Formulation and in-vitro evaluation of gemifloxacine orodispersible tablet

العناوين الأخرى

تحضير و تقييم خارج الجسم لحبوب الجيمافلوكساسين المتناثرة فمويا

مقدم أطروحة جامعية

Dalawi, Muhammad Layth Hamzah

مشرف أطروحة جامعية

al-Mulla, Muayyad A. Shihab

الجامعة

جامعة الإسراء

الكلية

كلية الصيدلة

دولة الجامعة

الأردن

الدرجة العلمية

ماجستير

تاريخ الدرجة العلمية

2014

الملخص الإنجليزي

Gemifloxacin is a fluoroquinolone antibacterial with actions and uses similar to those of ciprofloxacin.

It is given orally, as the mesylate, for the treatment of community acquired pneumonia and acute bacterial exacerbations of chronic bronchitis.

Many trials were made to prepare a satisfactory gemifloxacin orodispersible tablet using direct compression method.

The purpose of the present research is to prepare an fast disintegrating tablet of gemifloxacin to fasten its onset of action and to improve patient compliance.

Various super disintegrants were used in this study including croscarmellose sodium, sodium starch glycolate and crospovidone.

The formulas were evaluated for flow properties, tablet hardness, friability, content uniformity, wetting time, in-vitro disintegration time (DT), and drug release profiles.

CP showed the shortest DT (p < 0.05) among other superdisintegrants and fast drug release.

It was showed that the disintegration time of the gemifloxacin orodispersible tablet was decreased to a significant level upon addition of glycine (disintegration enhancer).

It is worthwhile to mention that the addition of chitin (porosity enhancer) have a dramatic effect on the disintegration time of the prepared gemifloxacin orodispersible tablet.

Preformulation studies including physicochemical properties of the active pharmaceutical ingredients and compatibility were performed.

Physical characterization of the prepared powder mixtures and physicochemical evaluations of the prepared tablets were performed.

In addition, accelerated stability studies and in vivo taste evaluation of the selected formulae were also carried out.

The formula containing 15 % of CP and 8 % of chitin (GF15) had the shortest DT (24.6sec.), superior drug release profile [the time required for 80 % of the drug to be released (t80 %) and percent drug released in 2 min (D2min) were 6.1 min.

and 55.3 % respectively] so it was selected as the best formula.

The stability study of Gemifloxacin in this formula showed no significant changes (p < 0.05) in drug content, hardness and in-vitro disintegration time at 40 0C accelerated condition and the same finding has almost been observed with UV light exposure except the drug content, where it exhibited a dramatic changes in its amount on such condition and there is obvious instability in it, this strictly recommend that Gemifloxacin ODT to be packed in light proof sheet foil.

التخصصات الرئيسية

علم الصيدلة

الموضوعات

• التقييم
• الأدوية

عدد الصفحات

100

قائمة المحتويات

• APA
• MLA
• AMA

لغة النص

الإنجليزية

نوع البيانات

رسائل جامعية

رقم السجل

BIM-596466