A high melting point lipid for use in modified release oral solid dosage forms (lipid matrix for sustained release, delayed release).
Glycerol distearate (type I) EP
Glyceryl distearate NF
Glyceryl palmitostearate (USA FDA IIG)
- Fine white powder of well-controlled particle size distribution with an indicative particle size of 50µm
- A high melting point lipid for use in modified release oral solid dosage forms (lipid matrix for sustained release, delayed release).
- Use in coating techniques to provide taste masking.
- In coating techniques the physicochemical properties and plasticity of the lipid film provides high resistance to fracture, useful for flash melt and chewable tablets.
- Effective lubricant for capsule filling.
- Chemically inert and compatible with other ingredients.
Safety of use is supported by toxicological data, GRAS status and precedence of use in approved pharmaceutical products.
Hydrophilic-Lipophilic Balance (HLB)
Field of use
- Human pharmaceutical products, veterinary products excluding food producing animals (EU)
Formulation techniques and dosage forms
- Forms lipid matrix for modified release tablets by direct compression.
- Provides lubrication for capsule filling.
- Suitable for use in melt processing techniques: spray cooling /prilling, hot melt coating and melt extrusion techniques for capsule filling, tabletting, sachets, suspensions etc
- Suitable for hard gelatin capsule molding.