COMPARATIVE IN-VITRO DISSOLUTION STUDY OF VARIOUS MARKETED BRANDS OF ALPRAZOLAM TABLETS

Authors

  • Jwala Patel Bhopal Institute of Technology and Science, Bhopal M.P., India
  • Dr. Vivek Shrivastava Bhopal Institute of Technology and Science, Bhopal M.P., India
  • Dr. U. K. Jain

Abstract

Alprazolam is a benzodiazepine anxiolytic commonly prescribed as a sleeping aid and for the treatment of anxiety disorders. The current study was undertaken with the aim of analyzing quality of commercially available brands of alprazolam tablets available in market. To assess the quality, locally available 0.25 mg alprazolam tablet of seven different manufacturers were selected and certain physico-chemical parameters like weight variation, hardness, friability, disintegration time and dissolution profile etc. were evaluated using in-vitroanalytical methods. All the tablet brands met the requirements of IP as they showed acceptable weight variation and friability. Brands were slightly different in hardness, disintegration time and dissolution profile from each other. The hardness of all the brands was found to bein the range of 1.50±0.18 to 4.21±0.11 kg-ft. In water medium the disintegration time of all brands were found to be 0.57±0.45 to 2.22±0.23 min. Five out of seven brands showed better dissolution profile as they released more than 90% drug in 30 min. The study revealed that most of the marketed alprazolam tablets met the BP standards for physico-chemical properties which are the indicators of drug quality. It can be concluded that drug products should always comply standard quality parameters that are the prerequisites for getting satisfactory clinical effects.

 

Key words: Alprazolam, anxiolytic, anxiety, disintegration, dissolution

References

Dakkuri, A.; Shah, A. C. Pharm. Technol. 1982, 6, 28–47.

Dissolution 711 . In United States Pharmacopeia and National Formulary

USP 29–NF 24; The United States Pharmacopeial Convention, Inc.: Rockville,

MD, 2005; pp 123–135.

Subcommittee on Dissolution Calibration, Pharmaceutical Research and Manufacturers of America (PhRMA). Dissolution Calibration: Recommendations forReduced Chemical Testing and Enhanced Mechanical Calibration. Pharm. Forum2000, 26 (4), 1149–1166.

Gray, V. A.; Brown, C. K.; Dressman, J. B.; Leeson, L. J. A New General Information Chapter on Dissolution. Pharm. Forum 2001, 27 (6), 3432–3439.

Ross, M. S. F.; Rasis, M. Mega Paddle—A Recommendation to Modify Apparatus2 Used in the USP General Test for Dissolution 711 .Pharm. Forum1998, 24 (3), 6351–6359.

Drug Release 724 . In United States Pharmacopeia and National FormularyUSP 29–NF 24; The United States Pharmacopeial Convention, Inc.: Rockville,MD, 2005; pp 2690–2693.

Intrinsic Dissolution 1087 . In United States Pharmacopeia and NationalFormulary USP 29–NF 24; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2005; pp 2923–2924.

Dissolution Testing of Immediate Release Solid Oral Dosage Forms; Guidance for Industry; U.S. Department of Health and Human Services, Food and DrugAdministration, U.S. Government Printing Office: Washington, DC, August1997.

http://en.wikipedia.org /wiki/Alprazolam; Accessed on Nov. 12th, 2014.

www.xanaxxr.com/utilities/xanaxxr.pdf; Accessed on Nov. 12th, 2014.

http://www.medicinenet.com/alprazolam extended release oral/article.htm;Accessed on Feb. 12th, 2014.

Lachman L, Lieberman H A and KanigJL,"The theory and practice of industrialpharmacy", 3rd Ed., Philadelphia: Lea and Febiger, 1986, 297-304.

USP/NF: the United States Pharmacopoeia/National Formulary. USP 24thEd., NF 19th Ed., New York; Twinbrooke Parkway, 2000, 64, 1885-2002.

Banakar, UV, "Pharmaceutical Dissolution Testing", 1st Ed., Marcel Dekker Inc.NewYork, 1992, 103.

O’neilMJ,”The Merck Index”, 13th Ed., Washington, Merck andCo.Inc,Whitehouse station, NY, USA, 2001, 310-311.

Downloads

Published

2017-06-09

Issue

Section

Original Research Article