Development of a stable oral liquid dosage form of spironolactone.
A clear, stable, oral liquid dosage form of spironolactone has been developed. Solubility profiles of spironolactone were obtained in several co-solvent blends. Using this data, a co-solvent blend containing polyethylene glycol 400 (30% v/v), propylene glycol (10% v/v), glycerin (10% v/v) and ethyl alcohol (10% v/v) was used to solubilize spironolactone at a concentration of 2 mg/ml. The final formulation contained sweetening agents (sucrose, saccharin sodium), flavours (cherry, sweet), a desensitizing agent (menthol), a dye (FD&C Red #40) and a preservative (benzoic acid) to incorporate the desired organoleptic and preservative properties. A phosphate buffer was used to maintain a pH value of 4.5 (pH of maximum stability as reported earlier) to minimize hydrolysis. The final dosage form was stable for at least 93 days at 40 degrees C (loss of potency less than 4%). According to FDA guidelines, a tentative expiration date of 2 years at 25 degrees C is justifiable.
Pramar
Y
Y
Department of Pharmaceutics, University of Houston, TX 77030.
Das Gupta
V
V
Bethea
C
C
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry; D011092:Polyethylene Glycols; D012995:Solubility; D013148:Spironolactone / Q000008:administration & dosage / Q000737:chemistry*; D013649:Taste
D005079:Excipients; D013148:Spironolactone; D011092:Polyethylene Glycols