Pregelatinized Starch as a Binder in Wet Granulation: Optimization of the Incorporation Rate – Scientific Poster

The 12th APV PBP World Meeting took place from 28 – 31 March 2022 in Rotterdam. There was a poster section at the event where really interesting scientific posters were presented. Therefore we asked the presenting scientists if we could share their work in addition online with the Pharma Excipients community.

We already shared more than 15 posters from the PBP World Meeting 2022.

Here you see another one by O. Häusler; G. Le Bihan; P. Lefèvre; JB. Palmieri from Roquette:

Introduction:

In wet granulation, pregelatinized starches are preferred to starches (which require a cooking step), and when coupled with new generation high shear equipment leads to faster and consistent granules production due to a homogeneous binder and granulation liquid distribution  . It is common practice to use up to 15% of pregelatinized starches  in a formulation. The objective of this study is to evaluate the optimum amount of LYCATAB® PGS (pregelatinized maize starch) as a binder and granulation process conditions in order to get mannitol based tablet with desired properties.

Materials and Methods:

PEARLITOL® 50 C crystalline mannitol powder, Extra White maize starch, and LYCATAB® PGS pregelatinized maize starch are from Roquette Frères, France. Vegetal magnesium stearate is from Baerlocher, Germany.
Granulation trials: 1500 g of mannitol and maize starch (80/20) were granulated in a high shear mixer Diosna P16 (Diosna, Germany) (impeller at 250 rpm and chopper at 1800 rpm) with LYCATAB® PGS as binder at different incorporation rate (0, 3, 6, 9 and 15%) and 300 g of demineralized water. Mannitol, maize starch and LYCATAB® PGS were mixed together for 5 minutes (impeller and chopper rotation speeds at respectively 250 rpm and 1800 rpm); water was sprayed for 4 minutes, and mixing continued for 4 additional minutes.

Generated granules were dried in an Aeromatic Strea 1TM (Aeromatic, UK) at 50 C and calibrated with an Erweka oscillating calibrator (1000µm) (Erweka, Germany). Tableting trials: 600 g of granules (99.5%) and magnesium stearate (0.5%) mixed in a Turbula mixer (WAB, Switzerland) for 5 minutes. Tablets were made with Korsch XP1 single punch tablet press (Korsch AG, Germany) equipped with D13R13 concave punches at 20 tablets/min and
5 compression forces (5, 10, 15, 20 , 25 kN). Tablet characterization: weight, thickness, diameter, hardness were evaluated with a Pharmatron® ST50 (Sotax AG, Switzerland). Disintegration times were measured with a Pha rmatron® DT50 (Sotax AG, Switzerland). Tablets friability were measured with an Erweka TAR220 (Erweka, Germany).

See the results in the poster:
(click picture to enlarge)

Download the poster as PDF: Pregelatinized Starch as a Binder in Wet Granulation – Poster-2

Authors: O. Häusler; G. Le Bihan; P. Lefèvre; JB. Palmieri
from Roquette
Roquette Frères, 62136 Lestrem, France,
Contact: olaf.haeusler(at)roquette.com