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Published on: February 3, 2023
Characterisation Data of common pharmaceutical excipient Powders and Tablets for Formulation Development
Dingeman L H van der Haven1, Maria Mikoroni2, René Jensen2
1University of Cambridge, Department of Materials Science & Metallurgy, 27 Charles Babbage Road, Cambridge, CB3 0FS, United Kingdom.
This study provides crucial reference data on pharmaceutical excipients like micro-crystalline cellulose (MCC), dibasic calcium phosphate dihydrate (DCPD), and partially pre-gelatinised corn starch (PGS). The data aids in optimizing drug formulation design and production processes.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Chemical Engineering
Background:
- Excipients are vital for drug formulation performance and patient acceptance.
- Key excipients include micro-crystalline cellulose (MCC), dibasic calcium phosphate dihydrate (DCPD), and partially pre-gelatinised corn starch (PGS).
- Publicly available reference data for these essential pharmaceutical powders are lacking.
Purpose of the Study:
- To generate a comprehensive data set for MCC, DCPD, and PGS.
- To characterize individual powder grains, including particle size, crushing strength, and geometry.
- To evaluate the mechanical properties of tablets formed from these excipients and their mixtures.
Main Methods:
- Detailed characterization of individual excipient grains (MCC, DCPD, PGS).
- Tablet compression using a compaction simulator.
- Extensive mechanical testing of manufactured tablets.
Main Results:
- An extensive data set detailing the physical properties of MCC, DCPD, and PGS has been compiled.
- Mechanical properties of tablets made from these excipients and their mixtures were systematically evaluated.
- The generated data provides a valuable reference for pharmaceutical applications.
Conclusions:
- The presented data set serves as a critical reference for the pharmaceutical industry.
- This information will support educators and process developers in drug formulation.
- Availability of this data facilitates improved drug product design and manufacturing.
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