A glyceride with an intermediate melting point used as lubricant and flow aid in powder blends for capsule filling and as a coating agent for taste masking.
Names & synonyms
| USP NF Name | Glyceryl distearate |
|---|---|
| EP Name | Glycerol distearate (type I) |
| UNII Code (FDA) | 73071MW2KM |
| Preferred Substance Name (FDA) | GLYCERYL DISTEARATE |
| Handbook of Pharmaceutical Excipients | Glyceryl palmitostearate |
| Chemical description | Consists of esters of palmitic (C16) and stearic (C18) acids, the diester fraction being predominant |
Key characteristics
| Product form | Powder |
|---|---|
| Melting range (°C) | 50 - 60 |
| HLB | 2 |
Main functionalities
Coating agent for taste masking. Lubricant and flow aid for capsule filling with powders. Modified release matrix former for tablets. Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.
Main formulation technologies
Tablet compression (direct and wet granulation). Powder-filled capsules. Melt processes: granulation, extrusion, coating, prilling, spray congealing. Nanoparticle formulation.
Resources
Technical documentation
Brochures
-
Gattefosse brochure Selecting the best excipients to optimize drug delivery
-
Gattefosse brochure Gattefosse products in pediatric dosage forms
-
Gattefosse brochure Lipid excipients for cannabinoid drug products
-
Gattefosse brochure Oral drug delivery with lipid excipients
-
Gattefosse Brochure Skin-Friendly Textures
-
Gattefosse brochure veterinary medicines with Lipid excipients
Scientific document
-
Poster AAPS 2017: Taste Masked Drugs For Pediatric Medicines Through Lipid Coating
-
Poster EUPFI 2017PRECIROL_ATO_5_Efficient taste masking through high shear coating
-
Poster AAPS 2014: Compritol 888 Ato Vs Precirol Ato 5 in Hot Melt Extrusion Investigation of Operating Window Limits
-
Poster CRS 2019: In Vitro Studies Indicate Promising Properties Of Solid Lipid Nanosuspensions for oral peptide delivery
-
Poster PBP 2024 - Implementation of an at-line nanoparticle size analyzer in a continuous nano-manufacturing line considering critical measurement and process conditions
Associated content
Excipients for taste masking and API protection
Some APIs present poor organoleptic properties; therefore, taste or odor need to be…
Excipients for lubrication
During tablet and capsule production, lubricants are necessary to improve powder…
High shear coating
High shear coating is a process in which powdered lipid excipient is mixed with the…