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Pharmaceutics
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ODX Formulations for Drug Delivery and Other Approaches to Overcome...
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ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems

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

Deadline for manuscript submissions: closed (30 November 2021) | Viewed by 22701

Special Issue Editors

Dr. J. Carolina Visser

E-Mail
Guest Editor
Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, The Netherlands
Interests: orodispersible films; drug formulations for patient groups with special needs; pharmaceutical product care; pharmaceutical compounding
Dr. Herman J. Woerdenbag

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Guest Editor
Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands
Interests: pharmaceutical product care; pharmaceutical compounding; extemporaneous pharmacy preparations; herbal medicinal products; pharmacy education

Special Issue Information

Dear colleagues,

Orodispersible drug delivery systems (ODx) have received a considerable amount of interest in recent years due to their suitability for patients suffering from dysphagia. These patients have difficulty swallowing common oral formulations, such as tablets and capsules, and as such, ODx present a much more acceptable alternative for them.

ODx rapidly disintegrate after placement in the oral cavity. The active pharmaceutical ingredients are swallowed with the saliva and/or are absorbed via the oral mucosa. They comprise orodispersible films (ODF), orodispersible (mini)tablets (OD(M)T), lyophilisates, and granules. The various ODx formulations currently available can be used for the treatment of local and systemic disorders and vaccination. ODX formulations can be prepared on a small as well as (semi-)industrial scale using different manufacturing techniques (e.g., solvent casting technique, various printing techniques).

This Special Issue aims to highlight the current research activities in the areas of formulations intended to be used in the oral cavity. Authors are invited to submit original work and review articles covering all aspects of ODx formulation development and other approaches to overcome swallowing problems.

Publications on mucoadhesive buccal drug delivery systems (MBx), such as mucoadhesive buccal films and tablets, may also be included.

Dr. J. Carolina Visser
Dr. Herman Woerdenbag
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

  • orodispersible drug delivery systems
  • mucoadhesive buccal drug delivery systems
  • oral cavity
  • pharmaceutical preparations
  • patient groups with special needs
  • patient acceptance
  • tailor made formulations
  • personalized medications
  • dysphagia
  • solvent casting technique
  • printing techniques

Published Papers (6 papers)

