In vitro and in vivo evaluation of nimesulide lyophilized orally disintegrating tablets

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 73, Issue 1, 2009, Pages 162-171

  Shoukri, Raguia Ali ^a   Ahmed, Iman Saad ^b   Shamma, Rehab N ^a  

^a CAIRO UNIVERSITY   (Egypt)

^b UNIVERSITY OF SHARJAH   (United Arab Emirates)

Author keywords

Bioavailability; Dissolution rate; Freeze drying; In vivo absorption; Nimesulide; Orally disintegrating tablets

Indexed keywords

NIMESULIDE; SULIDE; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG SOLUBILITY; DRUG STABILITY; DRUG STORAGE; FREEZE DRYING; HALF LIFE TIME; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; NORMAL HUMAN; PLASMA CONCENTRATION-TIME CURVE; POWDER; RANDOMIZED CONTROLLED TRIAL; TABLET DISINTEGRATION; TABLET DISINTEGRATION TIME; TABLET FORMULATION; TABLET FRIABILITY; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, ORAL; ADULT; BIOLOGICAL AVAILABILITY; CROSS-OVER STUDIES; DRUG EVALUATION; FREEZE DRYING; HUMANS; MALE; MIDDLE AGED; MOUTH MUCOSA; SOLUBILITY; SULFONAMIDES; TABLETS; TIME FACTORS; X-RAY DIFFRACTION; YOUNG ADULT;

EID: 68349144732     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2009.04.005     Document Type: Article

References (30)

1. Biscarini L., Patoia L., and Favero A.D. Nimesulide - a new non-steroidal anti-inflammatory agent. Drugs Today 24 (1988) 23-27
2. Amidon G.L., Lennernäs H., Shah V.P., and Crison J.R. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 12 (1995) 413-420
3. Meriani F., Coceani N., Sirotti C., Voinovich D., and Grassi M. Characterization of a quaternary liquid system improving the bioavailability of poorly water soluble drugs. J. Coll. Inter. Sci. 263 (2003) 590-596
4. Piel G., Pirotte B., Delneuville I., Neven B., Labres G., Delarge J., and Delattre L. Study of the influence of both cyclodextrins and l-lysine on the aqueous solubility of nimesulide; isolation and characterization of nimesulide l-lysine-cyclodextrin complexes. J. Pharm. Sci. 86 (1997) 475-480
5. Barbato F., Cappello B., La Rotando M.I., Miro A., and Morrica P. Nimesulide/β-cyclodextrin inclusion compounds: characterization and dissolution studies. Proc. Int. Symp. Control. Rel. Bioact. Mater. 24 (1997) 385-386
6. Buchi Nalluri N., Chowdary K.P.R., Murthy K.V.R., Becket G., and Peter Crooks A. Tablet formulation studies on nimesulide and meloxicam - cyclodextrin binary systems. AAPS Pharm. Sci. Tech. 8 2 (2007) (Article 36)
7. Kapoor A., Majumdar D.K., and Yadav M.R. Crystal forms of nimesulide - a sulfonanilide (NSAID). Indian J. Chem. 37B (1998) 572-575
8. Bernareggi A. The pharmacokinetic profile of nimesulide in healthy volunteers. Drugs 46 1 (1993) 64-72
9. European Pharmacopoeia, fourth ed., Suppl. 4.1. Published by the directorate for the quality of medicines of the council of Europe 9EDQM, Strasbourg, France, 2002.
10. Abdelbary G., Eouani C., Prinderre P., Joachim J., Reynier J., and Piccerelle P. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int. J. Pharm. 292 (2005) 29-41
11. Sherimeier S., and Schmidt P.C. Fast dispersible ibuprofen tablets. Eur. J. Pharm. Sci. 15 (2002) 295-305
12. FDA - guidance for industry, Q1A(R2), Stability testing of new drug substances and products.
13. FDA, Guidance of Industry, Food-effect Bioavailability and Bioequivalence Studies, 2002.
14. Ptáček P., Macek J., and Klima J. Rapid and simple high-performance liquid chromatographic determination of nimesulide in human plasma. J. Chrom. B 758 (2001) 183-188
15. Djagny K.B., Wang Z., and Xu S. Gelatin: a valuable protein for food and pharmaceutical industries. Crit. Rev. Food Sci. Nutr. 41 (2001) 481-492
16. Mizumoto T., Masuda Y., Yamamoto T., Yonemochi E., and Terada K. Formulation design of a novel fast disintegrating tablet. Int. J. Pharm. 306 (2005) 83-90
17. Sastry S.V., Nyshadham J.R., and Fix J.A. Recent technological advances in oral drug delivery: a review. Pharm. Sci. Technol. To. 3 4 (2000) 138-145
18. Dobetti L. Fast-melting tablets: developments and technologies. Pharm. Technol. 25 9 (2001) 44-50
19. Allen L.V.J., Levinson R.S., and Martono D.D. Dissolution rates of hydrocortisone and prednisone utilizing sugar solid dispersion systems in tablet form. J. Pharm. Sci. 67 (1978) 979-981
20. Kuno Y., Kojima M., Ando S., and Nakagami H. Evaluation of rapidly disintegrating tablets manufactured by phase transition of sugar alcohols. J. Control. Rel. 105 (2005) 6-22
21. O{combining double acute accent}zkan Y., Doǧanay N., Dikmen N., and Işimer A. Enhanced release of solid dispersions of etodolac in polyethylene glycol. IL Farmaco 55 (2000) 433-438
22. Corrigan O.I., Murphy C.A., and Timoney R.F. Dissolution properties of polyethylene glycols and polyethylene glycol-drug systems. Int. J. Pharm. 4 (1979) 67-74
23. Ford L.J., Stewart A.F., and Dubois J.L. The properties of solid dispersions of indomethacin or phenylbutazone in polyethylene glycol. Int. J. Pharm. 28 (1986) 11-22
24. Buchi Nalluri N., Chowdary K.P.R., Murthy K.V.R., Becket G., and Hayman A.R. Physicochemical characteristics and dissolution properties of nimesulide-cyclodextrin binary systems. AAPS PharmSci. Technol. 4 1 (2003) (Article 2)
25. Yalkowsky S. Solubility and Solubilization of Nonelectrolytes. Techniques of Solubilization of Drugs (1981), Dekker, New York pp. 2-15
26. Nair R., Nyamweya N., Go{combining double acute accent}en S., Martinez-Miranda L.J., and Hoag S.W. Infleunce of various drugs on the glass transition temperature of poly-(vinylpyrrolidone): a thermodynamic and spectroscopic investigation. Int. J. Pharm. 225 (2001) 83-96
27. Sekikawa H., Nakano M., and Arita T. Dissolution mechanisms of drug-polyvinylpyrrolidone coprecipitates in aqueous solution. Chem. Pharm. Bull. 27 (1979) 1223-1230
28. Tantishaiyakul V., Kaewnopparat N., and Ingkatawornwong S. Properties of solid dispersions of piroxicam in polyvinylpyrrolidone. Int. J. Pharm. 181 (1999) 143-151
29. Ahlneck C., and Zeografi G. The molecular basis of moisture effects on the physical and chemical stability of drugs in the solid-state. Int. J. Pharm. 62 (1990) 87-95
30. Shargel L., Wu-Pong S., and Yu A. Applied Biopharmaceutics and Pharmacokinetics. fifth ed. (2005), McGraw-Hill Companies, Inc. (p. 303)