Albert Science International Organization

ARTICLE DESCRIPTION: 

Veerbhadra Tripathi, Yogendra Singh, Ashok Baghel, Pradeep Yadav, Vishnu Kant Rai, Formulation and evaluation of enteric coated tablets of pantoprazole, ASIO Journal of Drug Delivery (ASIO-JDD), 2025, 7(1): 10-22.

ARTICLE TYPE: REVIEW

DOI Link:: http://doi-ds.org/doilink/10.2016-21915953/ ; DOI Link :: https://doi-ds.org/doilink/10.2025-76127896/ASIO-JDD/V7/I1/VT

ABSTRACT

Pantoprazole is a proton pump inhibitor, belongs to group of benzimidazole, Pantoprazole sodium tablets were prepared by direct compression method using different concentration of microcrystalline cellulose as filler, mannitol and dicalcium phosphate as diluents, crosscarmellose sodium as disintegrating agents, magnesium stearate and talc was used as a glidant and lubricant respectively. Direct compression is economic compare to wet granulation since it requires fewer unit operations. This means less equipment, lower power consumption, less space, less time and less labour leading to reduced production cost of tablets. The prepared tablets were evaluated for hardness, weight variation, friability and drug content uniformity and it was found that the results comply with official standards. The prepared tablets were coated using enteric coating polymer such as cellulose acetate phthalate, Eudragit L100 and by dip coating method. The in vitro release was studied using 0.1 N HCl (pH 1.2) and phosphate buffer (pH 6.8). Among all the prepared batches C2F9 was found best, with hardness 5.60 ± 0.24 (Kg/cm²), drug content 99.08 ± 0.35(%), disintegration time 7.02± 0.21(min), and percentage cumulative drug released which was started after 120 min and reached upto 99.72% after 180 min. Stability studies indicated that the developed tablets were stable and retained their pharmaceutical properties at room temperature and 40 °C /75% RH for a period of 3 months. Tablets were prepared and developed successfully.

Keywords: Pantoprazole, Direct compression, Proton pump inhibitor, Cellulose acetate phthalate, Eudragit L100.

