D Jeslin¹*, N Deepa² and G Jaya Vasavi³

¹Associate Professor, Department of Pharmaceutics, Faculty of Pharmacy, Sree Balaji Medical College and Hospital Campus, Bharath Institute of Higher Education and Research, Chromepet, Chennai, India
²Dean and Professor, Department of Pharmacognosy, Sree Balaji Medical College and Hospital Campus, Bharath Institute of Higher Education and Research, Chromepet, Chennai, India
³Associate Professor, Department of Pharmaceutics, Sree Balaji Medical College and Hospital Campus, Bharath Institute of Higher Education and Research, Chromepet, Chennai, India

*Corresponding Author: D Jeslin, Associate Professor, Department of Pharmaceutics, Faculty of Pharmacy, Sree Balaji Medical College and Hospital Campus, Bharath Institute of Higher Education and Research, Chromepet, Chennai, India., India.

Received: April 04, 2024; Published: June 03, 2024

Abstract

Pantoprazole is a proton pump inhibitor belongs to group of benzimidazole which has been widely used in the treatment of gastric, duodenal ulcer and also in gastro-esophageal reflux disease (GERD), Zollinger Ellison syndrome. It suppresses the acid production by inhibiting the H+ K+ ATPase. In this present study, an effort has been made to formulate and evaluate of fast dissolving or rapid release tablets, of Pantoprazole Sodium using three different Superdisintegrants like Sodium starch glycolate (SSG), Croscarmellose Sodium (CCS) and Crospovidone (CP) by direct compression method using different concentration (5%, 7.5%, and 10%). The prepared tablets were evaluated pre and post compression parameter. The pre-compression parameter like Angle of repose, bulk density, tapped density, compressibility index, Hausners ratio, solubility, and melting point. The post-compression parameter like thickness, hardness, friability, weight variation, wetting time, weight volume, drug content uniformity, water absortion ratio, in-vitro disintegration time, in-vitro dispersion time, in vitro dissolution study and stability study. The formulated tablets were evaluated for various parameter mention in above and compiled with the limits. Among all the formulations F9 containing Crospovidone with a concentration of 10% produce the least disintegrating time 24.53 sec. and dispersion time 31.71 sec. resulting in higher drug release rate 96.42% in 10 minutes. Hence it is considered an optimized formulation. The present study revealed that the Crospovidone showed better disintegrating properties then the most widely used superdisintegrants like sodium starch glycolate and croscarmellose sodium in the formulation of fast dissolving tablets.

Keywords: Pantoprazole; Proton Pump Inhibitor; Superdisintegrants; Fast Dissolving; Direct Compression Method

