Development and uniform evaluation of ropinirole osmotic pump tablets with REQUIP XL both in vitro and in beagle dogs

References

• Picchietti DL, Bruni O, de Weerd A, et al. Pediatric restless legs syndrome diagnostic criteria: an update by the International Restless Legs Syndrome Study Group. Sleep Med 2013;14:1253–9
   PubMed Web of Science ®Google Scholar
• Stefanidis I, Vainas A, Dardiotis E, et al. Restless legs syndrome in hemodialysis patients: an epidemiologic survey in Greece. Sleep Med 2013;14:1381–6
   PubMed Web of Science ®Google Scholar
• Garcia-Borreguero D, Grunstein R, Sridhar G, et al. A 52-week open-label study of the long-term safety of ropinirole in patients with restless legs syndrome. Sleep Med 2007;8:742–52
   PubMed Web of Science ®Google Scholar
• Giorgi L, Asgharian A, Hunter B. Ropinirole in patients with restless legs syndrome and baseline IRLS total scores ≥24: efficacy and tolerability in a 26-week, double-blind, parallel-group, placebo-controlled study followed by a 40-week open-label extension. Clin Ther 2013;35:1321–36
   PubMed Web of Science ®Google Scholar
• Hening W, Walters AS, Allen RP, et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004;5:237–46
   PubMed Web of Science ®Google Scholar
• Chesson AL, Wise M, Davila D, et al. Practice parameters for the treatment of restless legs syndrome and periodic limb movement disorder. An American Academy of Sleep Medicine Report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep 1999;22:961–8
   PubMed Web of Science ®Google Scholar
• Littner MR, Kushida C, Anderson WM, et al. Practice parameters for the dopaminergic treatment of restless legs syndrome and periodic limb movement disorder: an American Academy of Sleep Medicine Report. Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep 2004;27:557–9
   PubMed Web of Science ®Google Scholar
• Valldeoriola F, Cobaleda S, Lahuerta J. A multicentre retrospective study of the clinical use of ropinirole in the treatment of Parkinson’s disease: the ROPI-PARK study. Clin Neurol Neurosurg 2009;111:742–7
   PubMed Web of Science ®Google Scholar
• Tompson DJ, Vearer D. Steady-state pharmacokinetic properties of a 24-hour prolonged-release formulation of ropinirole: results of two randomized studies in patients with Parkinson’s disease. Clin Ther 2007;29:2654–66
   PubMed Web of Science ®Google Scholar
• Kaye CM, Nicholls B. Clinical pharmacokinetics of ropinirole. Clin Pharmacokinet 2000;39:243–54
   PubMed Web of Science ®Google Scholar
• Requip/Requip Modutab [Swiss summary of product characteristics]. Available from: http://www.kompendium.ch/Monographie.aspx?Id=d40f2ff7-8630-4de1-832f-88be6f9463f1&lang=de&MonType=fi [last accessed 19 Nov 2007]
   Google Scholar
• Stockwell KA, Virley DJ, Perren M, et al. Continuous delivery of ropinirole reverses motor deficits without dyskinesia induction in MPTP-treated common marmosets. Exp Neurol 2008;211:172–9
   PubMed Web of Science ®Google Scholar
• Jafarieh O, Md S, Ali M, et al. Design, characterization, and evaluation of intranasal delivery of ropinirole-loaded mucoadhesive nanoparticles for brain targeting. Drug Dev Ind Pharm 2014. [Epub ahead of print]. doi:10.3109/03639045.2014.991400
   Google Scholar
• Onofrj M, Bonanni L, De Angelis MV, et al. Long half-life and prolonged-release dopamine receptor agonists: a review of ropinirole prolonged-release studies. Parkinsonism Relat D 2009;15S:S85–92
   Google Scholar
• Conte U, Maggi L. Modulation of the dissolution profiles from Geomatrix multi-layer matrix tablets containing drugs of different solubility. Biomaterials 1996;17:889–96
   PubMed Web of Science ®Google Scholar
• Rxlist. [RxList.com]. WebMD and part of the WebMD network. The United States of America 2004. Available from: http://www.rxlist.com/requip-xldrug.htm [last accessed 30 Nov 2010]
   Google Scholar
• Xu H, Li Z, Pan H, et al. A novel bilayer ascending release osmotic pump tablet: in vitro investigation and in vivo investigation in pharmacokinetic study and IVIVC evaluation. Int J Pharm 2013;458:181–7
