Background

Regulatory guidance mandates demonstration of the acceptability of new medicinal products prior to introduction for paediatric populations. No guidelines are available to direct these studies and there is limited existing expertise in this area. The Pharma Industry can benefit from our cost-effective specialist advice to ensure that they meet regulatory requirements.

Technology Overview

Researchers at the University of Strathclyde can provide advice on the development of acceptable, age-appropriate formulations. The laboratory has instrumentation to facilitate the design of prototype formulations using acceptable excipients. There is also equipment to evaluate the robustness and sensory aspects of the formulations developed.

Benefits

Developability assessment of paediatric formulations
Acceptability/palatability testing of prototype formulations
Provision of protocols to underpin acceptability study design

Applications

Tooling for minitablets
Extrusion spheronisation for multi-particulates
Coating apparatus
Our expertise is applicable to the formulation and assessment of paediatric formulations

Specialist Advice in Paediatric Formulation Design