Nanostructured Lipid Carrier of Cinacalcet HCl: Formulation, BBD Enabled Optimization, Pharmacokinetic and In-Vitro Cytotoxicity Study

Author:

Nayak Sabita1ORCID,Sruti Jammula1,Patra Chinam Niranjan1,Jena Goutam Kumar1,Panigrahi Kanhu Charan2,Kumar Nandika Khirod3

Affiliation:

1. Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha, Affiliated to Biju Patnaik University of Technology, Rourkela, India

2. Department of Pharmacy, Gayatri Institute of Science and Technology, Gunupur, India

3. Department of Pharmaceutics, Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha, Affiliated to Biju Pat-naik University of Technology, Rourkela, India

Abstract

Background: Cinacalcet hydrochloride (CINH) is a BCS class IV drug. It is mainly used for the treatment of chronic renal disease and parathyroid cancer. It exhibits poor oral bioavailabil-ity of less than 25%. Objectives: The main objective is to improve the bioavailability of CINH by formulating the nanostructure lipid carrier (NLC). Methods: In this research, glyceryl monostearate (GMS), labrasol, and tween 20 were the main ex-cipients selected for the formulation of NLC. Hot high-speed homogenization and ultra-sonication method was used for the NLC formulation of CINH. The characterization of the NLCs was done as per standard procedures. Optimization of the formulated NLC was carried out by applying Box-Behnken Design (BBD) with the help of the Design Expert software. The pharmacokinetic study was conducted to determine the improvement in the bioavailability of the CINH. The cytotoxicity study was performed by using the MTT assay method to know the cell viability. Results: The optimized NLC formulation exhibited high drug content with a particle size of less than 200nm. A pharmacokinetic study showed 4 fold increase in oral bioavailability for the opti-mized NLC in comparison to the aqueous suspension of CINH. Minimum viability was determined as 94%, which indicates the safety of the incubated formulations. Conclusion: NLC formulation has the potential to improve oral bioavailability with high drug load-ing and cell viability for CINH.

Publisher

Bentham Science Publishers Ltd.

Subject

General Earth and Planetary Sciences,General Environmental Science

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