Development of thin film oral drug delivery devices for use in paediatric and palliative care patient populations

  • Stewart Ian Watts

Student thesis: Doctoral Thesis

Abstract

There is a lack of "age-appropriate" medicines available for children which has led to the routine use of unlicensed or off-label medicines in children. Oral liquids and suspensions often contain preservatives and solvents which may be harmful to a developing child, and also rely on accurate measurement of small volumes to administer the correct dose. In order to determine the scale of the problem locally, an audit of current prescribing and excipient exposure was conducted in a sample of neonates at the Princess Royal Maternity, Glasgow. Oral thin films (OTFs), composed principally of water soluble polymers, dissolve quickly in saliva without the need to chew or drink water. They are ideally suited to patients who struggle to swallow other solid oral dosage forms such as tablets; for example, paediatric or elderly patients. In order to demonstrate the safety of OTFs in newborn infants, a phosphate supplement was formulated as an OTF for the prevention of bone abnormalities in preterm neonates. Characterisation, stability and release studies were carried out and the formulation conformed to ICH standards. In parallel, OTFs containing morphine sulphate were developed for the treatment of neonatal abstinence syndrome. Ion exchange resins may be 'loaded' with drug molecules to form drug 'resinates', which have proved useful in the production of sustained release pharmaceutical formulations. By combining these drug-resin complexes with OTF technology, several sustained release oral thin films were successfully formulated. An in vivo pharmacokinetic study in rats was carried out on one of these formulations - a sustained release morphine sulphate OTF. The development of a dissolution test method which was more relevant than the Pharmacopoeial designs for oral drug release in neonates was necessary for the characterisation of OTF formulations. Novel apparatus was developed which better mimicked the conditions of saliva production and likely in vivo performance. Oral thin films are proposed as a safe and age-appropriate alternative solid dosage platform for the oral delivery of medicines to both paediatric and elderly patient populations.
Date of Award27 Oct 2016
Original languageEnglish
Awarding Institution
  • University Of Strathclyde
SponsorsUniversity of Strathclyde & SULSA (University Administered)
SupervisorAlexander Mullen (Supervisor) & Iain Oswald (Supervisor)

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