Effect of formulation solubility and hygroscopicity on disintegrant efficiency in tablets prepared by wet granulation, in terms of dissolution.
The effect of tablet formulation solubility and hygroscopicity on the dissolution efficiency of three "super disintegrants" (sodium starch glycolate, crospovidone, and croscarmellose sodium) in tablets prepared by wet granulation was investigated. Lactose, calcium phosphate dibasic, sorbitol, and naproxen sodium, alone or in combination, provided varying degrees of solubility and hygroscopicity in the formulations. To monitor in vitro dissolution, 1% p-aminobenzoic acid was added to the formulation as a tracer. The results indicate that highly soluble and/or hygroscopic ingredients decrease the effectiveness of super disintegrants in promoting in vitro dissolution. The greater the overall hygroscopicity and solubility of the tablet formulation, the larger the decrease in the efficiency of the super disintegrant.
Johnson
J R
JR
Institute of Pharmaceutical Sciences, Syntex, Palo Alto, CA 94304.
Wang
L H
LH
Gordon
M S
MS
Chowhan
Z T
ZT
D002130:Calcium Phosphates / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D005079:Excipients; D006244:Hardness; D007785:Lactose / Q000737:chemistry; D011208:Powders; D012995:Solubility; D013607:Tablets
D002130:Calcium Phosphates; D005079:Excipients; D011208:Powders; D013607:Tablets; C485828:alpha-tricalcium phosphate; C485830:tetracalcium phosphate; C485838:calcium phosphate, monobasic, anhydrous; C020243:calcium phosphate; D007785:Lactose; C485829:calcium phosphate, dibasic, anhydrous