Abstract
The aim of the work was to analyze the influence of process parameters of high shear granulation on the process yield and on the morphology of granules on the basis of dynamic image analysis. The amount of added granulation liquid had a significant effect on all monitored granulometric parameters and caused significant changes in the yield of the process. In regard of the shape, the most spherical granules with the smoothest surface were formed at a liquid to solid ratio of ≈1. The smallest granules were formed at an impeller speed of 700 rpm, but the granules formed at 500 rpm showed both the most desirable shape and the highest process yield. Variation in the shape factors relied not only on the process parameters, but also on the area equivalent diameter of the individual granules in the batch. A linear relationship was found between the amount of granulation liquid and the compressibility of the granules. Using response surface methodology, models for predicting the size of granules and process yield related to the amount of added liquid and the impeller speed were generated, on the basis of which the size of granules and yield can be determined with great accuracy.
Highlights
A wet granulation process is predominantly used in the pharmaceutical industry to manufacture tablets, which are the most widely used dosage form
high shear wet granulation (HSWG) is considered a complicated and multivariate pharmaceutical process that is influenced by a large number of variables derived from equipment, formulations, and processes [4]
We focused on the processing of the commonly used pharmaceutical excipient microcrystalline cellulose (MCC) by HSWG, in a wide range of liquid to solid (L/S) ratios at different impeller speeds
Summary
A wet granulation process is predominantly used in the pharmaceutical industry to manufacture tablets, which are the most widely used dosage form. The high shear wet granulation (HSWG) represents the most common method, fluid bed granulation (FBG) process is recently frequent [1]. Pharmaceutics 2021, 13, 1894 of this technique include: a shorter processing time, a greater densification of granules, a narrow range of operating conditions, a lower granulating fluid requirement, better predictability of the granulation end-point and better reproducibility [2]. Other benefits of HSWG include: reduced dustiness which minimizes losses, inhalation and explosion risks, improved flow and handling, controlled dissolution rates and co-mixing of particles which would otherwise segregate during handling [3]. HSWG is considered a complicated and multivariate pharmaceutical process that is influenced by a large number of variables derived from equipment, formulations, and processes [4]. Wet massing time can influence content uniformity in HSWG [6]
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