Boateng, Joshua ORCID: https://orcid.org/0000-0002-6310-729X, Mitchell, John ORCID: https://orcid.org/0000-0003-2945-3292, Trivedi, Vivek ORCID: https://orcid.org/0000-0001-9304-9214 and Khan, Sajjad (2014) Formulation and characterisation of oral thin films for buccal mucosa drug delivery for paediatric patients. In: Pharmaceutical Sciences Abstracts: Annual International Conference on Pharmaceutical Sciences. 5-8 May 2014, Athens, Greece. Athens Institute for Education and Research, Athens, Greece, pp. 30-31. ISBN 9786185065355

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Abstract

This study involves the development of oral thin solvent cast films for the potential delivery of the proton pump inhibitor, omeprazole via the buccal mucosa for paediatric patients. The formulations were prepared using different polymers (hydroxypropyl methylcellulose (HPMC), methylcellulose (MC), sodium alginate (SA), carrageenan (CA) and metolose (MET), polyethylene glycol (PEG 400) as plasticiser, omeprazole (model drug) and L-alginate (to stabilise omeprazole). Polymeric gels (1% w/w) were prepared at 40 °C using water and ethanol (10% v/v and 20% v/v) as the casting solvent. PEG 400 (0 and 0.5 % w/w) was added as plasticiser. The films were obtained by drying the gels in an oven (40 °C). Optimised formulations containing (of omeprazole and L-alginine 1:1, 1:2 and 1:3) were prepared to investigate the stabilization of the drug in the gel. Texture analysis (TA) was used to investigate the tensile properties of the films. The physical form of the formulation components within the films was studied using differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD) and attenuated total reflectance Fourier transform infra red (ATR-FT-IR) spectroscopy. Scanning electron microscopy (SEM) provided topographic information with regard to surface architecture of the films. Based on the results from the TA investigation, SA and MET films were chosen for drug loading and further investigation (omeprazole stabilisation). These films showed a good balance between flexibility and toughness required for ease of transportation and patient handling. SEM showed significant differences depending on plasticiser and casting solvent. Plasticised MET (aqueous and ethanolic gels) films showed uniform and smooth surfaces whilst unplasticised films demonstrated rough lumpy surfaces. SA films prepared from aqueous gels showed some lumps present on the surface whilst SA films prepared from ethanolic gels showed similar topography to MET films. Drug loaded gels showed that omeprazole was unstable, with gels turning red after 20 minutes and therefore required addition of L-arginine. From the results obtained, plasticised (0.5 % w/w PEG 400) MET films prepared from ethanolic (20% v/v) gels and containing omeprazole : L-arginine ratio of 1:2 showed the most ideal characteristics (transparency, ease of peeling and flexibility) and was the formulation of choice for further investigation. The DSC, XRPD and ATR-FTIR results showed that the films were non-crystalline suggesting possible amorphous drug formation or molecular dispersion within the polymeric matrix. The films have potential for paediatric buccal administration and will be further functionally characterized to determine its in vitro and in vivo performance.

Item Type:	Conference Proceedings
Title of Proceedings:	Pharmaceutical Sciences Abstracts: Annual International Conference on Pharmaceutical Sciences. 5-8 May 2014, Athens, Greece
Additional Information:	[1] Abstract only, published in Pharmaceutical Sciences Abstracts: Annual International Conference on Pharmaceutical Sciences, 5-8 May 2014, Athens, Greece: Abstract Book - and hosted on Athens Institute for Education and Research (ATINER) website.
Uncontrolled Keywords:	paediatric, films, buccal mucosa drug delivery
Subjects:	Q Science > QD Chemistry R Medicine > RS Pharmacy and materia medica
Faculty / School / Research Centre / Research Group:	Faculty of Engineering & Science Faculty of Engineering & Science > School of Science (SCI)
Related URLs:	Publisher Publisher
Last Modified:	08 Nov 2019 13:13
URI:	http://gala.gre.ac.uk/id/eprint/12412

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