Physicochemical characterization of gliclazide–macrogol solid dispersion and tablets based on optimized dispersion

References

• 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.
   PubMed Web of Science ®Google Scholar
• Parfitt K. (1999). Martindale. The complete drug reference. London: Pharmaceutical Press.
   Google Scholar
• 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, 1485–6.
   Google Scholar
• 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):413–20.
   PubMed Web of Science ®Google Scholar
• Hancock BC, Zografi G. (1997). Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci, 86(1):1–12.
   PubMed Web of Science ®Google Scholar
• Leuner C, Dressman J. (2000). Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm, 50:47–60.
   PubMed Web of Science ®Google Scholar
• Yu L. (2001). Amorphous pharmaceutical solids: Preparation, characterization and stabilization. Adv Drug Deliv Rev, 48(1):27–42.
   PubMed Web of Science ®Google Scholar
• 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):222–30.
   Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Sethia S, Squillante E. (2004). Solid dispersion of carbamazepine in PVP K30 by conventional solvent evaporation and supercritical methods. Int J Pharm, 272(1–2):1–10.
   PubMed Web of Science ®Google Scholar
• Teresa MM, Victoria MM, Gloria ES. (2002). Characterization and solubility study of solid dispersions of flunarizine and polyvinylpyrrolidone. Farmaco, 57:723–7.
   PubMedGoogle Scholar
• Yamashita K, Nakate T, Okimoto K, Ohike A, Tokunaga Y, Ibuki R, . (2003). Establishment of new preparation method for solid dispersion formulation of tacrolimus. Int J Pharm, 267:79–91.
   PubMed Web of Science ®Google Scholar
• Liu C, Desai KG. (2005). Characteristics of rofecoxib-polyethylene glycol 4000 solid dispersions and tablets based on solid dispersions. Pharm Dev Technol, 10:467–77.
   PubMed Web of Science ®Google Scholar
• 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.
   Google Scholar
• Özkan Y, Doğanay N, Dikmen N, Işimer A. (2000). Enhanced release of solid dispersions of etodolac in polyethylene glycol. Farmaco, 55:433–8.
   PubMedGoogle Scholar
• 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, 127:261–72.
   Web of Science ®Google Scholar
• 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):400–10.
   PubMedGoogle Scholar
• 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):563–70.
   PubMed Web of Science ®Google Scholar
• 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):185–92.
   PubMed Web of Science ®Google Scholar
• Sapkal NP, Kilor VA, Bhusari KP, Daud AS. (2007). Evaluation of some methods for preparing gliclazide-β-cyclodextrin inclusion complexes. Trop J Pharm Res, 6(4):833–40.
   Web of Science ®Google Scholar
• Moyano JR, Arias-Blanco MJ, Gines JM, Rabasco AM, Perez-Martinez JI, Mor M, . (1997). Nuclear magnetic resonance investigations of the inclusion complexation of gliclazide with beta-cyclodextrin. J Pharm Sci, 86(1):72–5.
   PubMed Web of Science ®Google Scholar
• Lo K, Hsu C, Ttsai T, Cham T. (2006). Comparison of the solubility and dissolution rate of gliclazide-β-cyclodextrin inclusion complexes prepared by liquid/liquid extraction and neutralization. Anal Foods Drugs, 14(3):230–5.
   Web of Science ®Google Scholar
• Özkan Y, Atay T, Dikmen N, Işimer A, Aboul-Enein HY. (2000). Improvement of water solubility and in vitro dissolution rate of gliclazide by complexation with beta-cyclodextrin. Pharm Acta Helv, 74:365–70.
   PubMedGoogle Scholar
• Aggarwal S, Singh PN, Mishra B. (2002). Studies on solubility and hypoglycemic activity of gliclazide betacyclodextrin-hydroxypropylmethyl cellulose complexes. Pharmazie, 57:191–3.
   PubMed Web of Science ®Google Scholar
• Winters CS, York P, Timmins P. (1997). Solid state examination of a gliclazide-β-cyclodextrin complex. Eur J Pharm Sci, 5(4):209–15.
   Web of Science ®Google Scholar
• Shewale DB, Fursule RA, Sapkal NP. (2008). Effect of pH and hydroxypropyl-β-cyclodextrin on solubility and stability of gliclazide. Int J Health Res, 1(2):95–9.
   Google Scholar
• 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, 302:103–12.
   PubMed Web of Science ®Google Scholar
• Higuchi T, Connors KA. (1965). Phase solubility techniques. Adv Anal Chem Instrum, 4:117–212.
   Google Scholar
• [USP] The United States Pharmacopoeia 25 and National Formulary 20 (2002). US Pharmacopoieal Convention Inc. 12th ed. (786), Maryland, USA.
   Google Scholar
• Moore JW, Flanner HH. (1996). Mathematical comparison of dissolution profile. Pharm Technol, 20:64–74.
   Google Scholar