Dry Granulation It is possible to form granulates without the addition of a granulating fluid, by techniques generically referred to as dry granulation.

These methods are useful for materials that are sensitive to heat and moisture, but which may not be suitable for direct compression. Dry granulation involves the aggregation of particles by high pressure to form bonds between particles by virtue of their close proximity. Two approaches to dry granulation are used in the pharmaceutical industry: slugging and roller compaction. In either method, the material can be compacted with a binder to improve the bonding strength. Slugging. Granulation by slugging is, in effect, the manufacture of large compacts by direct compression. The slugs produced are larger than tablets and are often poorly formed tablets exhibiting cracking and lamination. As with tablets, it may be necessary to add a lubricant to prevent the compacts sticking to the punches and dies. The compressed material is broken up and sieved to form granules of the appropriate size. The granules are then blended with disintegrant and lubricant, and compressed on a normal tablet machine. Roller compaction. In roller compaction, the powder is compacted by means of pressure rollers (Fig. 23). It is fed between two cylindrical rollers, rotating in opposite directions. The rollers may be flat, which will produce sheets of compacted material, or they may be dimpled, in which case, briquettes in the shape of the dimples will be formed. If sheets are produced,
they are milled and screened to the required size. Roller compaction requires less lubricant to be added than does slugging. Selection of the Appropriate Process The methods of formulating and manufacturing tablets have been described in the preceding sections. Each method has certain unique benefits and advantages as well as drawbacks, and these are summarized in Table 14. For any given compound, there will normally be more than one approach that is technically feasible, so how does one choose which approach to take? For most formulators, the choice is strongly influenced by the philosophy of the production department of the company in which they work. Different companies can have very different philosophies; some believe that the cost savings of direct compression are such that attempts should be made to formulate all tablets by this route, other companies feel that wet granulation is a more robust process, and should be used even when a compound looks amenable to the direct compression route.