Screening of process variables to enhance the solubility of famotidine with 2-HydroxyPropyl–β-Cyclodextrin & PVP K-30 by using Plackett–Burman design approach

Verma, U and Naik, J B and Patil, J S and Yadava, S K (2017) Screening of process variables to enhance the solubility of famotidine with 2-HydroxyPropyl–β-Cyclodextrin & PVP K-30 by using Plackett–Burman design approach. Materials Science and Engineering: C, 77. pp. 282-292. ISSN 0928-4931

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Abstract

In the present work, inclusion complex of famotidine (FMT) was prepared with (2-HydroxyPropyl)–β-Cyclodextrin (HP-β-CyD) and polyvinylpyrrolidone K-30 (PVP K-30) by spray drying technique to enhance the solubility of famotidine. FMT is a potent histamine H2-receptor antagonist having low solubility as well as oral bioavailability. In order to enhance the solubility of FMT, a quality by design (QbD) approach has been used by employing Plackett–Burman design (PBD). With the application of PBD, seven independent process variables were investigated and optimized for maximum solubility. The developed inclusion complex was characterized for solubility, encapsulation efficiency, FTIR, FESEM, XRD. In-vitro drug release study was also performed by preparing fast dissolving tablets of inclusion complex. Solubility of FMT in prepared complex was found 38 fold higher than pure FMT while %EE was found 92.10%. Statistical analysis of the data (ANOVA) indicates an adequate model fitting predicting the effect of process parameters affecting the solubility. In conclusion, spray dried inclusion complex can effectively increases the solubility as well as dissolution rate of the FMT and other active pharmaceutical ingredients in combination of the fast dissolving tablets.

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IITH Creators:
IITH CreatorsORCiD
Item Type: Article
Additional Information: We would like to gratefully acknowledge Lupin Ltd., Pune, (India) and Nanhang Industrial, P.R. China for providing a gift sample of Famotidine and PVP K-30, respectively.
Uncontrolled Keywords: Famotidine; Solubility; Plackett–Burman design; Inclusion complex; Spray drying
Subjects: Biomedical Engineering
Divisions: Department of Biomedical Engineering
Depositing User: Team Library
Date Deposited: 17 Apr 2017 09:43
Last Modified: 20 Jun 2017 11:32
URI: http://raiithold.iith.ac.in/id/eprint/3168
Publisher URL: http://doi.org/10.1016/j.msec.2017.03.238
OA policy: http://www.sherpa.ac.uk/romeo/issn/0928-4931/
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