Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

Overview

Journal AAPS PharmSciTech

Publisher Springer

Specialty Pharmacology

Date 2020 Jun 24

PMID 32572701

Citations 11

Authors

Josip Matic

Amrit Paudel

Hannes Bauer

Raymar Andreina Lara Garcia

Kinga Biedrzycka

Johannes G Khinast

Affiliations

Soon will be listed here.

Abstract

This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-of-the-art theoretical concepts, modeling, and experimental characterization described in the literature and developed by us. Next, lab-scale extruder setups are designed (processing conditions and screw design) based on a rational, model-based framework that takes into account the thermal load required, the mixing capabilities, and the thermo-mechanical degradation. The predicted optimal process setup can be validated quickly in the pilot plant. Lastly, a transfer of the process to any GMP-certified manufacturing site can be performed in silico for any extruder based on our validated computational framework. In summary, the proposed workflow massively reduces the risk in product and process development and shortens the drug-to-market time for enabling formulations.

Citing Articles

Scope and Application of Hot Melt Extrusion in the Development of Controlled and Sustained Release Drug Delivery Systems.

Joshi P, Koteswara Rao G, Chatterjee B Curr Pharm Des. 2024; 30(32):2513-2523.

PMID: 39108005 DOI: 10.2174/0113816128299356240626114734.

The Increase in the Plasticity of Microcrystalline Cellulose Spheres' When Loaded with a Plasticizer.

Paulausks A, Kolisnyk T, Mohylyuk V Pharmaceutics. 2024; 16(7).

PMID: 39065642 PMC: 11279479. DOI: 10.3390/pharmaceutics16070945.

Transfer of a rational formulation and process development approach for 2D inks for pharmaceutical 2D and 3D printing.

Schulz M, Bogdahn M, Geissler S, Quodbach J Int J Pharm X. 2024; 7:100256.

PMID: 38882398 PMC: 11176655. DOI: 10.1016/j.ijpx.2024.100256.

Material-Sparing Feasibility Screening for Hot Melt Extrusion.

Pluntze A, Beecher S, Anderson M, Wright D, Mudie D Pharmaceutics. 2024; 16(1).

PMID: 38258087 PMC: 10819182. DOI: 10.3390/pharmaceutics16010076.

Tailored ASD destabilization - Balancing shelf life stability and dissolution performance with hydroxypropyl cellulose.

Luebbert C, Stoyanov E Int J Pharm X. 2023; 5:100187.

PMID: 37396620 PMC: 10314205. DOI: 10.1016/j.ijpx.2023.100187.

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