DESIGN AND OPTIMIZATION OF PEDIATRIC CEFUROXIME AXETIL DISPERSIBLE TABLET CONTAINING ION-EXCHANGE RESIN

  • NISHANT OZA C. U. Shah College of Pharmacy and Research, Wadhwan City 363030, Gujarat, India
  • SWATI SAGAR C. U. Shah College of Pharmacy and Research, Wadhwan City 363030, Gujarat, India

Abstract

Objective: The aim of present work was to develop of pediatric cefuroxime axetil 125 mg dispersible tablets by using ion exchange resin as a taste masking agent and quality target product profile was defined based on the properties of the cefuroxime axetil.


Methods: Initially, cefuroxime axetil and various resin complexes (DRC) were prepared with different conditions and evaluated for taste masking and drug loading. Optimized DRC was used to formulate the dispersible tablet. A 32 full factorial design was employed to study the effect of mannitol (X1) and microcrystalline cellulose PH-101 (X2) on drug release at 10 min and time taken to 80% drug release. In the present study, the following constraints were arbitrarily used for the selection of an optimized batch: Q10>65% and T80%<30 min. Multiple linear regression analysis, ANOVA and graphical representation of the influence factor by 3D plots were performed by using Sigmaplot 11.0. Checkpoint batch was prepared to validate the evolved model.


Results: Among the various drug resins complex DRC-9 was found with less bitter taste which was containing kyron T-114 and among the all factorial batch F7 showed highest drug release at 10 min (Q10) and lowest time taken to 80% drug release (T80) hence batch F7 was selected as an optimized batch and it’s found to be stable in the stability evaluation.


Conclusion: The results of full factorial design indicate mannitol and MCC PH-101 have a significant effect on drug release.

Keywords: Taste masking, Ion exchange resin, Cefuroxime axetil, Dispersible Tablet, 32 Full Factorial Design

