NOVATA B

NOVATA B

CAS Number: 67701-26-2 
EC Number: 266-944-2

Novata B is white or almost white, waxy, brittle pellets.

USES and APPLICATIONS of NOVATA B:
-Structurants & matrix builders
-Solid Dosage

-Suppositories
-The main application of the Novata B 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 B dissolves or melts. 

-Suppositories may be used for patients (e.g. children) in case Novata B 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. 

-Suppositories are made from a greasy or waxy base, containing different Novata B 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. 

-In topical formulation they can act as a sensory enhancer, because of their low melting point.

 
FEATURES of NOVATA B:
-Suppository matrix
-Ability to formulate specific melting points

BENEFITS of NOVATA B:
-Hard fat offering 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
-Best option for suppository masses or solid compositions

PHYSICAL and CHEMICAL PROPERTIES of NOVATA B:
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 20 – 30 
Saponification value 225 – 240 
Mellting point (°C) 33.5 – 35.5 

FIRST AID MEASURES of NOVATA B:
-Description of first aid measures
*General advice:
Remove contaminated clothing.

*If on skin:
Wash thoroughly with soap and water

*If in eyes:
Wash affected eyes for at least 15 minutes under running water with eyelids held open. 
Seek medical attention.

*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 B:
-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 B:
-Extinguishing media:
*Suitable extinguishing media:
Carbon dioxide, foam, dry powder, water spray.

EXPOSURE CONTROLS/PERSONAL PROTECTION of NOVATA B:
-Personal protective equipment:
*Eye protection:
Wear safety goggles.

-General safety and hygiene measures: 
Handle in accordance with good industrial hygiene and safety practice. 
Hands and/or face should be washed before breaks and at the end of the shift.

HANDLING and STORAGE of NOVATA B:
-Precautions for safe handling
*Protection against fire and explosion:

-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 B:
-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.