Experimental granulations were produced using aqueous and alcoholic solutions of polymeric celluloses, vinyls, acrylamides, pyrrolidones, oxazolidinones, and ethylene oxide condensation products. Products were compared to control formulations granulated with starch paste. Dextroamphetamine sulfate was employed in a preliminary dialysis and dissolution study in the presence of the polymers shown to be of value. The experimental products exhibited gloss equal or superior to coated tablets in many instances, and no drug binding or inhibition of release occurred. The polymer-bound granulations displayed excellent flow properties, were easily compressed into tablets of various degrees of hardness, were generally more resistant to friabilation than the control; some of the polymers produced tablets which had equal or superior disintegration times compared to the control.
HE PHARMACEUTICAL elegance and ease of Tcompression of tablets are related directly to the particulate material or granulation from which the tablets are compressed. Granulation quality, in turn, is dependent on the materials used, processing techniques, and equipment employed. Of these variables, the materials used-especially the binding agent employed -are fundamental t o granulation particulate size uniformity, adequate hardness, and general quality.
Direct compression, facilitated by techniques such as induced die feeding and the availability of diluent granulation materials for admixture with drug, is a streamlined and substantially more economical method of tablet manufacture than the wet granulation approach. However, direct compression cannot completely replace wet granulation in the immediate future. Wet granulation may be required to produce uniform colored tablets, tablets containing potent drugs in low dosage levels with minimal intertablet variation, and special granulations such as those used in compression coating or pilule preparation.
Natural polymers, such as gums, have been used in the wet granulation operation as pilule or tablet granule binders, but few of the newer synthetic materials have thus far found application in this area. However, the synthetic polymeric materials do have a strong potential as binders based on their solubility characteristics, fibrous nature, long chain length, plasticity, compressibility, adhesive and binding abilities, as well as their ability to produce tablet surfaces of superior esthetic value (smoothness and gloss). This study of selected, nontoxic, commercially