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Preparation and Characterization of Co-Processed Mannitol and Sorbitol Using NanoCrySP Technology
Srilaxmi G Rao1, Prashantkumar K Parmar1, Katangur Vishruth Reddy1
1Solid 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.
AAPS Pharmscitech
|July 7, 2021
Summary
NanoCrySP technology created co-processed mannitol and sorbitol (SD-CSM) with enhanced functionality. This novel excipient demonstrates superior compactibility and tabletability for direct compression applications.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- Particle engineering of excipients using co-processing enhances functionality at the sub-particulate level.
- NanoCrySP technology offers a novel spray-drying approach for nanocrystalline solid dispersions of poorly soluble drugs.
Purpose of the Study:
- To generate co-processed mannitol and sorbitol (SD-CSM) via NanoCrySP technology.
- To create an excipient with a composition similar to commercial co-processed excipient (Compressol® SM, CP).
- To evaluate the physicomechanical properties and functionality of the novel SD-CSM.
Main Methods:
- Co-processing of mannitol and sorbitol using NanoCrySP technology (spray drying).
- Characterization of physicomechanical properties.
- Determination of sub-micron crystallite size using Williamson-Hall and Halder-Wagner equations.
- Evaluation of compactibility, tabletability, and compressibility using CTC profile and Heckel plot analysis.
Main Results:
- SD-CSM exhibited reduced crystallite size for sorbitol and mannitol.
- Lower melting point and heat of fusion were observed in SD-CSM compared to CP.
- SD-CSM demonstrated excellent compactibility, improved tabletability, and comparable compressibility to CP.
- CTC profile and Heckel plot analysis confirmed enhanced properties.
Conclusions:
- NanoCrySP technology successfully generated SD-CSM with improved excipient functionalities.
- The novel SD-CSM exhibits superior performance for direct compression applications.
- This particle engineering approach offers a promising alternative for developing high-performance pharmaceutical excipients.
