PhD Scientific Days 2026

Pharmaceutical Sciences and Health Technologies 3.

Production and Testing of High Active Ingredient Tablets

Előadó neve

Berenji, Péter, MSc

Neptune code

HY340R

Előadó munkahelye

Semmelweis University, Faculty of Pharmacy, 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: Semmelweis University, Faculty of Pharmacy, Department of Pharmaceutics

Bemutatás módja

Szóbeli

Szekció

Pharmaceutical Sciences and Health Technologies 3.

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, especially for tablets with high active pharmaceutical ingredient (API) content. It improves flowability, compressibility, and content uniformity, while preventing ingredient sedimentation and reducing dusting. For micronized APIs, producing homogeneous granules with excellent rheological properties is essential for high-quality final products.
Aims: The strategic goal is to improve patient compliance by developing smaller, easier-to-swallow tablets with reduced excipient content. This study investigates different molecular weight polyethylene glycols (PEG 4000, 6000, 8000) as binders to produce wet granulation formulations with high API content (>85%).
Methods: Granules of five different APIs were produced using a Procept laboratory high-shear wet granulator and a Romaco Ventilus 2.5L fluid bed dryer. Granulation solutions contained purified water and PEG (1-10% w/w calculated on the API). The dried granules were regranulated on a 2 mm sieve and characterized for moisture content, bulk/tapped density, flowability, and particle size distribution using Malvern Mastersizer 3000. Tablets were then compressed using a Korsch single-punch press with a uniform external phase.
Result: PEG-based granulation yielded granules with narrower particle size distributions and superior rheological properties compared to traditional polyvinyl alcohol-based reference samples. While Metamizole sodium showed unexpected rheological behavior, Diosmin, Paracetamol, and Levetiracetam granules exhibited excellent flowability. These results led to improved tableting consistency, uniform weight distribution, and high-strength tablets with appropriate disintegration times.
Conclusion: Polyethylene glycols of various molecular weights are suitable binders for high-dose formulations across diverse chemical profiles. The technology enables the production of tablets with reduced size and high API loads, potentially enhancing patient adherence.
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, Dr Pál Fekete

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

nem rendelkezett róla

Előadó

9072

Start

13:00

End

13:10