References

1. Mishra J., et al. “A Review of Formulation Technology for Recent Advancements in Fast Dissolving Tablets”. International Journal of Innovative Science and Research Technology6 (2023): 195-206.
2. Bhowmik D., et al. “Fast dissolving tablet: an overview”. Journal of Chemical and Pharmaceutical Research 1 (2009): 163-177.
3. Remon JP and Corveleyn S. “Universiteit Gent, 2000. Freeze-dried disintegrating tablets. U.S. Patent 6.010 (2000): 719.
4. Modi J., et al. “Formulation and Optimization of Oro dispersible Tablet of Pentoprazole Sodium as Proton Pump Inhibitor”. International Journal of Pharmaceutical Research and Allied Sciences3 (2013).
5. Ward RM and Kearns GL. “Proton pump inhibitors in pediatrics: mechanism of action, pharmacokinetics, pharmacogenetics, and pharmacodynamics”. Pediatric Drugs 15 (2013): 119-31.
6. Senn‐Bilfinger J and Sturm E. “The development of a new proton‐pump inhibitor: the case history of pantoprazole”. Analogue‐ Based Drug Discovery (2006): 115-136.
7. Karljikovic-Rajic K., et al. “First-order UV-derivative spectrophotometry in the analysis of omeprazole and pantoprazole sodium salt and corresponding impurities”. Journal of Pharmaceutical and Biomedical Analysis 4-5 (2003): 1019-1027.
8. Rafiq A., et al. “Quantitative analysis of pantoprazole sodium sesquihydrate in bulk and solid dosage form via UV-spectrophotometric method”. In International Conference on Harmonization (ICH) 14 (2000): 15.
9. Badwan AA., et al. “Pantoprazole sodium”. In Analytical Profiles of Drug Substances and Excipients 29 (2002): 213-259.
10. Reddy GM., et al. “Structural identification and characterization of potential impurities of pantoprazole sodium”. Journal of Pharmaceutical and Biomedical Analysis2 (2007): 201-210.
11. Zupančič V., et al. “Physical characterization of pantoprazole sodium hydrates”. International Journal of Pharmaceutics1-2 (2005): 59-68.
12. Sodeifian G., et al. “Solubility measurement and thermodynamic modeling of pantoprazole sodium sesquihydrate in supercritical carbon dioxide”. Scientific Reports1 (2022): 7758.
13. Badwan AA., et al. “Pantoprazole sodium”. In Analytical Profiles of Drug Substances and Excipients 29 (2002): 213-259.
14. Arumilli S., et al. “Exploring the super-disintegrating properties of fenugreek seed mucilage for fast-dissolving amlodipine tablets”. World Journal of Biology Pharmacy and Health Science 1 (2010): 186-197.
15. Jawahar N., et al. “Formulation and evaluation of ora-solv tablets of pantoprazole sodium”. Journal of Pharmaceutical Sciences and Research6 (2012): 1839.
16. Rangari MN and Sheikh NV. “Formulation and evaluation of mouth dissolving drug delivery system of Pantoprazole sodium” 3.4 (2018): 84-90.
17. Jawahar N., et al. “Formulation and evaluation of ora-solv tablets of pantoprazole sodium”. Journal of Pharmaceutical Sciences and Research6 (2012): 1839-1843.
18. Shrilatha KS., et al. “Formulation and in-vitro evaluation of fast dissolving tablets of anti- ulcer drugs”. American Journal of PharmTech Research 2 (2020): 49-59.
19. Siddiqui MN., et al. “Fast dissolving tablets: preparation, characterization and evaluation: an overview”. International Journal of Pharmaceutical Sciences Review and Research2 (2010): 87-96.
20. Rahane RD and Rachh PR. “A review on fast dissolving tablet”. Journal of Drug Delivery and Therapeutics 5 (2018): 50-55.
21. Poojan P., et al. “Orodispersible Tablet of Proton Pump Inhibitor Drugs: A Review”. JPSBR2 (2013): 68-76.
22. Patel SA., et al. “Multiple unit pellet system (mups) based fast disintegrating delayed-release tablets for pantoprazole delivery”. International Journal of Electrochemical Science 10 (2018): 77.
23. Fouda AS., et al. “Expired drug (pantoprazole sodium) as a corrosion inhibitor for high carbon steel in hydrochloric acid solution”. International Journal of Electrochemical Science 7 (2018): 6327-6346.
24. Gupta NV and Shivakumar HG. “Preparation and characterization of superporous hydrogels as pH-sensitive drug delivery system for pantoprazole sodium”. Current Drug Delivery5 (2009): 505-510.
25. Raffin RP., et al. “Gastro-resistant microparticles containing sodium pantoprazole: stability studies and in vivo anti-ulcer activity”. The Open Drug Delivery Journal1 (2007).
26. Ferron GM., et al. “Oral bioavailability of pantoprazole suspended in sodium bicarbonate solution”. American Journal of Health-System Pharmacy13 (2003): 1324-1329.
27. Bi YX., et al. “Evaluation of rapidly disintegrating tablets prepared by a direct compression method”. Drug Development and Industrial Pharmacy5 (1999): 571-781.
28. Zupančič V., et al. “Physical characterization of pantoprazole sodium hydrates”. International Journal of Pharmaceutics1-2 (2005): 59-68.
29. Gupta NV and Shivakumar HG. “Preparation and characterization of super porous hydrogels as pH-sensitive drug delivery system for pantoprazole sodium”. Current Drug Delivery5 (2009): 505-10.
30. Badwan AA., et al. “Pantoprazole sodium”. In Analytical Profiles of Drug Substances and Excipients 29 (2002): 213-259.
31. Zupančič V., et al. “Physical characterization of pantoprazole sodium hydrates”. International Journal of Pharmaceutics1-2 (2005): 59-68.
32. Aravind PM., et al. “Stability enhancement of proton pump inhibitor in stomach: Formulation and in vitro evaluation of stabilized proton pump inhibitor”. Asian Journal of Pharmaceutical and Clinical Research5 (2017): 88-92.
33. Shrilatha KS., et al. “Formulation and in-vitro evaluation of fast dissolving tablets of anti- ulcer drugs”. American Journal of PharmTech Research 2 (2000): 49-59.
34. Srinivasa DS., et al. “Formulation and in vitro comparative evaluation of orodispersible tablets of Pantoprazole”. Research Journal of Pharmacy and Technology10 (2015): 1389-1393.
35. Reddy MS and Jalajakshi B. “Formulation and evaluation sustained release mucoadhesive gastroretentive pantoprazole sodium sesquihydrate tablets for anti–ulcer”. Journal of Drug Delivery and Therapeutics6-s (2018): 304-310.
36. Patel SA., et al. “Multiple unit pellet system (mups) based fast disintegrating delayed-release tablets for pantoprazole delivery”. International Journal of Pharmacy and Pharmaceutical Sciences 10 (2010): 77-84.

Citation

Citation: D Jeslin., et al. “Design and Performance of Pantoprazole Sodium Fast-Dissolving Tablets: A Promising Tablet Dosage Form".Acta Scientific Pharmaceutical Sciences 8.7 (2024): 03-15.

Copyright

Copyright: © 2024 D Jeslin., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.