Miconazole nitrate oral disintegrating tablets: In vivo performance and stability study

AAPS PharmSciTech

Volumn 13, Issue 3, 2012, Pages 760-771

  Ahmed, Tarek A ^a,b   El Say, Khalid M ^a,b   Mahmoud, Maged F ^b   Samy, Ahmed M ^b   Badawi, Alia A ^c  

^a KING ABDULAZIZ UNIVERSITY   (Saudi Arabia)

^b Al Azhar University   (Egypt)

^c CAIRO UNIVERSITY   (Egypt)

Author keywords

accelerated stability testing; bioavailability; foam granulation technique; miconazole nitrate; oral disintegrating tablet

Indexed keywords

AEROSIL; MAGNESIUM STEARATE; MANNITOL; MICONAZOLE NITRATE; MICROCRYSTALLINE CELLULOSE; POVIDONE;

ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG FORMULATION; DRUG PACKAGING; DRUG SOLUBILITY; DRUG STABILITY; DRUG STORAGE; EVALUATION; HUMIDITY; IN VITRO STUDY; IN VIVO STUDY; PRIORITY JOURNAL; SHELF LIFE; TABLET DISINTEGRATION; TABLET DISINTEGRATION TIME; TABLET FRIABILITY; TEMPERATURE; TENSILE STRENGTH; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADMINISTRATION, ORAL; ANIMALS; DRUG STABILITY; HUMANS; MICONAZOLE; RATS, WISTAR; SOLUBILITY; TABLETS;

EID: 84866129823     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-012-9798-z     Document Type: Article

References (42)

