Development of Orally Dissolving Films for Pediatric-Centric Administration of Anti-Epileptic Drug Topiramate – a Design of Experiments (DoE) Study

Abstract

Children have often been treated as small adults in relation to drug formulation, but research has now shown this not to be the case. Therefore, there is a push from regulatory bodies to provide drug formulations specifically tailored towards the needs of this fragmented population. Orally dissolving films (ODFs) have been identified as an emerging opportunity, to bridge this gap. Therefore, the aim of this study was to prepare ODFs containing topiramate, an antiepileptic drug, using solvent casting method as a potential alternative to oral tablets/powders for paediatrics. For this purpose, a Design of Experiment (DoE) was employed to optimise formulation parameters. 24 formulations were prepared by changing the polymer type (HPMC, Guar-Gum or PEO), concentration (0.4%-1.2%w/v); plasticizer type (glycerol\sorbitol) and concentration (0.1-0.3%w/v). Disintegration time, content-uniformity, film quality and thickness uniformity were the responses. Surface and molecular profiling were conducted on the optimal formulation (N4). TGA and XRD results demonstrated the stability of materials upon production into films, while the SEM images showed smooth films that proved to be resilient due to good mechanical properties. HPMC-glycerine based ODFs are presented as an effective dosage form to enhance the ease of administration and patient compliance of topiramate, specifically for paediatric patients.

Publication DOI: https://doi.org/10.1016/j.jsps.2021.04.025
Divisions: College of Health & Life Sciences
College of Health & Life Sciences > Applied Health Research Group
Additional Information: Copyright: 2021 The Author(s). Published by Elsevier B.V. on behalf of King Saud University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Funding: The authors would like to acknowledge the funding from Isra University (Jordan) for funding E.D. Najran University are thanked for their financial support in funding H.A work in this research and Aston University for supporting A.I.
Uncontrolled Keywords: Design of experiment (DoE),Drug load,Orally dissolving films,Pediatric formulations,Solvent casting,Topiramate,Pharmacology,Pharmaceutical Science
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Related URLs: https://www.sci ... 0827?via%3Dihub (Publisher URL)
http://www.scop ... tnerID=8YFLogxK (Scopus URL)
PURE Output Type: Article
Published Date: 2021-07-01
Published Online Date: 2021-05-01
Accepted Date: 2021-04-21
Authors: Zmaily Dahmash, Eman
Iyire, Affiong (ORCID Profile 0000-0002-2684-2260)
Alyami, Hamad S.

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