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Formulation, Characterisation and Stabilisation of Buccal Films for Paediatric Drug Delivery of Omeprazole

Khan, Sajjad, Boateng, Joshua S., Mitchell, John C., Trivedi, Vivek (2015) Formulation, Characterisation and Stabilisation of Buccal Films for Paediatric Drug Delivery of Omeprazole. AAPS PharmSciTech, 16 (4). pp. 800-810. E-ISSN 1530-9932. (doi:10.1208/s12249-014-0268-7)

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Abstract

This study aimed to develop films for potential delivery of omeprazole (OME) via the buccal mucosa of paediatric patients. Films were prepared using hydroxypropylmethylcellulose (HPMC), methylcellulose (MC), sodium alginate (SA), carrageenan (CA) and metolose (MET) with polyethylene glycol (PEG 400) as plasticiser, OME (model drug) and L-arg (stabiliser). Gels (1% w/w) were prepared at 40°C using water and ethanol with PEG 400 (0–1% w/w) and dried in an oven (40°C). Optimised formulations containing OME and L-arg (1:1, 1:2 and 1:3) were prepared to investigate the stabilisation of the drug. Tensile properties (Texture analysis, TA), physical form (differential scanning calorimetry, DSC; X-ray diffraction, XRD; thermogravimetric analysis, TGA) and surface topography (scanning electron microscopy, SEM) were investigated. Based on the TA results, SA and MET films were chosen for OME loading and stabilisation studies as they showed a good balance between flexibility and toughness. Plasticised MET films were uniform and smooth whilst unplasticised films demonstrated rough lumpy surfaces. SA films prepared from aqueous gels showed some lumps on the surface, whereas SA films prepared from ethanolic gels were smooth and uniform. Drug-loaded gels showed that OME was unstable and therefore required addition of L-arg. The DSC and XRD suggested molecular dispersion of drug within the polymeric matrix. Plasticised (0.5% w/w PEG 400) MET films prepared from ethanolic (20% v/v) gels and containing OME: L-arg 1:2 showed the most ideal characteristics (transparency, ease of peeling and flexibility) and was selected for further investigation.

Item Type: Article
DOI/Identification number: 10.1208/s12249-014-0268-7
Uncontrolled keywords: buccal drug delivery, omeprazole, oral films, paediatric formulation, plasticiser
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: Central Services > Universities at Medway
Faculties > Sciences > Medway School of Pharmacy
Depositing User: Vivek Trivedi
Date Deposited: 25 Apr 2019 12:57 UTC
Last Modified: 03 Jun 2019 09:44 UTC
Resource URI: https://kar.kent.ac.uk/id/eprint/73633 (The current URI for this page, for reference purposes)
Trivedi, Vivek: https://orcid.org/0000-0001-9304-9214
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