AAPS 2020 Poster - Flexible formulation assessments in FIH studies for poorly soluble drugs accelerates dosage form development, manufacturing and 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 potential for clinical success.
AAPS 2020 Poster - 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.
AAPS 2020 Poster - 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.
AAPS 2020 Poster - 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 prior to clinical trial manufacturing (CTM).
AAPS 2020 Poster - A Quality by Deisgn 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 with the aim of achieving a robust process prior to the product registration campaign.
AAPS 2020 Poster - 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 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.
Maximising Formulation Flexibility in First-in-Human Trials
This edition of OBN’s Digital Event series is being organized in collaboration with Quotient Sciences and will highlight how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.
Advancing the CMC Development of Oncology Medicines
Oncology drugs dominate today’s industry pipeline with over >5500 molecules in development for 2019 alone. With this number of molecules, the stakes are high, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the challenges that come with oncology drug products in order to accelerate to proof-of-concept and onwards towards a successful commercial launch.
Advancing the Pharmaceutical Development of Orphan Drugs for Rare Diseases
With over 300 million people worldwide living with one or more identified rare diseases, the development of new treatments to address these unmet clinical needs is an area of significant focus in the pharmaceutical industry.
Strategies for Accelerating the Development of Modified Release Oral Forms
MR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
Current practice in the conduct of the acceptability - Palatability - swallowability trials - A review of methodology associated with trials registered on the EU clinical trials portfolio
Guidance issued by the European Medicines Agency (EMA) states that patient acceptability must be an integral part of paediatric formulation development and described in the paediatric 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