1. Himanshu KS, Tarashankar B, Jalaram HT, Chirag AP. Recent advances in granulation technology. Int J Pharm Sci Rev Res. 2010;5(3):Article-008.
2. Sandler N, Lammens RF. Pneumatic dry granulation: potential to improve roller compaction technology in drug manufacture. Expert Opin Drug Deliv. 2011;8(2):225-36.
3. Powder pro (2012) http://www.powderpro.se/products/technology/. Accessed 8 Apr 2012.
4. Ochoa L, Igartua M, Hernández RM, Gascón AR, Pedraz JL. Preparation of sustained release hydrophilic matrices by melt granulation in a high-shear mixer. J Pharm Pharm Sci. 2005;8(2):132-40.
5. Rodriguez L, Cavallari C, Passerini N, Albertini B, González- Rodríguez M, Fini A. Preparation and characterization by morphological analysis of diclofenac/PEG 4000 granules obtained using three different techniques. Int J Pharm. 2002;242(1-2):285-9.
6. Ismat U, Jennifer W, Shih-Ying C, Gary JW, Nemichand BJ, San K. Moisture activated dry granulationpart I: a guide to excipient and equipment selection and formulation development. Pharm Technol. 2009;33(11):62-70.
7. Lin HL, Ho HO, Chen CC, Yeh TS, Sheu MT. Process and formulation characterizations of the thermal adhesion granulation (TAG) process for improving granular properties. Int J Pharm. 2008;357(1-2):206-12.
8. Paul J, Shesky R, Colin K. New foam binder technology from Dow improves granulation process. Pharm Can. 2006; 19-22.
9. Bouckaert S, Remon JP. In vitro bioadhesion of a buccal, miconazole slow release tablets. J Pharm Pharmacol. 1993;45:504-7.
10. Minghetti P, Cilurzo F, Casiraghi A, Molla FA, Montanari L. Dermal patches for the controlled release of miconazole: influence of the drug concentration on the technological characteristics. Drug Dev Ind Pharm. 1999;25:679-84.
11. Mandal TK. Swelling-controlled release system for the vaginal delivery of miconazole. Eur J Pharm Biopharm. 2000;50:337-43.
12. Pedersen M, Rassing MR. Miconazole chewing gum as a drug delivery system: test of release promoting additives. Drug Dev Ind Pharm. 1991;17:411-20.
13. Bouckaert S, Schautteet H, Lefebvre RA, Remon JP, van Clooster R. Comparison of salivary miconazole concentrations after administration of a bioadhesive slow-release buccal tablet and an oral gel. Eur J Clin Phamacol. 1992;43:137-40.
14. ICH. Stability testing of new drug substances and products. Geneva: International Conference on Harmonization, IFPMA; 1993.
15. ICH. Impurities in new drug products. Geneva: International Conference on Harmonization, IFPMA; 1996.
16. Hui Y, Huang NH, Ebbert L, Bina H, Chiang A, Maples C, Pritt M, Kern T, Patel N. Pharmacokinetic comparisons of tail-bleeding with cannula- or retro-orbital bleeding techniques in rats using six marketed drugs. J Pharmacol Toxicol Methods. 2007;56:256-64.
17. EMEA, The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on quality of modified release products. A: oral dosage forms. B: transdermal dosage forms, Section I (quality). 1999. CPMP/QWP/604/96, 1-15.
18. USP 28, the United States Pharmacopoeia, 28th Revision. Rockville, MD: Pharmacopoeial Convention, Inc. 2005.
19. Burgess DJ, Crommelin DJA, Hussain AS, Chen ML. Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report. AAPS PharmSci. 2004;6(1):Article 11.
20. Harshal AP, Priscilla MD. Development and evaluation of herbal laxative granules. J Chem Pharm Res. 2011;3(3):646-50.
21. Aulton ME. Pharmaceutics: the science of dosage form design. 2nd ed. New York: Churchill Livingstone; 2002. p. 154-5.
22. Wells J. Pharmaceutical preformulation. In: Aulton ME, editor. Pharmaceutics the science of dosage form design. 2nd ed. Edinburgh: Churchill Livingstone; 2003. p. 133-4.
23. Haririan I, Newton JM. Tensile strength of circular flat and convex-faced avicel PH102 tablets. Daru. 1999;7(3):36-9.
24. USFDA. Dissolution methods database. 2010. accessdata.fda.gov/scripts/ cder/dissolution. Accessed on 15 Jun 2010.
25. Okuda Y, Irisawa Y, Okimoto K, Osawa T, Yamashita S. A new formulation for orally disintegrating tablets using a suspension spray-coating method. Int J Pharm. 2009;382:80-7.
26. USFDA. Bioequivalence guidelines. 2010. accessdata.fda.gov/scripts/cder/ dissolution. Accessed 15 Jun 2010.
27. Kobylifiska M, Kobylifiska K, Sobik B. High-performance liquid chromatographic analysis for the determination of miconazole in human plasma using solid phase extraction. J Chromatogr B Biomed Appl. 1996;685:191-5.
28. Sheskey P, Keary C, Clark D, Balwinski K. Scale up formulae of foam granulation technology-high shear. Pharm Technol. 2007;31(4):94-9.
29. Barillaro V, Bertholet P, Sandrine HH. Effect of acidic ternary compounds on the formation of miconazole/cyclodextrin inclusion complexes by means of supercritical carbon dioxide. J Pharm Pharm Sci. 2004;7(3):378-88.
30. Barillaro V, Dive G, Bertholet P, Evrard B, Delattre L, Frederich M, Ziemons E, Piel G. Theoretical and experimental investigations of organic acids/ cyclodextrin complexes and their consequences upon the formation of miconazole/previous termcyclodextrin/acid ternary inclusion complexes. Int J Pharm. 2007;342:152-60.
31. Yoshinari T, Forbes RT, York P, Kawashima Y. The improved compaction properties of mannitol after a moisture-induced polymorphic transition. Int J Pharm. 2003;258:121-31.
32. Nie X. Heat and moisture migration within a porous urea particle bed. PhD thesis, University of Saskatchewan, 2010; p. 8-9.
33. USP, the United States Pharmacopoeia. 34th edn., Rockville, MD: Pharmacopoeial Convention, Inc. 2011.
34. Lerk CF, Lagas M, Fell JT, Nauta P. Effect of hydrophilization of hydrophobic drugs on release rate from capsules. J Pharm Sci. 1978;67(7):935-9.
35. Jafari MR, Danti AG, Ahmed I. Comparison of polyethylene glycol, polyvinylpyrrolidone and urea as excipients for solid dispersion systems of MN. Int J Pharm. 1988;48:207-15.
36. ICH. International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use, by the ICH Steering Committee, version 2, 2005.
37. The European Pharmacopoeia (Ph.Eur.). 6th ed., Strasbourg, France: European Directorate for the Quality of Medicines, Council of Europe, 2010
38. Faroongsarng D, Peck GE. Thermal porosity analysis of croscarmellose sodium and sodium starch glycolate by differential scanning calorimetry. AAPS Pharma Sci Tech. 2003;4:E67.
39. Stubberud L, Arwidsson HG, Graffner C. Water-solid interactions: a technique for studying moisture sorption/ desorption. Int J Pharm. 1995;114:55-64.
40. Rowe RC, Shesky PJ, Quinn ME. Handbook of pharmaceutical excipients. 6th ed. London: Pharmaceutical Press; 2009. p. 196-8.
41. Wong SM, Kellaway IW, Murdan S. Enhancement of the dissolution rate and oral absorption of a poorly water soluble drug by formation of surfactant-containing microparticles. Int J Pharm. 2006;317:61-8.
42. Barillaro V, Bertholet P, Sandrine HH. Effect of acidic ternary compounds on the formation of miconazole/cyclodextrin inclusion complexes by means of supercritical carbon dioxide. J Pharm Sci. 2004;7(3):378-88.