Dilip M. Parikh
Synthon Pharmaceuticals Inc., Research Triangle Park, North Carolina, U.S.A.

 PHARMACEUTICAL GRANULATION TECHNOLOGY

INTRODUCTION

Perry’s Chemical Engineer’s Handbook (1) defines the granulation process as ‘‘any process whereby small particles are gathered into larger, permanent masses in which the original particles can still be identified.’’ This definition is of course particularly appropriate to a pharmaceutical granulation where the rapid breakdown of agglomerates is important to maximize the available surface area and aid in solution of the active drug.

The granulation process of size enlargement used within the pharmaceutical industry has its roots in ancient times. The practice of delivering medicinal powder by hand rolling into a pill by using honey or sugar has been used for centuries. It is still the practice to deliver the botanical and herbal extract in homeopathic and ayurvedic branches of medicine, which are still practiced in India along with allopathic medicine.

The term ‘‘granulated’’ material is derived from the Latin word ‘‘granulatum,’’ meaning grained. The granulated material can be obtained by direct size enlargement of primary particles, or size reduction from dry compacted material. In modern times, granulation technology has been widely used by a wide range of industries, such as coal, mining, and agrochemical. These industries employ agglomeration techniques to reduce dust, provide ease of handling, and enhance the material’s ultimate utility.

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