scholarly journals Quality-by-Design Approach and Optimization of Risk Factors by Box-Behnken Design in Formulation Development of Aspirin and Glycine Orally Disintegrating Tablet

2021 ◽  
Vol 13 (3) ◽  
pp. 935-950
Author(s):  
R. Kayesh ◽  
M. R. H. Bhuiya ◽  
M. F. Islam ◽  
J. A. Chowdhury
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Formulation Development ◽  
Disintegration Time ◽  
Box Behnken Design ◽  
Orally Disintegrating Tablet ◽  
Quality Profile ◽  
Croscarmellose Sodium ◽  
Quality By Design Approach ◽  
Fmea Method

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.

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
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Box Behnken Design ◽  
Quality By Design Approach ◽  
Buccal Tablets

scholarly journals QUALITY BY DESIGN APPROACH IN FORMULATION DEVELOPMENT AND EVALUATION OF IN SITU OPHTHALMIC GEL OF OLOPATADINE HCL

2019 ◽  
Vol 10 (2) ◽  
pp. 134-142
Author(s):  
Sadhana R Shahi ◽  
Talat Farheen ◽  
Khan Arshiya ◽  
Bhalerao Pravin ◽  
Ade Pavankumar
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Formulation Development ◽  
Quality By Design Approach

Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine

2015 ◽  
Vol 8 (2) ◽  
pp. 2881-2888
Author(s):  
Sudarshan Singh ◽  
S S Shyale ◽  
P Karade
Keyword(s):  
Drug Release ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Disintegration Time ◽  
Orally Disintegrating Tablet ◽  
Drug Content ◽  
Weight Variation ◽  
Wetting Time ◽  
Croscarmellose Sodium

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.

Optimization and Quality by Design Approach for Piroxicam Fast Dissolving Tablet Formulations Using Box-Behnken Design

2020 ◽  
Vol 15 (2) ◽  
pp. 152-165
Author(s):  
Harekrishna Roy ◽  
Sisir Nandi ◽  
Ungarala Pavani ◽  
Uppuluri Lakshmi ◽  
Tamma Saicharan Reddy ◽  
...  
Keyword(s):  
Quality By Design ◽  
Methyl Cellulose ◽  
Statistical Technique ◽  
Quadratic Model ◽  
Contour Plot ◽  
Compression Technique ◽  
Disintegration Time ◽  
Box Behnken Design ◽  
The Impact ◽  
The Relationship

Background: The present study deals with the formulation and optimization of piroxicam fast dissolving tablets and analyzes the impact of an independent variable while selecting the optimized formulation utilizing Quality by Design (QbD) and Box-Behnken Design (BBD). Methods: Seventeen formulations were prepared by direct compression technique by altering the proportion of cross carmellose sodium, spray dried lactose and hydro propyl methyl cellulose (HPMC K4M). The BBD statistical technique was used to optimize formulations and correlate the relationship among all the variables. Also, the powder mixture characteristics and tablet physiochemical properties such as hardness, friability, drug content, Disintegration Time (DT) and dissolution test were determined using 900 ml of 0.1N HCl (pH-1.2) at 37 ± 0.5°C. Results: Significant quadratic model and second order polynomial equations were established using BBD. To find out the relationship between variables and responses, 3D response surface and 2D contour plot was plotted. A perturbation graph was also plotted to identify the deviation of the variables from the mean point. An optimized formula was prepared based on the predicted response and the resulting responses were observed to be close with the predicted value. Conclusion: The optimized formulation with the desired parameter and formulation with variables and responses can be obtained by BBD and could be used in the large experiment with the involvement of a large number of variables and responses.

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