Formulation and development of florfenicol and flunixin meglumine injectable solution

العناوين الأخرى

تحضير و تطوير تركيبة محلول دوائي للحقن مكون من الفلورفنيكول و الفلونكسين مغلومين

مقدم أطروحة جامعية

Batrawi, Nidal

مشرف أطروحة جامعية

Shtaya, Hani

أعضاء اللجنة

Qurt, Moamal
al-Rimawi, Fuad

الجامعة

جامعة بيرزيت

الكلية

كلية الصيدلة و التمريض و المهن الصحية

دولة الجامعة

فلسطين (الضفة الغربية)

الدرجة العلمية

ماجستير

تاريخ الدرجة العلمية

2017

الملخص الإنجليزي

The combination Florfenicol and Flunixin meglumine injectable solution (Flr&Flx) is an effective antimicrobial and non-steroidal anti-inflammatory for veterinary use.

A stable and high quality injectable solution of Flr and Flx in a mixture of excipients was developed, by performing various experimental studies of pre-formulation and formulation.

Achieving that was not easy, as the great variation in the nature and behavior of the active substances in solubility and stability was a real challenge during this stage.

Organic solvents and co-solvents were used to overcome the problem of variation in solubility of the active substances; a 1% citric acid was used in the formulation to solve the problem of Flx instability.

A 20% ethyl alcohol was incorporated in the formula to enhance syringeability and injectability of the solution by decreasing its viscosity.

It was very important during the formulation stage to carry out some tests, such as assay test, to evaluate the formulation; therefore, developing an analytical method for the quantitative determination of the active pharmaceutical ingredient was required, by which the decision is made to evaluate the developed formulation and its critical quality characteristics and to evaluate the drug product stability.

Developing an analytical method was another challenge, because of the difficulty of obtaining a method of simultaneous quantitative analysis of two components of different solubility and polarity.

For that series of trials were performed, by using different RP-HPLC chromatographic conditions.

Chromatographic parameters of Flr and Flx peaks were optimized, and the second challenge has been overcome where a novel, valid stability-indicating HPLC method for the simultaneous determination of florfenicol and flunixin in their combined pharmaceutical dosage form, was successfully obtained.

Not only that, but also the analytical validation study has been published as a novel scientific research in reputed scientific journal “Journal of Analytical Methods in Chemistry”, with an impact factor of 1.8, the paper can be easily accessed at the link (https://doi.org/10.1155/2017/1529280).

This is a strong indication of the quality and the strength of the research and the thesis generally.

An accelerated stability study was performed as a final stage of this product development, the study was conducted as a fast prediction, in short time of tests, and approved that the drug product is able to maintain its quality attributes during shelf-life and storage conditions.

All these studies were performed in accordance with the international regulations of pharmaceutical industry, such as International Conference on Harmonization (ICH), the United States Food and Drug Administration (USFDA), and the official compendia, such as the British Pharmacopeia (BP), the United States Pharmacopeia (USP).

During the product development stage, beginning of pre-formulation till obtaining the final drug product, the concept of quality by design (QbD) was considered, and building the quality in the product was focused on.

That was achieved by the identification and the knowledge of the critical process parameters (CPPs) and the finished product quality attributes (CQAs), and assuring product quality and stability using a reliable analytical method.

التخصصات الرئيسية

علم الصيدلة

عدد الصفحات

111

قائمة المحتويات

• APA
• MLA
• AMA

لغة النص

الإنجليزية

نوع البيانات

رسائل جامعية

رقم السجل

BIM-780683