PhD Scientific Days 2025

Pharmaceutical Sciences and Health Technologies II.

Production and Testing of High Active Ingredient Tablets

Előadó neve

Ms. Berenji Péter

Neptun code

HY340R

Előadó munkahelye

Department of Pharmaceutics

Előadó telefonszáma

+36202831562

Előadó e-mail címe

berenji.peter@phd.semmelweis.hu

Az előadás címe

Production and Testing of High Active Ingredient Tablets

Szerző(k) neve és munkahelye

Péter Berenji¹

1: Department of Pharmaceutics

Bemutatás módja

Szóbeli

Szekció

Pharmaceutical Sciences and Health Technologies II.

Language of the presentation

Hungarian

Preferred session

Pharmaceutical Sciences and Health Technologies

Összefoglaló szövege

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.”

University

Semmelweis University

Supervisor

Dr István Antal Department of Pharmaceutics, Semmelweis University, Dr Pál Fekete MEDITOP Pharmaceutical Ltd.

Publication of my abstract

I give consent to the publication of my abstract on the website of the congress.

phd.section.field

in doctoral studies before complex exam (PhD)

Kind

Szabad

Status

elfogadva

Accepted presentation method

szóbeli

Előadás fájl jóváhagyás

jóváhagyta

Előadó

9072

Start

12:30

End

12:45