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Preparation and Characterization of Co-Processed Mannitol and Sorbitol Using NanoCrySP Technology

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Abstract

Particle engineering of excipients, at sub-particulate level using co-processing, can provide high functionality excipients. NanoCrySP technology has been recently explored as a novel approach for the generation of nanocrystalline solid dispersion of poorly soluble drugs, using spray drying process. The purpose of the present study was to generate co-processed mannitol and sorbitol (SD-CSM) using NanoCrySP technology having similar composition to commercial co-processed excipient (Compressol® SM, CP). The characterization of excipients was performed to evaluate their various physicomechanical properties. The sub-micron crystallite size of sorbitol in the matrix of mannitol was determined using the Williamson-Hall equation and Halder-Wagner equation. The reduction in crystallite size of sorbitol and mannitol, lower melting point, and lower heat of fusion of SD-CSM could be responsible for excellent compactibility, better tabletability, and comparable compressibility with respect to CP. This was confirmed by the compressibility-tabletability-compactibility (CTC) profile and Heckel plot analysis. Overall, SD-CSM generated using NanoCrySP technology improved functionalities of excipients over CP and would be useful for direct compression application.

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Acknowledgments

Srilaxmi G. Rao would like to gratefully acknowledge SPI Pharma, United States, for providing gift samples of Compressol® SM. Srilaxmi G. Rao and Prashantkumar K. Parmar would like to thank Dnyaneshwar P. Kale and Sneha Sheokand for their support and help during this project. The authors would like to acknowledge NIPER-S.A.S. Nagar for providing the necessary facilities for this project.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Solid State Pharmaceutics Lab, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Sector-67, S.A.S. Nagar, Mohali, Punjab, 160 062, India

    Srilaxmi G. Rao, Prashantkumar K. Parmar, Katangur Vishruth Reddy & Arvind K. Bansal

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  1. Srilaxmi G. Rao
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  2. Prashantkumar K. Parmar
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Contributions

Srilaxmi G. Rao: conceptualization, methodology, investigation, formal analysis, software, data curation, and writing—original draft. Prashantkumar K. Parmar: conceptualization, investigation, formal analysis, data curation, and writing—review and editing. Katangur Vishruth Reddy: conceptualization, methodology, formal analysis, and data curation. Arvind K. Bansal: conceptualization, writing—review and editing, and supervision. All persons mentioned above have made substantial contributions to the work in the manuscript.

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Correspondence to Arvind K. Bansal.

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Rao, S.G., Parmar, P.K., Reddy, K.V. et al. Preparation and Characterization of Co-Processed Mannitol and Sorbitol Using NanoCrySP Technology. AAPS PharmSciTech 22, 201 (2021). https://doi.org/10.1208/s12249-021-02071-1

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