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Register a new userComparison of Dissolution Time of Sodium Ceftriaxone Preparations for Injection and Studying the Factors Affecting it
مقارنة زمن انحلال مستحضرات سفترياكسون الصوديوم المُعدَّة للإعطاء حقناً و دراسة العوامل المؤثرة عليها
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محمد هارون( باحث )
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تهدف هذه الدراسة لمقارنة معدلات انحلال ستة مستحضرات من مادة سفترياكسون الصوديوم المعدة للإعطاء حقناً، أحدها المستحضر الأصلي و خمسة مستحضرات جنيسة محلية الصنع. تم قياس زمن الإنحلال بدقة عند النقطة التي تصبح فيها البودرة الدوائية لسفترياكسون الصوديوم محلولاً شفافاً بعد إضافة محلول فيزيولوجي من كلوريد الصوديوم %0,9. تبين بالقياس أن زمن الإنحلال مختلف بين المستحضرات المدروسة. لمعرفة العوامل المؤثرة على الإنحلال تم بدايةً إخضاع البودرة الدوائية المدروسة للفحص بمطيافية الأشعة تحت الحمراء بتحويل فورييه (FTIR) للتأكد من ذاتيتها و نقاوتها و عدم تخربها، كذلك تمت دراسة المحتوى المائي للبودرة الجافة الخاصة بكل صنف تجاري مدروس باستخدام تقنية التجفيف بالأشعة تحت الحمراء IR. أخيراً تمت دراسة أبعاد و أشكال البلورات في البودرة الحقنية باستخدام المجهر الضوئي. أظهرت الدراسة أن الإختلاف في زمن الإنحلال بين المنتجات الحقنية الست المدروسة يعود بشكل أساسي للإختلافات في خصائص البودرة الدوائية كنسبة الرطوبة و الشكل البلوري للجزيئات و أبعادها. و قد استطاع أحد المنتجات الوطنية الجنيسة مجاراة المنتج العالمي في زمن انحلاله و الخواص الفيزيوكيميائية المختلفة للبودرة.
The aim of this study is to compare the dissolution time of six formulations of paranteralSodium Ceftriaxonepreparation, the original product and five generic local ones. The dissolution time was measured precisely as the point at which the dried powder of Sodium Ceftriaxone preparation became a transparent solution on the addition of physiologicalsolution 0,9% of Sodium Chloride. The dissolution time of the six products were different. The measurement of infrared spectroscopy (FTIR) of different powder preparations was conducted, then the weight, the humidity and the morphology of different medical powders were studied to investigate the factors influencing the dissolution time. The difference in dissolution time between the six products was due to differences in powder characteristics such as water content, crystal shape and dimension. It was shown that one local generic product of Sodium Ceftriaxone islook like the original one.
References used
TANGE, M. , HATTORI, Y. , OTSUKA, M. , YOSHIDA, M., HAGINAKA, J. , UCHIDA, T. Comparison of the dissolution rate of Cefteriaxone Sodium preparations for injection. Chem. Pharm. Bull. Vol. 61, Nº 11, 2013, 1121-1129
MANDELL, GL., SANDE, MA. Antimicrobial agents: penicillins, cephalosporins, and other beta-lactam antibiotics. In Gilman AG, (Ed). Goodman and Gilman’s Pharmacological Basis of Therapeutics 8th ed. New York: Pergamon Press 1990 , 1065–1097
Clarke’s Analysis of Drugs and Poisons in pharmaceuticals, body fluids and postmortem material. London, UK, Pharmaceutical Press 2011
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