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  • Formulation Development and Evaluation of Gastroretentive Floating Tablet of Vildagliptin
  • 1Department of Pharmaceutical Quality Assurance, R. G, Sapkal College of Pharmacy, Anjaneri - 422212
    2Department of Pharmaceutical Chemistry, R. G, Sapkal College of Pharmacy, Anjaneri, - 422212
    3Department of Pharmacology, R. G, Sapkal College of Pharmacy, Anjaneri - 422212

Abstract

The present study was an attempt to formulate and evaluate a floating tablet of vildagliptin using polymers such as HPMC K4M, Carbopol 934, NaHCO3, and citric acid as gas producers. vildagliptin, an antidiabetic drug with 85% oral bioavailability, short half-life (1.5 hours) and largely associated with an acidic pH, is believed to increase gastric survival and therapeutic efficacy. This can be achieved by making floating pills that stay in the stomach for a long time to release the drug. The tablets are formulated using the direct compression method. The effects of sodium bicarbonate and citric acid on pharmacokinetic and potentiating properties were studied. The tablets were evaluated for pressure parameters before and after compression such as fragility, hardness, thickness, drug content, weight change, in vitro buoyancy studies, and in vitro drug release studies, and the results were in range. In vitro drug release studies were performed in USP Type II with 0.1 N HCl. Of all the prepared formulas (F1 to F9), Trust F3 was the best with a lift delay of 82 seconds. This tablet is fresh for more than 12 hours. The drug release data were fitted into various kinetic models in vitro and the best fit was obtained with zero order models. The improved F3 formula follows zero diffusion kinetics through non-viscous diffusion.

