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

There is a lack of “age-appropriate” medicines available for children whichhas led to the routine use of unlicensed or off-label medicines in children.Oral liquids and suspensions often contain preservatives and solvents whichmay be harmful to a developing child, and also rely on accuratemeasurement of small volumes to administer the correct dose. In order todetermine the scale of the problem locally, an audit of current prescribing andexcipient exposure was conducted in a sample of neonates at the PrincessRoyal 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 areideally suited to patients who struggle to swallow other solid oral dosageforms such as tablets; for example, paediatric or elderly patients.In order to demonstrate the safety of OTFs in newborn infants, a phosphatesupplement was formulated as an OTF for the prevention of boneabnormalities in preterm neonates. Characterisation, stability and releasestudies were carried out and the formulation conformed to ICH standards. Inparallel, OTFs containing morphine sulphate were developed for thetreatment 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 releasepharmaceutical formulations. By combining these drug-resin complexes with OTF technology, several sustained release oral thin films were successfullyformulated. An in vivo pharmacokinetic study in rats was carried out on oneof these formulations - a sustained release morphine sulphate OTF.The development of a dissolution test method which was more relevant thanthe Pharmacopoeial designs for oral drug release in neonates was necessaryfor the characterisation of OTF formulations. Novel apparatus was developedwhich better mimicked the conditions of saliva production and likely in vivoperformance.Oral thin films are proposed as a safe and age-appropriate alternative soliddosage platform for the oral delivery of medicines to both paediatric andelderly patient populations.

Name dc:type.qualificationname

phd

Level dc:type.qualificationlevel

doctoral-pg

Grantor dc:publisher.institution

University of Strathclyde

Year dc:date.issued

2016

Author dc:creator

• Watts, Stewart Ian

Advisors dc:contributor.advisor

• Gibson, Alan
• Mullen, Alex
• Oswald, Iain
• Ingram, Andrew

DOI

10.48730/wbcy-1998

Identifier

T14462

Author Identifier

201172502

OAI identifier oai:identifier

oai:strathclyde:pk02c977h