High shear coating
High shear coating is a process in which powdered lipid excipient is mixed with the API in a high shear coater, without external heating. During mixing, frictions are generated. They are responsible for the production of heat and consequently of the partial melting of the lipid excipient. The partially molten lipid excipient coats the drug particles. Upon cooling the lipid coating solidifies and efficiently covers the drug particle, masking its taste.
Advantages of lipid excipients in high shear coating:
- no external heating required
- low process temperature (48°C) ideal for heat sensitive APIs
- solvent-free process
- ideal for hygroscopic APIs
- possible to coat pure API particles
- narrow melting/crystallization range to prevent particle agglomeration
- quick process—no evaporation or downstream curing
- easy equipment cleaning
Range of excipients for high shear coating
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Excipients for taste masking and API protection
Some APIs present poor organoleptic properties; therefore, taste or odor need to be masked. Others are sensitive to water, oxidation, or temperature and need to be protected to maintain stability. Certain lipid excipients are used in melt processes to effectively protect the API from degradation or mask taste and odor.