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Research

15 pages, 1137 KiB  
Article
Modernising Orodispersible Film Characterisation to Improve Palatability and Acceptability Using a Toolbox of Techniques
by Neel Desai, Marc Masen, Philippa Cann, Ben Hanson, Catherine Tuleu and Mine Orlu
Pharmaceutics 2022, 14(4), 732; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics14040732 - 29 Mar 2022
Cited by 7 | Viewed by 2550
Abstract
Orodispersible films (ODFs) have been widely used in paediatric, geriatric and dysphagic patients due to ease of administration and precise and flexible dose adjustments. ODF fabrication has seen significant advancements with the move towards more technologically advanced production methods. The acceptability of ODFs [...] Read more.
Orodispersible films (ODFs) have been widely used in paediatric, geriatric and dysphagic patients due to ease of administration and precise and flexible dose adjustments. ODF fabrication has seen significant advancements with the move towards more technologically advanced production methods. The acceptability of ODFs is dependent upon film composition and process of formation, which affects disintegration, taste, texture and mouthfeel. There is currently a lack of testing to accurately assess ODFs for these important acceptability sensory perceptions. This study produced four ODFs formed of polyvinyl alcohol and sodium carboxymethylcellulose using 3D printing. These were assessed using three in vitro methods: Petri dish and oral cavity model (OCM) methods for disintegration and bio-tribology for disintegration and oral perception. Increasing polymer molecular weight (MW) exponentially increased disintegration time in the Petri dish and OCM methods. Higher MW films adhered to the OCM upper palate. Bio-tribology analysis showed that films of higher MW disintegrated quickest and had lower coefficient of friction, perhaps demonstrating good oral perception but also stickiness, with higher viscosity. These techniques, part of a toolbox, may enable formulators to design, test and reformulate ODFs that both disintegrate rapidly and may be better perceived when consumed, improving overall treatment acceptability. Full article
(This article belongs to the Special Issue ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems)
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14 pages, 260 KiB  
Article
Performance of Tablet Splitters, Crushers, and Grinders in Relation to Personalised Medication with Tablets
by Herman J. Woerdenbag, J. Carolina Visser, Marlyn P. A. M. Leferink op Reinink, Roël R. van Orsoy, Anko C. Eissens, Paul Hagedoorn, Hilda Dijkstra, Derk P. Allersma, Shi W. Ng, Oscar S. N. M. Smeets and Henderik W. Frijlink
Pharmaceutics 2022, 14(2), 320; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics14020320 - 28 Jan 2022
Cited by 12 | Viewed by 3426
Abstract
Swallowing problems and the required dose adaptations needed to obtain optimal pharmacotherapy may be a hurdle in the use of tablets in daily clinical practice. Tablet splitting, crushing, or grinding is often applied to personalise medication, especially for the elderly and children. In [...] Read more.
Swallowing problems and the required dose adaptations needed to obtain optimal pharmacotherapy may be a hurdle in the use of tablets in daily clinical practice. Tablet splitting, crushing, or grinding is often applied to personalise medication, especially for the elderly and children. In this study, the performance of different types of (commercially available) devices was studied. Included were splitters, screwcap crushers, manual grinders, and electric grinders. Unscored tablets without active ingredient were prepared, with a diameter of 9 and 13 mm and a hardness of 100–220 N. Tablets were split into two parts and the difference in weight was measured. The time needed to pulverise the tablets (crush time) was recorded. The residue remaining in the device (loss) was measured. The powder was sieved to obtain a particle fraction >600 µm and <600 µm. The median particle size and particle size distribution of the later fraction were determined using laser diffraction analysis. Splitting tablets into two equal parts appeared to be difficult with the devices tested. Most screwcap grinders yielded a coarse powder containing larger chunks. Manual and especially electric grinders produced a finer powder, making it suitable for administration via an enteral feeding tube as well as for use in individualised preparations such as capsules. In conclusion, for domestic and incidental use, a screwcap crusher may provide sufficient size reduction, while for the more demanding regular use in hospitals and nursing residences, a manual or electric grinder is preferred. Full article
(This article belongs to the Special Issue ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems)
18 pages, 4120 KiB  
Article
Concept of Orodispersible or Mucoadhesive “Tandem Films” and Their Pharmaceutical Realization
by Anja Göbel and Jörg Breitkreutz
Pharmaceutics 2022, 14(2), 264; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics14020264 - 22 Jan 2022
Cited by 3 | Viewed by 3554
Abstract
Orodispersible or mucoadhesive films as a patient-oriented dosage form for low-dosed drugs are usually produced using solvent casting. This paper presents a modification of the solvent casting technique that aimed to divide oral films into two or more compartments. The proposed objectives and [...] Read more.
Orodispersible or mucoadhesive films as a patient-oriented dosage form for low-dosed drugs are usually produced using solvent casting. This paper presents a modification of the solvent casting technique that aimed to divide oral films into two or more compartments. The proposed objectives and fields of applications include improved handling properties and safety of application, the optimization of drug release kinetics and the enhancement of long-term stability when combining two or more active pharmaceutical ingredients into one oral film. A feasibility study for the combination of different film-forming polymers to generate the so-called tandem films was performed. As examples of practical implementation, orodispersible applicator films consisting of a drug-loaded section and a handheld piece were cast, and mucoadhesive buccal tandem films were cast to optimize the dissolution rate of the films. Full article
(This article belongs to the Special Issue ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems)
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17 pages, 10468 KiB  
Article
Orodispersible Films: A Delivery Platform for Solid Lipid Nanoparticles?
