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 |
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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 |
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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.
Documentation
Documentation technique
Brochures
Scientific document
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Poster AAPS 2017: Taste Masked Drugs For Pediatric Medicines Through Lipid Coating
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Poster EUPFI 2017PRECIROL_ATO_5_Efficient taste masking through high shear coating
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Poster AAPS 2014: Compritol 888 Ato Vs Precirol Ato 5 in Hot Melt Extrusion Investigation of Operating Window Limits
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Poster CRS 2019: In Vitro Studies Indicate Promising Properties Of Solid Lipid Nanosuspensions for oral peptide delivery
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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
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High shear coating
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