A glyceride with an intermediate melting point used as a lipidic vehicle and modified release agent.
Names & synonyms
| USP NF Name | Mono and Diglycerides |
|---|---|
| EP Name | Glycerol Monostearate 40-55 (Type I) |
| UNII Code (FDA) | KC98RO82HJ |
| Preferred Substance Name (FDA) | Glyceryl Monostearate |
| Handbook of Pharmaceutical Excipients | Glyceryl Monostearate |
| Chemical description | Consists of mono-, di- and triesters of palmitic (C16) and stearic (C18) acids |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 54 - 64 |
| HLB | 3 |
Main functionalities
Modified release matrix former for capsule. Coating agent for taste masking. Consistency agent. Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.
Main formulation technologies
Melt processes: granulation, coating, capsule molding. Consistency agent for several topical dosage forms.
Resources
Technical documentation
Brochures
Scientific document
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Poster PBP 2024 - Formulating pharmaceutical topical dosage forms with high level of solvents and minimal quantity of water
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Poster CRS 2024 - Rheology as a tool for characterizing topical product formulations: impact of solubilizer variation on stability and structure
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Poster AAPS 2018_A systematic approach to formulate and evaluate the stability of topical creams with high concentrations of Transcutol® HP
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Poster ABCF Congress 2024 - Bigels case studies of an innovative topical dosage form
Associated content
Excipients for modified release
Modified- or sustained-release matrices are designed to release a drug slowly over…
Excipients for taste masking and API protection
Some APIs present poor organoleptic properties; therefore, taste or odor need to be…
Adjusting consistency of topical dosage forms
Besides consistency, thickeners contribute to the stability of formulations,…