FORMULATION, DEVELOPMENT AND IN VITRO EVALUATION OF TRAMADOL EXTENDED RELEASE TABLETS

  • SANJAY KUMAR GUPTA Shadan College of Pharmacy, Peerancheru, Hyderabad, 500091, Telangana,
  • AFRAH HUNEZA Shadan College of Pharmacy, Peerancheru, Hyderabad, 500091, Telangana,
  • SRADHANJALI PATRA University Department of Pharmaceutical Sciences, Utkal University, Bhubaneswar, Odisha, India

Abstract

Objective: The objective of the present study was to develop “once daily” extended release tablets of tramadol (100 mg) by wet granulation using hydrophilic polymer like hydroxy propyl methyl cellulose K100M,K15M and polyethylene oxide (PEO).


Methods: The tramadol matrix tablets were prepared by using different polymers like hydroxy propyl methyl cellulose (HPMC K15M and K100M), polyethylene oxide (PEO) as the nontoxic and easily available suitable matrix system. The extended release tablets of tramadol (400 mg) were prepared wet granulation technique. Different pre compression and post compression were performed. In vitro dissolution tests were performed and percentage drug release was calculated. The fourier-transform infrared spectroscopy (FTIR) studies conducted on pure drug tramadol and the optimize formulation (T6). Different release models like zero order, first order, higuchi and Korsemeyer-Peppas were applied to in vitro drug release data in order to evaluate the drug release mechanisms and kinetics.


Results: Pre compression and post compression parameters satisfied with pharmacopeia specifications. The In vitro release studies were performed using USP type II apparatus showed that optimized formulation T6 consisting of polyethylene oxide (PEO) with 25 mg of the polymer was found to extended release of tramadol over a period of 24h. The optimized formulation T6 followed the zero order kinetics as correlation coefficient (r2) values are higher than that of first-order release kinetics. In order to understand the complex mechanism of drug release from the optimized formulation T6 matrix system, the in vitro release rate were fitted to Korsemeyer-Peppas model and the release exponent value (n) obtained was 0.82105 exhibited anomalous (non fickian) diffusion mechanism.


Conclusion: The present study shows that polyethylene oxide was found to play a great role in controlling release of tramadol from the matrix system. Accordingly it can be concluded that the formulation is robust in the performance is less likely to be affected by the various factors studied.

Keywords: HPMC K100M, Polyethylene oxide, Extended release (ER), Sustained release (SR)

Downloads

Download data is not yet available.

