A critical review on granulation of pharmaceuticals and excipients: Principle, analysis and typical applications

Solid dosage forms require the addition of different types of excipients such as flowability, compressibility, disintegration, solubility, stability and other physical and chemical properties to the active pharmaceutical ingredient (API) in order to achieve the physical and chemical properties required by the pharmaceutical industry. In the pharmaceutical industry, the most common way to achieve these properties is by mixing the drug substance with a variety of excipients and granulating them using different techniques to ensure uniform mixing, such as direct mixing, roll granulation, spray drying or freeze drying. This paper introduces in detail the mixing granulation process, equipment, technical principles, key parameters, detection methods and typical applications which are most commonly used in the pharmaceutical industry. It is hoped that this review will provide some insight for all researchers engaged in the granulation method of formulating solid dosage forms.