Preparation and Evaluation of Mosapride Citrate Dual-Release Dry Suspension View Full Text


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Article Info

DATE

2019-05

AUTHORS

Kuntang Liu, Zhengjie Meng, Yang Li, Jiwei Liu, Yan Xu, Yonglu Wang, Xueming Li

ABSTRACT

In this paper, a novel formulation of dual-release dry suspension of mosapride citrate (DRDS-MC) was designed which can be quickly released in the stomach while having sustained-release effect. Co-grinding mixture of mosapride citrate (MC) together with L-HPC as hydrophilic excipient was prepared in order to improve the solubility of MC. The co-grinding mixture was characterized by solubility studies, DSC, X-RD, SEM, FTIR, and size distribution before the preparation of the DRDS-MC. Then, the co-grinding mixture was used to prepare DRDS-MC via wet granulation method. The evaluation of DRDS-MC was focused on physicochemical properties, intestinal absorption, and pharmacokinetics. The results of DSC, X-RD, SEM, FTIR, and size distribution indicated that MC resides in co-grinding mixture with no crystalline changes, hydrogen bonds made L-HPC greatly improving the solubility of MC. Then, the dissolution of DRDS-MC reached 70% in pH 1.2 within 2 h, and the 12-h dissolution of MC in pH 6.8 was nearly 80%. The sedimentation volume after 3 h was 0.94 and redispersibility was good. The linear regression equation between in vitro release of DRDS-MC and intestinal absorption fraction in rats was: Y = 29.215 + 47.535*X (r = 0.952). At last, pharmacokinetic studies in beagle dogs demonstrated that DRDS-MC has prolonged effect compared with commercial formulation Gasmotin as a reference. All results indicated that the DRDS-MC could be quickly released in the stomach while having sustained-release effect. More... »

PAGES

155

Identifiers

URI

http://scigraph.springernature.com/pub.10.1208/s12249-019-1343-x

DOI

http://dx.doi.org/10.1208/s12249-019-1343-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1113056211

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30924008


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