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SHI Qinqing, WANG Jinghua, CHENG Manman, YIN Lifang, QIN Chao. Preparation and in vitro release of ivabradine hydrochloride elementary osmotic pump tablets[J]. Journal of China Pharmaceutical University, 2021, 52(3): 311-317. DOI: 10.11665/j.issn.1000-5048.20210307
Citation: SHI Qinqing, WANG Jinghua, CHENG Manman, YIN Lifang, QIN Chao. Preparation and in vitro release of ivabradine hydrochloride elementary osmotic pump tablets[J]. Journal of China Pharmaceutical University, 2021, 52(3): 311-317. DOI: 10.11665/j.issn.1000-5048.20210307
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Preparation and in vitro release of ivabradine hydrochloride elementary osmotic pump tablets

  • Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China

Funds: This study was supported by the National Natural Science Foundation of China(No.81871477)
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  • Received Date: January 05, 2021
  • Revised Date: May 11, 2021
    Graphical Abstract
    • Abstract
  • In this study, ivabradine hydrochloride (IVB) was prepared as elementary osmotic pump tablets whose administration frequency was reduced to once daily. The dissolution method was developed, and effects on drug release profiles were evaluated by single factor analysis involving suspending agents, osmotic active agents and aging process. Orthogonal test was carried out at 3 levels on 3 factors including the amount of polyoxyethylene (PEO) in the core, polyethylene glycol (PEG) percentage and weight increase of controlled-release film coatings. The final formulation consisted of IVB (16.25 mg), PEO N80 (60 mg), hypromellose E5 (10 mg), lactose (111.75 mg), magnesium stearate (2 mg); and the film coatings consisted of PEG (15%), cellulose acetate (85%), with a weight increase of 7.5%. In vitro drug release behaviors were investigated. Prepared tablets exhibited similar release profiles in different pH dissolution media, with no risk of dose dumping in 40% ethanol solutions. The osmotic pressure differences inside and outside the membrane drove drug release. IVB osmotic pump tablets could reduce the frequency of administration and improve patients'' compliance, thus with better application values.
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    • References (15)
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