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Studies on the Sustained-Release Dosage Forms of Bupropion Hydrochloride

Author: WangZhenHong
Tutor: PanWeiSan
School: Shenyang Pharmaceutical University
Course: Pharmacy
Keywords: Hydrochloride bupropion Sustained Release Tablets Liquid sustained release suspension Pharmacokinetics
CLC: R94
Type: Master's thesis
Year: 2008
Downloads: 69
Quote: 0
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Abstract


Hydrochloride Ann-ketone (Bupropion Hydrochloride) as a model drug, a study prepared by hydrochloric Ann bupropion sustained-release tablets, liquid sustained release suspensions. Hydrochloric Ann bupropion sustained-release tablets and liquid sustained release suspension beagle dogs in vivo pharmacokinetic studies. First, hydrochloric acid-prescription bupropion Matrics Sustained Release Tablets. This selection of hydroxypropyl methyl cellulose (HPMC), citric acid, and other accessories, from the formulation factors and process factors examined in detail the effects of various factors hydrochloride Ann non bupropion sustained-release tablets release behavior, the results show that: HPMC the type and amount of porogen release rate, and other factors on the release of the tablet, the single factor based on orthogonal experimental design to optimize the prescription, prepared hydrochloric Ann non bupropion sustained release tablets. Homemade Sustained Release Tablets quality factors study results show that the uniformity of its release, process reproducibility. Second hydrochloride bupropion drug resin liquid sustained release oral suspension prescription. Release oral suspensions are sustained release preparation of a novel liquid, composed of two parts by the sustained-release fine particles and suspension medium, as a multi-unit drug delivery system, has a smooth release, gastric emptying effect, easy sub-doses and other advantages. In this paper, polystyrene sulfonate ion exchange resin as the carrier bupropion hydrochloride security as a model drug, the drug-resin complexes were prepared and hydrochloride Bupropion sustained release microspheres of ketone drug resin coating prepared by emulsion solvent capsule, through the study of the key factors (such as resin particle size, temperature, concentration, etc.), drug resin exchange reaction rate and exchange reaction equilibrium investigated under different conditions. Finally, as a control, a commercially available conventional tablets hydrochloride Ann bupropion sustained-release tablets and liquid sustained release suspension beagle dogs in vivo pharmacokinetic studies. A three-period crossover study, six healthy beagle dogs in vivo plasma concentration were measured by high-performance liquid chromatography. Experimental results show that: the homemade hydrochloride bupropion sustained-release tablets, liquid sustained release suspension and hydrochloric acid-bupropion ordinary piece AUC 0 - ∞ were (994.46 ± 140.99), (949.76 ± 137.16) and (898.22 ± 63.02) ng · h · mL -1 ; the T max , respectively (3.50 ± 0.55), (4.00 ± 0.63) and (1.67 ± 0.26) h; C max , respectively (106.61 ± 21.31), (92.00 ± 5.59) and (367.89 ± 68.43) ng · mL -1 ; t the 1 / 2 , respectively (7.96 ± 1.16), (9.06 ± 2.09) and (4.00 ± 0.64) h, the relative bioavailability of 110.7% and 105.7%. The bioequivalence analysis showed that two homemade preparations and conventional tablets are bioequivalent; vivo correlation judged good that two homemade preparations in vitro and in vivo correlation (r = 0.9827,0.9714).

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