An optimisation of critical quality attributes for acyclovir dispersible tablets: a quality by design approach

Quality by design (QbD) is a systematic, scientific, risk-based approach to product development and manufacturing process to consistently deliver the quality product. In this chapter, application, benefits, opportunities, regulatory requirements involved in quality by design of pharmaceutical products are discussed. In quality by design approach, during development, the developer defines quality target product profile (QTPP) and identifies critical quality attributes (CQA). Critical process parameters (CPP) of unit operations which impacts critical quality attributes need to be identified to understand the impact of critical material attributes (CMA) on quality attributes of the drug product. Quality by design approach is defined in ICH guidelines Q8 – Pharmaceutical Development, Q9 – Quality Risk Management, Q10 – Pharmaceutical Quality System. This chapter describes the implementation of new concepts in quality by design like design of experiments to achieve design space, control strategy to consistently manufacture quality product throughout the product lifecycle.

Download Full-text

Quality by design approach for formulation development: A case study of dispersible tablets

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2011.12.024 ◽

2012 ◽

Vol 423 (2) ◽

pp. 167-178 ◽

Cited By ~ 72

Author(s):

Naseem A. Charoo ◽

Areeg A.A. Shamsher ◽

Ahmed S. Zidan ◽

Ziyaur Rahman

Keyword(s):

Quality By Design ◽

Design Approach ◽

Formulation Development ◽

Dispersible Tablets ◽

Quality By Design Approach

Download Full-text

Development and Validation of a Ultra Flow Liquid Chromatography Method for the Assay of Boceprevir Using a Quality-by-Design Approach

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v11ispl4.4599 ◽

2020 ◽

Vol 11 (SPL4) ◽

pp. 3023-3032

Author(s):

Manish Majumder ◽

Ramesh B ◽

Minaketan Tripathy

Keyword(s):

Risk Assessment ◽

Flow Rate ◽

Mobile Phase ◽

Quality By Design ◽

Quality Attributes ◽

Assay Method ◽

Chromatography Method ◽

Critical Quality Attributes ◽

Critical Method ◽

Quality By Design Approach

Quality by design guided. The assay method of Boceprevir is developed in accordance with ICH Q8(R2) guideline with due validation. .In this process, the Target analytical profile (TAP) of the drug was set and critical method parameters (CMP) were investigated by systematic risk assessment experimentation to control critical Quality Attributes (CQA). In this, A Cause Effect Risk Assessment Matrix with Control-Noise-Experiment (CNX) is used for identifying the high-risk variables i.e Percentage of Organic Modifier (% methanol), pH of the Buffer and flow rate of the mobile phase. The surface response methodology was applied to optimize the critical method parameters (CMP) as well as Critical Quality Attributes (CQA) to find out the Design space of the method. The Optimum assay method condition was mobile phase Acetate Buffer (50mM) pH 5.4: Methanol (11:89), Flow rate: 0.9 ml/min, Lambda Max: 207. The separation was achieved in the Eclip Plus C-18 column (250 × 4.6 mm, 5μm) at ambient temperature. The retention time of Boceprevir was found to be 4.2 min. The method evaluation was performed according to the (Q2R1) ICH guideline.

Download Full-text