Rheological Analysis and Quantitative Evaluation of Wet Kneaded Wax Matrix

Abstract

Clarification of various factors affecting the quality characteristics of product and establishment of an acceptable range of characteristics play an essential role in stable manufacturing of the sophisticated and desired products. Wet mass properties during agitating granulation process provide strong influence on the quality of final products, and this process is widely used in the pharmaceutical, the plastic and the foods industries. However, agitating granulation process is associated with many operating parameters, which can be classified as apparatus variables (vessel shape and impeller shape), process variables (method of binder addition, wet kneading time and impeller speed) and product variables (powder properties, formulation and binder liquid volume). Both the evaluation of wet granulation and the analysis of observed behavior are very difficult.Many researchers [1][2][3][4][5][6] have studied the determination method for the critical parameters involved in wet granulation and wet kneaded mass; furthermore, they investigated the effects of such parameters on the granule size, its distribution and density. Although properties of wet granules are not directly and universally quantified by using the torque rheometry and power consumption measurements specific to respective machines, some attempts 7-9) have been carried out on the evaluation of granulation and its end point determination. Nevertheless, few reports have focused on the related properties of the wet kneaded mass to the dissolution of sustained-release drug despite of the fact that many different types of sustained-release dosage forms are urgently needed by medical circles to improve clinical efficacies and relevant patient compliance. 10)Watano et al. [11][12][13] have recently demonstrated that properties of the wet kneaded mass are directly characterized by internal pressure transmissions which are determined by using a newly developed compression tester instead of the torque rheometry. Furthermore, it was also documented that the pressure transmissions were strongly associated with water dispersion among the wet kneaded mass. Despite of these available findings, however, the pressure transmissions of the wet kneaded mass are not well identified. What's worse, to make full use of the features of the wet kneaded mass for manufacturing the sustained-release dosage forms, e.g. wax matrix products, all we have to do is to address the relationship between the pressure transmissions and the drug dissolution. In the present study, the author managed to expand the pressure transmission to the form of the rheological behavior to identify the character of the transmission. Scrutinized investigations about the expanded pressure transmission disclosed the plastic property of the wet kneaded mass that turned out to be the most decisive and direct criterion in the kneading process control. It is because the kneading process subjects the powder sample to be plastic for the preparation of the extrusion granulation. From a theoretical point of view, the e...

Differences in Powder Properties of Two 1,4-Dihydropyridine-Type Compounds Evaluated through Thermal Analysis

“…In some papers, compression properties have been discussed by analyzing compaction parameters. [3][4][5][6][7][8] The information obtained from these studies is useful for formulation development with appropriate tablet hardness and forecasting tableting trouble (capping or sticking tendency) at a commercial scale. However, information about the crystallinity of the compressed materials has not been considered.…”