دراسات الثبات لمشاركة الليفوسيتيريزين والبسودوإفدرين في الأشكال الصيدلانية السائلة

الموضوعات

علوم بحتة وطبيعية

روابط وملفات

التعريف والنوع

رقم الوثيقة

f9e93472-875d-49c6-bbb2-d67eb01a5ce3

رقم العقد

0

نوع الوسائط

Crawler

نوع المحتوى

الرسائل العلمية

صيغة المصدر

رسائل ماجيستير

نوع الملف

pdf text

أسماء الملفات

1965966_1.pdf

بيانات النشر

ترجمة العنوان

Stability Studies of Levocetirizine and Pseudoephedrine Combination in Liquid Dosage Forms

ألقاب المؤلفين

[{"name_ar":"ميرفت عبدو مراد","title_ar":"اعداد","title_en":"Preparation"},{"name_ar":"ياسر بيطار ","title_ar":"اشراف","title_en":"Supervision"}]

اللغة

Arabic

المصدر والدورية

اسم المصدر

دراسات الثبات لمشاركة الليفوسيتيريزين والبسودوإفدرين في الأشكال الصيدلانية السائلة

المحتوى والصفحات

عدد الصفحات

0

ترجمة الملخص

The aim of this study is to evaluate the stability of Levocetirizine and Pseudoephedrine when they are combined in liquid dosage form. This combination is only available as solid dosage form for adults and there is no liquid alternatives for children.Initially, a stability-indicating chromatographic analytical method was developed for the simultaneous determination of levocetirizine and pseudoephedrine in liquid forms, Ion-pairing Reversed Phase High Performance Liquid Chromatography, and validated according to International Conference on Harmonization)ICH). The validation study showed that the developed analytical method is: specific, linear, accurate, and precise. Then, preformulation study and liquid-state stability study of levocetirizine and Pseudoephedrine was performed via performing the study of the effects of factors affecting the stability of the two drugs in the liquid form. These factors are: pH, buffer species and buffer concentration, drug combination, drug-excipient compatibilities, light, heat, and adding of chelating agent. This study showed that: the pH of maximum stability of the two drugs in liquid form is 5.0, there is no effect of drug combination on the stability of Levocetirizine or Pseudoephedrine, the use of disodium edetate as indirect antioxidant (chelating agent)improved the stability of Levocetirizine and Pseudoephedrine in liquid form, and this liquid form should be stored in an amber glass bottles protected from light because the two drugs are sensitive to light and oxidation,whether levocetirizine dihydrochloride is combined with pseudoephedrine sulfate or pseudoephedrine hydrochloride.Then, formulation study was performed and a novel pharmaceutical formulation of levocetirizine and pseudoephedrine in liquid dosage form was developed and prepared as two combinations (The first combination contains Levocetirizine dihydrochloride 0.5 mg/ml and pseudoephedrine sulfate 12 mg/ml, the second contains levocetirizine dihydrochloride 0.5 mg/ml and pseudoephedrine hydrochloride 6 mg/ml). Quality control tests was performed on the liquid form of the two combinations. These tests showed that the liquid preparation was complied with the accepted specifications and limits.The long-term stability study of the two combinations was performed at 25 ± 2°C temperature and 60 ± 5% relative humidity.The degradation of levocetirizine and pseudoephedrine in the two combinations was slow, limited and within the accepted limits but the degradation of them in the second combination was little faster than the first one and no significant changes were reported in the two combinations.So, liquid dosage form of Levocetirizine and Pseudoephedrine combination could be formulated by using two types of pseudoephedrine salts and can remain stable for at least 2 years when is stored in dry place at 25°C temperature and protected from light.

إشراف وإعداد

الإشراف

ياسر بيطار

الإعداد

ميرفت عبدو مراد

الاقتباسات الببليوغرافية