Comparative in vitro and in vivo study of a sugar-coated chloroquine preparation marketed in Tanzania versus an ordinary brand.
J Clin Pharm Ther
; 26(1): 43-8, 2001 Feb.
Article
em En
| MEDLINE
| ID: mdl-11286606
ABSTRACT
OBJECTIVE:
To investigate the absorption and the quality of a sugar-coated chloroquine (CQ) marketed in Tanzania.METHOD:
Twenty healthy volunteers were randomised to take either the test brand (group A) or a control chloroquine phosphate (group B). Each subject received 300 mg chloroquine base. Whole blood dried on filter papers were collected at time 0 and at 15 and 30 min and at 1, 2, 3, 4, 6, 8, 24, 36, 48, 72 and 168 h after drug intake. Urine samples were collected at time 0, 0-4 h, 4-8 h, 8-24 h, 24-48 h and 48-72 h after drug administration. In an in vitro study, six tablets from each of the two CQ preparations were checked for the amount of active drug contained in each tablet and their dissolution rates.RESULTS:
The blood concentration Area Under the Curve (AUC) of group B was about 10% larger than that of group A. The total amounts of CQ plus deethylchloroquine excreted with the urine during the 72-h study period were 5% for group A and 6% for group B. None of the pharmacokinetic parameters were significantly different between the two groups. All the tablets contained the labelled amount of chloroquine; however, one tablet from the test drug failed to fulfil the required dissolution rate.CONCLUSION:
We found no major difference between the AUCs of the two CQ preparations, but the sugar-coated brand has shown to have variable dissolution rate.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cloroquina
/
Antimaláricos
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
Africa
Idioma:
En
Revista:
J Clin Pharm Ther
Assunto da revista:
FARMACIA
/
TERAPEUTICA
Ano de publicação:
2001
Tipo de documento:
Article
País de afiliação:
Tanzânia