Volume : 09, Issue : 07, July – 2022
Title:
63.FORMULATION AND DEVELOPMENT OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE ORO-DISPERSIBLE TABLETS
Authors :
K. Vinod Kumar*, S. Manohar Babu., T. Srinivas, B. Gopi, G. Sravani, M. Rajesh, P. Susanna, Sk. Aathika, Sk. Waseem.
Abstract :
Now-a-days the demand for mouth dissolving tablets has been rapidly increasing, especially for gediatric and pediatric patients who have swallowing difficulties. Esomeprazole is a Proton Pump Inhibitor used in the treatment of certain stomach and esophagus problems such as acid reflux, ulcers. In the present work, the Oro-dispersible tablets of esomeprazole by Direct Compression method using Superdisintegrants approach and effervescent approach. Bulk density, Tapped density, Compressibility index and Hauser’s ratio are the powder flow properties evaluated for the final blend of drug and excipients. All the formulations were evaluated for thickness , weight variation , disintegration time , hardness , friability , drug content , water absorption ratio , and In-vitro dissolution studies. The lowest disintegration time and maximum in -vitro dissolution profile is performed by F6 formulation.
Keywords: Proton pump inhibitor, Oro-dispersible, Esomeprazole, Super disintegrates.
Cite This Article:
Please cite this article in press K.Vinod kumar et al, Formulation And Development Of Esomeprazole Magnesium Trihydrate Oro-Dispersible Tablets., Indo Am. J. P. Sci, 2022; 09(7).,
Number of Downloads : 10
References:
REFERENCES:
1. Leon Lachamnn; Herbert A.Liebermann; Joseph L.Kanig. The Theory and practice of Industrial Pharmacy; Third Edition; pg.no.293.
2. Loyd.V.Allen, Nicholas .G.Popovich, Howard.C.Ansel; Ansel’s pharmaceutical dosage form and drug delivery system 8th edition.
3. Bentley’s Text book of Pharmaceutics; Eight edition; pg.no.140
4. HowardC.AnselLloyd;V.Allen;Jr.Nicolas;G.Popovich Pharmaceutical Dosage forms and Delivery systems;pg.no.209.
5. US Food and Drug Administration, CDER Data Standards Manual, 2003,
6. European Directorate for the Quality of Medicines, Pharm Europa, 10 (4), 547 (1988),
7. T.K. Ghosh et al., “Quick Dissolving Oral Dosage Forms: Scientific and Regulatory Considerations from a Clinical Pharmacology and Biopharmaceuticals Perspective,” in Drug Delivery to the Oral Cavity: Molecules to Market, T.K. Ghosh and W.R. Pfister, Eds. (CRC Press, New York, NY, 2005), pp. 337–356.
8. L. Dobetti, “Fast-Melting Tablets: Developments and Technologies,” Pharm. Technol. 25 (9 Suppl), 44–50 (2001).
9. S.I. Pather, R. Khankari, and J. Siebert, “Quick-Dissolving Intraoral Tablets,” in Drug Delivery to the Oral Cavity: Molecules to Market, T.K. Ghosh and W.R. Pfister, Eds. (CRC Press, New York, NY, 2005), pp. 291–336
10. K. Deepak, “Orally Disintegrating Tablets,” Tablets and Capsules 7 , 30–35 (2004).
11. D. Brown, “Orally Disintegrating Tablets: Taste Over Speed,” Drug Deliv. Technol. 3 (6), 58–61 (2001).
12. J. Aurora and V. Pathak, “Oral Disintegrating Technologies: Oral Disintegrating Dosage Forms: An Overview,” Drug Deliv. Technol. 5 (3), 50–54 (2005).
13. C.C. DeRoche et al., “Consumer Preference for Orally Disintegrating Tablets Over Conventional Forms of Medication: Evolving Methodology for Medication Intake in Dysphasia,” lecture presented at the 12th Annual Meeting of the Dysphasia Research Society, San Francisco, CA, Oct. 2–4, 2003.
14. N. Sharma et al., “Manufacturing Technology Choices for Mouth Dissolving Tablets,” Pharm. Technol. 27 (10 Suppl), 10–13 (2003).
15. F. Wehling et al.,”Pediatric Effervescent Dosage Form,” US Patent 5,223,264 (1993).
16. F. Wehling et al., “Effervescent Dosage Form With Microparticles,” US Patent 5,178,878 (1993).
17. F. Wehling and S. Schuehle, “Base Coated Acid Particles and Effervescent Formulation Incorporating Same,” US Patent 5,503,846 (1996).
18. S.V. Sastry and J. Nyshasham, “Process Development and Scale-Up of Oral Fast-Dissolving Tablets,” in Drug Delivery to the Oral Cavity: Molecules to Market, T.K. Ghosh and W.R. Pfister, Eds. (CRC Press, New York, NY, 2005), pp. 311–336.
19. M.C. Iles et al., “Freeze-Dried Dosage Forms and Methods for Preparing the Same,” US Patent 5,188,825 (1993).
20. S.R. Cherukuri et al., “Process for Forming Quickly Dispersing Compressible Unit and Product Therefrom,” US Patent 5,587,172 (1996).
21. R. Fuisz, “Ulcer Prevention Method Using a Melt-Spun Hydrogel,” US Patent 5,622,717 (1997).
22. S.R. Cherukruri and R. Fuisz, “Process and Apparatus for Making Tablets and Tablets Made Therefrom,” European Patent 0,677,147 A2 (1995).
23. G.L. Myers et al.,”Delivery of Controlled-Release Systems,” US Patent 5,567,439 (1996).
24. Lawrence Brunton/ John Lazo: Goodman& Gilamn –Pharmacological Basis Of Therapeutics
25. Mary .J. Mycek, Richard.A. Harvey, Pamela .C. Champe-Lippincott’s Illustrated Reviews: Pharmacology 2nd Edition.
26. Eby GA, Halcomb WW (2006). High-Dose zinc to terminate migraine: a review and hypothesis for action by ICAM inhibition. Med Hypotheses 66 (1): 169–72
27. A Text Book of Materia Medica, Therapeutics,and Pharmacology by George Frank Butler, Published by W. B. Saunders, 1899, page 752
28. National Human LaBI, U.S.Department of Health and Human Services. Facts About migraine.2001. National Institute of Health. Ref Type: Pamphlet
29. Bruk, G.M.; Mendes, R.W. and Jambhekar, S.S.; Drug. Dev.Ind.Pharm, 12,1986, pp 712-732
30. K.D.Tripathi Pharmacology Clinical Uses
31. Drug Information Handbook 11th Addition Charles.F.Lacy,etal 2002.
32. H.S.Mahajan, B.S.Kuchekar, A.C.Badhan. Government college of pharmacy,karad. Mouth dissolve tablets of Esomeprazole ,Indian Journal of Pharmaceutical sciences. (Mar-Apr 2004): 238-240.
33. Purnima, Amin Prabhu amita, Wadhwani Anita. Indian 414 as superdisintegrant in formulation of mouth dissolve tablets. Indian Journal of Pharmaceutical Sciences,2006:68(1):15-18.
34. Fast Dissolving Tablets of Aloe Vera GelTropical Journal of Pharmaceutical Research, February 2009; 8 (1): 63-70.
35. Hand Book of Excipients 223-226 ; 352-355 ; 455-457; 687-725.
36. Irwin, W.J.; Belaid, K.A.; Alpar, H.O.; Drug. Dev. Ind.Pharm,1987,13,, pp 2047-2066
37. Swarbik,J.; Ion exchange resins and sustained release;Encyclopedia of Pharmaceutical Technology, Vol-8,2003, pp 203-217