Role of surfactant and pH on dissolution properties of fenofibrate and glipizide - A technical note

AAPS PharmSciTech

Volumn 7, Issue 2, 2006, Pages

  Jamzad, Shahla ^a   Fassihi, Reza ^a  

^a TEMPLE UNIVERSITY   (United States)

Author keywords

Fenofibrate; Glipizide; Sink condition

Indexed keywords

ANTILIPEMIC AGENT; FENOFIBRATE; GLIPIZIDE; LACTOSE; MAGNESIUM STEARATE; ORAL ANTIDIABETIC AGENT; SILICON DIOXIDE; SURFACTANT; ANTIDIABETIC AGENT; SOLVENT;

ARTICLE; CONTROLLED RELEASE FORMULATION; DRUG SOLUBILITY; DRUG STRUCTURE; LIPOPHILICITY; PH; QUALITY CONTROL; TABLET; CHEMISTRY; COMPARATIVE STUDY; DELAYED RELEASE FORMULATION; DIFFUSION; DRUG SCREENING; EVALUATION; MATERIALS TESTING; METHODOLOGY; SOLUBILITY;

ANTILIPEMIC AGENTS; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DIFFUSION; DRUG EVALUATION, PRECLINICAL; GLIPIZIDE; HYDROGEN-ION CONCENTRATION; HYPOGLYCEMIC AGENTS; MATERIALS TESTING; PROCETOFEN; QUALITY CONTROL; SOLUBILITY; SOLVENTS; SURFACE-ACTIVE AGENTS; TABLETS;

EID: 33746101876     PISSN: 15309932     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/pt070233     Document Type: Article

References (22)

1. Dressman JB, Amidone GL, Reppas C, Shah VP. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm Res. 1998;15:11-22.
2. Pillay V, Fassihi R. Evaluation and comparison of dissolution data derived from different modified release dosage forms: an alternative method. J Control Release. 1998;55:45-55.
3. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Guidance for Industry. Modified Release Solid Oral Dosage Forms: Scale up and Post Approval Changes (SUPAC): Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. Rockville, MD: FDA; 1997.
4. 4 Shah VP, Konecny JJ, Everett RL, McCullough B, Noorizadeh AC, Skelly JP. In vitro dissolution profile of water-insoluble drug dosage forms in the presence of surfactants. Pharm Res. 1989;6:612-618.
5. Abdou HM. Dissolution, Bioavailability, and Bioequivalence. Easton, PA: Mack; 1989.
6. United States Pharmacopeial Convention. In vitro and in vivo evaluation of dosage forms. USP 28. Rockville, MD: United States Pharmacopeial Convention Inc; 2005:1088.
7. Carstensen JT. Physico-chermical aspects of drug release. In: Polderman J, ed. Formulation and Preparation of Dosage Forms. Amsterdam, The Netherlands: North-Holland Biomedical Press, Elsevier; 1977.
8. Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res. 1995;12:413-420.
9. Jinno J, Oh DM, Crison JR, Amidon GL. Dissolution of water-insoluble drugs: the combined effect of pH and surfactant. J Pharm Sci. 2000;89:268-274.
10. Jamzad S, Fassihi R. Development of a controlled release low dose class II drug-glipizide. Int J Pharm. 2006;312:24-32.
11. Durig T, Fassihi R. Evaluation of floating and sticking extended release delivery systems: an unconventional dissolution test. J Control Release. 2000;67:37-44.
12. Mukerjee P, Mysels KJ. Critical micelle concentrations of aqueous surfactant systems; US department of commerce. NSRDS-NBS. 1971;36:51.
13. Amidon GE, Higuchi WI, Ho NF. Theoretical and experimental studies of transport of micelle-solubilized solutes. J Pharm Sci. 1982;71:77-84.
14. Higuchi WI. Effects of interacting colloids on transport rates. J Pharm Sci. 1964;53:532-535.
15. Crison JR, Shah VP, Skelly JP, Amidon GL. Drug dissolution into micellar solutions: development of a convective diffusion model and comparison to the film equilibrium model with application to surfactant-facilitated dissolution of carbamazepine. J Pharm Sci. 1996;85:1005-1011.
16. Balakrishnan A, Rege BD, Amidon GL, Polli JE. Surfactant-mediated dissolution: contributions of solubility enhancement and relatively low micelle diffisivity. J Pharm Sci. 2004;93:2064-2075.
17. Nerurkar MM, Ho NFH, Burton PS, Vidmar TJ, Borchardt RT. Mechanistic roles of neutral surfactants on concurrent polarized and passive membrane transport of a model peptide in Caco-2 cells. J Pharm Sci. 1997;86:813-821.
18. Turro NJ, Yekta A. Luminescent probes for detergent solutions, a simple procedure for the determination of the mean aggregation number of micelles. J Am Chem Soc. 1978;100:5951-5952.
19. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Chemistry review for metaglip tablets. Available at: http://www.fda.gov/cder/foi/nda/2002/21-460_Metaglip_Chemr.pdf. Accessed: September 1, 2005.
20. Dow Chemical Company. Methocel Cellulose Ethers Technical Handbook. Midland, MI: Dow Chemical Co; 2002.
21. Tang L, Khan SU, Muhammad NA. Evaluation and selection of bio-relevant dissolution media for a poorly water soluble new chemical entity. Pharm Dev Technol. 2001;6:531-540.
22. Gu CH, Gandhi RB, Tay LK, Zhou S, Raghavan K. Importance of using physiologically relevant volume of dissolution medium to correlate the oral exposure of formulations of BMS-480188 mesylate. Int J Pharm. 2004;269:195-202.