SODIUM CMC COATED MICROCRYSTALLINE CELLULOSE POWDER ALFACEL – P(CC) – AS MAGICAL SUSPENDING AGENT GENERAL INFORMATION
ALFACEL P(CC) an innovative product manufactured by Ashok Brothers Products Limited is an improved product over ALFACEL - Microcrystalline Cellulose, which already enjoys wide acceptability in the drug industry, in terms of its rheological properties. • Better rheological Properties. • Temperature Changes have little effect on Viscosity. • No Phase separation for shelf life of Product. • Thixotropy evident with levels as low as 1%. • Lengthy Hydration not required. • Insensitive to sterilisation at high Temperatures. • Leaves no Residual Chalky, Drying effect. • Helps Mask Unpleasant Drug or Oily tastes.
Pharmaceutical formulators need no Introduction to ALFACEL, Microcrystalline Cellulose Powder manufactured by Ashok Brothers. It enjoys wide acceptability in the drug industry world wide especially in tableting drugs. However keeping in tune with our policy of fine-tuning our products to suit different applications. Ashok Brothers has fine-tuned its popular and widely accepted Microcrystalline Cellulose Powder. The result is ALFACEL P(CC) which has outstanding rheological properties as a result of which it serves as a magical suspending agent far superior to all existing suspending agents.
PRODUCT
ALFACEL -P(CC) is an improvement in terms of its suspension over our earlier grades of Microcrystalline Cellulose in terms of its rheological properties. It is a colloidal form of Microcrystalline Cellulose, which has been blended with NaCMC and dried.
The original crystalline areas of the fiber are combined with NaCMC to produce the colloidal ALFACEL-P (CC). The CMC serves as a protective colloid and also aids in dispersion of the product. ALFACEL-P (CC) disperses easily in water to form a colloidal solution or white opaque gel depending on the concentration.
PRODUCT BROAD APPLICATIONS
| o/w Emulsifier |
As in Pharmaceutical and Cosmetic Lotions and Creams. |
| Emulsion Stabiliser |
As in Pharmaceutical and Cosmetic Lotions and Creams. |
| Foam Stabiliser |
As in Aerosol Foams. |
| Suspending Agent |
As in Pharmaceutical and Cosmetic Suspensions, Reconstitutable Pharmaceutical Suspensions such as Antibiotics. |
| Body Agent, Stiffener, Opacifier |
As in Pharmaceutical and Cosmetic Creams, Vaginal Gels, Cosmetic Gels. |
ADVANTAGES OF USING ALFACEL -P (CC)
ALFACEL - Microcrystalline Cellulose Powder is a very good product especially for tableting. . However it is not a very good suspending agent and its dispersion settles down. The addition of NaCMC to Microcrystalline Cellulose gives it wonderful rheological properties.
- Forms Highly Thixotropic Gels and have finite yield value at concentrations as low as 1%.
- Gels are shear thinking and upon resting yield value returns to Equilibrium value and formulation with an optimum level of ALFACEL -P (CC) will result in a well-structured suspension vehicle, which will not exhibit any phase separation for the shelf life of the Product.
- Changes in Temperature have little effect on the Viscosity of ALFACEL-P(CC)
- Sterilisation at High Temperatures will not alter the Physical Properties.
- Can be Hydrated and used the same day, Lengthy Hydration not required as Equilibrium Viscosity is Rapidly attained.
- Helps mask many unpleasant Drug, Surfactant, or Oily Tastes.
- ALFACEL-P(CC) suspensions do not leave a residual Chalky, Drying effect after oral Administration.
- Can be Dispersed Quickly in water in any Pharmaceutical Plant using Standard mixing Equipment.
- Compatible with many Hydrocolloids.
- Suspension Viscosity stable over a pH range of 4-11.
- Suspension prepared with ALFACEL-P(CC) can tolerate large Quantities of Glycol and Alcohol Excipient Liquids. Commonly used in suspension Compounding.
PACKING AND STORAGE
ALFACEL-P(CC). Is supplied in 25 kilos net weight HDPE Polylined sacks with extra liner inside. It should be stored in the dry place under which conditions, it can be kept indefinitely.
STANDARD SPECIFICATION OF SODIUM CMC COATED MICROCRYSTALLINE CELLULOSE POWDER
ALFACEL P (CC)
PHYSICAL PROPERTIES.
| Composition |
89 + 4 Parts Microcrystalline Cellulose 11 + 4 Parts NaCMC. |
| Physical Form |
White water dispersible powder. |
| Particle Size |
Powder less than 0.1% on 60-mesh screen. Less than 35% on 325 mesh screen. Average particle size is 28 microns. In Dispersion Ultimate particle size is 0.15 microns |
| Bulk Density |
0.59 gm/cc - loose pack0.83 gm/cc - tight pack |
| Specific Gravity |
1.55 |
| Ash |
2.5% |
| Heavy Metals |
< 10 ppm |
| pH of 2% Dispersion |
6 to 8 |
| Moisture Content |
6% (maximum) |
| Solubility |
Insoluble in water and Organic solvents, Disperses in water to form colloidal sols and gels. |
| Moisture Regain |
R.H (%) Moisture Content. |
| 25 |
5.0 |
| 50 |
7.0 |
| 75 |
10.2 |
GRADES OF ALFACEL P (CC)
| |
Alfacel P(CC) 501 |
Alfacel P(CC) 581 |
Alfacel P(CC)591 |
Alfacel P(CC)611 |
| MoistureContent(When Shipped) |
< 6.0% |
< 6.0% |
< 6.0% |
< 6.0% |
| Heavy Metals |
< 10 ppm |
< 10 ppm |
< 10 ppm |
< 10 ppm |
| Ash |
< 2.5% |
< 2.5% |
< 2.5% |
< 5.0% |
| Percent NaCMC |
8.5 ± 2.1 |
11.1 ± 2.7 |
11.1 ± 2.7 |
11.3-18.8 |
| Granular / Powder Particle size |
60 mesh < 0.1%200 mesh < 35.0% |
60 mesh < 0.1%200 mesh < 35.0% |
60 mesh < 0.1%200 mesh < 20.0% |
60 mesh < 0.1 % 325 mesh < 50.0% |
| PH(1-2% solid dispersion) |
6 to 8 |
6 to 8 |
6 to 8 |
6 to 8 |
| Viscosity, cps 1.2% Solution |
|
120 ± 48 |
65 ±26 |
5 - 20 |
| Viscosity |
cps 2.1% Solution |
120 ± 48 |
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