دراسة تأثير أبعاد الجسيمات علي تجانس وتحرر بعض المضادات الحيية فى الأشكال الصيدلانية الصلبة بإستخدام تقنية الأشعة تحت الحمراء القريبة

الموضوعات

طب

روابط وملفات

التعريف والنوع

رقم الوثيقة

0f927a34-87a8-47a6-86be-3c687008ee80

رقم العقد

0

نوع الوسائط

Crawler

نوع المحتوى

الرسائل العلمية

صيغة المصدر

رسائل ماجيستير

نوع الملف

pdf text

أسماء الملفات

1967724_1.pdf

بيانات النشر

ترجمة العنوان

Evaluation of the effect of particle sizes on homogeneity and release for some antibiotic agents in solid dosage forms using Near-Infrared technique

ألقاب المؤلفين

[{"name_ar":"علي الرغبان","title_ar":"اشراف","title_en":"Supervision"},{"name_ar":"ليانا شحط","title_ar":"اعداد","title_en":"Preparation"},{"name_ar":"مصطفي فواز شحنة","title_ar":"اشراف","title_en":"Supervision"}]

اللغة

Arabic

المصدر والدورية

اسم المصدر

دراسة تأثير أبعاد الجسيمات علي تجانس وتحرر بعض المضادات الحيية فى الأشكال الصيدلانية الصلبة بإستخدام تقنية الأشعة تحت الحمراء القريبة

المحتوى والصفحات

عدد الصفحات

156

ترجمة الملخص

The purpose of this research was to investigate and improve some physicochemical and solid-state properties of amoxicillin trihydrate. Amoxicillin trihydrate as a raw material with various particle sizes and crystal shapes were obtained from several suppliers. The particle size and crystal shape have been determined using eight sieves and scanning fluorescence microscope as reference methods. Near Infrared Reflectance(NIR)Spectroscopy was used as an advanced technique for determining particle size distribution and crystal shape differentiation of amoxicillin trihydrate powder .The drug was filled in hard gelat in capsules as a single dose of 250 mg. Drug dissolution was evaluated using dissolution tester(I). Samples were analyzed using U.V spectrophotometer at absorbance of about 272nm .The study has shown that amoxicillin trihydrate obtained from several suppliers differed in particle size distribution (from less than 45μm to 1mm), The results have shown that the dissolution rates of amoxicillin trihydrate increased as the particle size decreased for particles of sizes more than or equal to 63m and decreased as the particle size decreased for particles of sizes less than 63m. The results have also shown that the dissolution rate of amoxicillin trihydrate in creasedas the length of the raw material needle crystal increased from 2.2m to 8.5m.To improve the dissolution rates of amoxicillin trihydrate , it was recrystallized from aqueous solutions at different pH values (pH= 2, 4, 7, 9 and 11). Amoxicillin trihydrate samples recrystallized from aqueous solutions with pH values (pH=7, 9, 11) appear to have superior physicochemical properties to the original amoxicillin trihydrate samples in purity, crystal length and dissolution rate .The results have also shown that amoxicillin trihydrate samples recrystallized at pH value (pH=11)appear to have superior mechanical properties and very bad powder flowability compared to other samples. The results confirmed the importance role of amoxicillin trihydrate solution (2mg/ml) pH on the length of the crystals and it's solubility. The pH of crystallization medium had a significant effect on the physicochemical properties of amoxicillin trihydrate powder which contain dissolution rate, crystal length, melting point, purity, flowability of the powder and the pH value of the resulting raw material solutions .The crystallization technique can change the crystal habit form and particle size. The nature and extent of these changes depend on the crystallization conditions such as type of crystallization medium and the pH of crystallization. Crystallization of amoxicillin trihydrate, like the other crystalline drugs, plays a critical role in controlling the crystal form, shape, size, and size distribution. Different solid forms of the same chemical compound can exhibit different physical and chemical properties including different solubility and dissolution profiles, which in turn affect the bioavailability and stability of the drug substance. The influence of particle size and crystal shape on near infrared (NIR) spectra has been used to develop effective alternative methods to traditional ones in order to determine these parameters. In this work, we used the chemometrical technique principal component analysis (PCA) which contains Cluster calibrations (CLU) to simultaneously predict several variables to the rapid construction of particle size distribution and crystal shape calibrations .Samples obtained from eight suppliers were passed through eight sieves of different sieve opening in order to separate several size fractions that were used to construct particle size distribution curves. The samples were recorded by NIR and their spectra were used with CLU to develop calibration models. Amoxicillin trihydrate samples obtained from three suppliers and recrystallized at five pH values were used to construct types of crystal length curves. The samples were recorded by NIR and their spectra were used with CLU to develop calibration models. The correlation coefficients and Root Mean Square Error of Cross Validation (RMSECV) have been used to assess the goodness or fit of the results. Prediction of a validation set with particle sizes at different eight ranges (n=2304) in the calibration set yielded an root mean square error of cross validation (RMSEP) of 1.414%. prediction of avalidation set with crystal lengths crystallized at five different pH values (n=480) in the calibration set yielded a RMSEP of0.0351%. Performance of the models were influenced by several physical and chemical properties which could be reduced by spectral pre-processing .The Standard Normal Variate (SNV)transformation with 1stderivative were used to remove slope variations between spectra by mean centering each spectrum and normalizing the standard deviation of the absorbance to one. The calibration models studies provided statistically acceptable results based on RMSECV values. Therefore, the combined use of NIR spectroscopy and calibration models allow determining the particle size distributions and crystal length differentiations. Near-infrared(NIR) spectroscopy is one of the techniques found to be suitable for a variety of PAT(Process Analytical Technology) applications, and is subject of many studies in the pharmaceutical and nutritional field. Major advantages of NIR spectroscopy are its non-destructive nature, its immediate (real time) delivery of results and simple sample preparation

إشراف وإعداد

الإشراف

علي الرغبان, مصطفي فواز شحنة

الإعداد

ليانا شحط

الاقتباسات الببليوغرافية