Design and optimization of a stomach-specific drug delivery system of repaglinide: Application of simplex lattice design

References

• FDA guidance of industry, ICH Q8 pharmaceutical development, U.S. Department of Health and Human Services, FDA/CDER/CBER. Accessed 12 August 2009 from the website: http://www.fda.gov/CbER/gdlns/ichq8pharm.pdf.
   Google Scholar
• Bolton S, Bon C. Pharmaceutical statistics: Practical and clinical Applications. 4th ed. New York: Marcel Dekker: 2005.
   Google Scholar
• Hoffman A, Stepensk D, Lavy E, Eyal S, Klausner E, Friedman M. Pharmacokinetic and pharmacodynamic aspects of gastroretentive dosage forms. Int J Pharm 2004;277:141–153.
   PubMed Web of Science ®Google Scholar
• Sleevi M. Insulin and hypoglycemic agents. In: Abraham DJ, editor. Burger’s medicinal chemistry and drug discovery, autocoids, diagnostics, and drugs from new biology. New York: John Wiley & Sons, Inc; 2003.
   Google Scholar
• Inzucchi SE. Oral antihyperglycemic therapy for type 2 diabetes: Scientific review. JAMA 2002;287:360–372.
   PubMed Web of Science ®Google Scholar
• Yale JF. Oral antihyperglycemic agents and renal disease: New agents, new consepts. J Am Soc Nephrol 2005;16:S7–10.
   PubMedGoogle Scholar
• Kar P, Richard Holt, IG. The effect of sulphonylureas on the microvascular and macrovascular complications of diabetes. Cardiovasc Drugs Ther 2008;22:207–213.
   PubMed Web of Science ®Google Scholar
• Jain SK, Awasthi AM, Jain NK, Agrawal GP. Calcium silicate based microspheres of repaglinide for gastroretentive floating drug delivery: Preparation and in vitro characterization. J Contr Rel 2005;107:300–309.
   PubMed Web of Science ®Google Scholar
• Bardonnet PL, Faivre V, Pugh WJ, Piffaretti JC, Falson F. Review gastroretentive dosage forms: Overview and special case of helicobacter pylori. J Control Rel 2006;111:1–18.
   PubMed Web of Science ®Google Scholar
• Hwang SJ, Park H, Park K. Gastric retentive drug-delivery systems. Crit Rev Ther Drug Carrier Syst 1998;15:243–284.
   PubMed Web of Science ®Google Scholar
• Streubel A, Siepmann J, Bodmeier R. Gastroretentive drug delivery systems: Comprehensive review of gastric retentive drug delivery systems. Expert Opin Drug Deliv 2006;3:217–233.
   PubMed Web of Science ®Google Scholar
• Gu JM, Robinson JR, Leung SS. Binding of acrylic polymers to mucin epithelial surfaces: Structure-property relationships. Crit Rev Ther Drug Carrier Syst 1988;5:21–67.
   PubMed Web of Science ®Google Scholar
• Lehr CM. Bioadhesion technologies for the delivery of peptide and protein drugs to the gastrointestinal tract. Crit Rev Ther Drug Carrier Syst 1994;11:119–160.
   PubMed Web of Science ®Google Scholar
• Takeuchi H, Yamamoto H, Kawashima Y. Mucoadhesive nanoparticulate systems for peptide drug delivery. Adv Drug Deliv Rev 2001;47:39–54.
   PubMed Web of Science ®Google Scholar
• Chowdary KP, Rao YS. Mucoadhesive microspheres for controlled drug delivery. Biol Pharm Bull 2004;27:1717–1724.
   PubMed Web of Science ®Google Scholar
• Peppas NA. Devices based on intelligent biopolymers for oral protein delivery. Int J Pharm 2004;277:11–17.
   PubMed Web of Science ®Google Scholar
• Bruschi ML, Freitas O. Oral bioadhesive drug delivery systems. Drug Dev Ind Pharm 2005;31:293–310.
   PubMed Web of Science ®Google Scholar
• Ahuja A, Khar RK, Ali J. Mucoadhesive drug delivery systems. Drug Dev Ind Pharm 1997;23:489–515.
   Web of Science ®Google Scholar
• Woodley J. Bioadhesion: New possibilities for drug administration? Clin Pharmacokinet 2001;40:77–84.
   PubMed Web of Science ®Google Scholar
• Wang J, Tabata Y, Bi D, Morimoto K. Evaluation of gastric mucoadhesive properties of aminated gelatin microspheres. J Contr Rel 2001;73:223–231.
   PubMed Web of Science ®Google Scholar
• Nagahara N, Akiyama Y, Nakao M, Tada M, Kitano M, Ogawa Y. Mucoadhesive microspheres containing amoxicillin for clearance of Helicobacter pylori. Antimicrob Agents Chemother 1988;42:2492–2494.
