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Studies on Fexofenadine Hydrochlorid Sustained-Release Tablets

Author: MaLei
Tutor: HeZhongGui
School: Shenyang Pharmaceutical University
Course: Pharmacy
Keywords: Hydrochloric fexofenadine Hydrophilic gel matrix tablets Pharmacokinetics HPMC HPLC
CLC: R944
Type: Master's thesis
Year: 2005
Downloads: 45
Quote: 0
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Abstract


Hydrochloride Fexofenadine (fexofenadine hydrochloride, hereinafter referred FXD) is terfenadine that given the active metabolite in the human body, to histamine H 1 receptor antagonists, non-anticholinergic or α < sub> 1 - adrenoceptor blocking action. The third-generation antihistamines are no sedation for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Maintain effective blood concentration in order to improve the quality of life of patients, for a long time, this paper, hydroxypropyl methyl cellulose (HPMC) as the basic skeleton material, combined with other accessories, prepared once served on the hydrochloric fexofenadine The sustained-release tablets. Using different methods of in vivo and its scientific evaluation. First preformulation studies:, FXD almost insoluble at physiological pH conditions; using non-aqueous titration as a method for the determination of FXD; related substances and the establishment of a High Performance Liquid Chromatography FXD FXD bulk drugs. After the stability test in accordance with the relevant provisions of the 2005 edition of the Chinese Pharmacopoeia Appendix Ⅺ Ⅹ C FXD bulk drugs. The FXD bulk drugs influencing factors test results show that the FXD light, temperature, oxygen and humidity are relatively stable, and no significant change in content and related substances. The FXD the bulk drugs long-term 24 month and in June accelerated test results show that there is no obvious change in the content and related substances. Good seen FXD stability. HPMC is widely used a hydrophilic matrix material, the paper select HPMC as a sustained-release tablets of the skeleton material, reference to similar products, prepared 24 hours in vitro release hydrochloride sustained-release tablets fexofenadine. After a single factor, gradually determine optimal prescription, and the establishment of a high-performance liquid chromatography given fexofenadine homemade hydrochloride sustained release tablets release provides a reliable method for the determination of its quality control;, and drugs release of factors were investigated; preliminary quality assessment given sustained-release tablets fexofenadine of homemade three batches of hydrochloric acid. FXD case of water-insoluble drugs, and discuss the results of its drug release mechanism: sustained release tablets in HPMC skeleton material, hydrochloric fexofenadine sustained-release tablets of the drug release process can be summarized as follows: In the drug release in drug delivery, pre-diffusion and dissolution mechanism of synergy release; late, mainly based on the dissolution mechanism of drug release. The preparation is non-pH-dependent formulation. Sustained-release tablets, a comprehensive stability study results show that the stable: light, temperature and humidity of the preparation, content and release after hydrochloride fexofenadine given according to the relevant provisions of the 2005 edition of the Chinese Pharmacopoeia Appendix Ⅺ Ⅹ C no significant change under the conditions of high humidity RH92.5% moisture situation is more serious appearance, content and release, under the conditions of high humidity RH75%, no significant change; accelerated based on the six-month trial and twelve months long-term retention samples test results can be expected hydrochloric fexofenadine given validity period of up to two years of sustained-release tablets. Established UV-performance liquid chromatography method for the determination of plasma FXD. Homemade hydrochloric fexofenadine tablets for control, hydrochloric acid was investigated fexofenadine pharmacokinetics of sustained-release tablets in Beagle dogs, and homemade hydrochloric acid relative bioavailability of fexofenadine Sustained Release Tablets degree studies. Compartment model applying the classical theory and statistical moments non-compartment kinetic theory: feedback FXD plasma concentration - time relationship, and the pharmacokinetic parameters. The pharmacokinetic parameters calculated results show that, FXD ordinary film with sustained release tablets the T max were 2.6 ± 0.2h, 13.5 ± 0.5 h; C max , respectively for 977.4 ± 19.8 ng · mL -1 , 662.1 ± 28.4 ng · mL -1 ; AUC (0-t) 4841.9 ± 485.5 ng · h · mL -1 , 5178.9 ± 146.0 ng · h · mL -1 ; relative bioavailability of 107.0%.

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