Development and validation of discriminatory dissolution procedure for poorly soluble glyburide

Main Article Content

Sachin K Singh
K K Srinivasan
K Gowthamarajan
G B Narayan

Abstract

In the present study, parameters such as solubility, medium pH, surfactant type and dissolution behavior of formulations, influence of sink conditions, stability and discriminatory effect of dissolution testing were studied for the selection of a
proper dissolution medium for glyburide (BCS Class II drug). Results of solubility data revealed that solubility increased with an increase in pH. Sink conditions were exhibited in the 0.05 M borate buffer pH 9.6, 0.05 M phosphate buffer pH 6.5 containing 0.1-2% (w/v) cetyl trimethyl ammonium bromide (CTAB) and 0.05 M phosphate buffer pH 7.4 containing 0.1- 2% CTAB (w/v), respectively. The 0.05 M phosphate buffer at pH 6.5 containing 0.1% CTAB (w/v) with an agitation speed of 50 rpm (USP II) showed a more discriminating drug release profile when compared with 0.05 M phosphate buffer at pH 7.4 containing 0.1% CTAB (w/v) with an agitation speed of 75 rpm. The spiked samples have shown better recovery at 50, 100 and 150% levels. There was no degradation, as observed in the mass spectrum of recovered dissolution samples when compared with the mass spectrum of standard drug solution, which promised that the method was specific and can be used for routine Quality Control analysis as well as for assessment of formulation variables in future dissolution studies of glyburide.

Downloads

Download data is not yet available.

Article Details

How to Cite
Singh, S. K., Srinivasan, K. K., Gowthamarajan, K., & Narayan, G. B. (2014). Development and validation of discriminatory dissolution procedure for poorly soluble glyburide. Asian Journal of Pharmaceutics (AJP), 4(4). https://doi.org/10.22377/ajp.v4i4.230
Section
Articles

References

Carstensen JT. Physico-chemical aspects of drug release. In Formulation

and Preparation of Dosage Forms, Proceedings of the 37th International

Congress of Pharmaceutical Sciences of F.I.P., The Hague, Netherlands,

Elsevier: Amsterdam; Sept 5–9, 1977.

Shah VP, Konecny JJ, Everett RL, McCullough B, Noorizadeh AC, Skelly

JP. In vitro dissolution profile of water-insoluble drug dosage forms in

the presence of surfactants. Pharm Res 1989;6:612-8.

Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a

biopharmaceutic drug classification: The correlation of in vitro drug

product dissolution and in vivo bioavailability. Pharm Res 1995;12:

-20.

Jinno J, Oh D, Crison JR, Amidon GL. Dissolution of ionizable water-

insoluble drugs: the combined effect of pH and surfactant. J Pharm

Sci 2000;89:268-74.

HoenerB, Benet LZ. In: Banker GS, Rhodes CT, editors. Modern

pharmaceutics. New York: Marcel Dekker; 1990. p. 143.

JorgensenED. Bhagwat. Pharm Sci Technol Today 1998;1:128-35.

Available from: http://www.drugscard.com. [cited in 2009].

Dissolution Method for Drugs, 2004, U.S. Department of Health and

Human Services, Food and Drug Administration, Center for Drug

Evaluation and Research (CDER)

Klein S, Wunderlich M, Dressman J, Stippler E. Development of

dissolution tests the basis of gastrointestinal physiology. Pharmaceutical

dissolution testing. In: Dressman J, editor. 1st ed. Taylor and Francis;

p. 195.

Gray V. Compendial testing equipment: Calibration, qualification and

sources of pharmaceutical dissolution testing. In: Dressman J, editor.

st ed. Taylor and Francis; 2005. p. 63.

Kramer J, Grady L, Gajendran J. Historical development of dissolution

testing. Pharmaceutical Dissolution Testing. In: Dressman J, editor. 1st

ed. Taylor and Francis; 2005. p. 28.

Moore JW, Flanner HH. Mathematical comparison of dissolution profiles.

Pharm Technol 1996;20:64-74.

Brown CK. Dissolution method development: An industry perspective.

Pharmaceutical Dissolution Testing. In: Dressman J, editor. 1st ed. Taylor

and Francis; 2005. p. 28.