Development and characterization of metformin hydrochloride- and glyburide-containing orally disintegrating tablets

References

• Abd Elbary A, Ali AA, Aboud HM. 2012. Enhanced dissolution of meloxicam from orodispersible tablets prepared by different methods. Bull Fac Pharm. 50(2):89–97.
   Google Scholar
• Alberti KG, Zimmet P.; WHO Consultation. 1998. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus. Provisional report of a WHO consultation. Diabet Med. 15(7):539–553.
   PubMed Web of Science ®Google Scholar
• Al-Khattawi A, Iyire A, Dennison T, Dahmash E, J Bailey C, Smith J, Rue P, R Mohammed A. 2014. Systematic screening of compressed ODT excipients: cellulosic versus non-cellulosic. Curr Drug Deliv. 11(4):486–500.
   PubMed Web of Science ®Google Scholar
• Alvi MM, Chatterjee P. 2014. A prospective analysis of co-processed non-ionic surfactants in enhancing permeability of a model hydrophilic drug. AAPS PharmSciTech. 15(2):339–353.
   PubMed Web of Science ®Google Scholar
• Aslani A, Beigi M. 2016. Design, formulation, and physicochemical evaluation of montelukast orally disintegrating tablet. Int J Prev Med. 7(1):120.
   PubMedGoogle Scholar
• Barot BS, Parejiya PB, Patel TM, Parikh RK, Gohel MC. 2010. Development of directly compressible metformin hydrochloride by the spray-drying technique. Acta Pharm. 60(2):165–175.
   PubMed Web of Science ®Google Scholar
• Benet LZ, Broccatelli F, Oprea TI. 2011. BDDCS applied to over 900 drugs. AAPS J. 13(4):519–547.
   PubMed Web of Science ®Google Scholar
• Betageri GV, Makarla KR. 1996. Characterization of glyburide-polyethylene glycol solid dispersions. Drug Dev Ind Pharm. 22(7):731–734.
   Web of Science ®Google Scholar
• Brockmeier D, Grigoleit H-G, Leonhardt H. 1985. Absorption of glibenclamide from different sites of the gastro-intestinal tract. Eur J Clin Pharmacol. 29(2):193–197.
   PubMed Web of Science ®Google Scholar
• Chakrabarti R, Rajagopalan R. 2002. Diabetes and insulin resistance associated disorders: disease and the therapy. Current Science. 83(12):1533–1538.
   Web of Science ®Google Scholar
• Crouter A, Briens L. 2014. The effect of moisture on the flowability of pharmaceutical excipients. AAPS PharmSciTech. 15(1):65–74.
   PubMed Web of Science ®Google Scholar
• Davidson MB, Peters AL. 1997. An overview of metformin in the treatment of type 2 diabetes mellitus. Am J Med. 102(1):99–110.
   PubMed Web of Science ®Google Scholar
• European Pharmacopoeia. 2014. 8th ed. [accessed 2019 September 15]. http://online6.edqm.eu/ep802/.
   Google Scholar
• FDA Guidance for Industry. 2008. Orally disintegrating tablets. Silver Spring (MD): U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER).
   Google Scholar
• Fowler MJ. 2011. Microvascular and macrovascular complications of diabetes. Clin Diabetes. 29(3):116–122.
   Google Scholar
• Gosai AR, Patil SB, Sawant KK. 2008. Formulation and evaluation of orodispersible tablets of ondansetron hydrochloride by direct compression using superdisintegrants. Int J Pharm Sci Nanotechnol. 26(1):106–111.
   Google Scholar
• Grzybowska M, Bober J, Olszewska M. 2011. [Metformin - mechanisms of action and use for the treatment of type 2 diabetes mellitus]. Postepy Hig Med Dosw. 65:277–285.
   Web of Science ®Google Scholar
• Gulsun T, Akdag Cayli Y, Izat N, Cetin M, Oner L, Sahin S. 2018. Development and evaluation of terbutaline sulfate orally disintegrating tablets by direct compression and freeze-drying methods. J Drug Deliv Sci Technol. 46:251–258.
   Web of Science ®Google Scholar
• Gulsun T, Ozturk N, Kaynak MS, Vural I, Sahin S. 2017. Preparation and evaluation of furosemide containing orally disintegrating tablets by direct compression. Pharmazie. 72(7):389–394.
   PubMed Web of Science ®Google Scholar
• Gulsun T, Sahin S. 2016. Development and validation of a RP-HPLC method for simultaneous determination of metformin hydrochloride, phenol red and metoprolol tartrate for intestinal perfusion studies. Lat Am J Pharm. 35(1):50–57.
   Web of Science ®Google Scholar
• Gülsün T, Budak Ç, Vural İ, Sahin S, Öner L. 2013. Preparation and characterization of nimesulide containing nanocrystal formulations. Pharm Dev Technol. 18(3):653–659.
   PubMed Web of Science ®Google Scholar
• Hirani JJ, Rathod DA, Vadalia KR. 2009. Orally disintegrating tablets: a review. Trop J Pharm Res. 8(2):161–172.
