Development and Evaluation Controlled Release Diclofenac Sodium Matrix Tablets

الموضوعات

طب

الملخص

In vitro release profiles were studied for the matrix controlledrelease Diclofenac sodium tablets (MT20, MT33, MT34) in comparisonwith Voltaren retard (V.R) a well known marketed Diclofenac sodiumcontrolled release tablets from Novartis® (Switzerland). Percentagerelease of Diclofenac sodium was studied in gradient pHS (1.2, 2.1, 4.2,5.5, 6.5, 6.7, & 7.2) in accordance with gastric pHS, which are varyingfrom pH one to eight. The study included the release profiles andevaluated the kinetics of diffusion and diffusion exponents.Analysis of new controlled release oral drug delivery systems using, C8(Eurosphere-100 (5 µm) 4.6 mm ID x 250 mm) and C18 (Eurosphere-100(5 µm) 4 mm ID x 100 mm) columns was carried out. The mobile phasewas phosphate buffer/methanol. Spectrophotometric detection was at 272nm. Percentages of content for the different matrices were evaluated.Based on t-test no significantdifference was found betweencontent measurements using C8 and C18 columns at p′-value of 0.05.(Observed t-value was 0.062 compared to the theoretical value of 2.15.Content analysis showed good precision and accuracy with C8 rather thanC18.In vivo performance and bio-equivalence of controlled releasematrix tablets (MT33) containing gum Arabic and Guar gum wascompared to a standard control drug Voltaren retard in healthy malevolunteers. The study design was randomized cross-over study. Blood sampleswere collected at pre-determined periods, up to 12 hours and one samplewas taken after 24 hours.High performance liquid chromatographic (HPLC) analysis wasdone for both sample and control. Parameters such as Cmax,Tmax, AUC0-24,iiiKeland MRT0-24. AUMC0-t, AUMC0-∞were obtained. The bioequivalence of both formulationswas evaluated which showed nodifference in prolonged action in vivo performance between controlledmatrix tablets (MT33 ) containing gum Arabic and guar gum comparedto a standard control drug ; Voltaren retard in healthy volunteers.Accelerated stability study for six months was performed forcontrolled release matrix tablets (MT20, MT33, MT34, MT33p, MT34p)containing natural gums (gum Arabic, guar gum), semi-synthetic gum(Xanthan gum), Eudragit L100 (methacrylic acid and methylmethacrylate), and Hydroxypropylmethylcellulose. Microbiological tests for matrices were evaluated by comparingpreserved and non preserved tablets. Content was found to be 90-105% inall the five matrix formulae. Applying out of trend stability rules (OOT),the best formula was MT33 which contain guar gum 15% and gumArabic 15%. No changes in physical appearance and organolepticproperties were observed. No microbiological growth (bacteria or fungi)was observed in both preserved and non-preserved controlled releaseformulae.

روابط وملفات

التعريف والنوع

رقم الوثيقة

05e23d85-6526-4b5c-9630-6d22caeea1d9

رقم العقد

0

نوع الوسائط

Crawler

نوع المحتوى

الرسائل العلمية

صيغة المصدر

رسائل دكتوراة

نوع الملف

pdf text

أسماء الملفات

1639268_1.pdf

بيانات النشر

ألقاب المؤلفين

[{"name_ar":"عبدالكريم محمد","title_ar":"اشراف","title_en":"Supervision"},{"name_ar":"عبدالله احمد","title_ar":"اعداد","title_en":"Preparation"}]

اللغة

English

المصدر والدورية

اسم المصدر

Development and Evaluation Controlled Release Diclofenac Sodium Matrix Tablets

المحتوى والصفحات

عدد الصفحات

0

إشراف وإعداد

الإشراف

عبدالكريم محمد

الإعداد

عبدالله احمد

الاقتباسات الببليوغرافية