Processing of nimesulide-PEG 400-PG-PVP solid dispersions: Preparation, characterization, and in vitro dissolution

Drug Development and Industrial Pharmacy

Volumn 29, Issue 3, 2003, Pages 299-310

  Gohel, M C ^a   Patel, L D ^a  

^a L M COLLEGE OF PHARMACY   (India)

Author keywords

Cogrinding methods; Nimesulide dissolution improvement; Pseudosolid dispersions

Indexed keywords

ADJUVANT; DODECYL SULFATE SODIUM; LACTOSE; MACROGOL 400; MICROCRYSTALLINE CELLULOSE; NIMESULIDE; POLYSORBATE 80; POVIDONE; PROPYLENE GLYCOL; SOLUBILIZER; SOLVENT; WATER;

AQUEOUS SOLUTION; ARTICLE; BATCH PROCESS; DISPERSION; DRUG FORMULATION; DRUG GRANULE; DRUG RELEASE; DRUG SOLUBILITY; EVAPORATION; EXPERIMENTAL DESIGN; FLOW; GRINDING; MODEL; PARTICLE SIZE; PHYSICAL CHEMISTRY; POWDER; PROCESS OPTIMIZATION; SOLID; VALIDATION PROCESS; WETTABILITY; X RAY DIFFRACTION;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; PHARMACEUTIC AIDS; POLYETHYLENE GLYCOLS; POLYSORBATES; POVIDONE; PROPYLENE GLYCOL; SODIUM DODECYL SULFATE; SOLUBILITY; SULFONAMIDES; SURFACE-ACTIVE AGENTS; TIME FACTORS; WETTABILITY;

EID: 0037965572     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1081/DDC-120018203     Document Type: Article

References (34)

