showed that the fibrillar structure of collagen changed to a rougher structure with the addition of AV, in accordance with the decrease in the lateral packaging of collagen chains observed by XRD analysis. These results suggested interactions between collagen and AV, as observed by FTIR. Considering that AV content higher than 20 wt % did not promote further interactions, this formulation was employed for biological assays and the suitability of AV/collagen films developed for biomedical applications was confirmed. Full article
(This article belongs to the Special Issue Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications)
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21 pages, 819 KiB  
Article
Enhanced Loading Efficiency and Mucoadhesion Properties of Gellan Gum Thin Films by Complexation with Hydroxypropyl-β-Cyclodextrin
by Alessandra Adrover, Laura di Muzio, Jordan Trilli, Chiara Brandelli, Patrizia Paolicelli, Stefania Petralito and Maria Antonietta Casadei
Pharmaceutics 2020, 12(9), 819; https://doi.org/10.3390/pharmaceutics12090819 - 28 Aug 2020
Cited by 10 | Viewed by 2546
Abstract
Polymeric oral thin films (OTFs) were prepared by the casting method, combining gellan gum (GG), a water-soluble polysaccharide, and glycerol (Gly) as a plasticizing agent. GG-Gly films were investigated as potential systems for buccal drug delivery using fluconazole (Class I of the Biopharmaceutical [...] Read more.
Polymeric oral thin films (OTFs) were prepared by the casting method, combining gellan gum (GG), a water-soluble polysaccharide, and glycerol (Gly) as a plasticizing agent. GG-Gly films were investigated as potential systems for buccal drug delivery using fluconazole (Class I of the Biopharmaceutical Classification System) as a model drug. At a low concentration of Gly drug precipitation occurred while, for higher concentrations of Gly, a significant deterioration of mucoadhesive and mechanical properties was observed. One possible way to overcome all these problems could be the addition of hydroxypropyl-β-cyclodextrin (HP-β-CD) to the GG-Gly formulation as a drug-precipitation inhibitor. In this work the effect of cyclodextrin addition on the mechanical, mucoadhesive, swelling and release properties of GG-Gly films was investigated. In-vitro drug release studies were carried out using the paddle type dissolution apparatus (USP II) and the millifluidic flow-through device (MFTD). A moving-boundary model for swelling dynamics and release in USP II is proposed to estimate the effective diffusivity of the solvent, HP-β-CD, fluconazole and complex fluconazole/HP-β-CD in the swelling film. Experimental results, supported by theoretical modeling, confirmed that gellan gum-low glycerol thin films including HP-β-CD represent a suitable formulation for fluconazole drug delivery. A sustained release was observed when GG-Gly film is loaded with a preformed complex fluconazole/HP-β-CD. Full article
(This article belongs to the Special Issue Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications)
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17 pages, 2660 KiB  
Article
Influence of Polymer Composition on the Controlled Release of Docetaxel: A Comparison of Non-Degradable Polymer Films for Oesophageal Drug-Eluting Stents
by Paris Fouladian, Franklin Afinjuomo, Mohammad Arafat, Amanda Bergamin, Yunmei Song, Anton Blencowe and Sanjay Garg
Pharmaceutics 2020, 12(5), 444; https://doi.org/10.3390/pharmaceutics12050444 - 11 May 2020
Cited by 8 | Viewed by 3468
Abstract
Following the huge clinical success of drug-eluting vascular stents, there is a significant interest in the development of drug-eluting stents for other applications, such as the treatment of gastrointestinal (GI) cancers. Central to this process is understanding how particular drugs are released from [...] Read more.
Following the huge clinical success of drug-eluting vascular stents, there is a significant interest in the development of drug-eluting stents for other applications, such as the treatment of gastrointestinal (GI) cancers. Central to this process is understanding how particular drugs are released from stent coatings, which to a large extent is controlled by drug-polymer interactions. Therefore, in this study we investigated the release of docetaxel (DTX) from a selection of non-degradable polymer films. DTX-polymer films were prepared at various loadings (1, 5 and 10% w/w) using three commercially available polymers including poly(dimethylsiloxane) (PSi), poly (ethylene-co-vinyl acetate) (PEVA) and Chronosil polyurethane (PU). The formulations were characterised using different techniques such as photoacoustic Fourier-transform infrared (PA-FTIR) spectrophotometry, X-ray diffraction (XRD) and differential scanning calorimetry (DSC). The effect of DTX on the mechanical properties of the films, in-vitro release, and degradation tests were also assessed. For all polymers and DTX loadings, the drug was found to disperse homogenously without crystallisation within the polymer matrix. While no specific interactions were observed between DTX and PSi or PEVA, hydrogen-bonding appeared to be present between DTX and PU, which resulted in a concentration-dependent decrease in the Young’s moduli of the films due to disruption of inter-polymeric molecular interactions. In addition, the DTX-PU interactions were found to modulate drug release, providing near-linear release over 30 days, which was accompanied by a significant reduction in degradation products. The results indicate that DTX-loaded PU films are excellent candidates for drug-eluting stents for the treatment of oesophageal cancer. Full article
(This article belongs to the Special Issue Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications)
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14 pages, 1613 KiB  
Article
Development of an Orodispersible Film Containing Stabilized Influenza Vaccine
by Yu Tian, Yoshita C. Bhide, Herman J. Woerdenbag, Anke L. W. Huckriede, Henderik W. Frijlink, Wouter L. J. Hinrichs and J. Carolina Visser
Pharmaceutics 2020, 12(3), 245; https://doi.org/10.3390/pharmaceutics12030245 - 08 Mar 2020
Cited by 19 | Viewed by 3631
Abstract
Most influenza vaccines are administered via injection, which is considered as user-unfriendly. Vaccination via oral cavity using an orodispersible film (ODF) might be a promising alternative. To maintain the antigenicity of the vaccine during preparation and subsequent storage of these ODFs, sugars such [...] Read more.
Most influenza vaccines are administered via injection, which is considered as user-unfriendly. Vaccination via oral cavity using an orodispersible film (ODF) might be a promising alternative. To maintain the antigenicity of the vaccine during preparation and subsequent storage of these ODFs, sugars such as trehalose and pullulan can be employed as stabilizing excipients for the antigens. In this study, first, β-galactosidase was used as a model antigen. Solutions containing β-galactosidase and sugar (trehalose or trehalose/pullulan blends) were pipetted onto plain ODFs and then either air- or vacuum-dried. Subsequently, sugar ratios yielding the highest β-galactosidase stability were used to prepare ODFs containing H5N1 whole inactivated influenza virus vaccine (WIV). The stability of the H5N1 hemagglutinin was assessed by measuring its hemagglutination activity. Overall, various compositions of trehalose and pullulan successfully stabilized β-galactosidase and WIV in ODFs. WIV incorporated in ODFs showed excellent stability even at challenging storage conditions (60 °C/0% relative humidity or 30 °C/56% relative humidity) for 4 weeks. Except for sugars, the polymeric component of ODFs, i.e., hypromellose, possibly improved stability of WIV as well. In conclusion, ODFs may be suitable for delivering of WIV to the oral cavity and can possibly serve as an alternative for injections. Full article
(This article belongs to the Special Issue Polymeric Thin Films as an Emerging Formulation Approach for Biomedical and Pharmaceutical Applications)
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