   Web of Science ®Google Scholar
• Hirota J, Shimizu S. 2012. Chapter 5.2-routes of administration. In: Hedrich H, editor. The laboratory mouse. Cambridge (MA): Academic Press; p. 709–725.
   Google Scholar
• Hu L, Gu D, Hu Q, Zhang H, Yang X. 2013. A novel approach to formulate and optimize orally disintegrating tablets of bambuterol hydrochloride. Pharmaceut Anal Acta. 4(3):216.
   Google Scholar
• Hubert S, Chadwick A, Wacher V, Coughlin O, Kokai-Kun J, Bristol A. 2018. Development of a modified-release formulation of lovastatin targeted to intestinal methanogens implicated in irritable bowel syndrome with constipation. J Pharm Sci. 107(2):662–671.
   PubMed Web of Science ®Google Scholar
• International Diabetes Federation. 2015. IDF diabetes atlas. 7th ed. Brussels, Belgium: International Diabetes Federation.
   Google Scholar
• Jain SK, Gupta A. 2009. Development of gelucire 43/01 beads of metformin hydrochloride for floating delivery. AAPS PharmSciTech. 10(4):1128–1136.
   PubMed Web of Science ®Google Scholar
• Jyoti V, Prajapati S, Irchhiaya R. 2017. An overview on superdisintegrants: a review. Eur J Pharm Med Res. 4(9):252–260.
   Google Scholar
• Kumar A, Bali V, Kumar M, Pathak K. 2013. Comparative evaluation of porous versus nonporous mucoadhesive films as buccal delivery system of glibenclamide. AAPS PharmSciTech. 14(4):1321–1332.
   PubMed Web of Science ®Google Scholar
• Li J, Wu Y. 2014. Lubricants in pharmaceutical solid dosage forms. Lubricants. 2(1):21–43.
   Google Scholar
• Ludiflash® Btc-europe.com. 2019. [Accessed 17 Dec 2019] https://www.btc-europe.com/fileadmin/user_upload/Downloads/Pdf_s/Industries/Ludiflash_Brochure_EN.pdf
   Google Scholar
• McCreight LJ, Bailey CJ, Pearson ER. 2016. Metformin and the gastrointestinal tract. Diabetologia. 59(3):426–435.
   PubMed Web of Science ®Google Scholar
• Morin G, Briens L. 2013. The effect of lubricants on powder flowability for pharmaceutical application. AAPS PharmSciTech. 14(3):1158–1168.
   PubMed Web of Science ®Google Scholar
• Motz SA, Schaefer UF, Balbach S, Eichinger T, Lehr CM. 2007. Permeability assessment for solid oral drug formulations based on Caco-2 monolayer in combination with a flow through dissolution cell. Eur J Pharm Biopharm. 66(2):286–295.
   PubMed Web of Science ®Google Scholar
• Nagar P, Singh K, Chauhan I, Verma M, Yasir M, Khan A, Sharma R, Gupta N. 2011. Orally disintegrating tablets: formulation, preparation techniques and evaluation. J Appl Pharm Sci. 1(04):35–45.
   Google Scholar
• Nicklin P, Keates AC, Page T, Bailey CJ. 1996. Transfer of metformin across monolayers of human intestinal Caco-2 cells and across rat intestine. Int J Pharm. 128(1–2):155–162.
   Google Scholar
• Ölmez SS, Vural İ. 2009. Advantages and quality control of orally disintegrating tablets. FABAD J Pharm Sci. 34(3):167–172.
   Google Scholar
• Pabari R, Ramtoola Z. 2012. Effect of a disintegration mechanism on wetting, water absorption, and disintegration time of orodispersible tablets. J Young Pharm. 4(3):157–163.
   PubMedGoogle Scholar
• Pahwa R, Gupta N. 2011. Superdisintegrants in the development of orally disintegrating tablets: a review. Int J Pharm Sci Res. 2(11):2767.
   Google Scholar
• Panigrahi R, Behera SP, Panda CS. 2010. A review on fast dissolving tablets. Webmedcentral. 1(11):WMC001107.
   Google Scholar
• Philip AK, Srivastava M, Pathak K. 2009. Buccoadhesive gels of glibenclamide: a means for achieving enhanced bioavailability. Drug Deliv. 16(7):405–415.
   PubMed Web of Science ®Google Scholar
• Piao J, Lee -E, Weon KY, Kim DW, Lee JS, Park JD, Nishiyama Y, Fukui I, Kim JS. 2009. Development of novel mucoadhesive pellets of metformin hydrochloride. Arch Pharm Res. 32(3):391–397.
   PubMed Web of Science ®Google Scholar
• Proctor WR, Bourdet DL, Thakker DR. 2008. Mechanisms underlying saturable intestinal absorption of metformin. Drug Metab Dispos. 36(8):1650–1658.
   PubMed Web of Science ®Google Scholar
• Proks P, Reimann F, Green N, Gribble F, Ashcroft F. 2002. Sulfonylurea stimulation of insulin secretion. Diabetes. 51(3):S368–S376.
