Nanoparticle-based chewable gels of praziquantel

References

• Allen LV. 2003. Troches and lozenges. Secundum Artem. Current & Practical Compounding Information for the Pharmacist. 4(2):1–6. [accessed 2023 Jan 26] https://www.padagis.com/wp-content/uploads/2021/10/Sec-Artem-4.2.pdf.
   Google Scholar
• Bourne MC. 1968. Texture profile of ripening pears. J Food Science. 33(2):223–226.
   Web of Science ®Google Scholar
• Buontempo F. 2010. [Desarrollo galénico de formulaciones huérfanas en pediatría. [Galenic development of orphan formulations in pediatrics]. [Doctoral Thesis]. Universidad de Buenos Aires. Spanish.
   Google Scholar
• Burey P, Bhandari BR, Rutgers RPG, Halley PJ, Torley PJ. 2009. Confectionery gels: a review on formulation, rheological and structural aspects. Int J Food Prop. 12(1):176–210.
   Web of Science ®Google Scholar
• Čižauskaitė U, Jakubaitytė G, Žitkevičius V, Kasparavičienė G. 2019. Natural ingredients-based gummy bear composition designed according to texture analysis and sensory evaluation in vivo. Molecules. 24(7):1442.
   PubMed Web of Science ®Google Scholar
• Comoglu T, Ozyilmaz ED. 2019. Orally disintegrating tablets and orally disintegrating mini tablets – novel dosage forms for pediatric use. Pharm Dev Technol. 24(7):902–914.
   PubMed Web of Science ®Google Scholar
• Coppola M, Djabourov M, Ferrand M. 2008. Phase diagram of gelatin plasticized by water and glycerol. Macromol Symp. 273(1):56–65.
   Google Scholar
• Davydova N. 2018. USP Chewable Gels Monographs. [accessed 2022 Nov 28] https://www.usp.org/sites/default/files/usp/document/stakeholder-forum/chewable-gels.pdf.
   Google Scholar
• De la Torre P, Torrado S, Torrado S. 1999. Preparation, dissolution and characterization of praziquantel solid dispersions. Chem Pharm Bull. 47(11):1629–1633.
   Web of Science ®Google Scholar
• Delgado Estrella PS. 2018. [Acciones tecnológicas para mejorar la calidad nutricional y sensorial de los caramelos de goma. [Technological actions to improve the nutritional and sensory quality of jelly candies]. [Doctoral Thesis]. Universidad de Murcia, Spain. Spanish.
   Google Scholar
• Delgado P, Bañon S. 2015. Determining the minimum drying time of gummy confections based on their mechanical properties. CYTA – J Food. 13(3):329–335.
   Web of Science ®Google Scholar
• Dille MJ, Hattrem MN, Draget KI. 2018. Soft, chewable gelatin-based pharmaceutical oral formulations: a technical approach. Pharm Dev Technol. 23(5):504–511.
   PubMed Web of Science ®Google Scholar
• Dille MJ, Hattrem MN, Draget KI. 2018. Bioactively filled gelatin gels; challenges and opportunities. Food Hydrocolloid. 76:17–29.
   Web of Science ®Google Scholar
• Donauer N, Löbenberg R. 2007. A mini review of scientific and pharmacopeial requirements for the desintegration test. Int J Pharm. 345(1-2):2–8.
   PubMedGoogle Scholar
• [EMA]. European Medicines Agency. 2006 Reflection Paper: Formulation of choice for the paediatric population.. Committee for Medicinal Products for Human Use. EMEA/CHMP/PEG/194810/2005; London, United Kingdom. [accessed 2023 Jan 05] https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-formulations-choice-paediatric-population_en.pdf.
   Google Scholar
• Ergun R, Lietha R, Hartel RW. 2010. Moisture and shelf life in sugar confections. Crit Rev Food Sci Nutr. 50(2):162–192.
   PubMed Web of Science ®Google Scholar
• FDA Food and Drug Administration 2017. Guidance for Industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Center for Drug Evaluation and Research (CDER), Office of Communications, Division of Drug Information. Silver Spring, MD; United States of America. [accessed 2022 Nov 28] https://collections.nlm.nih.gov/master/borndig/101720038/UCM070246.pdf.
   Google Scholar
• FNA 2013. Farmacopea Argentina [Argentine Pharmacopeia], 7ma. Edición Comisión Permanente para la Farmacopea Argentina. Ministerio de Salud de la Nación. [Accessed 2022 Nov 28] http://www.anmat.gov.ar/webanmat/fna/pfds/Farmacopea_Argentina_2013_Ed.7.pdf.
