To characterize dry powder properties and evaluate difference between wet and dried microcrystalline cellulose (MCC 105) granules formed by different amounts of Plasdone S-630 by using rheological and thermal tools.

摘要

Powder rheology is an important factor considered in tablet manufacturing. During tablet processes like blending, transfer, storage and feeding to press can lead to powder becoming segregated which further leads to problems in content uniformity and weight variation. The objective of this study is to determine the end point of wet granulation using thermal and rheological properties of powders. Microcrystalline cellulose grades are the polymers, which are widely used in pharmaceutical industries. Microcrystalline cellulose 105 (Avicel 105) was used as model powder to investigate behavior of wet and dry granules formed by using wet granulation process. Each batch of powder was granulated with 5 and 10% w/w binder concentrations solutions.;The powder characterization was done using Freeman technology Rheometer and it gives huge insight into powder flowability character. Various Shear, bulk, flow energies and processability studies are done to evaluate the flow characteristics of Microcrystalline cellulose 105.;Wet granulation is a common unit operation in a chemical industry but finding an accurate end point in wet granulation still remains a challenge. So, different concentrations of binder are added to determine the critical end point for wet granulation. Lab and large-scale batches were made. In lab scale thermal effusivity tests were done to find an optimum end point while in large scale research rheological studies are done on both the wet and dry granules. The results of both scales were compared to find critical end point of wet granulation, which gives insight into MCC-105 granule behavior.;Granule strength and tablet hardness tests were performed to find tablet toughness. As the concentration of binder increased, hardness of tablets increased.;Differential scanning Calorimetry (DSC) was used to determine changes in enthalpy values of wet granules.