Systematic Approach to High Dosage Formulation Development for Continuous Direct Compression

Barbara Schaller, Kevin Moroney, Bernardo Castro Dominguez, Patrick Cronin, Denise Croker, Gavin Walker

Research output: Contribution to conferenceAbstract

Abstract

Continuous direct compaction for high dosage formulations is a challenging topic. The understanding of the raw material properties and identification of the critical material and process parameters is key to predicting a continuous manufacturing process and implementing control parameters. A systematic strategy has been developed to enable formulation and process design for poorly flowing active pharmaceutical ingredients (API). Currently, high dosage formulations are manufactured mainly via wet granulations including various processing steps. The length of process makes it more time consuming, costly and challenging to minimise process deviations relative to direct compression A case study using a poor flowing model API at a high drug loading (~ 50 wt%) was used to evaluate the strategy. The approach adopted is material sparing, targeted and time efficient. The accumulated material database can be used to expedite future developments. A series of characterisation techniques have been used to analyse various pharmaceutical powders to identify their flow and compaction behaviour. This information was used to predict blend behaviour and inform formulation design. Independent lab scale predictors of manufacturing performance have been developed on a benchtop compaction simulator. The success of this strategy has been shown by scaling up to an R&D rotary tablet press maintaining all critical quality attributes (CQAs).
Original languageEnglish
Publication statusPublished - 29 Oct 2018
Event2018 AIChE Annual Meeting: Today, Tomorrow & Leading the Future - David L. Lawrence Convention Center, Pittsburgh, USA United States
Duration: 28 Oct 20182 Nov 2018
https://www.aiche.org/conferences/aiche-annual-meeting/2018

Conference

Conference2018 AIChE Annual Meeting
Abbreviated title18AIChE
CountryUSA United States
CityPittsburgh
Period28/10/182/11/18
Internet address

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    Schaller, B., Moroney, K., Castro Dominguez, B., Cronin, P., Croker, D., & Walker, G. (2018). Systematic Approach to High Dosage Formulation Development for Continuous Direct Compression. Abstract from 2018 AIChE Annual Meeting, Pittsburgh, USA United States.