Biomaterial Database

Effect of tablet solubility and hygroscopicity on disintegrant efficiency in direct compression tablets in terms of dissolution. 1987

M S Gordon, and Z T Chowhan

Institute of Pharmaceutical Sciences, Syntex, Inc., Palo Alto, CA 94304.

The effect of tablet composite solubility and hygroscopicity on the dissolution efficiency of three "super disintegrants", sodium starch glycolate, crospovidone, and croscarmellose sodium, was investigated. Lactose, dicalcium phosphate dihydrate, and sorbitol, alone or in combination, provided varying degrees of solubility and hygroscopicity to the direct compression tablet formulations. To monitor in vitro dissolution, 1% p-aminobenzoic acid was added to the formulation as a tracer. The results indicate that hygroscopic ingredients decrease the effectiveness of super disintegrants in promoting in vitro dissolution. The greater the overall hygroscopicity of the tablet formulation, the larger the decrease in the efficiency of the super disintegrant. Composite tablet solubility did not influence the effectiveness of the super disintegrants. Super disintegrants that complied with the same compendial specifications, but were manufactured by different companies, behaved similarly in promoting tablet dissolution.

UI	MeSH Term	Description	Entries
D011208	Powders	Substances made up of an aggregation of small particles, as that obtained by grinding or trituration of a solid drug. In pharmacy it is a form in which substances are administered. (From Dorland, 28th ed)	Powder
D002626	Chemistry, Pharmaceutical	Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.	Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D004339	Drug Compounding	The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814).	Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, Drug
D005079	Excipients	Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.	Excipient,Stabilizing Agent,Stabilizing Agents,Suspending Agent,Suspending Agents,Agent, Stabilizing,Agent, Suspending,Agents, Stabilizing,Agents, Suspending
D006245	Hardness Tests	A test to determine the relative HARDNESS of a metal, mineral, or other material according to one of several scales, such as Brinell, Mohs, Rockwell, Vickers, or Shore. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed).	Hardness Test,Test, Hardness,Tests, Hardness
D012995	Solubility	The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)	Solubilities
D013607	Tablets	Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)	Tablet