دراسة مقارنة لسلوك انحلال مضغوطات الإيبوبروفن المتوفّرة في السوق المحليّة
Abstract
تمَّت دراسة مقارنة انحلال مضغوطات الإيبوبروفن الموجودة في السوق المحليّة بالعيارين (400) و(600 ملغ)، والمصنّعة محليّاً من قِبَل شركات تجاريّة عِدّة (A) و(B) و(C) و(D)، مع انحلال مضغوطات شركة واحدة عالميّة (X)، وذلك وفقاً لمتطلبات دستور الأدوية الأمريكي (USP34-NF29).
كما أظهرت النتائج أنَّ كُلّ المستحضرات التجاريّة التي أجريت عليها الدراسة قد حقّقت المتطلبات الدستوريّة؛ حيث أنَّها حررّت أكثر من (85%) من محتواها الفعّال بعد (60 دقيقة)، ماعدا المضغوطات ذات العيار (400 ملغ) المُلبَّسة سكرياً للشركة (A) الطبخة رقم (1)؛ حيث لم تُحرّر سوى (77.45%) من محتواها الفعّال بعد (60 دقيقة)، في حين يطلب الدستور تحرير (85%) خلال (60 دقيقة).
أجرينا أيضاً اختبار مقارنة منحنيات الانحلال مع الزمن بين المضغوطات ذات العيار (400 ملغ) المُلبَّسة بالفلم والمُصنَّعة محليّاً مع المضغوطات المُصنَّعة عالميّاً من قبل الشركة (X).
ولم تتشابه أيّ من المستحضرات المُصنَّعة محليّاً مع المستحضر العالمي، وبحسب قيم معامل التشابه (F2 )
(يجب أن يكون أكبر من 50) كانت الشركة (D) هي الأكثر قرباً (47.60)، فالشركة (C) (38.99)، فالشركة (B) (36.80).
وعند إجراء هذا الاختبار على المضغوطات ذات العيار (600 ملغ) المُلبَّسة بالفلم والمُصنَّعة محليّاً مع الشركة (X) العالميّة، كانت الشركة (B) فقط مشابهة للشركة (X) (قيمة معامل التشابه /F2/ هي 59.28). وكان ترتيب باقي الشركات حسب قربها من مضغوطات الشركة (X) العالميّة اعتماداً على قيم معامل التشابه (F2): الشركة A (45.48)، فالشركة D (29.89)، فالشركة C (25.12).
A comparative dissolution study of ibuprofen tablets for two strengths 400 & 600 mg has been done according to the united state pharmacopeia (USP34-NF29). The tablets are from the local market and manufactured by four local pharmaceutical companies A,B,C, D & an international company X.
The results revealed that all the studied commercial preparations had been achieved the USP34-NF29 requirements. Only 400mg strength sugar coated tablets manufactured by company A (batch A1) released 77.45% of ibuprofen, while the other preparations released 85% or more.
The dissolution profiles of 400 mg strength ibuprofen film coated tablets were compared between those manufactured locally and those manufactured internationally by company X. None of the preparations manufactured locally was similar to the product of company X. The product manufactured by Company D was the closest one according to the similarity factor (F2).
When this study was applied on the 600 mg strength film coated tablets manufactured locally in comparison with company X. It was found that Company B was the only similar one to company X (F2= 59.28).The other companies were listed according to their closeness to the tablets manufactured by the company X, according to the similarity factor (F2) as the following : Company A, Company D & Company C.
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