   Google Scholar
• García Sanchez MJ, Santos Buelga D. 2001. Formas sólidas orales [Oral solid dosaje forms.]. In Vila Jato JLeditor. Tecnología farmacéutica. Madrid (España): Editorial Síntesis; p 55–155. Spanish.
   Google Scholar
• Gonzalez MA, Ramírez Rigo MV, Gonzalez Vidal NL. 2019. Orphan formulations in pediatric schistosomiasis treatment: development and characterization of praziquantel nanoparticle — loaded powders for reconstitution. AAPS PharmSciTech. 20(8):318–329.
   PubMed Web of Science ®Google Scholar
• Gonzalez MA, Ramírez-Rigo MV, Gonzalez Vidal NL. 2018. Praziquantel systems with improved dissolution rate obtained by high pressure homogenization. Mater Sci Eng C Mater Biol Appl. 93:28–35.
   PubMed Web of Science ®Google Scholar
• Hartel RW, Joachim H, Hofberger R. 2018. Jellies, Gummies and Licorices. In Confectionery science and technology. New York: Springer Cham; p 329–359.
   Google Scholar
• Hartel RW, von Elbe JH, Hofberger R. 2017. Water. In Confectionery Science and Technology. New York: Springer Cham; p 69–83.
   Google Scholar
• Hattrem MN, Molnes S, Draget KI. 2014. Investigation of physico-chemical properties of gelatin matrices in correlation with dissolution studies. In: Williams P, Philips G editors. Gums and stabilisers for the food industry 17: the changing face of food manufacture: the role of hydrocolloids. United Kingdom: The Royal Society of Chemistry, p. 369–376.
   Google Scholar
• Haug IJ, Draget KI. 2009. Gelatin. In: Phillips GO, Williams PA editors. Handbook of hydrocolloids. Cambridge, UK: Woodhead Publishing Ltd, p 142–163.
   Google Scholar
• Ikeda S, Henry K. 2016. Effects of partial replacement of gelatin in high sugar gels with gellan on their textural, rhelogical, and thermal properties. Food Biophys. 11(4):400–409.
   Web of Science ®Google Scholar
• Ivanovska V, Rademaker CM, van Dijk L, Mantel-Teeuwisse AK. 2014. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 134(2):361–372.
   PubMed Web of Science ®Google Scholar
• Jacobs IC. 2014. Semi-solid Formulations. In: Bar-Shalom D, Rose K editors. Pediatric formulations: a roadmap, AAPS advances in the pharmaceutical sciences series. New York: Springer; p. 171–179.
   Google Scholar
• Khan KA. 1975. The concept of dissolution efficiency. J Pharm Pharmacol. 27(1):48–49.
   PubMed Web of Science ®Google Scholar
• Lindenberg M, Kopp S, Dressman JB. 2004. Classification of orally administered drugs on the World Health Organization model list of essential medicines according to the biopharmaceutics classification system. Eur J Pharm Biopharm. 58(2):265–278.
   PubMed Web of Science ®Google Scholar
• Liu F, Ranmal S, Batchelor HK, Orlu-Gul M, Ernest TB, Thomas IW, Flanagan T, Tuleu C. 2014. Patient-centered pharmaceutical design to improve acceptability of medicines: similarities and differences in paediatric and geriatric populations. Drugs. 74(16):1871–1889.
   PubMed Web of Science ®Google Scholar
• McGurk SL, Czekai DA. 2010. Gel Stabilized Nanoparticulate active agent compositions. U.S. Patent No. 7,713,551. Washington, DC: U.S. Patent and Trademark Office.
   Google Scholar
• Mochizuki Y. 2001. Texture profile analysis. In: Wrolstad RE, editor. Current protocols in food analytical chemistry. New York: Wiley, p. H2.3.1–H2.3.7.
   Google Scholar
• Noyes AA, Whitney WR. 1897. The rate of solution of solid substances in their own solutions. J Am Chem Soc. 19(12):930–934.
   Google Scholar
• Olliaro PL, Vaillant M, Hayes DJ, Montresor A, Chitsulo L. 2013. Practical dosing of praziquantel for schistosomiasis in preschool-aged children. Trop Med Int Health. 18(9):1085–1089.
   PubMed Web of Science ®Google Scholar
• Patel S, Scott N, Patel K, Mohylyuk V, McAuley WJ, Liu F. 2020. Easy to swallow instant jelly formulations for sustained release gliclazide delivery. J Pharm Sci. 109(8):2474–2484.
