International Journal of Pharmaceutical Sciences and Nanotechnology (IJPSN)

Open Access Open Access  Restricted Access Subscription Access

Development of Prolonged Delivery of Tramadol and Dissolution Translation by Statistical Data Treatment


Affiliations
1 K.B. Institute of Pharmaceutical Education and Research, Gandhinagar,, India
 

The present study was carried out to fabricate a prolonged design for tramadol using Kollidon SR(Polyvinyl acetate and povidone based matrix retarding polymer). Matrix tablet formulations were prepared by direct compression of Kollidon SR of a varying proportion with a fixed percentage of tramadol. Tablets containing a 1:0.5 (Drug:Kollidon SR) ratio exhibited a rapid rate of drug release with an initial burst effect. Incorporation of more Kollidon SR in the matrix tablet extended the release of drug with subsequent minimization of the burst effect as confirmed by the mean dissolution time, dissolution efficiency and f2 value. Among the formulation batches, a direct relationship was obtained between release rate and the percentage of Kollidon SR used. The formulation showed close resemblance to the commercial product Contramal and compliance with USP specification. The results were explored and explained by the difference of micromeritic characteristics of the polymers and blend of drug with excipients. Insignificant effects of variousfactors, e.g. pH of dissolution media, ionic strength, speed of paddle were found on the drug release from Kollidon-SR matrix. The formulation followed the Higuchi kinetic model of drug release. Stability study data indicated stable character of Batch T6 after short-term stability study.
User
Notifications
Font Size

  • Alderman DA. A review of cellulose ethers in hydrophilic matrices for oral controlled-release dosage forms. Int J Pharm Tech Prod Mfr. 5:1-9 (1984).

  • Amidon GL, Lobenberg R. Modern Bioavailability, Bioequivalence and Biopharmaceutics Classification system. New Scientific Approaches to International Regulatory Standards. Eur J Pharm Biopharm.50 (2):3–12 (2000)

  • Bamba, M, Puisievx F, Marty J, Carstensen J. Release mechanism in gel forming sustained release formulation. Int. J. Pharm. 2(5-6):307-315(1979).

  • Banakar UV. Pharmaceutical Dissolution Testing. New York, NY: Marcel Dekker Inc; 1992.

  • Costa P, Manuel J. Modeling and comparison of dissolution profiles. Eur J Pharm Sci. 13:123-133(2001).

  • Ford JL, Rubinstein MH, Hogan JE. Formulation of sustained release promethazine hydrochloride tablets using hydroxypropyl methyl cellulose matrixes, Int J Pharm.24: 327-338(1985).

  • Gibaldi M. Feldman S. Establishment of sink conditions in dissolution rate determination. J. Pharm. Sci. 56(10):1238- 1242(1967).

  • Gohel MC, Panchal MK. Novel use of similarity factors f2 and sd for the development of diltiazem HCl modified-release tablets using a 32 factorial design. Drug Dev Ind Pharm.28:77- 87(2002).

  • Gundert Remy, U. Oral Controlled release products. WVG.Stuttgart, 1990.

  • Higuchi, T. Rate of release of medicaments from ointment bases containing drugs in suspensions. J. Pharm. Sci.50(10):874– 875(1961).

  • Korsmeyer R, Gurny R, Doelker E, Buri P, Peppas N. Mechanisms of solute release from porous hydrophilic polymers. Int. J. Pharm.15(1):25-35(1983).

  • Lachman L, Lieberman HA, Kanig, JL. The theory and practice of Industrial Pharmacy, 3rd ed., Varghese Publishing House,1991, pp. 442-454.

  • Langenbucher, F. Linearization of dissolution rate curves by the weibull distribution. J. Pharm. Pharmacol. 24(12): 979- 989(1972).

  • Lehmann KA. Tramadol in acute pain. Drugs. 53(2):25-33(1997).

  • Lieberman HA, Lachman L, Schwartz JB. Pharmaceutical Dosage Forms: Tablets, Vol. 2, Marcel Dekker, New York; 1990, pp. 201-243.

  • Reddy RK, Mutalik S, Reddy S. Once daily sustained release matrix tablets of Nicorandil: formulation and in-vitro evaluation, AAPS. Pharm Sci Tech.4(4):25-29(2003).

  • Scott LJ, Perry CM. Tramadol: a review of its use in perioperative pain. Drugs.60 (1):139-176(2000).

  • Terashita, K, Imamura, K. Preparation of antipyretic canalgesic by direct compression and its evaluation. Chem. Pharm. Bull. 12:1542-1549(2000).


Abstract Views: 61

PDF Views: 39




  • Development of Prolonged Delivery of Tramadol and Dissolution Translation by Statistical Data Treatment

Abstract Views: 61  |  PDF Views: 39

Authors

P.B. Parejiya
K.B. Institute of Pharmaceutical Education and Research, Gandhinagar,, India
B.S. Barot
K.B. Institute of Pharmaceutical Education and Research, Gandhinagar,, India
P.K. Shelat
K.B. Institute of Pharmaceutical Education and Research, Gandhinagar,, India

Abstract


The present study was carried out to fabricate a prolonged design for tramadol using Kollidon SR(Polyvinyl acetate and povidone based matrix retarding polymer). Matrix tablet formulations were prepared by direct compression of Kollidon SR of a varying proportion with a fixed percentage of tramadol. Tablets containing a 1:0.5 (Drug:Kollidon SR) ratio exhibited a rapid rate of drug release with an initial burst effect. Incorporation of more Kollidon SR in the matrix tablet extended the release of drug with subsequent minimization of the burst effect as confirmed by the mean dissolution time, dissolution efficiency and f2 value. Among the formulation batches, a direct relationship was obtained between release rate and the percentage of Kollidon SR used. The formulation showed close resemblance to the commercial product Contramal and compliance with USP specification. The results were explored and explained by the difference of micromeritic characteristics of the polymers and blend of drug with excipients. Insignificant effects of variousfactors, e.g. pH of dissolution media, ionic strength, speed of paddle were found on the drug release from Kollidon-SR matrix. The formulation followed the Higuchi kinetic model of drug release. Stability study data indicated stable character of Batch T6 after short-term stability study.

References