Organic-aqueous crossover coating process for the desmopressin orally disintegrating microparticles

References

• Nevéus T, von Gontard A, Hoebeke P, et al. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children’s Continence Society. J Urol 2006;176:314–24
   PubMed Web of Science ®Google Scholar
• Lottmann H, Alova I. Primary monosymptomatic nocturnal enuresis in children and adolescents. Int J Clin Pract 2007;61:8–16
   Web of Science ®Google Scholar
• Wein A, Lose G, Fonda D. Nocturia in men, women and the elderly: a practical approach. BJU Int 2002;90:28–31
   PubMed Web of Science ®Google Scholar
• Swithinbank L, Donovan J, James M, et al. Female urinary symptoms: age prevalence in a community dwelling population using a validated questionnaire. Neurourol Urodyn 1997;16:432--4
   Google Scholar
• Malmsten UG, Milsom I, Molander U, Norlen LJ. Urinary incontinence and lower urinary tract symptoms: an epidemiological study of men aged 45 to 99 years. J Urol 1997;158:1733–7
   PubMed Web of Science ®Google Scholar
• Weatherall M. The risk of hyponatremia in older adults using desmopressin for nocturia: a systematic review and meta-analysis. Neurourol Urodyn 2004;23:302–5
   PubMed Web of Science ®Google Scholar
• Vande Walle JGJ, Bogaert GA, Mattsson S, et al. A new fast-melting oral formulation of desmopressin: a pharmacodynamic study in children with primary nocturnal enuresis. BJU Int 2006;97:603–9
   PubMed Web of Science ®Google Scholar
• Summary of Product Characteristics, The electronic Medicines Compendium (eMC) website. 2012; Available from: http://medicines.org.uk/emc/medicine/17265/SPC/DDAVP+Melt+60mcg%2c+120mcg+and+240mcg++oral+lyophilisate/ [last accessed 14 Jun 2013]
   Google Scholar
• Navarro V. Improving medication compliance in patients with depression: use of orodispersible tablets. Adv Ther 2010;27:785–95
   PubMed Web of Science ®Google Scholar
• Jain SP, Mehta DC, Shah SP, et al. Melt-in-mouth pellets of fexofenadine hydrochloride using crospovidone as an extrusion–spheronisation aid. AAPS PharmSciTech 2010;11:917–23
   PubMed Web of Science ®Google Scholar
• Politis SN, Rekkas DM. Pelletization processes for pharmaceutical applications: a patent review. Recent Pat Drug Deliv Formul 2011;5:61–78
   PubMedGoogle Scholar
• Breitkreutz J, Joachim B. Paediatric and geriatric drug delivery. Expert Opin Drug Deliv 2007;4:37–45
   PubMed Web of Science ®Google Scholar
• Strickley RG, Iwata Q, Wu S, Dahl TC. Pediatric drugs—a review of commercially available oral formulations. J Pharm Sci 2008;97:1731–74
   PubMed Web of Science ®Google Scholar
• Kawabe Y, Nakamura H, Hino E, Suzuki S. Photochemical stabilities of some dihydropyridine calcium-channel blockers in powdered pharmaceutical tablets. J Pharm Biomed Anal 2008;47:618–24
   PubMed Web of Science ®Google Scholar
• Douroumis DD, Gryczke A, Schminke S. Development and evaluation of cetirizine HCl taste-masked oral disintegrating tablets. AAPS PharmSciTech 2011;12:141–51
   PubMed Web of Science ®Google Scholar
• Schiermeier S, Schmidt PC. Fast dispersible ibuprofen tablets. Eur J Pharm Sci. 2002;15:295–305
   PubMed Web of Science ®Google Scholar
• Okuda Y, Irisawa Y, Okimoto K, et al. A new formulation for orally disintegrating tablets using a suspension spray-coating method. Int J Pharm 2009;382:80–7
   PubMed Web of Science ®Google Scholar
• Scheidl H, Hantich G, Hesse E, Zapf T. Stable, nasally, orally or sublingually applicable pharmaceutical preparation. U.S. Patent Application. Pub. No. US 2003/0119728 Al; 2002
   Google Scholar
