Novel risperidone orally disintegrating minitablets for pediatric use: patient acceptance and dose adjustment

References

• Ivanovska V, Rademaker CMA, van Dijk L, et al. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134:361–372.
   PubMed Web of Science ®Google Scholar
• Elias-Jones A. Problems in pediatric drug therapy. 4th ed. Postgrad Med J. 2003;79:487–487.
   Web of Science ®Google Scholar
• Canitano R, Scandurra V. Risperidone in the treatment of behavioral disorders associated with autism in children and adolescents. Neuropsychiatr Dis Treat. 2008;4:723–730.
   PubMedGoogle Scholar
• Accardo P. Risperidone in children with autism and serious behavioral problems. J Pediatr. 2003;142:86–87.
   PubMedGoogle Scholar
• Myers SM, Johnson CP, American D, American Academy of Pediatrics Council on Children With Disabilities. Management of children with autism spectrum disorders. Pediatrics. 2007;120:1162–1182.
   PubMed Web of Science ®Google Scholar
• Scahill L, Koenig K, Carroll DH, et al. Risperidone approved for the treatment of serious behavioral problems in children with autism. J Child Adolesc Psychiatr Nurs. 2007;20:188–190.
   PubMedGoogle Scholar
• Tawakkul MA, Shah RB, Zidan A, et al. Complexation of risperidone with a taste-masking resin: novel application of near infra-red and chemical imaging to evaluate complexes. Pharm Dev Technol. 2009;14:409–421.
   PubMed Web of Science ®Google Scholar
• Batchelor HK, Marriott JF. Formulations for children: problems and solutions. Br J Clin Pharmacol. 2015;79:405–418.
   PubMed Web of Science ®Google Scholar
• Lopez FL, Ernest TB, Tuleu C, et al. Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms. Expert Opin Drug Deliv. 2015;12:1727–1740.
   PubMed Web of Science ®Google Scholar
• Mennella JA, Pepino MY, Beauchamp GK. Modification of bitter taste in children. Dev Psychobiol. 2003;43:120–127.
   PubMed Web of Science ®Google Scholar
• Llorens J. The physiology of taste and smell: how and why we sense flavors. Water Sci Technol. 2004;49:1–10.
   PubMed Web of Science ®Google Scholar
• Guo Z, Wu F, Singh V, et al. Host-guest kinetic interactions between HP-beta-cyclodextrin and drugs for prediction of bitter taste masking. J Pharm Biomed Anal. 2017;140:232–238.
   PubMed Web of Science ®Google Scholar
• Shukla D, Chakraborty S, Singh S, et al. Fabrication and evaluation of taste masked resinate of risperidone and its orally disintegrating tablets. Chem Pharm Bull (Tokyo). 2009;57:337–345.
   PubMed Web of Science ®Google Scholar
• Li X, et al. Synergetic taste masking of lipid coating and beta-cyclodextrin inclusion. Yao Xue Xue Bao. 2014;49:392–398.
   PubMedGoogle Scholar
• Lennartz P, Mielck JB. Minitabletting: improving the compactability of paracetamol powder mixtures. Int J Pharm. 1998;173:75–85.
   Web of Science ®Google Scholar
• de Mey C, Dimitrova V, Lennartz P, et al. Bioequivalence of a novel minitablet formulation of levetiracetam. Arzneimittelforschung. 2012;62:94–98.
   PubMed Web of Science ®Google Scholar
• El-Say KM, Ahmed TA, Abdelbary MF, et al. Risperidone oral disintegrating mini-tablets: a robust-product for pediatrics. Acta Pharm. 2015;65:365–382.
   PubMed Web of Science ®Google Scholar
• Thomson SA, Tuleu C, Wong ICK, et al. Minitablets: new modality to deliver medicines to preschool-aged children. Pediatrics. 2009;123:e235–e238.
   PubMed Web of Science ®Google Scholar
• Klingmann V, Spomer N, Lerch C, et al. Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children. J Pediatr. 2013;163:1728–1732.e1.
   PubMed Web of Science ®Google Scholar
• Stoltenberg I, Breitkreutz J. Orally disintegrating mini-tablets (ODMTs) – a novel solid oral dosage form for paediatric use. Eur J Pharm Biopharm. 2011;78:462–469.
   PubMed Web of Science ®Google Scholar
• Preis M. Orally disintegrating films and mini-tablets-innovative dosage forms of choice for pediatric use. AAPS PharmSciTech. 2015;16:234–241.
   PubMed Web of Science ®Google Scholar
• Dubois D. Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer? Curr Opin Pediatr. 2005;17:227–233.
   PubMed Web of Science ®Google Scholar
• Juluri A, Popescu C, Zhou L, et al. Taste masking of griseofulvin and caffeine anhydrous using Kleptose Linecaps DE17 by hot melt extrusion. AAPS PharmSciTech. 2016;17:99–105.
   PubMed Web of Science ®Google Scholar
• Bond L, Allen S, Davies MC, et al. Differential scanning calorimetry and scanning thermal microscopy analysis of pharmaceutical materials. Int J Pharm. 2002;243:71–82.
   PubMed Web of Science ®Google Scholar
• Rahman Z, Zidan AS, Khan MA. Risperidone solid dispersion for orally disintegrating tablet: its formulation design and non-destructive methods of evaluation. Int J Pharm. 2010;400:49–58.
   PubMed Web of Science ®Google Scholar
• Uchida T, Yoshida M, Hazekawa M, et al. Evaluation of palatability of 10 commercial amlodipine orally disintegrating tablets by gustatory sensation testing, OD-mate as a new disintegration apparatus and the artificial taste sensor. J Pharm Pharmacol. 2013;65:1312–1320.
   PubMed Web of Science ®Google Scholar
• El-Refaie WM, El-Massik MA, Abdallah OY, et al. Formulation and evaluation of taste-masked paracetamol-lipid sachets and chewable tablets. J Pharm Investig. 2014;44:431–442.
   Google Scholar
• Bhupendra G, Prajapati RPP, Saitsh NP. Formulation, evaluation and optimization of orally disintegrating tablet of cinnarizine using sublimation method. Bio Phys. 2011;38:4089–4092.
   Google Scholar
• Zaid AN, Al-Ramahi RJ, Ghoush AA, et al. Weight and content uniformity of lorazepam half-tablets: a study of correlation of a low drug content product. Saudi Pharm J. 2013;21:71–75.
   PubMed Web of Science ®Google Scholar
• Breitkreutz J, Boos J. Drug delivery and formulations. Handb Exp Pharmacol. 2011;205:91–107.
   PubMedGoogle Scholar
• Su Z, Sun F, Shi Y, et al. Effects of formulation parameters on encapsulation efficiency and release behavior of risperidone poly(D,L-lactide-co-glycolide) microsphere. Chem Pharm Bull (Tokyo). 2009;57:1251–1256.
   PubMed Web of Science ®Google Scholar
• Nakatsu T, Mazeiko Peter J, Lupo Andrew T, et al. Sensate composition imparting initial sensation upon contact. 2004. Google Patents.
   Google Scholar
• Page CB, Calver LA, Isbister GK. Risperidone overdose causes extrapyramidal effects but not cardiac toxicity. J Clin Psychopharmacol. 2010;30:387–390.
   PubMed Web of Science ®Google Scholar
• Sun F, Su Z, Sui C, et al. Studies on the acute toxicity, pharmacokinetics and pharmacodynamics of paliperidone derivatives-comparison to paliperidone and risperidone in mice and rats. Basic Clin Pharmacol Toxicol. 2010;107:656–662.
   PubMed Web of Science ®Google Scholar