Abstract
The purpose of this paper is to investigate inter-tablet coating thickness variability based on different tablet shapes and filling levels. To achieve this goal, the Discrete Element Method (DEM) is applied, and efforts are made as following: For the first step, four different tablet shapes, referred to as Sphere, SRC (Standard Round Concave), Oval and Triangular, are built by importing three (except Sphere) CAD templates to create one or more spherical surfaces. Furthermore, a spray zone in the coating pan is presented to monitor the change of the “coating mass”, by virtue of which we calculate the inter-tablet coating variability. And to complete this work, custom contact models and properties are created to describe coating. Then, three different filling levels are added to the simulation. Eventually, the compared results are analyzed between three diverse filling degrees among tablet particles with four discrepant shapes.
Highlights
2 BackgroundCoating serves a wide variety of functions in pharmaceutical industry, such as avoiding the influences of external factors and gastric acidity to guarantee the bioavailability effectiveness of drugs, masking drugs color, flavors and odors to improve the physical attribution and esthetics level of medicines and controlling the release profile of the drug to regulate its absorption degree
It can be observed that under different filling levels, tablets of different shapes take on similar features from Fig. 4 (a)-(c)
Four kinds of tablets have an approximately linear increasing average coating mass, among which Triangular tablets possess greatest average coating mass due to the bigger surface area comparative to other different-shaping tablets, and the rest three kinds of tablets (Sphere, SRC and Oval) have close values in mean coating mass, but Oval tablets bear the least average coating mass resulting from the smaller surface area
Summary
2 BackgroundCoating serves a wide variety of functions in pharmaceutical industry, such as avoiding the influences of external factors (moisture, air, light) and gastric acidity to guarantee the bioavailability effectiveness of drugs, masking drugs color, flavors and odors to improve the physical attribution and esthetics level of medicines and controlling the release profile of the drug to regulate its absorption degree. Controlling inter-tablet coating variability is of great significance for film coated tablets to work well. To succeed in obtaining a qualified batch of tablets, a prescribed coating with a thin film of polymer onto each tablet’s surface which means low inter-tablet variability is needed. Coating variability is divided into two types [1]: the inter-tablet coating variability which represents the coating variability from tablet to tablet, and the intra-tablet coating variability which indicates the variability in the coating mass over the surface of a single tablet. The inter-tablet variability is of particular notice to research the influential factors in the coating to minimize the inter-tablet variability. The Discrete Element Method (DEM) is used to simulate the coating process so as to track the inter-tablet variability. A spray zone and the spray droplets are modeled to get the coating mass in order to calculate the inter-tablet variability. An analytical work and a comparative study have been done between tablet particles in various shapes, and between several kinds of filling levels
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