Excipients for API Taste Masking and 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.

Advantages of Gattefossé’s taste-masking and API protection agents:

• thermoplastic behavior conducive to processes used (high shear coating, hot melt coating, granulation, extrusion, and capsule molding) • solvent-free process • chemically inert—highly compatible with other excipients in the formulation • plastic deformation for high resistance to compaction • lipid coating that does not impact bioavailability

Range of taste-masking and API protection agents

Compritol^® 888 ATO for API protection:

• finely atomized powder
• crystalline material with narrow melting range (∼70 °C) and rapid recrystallization; ideal for hot melt processes
• GRAS status and precedence of use with many APIs (FDA IID)

Precirol^® ATO 5 for API taste masking: 

• finely atomized powder
• crystalline material with narrow melting range (∼55 °C) and rapid recrystallization; ideal for hot melt processes
• GRAS status and precedence of use with many APIs (FDA IID)

Geleol™ Mono and Diglycerides NF for taste masking:

• available in pellet form
• crystalline material with narrow melting range (∼60 °C) and rapid recrystallization; suitable for melt processes
• GRAS status and precedence of use with many APIs (FDA IID)

Gelucire^® 43/01 for API protection:

• available in pellet form
• lipid excipient with intermediate melting point (43 °C)
• ideal for capsule molding process