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Study on the Preparation of Double Pulse Control Release Pellet of Zolpidem Tatrate

Author: XieQiAng
Tutor: HuFuQiang;YuanHong
School: Zhejiang University
Course: Pharmacy
Keywords: Pharmacy Pulse preparations Zolpidem tartrate Extrusion spheronization Fluidized bed technology Average slope method
CLC: R944
Type: Master's thesis
Year: 2010
Downloads: 197
Quote: 1
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Abstract


Insomnia is a common physiological, psychological disorders, chronic insomnia can affect people's normal life and work, and even cause a serious accident. Years of clinical use of proven, zolpidem tartrate sleeping pills as a drug of choice, but commercially available ordinary preparations and hysteresis preparations of sleep time exists to maintain enough; poor efficacy in patients in the middle of the night awakening, and there are residual effects, hinder the further clinical application. As the hour of pharmacology and pharmaceutics research progress, a new generation of drug delivery systems (pulse preparations), pulse preparations appear to achieve certain the rhythmic characteristics diseases timely and appropriate administration, according to the insomnia patients sleep difficult, midnight easy awakening disease characteristics and physiological characteristics of the development of the human sleep the zolpidem pulse preparations will undoubtedly have broad application prospects. On the basis of comprehensive analysis of insomnia, insomnia drugs, pulse preparation research progress, a low dose tartrate zolpidem Tanzania double pulse research and development of controlled-release pellets by the blasting of the controlled-release coating carrier pills core loaded drug-containing layer to achieve the double pulse of drug release, the first pulse release to help patients with insomnia fall asleep quickly, to solve the problem of the middle of the night awakening with the second pulse release, there is a reasonable release interval between two pulse release ( The lag time), so that the drug release only when needed, thereby reducing the preparations total dose, relieve residual effect, expect to provide better targeted treatment options for patients with insomnia. Through comprehensive analysis and evaluation of the conventional Pill in Pellets way, we choose the joint use of extrusion-spheronization and fluid bed process route. The topics developed content including prescription extrusion spheronization preparation blasting upload pills core: ① uniform design method, screening process; ② washed with fluidized bed technology is the core of the carrier pills smooth processing (hypromellose Pharmacoat 606 lactose ), the controlled release layer coating (ethylcellulose aqueous dispersion of Surelease ?), the drug-containing layer is loaded, the operation of the film coating (Pharmacoat 606); ③ three batches repetitive experiments to verify the screening optimized prescription process in Beagle dogs pharmacokinetic performance, inspect preparations pharmacokinetic characteristics; ④ observed sample; ⑤ zolpidem tartrate double pulse release pellets in vitro evaluation system; ⑥ traditional graphical method based on the development of average slope method, in order to more accurately describe the release characteristics of the pulse preparation, and the application of this method in the study of this subject was discussed; ⑦ establish sub-step sampling method to achieve the targeted pulse preparations release process intensive sampling . The results of this study show that 50% of the amount of cross-linked sodium carboxymethyl cellulose is the most suitable blasting the type carriers pills core disintegrant; smooth processing of the pill core weight gain of 6.00%, the controlled release layer coating weight 22.00% , film coating weight gain of 2.00%, prepared by the double pulse pellets released from the effect of pH, the first pulse dose of approximately completely released within 30min lag time of about 150min, a second pulse dose is about the lag time release completely after 45min; optimized formulation and process reproducibility; the double pulse Pellets in Beagle dogs have good double pulse release characteristics in vivo correlation and better than ordinary preparations bioavailability, the pharmacokinetic administered at intervals and pharmacokinetic characteristics of two similar; vitro evaluation of the system can be fully developed reaction prescription process adjustment process of change in the preparation process. All in all, the subject of the research and development zolpidem tartrate double pulse release pellets prescription process is stable and reliable, with good reproducibility, product quality and stability, in the beagle dog vivo good double pulse release characteristics to develop in vitro evaluation system reaction of the quality of the preparation can realistically; has to develop into a clinical application, give patients more personalized and targeted administration of the value of the new formulation of zolpidem; proposed average slope method and step-by-step sampling method, for the development of the preparation of the other pulses, to provide a new reference.

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