In Vivo Comparative Bioavailability Study Of Two Sodium Valproate Syrup Formulations Marketed In Gaza Strip

الموضوعات

طب

الملخص

Title: In vivo comparative bioavailability study of two sodium valproate syrup formulations marketed in Gaza Strip. Introduction: Valproic acid (VA) is an antiepileptic drug. Regarding pharmacokinetic behavior of VA, absorption is almost complete and rapid after oral administration of different dosage form. The plasma half- life (t1/2) is 6 to 20 hours and is metabolized mainly (95%) in the liver (Parker, Lazo and Burnton, 2006). Changes in VA-bioavailability during therapy resulted either in loss of seizure control or intoxication. A reason for such condition can be changing the drug product from a reference to another one (generic as test) (Crawford et al., 2006). Aim: To investigate the bioequivalence of Palestinian sodium valproate syrup as test with trade sodium valproate syrup as reference. Both dispensed usually in pediatric clinics of Gaza Strip. Methodology: A randomized, two crossover design study was conducted on six healthy male rabbits. Rabbits received a single oral dose (25 mg/kg) of valproic acid formulations with a washout period of one week. Serial blood samples were collected over a period of 48 hours. Chemiluminescent enzyme immunoassay (CLEIA) was used to measure valproic acid concentration in serum. Pharmacokinetic (PK) parameters Cmax, tmax, t1/2, AUC0-t, AUC0-∞, and ke were determined for the two formulations. After log-transformation of the data obtained the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of test and reference formulations were used to test bioequivalence. The two formulations were to be considered bioequivalent if the log transformed ratios of Cmax, AUC0-t and AUC0-∞ were within predetermined criteria for bioequivalence range 80 – 125 %. Results: Six rabbits were enrolled in the study which exhibited good tolerability to VA formulations. No statistical differences were found based on analysis of variance. The mean values of PK for test and reference and 90 % confidence intervals ratios of log-transformed data for test/reference of the corresponding parameters were as follows: Cmax; 49.58 versus 49.30 μg/ml (86.80 % to 112.28 %), AUC0-t ; 355.90 versus 381.21 μg.h/ml (81.24 % to 116.22 %) and AUC0-∞; 399.70 versus 409.70 μg.h/ml (83.35 % to118.50 %), respectively. Conclusion: Pharmacokinetic analysis of VA test as bioequivalent with the VA reference.

روابط وملفات

التعريف والنوع

رقم الوثيقة

eba0d8b3-0e81-4953-9cb0-8d930ecc7c45

رقم العقد

0

نوع الوسائط

Crawler

نوع المحتوى

الرسائل العلمية

صيغة المصدر

رسائل ماجيستير

نوع الملف

pdf text

أسماء الملفات

2102278_1.pdf

بيانات النشر

ترجمة العنوان

دراسة مقارنة للإتاحة الحيوية بين شرابين لحمض الصوديوم فالبرويت المسوقين في قطاع غزة

ألقاب المؤلفين

[{"name_ar":"Issam Abushammala ","title_ar":"اشراف","title_en":"Supervision"},{"name_ar":"Mai Ramadan","title_ar":"اشراف","title_en":"Supervision"},{"name_ar":"ابتهال حسين محمد الأسطل","title_ar":"اعداد","title_en":"Preparation"}]

اللغة

English

المصدر والدورية

اسم المصدر

In Vivo Comparative Bioavailability Study Of Two Sodium Valproate Syrup Formulations Marketed In Gaza Strip

المحتوى والصفحات

عدد الصفحات

0

إشراف وإعداد

الإشراف

Issam Abushammala , Mai Ramadan

الإعداد

ابتهال حسين محمد الأسطل

الاقتباسات الببليوغرافية