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	Development of Monolithic Osmotic Pump Tablet System for Isosorbide-5-Mononitrate Delivery and Evaluation of it In Vitro and In Vivo
	Duan, Xueyan ; Liu, Qingfei ; Zhang, Yu ; Bi, Kaishun ; Chen, Xi ; Wang, Yiming ; Luo, Guoan
	2010-10-12 ; 2010-10-12
关键词	isosorbide-5-mononitrate monolithic osmotic tablet system in vitro in vivo in vivo-in vitro correlation STABLE ANGINA-PECTORIS RELEASE ISOSORBIDE-5-MONONITRATE ISOSORBIDE DINITRATE SUSTAINED-RELEASE DOSAGE FORM PHARMACOKINETICS BIOAVAILABILITY FORMULATION DRUG TOLERANCE Chemistry, Medicinal Pharmacology & Pharmacy
中文摘要	The objective of this study is to develop the monolithic osmotic pump tablet system (MOTS) containing isosorbide-5-mononitrate (5-ISMN), and to evaluate its in vitro and in vivo properties. The influences of tablet formulation variables, size and location of the delivery orifice, membrane variables, and pH value of the dissolution medium on 5-ISMN release from MOTS have been investigated. These results demonstrated that the tablet core played an important role in MOTS, and membrane variables could affect the 5-ISMN release rate. The optimal formulation of 5-ISMN MOTS was determined by uniform design. Furthermore, the dog pharmacokinetics and relative bioavailability of the test formulation (5-ISMN MOTS) have been compared with the reference formulation (Imdur: 60 mg/tablet, a sustained release, SR, tablet system) following an oral single dose of 60 mg given to each of six Beagle dogs. The mean drug fraction absorbed by the dog was calculated by the Wagner-Nelson technique. The results showed that drug concentration in plasma could be maintained more stable and longer after the administration of 5-ISMN MOTS compared with the matrix tablets of Imdur, and a level A in vitro-in vivo correlation was observed between the percentage released in vitro and percentage absorbed in vivo. It is concluded that 5-ISMN MOTS is more feasible for a long-acting preparation than 5-ISMN SR tablet system as once-a-day treatment, and it is very simple in preparation, and can release 5-ISMN at the rate of approximately zero order for the combination of hydroxypropylmethyl cellulose as retarder and NaCl as osmogent.
语种	英语 ; 英语
出版者	TAYLOR & FRANCIS INC ; PHILADELPHIA ; 325 CHESTNUT ST, SUITE 800, PHILADELPHIA, PA 19106 USA
内容类型	期刊论文
源URL	[http://hdl.handle.net/123456789/80922]
专题	清华大学
推荐引用方式 GB/T 7714	Duan, Xueyan,Liu, Qingfei,Zhang, Yu,et al. Development of Monolithic Osmotic Pump Tablet System for Isosorbide-5-Mononitrate Delivery and Evaluation of it In Vitro and In Vivo[J],2010, 2010.
APA	Duan, Xueyan.,Liu, Qingfei.,Zhang, Yu.,Bi, Kaishun.,Chen, Xi.,...&Luo, Guoan.(2010).Development of Monolithic Osmotic Pump Tablet System for Isosorbide-5-Mononitrate Delivery and Evaluation of it In Vitro and In Vivo..
MLA	Duan, Xueyan,et al."Development of Monolithic Osmotic Pump Tablet System for Isosorbide-5-Mononitrate Delivery and Evaluation of it In Vitro and In Vivo".(2010).

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