Formulation and in-vitro evaluation of nizatidine orodispersible tablet

العناوين الأخرى

تحضير و تقييم خارج الجسم لحبوب النيزادتين المتناثرة فمويا

مقدم أطروحة جامعية

Mahal, Rafah Khamis

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

The formulation researches are oriented towards increasing safety and efficacy of existing drug molecule through a novel concept of drug delivery, one of these is the orodispersible tablet.

Nizatidine inhibit acid production by reversibly competing with histamine for binding to H2 receptors on the basolateral membrane of parietal cells.

The major therapeutic indications for Nizatidine are to promote healing of gastric and duodenal ulcers, to treat uncomplicated GERD, and to prevent the occurrence of stress ulcers.

In the present work firstly the aim is to mask the bitter taste of the nizatidine.

Secondly an attempt has been made to formulate and invitro evaluate of nizatidine orodispersible tablets.

Complexation of nizatidine with Kyron T134 showed a better way to mask the bitterness taste of the nizatidine.

Nizatidine orodispersible tablet were prepared by direct compression method using sodium starch glycolate, croscarmellose sodium, crospovidone as superdisintegrants.

The prepared tablets were evaluated for pre and post compression parameter including Carr’s index, angle of repose, Hausner ratio, hardness friability, wetting time, in vitro disintegration time, and drug release.

The tablets prepared by direct compression method showed an acceptable flow character.

All the formulas exhibited a good mechanical strength.

Crospovidone showed the shortest disintegration time among other superdisintegrants.

Moreover the addition of microcrystalline cellulose (Avicel PH102) in a suitable concentration to the formulas containing crospovidone will decrease the disintegration time.

It’s worthwhile to mention that mixing two types of superdisintegrants have a valuable effect in decreasing the disintegration.

The formula containing 15 % crospovidone and 5 % microcrystalline cellulose (i.e.NF11) showed a lowest disintegration time (14 sec.),a good drug release profile [the time required for 80 % of the drug to be released (t80 %) and percent drug dissolved in 2 min (D2min) were 1.73 min.

and 91.4 % respectively] so it was selected as the best formula.

The stability study of Nizatidine in this formula showed no significant changes (p < 0.05) in drug content, hardness and in-vitro disintegration time at 40 0C accelerated condition The overall results suggested that the prepared formula of nizatidine orodispersible tablet (NF 11) could be promising as a new dosage form for the oral administration.

التخصصات الرئيسية

علم الصيدلة

الموضوعات

• التقييم
• الأدوية

عدد الصفحات

104

قائمة المحتويات

• APA
• MLA
• AMA

لغة النص

الإنجليزية

نوع البيانات

رسائل جامعية

رقم السجل

BIM-596494