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PRIMOJEL

 

 

Primojel is used as an additive in the pulp industry, it has the functions of retention, filtration, and enhancement. 
Primojel is also used for surface gluing of paper.
In higher concentrations, Primojel can act as a dissolution enhancing agent.


CAS Number: 9063-38-1
EC Number: 618-597-7
Molecular Formula: C2H4O3·xNa·x

SYNONYMS:
CMS-Na, Primojel, PRIMOJEL(R), SODIUM STARCH GLYCOLATE, SODIUM STARCH GLYCOLLATE, CARBOXYMETHYL STARCH SODIUM, Sodium carboxymethyl starch, sodium carboxyl methylstarch, SodiumStarchGlycolateExtraPure, CARBOXYMETHYL STARCH SODIUM SALT, Primojel, Sodium Starch Glycolate, Sodium Carboxymethyl Starch, Glycolate Starch Sodium, Sodium Glycolate Starch

Primojel is sodium starch glycolate. 
Primojel is a fine, white or almost white, free-flowing powder.
Primojel takes up more than 20 times its own weight of water. 


Rapid water penetration into the tablets and powerful swelling results in rapid disintegration. 
The swelling actions makes Primojel most effective in non-soluble matrices. 
Studies show that Primojel takes up more water than comparative products on the market and develops a strong disintegrating force making it a highly effective product. 


The botanic source, degree of cross-linking and degree of substitution of Primojel have been optimized in order to give rapid water uptake by the polymer without the formation of a viscous gel that may impede water penetration into the tablet.
Primojel is a super disintegrant suitable for various tablet and capsule formulations. 


In higher concentrations, Primojel can act as a dissolution-enhancing agent. 
Primojel is highly effective when used intragranular and/or extragranular in dry/wet granulation processes.
Primojel is used Direct compression / Dry granulation / Wet granulation / Dry blending.


Primojel's exceptional swelling performance ensures rapid disintegration.
Primojel uses robust functionality across a variety of processes
Primojel is the sodium salt of starch methyl ether produced by the reaction of starch with gas acetic acid under alkaline conditions. 


The sodium (Na) content should be 80% ~ 2.0% based on the dry product washed with ethanol.
Primojel is white or off-white powder; Odorless; With hygroscopicity.
Primojel is dispersed into a viscous colloidal solution in water, which is insoluble in ethanol or ether.


Primojel is a odorless, tasteless, non-toxic, heat and moisture absorption. 
Primojel is dissolve in water to form a colloidal solution, which is stable to light and heat. 
Primojel is insoluble in ethanol, ether, chloroform and other organic solvents. 


Primojel's aqueous solution has good viscosity, stability, protective colloidity and film-forming properties, is not easy to decay and mold, is stable under alkaline and weak acid conditions, and will produce precipitation under strong acid conditions. 
The aqueous solution is more stable in alkali and worse in acid. 


Primojel generates free acid that is insoluble in water and reduces its viscosity, so it is not suitable for strong acidic foods. 
When the aqueous solution of Primojel is heated for a long time above 80°C, the viscosity decreases. 
Primojel has similar properties to carboxymethyl cellulose (CMC), with various properties such as thickening, suspension, dispersion, emulsification, bonding, water retention, and colloid protection.


Primojel is produced by cross-linking and carboxy- methylation of potato starch. 
Primojel is a white, free flowing powder.
Primojel is cross-linked carboxymethylcellulose sodium. 


Primojel is also a white, free flowing powder.
Primojel is produced by cross-linking and carboxy- methylation of potato starch. 
Primojel is a white, free-flowing powder.


Primojel is the carboxymethyl ether sodium salt. 
Primojel is a white to off-white tasteless, odorless powder. 
Primojel is a super disintegrant suitable for a variety of tablet and capsule formulations. 


In addition, at high concentrations Primojel acts as a dissolution enhancer.
Primojel is highly effective when added intragranularly or extragranularly during granulation.
Primojel is the sodium salt of carboxymethyl ether. 


Starch glycolates are of rice, potato, wheat or corn origin.
Primojel is a white to off-white, tasteless, odorless, relatively free flowing powder.
Primojel is a white or almost white, fine, very hygroscopic powder


Primojel is a superdisintegrant for swallowable tablets, orally dispersible tablets and hard capsules. 
The usual concentration of Primojel employed is between 2% and 8%.
Primojel, or SSG, is a cross-linked variant of Carboxymethyl starch. 


