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Volume 17, Issue 2
  • ISSN: 2666-1454
  • E-ISSN: 2666-1462

Abstract

Background

The primary intent of the study is to formulate the inclusion complex of lisinopril with the varied compositions of polymers like β-cyclodextrin for the enhancement of oral drug solubility and bioavailability using QbD approach.

Methods

The application of Box-behnken design to determine the optimized run from the prepared inclusion complexes. The physical kneading technique with β-cyclodextrin at varied amounts was used to create the inclusion complex of lisinopril.

Results

The FT-IR analysis study confirmed the selected drug, polymers, and other excipients showed no physical interactions. The prepared inclusion complexes' particle sizes and encapsulation efficiency were between 802 to 3259µm, 19.22 to 93.28%. The optimized formulation batch (F5) showed 90.16% drug release at 24h compared to the pure drug. From the study, the pharmacokinetic parameters for the optimized formulation (F5) were found to be C of 94.336 ng/ml, T of 12h, and AUC 94.336 ng.h/ml, K of 0.0395h-1 and t of 12h. After three months, stability studies for the optimized formulation batch indicate no change in drug entrapment efficiency and other parameters.

Conclusion

The β-cyclodextrin inclusion complex of lisinopril exhibited a 2-fold increase in the oral bioavailability of the model drug, which will be the novel drug-delivery strategy for the treatment of hypertension.

© 2024 Bentham Science Publishers
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2024-06-01
2024-11-26

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/content/journals/cms/10.2174/2666145416666230407100318
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Quality by Design Enabled β-Cyclodextrin Complexes of Lisinopril by Kneading Method: Improved Solubility and Bioavailability
Current Materials Science 17, 135 (2024); https://doi.org/10.2174/2666145416666230407100318
/content/journals/cms/10.2174/2666145416666230407100318
/content/journals/cms/10.2174/2666145416666230407100318
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  • Article Type:     Research Article
Keyword(s): bioavailability; box-behnken design; in vitro drug release; kneading method; short term stability; solubility; β-cyclodextrin

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