Hard fat suppository base with emulsifier to improve dispersion of hydrophilic APIs, recommended for formulation of glycerin suppositories.
Names & synonyms
| USP NF Name | Hard fat EP/NF/JPE with Glycerol Monostearate EP/NF and PEG-75 Stearate (type I) NF |
|---|---|
| EP Name | Hard fat EP/NF/JPE with Glycerol monostearate EP/NF and PEG-75 Stearate (type I) NF |
| UNII Code (FDA) | 8334LX7S21 230OU9XXE4 OT38R0N74H |
| Preferred Substance Name (FDA) | FAT, HARD GLYCERYL MONOSTEARATE PEG-75 STEARATE |
| 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 and containing glycerol monostearate (C18) and PEG-75 (MW 3500) stearate (C18) |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 34.5 - 37.5 |
| Hydroxyl value (mg KOH/g) | 40 - 50 |
Main functionalities
Optimized base for hydrophilic APIs (glycerin), plant extracts, Traditional Chinese Medicines.
Main formulation technologies
Suppository molding.
Resources
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