Hard fat suppository base containing polysorbate additive to improve dispersion of hydrophilic APIs in aqueous solutions or hydroalcoholic extracts.
Names & synonyms
| USP NF Name | Hard fat with additive (polysorbate) |
|---|---|
| EP Name | Hard fat with additive |
| UNII Code (FDA) | 14BGY2Y3MJ |
| Preferred Substance Name (FDA) | |
| 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 polysorbate 65 |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 35 - 39 |
| Hydroxyl value (mg KOH/g) | 15 - 25 |
Main functionalities
Facilitates dispersion of hydrophilic APIs. Prevents the exudation of APIs.
Main formulation technologies
Suppository molding.
Resources
Associated content
Hard fats for suppositories
If not always popular, suppositories remain an ultimate dosage form, when the…
Alternative dosage forms for rectal and vaginal drug delivery
If solid dosage units, i.e. suppositories and pessaries, are very frequent for…