Hard fat pessary base with emulsifier to improve dispersibility and wettability of hydrophobic APIs.

Names & synonyms

USP NF Name

Mixture of hard fat and ethoxylated fatty alcohols

EP Name

Mixture of hard fat and ethoxylated fatty alcohols

UNII Code (FDA)

8334LX7S21 YRC528SWUY

Preferred Substance Name (FDA)

Hard fat Polyoxyl 20 cetostearyl ether

Handbook of Pharmaceutical Excipients

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Chemical description

Consists of a mixture of  mono-, di- and triglyceride esters of fatty acids (C10 to C18), the triester fraction being predominant and ethoxylated fatty alcohols

Key characteristics

Product form

Pellets

Melting range (°C)

32 - 35

Hydroxyl value (mg KOH/g)

40 - 60

ovucire 3264 thermorheogram

Main functionalities

Enables fast-melting at normal temperature of the vaginal cavity.

Main formulation technologies

Pessary molding.

Associated content

Hard fats for pessaries

  • Formulation technologies

Pessary, sometimes described as vaginal suppository, is the most common dosage form…

Alternative dosage forms for rectal and vaginal drug delivery

  • Formulation technologies

If solid dosage units, i.e. suppositories and pessaries, are very frequent for…