This invention generally relates to a novel method of producing readily disintegrable pharmaceutical compositions. More particularly, it relates to pharmaceutical compositions in the form of tablets containing soy polysaccharides as a disintegrant.
Pharmacological substances are commonly administered orally by means of solid dosage forms such as tablets. Tablets are solid pharmaceutical compositions containing pharmacological or therapeutically active substances in desired, accurate amounts with or without suitable diluents and prepared either by compression or molding methods. Production methods for making tablets require the presence of materials other than the therapeutically active substances for the efficient and economical manufacture of the tablet dosage form. Additional ingredients may also be present in the tablet formulation to enhance the appearance of the tablet, improve stability and aid in disintegration after administration. A disintegrating agent is a material or mixture of materials added to a tablet to facilitate its breakup or disintegration after administration. The therapeutically active substance must be released from the tablet composition as efficiently as possible to allow for its rapid dissolution. The disintegrating agent is usually admixed with the therapeutically active substance prior to granulation. Materials serving as disintegrating agents have been chemically classified as starches, clays, cellulose, algins or gums. Starches are the most widely used disintegrating agents. Other disintegrating agents include veegum HV [Gross, H. M.. and C. H. Becker. "A Comparative Study of Tablet Disintegrating Agent," J. Amer. Pharm. Assoc. Sci. Ed., 41:157 (1952).]; methylcellulose, agar [Firouzabadian, A., and C. I. Huyck. 37 Some Recently Developed Chemicals as Disintegrating Agents for Compressed Tablets," J. Amer. Pharm. Assoc. Sci. Ed., 43:248 (1954).]; bentonite [Granberg, C. B., and B. E. Benton. "The Use of Dried Bentonite As A Disintegrating Agent in Compressed Tablets of Thyroid," J. Amer. Pharm. Assoc. Sci. Ed., 36:648 (1949).]; cellulose product [Fakouhi, T. A., et al. "Wood Products, Corncob, and Cellullose as Tablet Disintegrating Agents," J. Pharm. Sci., 52:700 (1963).]; [Bequette, R. J., and C. L. Huyck. "Tablet Disintegration with Cellulose," Drug Cosmetic Ind., 81:166 (1957).]; natural sponge [Crisafi, R. C. and C. H. Becker. "A study of Natural Sponge As a Disintegrating Agent in Compressed Tablets," J. Amer. Phar. Assoc. Sci. Ed., 47:363 (1958)]; cation-exchange resin [Van Abbe, N. J., and J. T. Rees. "Amberlite Resin XE-88 As A Tablet Disintegrant," J. Amer. Pharm. Assoc. Sci. Ed. 47:487 (1958)]; alginic acid [Gerding, T. G., and Dekay, H. G. "Alginic Acid and Its Derivatives as Binding and Disintegrating Agents in Tablet Manufacture," Drug Std., 23:132 (1955).]; and guar gum [Eatherton, L. E., et al. "Guar Gum As A Binder and Disintegrator for Certain Compressed Tablets," Drug Std., 23:42 (1955).]
When the more common disintegrating agents, such as starch, do not provide the required functionality in a particular system, there are still other commercially available disintegrating agents such as carboxymethyl starch, polyvinylpyrolidone, sodium carboxymethyl di-cellulose, cross-linked carboxymethyl cellulose and mechanically modified starch. For various reasons, i.e., poor efficiency, deterioration, adverse effects upon the therapeutically active substance, high cost, etc., there is a need for a low cost, efficient, disintegrating agent that is effective at low use levels.
The present invention represents an improvement in the art of preparing readily disintegrable pharmaceutical compositions. A small amount of soybean polysaccharides can be mixed with the therapeutically active substance and made into a tablet by conventional tableting techniques to produce a sufficiently hard, readily disintegrable tablet.