Hard fat suppository base that provides excellent chemical stability with acidic APIs and high crystallization rate. A versatile base with precedence of use with a wide range of APIs.
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 | Suppository bases, hard fat |
| Chemical description | Consists of mono-, di- and triglyceride esters of fatty acids (C10 to C18), the triester fraction being predominant |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 34 - 36 |
| Hydroxyl value (mg KOH/g) | <10 |
Main functionalities
Versatile base for straightforward formulations recommended for acidic APIs.
Main formulation technologies
Suppository molding.
Resources
Associated content
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