   PubMedGoogle Scholar
• Rao KP, Chawla G, Kaushal AM, Bansal AK. 2005. Impact of solid-state properties on lubrication efficacy of magnesium stearate. Pharm Dev Technol. 10(3):423–437.
   PubMed Web of Science ®Google Scholar
• Ratnaparkhi MP, Mohanta G, Upadhyay L. 2015. Review on: fast dissolving tablet. J Pharm Res. 2(1):5–12.
   Google Scholar
• Rozehnal V, Nakai D, Hoepner U, Fischer T, Kamiyama E, Takahashi M, Yasuda S, Mueller J. 2012. Human small intestinal and colonic tissue mounted in the Ussing chamber as a tool for characterizing the intestinal absorption of drugs. Eur J Pharm Sci. 46(5):367–373.
   PubMed Web of Science ®Google Scholar
• Sander C, Madsen KD, Hyrup B, Nielsen HM, Rantanen J, Jacobsen J. 2013. Characterization of spray dried bioadhesive metformin microparticles for oromucosal administration. Eur J Pharm Biopharm. 85(3 Pt A):682–688.
   PubMed Web of Science ®Google Scholar
• Sander C, Nielsen HM, Jacobsen J. 2013. Buccal delivery of metformin: TR146 cell culture model evaluating the use of bioadhesive chitosan discs for drug permeability enhancement. Int J Pharm. 458(2):254–261.
   PubMedGoogle Scholar
• Singh SK, Srinivasan K, Gowthamarajan K, Narayan G. 2010. Development and validation of discriminatory dissolution procedure for poorly soluble glyburide. Asian J Pharm. 4(4):205–212.
   Google Scholar
• Tawfeek HM, Faisal W, Soliman GM. 2018. Enalapril maleate orally disintegrating tablets: tableting and in vivo evaluation in hypertensive rats. Pharm Dev Technol. 23(5):496–503.
   PubMed Web of Science ®Google Scholar
• Thalberg K, Lindholm D, Axelsson A. 2004. Comparison of different flowability tests for powders for inhalation. Powder Techol. 146(3):206–213.
   Web of Science ®Google Scholar
• Tsume Y, Amidon GL. 2010. The biowaiver extension for BCS class III drugs: the effect of dissolution rate on the bioequivalence of BCS class III immediate-release drugs predicted by computer simulation. Mol Pharm. 7(4):1235–1243.
   PubMed Web of Science ®Google Scholar
• USP 30 - Glyburide Monograph. 2005. United States pharmacopeia 30-NF 25. Rockville (MD): United States Pharmacopeial Convention, p. 2236.
   Google Scholar
• USP30 - Glyburide and Metformin Hydrochloride Tablets Monograph. 2005. United States pharmacopeia 30-NF 25. Rockville (MD): United States Pharmacopeial Convention, p. 2237.
   Google Scholar
• USP30 - Powder Flow. 2005. United States pharmacopeia 30-NF 25. Rockville (MD): United States Pharmacopeial Convention, p. 643.
   Google Scholar
• USP30 - Uniformity of Dosage Units. 2005. United states pharmacopeia 30-NF 25. Rockville (MD): United States Pharmacopeial Convention, p. 905–910.
   Google Scholar
• Valleri M, Mura P, Maestrelli F, Cirri M, Ballerini R. 2004. Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique. Drug Dev Ind Pharm. 30(5):525–534.
   PubMed Web of Science ®Google Scholar
• Varma MV, Scialis RJ, Lin J, Bi YA, Rotter CJ, Goosen TC, Yang X. 2014. Mechanism-based pharmacokinetic modeling to evaluate transporter-enzyme interplay in drug interactions and pharmacogenetics of glyburide. Aaps J. 16(4):736–748.
   PubMed Web of Science ®Google Scholar
• Vidon N, Chaussade S, Noel M, Franchisseur C, Huchet B, Bernier J. 1988. Metformin in the digestive tract. Diabetes Res Clin Pract. 4(3):223–229.
   PubMed Web of Science ®Google Scholar
• Wei H, Löbenberg R. 2006. Biorelevant dissolution media as a predictive tool for glyburide a class II drug. Eur J Pharm Sci. 29(1):45–52.
   PubMed Web of Science ®Google Scholar
• Yki-Järvinen H. 2002. Combination therapy with insulin and oral agents: optimizing glycemic control in patients with type 2 diabetes mellitus. Diabetes Metab Res Rev. 18 (3):S77–S81.
   PubMedGoogle Scholar
• Zerrouk N, Corti G, Ancillotti S, Maestrelli F, Cirri M, Mura P. 2006. Influence of cyclodextrins and chitosan, separately or in combination, on glyburide solubility and permeability. Eur J Pharm Biopharm. 62(3):241–246.
   PubMed Web of Science ®Google Scholar
• Zimmet P, Alberti KG, Magliano DJ, Bennett PH. 2016. Diabetes mellitus statistics on prevalence and mortality: facts and fallacies. Nat Rev Endocrinol. 12(10):616–622.
   PubMed Web of Science ®Google Scholar