1. Anne W, Allison G, in Ross, Wilson. Anatomy and Physiology in Health and Illness. 9^th Ed: Churchill Livingstone, Spain; 2001; 296.
2. Rang HP, Dale MM, Ritter JM, Morre PK. Pharmacology. 5^th Ed: Churchill Livingstone, 2005; 374.
3. Laurence L,John S, Keith L, in Goodman &Gilman's The pharmacological basis of therapeutics. 11^th Ed, McGraw-Hill, 2006: 623- 634.
4. Heinz L, Albrecht Z, Klaus M. Color Atlas of Pharmacology. 2^nd Ed. Thieme  Stuttgar, NewYork· 2000;166
5. Tripathi KD. Essential of Medical Pharmacology.5thEd.JaypeeBrothersMedical Publishers (P) Ltd. New Delhi: 2003; 631
6. Joseph T, Robert L, Gary C, Gary R, Barbara G, L. Michael. Pharmacotherapy: A Pathophysiologic Approach, 6th Ed. 613-615.
7. Nicole GM. Clinical effects of proton pump inhibitors.Erasmus University.2010; 1-2.
8. Richard F, Michelle A, Luigi X. Lippincott's Illustrated Reviews: Pharmacology, 4th Ed. Lippincott Williams & Wilkins. 2009; 331.
9. Bertram GK, Susan B. Masters, Anthony J. Trevor. Basic & Clinical Pharmacology, 11th Ed. by The McGraw-Hill Companies, 2009; 1479.
10. Jayesh P, Manish R. Tablet Formulation Design and Manufacture: Oral Immediate Release Application. Pharma Times April 2019; 41(4): 22.
11. Karl T, Karoline B, Enteric coated hard gelatin capsules. Department of Pharmaceutical Technology, Ludwig Maximilian University, 8000 Munich 2, Germany. Capsugel Library. 1-3.
12. Liberman, Lachman L. The Theory and Practice of Industrial Pharmacy.3rd Ed, Verghese Publication House.1987; 293.
13. Neelam DK, Prafulla SC, Rajesh J. Innovations In Tablet Coating Technology: A Review. IJABPT. Jan-Mar -2021; 2(1): 214-217.
14. Salam W. Dumitru L. Directly Compressible Adjuvants-A Pharmaceutical Approach. Farmacia.2008; Vol LVI6:591-593.
15. Rabia B, Muhammad H, Nousheen A. Formulation Development and Optimization Of Ibuprofen Tablets By Direct Compression Method. Pak. J. Pharm. Sci. April 2018; 21(2) : 113.
16. Rakesh P, Mansi B, Directly Compressible Materials via Co-Processing International Journal of PharmTech Research. 2019; 1(3): 745-748.
17. Olowosulu AK, Avosuahi O, Isah AB. Formulation and Evaluation of Novel Coprocessed Excipients of Maize Starch and Acacia Gum (StarAc) For Direct Compression Tabletting. International Journal of Pharmaceutical Research and Innovation. 2011; 2: 39-40.
18. Herbert A. Lieberman, Leon Lachman, Joseph B. Schwartz. Pharmaceutical Dosage Forms: Tablets. 2nd Ed.. Marcel Dekker. 1989; 214.
19. British Pharmacopoeia. London:The stationary office.2003;(1).
20. Indian Pharmacopoeia. Delhi:The controller of publications. 1996; (1).
21. Pantoprazole sodium sesquihydrate available at:http://wwwRxlist.com.
22. Raymond C ,Paul J, Marian E. Handbook of pharmaceutical excipients. 6thEd. London: The Pharmceutical Press.2009; 94,129,206,404,424, 928.
23. Sumit C, Sibaji S,Sujit D. Formulation Development and Evaluation of Pantoprazole Enteric Coated Tablets. Int. J. Chem Tech Res. 2019; 1(3): 663-666.
24. Anroop N, Rachna G, Rachna K, Shery J, Mahesh A. Formulation and Evaluation of Enteric Coated Tablets of Proton Pump Inhibitor, Journal of Basic and Clinical Pharmacy. 2010; 1(4).
25. Saffar M, Rajeev S, Sophia D. Comparative in vitro evaluation of commercially available pantoprazole tablets. Kathmandu University Journal Of Science, Engineering And Technology. 2017; 1(3): 1-7
26. Chanchal M, Anil G, Mukesh S, Asha R. Pantoprazole and its enteric coating polymer concentration for stable coating in acid media in stomach. International Journal of Pharmaceutical and Clinical Research. 2011; 3(2): 45-47.
27. Putta K, Hiremath D, S. Rajendra. Enteric coated tablets of novel proton pump inhibitor with super disintegrants design, in-vitro evaluation and stability studies. Journal of Applied Pharmaceutical Science. 2021; 01 (06): 106-111.
28. Bozdag S, Çalis S, Sumnu M. Formulation and stability evaluation of enteric-coated omeprazole formulations. S.T.P. Pharma Sciences. 1999; 9 (4): 321-327.
