Assessment of dissolution profile of marketed aceclofenac formulations

Journal of Young Pharmacists

Volumn 2, Issue 1, 2010, Pages 21-26

  Soni, T ^a   Chotai, N ^a  

^a SARDAR PATEL UNIVERSITY   (India)

Author keywords

Aceclofenac; pair wise procedures; ratio test procedures; Weibull parameters

Indexed keywords

ACECLOFENAC; GENERIC DRUG;

ANALYSIS OF VARIANCE; ARTICLE; BIOEQUIVALENCE; DRUG BLOOD LEVEL; DRUG RELEASE; DRUG SOLUBILITY; KINETICS; MATHEMATICAL ANALYSIS; MATHEMATICAL MODEL; PRIORITY JOURNAL; SPECTROPHOTOMETRY; TABLET FORMULATION;

EID: 77957937682     PISSN: 09751483     EISSN: 09751505     Source Type: Journal    
DOI: 10.4103/0975-1483.62208     Document Type: Article

References (17)

1. FDA Guideline for Industry, Immediate Release solid oral dosage forms scale-up post approval changes (SUPAC) In vitro dissolution testing, US Department of Health and Human Services; 1995.
2. US FDA Rockville Guidance for Industry. Dissolution testing of immediate release solid oral dosage forms; 1997.
3. Committee for proprietary medicinal products (CPMP), Note for Guidance on quality of modifed release products; 1999.
4. O'Hara T, Dunne A, Kinahan A, Cunningham S, Stark P, Devane J. Review of methodologies for the comparison of dissolution profle data. Adv Exp Med Biol 1997;423:167-71
5. Mauger JW, Chilko D, Howard S. On the analysis of the dissolution data. Drug Dev Ind Pharm 1986;12:969-92.
6. Polli JE, Rekhi GS, Augsburger LL, Shah VP. Methods to compare dissolution profles and a rationale for wide dissolution specifcations for metoprolol tartarate tablets. J Pharm Sci 1997;86:690-700.
7. Costa P, Lobo JMS. Modeling and comparison of dissolution profles. Eur J Pharm Sci 2001;13:123-33.
8. Chow SC, Ki F YC. Statistical comparison between dissolution profles of drug product. J Biopharm Statist 1997;7:241-58.
9. Gill JL. Repeated measurement: Split-plot trend analysis versus analysis of frst difference. Biometrics 1998;44:289-97.
10. 2 as a criterion for assessment of similarity between dissolution profles. Drug Inform J 1997;31:1255-71.
11. Yuksel N, Kanik AE, Baykara T. Comparison of in vitro dissolution profles by AN OVA-based model-dependent and independent methods. Int J Pharm 2000;209:57-67.
12. Tsong Y, Hammerstrom T, Sathe P, Shah VP. Statistical assessment of mean differences between two dissolution data sets. Drug Inform J 1996;30:1105-12.
13. Tsong Y, Hammerstrom T, Sathe P, Shah VP. Comparing two dissolution data sets for similarity. Amer Statist Assoc; Proceedings of the Biopharmaceutical Section, 1996. p. 129-134
14. th ed. Whitehouse Station,NJ: Merck and Co, Inc.; 2001.
15. Yamazaki R, Kawai S, Matsuzaki T, Kaneda N, Hashimoto S, Yokokura T, et al. Aceclofenac blocks prostaglandin E2 production following its intracellular conversion into cyclo-oxygenase inhibitors. Eur J Pharmacol 1997;329:181-7.
16. Martindale: The Extra Pharmacopoeia. Chicago, Itt: Pharmaceutical Press 2005. p. 67.
17. Freitag G. Guidelines on dissolution profle comparison. Drug Inform J 2001;35:865-74.