References

1. Deshkar SS, Pawara AS, Shirolkar SV. Formulation and optimization of floating tablets of clopidogrel bisulphate using design of experiments. Int J Appl Pharm 2018;10:126-34.
2. Abdelbary G, Prinderre P, Eouani C, Joachim J, Reynier JP, Piccerelle P. The preparation of orally disintegrating tablets using a hydrophilic waxy binder. Int J Pharm 2004;278:423-33.
3. Patel BP, Patel JK, Rajput GC, Thakor RS. Formulation and evaluation of mouth dissolving tablets of cinnarizine. Indian J Pharm Sci 2010;72:522-5.
4. Al-dhahir RK, Al-kotaji M. Formulation of orally disintegrating tablets of cinnarizine by using direct compression method. Int J Appl Pharm 2018;11:117-23.
5. Bhowmik D, Chiranjib B, Chandira RM. Fast dissolving tablet: an overview. J Chem Pharm Res 2009;1:163-77.
6. Sharma S, Lewis S. Taste masking technologies: a review. Int J Pharm Pharm Sci 2010;2:6-13.
7. Nanda A, Kandarapu R, Garg S. An update on taste masking technologies for oral pharmaceuticals. Indian J Pharm Sci 2002;64:10-7.
8. Sohi H, Sultana Y, Khar R. Taste masking technologies in oral pharmaceuticals: recent developments and approaches. Drug Dev Ind Pharm 2004;30:429-48.
9. 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;1:370-6.
10. 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.
11. Rajendra Prasad A, Ratna JV. Development and validation of a simple UV-spectrophotometric method for the determination of ciprofloxacin HCL present in taste masked drug resin complex. Int J Appl Pharm 2018;10:37-41.
12. Sanghavi NM. Ion-exchange resins as matrix for controlled drug release. Indian Drugs 1988;26:27-32.
13. Prajapati BG, Patel SN. Formulation, evaluation, and optimization of the orally disintegrating tablet of cinnarizine. E-J Sci Technol 2010;1:9-21.
14. Patel BP, Patel JK, Rajput GC, Thakor RS. Formulation and evaluation of mouth dissolving tablets of cinnarizine. Indian J Pharm Sci 2010;72:522-5.
15. Yadav K, Yadav D, Srivastava A. Evaluation of hydrophilic, hydrophobic and waxy matrix excipients for sustained release tablets of venlafaxine hydrochloride. Drug Dev Ind Pharm 2013;39:1197-206.
16. Khar RK, Mohapatra S, Barik BB. Design and characterization of controlled release matrix tablets of Zidovudine. Asian J Pharm Clin Res 2009;2:54-61.
17. Madgulkar AR. Formulation and optimization of sustained release tablets of venlafaxine resinates using response surface methodology. Indian J Pharm Sci 2009;71:387-94.
18. Lakade SH, Bhalekar MR. Formulation and evaluation of sustained release matrix tablet of anti-anginal drug influence of combination of hydrophobic and hydrophilic matrix former. Res J Pharm Technol 2008;1:410-4.
19. Puttewar TY. Formulation and evaluation of orodispersible tablet of taste masked doxylamine succinate using ion exchange resin. J King Saud Univ 2010;22:229-40.
20. Anand V, Kandrapu R, Garg S. Preparation and evaluation of taste-masked orally disintegrating tablets of prednisolone. Asian J Pharm Sci 2007;6:227-38.
21. Das S, Shrikant L. Taste masking of ciprofloxacin by ion exchange resin. IJPPR 2010;1:7-13.
22. Bolton S. Optimization techniques in pharmaceutical statistics. Practical and Clinical Applications. 3rd ed. New York: Marcel Dekker; 1997.
23. Anthony NA. Pharmaceutical experimental design and interpretation. 2nd ed. Taylor and Francis Group; 2006.
24. Lionberger RA, Lee SL, Lee L. Quality by design: concepts for ANDAs. Adv Appl Pharm Sci J 2008;10:268-76.
25. Guideline IH. Stability testing guidelines: stability testing of new drug substances and products. ICH Q1A (R2) (CPMP/ICH/2736/99); 1999.
26. Singh S. Stability testing during product development. In: Jain NK. Pharmaceutical product development. CBS publisher and distributors India; 2000. p. 272-93.
27. Bajaj S, Singhla D, Sakhuja N. Stability testing of pharmaceutical products. J Appl Pharm Sci 2012;2 Suppl 3:129-38.
28. Parfati N, Rani KC, Charles N, Geovanny V. Preparation and evaluation of atenolol-β-cyclodextrin orally disintegrating tablets using co-process crospovidone-sodium starch glycolate. Int J Appl Pharm 2018;10:190-4.
29. Nagar P, Singh K, Chauhan I, Madhu V, Yasir M, Khan A, et al. Orally disintegrating tablets: formulation, preparation, techniques, and evaluation. J Appl Pharm Sci 2011;4:35-45.
30. Gattu J, Lakshmi P. Comparative evaluation of natural and synthetic superdisintegrants with newer superdisintegrant kyron T-314. Acta Pharm Sci 2011;53:35-44.
31. Prajapati BG, Patel SN. Formulation, evaluation, and optimization of the orally disintegrating tablet of cinnarizine. E-J Sci Technol 2010;1:9-21.
32. Bhowmik D, Chiranjib B, Chandira RM. Fast dissolving tablet: an overview. J Chem Pharm Res 2009;1:163-77.
33. Khanam N, Alam MI, MD Yusuf Ali, QMAI Siddiqui, A Ur Rahman. A review on optimization of drug delivery system with experimental designs. Int J Appl Pharm 2018;10:7-12.
34. Anthony NA. Pharmaceutical experimental design and interpretation. 2nd ed. Taylor and Francis Group; 2006.
35. Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical experimental design. New York: Marcel Dekker; 1999.
36. Montgomery DC. Design and analysis of experiments. 5th ed. New York: Wiley; 2001.
37. Patel KN, Mehta TA. Design and optimization of nicardipine hydrochloride push-pull osmotic pump tablet using 32 full factorial design. Int J Pharm Biomed Res 2013;4:155-63.
38. Othiya OM, Patel BA, Patel KN, Patel MM. Formulation and characterization of sustained release matrix tablets of ivabradine using 32 full factorial design. Int J Appl Pharm 2018;10:59-66.
Statistics
68 Views | 90 Downloads
Citatons
How to Cite
OZA, N., & SAGAR, S. (2019). DESIGN AND OPTIMIZATION OF PEDIATRIC CEFUROXIME AXETIL DISPERSIBLE TABLET CONTAINING ION-EXCHANGE RESIN. International Journal of Applied Pharmaceutics, 11(4), 325-332. https://doi.org/10.22159/ijap.2019v11i4.32012
Section
Original Article(s)