The color of Primojel varies from white to off-white tone. 
Primojel powder is odorless, tasteless, hygroscopic & free-flowing.

USES and APPLICATIONS of PRIMOJEL:
Primojel is a super disintegrant suitable for a variety of tablet and capsule formulations. 
In higher concentrations, Primojel can act as a dissolution enhancing agent. 
Primojel is highly effective when used intragranular and/or extragranular in granular formulations.


Primojel is used as an additive in the pulp industry, it has the functions of retention, filtration, and enhancement. 
Primojel is also used for surface gluing of paper.
Primojel is suitable for a variety of tablet and capsule formulations. 


In higher concentrations, Primojel can act as a dissolution enhancing agent.
Primojel is suitable for a variety of tablet and capsule formulations.
Primojel is effective in combination with both insoluble filler-binders, such as MCC and dicalciumphosphate and slightly soluble to soluble filler-binders such as mannitol and lactose at concentrations of 2-6%. 


Primojel is also a choice for formulations that require non-starch products.
Primojel is used in the pharmaceutical industry as an excipient helping in rapid disintegration. 
Primojel absorbs water quickly which result in swelling and this in turn provides rapid disintegration of granules as well as tablets. 


Primojel also acts as a suspending and gelling agent.
Primojel is used as a pharmaceutical grade dissolution excipient for tablets and capsules. 
Primojel absorbs water rapidly, resulting in swelling which leads to rapid disintegration of tablets and granules.


Primojel is used as a disintegrant, a suspending agent and as a gelling agent. 
Primojel is most widely used excipient in the field of pharmaceutical sciences. 
Primojel is extensively used as a superdisintegrant in different drug formulations. 


Primojel is a superdisintegrant suitable for a variety of tablet and capsule formulations. 
In higher concentrations, Primojel can act as a dissolution enhancing agent. 
Primojel is highly effective when used intragranular and/or extragranular in granular formulations.


-Functional Value of Sodium Starch Glycolate In the Pharmaceutical Industry:
As a basic excipient, Primojel always acts at the best level to boost the disintegration value in the processing of oral solid pharmaceutical products.
Primojel is also famous as a dissolution excipient in the pharmaceutical industry, with a standard absorption characteristic to enhance the swelling process, which is highly significant for the sustainable & classic texture of tablets and granules.

Triple unique characteristics of Primojel- suspending property, disintegrant & gelling agent play vital roles in tableting industries to ensure the clinical value of tablets. 
So, Primojel is essential as it provides active ingredients’ absorption in pharmaceutical formulations.


-Specific Applications of Primojel In the Pharmaceutical Industry:
The oral pharmaceutical products are processed with Primojel as a superb disintegrant.
For standard granulation in the tableting industry, Primojel plays an essential role in end-to-end compression.

The outstanding suspension capability makes Primojel a great choice as an excipient in the pharma industry.
The high-grade dissolution power of Primojel enhances the tablet and formulation textures.

ADVANTAGES OF PRIMOJEL:
Being a hydrophobic excipient, Primojel boosts the swelling while the granules contact with water. 
Primojel increases the compression pressure level to keep the disintegration process intact.

All these unique characteristics make Primojel one of the best choices as an excipient in clinical product manufacturing industries.
Primojel is primarily used as a disintegrant in pharmaceutical formulations to enhance the dissolution of tablets. 

PHYSICAL AND CHEMICAL PROPERTIES OF PRIMOJEL:
The aqueous solution of Primojel will be partially decomposed by bacteria in the atmosphere, reducing the viscosity. 
Primojel is harder to hydrolyze than ordinary starch. Insoluble in methanol, ethanol and other organic solvents. 

The pH of 1% aqueous solution of Primojel is 6.7~7.0. 
The aqueous solution of Primojel is more stable in alkali and worse in acid.

SOURCE OF PRIMOJEL:
Primojel is available in the starchy substance of potato & corn. 
The chemical treatments or modifications with starch properties produce Primojel. 

The proven chemical treatments with Primojel increase the hydrophilicity and reduce the water solubility level.
According to particle sizes, % of sodium chloride, and pH, the manufacturing companies use different grades of Primojel to meet the requirements of a faster disintegrant.

PRIMOJEL TYPE A:
Exceptional swelling performance ensures rapid disintegration
Robust functionality across a variety of processes
Primojel is a superdisintegrant suitable for various tablet and capsule formulations. 

