Physicochemical evaluation, study of stability and drug release kinetics from various semi-solid products of Tretinoin, available in Iran
Hormozgan Medical Journal: January 01, 2005, 8 (4); e90730
September 04, 2004
Article Type: Research Article
February 03, 2004
September 04, 2004
R. Physicochemical evaluation, study of stability and drug release kinetics from various semi-solid products of Tretinoin, available in Iran,
Hormozgan Med J.
Introduction: Acne is a disorder of the pilosebaceous unit of the skin and can
present as non inflammatory and or inflammatory lesions. Tretinoin has been
used therapeutically for over three decades. It is best known for its comedolytic
effects on acne. It also inhibits comedone rupture, thus decreasing inflammatory
events. Tretinoin is available in 0.01% to 0.1% as cream, gel or lotion. The
objective of this investigation was to evaluate the physicochemical stability of
various dermatological preparations of tretinoin marketed in Iran.
Methods: The in vitro release and penetration characteristics of tretinoin from
different formulations (Stieva-A solution, Retin-A cream, Retin-A gel and three
Iranian brands) were studied through a hydrophilic Dora pore diffusion barrier and
membrane excised rat skin using Franz cell over a period of 5th .The amount of drug
released from topical preparations were determined spectrophotometrically at
λmax=352 nm. Furthermore, the physicochemical stability of each formulation
including drug assay, content uniformity, viscosity, pH, cyclical temperature test
and centrifugal separation test were investigated.
Results: The obtained results showed that the formulations studied presented both
good chemical and physical stabilities. The generated rank order for the drug
release from different preparations using membrane was observed to be Stieva A
solution > IR-tretinoin lotion > Retin A cream > Retin A gel > IR-tretinoin
gel > IR-tretinoin cream. The in vitro penetration of tretinoin through excised
rat skin showed that the cumulative percent of penetrated drug at the end of each
experiment were 10.8%, 14.75% and 25.2% for IR-cream, IR-gel, Retin A
cream and Retin A gel respectively.
Conclusion: The in vitro release kinetics of tretinoin is affected by the kind of
pharmaceutical dosage form. The release of drug from gel formulation obeyed
higuchi’s kinetics, whereas the kinetic of drug release from cream was first order
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