Leveraging Artificial Intelligence for Advancements in Liquid Dosage Formulations in the Pharmaceutical Industry

Document Type

Article

Publication Title

Therapeutic Innovation and Regulatory Science

Abstract

Formulation strategies are vital in drug development, but trial-and-error optimization of critical parameters is inefficient. Artificial Intelligence (AI) addresses this by enabling data-driven decision-making. AI has emerged as a pivotal tool in drug discovery, formulation, and development. This manuscript explores the significant applications of AI in various aspects of liquid dosage form manufacturing, aligned with Industry 5.0 principles. This integration seeks to enhance productivity, monitor and modify development processes, enable human-centric automation, improve product quality, and optimize industry workflows. Essential steps in developmental design include solvent selection, drug-excipient compatibility, crystallinity, salt formation, permeability, and stability. This technological approach facilitates rapid decision-making and ensures batch-to-batch consistency by investigating major attrition rates in manufacturing and discovery. We highlight the utilization of AI tools and techniques alongside Process Analytical Technology (PAT) for real-time applications in the production of parenteral solutions, suspensions, emulsions, and other liquid forms. A comprehensive review of the current state of AI in common manufacturing steps involved in liquid dosage formulation development is provided, identifying potential research gaps. We discuss ongoing challenges, propose realistic strategies to address these challenges and outline future research directions.

First Page

1004

Last Page

1031

DOI

10.1007/s43441-025-00823-w

Publication Date

9-1-2025

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