by Denise Steiner, Jakob F. Emmendörffer and Heike Bunjes
Pharmaceutics 2021, 13(12), 2162; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13122162 - 15 Dec 2021
Cited by 13 | Viewed by 2776
Abstract
To overcome the poor bioavailability observed for many newly developed active pharmaceutical ingredients (APIs), an appropriate formulation strategy is necessary. One approach is the formulation of these substances in solid lipid nanoparticles and their further processing into solid dosage forms. A promising and [...] Read more.
To overcome the poor bioavailability observed for many newly developed active pharmaceutical ingredients (APIs), an appropriate formulation strategy is necessary. One approach is the formulation of these substances in solid lipid nanoparticles and their further processing into solid dosage forms. A promising and innovative oral delivery platform could be orodispersible films (ODFs). ODFs were already investigated more closely, e.g., for the administration of API nanoparticles, and proved their suitability for this formulation approach. The current study was aimed at investigating if the HPMC (hydroxypropyl methyl cellulose) film matrix is also suitable to serve as an appropriate delivery platform for solid lipid nanoparticles. Dependent on the type of triglyceride nanoparticles embedded in the film matrix and the formulation of the lipid particles, lipid contents of up to 54 wt.% could be realized in the film matrix without the loss of the nanoparticulate state. Good mechanical properties were confirmed for these films by determining the tensile strength as well as the elongation before breakage. Interestingly, processing of a lipid suspension into this solid dosage form led to a significantly reduced transformation of the lipid particles from the metastable α- into the stable β-polymorph. This could prove very beneficial when the lipid particles are loaded with APIs. Full article
(This article belongs to the Special Issue ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems)
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17 pages, 6160 KiB  
Article
Development, Evaluation, and Molecular Docking of Oral Dissolving Film of Atenolol
by Karina Citra Rani, Nani Parfati, Ni Luh Dewi Aryani, Agnes Nuniek Winantari, Endang Wahyu Fitriani, Aditya Trias Pradana, Roisah Nawatila, Astridani Rizky Putranti, Florencia Irine, Florentia Angelica, Cintya Yohanes and Christina Avanti
Pharmaceutics 2021, 13(10), 1727; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13101727 - 19 Oct 2021
Cited by 11 | Viewed by 3109
Abstract
The development of oral dissolving film (ODF) of atenolol is an attempt to enhance convenience and compliance for geriatric patients suffering from hypertension. Film former is the most essential component in ODF that determines the physical characteristic and drug release. In this study, [...] Read more.
The development of oral dissolving film (ODF) of atenolol is an attempt to enhance convenience and compliance for geriatric patients suffering from hypertension. Film former is the most essential component in ODF that determines the physical characteristic and drug release. In this study, three different types of film former including HPMC E5 4% (w/v), 5% (w/v), CMC-Na 3% (w/v), 4% (w/v), and Na-alginate 2.5% (w/v), 3% (w/v) were optimized in Formula 1 (F1) to Formula 6 (F6), respectively. A solvent casting method was employed to develop ODF of atenolol. The films formed by HPMC E5 produced a smooth and flexible surface, whereas CMC-Na and Na-alginate produced gritty textured films. Satisfactory results were obtained from several physical parameters such as film thickness, folding endurance, swelling index, and disintegration time. The homogeneity, drug content, and dissolution properties of ODF with HPMC exhibited better characteristics than the other formulas. Formula 1 exhibited the highest drug release compared to the other ODFs. The molecular docking results showed that there was a hydrogen bonding between atenolol and film formers which was also supported by the FTIR spectrum. The findings of this study suggest that HPMC E5 is the most favorable film former for ODF of atenolol. Full article
(This article belongs to the Special Issue ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems)
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17 pages, 2040 KiB  
Article
Development of an Age-Appropriate Mini Orally Disintegrating Carvedilol Tablet with Paediatric Biopharmaceutical Considerations
by Dilawar Khan, Daniel Kirby, Simon Bryson, Maryam Shah and Afzal Rahman Mohammed
Pharmaceutics 2021, 13(6), 831; https://0-doi-org.brum.beds.ac.uk/10.3390/pharmaceutics13060831 - 03 Jun 2021
Cited by 6 | Viewed by 3961
Abstract
Owing to considerable differences observed in anatomy and physiology between paediatric subsets, it has been well established that children respond to drugs differently compared to adults. Furthermore, from a formulation perspective, there is a distinct challenge to develop a dosage form that is [...] Read more.
Owing to considerable differences observed in anatomy and physiology between paediatric subsets, it has been well established that children respond to drugs differently compared to adults. Furthermore, from a formulation perspective, there is a distinct challenge to develop a dosage form that is capable of safely, accurately, and reliably delivering the dose across the whole paediatric population. Orally disintegrating mini-tablets (ODMT) have widely been considered as an age-appropriate formulation option that possess the ability for adequate dose flexibility, avoids swallowing difficulties, and exhibits superior stability due to its solid state. Within this study, two strengths (0.5 mg and 2 mg) of carvedilol ODMT formulations were developed using an excipient composition and load that is appropriate for paediatric use. The formulations demonstrated adequate mechanical strength (>20 N) and fast disintegration times (<30 s). Dissolution profiles observed were robust and comparable to the marketed conventional tablet formulation across various parts of the gastrointestinal (GI) tract in both the fed and fasted state, signifying appropriate efficacy, quality, and performance. As such, the formulations developed in this study show potential to address the need of an ‘age-appropriate’ formulation of carvedilol, as highlighted by the European Medicines Agency (EMA) Inventory of the Needs for Paediatric Medicine. Full article
(This article belongs to the Special Issue ODX Formulations for Drug Delivery and Other Approaches to Overcome Swallowing Problems)
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