Resource Centre

Download our EuPFI 2021 Conference Poster entitled: Development of a Novel Paediatric Belumosudil Oral Suspension

Presented at the 24th North American ISSX Meeting, in this poster, we determine Mass Balance, Metabolite Profile and Identification and Absolute Bioavailability of Nolasiban in Healthy Female Subjects, via an integrated radiolabelled study.

Download our CRS 2021 conference poster entitled: Using formulation design spaces and clinical data to optimize development of modified release (MR) dosage forms

Poster presentation at NERDG 2021 Annual Meeting. In this poster we demonstrate an optimized approach to developing oral modified-release (MR) dosage forms using the Translational Pharmaceutics platform. This approach uses emerging human data to inform adjustment of formulation composition in an adaptive clinical study.

Download our latest poster from the ASCPT 2021 conference, "A First in Human (FIH) Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses, and Alternative Formulations of R941552 (R552): A selective Receptor Interacting Protein 1 (RIP1) Kinase Inhibitor"

Risk-Based Site Monitoring (RBSM) has been developed as an effective approach to overseeing clinical trials without compromising ethics, volunteer safety, data integrity, quality, timelines, and regulatory compliance. This approach is based on risk assessment, mitigation and, when possible, the removal of risks allowing the allocation of the resources in the activities where they are needed the most.

Here we describe how the integration of formulation development, compounding and GMP manufacturing activities within the FIH to POC program can streamline development and maximize potential for clinical success.

During high shear wet massing, changes in impellor torque occur as a result of changes in cohesive forces in the wet powder bed, and can be used to assess end points. However, for these formulations the change in torque was not sensitive enough for end point identification. Optimal end point for extrusion-spheronization reached just before the traditional wet granulation end point.

Gamma scintigraphy is a proven imaging technique used to visualize the in vivo performance of pharmaceutical dosage forms. Combined with pharmacokinetic (PK) analysis, the clinical outcomes provide an understanding of the impact of formulation composition, patient factors and human physiology on in vivo drug absorption. For oral solid dosage forms, technetium-99m and indium-111 are the most commonly used radioisotopes for scintigraphy studies. These radioisotopes can be directly incorporated into the formulations during manufacture or spiking into the drug product. For formulations such as multiparticulates, it would be challenging to radiolabel using these conventional methods. Therefore a specifically designed radiolabelled surrogate with similar physical properties to active multiparticulate was required.

The purpose of this investigation was to address the content uniformity challenge faced during the scale up for a low dose tablet formulation of Drug X on an accelerated development program. Experiments were performed to demonstrate optimized processing prior to clinical trial manufacturing (CTM).

To improve the existing formulation composition and manufacturing process of compound X which was designed for early phase development Process optimization activities focused on improving the flow characteristics of the granules, minimizing or eliminating segregation and increasing the manufacturing yield with the aim of achieving a robust process prior to the product registration campaign.

Compound X (Cmp-X) belongs to the class of PDE-5 inhibitors and is a BCS Class II candidate with equilibrium solubility <3 μg/mL, thus exhibiting a dissolution rate limited bioavailability. The purpose of this work is to develop an amorphous solid dispersion (ASD) by spray drying and monitor and improve the physical and chemical stability upon storage for developing a successful solid dosage formulation.