Development of a new age-appropriate, chewable tablet of mebendazole 500 mg for preventive chemotherapy of soil-transmitted helminth infections in pre-school and school-age children.

Autor: Van Hove B; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium. Electronic address: BVHOVE@its.jnj.com., Kanagale P; Janssen India, Janssen, Higi House Johnson and Johnson LBS Marg, Mulund - W, Mumbai, Maharashtra 400080, India., Quinten T; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium., Gaiki S; Janssen R&D US, 1000 Route 202 South, Raritan, NJ 08869, USA., Collignon K; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium., Swar Y; Janssen India, Janssen, Higi House Johnson and Johnson LBS Marg, Mulund - W, Mumbai, Maharashtra 400080, India., Shah J; Janssen India, Janssen, Higi House Johnson and Johnson LBS Marg, Mulund - W, Mumbai, Maharashtra 400080, India., Verheyen E; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium., Preda FM; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium., Samanta A; Janssen India, Janssen, Higi House Johnson and Johnson LBS Marg, Mulund - W, Mumbai, Maharashtra 400080, India., Fernandez E; Janssen Supply Chain, Gubelstrasse 34, 6300 Zug, Switzerland., Caporicci G; Jan-Cil Italy, Janssen Cilag, Via C. Janssen, Latina 04100, Italy., Ferreira T; Lusomedicamenta/Recipharm Lisbon, Estrada Consiglieri Pedroso, 69-B, Queluz de Baixo, 2730-055 Barcarena, Portugal., Lequieu W; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium., Masschelein J; Janssen R&D BE, Turnhoutseweg 30, Beerse, Antwerp 2340, Belgium., Schaufelberger D; Schaufelberger Consulting LLC and Johns Hopkins University, School of Medicine, Neuroscience, All Children's Hospital, St. Petersburg, FL, USA.
Jazyk: angličtina
Zdroj: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2023 Jul; Vol. 188, pp. 217-226. Date of Electronic Publication: 2023 May 18.
DOI: 10.1016/j.ejpb.2023.05.013
Abstrakt: The aim of this study was to develop an age-appropriate tablet of mebendazole 500 mg to be used in large donation programs by the World Health Organization (WHO) for preventive chemotherapy of soil-transmitted helminth (STH) infections in pre-school and school-age children living in tropical and subtropical endemic areas. To that end, a new oral tablet formulation was developed that can be either chewed or given to young (≥1 year old) children by spoon after rapid disintegration to a soft mass with the addition of a small amount of water directly on the spoon. Although the tablet was manufactured using conventional fluid bed granulation, screening, blending, and compression processes, one of the main challenges was to combine properties of a chewable, dispersible, and regular (solid) immediate release tablet to meet the predefined requirements. The tablet disintegration time was below 120 s, allowing for administration by the "spoon method". The tablet hardness was higher (160-220 N) than normally applicable for chewable tablets, permitting shipment along a lengthy supply chain in a primary 200-tablet count bottle packaging. In addition, the resulting tablets are stable for 48 months in all climatic zones (I-IV). In this article, several aspects of the development of this unique tablet are described, including formulation, process development, stability, clinical acceptability testing, and regulatory filing.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: D.Sch. retired from Janssen and is an independent consultant, advising pharmaceutical companies, academic, and governmental organizations.
(Copyright © 2023 Janssen Pharmaceutica NV. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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