Medium and large scale preparation of Nanostructured Lipid Carriers of asenapine maleate: Quality-by-design based optimization, production,characterization and performance evaluation

Rao, Rajat Radhakrishna and Pisay, Muralidhar and Kumar, Sunil and Kulkarni, Sanjay and Pandey, Abhijeet and Mutalik, Srinivas (2022) Medium and large scale preparation of Nanostructured Lipid Carriers of asenapine maleate: Quality-by-design based optimization, production,characterization and performance evaluation. Journal of Drug Delivery Science and Technology, 71. pp. 1-16. ISSN 1773-2247

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Abstract

In the present study, scale-up of preparation of Asenapine maleate (ASPM) loaded Nanostructured lipid carriers (NLCs) to medium as well as the large scale was performed with the aid of Quality-by-Design (QbD) approach.High-pressure homogenization (HPH) was used to scale up the ASPM loaded NLCs to medium (40 mL) and largescale (300 mL) batches.The statistical experimental design was employed to optimize the HPH parameters and the results of the design showed that the size of ASPM loaded NLCs decreased with the increase in pressure and number of cycles of HPH. Also, increasing the number of cycles resulted in a slight increase in the %drug entrapped. FTIR and DSC were used to assess the compatibility between drug and excipients. The shape and surface morphology of NLCs studied by Transmission Electron Microscope revealed a spherical shape with an approximate size of less than 100 nm. The cytotoxicity of NLCs using MTT assay in Caco2 cells demonstrated the safety of ASPM-NLCs. Further, in vivo pharmacokinetics and efficacy studies strengthened the applicability of ASPM-NLCs produced at a large scale for further in vivo and clinical environments

Item Type: Article
Uncontrolled Keywords: Scale-up; Asenapine maleate; Nanostructured lipid carriers; High-pressure homogenization; Large scale
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Library
Date Deposited: 05 Jul 2022 05:52
Last Modified: 05 Jul 2022 05:52
URI: http://eprints.manipal.edu/id/eprint/158949

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