Physicochemical characterization of gliclazidemacrogol solid dispersion and tablets based on optimized dispersion

Drug Development and Industrial Pharmacy

Volumn 36, Issue 8, 2010, Pages 893-902

  Khattab, Ibrahim S ^a   Nada, Aly ^a   Zaghloul, Abdel Azim ^a  

^a KUWAIT UNIVERSITY   (Kuwait)

Author keywords

Dispersion tablets; Fusion method; Gliclazide; Macrogols; Solid dispersions

Indexed keywords

GLICLAZIDE; MACROGOL 10000; MACROGOL 20000; MACROGOL 4000; ANTIDIABETIC AGENT; DRUG CARRIER; MACROGOL DERIVATIVE;

ARTICLE; CONTROLLED STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG SOLUBILITY; INFRARED SPECTROSCOPY; MOLECULAR WEIGHT; TABLET FORMULATION; CHEMISTRY; COMPARATIVE STUDY; DRUG FORMULATION; HYDROPHOBICITY; KINETICS; OSMOLARITY; PHYSICAL CHEMISTRY; SOLUBILITY; SURFACE PROPERTY; SUSPENSION; TABLET;

CALORIMETRY, DIFFERENTIAL SCANNING; DRUG CARRIERS; DRUG COMPOUNDING; GLICLAZIDE; HYDROPHOBICITY; HYPOGLYCEMIC AGENTS; KINETICS; MOLECULAR WEIGHT; OSMOLAR CONCENTRATION; PHYSICOCHEMICAL PHENOMENA; POLYETHYLENE GLYCOLS; SOLUBILITY; SPECTROSCOPY, FOURIER TRANSFORM INFRARED; SURFACE PROPERTIES; SUSPENSIONS; TABLETS;

EID: 77954198573     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639040903578734     Document Type: Article

References (30)

