By Dilip M. Parikh

Using simple theories to commercial practices in pharmaceutical improvement, this moment version explains how new and rising applied sciences are used in the construction of pharmaceutical granulation-demonstrating reasonable ideas to fabricate solid-dosage kinds with constant actual homes whereas complying with present regulatory requisites.

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The states of pore filling have been defined as pendular (single bridges), Theory of Granulation 19 Figure 11 Static yield strength of wet agglomerates vs. pore saturation. ) (From Refs. ) funicular (partially complete filling and single bridges), capillary (nearly complete filling S % 80–100%) followed by drop formation, and loss of static strength. This approach will be extended in subsequent sections to include viscous forces and dynamic strength behavior (U 6¼ 0). The approach taken, in this chapter, follows this same vein of research as originally established by Rumpf and Kapur, namely, relating granule and particle level interactions to bulk behavior through the development of the rate processes of wetting and nucleation, granule growth and consolidation, and granule breakage and attrition.

Wetting promotes nucleation of fine powders, or coating in the case of feed particle size in excess of drop size. Often wetting agents such as surfactants are carefully chosen to enhance poorly wetting feeds. In the coalescence or growth stage, partially wetted primary particles and larger nuclei coalesce to form granules composed of several particles. The term nucleation is typically applied to the initial coalescence of primary particles in the immediate vicinity of the larger wetting drop whereas the more general term of Figure 4 The rate processes of agitative agglomeration, or granulation, which include powder wetting, granule growth, granule consolidation, and granule breakage.

Iveson SM, Litster JD, Hopgood K, Ennis B. Nucleation, growth, and breakage phenomenon in agitated wet granulation process: a review. Powder Technol 2001; 117:3–39. 9. Cambridge Healthcare Advisors (CHA) Report. com, September 29, 2004. 10. Guidance for Industry. Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations, Draft Guidance, September 2004. 2 Theory of Granulation: An Engineering Perspective Bryan J. A. 1. 1. Overview Wet granulation is a subset of size enlargement (1–5), which involves any process whereby small particles are agglomerated, compacted, or otherwise brought together into larger, relatively permanent structures in which the original particles can still be distinguished.

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