Design and characterisation of orally dissolving films as a potential new dosage form for paediatrics

Orally dissolving films (ODFs) have received much attention as potential delivery systems for oral administration of drugs to paediatric patients. With their unique properties and advantages, the technology offers improved patient compliance and wider acceptability, eliminated fear of choking, ease of administration and dosing convenience,without the requirement of water. This research focused on the formulation of ODFs with suitable physico-chemical and clinical properties as a potential dosage form for paediatric use. Initial studies focused on screening different film-forming materials used for the preparation of orally dissolving films in order to optimise and propose suitable polymers and plasticisers with a suitable manufacturing technique. Kollicoat Protect was a selected candidate for further studies, due to its excellent film forming capacity with rapid disintegration. The work also sought to improve the loading capacity, taste masking and drug content uniformity of both hydrophilic (dexchlorpheniramine malate) and hydrophobic(glipizide) drugs into ODFs, especially for poorly water soluble drugs, through complexation with cyclodextrins (CDs) and incorporation with nanoparticles. Results demonstrated that CD complexation showed improvement in the solubility profile of glipizide, whilst drug loading efficiency and drug content uniformity only improved at low doses, based on the limited cavity sizes. Nonetheless, the application of nanoparticles achieved good drug loading efficiency for glipizide at higher doses. In contrast, the loading capacity and other physico-chemical properties of dexchlorpheniramine maleateloaded films remain flexible. Further, method development to optimise the determination of disintegration time of ODFs proved that the media and media volume has no effect on disintegration time using either beaker or the texture analyser method, but the analyser method demonstrated to be more suitable for quality control setting of ODFs. Of the stability performance of ODFs, films packed with the prototype packaging remained stable over the period of time studied at both long term and accelerated conditions, which indicated their robust and clinical use through the product developmental stages