Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.

<h4>Background</h4>Praziquantel (PZQ) is currently the only recommended drug for infection and disease caused by the schistosome species that infects humans; however, the current tablet formulation is not suitable for pre-school age children mainly due to its bitterness and the large tab...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Muhidin K Mahende, Eric Huber, Elly Kourany-Lefoll, Ali Ali, Brooke Hayward, Deon Bezuidenhout, Wilhelmina Bagchus, Abdunoor M Kabanywanyi
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/8e1535fdaa314ef59361cd0f4087725f
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:8e1535fdaa314ef59361cd0f4087725f
record_format	dspace
spelling	oai:doaj.org-article:8e1535fdaa314ef59361cd0f4087725f2021-11-25T06:31:47ZComparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.1935-27271935-273510.1371/journal.pntd.0007370https://doaj.org/article/8e1535fdaa314ef59361cd0f4087725f2021-06-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0007370https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>Praziquantel (PZQ) is currently the only recommended drug for infection and disease caused by the schistosome species that infects humans; however, the current tablet formulation is not suitable for pre-school age children mainly due to its bitterness and the large tablet size. We assessed the palatability of two new orally disintegrating tablet (ODT) formulations of PZQ.<h4>Methodology</h4>This randomized, single-blind, crossover, swill-and-spit palatability study (NCT02315352) was carried out at a single school in Tanzania in children aged 6-11 years old, with or without schistosomiasis infection as this was not part of the assessment. Children were stratified according to age group (6-8 years or 9-11 years) and gender, then randomized to receive each formulation in a pre-specified sequence. Over 2 days, the children assessed the palatability of Levo-Praziquantel (L-PZQ) ODT 150 mg and Racemate Praziquantel (Rac-PZQ) ODT 150 mg disintegrated in the mouth without water on the first day, and L-PZQ and Rac-PZQ dispersed in water and the currently available PZQ 600 mg formulation (PZQ-Cesol) crushed and dispersed in water on the second day. The palatability of each formulation was rated using a 100 mm visual analogue scale (VAS) incorporating a 5-point hedonic scale, immediately after spitting out the test product (VASt = 0 primary outcome) and after 2-5 minutes (VASt = 2-5).<h4>Principal findings</h4>In total, 48 children took part in the assessment. Overall, there was no reported difference in the VASt = 0 between the two ODT formulations (p = 0.106) without water. Higher VASt = 0 and VASt = 2-5 scores were reported for L-PZQ ODT compared with Rac-PZQ ODT in older children (p = 0.046 and p = 0.026, respectively). The VASt = 0 and VASt = 2-5 were higher for both ODT formulations compared with the standard formulation (p<0.001 for both time points). No serious adverse events were reported.<h4>Conclusions/significance</h4>The new paediatric-friendly formulations dispersed in water were both found to be more palatable than the existing standard formulation of PZQ. There may be gender and age effects on the assessment of palatability. Further research is needed for assessing efficacy and tolerability of the newly ODTs Praziquantel drug in younger children.<h4>Trial registration</h4>The trial was registered on ClinicalTrials.gov (NCT02315352) and in the Pan African Clinical Trials Registry (PACTR201412000959159).Muhidin K MahendeEric HuberElly Kourany-LefollAli AliBrooke HaywardDeon BezuidenhoutWilhelmina BagchusAbdunoor M KabanywanyiPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 6, p e0007370 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Muhidin K Mahende Eric Huber Elly Kourany-Lefoll Ali Ali Brooke Hayward Deon Bezuidenhout Wilhelmina Bagchus Abdunoor M Kabanywanyi Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.
description	<h4>Background</h4>Praziquantel (PZQ) is currently the only recommended drug for infection and disease caused by the schistosome species that infects humans; however, the current tablet formulation is not suitable for pre-school age children mainly due to its bitterness and the large tablet size. We assessed the palatability of two new orally disintegrating tablet (ODT) formulations of PZQ.<h4>Methodology</h4>This randomized, single-blind, crossover, swill-and-spit palatability study (NCT02315352) was carried out at a single school in Tanzania in children aged 6-11 years old, with or without schistosomiasis infection as this was not part of the assessment. Children were stratified according to age group (6-8 years or 9-11 years) and gender, then randomized to receive each formulation in a pre-specified sequence. Over 2 days, the children assessed the palatability of Levo-Praziquantel (L-PZQ) ODT 150 mg and Racemate Praziquantel (Rac-PZQ) ODT 150 mg disintegrated in the mouth without water on the first day, and L-PZQ and Rac-PZQ dispersed in water and the currently available PZQ 600 mg formulation (PZQ-Cesol) crushed and dispersed in water on the second day. The palatability of each formulation was rated using a 100 mm visual analogue scale (VAS) incorporating a 5-point hedonic scale, immediately after spitting out the test product (VASt = 0 primary outcome) and after 2-5 minutes (VASt = 2-5).<h4>Principal findings</h4>In total, 48 children took part in the assessment. Overall, there was no reported difference in the VASt = 0 between the two ODT formulations (p = 0.106) without water. Higher VASt = 0 and VASt = 2-5 scores were reported for L-PZQ ODT compared with Rac-PZQ ODT in older children (p = 0.046 and p = 0.026, respectively). The VASt = 0 and VASt = 2-5 were higher for both ODT formulations compared with the standard formulation (p<0.001 for both time points). No serious adverse events were reported.<h4>Conclusions/significance</h4>The new paediatric-friendly formulations dispersed in water were both found to be more palatable than the existing standard formulation of PZQ. There may be gender and age effects on the assessment of palatability. Further research is needed for assessing efficacy and tolerability of the newly ODTs Praziquantel drug in younger children.<h4>Trial registration</h4>The trial was registered on ClinicalTrials.gov (NCT02315352) and in the Pan African Clinical Trials Registry (PACTR201412000959159).
format	article
author	Muhidin K Mahende Eric Huber Elly Kourany-Lefoll Ali Ali Brooke Hayward Deon Bezuidenhout Wilhelmina Bagchus Abdunoor M Kabanywanyi
author_facet	Muhidin K Mahende Eric Huber Elly Kourany-Lefoll Ali Ali Brooke Hayward Deon Bezuidenhout Wilhelmina Bagchus Abdunoor M Kabanywanyi
author_sort	Muhidin K Mahende
title	Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.
title_short	Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.
title_full	Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.
title_fullStr	Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.
title_full_unstemmed	Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.
title_sort	comparative palatability of orally disintegrating tablets (odts) of praziquantel (l-pzq and rac-pzq) versus current pzq tablet in african children: a randomized, single-blind, crossover study.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/8e1535fdaa314ef59361cd0f4087725f
work_keys_str_mv	AT muhidinkmahende comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT erichuber comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT ellykouranylefoll comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT aliali comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT brookehayward comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT deonbezuidenhout comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT wilhelminabagchus comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy AT abdunoormkabanywanyi comparativepalatabilityoforallydisintegratingtabletsodtsofpraziquantellpzqandracpzqversuscurrentpzqtabletinafricanchildrenarandomizedsingleblindcrossoverstudy
_version_	1718413692969680896

Comparative palatability of orally disintegrating tablets (ODTs) of Praziquantel (L-PZQ and Rac-PZQ) versus current PZQ tablet in African children: A randomized, single-blind, crossover study.

Ejemplares similares