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IJPER · Lens · Optimization of Pitavastatin Calcium and Micronized Fenofibrate Bi-layer Tablets Using Quality by Design

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Article · Volume 60, Issue 1 · pp. 124-131

Optimization of Pitavastatin Calcium and Micronized Fenofibrate Bi-layer Tablets Using Quality by Design

Jun Woo Park1, Il Dae Song2, Jae Seon Kang3, Kang Min Kim2

  1. 1Department of Pharmacy, Kyungsung University, Busan, SOUTH KOREA.
  2. 2Department of Pharmaceutical Science and Technology, Kyungsung University, Busan, SOUTH KOREA.
  3. 3Brain Busan Plus 21 Research Project Group, Busan, SOUTH KOREA.

Abstract

Background and Purpose: This study aimed to develop bilayer tablets containing pitavastatin calcium and micronized fenofibrate.Materials and Methods: For optimization of manufacturing based on preliminary formulation research, a 24+3 full factorial Design of Experiments (DoE) study was conducted to elucidate the effects of four factors (Ludipress®, crospovidone, Polyethylene Glycol (PEG) 6000, main compression) influencing tablet Critical Quality Attributes (CQAs) such as hardness, friability, assay and dissolution rates at pH 1.2 and pH 4.5 with 2.88% Sodium Lauryl Sulfate (SLS). Analysis of variance was conducted using Design Expert software to evaluate the 4 responses (hardness, friability, assay and dissolution).Results: Ludipress®(p=0.0212), crospovidone (p<0.0001), PEG 6000 (p=0.0011) and main compression (p=0.0314) significantly affected friability. Hardness was also affected by crospovidone (p=0.0208). Dissolution rates at pH 4.5 with 2.88% SLS were affected by the interaction between crospovidone and PEG 6000 (p=0.0417). These results indicate that the optimized ranges of Ludipress® (4.55-10.59%), crospovidone (7.36-8.94%), PEG 6000 (8.06-9.09%) and main compression (1903-2158.41 kgf) had a positive influence on the tablet CQAs.Conclusion: Process optimization of the bilayer tablets was conducted using a four-factor, two-level, full-factorial design. This enabled the rapid evaluation and identification of critical process variables, facilitating the successful evaluation of bilayer tablets with excellent quality using the quality by design approach.

Keywords: Design of experiment; Micronized fenofibrate; Pita vastatin calcium; Quality by design

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