   PubMed Web of Science ®Google Scholar
• Pediatric Praziquantel Consortium. 2022. [accessed 2022 Nov 28] https://www.pediatricpraziquantelconsortium.org/schistosomiasis.
   Google Scholar
• Pons M, Fiszman SM. 1996. Instrumental texture profile analysis with particular reference to gelled systems. J Texture Studies. 27(6):597–624.
   Web of Science ®Google Scholar
• Ranmal SR, Barker SA, Tuleu C. 2014. Paediatric Solid Formulations. In Bar-Shalom D, Rose K (Eds). Pediatric Formulations: A Roadmap, AAPS Advances in the Pharmaceutical Sciences Series. New York: Springer; p 153–170.
   Google Scholar
• Romero de Soto MD. 2012. [Estudios de farmacotecnia y desarrollo de formas de dosificación de vegetales deshidratados para su aplicación en pediatría y personas de la tercera edad]. [Pharmacotechnical studies and development of dosage forms of dehydrated vegetables for their application in pediatrics and the elderly]. [Doctoral Thesis]. Universidad de Granada, Spain. Spanish.
   Google Scholar
• Schrieber R, Gareis H. 2007. Gelatine handbook: theory and industrial practice. Weinheim: Wiley VCH Verlag GmbH & Co.
   Google Scholar
• Siewert M, Dressman J, Brown CK, Shah VP, Aiache J-M, Aoyagi N, Bashaw D, Brown C, Brown W, Burgess D, et al. 2003. FIP/AAPS guidelines for dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech. 4(1):43–52.
   Google Scholar
• Teratsubo M, Tanaka Y, Saeki S. 2002. Measurement of stress and strain during tensile testing of gellan gum gels: effect of deformation speed. Carbohyd Polym. 47(1):1–5.
   Web of Science ®Google Scholar
• Tiţa B, Fuliaş A, Bandur G, Marian E, Tiţa D. 2011. Compatibility study between ketoprofen and pharmaceutical excipients used in solid dosage forms. J Pharm Biomed Anal. 56(2):221–227.
   PubMed Web of Science ®Google Scholar
• Trastullo R, Dolci LS, Passerini N, Albertini B. 2015. Development of flexible and dispersible oral formulations containing praziquantel for potential schistosomiasis treatment of preschool age children. Int J Pharm. 495(1):536–550.
   PubMedGoogle Scholar
• USP. 2018. The United States Pharmacopeia and National Formulary USP 41-NF36. Rockville: The United States Pharmacopeial Convention, Inc.
   Google Scholar
• Vieira MA, Rovaris AA, Maraschin M, De Simas KN, Pagliosa CN, Podesta R, Amboni RDMC, Barreto PLM, Amante ER. 2008. Chemical characterization of candy made of Erva-Mate (Ilex paraguariensis A. St. Hil.) residue. J Agric Food Chem. 56(12):4637–4642.
   PubMed Web of Science ®Google Scholar
• [WHO] World Health Organization. 2019. World Health Organization, 7th List. Geneva, Switzerland: WHO Headquarters. [accessed 2022 Nov 28]. https://apps.who.int/iris/bitstream/handle/10665/325772/WHO-MVP-EMP-IAU-2019.07-eng.pdf?ua=1.
   Google Scholar
• [WHO] World Health Organization. 2020. Innovative delivery systems for paediatric medicines: technology landscape. Geneva, Switzerland. [accessed 2023 Jan 05].
   Google Scholar
• [WHO] World Health Organization. 2008. Report of the informal expert meeting on dosage forms of medicines for children. WHO Technical Report Series 958, Appendix 2. Geneva, Switzerland: WHO Headquarters. [accessed 2022 Nov 28]. https://www.who.int/publications/i/item/9789241209588.
   Google Scholar
• [WHO] World Health Organization. 2016. Schistosomiasis Strategy: Geneva, Switzerland WHO Headquarters.
   Google Scholar
• Yuksel N, Kanik AE, Baykara T. 2000. Comparison of in vitro dissolution profiles by ANOVA-based, model-dependent and -independent methods. Int J Pharm. 209(1-2):57–67.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Huo M, Zhou J, Zou A, Li W, Yao C, Xie S. 2010. DDSolver: an add-in program for modeling and comparison of drug dissolution profiles. AAPS J. 12(3):263–271.
   PubMed Web of Science ®Google Scholar