DYNASAN 118 is a multifunctional excipient, used primarily as a tablet aid with lubricating and retarding functions.
Description of DYNASAN 118:
DYNASAN 118 is a triglyceride of selected saturated single fatty acid C18 of plant origin and plant derived glycerol.
Tristearin.
DYNASAN 118 acts as a consistency agent for water-free, oil-based emulsions and products.
DYNASAN 118 is triester of glycerin and stearic acid.
DYNASAN 118 is 100 % natural, vegan and stable against oxidation.
DYNASAN 118 finds application in cake/pressed powders as binders and in creams & lotions as body-imparting and structure-forming components.
Furthermore, DYNASAN 118 is used as adjuvant in stick formulations and as crystallization accelerators & seeding agents to improve the solidification process.
DYNASAN 118 is used in color cosmetics, self-tanning formulas and skin-, baby-, body-, hair-, beard- and sun care products.
DYNASAN 118 has a shelf life of 24 months.
DYNASAN 118 is Ecocert and Cosmos approved.
Properties of DYNASAN 118:
When DYNASAN 118 is rapidly cooled after melting, a glassy, amorphous mass is initially formed.
Upon standing, DYNASAN 118 changes into crystalline modifications having volume expansion.
The stable ß-modification has a very sharp melting point and a triclinic structure.
Solubility of DYNASAN 118:
DYNASAN 118 is slightly soluble in n-hexane, as well as in diethyl ether.
DYNASAN 118 is virtually insoluble in ethanol and water.
Applications of DYNASAN 118:
DYNASAN 118 is used in the pharmaceutical industries in the following application fields:
- in tablets as a lubricant showing a very low influence on disintegration (see table below) or as retarding agent if used in higher concentrations (2-5%).
Base / Lubricant / Concentration (%) / Pressure (mPa.s) / Disintegration (sec.):
Lactose / Mg-stearate / 0.25 / 195 / 600
Lactose / Sterotex / 4 / 221 / 250
Lactose / Precirol / 2 / 211 / 210
Lactose / DYNASAN 118 / 1 / 228 / 111
Home > Products > DYNASAN 118
DYNASAN 118 is a triglyceride of selected saturated single fatty acid C18 of plant origin and plant derived glycerol.
When DYNASAN 118 is rapidly cooled after melting, a glassy, amorphous mass is initially formed.
Melting Point [C°] ~72
Description of DYNASAN 118:
DYNASAN 118 has a high melting point lipid for use in modified/sustained release in oral solid dosage matrices.
DYNASAN 118 is effective lubricant for tablets/capsules.
DYNASAN 118 is used in hot melt extrusion, hot melt coating, solid lipid nanoparticles.
Characteristics of DYNASAN 118:
DYNASAN 118 is a monoacid triglyceride based on C18 fatty acid with a high melting point (approx. 73°C).
DYNASAN 118 is available as a microfine powder and suitable for oral solid dosage matrices.
Properties and Applications of DYNASAN 118:
-modified / retard oral dosage forms with enhanced concentrations (2–5%) through an increase of the hydrophobic character
-no influence on drug release up to concentration of 1%
-effective lubricant for tablet production in low concentrations (~ 0.5%)
-enhances the tablet fracture stability due to an increased lubricity factor as a consequence of particle morphology and particle surface
-used for taste masking, applying hot melt coating technique
-suitable for hot melt extrusion and hot melt granulation
-utilisable for generating solid lipid nanoparticles (SLN)
Chemical and Physical Properties of DYNASAN 118:
Tests / Values / Typical values / Units / Methods
Melting range / 69 – 73 / 72 / °C / Ph. Eur. 2.2.34
Acid value / max. 1.0 / 0.2 / mg KOH/g / Ph. Eur. 2.5.1
Hydroxyl value / max. 5.0 / 3 / mg KOH/g / Ph. Eur. 2.5.3
Triglycerides / min. 90.0 / 97 / % / Ph. Eur. 2.2.30
Peroxide value / max. 3 / 0.4 / meq O/kg / Ph. Eur. 2.5.5
Water / max. 0.1 / 0.01 / % / Ph. Eur. 2.5.12
DYNASAN 118 is a triglyceride of selected saturated single fatty acid C18 of plant origin and plant derived glycerol.
