Alternative Granulation Technique: Melt Granulation
- 1 January 1996
- journal article
- research article
- Published by Taylor & Francis in Drug Development and Industrial Pharmacy
- Vol. 22 (9-10), 917-924
- https://doi.org/10.3109/03639049609065921
Abstract
A melt granulation process has been investigated (1, 2) which efficiently agglomerates pharmaceutical powders for use in both immediate- and sustained-release solid dosage forms. The process utilizes materials that are effective as granulating fluids when they are in the molten state. Cooling of the agglomerated powders and the resultant solidification of the molten materials completes the granulation process. Both the molten agglomeration and cooling solidification were accomplished in a high shear Collette Gral mixer equipped with a jacketed bowl. Hence, the melt granulation process replaces the conventional granulation and drying operations which use water or alcohol solutions. The melt granulation process has been investigated using immediate- and sustained-release TAVIST® (clemastine fumarate USP) tablet formulations. The TAVIST granulations have been characterized by power consumption monitoring, measurement of the granulation particle size distribution, bulk and tapped density determinations, and loss-on-drying measurements. Scale-up of the melt granulation process for the sustained release TAVIST tablet formulation was judged successful based on a comparison of the hardness, friability, weight uniformity during compression, disintegration time, and dissolution rate data obtained at different manufacturing scales.Keywords
This publication has 4 references indexed in Scilit:
- Melt Granulation in A Laboratory Scale High Shear MixerDrug Development and Industrial Pharmacy, 1990
- Granulation: A Review on Pharmaceutical Wet-GranulationDrug Development and Industrial Pharmacy, 1987
- The Control of Drug Release from Conventional Melt Granulation MatricesDrug Development and Industrial Pharmacy, 1987
- The evaluation of formulation and processing conditions of a melt granulation processInternational Journal of Pharmaceutics, 1984