DM2 platform II : development of an automated microscale manufacturing system for oral solid dosage forms

Moores, J and Abbas, F and Salehian, M and Macleod, C and Pierce, S G and Markl, D (2022) DM2 platform II : development of an automated microscale manufacturing system for oral solid dosage forms. In: CMAC Annual Open Day 2022, 2022-05-16 - 2022-05-18.

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Abstract

This platform aims to create a unique autonomous microscale drug product manufacturing and testing system to select formulation and process parameters that result in a stable product with desired critical quality attributes. The number of experiments increases drastically with the number of excipients, drug loadings and process conditions that need to be explored to find the optimal formulation and process settings. Integrating industrial digital technologies (IDTs) with innovative pharmaceutical process technologies will de-risk and accelerate drug product manufacture, reducing experiments and dramatically reducing development time and raw material/solvents use by 60%, whilst achieving CQA objectives by self-optimized formulation and process conditions. The platform is codeveloped and co-delivered with industry partners focusing on 1) tablets (via direct compression) and 2) capsules (via powder fill) . The initial aim of this platform is to deliver an automated microscale batch manufacturing system that ca n eliminate waste while preparing tablet batches of < 10 g per batch and < 50 tablets per batch.

ORCID iDs

Moores, J, Abbas, F, Salehian, M ORCID logoORCID: https://orcid.org/0000-0003-4073-292X, Macleod, C, Pierce, S G ORCID logoORCID: https://orcid.org/0000-0003-0312-8766 and Markl, D ORCID logoORCID: https://orcid.org/0000-0003-0411-733X;

Persistent Identifier

https://doi.org/10.17868/strath.00081202
CORE (COnnecting REpositories)