Design of Experiments: A Valuable “Quality by Design” Tool in Formulation Development

2015 ◽  
pp. 61-91 ◽  
Author(s):  
Lakshmi Kolluru ◽  
Rikhav Gala ◽  
Prathap Shastri ◽  
Ruhi Ubale
Keyword(s):  
Design Of Experiments ◽  
Quality By Design ◽  
Design Tool ◽  
Formulation Development

scholarly journals A Review on Computer - Aided Formulation Development

2019 ◽  
pp. 328-337
Author(s):  
Chaudhari R. G. ◽  
Raut D. B. ◽  
Barhewar P. A. ◽  
Mali A. S. ◽  
Burade K. B.
Keyword(s):  
Neural Networks ◽  
Design Of Experiments ◽  
Quality By Design ◽  
Processing Parameters ◽  
Computer Applications ◽  
Design Development ◽  
Formulation Development ◽  
Critical Quality Attributes ◽  
Double Emulsions ◽  
Computer Aided

This chapter introduces the concept of formulation development assisted by computer applications. Development and optimization of various types of pharmaceutical emulsions microemulsions, self- microemulsifying systems, and double emulsions are presented. Illustrative examples are presented to demonstrate the ability of computer-aided tools to facilitate formulation development. Various techniques, such as design of experiments and arti?cial neural networks, are implemented for optimization of the formulation and/or processing parameters. Furthermore, some of the critical quality attributes and processing parameters are optimized simultaneously. The examples presented should serve as the foundation for the future quality- by-design development of pharmaceutical emulsion and (self) microemulsion formulations.

scholarly journals Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

2018 ◽  
Vol 54 (spe) ◽  
Author(s):  
Isa Martins Fukuda ◽  
Camila Francini Fidelis Pinto ◽  
Camila dos Santos Moreira ◽  
Alessandro Morais Saviano ◽  
Felipe Rebello Lourenço
Keyword(s):  
Design Of Experiments ◽  
Quality By Design ◽  
Analytical Quality

scholarly journals Formulation Development and Evaluation of Mouth Dissolving Tablet of Aspirin by Using QbD Approach

2021 ◽  
Vol 20 (1) ◽  
pp. 19-29
Author(s):  
Nilima A Thombre ◽  
Pradeep S Ahire ◽  
Sanjay J Kshirsagar
Keyword(s):  
Drug Release ◽  
Quality By Design ◽  
Formulation Development ◽  
Compression Method ◽  
Disintegration Time ◽  
In Vitro Drug Release ◽  
Design Expert ◽  
32 Factorial Design ◽  
Mouth Dissolving Tablet

In the current investigations, mouth dissolving tablets (MDT) were developed by applying quality by design (QbD) approach. Direct compression method was applied for the preparation of MDT containing aspirin using 32 factorial design with quantity of drug, microcrystalline cellulose (MCC) and crosscarmellose sodium (CCS) as dependant variables. MCC and CCS were used as superdisintegrants. Sodium stearyl fumarate was used as lubricant. Developed MDT were evaluated for characteristics like hardness, friability, disintegration time (DT) and in vitro drug release . Design Expert 11.0 described adequately impact of selected variables (MCC and CCS) at various levels for response under study (DT and friability). The optimized batch showed disintegration time of 15-28 secs, friability within 1% and in vitro drug release of 75-98% after 30 mins, respectively. The present study of experimental design revealed that MCC and CCS are fruitful at low concentration to develop the optimized formulation. As per the results obtained from the experiments, it can be concluded that QbD is an effective and efficient approach for the development of quality into MDT with the application of QTPP, risk assessment and critical quality attributes (CQA). Dhaka Univ. J. Pharm. Sci. 20(1): 19-29, 2021 (June)

scholarly journals Formulation development of methylprednisolone dispersible tablets using quality by design approach

2019 ◽  
Vol 9 (1-s) ◽  
pp. 229-239
Author(s):  
J Nandhini ◽  
AN Rajalakshmi
Keyword(s):  
Patient Compliance ◽  
Quality By Design ◽  
Water Solubility ◽  
Magnesium Stearate ◽  
In Vitro Dissolution ◽  
Direct Compression ◽  
Formulation Development ◽  
Disintegration Time ◽  
Dispersible Tablets

The objective of this study was to enhance the solubility of Methylprednisolone by choosing micronized form of drug and to enhance patient compliance by formulating it as dispersible tablets using quality by design (QbD) approach. Dispersible tablets of Methylprednisolone were developed by 23 factorial design. In this study independent variables were concentrations of MCC 102, CCS and Magnesium stearate and dependent variables were disintegration time, hardness and dissolution. The resulting data was fitted into Design Expert Software (Trial Version) and analyzed statistically using analysis of variance (ANOVA). The response surface plots were generated to determine the influence of concentration of MCC 102, CCS and magnesium stearate on responses. The tablets were prepared by direct compression method by choosing micronized form of drug and formulations were evaluated for the standard of dispersible tablets. Results showed that no significant drug-polymer interactions in FTIR studies. According to QbD suggestion the formulation O1 (Desirability- 0.73) with MCC-38mg, CCS-3.5mg and magnesium stearate-2.5mg was formulated and evaluated. The disintegration time was found to be 69 seconds, hardness was found to be 64N and in vitro dissolution with in 30minutes. Optimized O1 formulation was within the limits of standards of dispersible tablets with increased water solubility and better patient compliance. Stability study on optimized O1 formulation showed that there is no significant changes during study period. Thus, O1 formulation was found to be stable. The study indicates that formulation of Methylprednisolone dispersible tablets by using QbD approach is a promising formulation development method. Keywords: Dispersible tablets, Methylprednisolone, Direct compression, Quality by Design and ANOVA.

Quality by Design: Comparison of Design Space construction methods in the case of Design of Experiments

2020 ◽  
Vol 200 ◽  
pp. 104002
Author(s):  
Diane Manzon ◽  
Magalie Claeys-Bruno ◽  
Sophie Declomesnil ◽  
Christophe Carité ◽  
Michelle Sergent
Keyword(s):  
Design Of Experiments ◽  
Quality By Design ◽  
Design Space ◽  
Construction Methods ◽  
Space Construction ◽  
Design Comparison
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