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Study on Ketoprofen Orally Delayed Release System

Author: PanXin
Tutor: RenZuo
School: Shanghai Institute of Pharmaceutical Industry
Course: Pharmacy
Keywords: Ketoprofen Timed release Delay time Fluidized bed Film coating
CLC: R943
Type: Master's thesis
Year: 2005
Downloads: 291
Quote: 1
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Abstract


Timed-release oral formulation is a novel drug delivery systems developed in recent years. After a specific delay, rapid release of the drug, in order to achieve the optimal treatment. Ketoprofen mainly used for clinical treatment of rheumatoid arthritis. In this paper, ketoprofen as a model drug, the application of film coating technology, were prepared by a timed-release tablets and timed-release pellets to meet the clinical medication needs. UV spectrophotometry as ketoprofen vitro analysis, including drug release assay and the study of the physical and chemical properties. The solubility results show that the apparent solubility of ketoprofen in water and pH6.8 phosphate buffer solution were O.2mg/mL and 5.7mg/mL. Order to facilitate the film Prescription casting prepared free membrane of different prescriptions of ethyl cellulose. By measuring and calculating the tensile strength, Young's modulus and Shenshi coefficient, different membrane prescription to predict the impact on the drug release and formulation stability. Prepared ketoprofen timed-release tablets, its oral and in the evening times rapidly in the early morning release of the drug. The sodium carboxymethyl starch is selected as the material of the tablet cores disintegrating. Ethyl cellulose (EC) is not soluble in water, and the solubility without influence of the change of pH, was used as a preparation outer coating. According to the experimental results of the free film, triethyl citrate (TEC) as a plasticizer. On the the composition fully clothed layer thickness of the coating prescription drug release were investigated. Application of central composite design arrangement experimental release Delay (T 1 0%), and the release rate (T 1 0-90%, T 1 < / sub> 0-90% smaller, the greater the release rate) as an indicator of the filter coating prescription. The results showed that the amount of EC and TEC of T 1 0% impact than significant. Through the control of the EC amount, i.e. the thickness of the outer layer film, which can effectively control the release Delay. According to the stepwise regression fitting equation to determine the EC an amount of 5%, and TEC is part of the membrane the amount of LO%, the actual measured T is 1 0% = 5.6h T 10-90 % = 0.72h, the fitting equation predicted deviation of less than 8%. Design prepared by the laboratory with bottom spray fluidized bed for ketoprofen timed-release pellets on drug and coating. Fluidized bed process factors and performance were investigated, and the results show that the device is suitable for on drug and coating. The pulse pellets by a five-layer structure composed of, from the inside, respectively pill core, a drug layer, a swelling layer, the blocking layer and a water-insoluble release layer. Factors affecting drug Delays and release rate were studied, such as the structure of the inner and outer layer thickness, the amount of plasticizer and porogen. The results showed that the swelling layer is still plays an important role, mainly by its outer layer and bursting release the drug. Within a certain range, increasing the outer EC film dosage amount of the blocking layer and a plasticizer, can prolong the amount of time delay, and to increase the amount of porogen used to early release of the drug. Ultimately, the

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