Request a copy of our scientific poster from EuPFI 2020 entitled, 'Current Practice in the Conduct of the Acceptability, Palatability, and Swallowability Trials.'

Guidance issued by the European Medicines Agency (EMA) states that patient acceptability must be an integral part of pediatric formulation development and described in the pediatric investigation plan (PIP). However, the methodology used to assess acceptability and the timing of this assessment is unclear. Previous reviews have used literature sources to review methods to assess acceptability with diverse methods reported.

Download our poster from AAPS 2020 titled, 'Improving the Stability of a Spray-Dried Peroxide-Susceptible Drug in Tablets.'

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 of 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.

Download our poster from AAPS 2020 titled, "A Quality by Design Approach to Optimize and Accelerate Formulation and Process Development Leading towards Registration Batches Manufacturing'.

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 to achieve a robust process before the product registration campaign.

Download our scientific poster from AAPS 2020 entitled, 'Scale-up Challenge of a Low-Dose Tablet Formulation through Blending and Roller Compaction Optimization.' 

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 before clinical trial manufacturing (CTM).

Request a copy of our poster presented at AAPS 2020 entitled, 'Development of Radiolabeled Surrogate Beads for Tracing Gastrointestinal Transit of Oral Multiparticulate Formulations'.

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.

Request a copy of our poster from AAPS 2020 titled, "Development of High Drug Load Multiparticulate Beads Using an Extrusion-Spheronization Process.

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.

Download our poster from AAPS 2020 entitled, 'Flexible formulation assessments in FIH studies for poorly soluble drugs accelerates dosage form development, manufacturing & supply for patient POC trials'.

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 the potential for clinical success.

Applied Molecular Transport Inc. is evaluating targeted drug delivery capsules for the administration of locally acting drugs directly to the site of action in the gastrointestinal (GI) tract. This study used gamma scintigraphy to evaluate GI transit and release from 3 capsule prototypes with different coating systems (1). In addition, data on pH, temperature, and pressure during GI transit was obtained using SmartPill® and correlated with scintigraphy data (2). Download our scientific poster today. 

Request a copy of our scientific poster entitled, "Risk-based Monitoring from a Phase I Clinical Site Perspective." 

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.

This approach improves the efficiency of the clinical trial site as the effort proactively concentrates on areas where the risks are deemed high, and a possible deficiency may be expected if the risk is not mitigated or removed.

Download Quotient Sciences' ASCPT 2021 poster, 'A FIH Study to Assess R941552 (R552): A selective Receptor Interacting Protein 1 (RIP1) Kinase Inhibitor'.
 

• RIPK1 (receptor interacting serine/threonine kinase 1) mediates cell survival through NF kB, or cell death through apoptosis or
  necroptosis downstream of TNF receptor activation.
• R552 is a potent and selective RIPK1 inhibitor that has been shown to block inflammatory cell death (necrotosis)
• R552 is being developed for the treatment of autoimmune and inflammatory disorders.
• Preclinical data suggested that solubility may limit exposure; alternative formulations were
  also assessed in this first in human (FIH) study.