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Hirllose - (Croscarmellose Sodium)

Croscarmellose Sodium manufactured by the company. It is as white creamish granular powder and superior tablet disintegrator the superiority arising due to its unique chemistry.

PRODUCTS BENEFITS

  • Superior table disintegrator
  • Effective at low use levels.
  • Superior long term dissolution stability.
  • Insensitive to tablet hardness.
  • Can be used in both wet granulation & direct compression.

Tablet dissolution can be greatly increased by the use of a super disintegrant. These can employ various mechanisms or combinations of mechanism to cause rapid tablet breakdown. Water wicking (uptake) and disintegrant swelling represent two means commonly used in determining disintegrant performance. The fibrous nature of Croscarmellose sodium gives it out standing water wicking capabilities and its cross-linked chemical structure creates an insoluble hydrophilic, highly absorbent material which results in good swelling properties. This duel functionality translates into superior disintegration characteristics at very low use levels compared to other super disintegrants.

IN DIRECT COMPRESSION

To increase drug dissolution in direct compression formulations, Croscarmellose sodium should be added to the other formulation components and dry blended to a homogeneous mixture prior to the addition of lubricants. This uniform distribution of croscarmellose sodium in the tablet matrix enables it to wick water and swell, therby breaking the tablet apart and exposing more surface area of the drug to gastric fluids.

IN WET GRANULATION

In most cases, Croscarmellose sodium should be added during the wet granulation process and to the dry granules prior to compression. This improves drug dissolution by taking full advantage of its wicking and swelling properties. The addition of Croscarmellose sodium during the wet mixing phase results in an intimate mixture of Croscarmellose sodium, drug, binder and filler within the granular matrix. This intragranular distribution of Carmecel –P (CC) allows it to break down the granules by swelling and exposes greater surface area of the drug to gastric fluids.

CROSSCARMELLOSE SODIUM

Chemical description

White or almost white, granular powder, Odorless or almost odorless, Hygroscopic

Solubility

Complies

Identification Test ( A,B,C )

Complies

PH

5.0-7.0

Settling Volume

10-30 ml

Water soluble Matter

10% Max

Heavy Metals

NMT :10 Ppm

Sodium Chloride &Sodium glycolate

NMT :0.50%

Lod( Max %)

NMT 10.0 %

D.S.

0.60- 0.85

Total Aerobic Microbial Count

NMT  1000 c fu /gm

Total yeast &muold count

NMT  100 c fu/gm

Pathogens (E Coli, pseudomonas,  aeruginosa, staphylococcus aureus, salmonella)

Absent