   Google Scholar
• Nagai T, Machida Y. Mucosal adhesive dosage forms. Pharm Int 1985;6:196–200.
   Google Scholar
• Ali J, Arora S, Ahuja A, Babbar AK, Sharma RK, Khar RK. Formulation and development of floating capsules of celecoxib: In vitro and in vivo evaluation. AAPS PharmSciTech 2007;8:119–124.
   Google Scholar
• Dhawan S, Dhawan K, Varma M, Sinha VR. Application of poly(ethylene oxide) in drug delivery systems. Pharm Tech 2005;29:72.
   Google Scholar
• Lee B, Ryu S, Cui JH. Formulation and release characteristics of hydroxypropyl methylcellulose matrix tablet containing melatonin. Drug Dev Ind Pharm 1999;25:493–501.
   PubMed Web of Science ®Google Scholar
• Kader A, Jalil R. Formulation factors affecting drug release from poly(lactic-acid)(PLA) microcapsule tablets. Drug Dev Ind Pharm 1999;25:141–151.
   PubMed Web of Science ®Google Scholar
• Aulton ME. Powder flow. In: Pharmaceutics – the science of dosage form design. 2nd ed. London, Churchill Livingstone; 2002:207–208.
   Google Scholar
• Martin A, Bustamante P, Chun A. Micromeritic. In: Physical pharmacy – physical chemical principles in the pharmaceutical sciences: 4th ed. Baltimore, MD: Lippincott Williams and Wilkins; 2002:446–448.
   Google Scholar
• Gandhimathi M, Ravi TK, Renu SK. Determination of repaglinide in pharmaceutical formulations by HPLC with UV detection. Analyt Sci 2003;19:1675–1677.
   PubMed Web of Science ®Google Scholar
• Yao J, Shi YQ, Li ZR, Jin SH. Development of a RP-HPLC method for screening potentially counterfeit anti-diabetic drugs. J Chromatogr B 2007;853:254–259.
   PubMed Web of Science ®Google Scholar
• Singh BN, Kim KH. Floating drug delivery systems: An approach to oral controlled drug delivery via gastric retention. J Contr Rel 2000;63:235–259.
   PubMed Web of Science ®Google Scholar
• Yang GM, Kuo JF, Woo EM. Preparation and control-release kinetics of isosorbide dinitrate microspheres. J Microencapsul 2006;23(6):622–631.
   PubMedGoogle Scholar
• Gupta A, Garg S, Khar RK. Measurement of bioadhesive strength of mucoadhesive buccal tablets: Design of an in vitro assembly. Indian Drugs 1993;30(4):152–155.
   Google Scholar
• Jivani RR, Patel CN, Jivani NP. Design and development of a self correcting monolithic gastroretentive tablet of baclofen. Sci Pharm 2009;77:651–667.
   Google Scholar
• Singh B, Ahuja N. Development of controlled-release buccoadhesive hydrophilic matrices of diltiazem hydrochloride: Optimization of bioadhesion, dissolution, and diffusion parameters. Drug Dev Ind Pharm 2002;28(4):431–442.
   PubMedGoogle Scholar
• Peniche C, Elvira C, San Roman J. Interpolymer complexes of chitosan and polymethacrylic derivatives of salicylic acid: Preparation, characterization and modification by thermal treatment. Polymer 1998;39:6549–6554.
   Web of Science ®Google Scholar
• Lewis GA, Mathieu D, Phan-Tann-Luu R. Pharmaceutical experimental design. New York, Marcel Dekker; 1999:265–276.
   Google Scholar
• Vaghani S, Vasanti S, Chaturvedi K, Satish CS, Jivani NP. Stomach-specific drug delivery of 5-fluorouracil using ethylcellulose floating microspheres. Pharm Dev Tech 2010;15(2):154–161.
   PubMedGoogle Scholar
• Caramella C, Colombo P, Conte U, Manna AL. Tablet disintegration update: The dynamic approach. Drug Dev Ind Pharm 1987;13(12):2111–2145.
   Google Scholar
• Wan LSC, Heng PWS, Wong LF. Matrix swelling: A simple model describing extent of swelling of HPMC matrices. Int J Pharm 1995;116:159–168.
   Web of Science ®Google Scholar
• Ju RTC, Nixon PR, Patel MV. Diffusion coefficients of polymer chains in the diffusion layer adjustments to a swollen hydrophilic matrix. J Pharm Sci 1997;86:1293–1298.
   PubMed Web of Science ®Google Scholar
• Derringer G, Suich R. Simultaneous optimization of several response variables. J Qual Technol 1980;12:214–219.
   Web of Science ®Google Scholar
• Rowe RC, Sheskey PJ, Owen SC. Handbook of pharmaceutical excipients. 5th ed. London: PhP Pharmaceutical Press; 2006.
   Google Scholar