1. Lobenberg, R.; Amidon G.L. Modern bioavailability, bioequivalence and biopharmaceutics classification system: new scientific approaches to international regulatory standards. Eur. J. Pharm. Biopharm. 2000, 50, 3-12.
2. Piel, G.; Pirotte, B.; Delneuville, I.; Neven, P.; Llabres, G.; Delarge, J.; Delattre, L. Study of the influence of both cyclodextrins and L-lysine on the aqueous solubility of nimesulide; isolation and characterization of nimesulide-L-lysinecyclodextrin complexes. J. Pharm. Sci. 1997, 86, 475-480.
3. Chiou, W.L.; Riegelman, S. Pharmaceutical applications of solid dispersion systems. J. Pharm. Sci. 1971, 60, 1281-1302.
4. Goldberg, A.H.; Gibaldi, M.; Kanig, J.L. Increasing dissolution rates and gastrointestinal absorption of drugs via solid dispersions and eutectic mixtures. J. Pharm. Sci. 1966, 55, 482-492.
5. Spiegel, A.J.; Noseworthy, M.M. Use of non-aqueous solvents in parenteral products. J. Pharm. Sci. 1963, 52, 917-927.
6. Rubino, J.T. Cosolvents and cosolvency. In Encyclopedia of Pharmaceutical Technology; Swarbrick, J., Boylan, J.C., Eds. Marcel Dekker, Inc.; New York, 1990; Vol. 3, 375-398.
7. Serajuddin, A.T.M.; Tejwani, R.W.; Joshi, H.N.; Varia, S.A. Study of phase behavior of poly(ethylene glycol)-polysorbate 80 and poly(ethylene glycol)-polysorbate 80-water mixtures. J. Pharm. Sci. 2000, 89, 946-950.
8. Myrdal, P.B.; Yalkowsky, S.H. Solubilization of drugs. In Encyclopedia of Pharmaceutical Technology; Swarbrick, J., Boylan, J.C., Eds.; Marcel Dekker, Inc.: New York, 1999; Vol. 18, 161-217.
9. Worthington, H. Propylene Glycol. In Handbook of Pharmaceutical Excipients, 2nd Ed.; Wade, A., Weller, P.J., Eds.; American Pharmaceutical Association/The Pharmaceutical Press: Washington, DC/London, 1994; 241-242.
10. Sarasija, S.; Dhir, S.S. Solubilization of carbamazepine for solution dosage forms. Indian J. Pharm. Sci. 1998, 60, 144-148.
11. Spireas, S.S.; Sadu, S. In-vitro release evaluation of hydrocortisone liquisolid tablets. J. Pharm. Sci. 1998, 87, 867-872.
12. Sheth, B.B.; Krishna, G. A novel self-emulsifying parenteral drug delivery system. PDA J. Pharm. Sci. Technol. 1999, 53, 168-176.
13. Tandon, P.; Mishra, R. Development of multiple w/o/w emulsions showing prolonged anti-inflammatory activity of nimesulide. Acta Pharm. Turcia. 1999, XLI (1), 15-18.
14. William, J.R. Pharmaceutical necessities. In Remington's Pharmaceutical Science, 19th Ed.; Mack Publishing Company: Pennsylvania, 1995; Chapter 80, Volume II, 1398-1399.
15. Kaneto, U.; Kengo, I.; Zheng, W.; Yasuhide, H.; Fumitoshi, H. Inhibitory effect of 2-hydroxy propyl-β-cyclodextrin on crystal growth of nifedipine during storage: superior dissolution and oral bioavailability compared with PVP K30. J. Pharm. Pharmacol. 1992, 44, 73-78.
16. Chowdary, K.P.R.; Murthy, K.V.R.; Prasad, C.D.S. Solid dispersions of nimodipine: physicochemical and dissolution rate studies. Indian Drugs. 1998, 32 (11), 537-542.
17. Ghosh, L.K.; Ghosh, N.C.; Chatterjee, M.; Gupta, B.K. Product development studies on the tablet formulation of ibuprofen to improve bioavailability. Drug. Dev. Ind. Pharm. 1998, 24, 473-477.
18. Ralph, L. Selection and use of crystallization inhibitors for matrix type transdermal drug delivery systems containing sex steroids. J. Pharm. Pharmacol. 1998, 50, 1343-1349.
19. Zeng, X.M.; Martin, G.P.; Marriott, C. The effect of molecular weight of polyvinyl pyrrolidone on crystallization of co-lyophilized sucrose. J. Pharm. Pharmacol. 1998, 50 (supplement), 65.
20. Wulff, M.; Alden, M. Solid state studies of drug-cyclodextrin complexes in polyethylene glycol 6000 prepared by a new method. Eur. J. Pharm. Sci. 1999, 8, 269-281.
21. Saha, P.; Kou, J.H. Effect of solubilizing excipients on permeation of poorly water-soluble compounds across Caco-2 monolayers. Eur. J. Pharm. Biopharm. 2000, 50, 403-411.
22. Spireas, S.S.; Rohera, B.D.; Jarowski, C.I. Powdered solution technology: principles and mechanism. Pharm. Res. 1992, 9, 1351-1358.
23. Liao, C.C.; Jarowski, C.I. Dissolution rates of corticoid solutions dispersed on silicas. J. Pharm. Sci. 1984, 73, 401-403.
24. Efentakis, M.; Dressman, J.B. Gastric juice as dissolution medium: surface tension and pH. Eur. J. Drug. Metab. Pharmacokinet. 1998, 3, 97-102.
25. Bakatselon, V.; Oppenheim, R.C.; Dressman, J.B. Solubilization and wetting effects of bile salts on the dissolution of steroids. Pharm. Res. 1991, 8, 1461-1469.
26. Mithani, S.D.; Bakatselon, V.; Tenhoor, C.N.; Dressman, J.B. Estimation of the increase in solubility of drugs as a function of bile salt concentration. Pharm. Res. 1996, 13, 163-167.
27. Gohel, M.C.; Patel, L.D. Improvement of Nimesulide Dissolution by a Co-grinding method using surfactants. Pharm. Pharmacol. Commun. 2000, 6 (10), 433-440.
28. McKenna, A.; McCafferty, D.F. Effect of particle size on the compaction mechanism and tensile strength of tablets. J. Pharm. Pharmacol. 1982, 34, 347-351.
29. Lefebvre, C.; Barthelemy, A.M.; Hermann, G. An attempt at bringing to light a "phase inversion" in a binary mixture of two-dimensional rounded particles. Drug. Dev. Ind. Pharm. 1988, 14 (15-17), 2443-2465.
30. Khan, K.A. The concept of dissolution efficiency. J. Pharm. Pharmacol. 1975, 27, 48-49.
31. Moore, J.W.; Flanner, H.H. Mathematical comparison of dissolution profiles. Pharm. Techno. 1996, 20, 64-74.
32. Spiro, S.S.; Srinivas, S. Enhancement of prednisolone dissolution properties using liquisolid compacts. Int. J. Pharm. 1998, 166, 177-188.
33. Hancock, B.C.; Parks, M. What is the true solubility advantage for amorphous pharmaceuticals? Pharm. Res. 2000, 17, 397-404.
34. Lin, S.Y.; Kao, Y.H.; Yang, J.C. Grinding effect on some pharmaceutical properties of drugs by adding β-cyclodextrin. Drug. Dev. Ind. Pharm. 1988, 14 (1), 99-118.