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Study of Dissolution Test on Progress Analysis for Three Antibiosis Drug Preparation

Author: YangShuMei
Tutor: ChenJian
School: Xinjiang Medical University
Course: Pharmacology
Keywords: Fibre drug dissolution apparatus Drug dissolution Process analysis Immediate release formulation
CLC: R927.2
Type: Master's thesis
Year: 2009
Downloads: 42
Quote: 0
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Abstract


Objective: the rate and extent of drug dissolution means a drug from a solid preparation such as tablets or capsules, or semi-solid formulation in a predetermined solvent eluted. Since the dissolution test was to evaluate the quality of the preparation and efficacy, as well as an important indicator of safe and effective medication. Drug dissolution testing instruments and measurement methods by hand sampling and analysis of the progressive development of robotic sampling or peristaltic pump sampling and analysis. But for the immediate release formulation due to its release speed, manual sampling or online sampling offline analysis are unable to monitor the real process of drug release, become the bottleneck of restricting the prescription process evaluation of the immediate release formulation. The establishment of the immediate release formulation the dissolution of FODT method to be urgent and important task. Methods: This topic Professor Chen Jian Task Force research and development of multi-channel fiber drug dissolution process analyzer (Fiber-Optic Drug Dissolution Test, FODT) amoxicillin tablet, cefixime dispersible tablets, cephalexin particles immediate release formulation antimicrobial fiber drug dissolution process analysis. For the excipients interfere with the measurement results, using a dual-wavelength method or K-ratio method to eliminate it. Methodology to examine include: day precision, the recovery rate, the Chinese Pharmacopoeia law or the United States Pharmacopoeia and FODT Act dissolution parameters comparison. And six manufacturers of the FODT visits cefixime dispersible tablets dissolution behavior. Results: 1) the establishment of a dual-wavelength dispersible tablets 法阿莫西林 and the cephalexin particles dissolution process monitoring method. Dissolution parameters of FODT measured and cumulative dissolution rate with Ch.P method or USP method was not statistically significant. 2) K-ratio method cefixime dispersible tablets dissolution process monitoring. The dissolution parameters FODT measured and cumulative the dissolution rate Ch.P method was not statistically significant 3) FODT. Investigated six different manufacturers cefixime dispersible tablets dissolution behavior. Found that the dissolution behavior of different manufacturers cefixime quite different. Even if the same product manufacturers dissolution behavior is also quite different. Description of the products of these manufacturers preparation process needs to be improved. The conclusion: FODT process monitoring of drug dissolution eliminating the need for a human to take liquid, fluid, filtration, dilution measured, calculated a series of steps, significant savings in labor intensity, to avoid human error and improve the precision and accuracy of the measured . Process analysis to increase the amount of information of great significance for the rapid release of the drug dissolution determination, but also provides a good method for the investigation of drug preparation process.

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CLC: > Medicine, health > Pharmacy > Pharmacopoeia Codex ( formulary ),drug identification > Drug identification > Determination of drug content
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