FORMULATION AND PHARMACOKINETIC STUDY FOR LIQUISOLID COMPACTS OF CINACALCET HCL
DOI:
https://doi.org/10.22159/ijap.2025v17i1.52296Keywords:
Kawakita analysis, Heckle analysis, Dissolution rate, and Pharmacokinetic studyAbstract
Objective: The objective of this study is to enhance the flowability, compressibility, and oral bioavailability of Cinacalcet Hydrochloride (HCl) using the liquisolid technique. It is a calcimimetic drug approved for treating secondary hyperparathyroidism in chronic kidney disease patients faces challenges due to its poor aqueous solubility and low bioavailability (20-25 %).
Methods: To address this, we formulated cinacalcet HCl liquisolid compacts with tween 80 and labrasol as the non-volatile solvents, neusilin US2 as the carrier material, and aerosil as the coating material. Our comprehensive analysis included Fourier-transform Infrared Spectroscopy (FT-IR), Differential Scanning Calorimetry (DSC), Powder X-ray diffraction (P-XRD), kawakita analysis and heckel analysis, quality control tests and pharmacokinetic study.
Results: The liquisolid powders of cinacalcet HCl exhibited desirable flowability and compressibility for processing into a tablet dosage form. Kawakita and Heckel analysis revealed reduced cohesiveness and increased plasticity. FT-IR and DSC studies did not exhibit any interaction between drug and carriers. P-XRD study for liquisolid formulation did not exhibit any peaks due to the presence of cinacalcet HCl in molecular form. In vitro dissolution study revealed 37 times improvement in dissolution at 30 min. The Area Under the Curve (AUC) values showed a 2.5-fold increase in oral bioavailability.
Conclusion: Overall, the liquisolid approach promises to develop a stable and scalable solid dosage form with improved flowability, compressibility, and oral bioavailability.
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Copyright (c) 2025 Somesu Macha, Dr. Ch Niranjan Patra, Dr. Goutam Kumar Jena, Dipthi Shree, Dr. Sudarsan Biswal
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