1. Palmer KJ, Brogden RN. (1993). Gliclazide. An update of its pharmacological properties and therapeutic efficacy in non-insulin-dependent diabetes mellitus. Drugs, 46(1):92-125.
2. Parfitt K. (1999). Martindale. The complete drug reference. London: Pharmaceutical Press.
3. Gillmann AG, Rall TW, Nies AS, Taylor P. (1990). Insulin, Oral hypoglycemic agents, and the Pharmacology of Endocrine Pancreas. In: Stephen N, Davis, Daryl K Granner, eds. Goodman and Gillmann's the pharmacological basis therapeutics. 8th ed. New York, USA: Pergamon, Maxwell House, 1485-1486
4. Amidon GL, Lennernas H, Shah VP, Crison JR. (1995). A theoretical basis for biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and invivo bioavailability. Pharm Res, 12(3):413-420
5. Hancock BC, Zografi G. (1997). Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci, 86(1):1-12.
6. Leuner C, Dressman J. (2000). Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm, 50:47-60.
7. Yu L. (2001). Amorphous pharmaceutical solids: Preparation, characterization and stabilization. Adv Drug Deliv Rev, 48(1):27-42.
8. Varshosaz J, Talari R, Mostafavi SA, Nokhodchi A. (2008). Dissolution enhancement of gliclazide using in situ micronization by solvent change method. Powder Technol, 187(3):222-230
9. Patel RP, Patel MM. (2007). Physicochemical characterization and dissolution study of solid dispersions of Lovastatin with polyethylene glycol 4000 and polyvinylpyrrolidone K30. Pharm Dev Technol, 12(1):21-33.
10. Sethia S, Squillante E. (2004). Solid dispersion of carbam-azepine in PVP K30 by conventional solvent evaporation and supercritical methods. Int J Pharm, 272(1-2):1-10.
11. Teresa MM, Victoria MM, Gloria ES. (2002). Characterization and solubility study of solid dispersions of flunarizine and poly-vinylpyrrolidone. Farmaco, 57:723-727
12. Yamashita K, Nakate T, Okimoto K, Ohike A, Tokunaga Y, Ibuki R, et al. (2003). Establishment of new preparation method for solid dispersion formulation of tacrolimus. Int J Pharm, 267:79-91.
13. Liu C, Desai KG. (2005). Characteristics of rofecoxib-polyethyl-ene glycol 4000 solid dispersions and tablets based on solid dispersions. Pharm Dev Technol, 10:467-477 (Pubitemid 41770031)
14. Leonardi D, Barrera MG, Lamas MG, Salomón CJ. (2007). Development of prednisone: Polyethylene glycol 6000 fast-release tablets from solid dispersions: Solid-state characterization, dissolution behavior, and formulation parameters. AAPS PharmSciTech, 8(4), Article 108.
15. Özkan Y, Doganay N, Dikmen N, Isimer A. (2000). Enhanced release of solid dispersions of etodolac in polyethylene glycol. Farmaco, 55:433-438
16. Lin CW, Cham TM. (1996). Effect of particle size on the available surface area of nifedipine from nifedipine-polyethylene glycol 6000 solid dispersions. Int J Pharm, 127:261-272
17. Asyarie S, Rachmawati H. (2007). In vivo and in vitro evaluation of a solid dispersion system of gliclazide:PEG 6000. PDA J Pharm Sci Technol, 61(5):400-410
18. Biswal S, Sahoo J, Murthy PN, Giradkar RP, Avari JG. (2008). Enhancement of dissolution rate of gliclazide using solid dispersions with polyethylene glycol 6000. AAPS PharmSciTech, 9(2):563-570
19. Hong SS, Lee SH, Lee YJ, Chung SJ, Lee MH, Shim CK. (1998). Accelerated oral absorption of gliclazide in human subjects from a soft gelatin capsule containing a PEG 400 suspension of gliclazide. J Control Release, 51(2-3):185-192
20. Sapkal NP, Kilor VA, Bhusari KP, Daud AS. (2007). Evaluation of some methods for preparing gliclazide-b-cyclodextrin inclusion complexes. Trop J Pharm Res, 6(4):833-840
21. Moyano JR, Arias-Blanco MJ, Gines JM, Rabasco AM, Perez-Martinez JI, Mor M, et al. (1997). Nuclear magnetic resonance investigations of the inclusion complexation of gliclazide with beta-cyclodextrin. J Pharm Sci, 86(1):72-75
22. Lo K, Hsu C, Ttsai T, Cham T. (2006). Comparison of the solubility and dissolution rate of gliclazide-b-cyclodextrin inclusion complexes prepared by liquid/liquid extraction and neutralization. Anal Foods Drugs, 14(3):230-235
23. Özkan Y, Atay T, Dikmen N, Isimer A, Aboul-Enein HY. (2000). Improvement of water solubility and in vitro dissolution rate of gliclazide by complexation with beta-cyclodextrin. Pharm Acta Helv, 74:365-370
24. Aggarwal S, Singh PN, Mishra B. (2002). Studies on solubility and hypoglycemic activity of gliclazide betacyclodextrin-hydroxypropylmethyl cellulose complexes. Pharmazie, 57:191-193
25. Winters CS, York P, Timmins P. (1997). Solid state examination of a gliclazide-b-cyclodextrin complex. Eur J Pharm Sci, 5(4):209-215
26. Shewale DB, Fursule RA, Sapkal NP. (2008). Effect of pH and hydroxypropyl-b-cyclodextrin on solubility and stability of gliclazide. Int J Health Res, 1(2):95-99
27. Susumu H, Takeshi H, Naho F, Akira K, Etsuo Y, Katsuhide T. (2005). Effects of water content in physical mixture and heating temperature on crystallinity of troglitazone-PVP K30 solid dispersions prepared by closed melting method. Int J Pharm, 302:103-112
28. Higuchi T, Connors KA. (1965). Phase solubility techniques. Adv Anal Chem Instrum, 4:117-212.
29. [USP] The United States Pharmacopoeia 25 and National Formulary 20 (2002). US Pharmacopoieal Convention Inc. 12th ed. (786), Maryland, USA.
30. Moore JW, Flanner HH. (1996). Mathematical comparison of dissolution profile. Pharm Technol, 20:64-74.