In higher concentrations, Primojel can act as a dissolution enhancing agent. 
Primojel is highly effective when used intragranular and/or extragranular in dry/wet granulation processes.

DISINTEGRATION PERFORMANCE OF PRIMOJEL:
Primojel takes up more than 20 times its own weight of water. 
Rapid water penetration into the tablets and powerful swelling results in rapid disintegration. 

The swelling actions makes Primojel most effective in non-soluble matrices. 
Studies show that Primojel takes up more water than comparative products on the market and develops a strong disintegrating force making it a highly effective product. 

The botanic source, degree of cross-linking and degree of substitution of Primojel have been optimized in order to give rapid water uptake by the polymer without the formation of a viscous gel that may impede water penetration into the tablet.

IN DIRECT COMPRESSION OF PRIMOJEL:
The recommended starting point is 2%w/w to 4%w/w of Primojel. 

The figure shows how the disintegration time of various placebo tablets (250 mg / 9 mm tablets containing 4%w/w Primojel and 0.5%w/w magnesium stearate) is maintained after storage for 6 months at 40˚C / 75% RH in open containers. 

The disintegration of reference tablets stored for 6 months under ambient laboratory conditions is also shown. 
This data confirms that Primojel remains an effective superdisintegrant.

IN WET GRANULATION OF PRIMOJEL:
We recommend that Primojel is incorporated at least partly (50% or more) during the granulation. 
This is especially important when a high proportion of insoluble diluent is employed. 
The intragranular components were wet granulated (high shear), dried, sieved and blended with the extragranular portion of Primojel® and magnesium stearate. 

Tablets were compressed at 250 mg and dissolution tested in 900ml of water using USP apparatus 2. 
Dissolution of Diclofenac Sodium is slower when Primojel is used only in the extragranular phase. 
If lactose is used instead of dibasic calcium phosphate, then the effect of Primojel location is greatly reduced.

PHYSICAL and CHEMICAL PROPERTIES of PRIMOJEL:
CAS: 9063-38-1
EINECS: 618-597-7
Molecular Formula: C2H4O3·xNa·x
Melting Point: >210°C (dec.)
Solubility: Practically insoluble in methylene chloride. It gives a translucent suspension in water.
Appearance: White powder
Color: White to Off-White

FIRST AID MEASURES of PRIMOJEL:
-Description of first-aid measures
*General advice:
Show this material safety data sheet to the doctor in attendance.
*If inhaled:
After inhalation: 
Fresh air.
*In case of skin contact: 
Take off immediately all contaminated clothing. 
Rinse skin with
water/ shower.
*In case of eye contact:
After eye contact: 
Rinse out with plenty of water. 
Call in ophthalmologist. 
Remove contact lenses.
*If swallowed:
After swallowing: 
Immediately make victim drink water (two glasses at most). 
Consult a physician.
-Indication of any immediate medical attention and special treatment needed.
No data available

ACCIDENTAL RELEASE MEASURES of PRIMOJEL:
-Environmental precautions:
Do not let product enter drains.
-Methods and materials for containment and cleaning up:
Cover drains. 
Collect, bind, and pump off spills. 
Observe possible material restrictions. 
Take up dry. 
Dispose of properly. 
Clean up affected area.

FIRE FIGHTING MEASURES of PRIMOJEL:
-Extinguishing media:
*Suitable extinguishing media:
Carbon dioxide (CO2) 
Foam 
Dry powder
*Unsuitable extinguishing media:
For this substance/mixture no limitations of extinguishing agents are given.
-Further information:
Prevent fire extinguishing water from contaminating surface water or the ground water system.

EXPOSURE CONTROLS/PERSONAL PROTECTION of PRIMOJEL:
-Control parameters:
--Ingredients with workplace control parameters:
-Exposure controls:
--Personal protective equipment:
*Eye/face protection:
Use equipment for eye protection. 
Safety glasses
*Body Protection:
protective clothing
*Respiratory protection:
Recommended Filter type: Filter A 
-Control of environmental exposure:
Do not let product enter drains.

HANDLING and STORAGE of PRIMOJEL:
-Conditions for safe storage, including any incompatibilities:
*Storage conditions:
Tightly closed. 
Dry.

STABILITY and REACTIVITY of PRIMOJEL:
-Chemical stability:
The product is chemically stable under standard ambient conditions (room temperature) .
-Possibility of hazardous reactions:
No data available

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