29. Mohamed N, and Hazem H. Pharmacokinetics and bioequivalence evaluation of two omeprazole enteric-coated formulations in healthy egyptian male volunteers. Journal of Applied Sciences Research. 2019; 5(9): 1190-1194.
30. Devraj, Bhatt DC. Studies on enteric coated sustained timed-release tablets of metronidazole. J. Chem. Pharm. Res. 2010; 2(2): 226-232.
31. Bankim Chandra Nandy, A. K. Gupta, A brief review on recent advances of extended release technology employed to design the oral dosage forms, International Journal of Medical and Biomedical Studies, 1(6)., Vol 1 No 6 (2017), 1-15.
32. Durriya H, Fahim M, Harris S, Zafar M, Rabia B, Rabial Y. Development of enteric coated flurbiprofen tablets using opadry/acryleze system-a technical note. AAPS PharmSciTech. 2018; 9(1): 116-121.
33. Senthil K, AshokkumarS, EzhilmuthuRP. Formulation and evaluation of didanosine enteric coated sustained release tablet. J Biomed Sci and Res. 2010; 2(3): 126-131.
34. Muhammad A, Syed S, Naqvi, Shahnaz G. Development of co-processed microgranles for direct compression. International Journal of Pharmacy and Pharmaceutical Sciences. 2010; 3(2): 64-69.
35. Vivek U, Haranadh S, Sreerama T, Seetha D, P Teja. KPR Chowdary. Formulation and in vitro evaluation of enteric coated tablets of didanosine. Pharmanest - An International Journal of Advances in Pharmaceutical Sciences. 2011; 2 (1): 40-45.
36. Singh C, Kumar R, Agarwal K, Nema K. Development and evaluation of enteric coated tablet containing diclofenac sodium. International Journal of Pharmaceutical Sciences and Nanotechnology 2009; 2(1): 443-449.
37. Rupesh K, Archana D, Kajale, Keshao P, Giradkar V. Formulation and development of enteric coated dosage form using ketorolac tromethamine. International Journal of Pharmaceutical Research and Development. 2010; 2(8): 126-135.
38. Rabia B, Muhammad Shoaib, Nousheen A, Zafar M, Durriya H. Enteric coating of ibuprofen tablets (200 mg) using an aqueous dispersion system. Brazilian Journal of Pharmaceutical Sciences. 2010; 46(1): 99-107.
39. Mominur Md, Saiful Md, Nahid S, Jakir C, Reza-ul J. Preparation and evaluation of cellulose acetate phthalate and ethyl cellulose based microcapsules of diclofenac sodium using emulsification and solvent evaporation method. Dhaka Univ. J. Pharm. Sci. 2010; 9(1): 39-46.
40. Rakesh T, Prashant P. Rabiprazole sodium delayed release multi-particulates: Effect of enteric coating layer on product performance. Journal of Advance Pharmaceutical Technology & Research. 2011; 2(3): 184-191.
41. B. C. Nandy, Bhaskar Mazumder, Three Levels Face Centered Central Composite Design of Colon Targeted Micro-Particulates System of Celecoxib: Screening of Formulations Variables and in Vivo Studies, Current Drug Delivery, 2014, 11(1), 1-7.
42. Gohel MC, Pranav J. A review of co-processed directly compressible excipients. J Pharm Pharmaceut Sci. 2005; 8(1):76-93: 76-93.
43. Rajeshwar a, vijayj, ripudaman s. Development and evaluation of gastro-resistant microspheres of pantoprazole. International Journal of Pharmacy and Pharmaceutical Sciences. 2010; 2(3): 112-116.
44. Martin A. Micromeretics. In: Martin A, ed. Physical Pharmacy. Baltimores, MD: Lippincott Williams and Wilkins. 2001; 423-454.
45. Liberman H, Lachman L. TheTheory and Practice of Industrial Pharmacy. 3^rd Ed. Bombay: Verghese Publication House.1991; 171-193.
46. Bankim Chandra Nandy, Bhaskar Mazumder. Optimization and Characterizations of Delayed Release Multi-Particulates System of Indomethacin: Screening of Formulations Variables and In Vitro Investigations, ASIO Journal of Pharmaceutical & Herbal Medicines Research, 2015, 1(1): 25-40.
47. Bankim Chandra Nandy, Bhaskar Mazumder, Preparation and Evaluations of Multi-Particulates System of Celecoxib: Optimization by Response Surface Methodology, ASIO Journal of Drug Delivery (ASIO-JDD), 2015, 1(1):11-25.