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| Research article summary (published 30 Mar 2009): |
Development of monolithic osmotic pump tablet system for isosorbide-5-mononitrate delivery and evaluation of it in vitro and in vivo.
Full Abstract
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.
Author information
Author/s: Duan, Xueyan (X); Liu, Qingfei (Q); Zhang, Yu (Y); Bi, Kaishun (K); Chen, Xi (X); Wang, Yiming (Y); Luo, Guoan (G);
Affiliation: Department of Pharmaceutics, Shenyang Pharmaceutical University, Shenyang, Liaoning, People's Republic of China.
Journal and publication information
Publication Type: Comparative Study; In Vitro; Journal Article; Research Support, Non-U.S. Gov't
Journal: Drug development and industrial pharmacy (Drug Dev Ind Pharm), published in United States. (Language: eng)
Reference: 2009-Apr; vol 35 (issue 4) : pp 499-507
Dates: Created 2009/03/16; Completed 2009/05/25;
PMID: 18979308, status: MEDLINE (last retrieved date: 5/25/2009)
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
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Associated Chemicals: Delayed-Action Preparations (0) ; Tablets (0) ; Vasodilator Agents (0) ; isosorbide-5-mononitrate (16051-77-7) ; Isosorbide Dinitrate (87-33-2)Related articles
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