A novel unit-dose approach for the pharmaceutical compounding of an orodispersible film

Foo, Wen Chin; Khong, Yuet Mei; Gokhale, Rajeev; Chan, Sui Yung

doi:10.1016/j.ijpharm.2018.01.047

Cited by 28 publications

(19 citation statements)

References 37 publications

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“…The morphology of films or filaments are evaluated by Scanning Electron Microscopy (SEM) [11,12,45,[118][119][120] and optical microscopy. [11,120,121] These evaluations allow to determine the smoothness of filament or film surfaces or small air bubbles intrusions into filaments or films. The SEM studies of film cross sections showed the formation of a network between the polymer and drug.…”

Section: Morphology Studymentioning

confidence: 99%

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

Ehtezazi

Algellay

Hardy

2020

DDF

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: 3D printing technique has been utilised to develop novel and complex drug delivery systems that are almost impossible to produce by employing conventional formulation techniques. For example, this technique may be employed to produce tablets or fast dissolving oral films (FDFs) with multilayers of active ingredients, which are personalised to patient’s needs. In this article, we compared the production of FDFs by 3D printing to conventional methods such as solvent casting. Then, we evaluated the need for novel methods of producing fast dissolving oral films; and why 3D printing may be able to meet the short falls of FDF production. The challenges of producing 3D printed FDFs are identified at commercial scale by referring to the identification of suitable materials, hardware, quality control tests and Process Analytical Technology. In this paper we discuss that the FDF market will grow to more than $1.3 billion per annum in next few years and 3D printing of FDFs may share part of this market. Although, companies are continuing to invest in technologies which provide alternatives to standard drug delivery systems, the market for thin film products is already well established. Market entry for a new technology such as 3D printing of FDFs will, therefore, be hard, unless, this technology proves to be a game changer. A few approaches are suggested in this paper.

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Section: Morphology Studymentioning

confidence: 99%

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

Ehtezazi

Algellay

Hardy

2020

DDF

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“…The formulation design, optimization and evaluation have been described in our previous study (Zhang et al, 2017). Briefly, risperidone ODF was prepared by solvent casting method (Foo et al, 2018).Weighted amount of risperidone was dispersed in purified water at ambient temperature under constant stirring. Subsequently, the required amount of citric acid, PEG 4000, HPMC E3, HPMC E15, aspartame, titanium dioxide, and peppermint essence were added separately under continuous grinding to obtain a homogeneous mixture.…”

Section: Preparation Of Risperidone Odfmentioning

confidence: 99%

“…Orodispersible films (ODFs) are single or multilayer sheets of water-soluble polymer materials (Madhav et al, 2009;Hoffmann et al, 2011;Lam et al, 2014;Krampe et al, 2016;Foo et al, 2018). Due to the instant disintegration and release of the drug into the saliva once the film is put into the oral cavity, there is no need of water for the ingestion and it is more convenient than conventional tablets (Poston and Waters, 2007;Hoffmann et al, 2011;Lam et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

et al. 2020

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The aim of the present study was to investigate the absorption routes as well as the potential application of the oral transmucosal delivery of risperidone orodispersible film (ODF) using physiologically based pharmacokinetic modeling. Methods: The pharmacokinetic study after intragastric (i.g.), supralingual, and sublingual administration of risperidone ODF was conducted in Beagle dogs. Then a mechanic absorption model which combined Oral Cavity Compartment Absorption and Transit (OCCAT) model with Advanced Compartment Absorption and Transit (ACAT) model for predicting the absorption routes of risperidone ODF in vivo was constructed using GastroPlus™. A sensitivity analysis was performed to investigate the impact of oral residence time on the in vivo absorption of risperidone ODF. Based on the fraction of intraoral absorption, the potential of the oral transmucosal delivery of risperidone were predicted. Results: There were no statistical differences in the AUC 0-t (P = 0.4327), AUC 0-∞ (P = 0.3278), C max (P = 0.0531), and T max (P = 0.2775) values among i.g., supralingual, and sublingual administration of risperidone ODF in Beagle dogs. The predicted absorption percentage via oral mucosa at oral residence time of 2 min, 5 min, and 10 min was 7.0%, 11.4%, and 19.5%, respectively. No obvious difference was observed for the bioavailability of risperidone ODF within 10 min of oral residence time. The PBPK absorption model for risperidone could be simplified to include ACAT model solely. Conclusion: The main absorption route for risperidone ODF was the gastrointestine. The absorption percentage via oral mucosa was almost negligible due to the physicochemical properties of risperidone although ODF dissolved completely in the oral cavity of Beagle dogs within 2 min.

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“…does not include any specified method or acceptance limits for testing the disintegration behavior of ODFs. Generally, the limit set for the disintegration time of orodispersible tablets (ODTs) (less than 3 min), has been used for ODFs as well [35,41]. Setting up a disintegration test that yields comparable and relevant results is challenging.…”

Section: Disintegrationmentioning

confidence: 99%

3D-Printed Veterinary Dosage Forms – A Comparative Study of Three Semi-Solid Extrusion Printers

Sjöholm¹,

Mathiyalagan²,

Prakash³

et al. 2020

Preprint

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Currently, the number of approved veterinary medicines are limited, and human medications are used off-label. These approved human medications are of too high potencies for a cat or a small dog breed. Therefore, there is a dire demand for smaller doses of veterinary medicines. This study aims to investigate the use of three semi-solid extrusion 3D printers in a pharmacy or animal clinic setting for extemporaneous manufacturing of prednisolone containing orodispersible films for veterinary use. Orodispersible films with adequate content uniformity and acceptance values defined by the European Pharmacopoeia was produced with one of the studied printers, namely, the Allevi 2 bioprinter. Smooth and flexible films, with high mechanical strength, neutral pH, and low moisture content were produced with high correlation between prepared design and obtained drug amount, indicating that the Allevi 2 printer could successfully be used to extemporaneously manufacture personalized doses for animals at the point-of-care.

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A novel unit-dose approach for the pharmaceutical compounding of an orodispersible film

Cited by 28 publications

References 37 publications

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

Next Steps in 3D Printing of Fast Dissolving Oral Films for Commercial Production

Physiologically Based Pharmacokinetic Modeling to Understand the Absorption of Risperidone Orodispersible Film

3D-Printed Veterinary Dosage Forms – A Comparative Study of Three Semi-Solid Extrusion Printers

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