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The main objective of the study is to apply the principles of QbD (Quality by Design) utilizing a predetermined risk-based approach to identify and optimize the Critical Process Parameters (CPPs) of roller compacted capsule product ensuring minimum impact on the Critical Quality Attributes (CQAs) to provide a product with desired quality.

Chronic drooling or sialorrhoea is evident in the pediatric population and is particularly prominent in those who suffer with neurological disorders such as cerebral palsy.

Development of an MR formulation of Cmp-1 was planned using RapidFACT®: an integrated approach that allows formulation optimization based on human PK data with an adaptive clinical design. Selection of a discriminatory in vitro dissolution test was an important early development activity.

The objective of the study is to evaluate the overall risk on the process transferability of a poorly flowing blend between two (2) - 10 cu.ft V blenders manufactured by different vendors.

Formulation strategies and the DevelopabilityClassification System (DCS). Benefits of spray-drying to address poor drug solubility. Fit-for-purpose systems in early clinical research and effectively transitioning to solid oral dosage forms. Adaptive clinical manufacturing “tailored” to the clinical study and patient recruitment.

The aim of the development program was to develop an aqueous, multidose oral liquid formulation of glycopyrronium bromide 2mg/5ml for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in paediatric patients aged 3 years and older with chronic neurological disorders.

Deutetrabenazine (Austedo, Teva) is approved for the treatment of chorea associated with Huntington’s disease (HD) and tardive dyskinesia (TD). Deutetrabenazine is the first deuterated product approved by the FDA and only the second product approved in HD and TD. Deutetrabenazine is a novel VMAT2 inhibitor that is structurally related to tetrabenazine, with two trideuteromethoxy groups at the 9- and 10-positions in tetrabenazine

The integration of formulation design space, real-time GMP manufacturing, and an iterative sequential pharmacokinetic (PK) study in healthy volunteers was successfully applied to develop an HPMC matrix tablet that achieved the desired PK characteristics for SLx-2101.The key formulation variables influencing performance were the range of dose and release rate, hence a two-dimensional (2D) design space was mapped by manufacturing and characterizing four “regulatory batches” bracketing the corners of the compositional ranges.

Conventional human metabolism studies are well understood study designs which help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required.

The aim of the phase 1, single-center, randomized, active-controlled study in healthy volunteers reported in this paper was to investigate the pharmacodynamic effects and safety of different dosing regimens of RDX7675 in humans.

This presentation describes the principles and applications of Translational Pharmaceutics: an R&D platform integrating formulation development, real-time adaptive GMP manufacturing and clinical testing in order to accelerate drug development cycles.

This poster describes how adopting a real-time drug product manufacturing approach allowed initiation of the FIH study within 12 weeks of initiating SDD process transfer.