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Published on:August 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(3s):s213-s224
Original Article | doi:10.5530/ijper.53.3s.90

Systematic Development with Quality by Design Approach of Effervescent Floating Multiple Unit Minitablets of Metoprolol Succinate using Hydrophobic Grade of Gelucire


Authors and affiliation (s):

Santosh Kumar Panda1,*, Manoranjan Sahu1, Kahnu Charan Panigrahi2, Chinam Niranjan Patra2

1School of Pharmaceutical Education and Research, Berhampur University, Odisha, INDIA.

2Roland Institute of Pharmaceutical Sciences, BPUT, Odisha, INDIA.

Abstract:

Objective: The objective of this study was to systematically develop with Quality by Design (QbD) approach of Effervescent Floating Multiple unit Minitablets (EFMM) of metoprolol succinate (MS) for once-a-day dosing using hydrophobic grade of gelucire in order to increase gastric residence time. Methods: Risk assessment using Failure Mode Effect Analysis (FMEA) was conducted and further screened using taguchi design. A Box-Behnken Design (BBD) was adopted for the process of optimization. The dissolution profile of optimised formulation was compared with the marketed formulation. Drug compatibility study and stability study were also conducted. Results: After conducting risk assessment and screening amount of gelucire 43/01(G 43/01), HPMC K15 M (HM) and NaHCO3 (SB) were found to be as significant factor. The process of optimisation results the single dose of EFMM MS consisting of 125 mg of G 43/01, 72 mg of HM and 28 mg of SB which shows an average of Floating Lag Time (FLT) within 3 min, Floating Time (FT) of 19 hr 36 min, time to release 50% of drug (t50) of 6 hr 38 min and time to release 90% of drug (t90) of 19 hr 12 min. The optimised formulation found to have better dissolution profile as compared to the marketed formulation. The stability study revealed no significant change in various parameters before and after storage. Conclusion: It can be concluded that an optimum combination of various excipient can be used to increase the gastric residence time, sustaining the drug release and ultimately achieve the desired objective of once-a-day dosing of MS.

Key words: Risk assessment, Failure mode effect analysis, Taguchi design, Box-Behnken design, Stability study.

 

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IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the 2019 Release of Journal Citation Reports (source: 2018 Web of Science Data).

 

Impact Factor® as reported in the 2018 Journal Citation Reports® (Clarivate Analytics, 2019): 0.425

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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