A glyceride with an intermediate melting point used as a matrix agent for sensitive APIs and a viscosity-increasing agent in oral and topical formulations.
Names & synonyms
| USP NF Name | Hard fat |
|---|---|
| EP Name | Hard fat |
| UNII Code (FDA) | 8334LX7S21 |
| Preferred Substance Name (FDA) | FAT, HARD |
| Handbook of Pharmaceutical Excipients | / |
| Chemical description | Consists of mono-, di- and triglyceride esters of fatty acids (C8 to C18), the triester fraction being predominant |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 42 - 46 |
| HLB | 1 |
Main functionalities
Matrix-forming agent for protection of APIs sensitive to oxidation, humidity, or light. Consistency agent in oral and topical formulations. Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Melt processes: granulation and capsule molding. Topical emulsion and ointment.
Resources
Technical documentation
Brochures
Associated content
Excipients for taste masking and API protection
Some APIs present poor organoleptic properties; therefore, taste or odor need to be…