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NOVATA BC = MIXTURE OF TRIGLYCERIDES, DIGLYCERIDES AND MONOGLYCERIDES
CAS Number: 67701-26-2
EC Number: 266-944-2
Novata BC is white or almost white, waxy, brittle pellets
Hard fat for suppository matrix, melting point 33.5 – 35.5 deg C.
USES and APPLICATIONS of NOVATA BC:
-Solid Dosage
-Suppositories
-Structurants & matrix builders
-The main application of the Novata BC Grades is suppositories.
-The suppository is a drug delivery system that is inserted into the rectum (rectal suppository), vagina (vaginal suppository) or urethra (urethral suppository), where Novata BC dissolves or melts.
-Suppositories may be used for patients (e.g. children) in case Novata BC may be easier to administer than tablets or syrups.
-Suppositories may also be used when a patient has a vomiting tendency, as oral medication can be vomited out.
-Another benefit of suppositories is, that drugs which often cause stomach upset during oral intake, for example diclofenac sodium are better tolerated in suppository form.
-In topical formulation Novata BC can act as a sensory enhancer, because of Novata BC low melting point.
-Suppositories are made from a greasy or waxy base, containing different Novata BC grades in which the active ingredient and the other excipients are dissolved.
-The main important point in formulating a suppository, is adjust the melting temperature of the complete formulation to the body temperature.
-Apart from suppository manufacturing, solid triglycerides (hard fats) are used as carriers in capsule fillings, inlets, ointments and creams and in dental products.
FEATURES of NOVATA BC:
-Suppository matrix
-Ability to formulate specific melting points
BENEFITS of NOVATA BC:
-Hard fat offers a sharp melting point for suppository applications
-Can be added to oil phases to modify the emollient or sensory properties of topical semi-solid emulsions
-The best option for suppository masses or solid compositions
PHYSICAL and CHEMICAL PROPERTIES of NOVATA BC:
Acid value: ≤0.5
Iodine value: ≤3.0
Peroxide value: ≤3.0
Alcaline impurities (mL): ≤0.15
Total ash (%): ≤0.05
Unsaponifialble (%): ≤0.6
Hydroxyl value: 30 – 40
Saponification value: 225 – 240
Mellting point (°C): 33.0 – 34.5
Form: solid, pastilles
Odour: fatty-like
Odour threshold: not determined
Colour: white
pH value: not applicable
Solidification temperature: 30.5 - 32.5 °C
Melting point: No data available.
Freezing point: No data available.
Boiling point: not applicable
Flash point: > 190.0 °C
Flammability: not highly flammable (other)
Vapour pressure: not applicable
Density: 0.955 - 0.975 g/cm3 ( 20 °C)
Relative density: No data available.
Vapour density: The product is a non-volatile solid.
Partitioning coefficient n-octanol/water (log Pow): not determined
Self-ignition temperature: not self-igniting
Thermal decomposition:
No decomposition if stored and handled as prescribed/indicated.
Viscosity, dynamic: not applicable
Viscosity, kinematic: No data available.
Solubility in water: insoluble
Molar mass: No data available.
Evaporation rate:
The product is a non-volatile solid.
Other Information:
If necessary, information on other physical and chemical parameters is indicated in this section.
FIRST AID MEASURES of NOVATA BC:
-Description of first aid measures
*General advice:
Remove contaminated clothing.
*If on skin:
Wash thoroughly with soap and water
*If swallowed:
Rinse mouth and then drink 200-300 ml of water.
Seek medical attention.
*Most important symptoms and effects, both acute and delayed:
Symptoms: No data available.
ACCIDENTAL RELEASE MEASURES of NOVATA BC:
-Personal precautions, protective equipment and emergency procedures:
*Environmental precautions:
Do not discharge into drains/surface waters/groundwater.
-Methods and material for containment and cleaning up:
For large amounts: Sweep/shovel up.
For residues: Sweep/shovel up.
FIRE FIGHTING MEASURES of NOVATA BC:
-Extinguishing media:
*Suitable extinguishing media:
carbon dioxide, foam, dry powder, water spray.
EXPOSURE CONTROLS/PERSONAL PROTECTION of NOVATA BC:
-Personal protective equipment:
*Eye protection:
Wear safety goggles.
-General safety and hygiene measures:
Hands and/or face should be washed before breaks and at the end of the shift.
HANDLING and STORAGE of NOVATA BC:
-Conditions for safe storage, including any incompatibilities:
*Suitable materials for containers: High density polyethylene (HDPE), Low density polyethylene (LDPE)
*Further information on storage conditions:
Keep only in the original container.
Keep container tightly closed and in a well-ventilated place.
*Storage stability:
Storage temperature: <= 25 °C
STABILITY and REACTIVITY of NOVATA BC:
-Reactivity:
No hazardous reactions if stored and handled as prescribed/indicated.
-Oxidizing properties:
not determined
-Chemical stability:
The product is stable if stored and handled as prescribed/indicated.
-Incompatible materials:
No substances known that should be avoided.
-Hazardous decomposition products:
*Decomposition products:
No hazardous decomposition products if stored and handled as prescribed/indicated.
*Thermal decomposition:
No decomposition if stored and handled as prescribed/indicated.