   PubMed Web of Science ®Google Scholar
• Yanfei M, Guoguang C, Lili R, Pingkai O. Controlled release of ziprasidone solid dispersion systems from osmotic pump tablets with enhanced bioavailability in the fasted state. Drug Dev Ind Pharm 2014. [Epub ahead of print]. doi:10.3109/03639045.2014.950273
   Google Scholar
• Abrahamsson B, Alpsten M, Bake B, et al. Drug absorption from nifedipine hydrophilic matrix extended-release (ER) tablet-comparison with an osmotic pump tablet and effect of food. J Control Release: Off J Control Release Soc 1998;52:301–10
   PubMed Web of Science ®Google Scholar
• Alam N, Beg S, Rizwan M, et al. Mucoadhesive elementary osmotic pump tablets of trimetazidine for controlled drug delivery and reduced variability in oral bioavailability. Drug Dev Ind Pharm 2014. [Epub ahead of print]. doi:10.3109/03639045.2014.900076
   Google Scholar
• Kan SL, Li J, Liu JP, Zhao Y. Preparation and IVIVC evaluation of salvianolic acid B micro-porous osmotic pump pellets. Drug Dev Ind Pharm 2015;41:476–81
   Google Scholar
• Liu LX, Che BJ. Preparation of monolithic osmotic pump system by coating the indented core tablet. Eur J Pharm Biopharm 2006;64:180–4
   PubMed Web of Science ®Google Scholar
• Gong W, Liu Y, Mei DY, et al. Preparation, release and pharmacokinetics of a risperidone elementary osmotic pump system. Drug Dev Ind Pharm 2015;41:464–9
   Google Scholar
• Theeuwes F. Elementary osmotic pump. J Pharm Sci 1975;64:1987–91
   PubMed Web of Science ®Google Scholar
• Tang X, Tai LY, Yang XG, et al. In vitro and in vivo evaluation of gliclazide push-pull osmotic pump coated with aqueous colloidal polymer dispersions. Drug Dev Ind Pharm 2013;39:67–76
   PubMed Web of Science ®Google Scholar
• Xue Y, Yu S, Wang H, et al. Design of a timed and controlled release osmotic pump system of atenolol. Drug Dev Ind Pharm 2014. [Epub ahead of print]. doi:10.3109/03639045.2014.913612
   Google Scholar
• Malaterre V, Ogorka J, Loggia N, et al. Oral osmotically driven systems: 30 years of development and clinical use. Eur J Pharm Biopharm 2009;73:311–23
   PubMed Web of Science ®Google Scholar
• Yang MY, Wang YL, Guo JF, et al. Comparison of pharmacokinetics in beagle dogs of nimesulide bilayer tablets with dispersible tablets. Drug Dev Ind Pharm 2013;39:156–61
   PubMed Web of Science ®Google Scholar
• Drugfuture. [USP35-NF30\USP32-NF27]. Drug Future. China; 2013. Available from: http://www.drugfuture.com/Index.html [last accessed 1 Mar 2013]
   Google Scholar
• Kumaravelrajan R, Narayanan N, Suba V, Bhaskar K. Simultaneous delivery of nifedipine and metoprolol tartarate using sandwiched osmotic pump tablet system. Int J Pharm 2010;399:60–70
   PubMed Web of Science ®Google Scholar
• Ropinirole Hydrochloride Tablet (Extended Release). Dissolution Methods. Available from: http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults_Dissolutions.cfm [last accessed 27 Aug 2009]
   Google Scholar
• Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996;20:64–74
   Google Scholar
• FDA. Guidance for industry: dissolution testing of immediate release solid oral dosage forms. Rockville (MD): FDA; 1997
   Google Scholar
• Donbrow M, Samuelov Y. Zero order drug delivery from double-layered porous films: release rate profiles from ethyl cellulose, hydroxypropyl cellulose and polyethylene glycol mixtures. J Pharm Pharmacol 1980;32:463–70
   PubMed Web of Science ®Google Scholar
• Higuchi T. Rate of release of medicaments from ointment bases containing drugs in suspension. J Pharm Sci 1961;50:874–5
   PubMed Web of Science ®Google Scholar
• Koresmeyer RW, Gurny R, Doelker EM, et al. Mechanism of solute release from porous hydrophilic polymers. Int J Pharm 1983;15:25–35
   Web of Science ®Google Scholar
• Grattoni A, Merlo M, Ferrari M. Osmotic pressure beyond concentration restrictions. J Phys Chem B 2007;111:11770–5
   PubMed Web of Science ®Google Scholar
• Dressman JB. Comparison of canine and human gastrointestinal physiology. Pharm Res 1986;3:123–31
   PubMed Web of Science ®Google Scholar