Our case studies have been designed to profile our capabilities in formulation design, liquid-fill development and commercial manufacture.
Case study I describes Colpermin® which was originally developed within Tillotts over 20 years ago and provides an example of our capabilities in developing a sustained release formulation for delivery to the distal small intestine and colon.
Tillotts Services manufacture the entire global needs for Colpermin® and are currently increasing capacity to meet the needs of current and new markets.
Case study II describes the optimisation of a Phase II formulation for a biotechnology customer who also required the expedient production of pilot batches of a semi-solid formulation within a two-piece, hard-shell capsule.
We were able to identify and optimise key process parameters and produce drug product to meet our customer’s planned clinical Phase II study.
Case study III is an NCE bioavailability enhancement study using a SMEDDS formulation. There are an increasing number of NCE’s coming through drug company pipelines that have poor aqueous solubility and consequently poor bioavailability.
Our formulation development group has considerable expertise in screening for compatible excipients for BCS Class II compounds and we were able to undertake a screening programme using our ExcipScreenTM service and identify a SMEDDS system and produce in vitro dissolution and oral PK results to demonstrate increased oral exposure in vivo.