• Wannerberger K, Lindner H, Olsson L, Svensson AE. Method for preparing solid dosage form of desmopressin. US Patent No. 7018653 B2; 2006
   Google Scholar
• Harris A, Tennhammar-Ekman B. Stabilized pharmaceutical peptide compositions US Patent No. 5,482,931; 1996
   Google Scholar
• United States Pharmacopeia Convention. United States Pharmacopeia and National Formulary (USP 35-NF 30) Official Monograph/Desmopressin; 2012:2827–9
   Google Scholar
• United States Pharmacopeia Convention. United States Pharmacopeia and National Formulary (USP 30-NF 25)/General Information Powder Flow; 2007:643
   Google Scholar
• European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia 5.0/2.9.16 Flowability; 2005:242–3
   Google Scholar
• Morton D, Simpson D, Staniforth J. Multiparticulate formulations for oral delivery. Pub. No.: US 2007/0154549 Al; 2004
   Google Scholar
• Engelen L, de Wijk RA, van der Bilt A, et al. Relating particles and texture perception. Physiol Behav 2005;86:111–17
   PubMed Web of Science ®Google Scholar
• Kurasawa T, Watanabe Y, Akiyama Y. Orally disintegrating solid preparation US Patent Application. Pub. No. US 2010/0316709 A1; 2009
   Google Scholar
• Shimizu T, Nakano Y, Morimoto S, et al. Formulation study for lansoprazole fast-disintegrating tablet. I. Effect of compression on dissolution behavior. Chem Pharm Bull 2003;51:942–7
   PubMed Web of Science ®Google Scholar
• Badawy SIF, Gawronski AJ, Alvarez FJ. Application of sorption–desorption moisture transfer modeling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations. Int J Pharm 2001;223:1–13
   PubMedGoogle Scholar
• Manning MC, Chou DK, Murphy BM, et al. Stability of protein pharmaceuticals: an update. Pharm Res 2010;27:544–75
   PubMed Web of Science ®Google Scholar
• Stevenson CL. Characterization of protein and peptide stability and solubility in non-aqueous solvents. Curr Pharm Biotechnol 2000;1:165–82
   PubMedGoogle Scholar
• Ameri M, Maa Y. Spray drying of biopharmaceuticals: stability and process considerations. Drying Technol 2006;24:763–8
   Web of Science ®Google Scholar
• Turton R, Cheng XX. The scale-up of spray coating processes for granular solids and tablets. Powder Technol 2005;150:78–85
   Web of Science ®Google Scholar
• Guignon B, Duquenoy A, Dumoulin ED. Fluid bed encapsulation of particles: principles and practice. Drying Technol 2002;20:419–47
   Web of Science ®Google Scholar
• Tang ES, Chan L, Heng PW. Coating of multiparticulates for sustained release. Am J Drug Deliv 2005;3:17–28
   Google Scholar
• Hou H, Sun CC. Quantifying effects of particulate properties on powder flow properties using a ring shear tester. J Pharm Sci 2008;97:4030–9
   PubMed Web of Science ®Google Scholar
• Flament MP. Development of 400 µm pellets by extrusion-spheronization application with gelucire 50/02 to produce a “Sprinkle” form. Drug Dev Ind Pharm 2004;30:43–51
   PubMed Web of Science ®Google Scholar
• Morita Y, Tsushima Y, Yasui M, et al. Evaluation of the disintegration time of rapidly disintegrating tablets via a novel method utilizing a CCD camera. Chem Pharm Bull 2002;50:1181–6
   PubMed Web of Science ®Google Scholar
• Kakutani R, Muro H, Makino T. Development of a new disintegration method for orally disintegrating tablets. Chem Pharm Bull 2010;58:885–90
   PubMed Web of Science ®Google Scholar
• Park JH, Holman KM, Bish GA, et al. An alternative to the USP disintegration test for orally disintegrating tablets. Pharm Technol [Online] 2008;32. Available from: http://www.pharmtech.com/pharmtech/Article/An-Alternative-to-the-USP-Disintegration-Test-for-/ArticleStandard/Article/detail/534704 [last accessed 10 June 2013]
   Google Scholar