Evaluation of galen IQ polymer in Tramadol Hydrochloride orally disintegrating tablet.

Manreet Chawla, Ganga Srinivasan

Abstract


The present work aims at the formulation development and evaluation of Tramadol Hydrochloride orally disintegrating tablets using galen IQ as a diluent. galen IQ, official as Isomalt doesn’t have much  generation of data with respect to its functionality. Attempts were made to prepare binder-free, 250 mg Tramadol Hydrochloride orally disintegrating tablets using different concentrations of Crospovidone, Croscarmellose Sodium, Sodium Starch Glycolate and Starch 1500 as disintegrants in different combinations by direct compression method. Tramadol Hydrochloride is a water soluble drug and the dose taken was 50 mg. Preformulation studies on Tramadol Hydrochloride were carried out, followed by excipient compatibility studies between the drug , galen IQ and other excipients being used in the formulation. Spectroscopic studies were also conducted in order to deduce out the λmax (lambda-max).A total of ten formulations (F1 to F10) were developed .F10 batch was found to give best results on the basis of disintegration time of 21 seconds. The powdered blend of F10 was evaluated for flow properties. The tablets of F10 batch were also evaluated for post compression tests like hardness, friability, weight variation, wetting time, water absorption ratio, content uniformity, assay, disintegration time and dissolution which were found to be within the prescribed limits. The tablets of F10 batch were also compared with the marketed formulation and were found to show pharmaceutical equivalence with a similarity factor (f2) of 85.72.All this work suggested that galen IQ could be successfully used as a diluent in the formulation of Tramadol Hydrochloride orally disintegrating tablet.


Keywords


Tramadol Hydrochloride, galen IQ, Orally Disintegrating Tablet

Full Text:

PDF

References


Fu Y, Yang S, Jeong SH, Kimura S, Park K. Orally Fast Disintegrating Tablets: Developments, Technologies, Taste-masking and Clinical Studies. Crit Rev Ther Drug Carrier Sys .2004; 21:433-476.

Seager H. Drug-delivery products and the Zydis fast-dissolving dosage. J Pharm Pharmacol. 1998 Apr; 50(4):375-82.

Brown D. Orally Disintegrating Tablets-Taste over Speed. Drug Del Tech. 2003; (3):58-61.

Sreenivas SA, Dandagi PM, Gadad AP, Godbloe AM, Hiremath SP, Mastiholimath VS. Orodispersible tablets: New-fangled drug delivery systems – A review. Indian J Pharm Educ Res. 2005; 39(4): 177-181.

Bradoo R, Shahani S, Deewan B, Sudarshan S. Fast dissolving drug delivery system. J Am Med Assoc India. 2001; 4 (10): 27-31.

Guidance for Industry .US Food and Drug Administration. CDER . 2008.

Harmon Troy M. Orally Disintegrating Tablets: A Valuable Life Cycle Management Strategy. Pharmaceutical Commerce. 1997 .

Betzing J, Heinrich J, Bartholomaeus A. Rapidly disintegrating, binder free tablets of Tramadol or a Tramadol salt. US Patent 5,776,492, 1998.

Ndindayino F Henrist D , Kiekens F, Van den Mooter G , Vervaet C , Remon JP.Direct compression properties of melt-extruded isomalt. International Journal of Pharmaceutics.2002; 235:149–157.

Souto C,Rodryguez A, Parajes S, Martynez-Pacheco R. A comparative study of the utility of two superdisintegrants in microcrystalline cellulose pellets prepared by extrusion spheronization. Eur J Pharm Biopharm. 2005;61:94-99.


Refbacks

  • There are currently no refbacks.




Copyright (c)

               AR Journals

18K, Street 1st, Gaytri Vihar, Pinto Park, Gwalior, M.P. India

Copyright@arjournals.org (Design) 2009-2021

 

Follow @arjournals on Twitter