KEYWORDS:
555-44-2, 209-098-1, Glycerin tripalmitate, Glycerol tripalmitate, PPP, 1 2 3-Propanetriyl Ester Hexadecanoic Acid, Barolub LCD, Dynasan 116, Dynosan 114, Palmitic Acid Triglyceride
Additional Information of DYNASAN 118:
Quality: USP
Composition: 100 % Glycerol Triester of only stearic acid
Dosage Form: beads, Tablets
Function: hot melt coating, Lubricant, SLN, Taste masking
Synonym: Tristearin
Technical Name: Glycerol Tristearate
Compendial Name: Glyceryl Tristearate
DYNASAN 118 production is fully EU GMP-certified.
Product Applications of DYNASAN 118:
-Hot Melt Extrusion
-Lubricant
-Ovule
-SLN Processes
-Suppository
-Topical
Product Certification:
-GMP
-Halal
-OU Kosher
Pharmaceutical Category:
-Solid triglycerides
DYNASAN 118 Applications
DYNASAN 118 is used in the pharmaceutical industries in the following application fields:
–in tablets as a lubricant showing a very low influence on disintegration or as retarding agent if used in higher concentrations (2-5%).
-In suppositories, ovules and pharmaceutical sticks as crystallisation accelerators to improve congealing processes
-In ointments, creams and lotions for body imparting and structure forming effects
-In hot melt coating processes (taste masking)
-In hot melt extrusion processes (bioavailability enhancement)
-In solid lipid nanoparticles (SLN) procedures
DYNASAN – Versatile Excipients for Solid Dosage Forms
The DYNASAN product range is a family of high-purity monoacid triglycerides.
Their chemical nature, raw materials, manufacturing and purification result in products with advantageous properties and impurity profile.
The optimized degree of esterification leads to almost no free OH functionality on the backbone of the excipients and removes formulation and stability challenges in tablets, typically encountered with lubricants based on metallic salts of fatty acids:
-Metal salt impurities interacting with APIs
-API interaction with lubricants due to their ionic characteristics
-Microenvironmental pH shift into alkaline milieu, creating a risk of drug hydrolysis
-Initiation of redox cascades degrading APIs – Metal ion-mediated degradation of APIs
-Ionic excipients and salt counter-ions show reactivity towards amines, which are common functional groups in APIs with metal soaps
Incompatibilities with metallic salts of fatty acids have been reported, e.g. for the following active ingredients:
-Acetylsalicylic Acid
-Captopril
-Besylate
-Cephalexin
-Clopidogrel Besylate
-Erythromycin
-Glibenclamide
-Glimepiride
-Ibuprofen
-Indomethacin
-Ketoprofen
-Norfloxacin
-Oxacillin
-Penicillin G
-Temazepam
Description of first aid measures of DYNASAN 118:
First-aid measures general:
In all cases of doubt, or when symptoms persist, seek medical attention.
First-aid measures after inhalation:
Remove person to fresh air and keep comfortable for breathing.
First-aid measures after skin contact:
Wash skin with plenty of water.
First-aid measures after eye contact:
Rinse eyes with water as a precaution.
First-aid measures after ingestion:
Call a poison center or a doctor if you feel unwell.
Extinguishing media:
-Suitable extinguishing media:
-Water spray.
-Dry powder.
-Foam.
-Use extinguishing media appropriate for surrounding fire.
Unsuitable extinguishing media:
Strong water jet.
Precautions for safe handling of DYNASAN 118:
Additional hazards when processed:
Dust could form explosive mixtures with air.
Precautions for safe handling:
Ensure good ventilation of the work station.
Wear personal protective equipment.
Hygiene measures:
Do not eat, drink or smoke when using DYNASAN 118.
Always wash hands after handling the product.