PhD Scientific Days 2025

Pharmaceutical Sciences and Health Technologies II.

Production and Testing of High Active Ingredient Tablets

Name of the presenter

Berenji Péter

Institute/workplace of the presenter

Department of Pharmaceutics

Authors

Péter Berenji¹

1: Department of Pharmaceutics

Text of the abstract

Introduction: Granulation is a critical operation in the manufacture of solid oral dosage forms, particularly tablets, as it improves the flowability, compressibility and content uniformity of powders. This process prevents sedimentation of ingredients, promotes accurate dosing and reduces dusting, thus contributing to a higher quality end product.

Aims: In this work, different polyethylene glycols (PEGs) were investigated that allow the production of high active ingredient (>85%), high shear strength wet granulation formulations.

Methods: Granules were produced using Procept's laboratory high shear wet granulation unit and Romaco's Ventilus 2.5L fluid bed dryer. 3 PEGs and 5 APIs were selected as starting materials. One API was micronised to a D95 particle size of less than 2µm. Due to the low bulk density of the APIs, kneading was performed in a 4L vessel. The granulation solutions contained purified water and PEG. The concentration of PEG was 1-10% w/w calculated on the API. The resulting granules were granulated on a 2 mm sieve. The resulting semi-finished product was tested for moisture, trap and bulk density, measured for rolling properties and particle size distribution.

Result: Some of the granules obtained are suitable for further tabletting. PEGs are suitable as binders for some APIs.

Conclusion: Based on the experiments carried out, it can be concluded that PEGs of different molecular weights are suitable for use as binders for APIs with different physical and chemical properties for the production of granules by wet granulation technology.

Funding: „PROJECT NO. EKÖP-24-KDP-2 HAS BEEN IMPLEMENTED WITH THE SUPPORT PROVIDED BY THE MINISTRY OF CULTURE AND INNOVATION OF HUNGARY FROM THE NATIONAL RESEARCH, DEVELOPMENT AND INNOVATION FUND, FINANCED UNDER THE 2024-2.1.2 UNIVERSITY RESEARCH SCHOLARSHIP PROGRAM - COOPERATIVE DOCTORAL PROGRAM FUNDING SCHEME.”