References

1. Remington, the science and practice of pharmacy, Lippincott Williams and Wilkins 20th edition; 2002. p. 903-14.
2. Lachmann L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy. Varghese Publishing House, Bombay. 3rd Edition; 1991. p. 430-42.
3. Pasa Gourishyam, Mishra Uma Shankar, Tripathy Niraj Kanti, Mahapatra Anjan Kumar, Panigrahi Ghanshyam. Formulation development and evaluation of didanosine sustained-release matrix tablets using HPMC K100. Int Res J Pharm 2011;11:144-6.
4. J Siepmann, NA Peppas. Modeling of drug release from delivery systems based on hydroxyl propyl methylcellulose (HPMC). Adv Drug Delivery Rev 2001;4:139–57.
5. Saptarshi D, Srinivas Rao. Formulation of evaluation of metformin hydrochloride sustained release matrix tablets. J Pharm Res 2010;3:781-9.
6. Tiwari SB, Krishna Murthy T, Raveendra Pai M, Mehta PR, Chowdary PB. Controlled release formulation of tramadol hydrochloride using hydrophilic and hydrophobic matrix system. AAPS PharmSciTech 2003;4:126-32.
7. Vinayak S Modi, Yogesh S Thorat, Shashikant C Dhavale. Formulation and evaluation of controlled release delivery of Tramadol hydrochloride using 32-full factorial design. Int J Chem Tech Res 2010;2:669-75.
8. Suryawanshi SS, Shruthi B, Sarvesh, Rama P, Zaranappa S. Sustained release formulations of aceclofenac: a brief review. J Chem Pharm Res 2017;9:302-7.
9. Prasad SR, Ratna KT, Panda S. Formulation development and evaluation of sustained release ibuprofen tablets with acrylic polymers (eudragit) and HPMC. Int J Pharm Pharm Sci 2016;8:131-5.
10. Ratnaparkhi MP, Gupta JP. Sustained release oral drug delivery system. Int J Pharm Res Rev 2013;2:11-21.
11. Ariani L, Surini S, Hayun. Formulation of diclofenac sodium sustained release tablet using co-processed excipients of cross-linked amylose–xanthan gum as a matrix. Int J Pharm Pharm Sci 2016;8:151-6.
12. Swain RP, Kumari TR, Panda S. Formulation development and evaluation of sustained release ibuprofen tablets with acrylic polymers (eudragit) and HPMC. Int J Pharm Pharm Sci 2016;8:131-52.
13. Patel NA, Makwana ST, Patel ZP, Solanki SM, Patel MB. Formulation and evaluation of once daily sustained release matrix tablet of pramipexole dihydrochloride. Int J Pharm Res Scholars 2012;1:370-82.
14. Ain S, Kumar B, Pathak K. Development and characterization of controlled release famotidine matrix tablets containing complexes. Int J Appl Pharm 2017;9:38-46.
15. Reddy MR, Manjunath K. Pharmaceutical applications of natural gums, mucilage and pectins. Chem Sci 2013;2:1233-91.
16. Joshi K, Dhole S, Doltode A. Formulation and in vitro evaluation of sustained release matrix tablet of dicyclomine hydrochloride by using hydrophilic polymers. Int J Pharm Sci Res 2014;5:1331-81.
17. Sudke SG, Madhusudan RY, Sakarkar DM. Formulation and release behaviour of sustain release fenoverine HPMC matrix tablets. Int J Univers Pharm Bio Sci 2013;2:491-500.
18. Asija R, Modi J, Kumawat R, Asija S, Goyal M. Formulation and evaluation of diclofenac sodium sustained release tablets using melt granulation technique. Int J Pediatr 2012;3:216-20.
19. Ramana G, Reddy KD, Sravanthi O. Design and evaluation of natural gum based oral controlled release matrix tablets of ambroxol hydrochloride. DPL 2012;4:1105-14.
20. Ain S, Kumar B, Pathak K. Development and characterization of controlled release famotidine matrix tablets containing complexes. Int J Appl Pharm 2017;9:38-46.
21. Mahajan P, Mahajan SC, Mishra DK. Valsartan release from sustained release matrix tablet and effect of cellulose derivatives. Int J Pharm Life Sci 2011;2:521-30.
22. Patel NA, Makwana ST, Patel ZP, Solanki SM, Patel MB. Formulation and evaluation of once daily sustained release matrix tablet of pramipexole dihydrochloride. Int J Pharm Res Scholars 2012;1:370-82.
23. Jadav MM, Teraiya SR. Formulation and evaluation of oral controlled porosity osmotic pump tablet of zaltoprofen. Int J Pharm Res Scholars 2012;1:254-67.
24. Tapaswi RD, Varma P. Matrix tablets: an approach towards oral extended release drug delivery. Int J Pharma Res Rev 2013;2:12-24.
25. Moses P, Subramanian L, Palanichamy S, Jeganath S, Thanga Thirupathi A. Formulation and evaluation of ciprofloxacin controlled release matrix tablets. DPL 2010;2:237-43.
26. Joshi K, Dhole S, Doltode A. Formulation and in vitro evaluation of sustained release matrix tablet of dicyclomine hydrochloride by using hydrophilic polymers. Int J Pharm Sci Res 2014;5:1331-42.
27. Nair A, Gupta R, Vasanti S. Worked on in vitro controlled release of alfuzosin hydrochloride using HPMC-based matrix tablets and its comparison with marketed product. Pharma Dev Technol 2007;12:621-51.
28. Hosseinali T, Seyed AM, Tina BG. Preparation of sustained–release matrix tablets of aspirin with ethyl cellulose, eudragit RL100, eudragit RS100, and studying the release profiles and their sensitivity to tablet hardness. Iranian J Pharm Res 2003;2:201-6.
29. Herting MG, Kleinebudde P. Worked on studies on the reduction of tensile strength of tablets after roll compaction/dry granulation. Eur J Pharma Bio Pharma 2008;70:372-91.
30. Saravanan M, Sri Nataraj K, Ganesh KS. worked on hydroxypropyl methylcellulose based cephalexin extended release tablets: influence of tablet formulation, hardness and storage on in vitro release kinetics. Chem Pharma Bull 2003;51:978-83.
31. Uhum wangho MU, Okor RS. Worked on modification of drug release from acetaminophen granules by melt granulation technique-consideration of release kinetics. Pak J Pharma Sci 2006;19:22-7.
32. Raghavendra Rao NG, Gandhi Sagar, Patil Tarun. Formulation of evaluation of sustained release matrix tablets of tramadol hydrochloride. Int J Pharm Pharm Sci 2009;1:60-70.
33. Shanmugam S, Kamaraj K, Vetrichelvan T. Formulation and evaluation of lamivudine sustained release matrix tablets using synthetic polymers. J Pharm Res 2012;5:1063-6.
34. The United States Pharmacopoeia/National Formulary, USP 37/NF 32. Vol. I. The United States Pharmacopoeial Convention, Timbrook Parkway, Rockville; 2014. p. 344-61.
35. Bhosale RR, Riyaz AM, Osmani PC, Moin A. Formulation and evaluation of sustained release dosage form using modified cashew gum. Int J Pharm Pharm Sci 2015;7:141-50.
36. Kambham V. Formulation and evaluation of sustained release matrix tablets of repaginate. Bangladesh Pharma J 2016;19:92-9.
37. Moses P, Subramanian L, Palanichamy S, Jeganath S, Thanga Thirupathi A. Formulation and evaluation of ciprofloxacin controlled release matrix tablets. DPL 2010;2:237-43.
38. Patel R, Baria A. Formulation development and process optimization of theophylline sustained release matrix tablet. Int J Pharm Pharm Sci 2009;1:30-42.
Statistics
165 Views | 159 Downloads
Citatons
How to Cite
GUPTA, S. K., A. HUNEZA, and S. PATRA. “FORMULATION, DEVELOPMENT AND IN VITRO EVALUATION OF TRAMADOL EXTENDED RELEASE TABLETS”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 11, no. 7, May 2019, pp. 63-73, doi:10.22159/ijpps.2019v11i7.32100.
Section
Original Article(s)