Quality by design approach for optimization of repaglinide buccal tablets using Box-Behnken Design

2018 ◽  
Vol 4 (2) ◽  
pp. 265-272 ◽  
Author(s):  
Raja Navamanisubramanian ◽  
Raghunandan Nerella ◽  
Chamundeeswari Duraipandian ◽  
Shanmuganathan Seetharaman
2021 ◽  
Vol 13 (3) ◽  
pp. 935-950
Author(s):  
R. Kayesh ◽  
M. R. H. Bhuiya ◽  
M. F. Islam ◽  
J. A. Chowdhury

Quality-by-design approach (QbD) was applied to develop an orally disintegrating tablet (ODT) formulation of aspirin and glycine. At first, the target quality profile and critical quality attributes (CQAs) of the product were identified. Risk assessment was accomplished by failure mode and effects analysis (FMEA) method to assess the factors having a significant effect on CQAs like disintegration time (DT), friability and assay of aspirin and glycine. Low substituted hydroxypropyl cellulose (L-HPC), croscarmellose sodium (CCS) and punch-diameter were found critical for DT and friability. The box-Behnken design was applied to optimize those 3 factors to reach a target DT of ≤ 30 sec. It was found that a punch-diameter between 8.7 ~ 9.3 mm, CCS in a range of 4 % ~ 5 %, and L-HPC in a range of 2 % ~ 8 % produced the best oral disintegrating property and reduced the risk. In summary, this work represented an excellent example of the application of QbD approach in ODT formulation development.


2021 ◽  
Vol 347 ◽  
pp. 129051
Author(s):  
Federica Bianchi ◽  
Fabio Fornari ◽  
Nicolò Riboni ◽  
Costanza Spadini ◽  
Clotilde Silvia Cabassi ◽  
...  

Author(s):  
Francesca Bettazzi ◽  
Serena Orlandini ◽  
Luna Zhang ◽  
Serena Laschi ◽  
Mari Mæland Nilsen ◽  
...  

2011 ◽  
Vol 17 (4) ◽  
pp. 389-397 ◽  
Author(s):  
Arnaud Baldinger ◽  
Lucas Clerdent ◽  
Jukka Rantanen ◽  
Mingshi Yang ◽  
Holger Grohganz

2021 ◽  
Vol 11 ◽  
Author(s):  
Santosh Kumar Panda ◽  
Manoranjan Sahu ◽  
Kahnu Charan Panigrahi ◽  
Chinam Niranjan Patra ◽  
Goutam Kumar Jena

Background: In order to achieve steady state concentration multiple dosing is required for bosentan. Hence formulating bosentan controlled release formulation could be an approach to solve this issue. Objective: The objective is to develop floating multiple unit minitablets of bosentan using Quality by design approach. Methods: : Failure mode effect analysis (FMEA) and taguchi design employed in order to screen highly critical factor. Box-Behnken design (BBD) was adopted for the process of optimization. Results: : Amount of gelucire 39/01, HPMC K15 M and sodium bicarbonate were screened as significant factor using Taguchi design. The Box-Behnken design results the optimised formulation showing floating lag time within 3 min, floating time of nearly 15 h, time to release 50% of drug of 3.6 h and time to release 90% of drug of 11h and better bioavailability compared to pure drug. Conclusion: : It can be concluded that floating multiple unit minitablet can be used as an encouraging approach for sustaining the drug release of bosentan.


2014 ◽  
Vol 15 (5) ◽  
pp. 1093-1104 ◽  
Author(s):  
Parind Mahendrakumar Desai ◽  
Patrick Xuan Hua Er ◽  
Celine Valeria Liew ◽  
Paul Wan Sia Heng

2021 ◽  
Vol 11 (3) ◽  
pp. 288-295
Author(s):  
Hasan Pasha Nazeer Ahmed Sholapur ◽  
Fatima Sanjeri Dasankoppa ◽  
Mudlapur Channabasavaraja ◽  
Revati Dharampal Sagare ◽  
Zaheer Abbas ◽  
...  

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