Direct Compaction Drug Product Process Modeling

Overview

Journal AAPS PharmSciTech

Publisher Springer

Specialty Pharmacology

Date 2022 Feb 1

PMID 35102457

Authors

Alexander Russell

John Strong

Sean Garner

William Ketterhagen

Michelle Long

Maxx Capece

Affiliations

Soon will be listed here.

Abstract

Most challenges during the development of solid dosage forms are related to the impact of any variations in raw material properties, batch size, or equipment scales on the product quality and the control of the manufacturing process. With the ever pertinent restrictions on time and resource availability versus heightened expectations to develop, optimize, and troubleshoot manufacturing processes, targeted and robust science-based process modeling platforms are essential. This review focuses on the modeling of unit operations and practices involved in batch manufacturing of solid dosage forms by direct compaction. An effort is made to highlight the key advances in the past five years, and to propose potentially beneficial future study directions.

Citing Articles

Advancements in the Application of Numerical Simulation During Tablet Compaction.

Li Z, Xiong H, Li Q, Naeem A, Yang L, Zhu W Pharmaceutics. 2025; 17(2).

PMID: 40006587 PMC: 11859525. DOI: 10.3390/pharmaceutics17020220.

The Comparison between Pilot-Grade Spray Dryer and Laboratory-Grade Spray Dryer: Structure, Powder Properties and Application for Direct Compaction.

Li Z, Peng W, Chen F, Zhu L, Naeem A, Zhu W AAPS PharmSciTech. 2024; 25(8):275.

PMID: 39604593 DOI: 10.1208/s12249-024-02991-8.

Design Space and Control Strategy for the Manufacturing of Wet Media Milled Drug Nanocrystal Suspensions by Adopting Mechanistic Process Modeling.

Bitterlich A, Mihorko A, Juhnke M Pharmaceutics. 2024; 16(3).

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