Keywords

Vildagliptin, HPMC K4M, Carbopol 934, Direct compression method

Reference

  1. M Seth; DS Goswami; H Dhaliwal; N Uppal; S Kashyap; KD Sharma. Int. J Res. Pharma Chem., 2013, 3(3), 605-611. 
  2. NK Jain. Gastro retentive drug delivery systems, in: progress in controlled and novel drug delivery system, 1st Edition, CBS Publishers and Distributors, New Delhi, 2004; 76-97. 
  3. Ashish Singh Nayal, Saurabh Pandey, G. Gnanarajan, Review: An Overview on Gestroretentive Floating Tablet, International Journal of Pharmaceutical and chemical science 2013,vol-2,page no.1357-1364
  4. Prafull Ghorpade, Shrenik Kamble, Review On- Gastroretentive Drug Delivery System, Asian Journal of Pharmacy and Life Science 2014.vol-4,page no.1-15
  5. Prathyusha Naik C.N*, K.B. Chandra Sekhar,A Novel Stability Indicating Chromatographic Method Development And Validation For The Quantification of Tofacitinib In Pure And Its Dosage Form,IOSR Journal of Applied Chemistry, Volume 11, Issue 2 Ver. III (February. 2018), PP 33-37.
  6. The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare,7th ed. vol II. the Controller of Publication, New Delhi:2014: Page no 959-961
  7. Robert M. Franz, D.C. Cooper, Experimental Design, Modelling and optimization strategies for product and process development ,pharmaceutical dosage form; disperse system,2nd Ed,vol-1.page no 437-445
  8. A. Arunachalam, M. Karthikeyan, Pottabathula Hari Prasad, Floating drug delivery systems: A review, International Journal of Research in Pharmaceutical Sciences 2011,Vol-2,Page no. 
  9. Dipesh Patidar, Sunil Kumar Shah, C.K. Tyagi, Harish Pandey, Controlled - Release Effervescent Floating Tablet of Verapamil Hydrochloride: Development and Opitmization, journal of pharmaceutical  science and research  2016; vol-8, pg no  732-740
  10. Schwartz JB,O’ Cannor RE, Schnaare RL. Optimization Techniques in Pharmaceutical Formulation and Processing. In: Banker GS, Rhodes CT,4th edition, modern pharmaceutics. New York: Basel: Marcel Deccker.INC;2006;121:607
  11. Drug Formulations Manual Eastern Publishers, 3rd edition; 2005, Pg. No. 65. 53. Fauci A.S, Braunwald E, Harrison’s Principles of Medicine 17th edition, 2008, Vol-I & II, Pg. No. 736, 737, 1530.
  12. V.Priyanka, C. Surya Prakash Reddy, Review Article on Floating Table and it’s Technology: AN Overview. International Journal of Pharmaceutics and Drug Analysis, Vol-2, 2014, Pg. No. 653-657
  13. Pooja Gupta, Gnanarajan, Preeti Kothiyal, Floating Drug Delivery System: A Review, International Journal of Pharma Research & Review 2015, vol-4, page no.37-44.
  14. ICH Harmonised Tripartite Guideline, International Conference On Harmonisation, Stability Testing Of New Drug Substances And Product Q1A (R2) And Evaluation Of Stability Data Q1E, Current Step Version. 6 February 2013: Pg. No. 1-18.
  15. Fauci A.S, Braunwald E, Harrison’s Principles of Medicine 17th edition, 2008, Vol-I & II, Pg. No. 736, 737, 1530.
  16. Florida Sharmin, Md. Abdullah Al Masum, Md. Selim Reza, Preparation and Evaluation of Gastro Retentive Floating Tablets of Atorvastatin Calcium,  Dhaka university journal of pharmaceutical science 2011,vol-2,page no.79-85
  17. Bhavna Patel, Formulation and Evaluation of Omeprazole Gastroretentive Floating Tablets for the Treatment of Peptic Ulcer, International Journal  of Scientific  Research 2015,vol-4 ,page no.81-82
  18. Jadhav. C.M, Bendale A.N, Halde P.T, Formulation and evaluation of effervescent floating tablet of felodipine, International Journal of Pharmaceutical Research and Development 2012,Vol-4,page no.10-15
  19. .Dash S, Murthy  PN, Nath L. Kinetic Modeling on drug release from controlled drug delivery system, acta poloniae pharmaceutical drug research 2010,vol-3 page no 217-223
  20. Rajesh Asija, Sangeeta Asija, Shailendra Bhatt, Formulation and Evaluation of floating tablet of Valsartan, Journal of Chemical and Pharmaceutical Research, 2015,vol-7,page no,708-715
  21. Carstensen JT, Rhodes CT, Drug Stability Principles and Practices,3rd ed ,Revised and Expanded,vol-107,page no.446-450
  22. P, Preetha, A. Sreenivasa rao, Formulation Evaluation of Effervescent Floating Tablet of Metaprolol Succinate, International journal of Applied Pharmaceutics, vol-6,page no.13-16
  23. Prasanth V, Ashutosh Lohumi, Sourav Tribedi,  Formulation and Evaluation of Gastro Retentive Floating Tablets of Stavudine, Research and Reviews: Journal of Pharmacy and Pharmaceutical Sciences 2013,vol-2,page no.69-77
  24. Fung H; Drug Stability; Principles & Practice, Drug and Pharmaceutical Sciences. Marcel Dekker, New York: vol-2, Page no.43:225
  25. https://www.drugbank.ca/drugs/DB09232
  26. https://pubchem.ncbi.nlm.nih.gov/compound/Vildagliptin

Photo
Suraj Kothule
Corresponding author

Department of Pharmaceutical Quality Assurance, R. G, Sapkal College of Pharmacy, Anjaneri - 422212

Photo
Smita Aher
Co-author

Department of Pharmaceutical Chemistry, R. G, Sapkal College of Pharmacy, Anjaneri, - 422212

Photo
Rishikesh Bachhav
Co-author

Department of Pharmacology, R. G, Sapkal College of Pharmacy, Anjaneri - 422212

Suraj Kothule, Formulation Development and Evaluation of Gastroretentive Floating Tablet of Vildagliptin, Int. J. in Pharm. Sci., 2021, Vol 1, Issue 1, 21-30. https://doi.org/10.5281/zenodo.5654051

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