Absorption Profile And Bioequivalence Of Two Locally Manufactured Cephalexins

الموضوعات

طب

الملخص

The disposition of three locally manufactured oral Cephalexins(two capsules and a suspension) was assessed by estimation of thepharmacokinetic parameters and bioavailability metrics of theirconstituent (Cephalexin monohydrate), in healthy subjects in comparisonwith the innovator's brand (Keflex®). The study was carried out at theDepartment of Pharmaceutics, Faculty of Pharmacy, University ofKhartoum. Ten healthy adult volunteers were included in the studyfollowing fulfillment of itsinclusion and exclusion criteria. A randomizedthree-way and two-way cross over design was performed. Blood sampleswere collected at specified time after medication with a single dose ofcephalexin (2 capsules or 10 ml suspension).Concentrations of cephalexin were measured in plasma by HPLCmethod using cefotaxim as an internal standard. Non-compartmentalpharmacokinetic analysis was performed on the plasma concentrationtime data. The pharmacokinetic parameters(Mean ± SD) of cephalexinfollowing administration of keflex®capsules, capsules B and capsules Cwere estimated as Tmax1.10 ± 0.29h, 1.15 ± 0.32h and 1.15 ± 0.32h,Cpmax25.56 ± 6.72µg/ml, 23.95 ± 11.09µg/ml and 13.17 ± 6.97 µg/ml,AUC 45.39 ± 14.94µg.h/ml, 53.48 ± 19.58µg.h/ml and 23.26 ± 12.31µg.h/ml, MRT 1.99 ± 0.3h, 2.44 ± 0.65h and 1.97 ± 0.3h, Ke 0.709 ± 0.11h-1, 0.65 ± 0.14 h-1and 0.732 ± 0.128 h-1. t½1.0 ± 0.18 h, 1.11 ±0.22 hand 0.97 ± 0.15 h. CL/F 23.86 ± 6.4 L/h, 21.36 ± 8.56 L/h and 29.59 ±20.98 L/h. Vd/F 33.87 ± 9.18 L, 35.48 ± 20.22 L and 42.51 ± 35.73 L. The pharmacokinetic parameters (Mean ±SD) of Keflex®suspension and suspension E are in the following order Tmax0.84 ± 0.35 hand 0.90± 0.17 h, Cpmax38.32 ± 4.74 µg/ml and 35.51 ± 11.52 µg/ml,iiiAUC∞52.67 ± 10.12µg.h/ml and 54.17 ± 11.52µg/ml, MRT 1.53 ± 0.2hand 1.56 ± 0.19h, Ke 0.87 ± 0.09 h-1and 0.9 ± 0.08h-1, T½ 0.81 ± 0.08 hand 0.78 ± 0.07h, CL/F 17.99 ± 3.46 L/h and 21.41 ± 9.88 L/h, Vd/F20.82 ± 3.7 L and 23.94 ± 10.79 L. Statistical analysis using student'st-test showed that there are nostatistically significant differences in all pharmacokinetic parametersbetween locally manufactured capsules B an C comparedto capsules A(Keflex®capsules) and suspension E from the local industry compared toreference suspension D (Keflex®suspension). The relative bioavailability ofcapsules B and capsules C incomparison with the standard brand Keflex®capsules were 117. . 8 % and102.48.%, respectively. On the other hand the relative bioavailability ofsuspension E in comparison with Keflex®suspension was 102.84%. The study concluded that the absorption profiles and dispositionpatterns of the locally produced test formulations is highly comparablewith that of the standard brands. The tested generics are equallydispositional as the standard brands and gave same plasma level. It isexpected that locally manufactured brands will achieve same clinicalefficacy as that of the innovator’s brand. Consequently they can beconsidered bioequivalent with the standard brands and accordingly can beused interchangeably.

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التعريف والنوع

رقم الوثيقة

01b18306-2dd9-4d8a-8f92-ecdd02c8dcc1

رقم العقد

0

نوع الوسائط

Crawler

نوع المحتوى

الرسائل العلمية

صيغة المصدر

رسائل ماجيستير

نوع الملف

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أسماء الملفات

01b18306-2dd9-4d8a-8f92-ecdd02c8dcc1_1.pdf

بيانات النشر

ألقاب المؤلفين

[{"name_ar":"زهير عبدالرحمن العوض","title_ar":"اعداد","title_en":"Preparation"},{"name_ar":"سمية سر الختم محمد","title_ar":"اشراف","title_en":"Supervision"}]

اللغة

English

المصدر والدورية

اسم المصدر

Absorption Profile And Bioequivalence Of Two Locally Manufactured Cephalexins

المحتوى والصفحات

عدد الصفحات

0

إشراف وإعداد

الإشراف

سمية سر الختم محمد

الإعداد

زهير عبدالرحمن العوض

الاقتباسات الببليوغرافية