Abdelhakim, Hend E.; (2021) Formulation and Assessment of Taste-masked Electrospun Fibre Mats for Paediatric Drug Delivery. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

Since the Paediatric Regulation came into force by the European Medicines Agency in 2007, the drive to formulate age-appropriate dosage forms has been accelerated. The aim of this thesis was to develop new approaches for paediatric formulation design through the optimisation of novel taste-masking and taste-assessment methods. Electrospinning was demonstrated to be a suitable taste-masking technology, producing fibre mats that can be further formulated into easy to swallow oral films. The electrospinning of Eudragit E PO, a taste-masking polymer, was optimised using Quality by Design principles and in particular Design of Experiment. To further enhance the taste-masking capability of the electrospun mat, co-axial electrospinning was utilised using another taste-masking polymer, Kollicoat Smartseal. The use of both polymers successfully taste-masked chlorpheniramine maleate, a known bitter anti-histamine. This was demonstrated using an electronic biosensor tasting system or E-tongue. The E-tongue was used to assess the bitterness threshold of this model drug but also of other standard bitter drugs for benchmarking. In addition, it was used to taste-assess various formulations which aided in ranking and deselecting formulations. Electrospun fibre mats can be further processed into a number of different dosage forms for final presentation to the patient. The fibre mats were designed to be presented as an oral film. A water-soluble outer layer was added to the films using multi-axial electrospinning. A human panel was conducted to investigate the mouthfeel and overall acceptability of electrospun PVA films versus solvent-cast PVA films. The electrospun films were found to be as acceptable as the standard solvent-cast films, a very promising result for clinical translation. PVA and PVP were electrospun with the previously optimised polymers using tri-axial and tetra-axial electrospinning. The taste of the multi-axial electrospun fibre mats were assessed and it was found that adding a water-soluble outer layer reduces the taste-masking ability. Thus, it was found that electrospinning of a bitter drug using hydrophobic taste-masking polymers is very promising in the formulation of paediatric oral films.

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