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Micro Crystalline Cellulose
Micro Crystalline Cellulose is a mechanically
disintegrated level of D.P. Cellulose. It comprises purified,
de-polymerised, Micro Crystalline sub micron size colloidal particles. It is
produced by treating Alfa Cellulose obtained as a pulp from fibrous plants
with minerals acid.
It is a white, odourless, tasteless, extra free flowing powder which is
relatively free from organic and non-organic contaminants. It is
metabolically inert, and has excellent water absorptive, swelling &
dispersion properties, is insoluble in water, dilute acid, common organic
solvents and oils. It is partially soluble in dilute alkali.
Brand
Micro Crystalline Cellulose is offered in ordinary
non spray dried & spray dried directly compressible forms under the
brand name LIBRAWCEL
Process
Rayon Grade wood pulp, the main raw material is
hydrolyzed under very carefully controlled conditions. After Hydrolysis,
specific inclusion of hydrophobic agents is done. This is followed by
thorogh washing with de-mineralised water. The depathogenised slurry
prepared is pumped for Spray Drying and finally blended and packed.
Spray Drying
For the first time in India, Spray Dried Micro
Crystalline Cellulose is being manufactured & offered to the customer at
competitive prices. The Spray drier has been supplied and installed by M/s.
ALFA Laval in technical collaboration with APV Pasilac Anhydro, A/S Denmark.
The atomization of the feed to be dried takes place concurrent to the
drying air in a very robust atomizer revolving at an ultra high speed. The
profile of temperatures in the drier can be adjusted to give optimum drying
conditions. The feed to the atomizer is governed automatically by the
temperature of the air. The powder is collected at two points.
Direct Compressible Grade
Librawcel, Direct Compressible Grade of Micro
Crystalline Cellulose can be compressed into self - binding tablets, a boon
for tablets manufacturers.
Advantages
Direct Compressible Grade of Micro Crystalline
cellulose performs as an excipient to assist in the flow, lubrication and
binding properties of the ingredients to be tableted and improves stability
of durgs. Facilitate rapid disintegration of the tablet. It can be used in
direct compression of most drugs and because of savings in material,
capital, equipment and labour, it compensates the higher price of Direct
Compressible Micro Crystalline Cellulose over non spray dried Micro
Crystalline Cellulose.
The conventional costly method of tableting through 6 process steps is
replaced by 2 steps direct compression method of tableting. Detailed tests
and investigations by various agencies for the use of Direct Compressible
Grade Micro Crystalline Cellulose powder in tableting have shown :
- Excellent Compression & Hardness
- No Sign of Lubrication Difficulties
- Good Flowing Properties
- Reduces Friability & Weight Loss
Librawcel Standards
|
Particle Size /
Moisture Content |
Grade |
Particle Size Standards |
Average Particle Size |
Moisture |
Librawcel 101 |
+60 Mesh Not more than 1%
+200 Mesh Less than 30% |
50 Micron |
5 |
Librawcel 102 |
+60 Mesh Not more than 8%
+200 Mesh Less than 45% |
100 Micron |
5 |
Librawcel 103 |
+60 Mesh Not more than 1%
+200 Mesh Less than 30% |
50 Micron |
3 |
|
|
|
Microbiological
Analysis |
A |
Total microbial count
- NMT 100 CFU |
B |
Staphylococuus aureus
negative |
C |
Salmonella species
negative |
D |
E. coli negative |
|
|
Comparison chart of Specificatoins
|
Specifications |
I.P. |
U.S.P. |
B.P. |
Librawcel Average
Analysis Result |
Tests |
Identificatoin |
To Comply |
To Comply |
To Comply |
To Comply USP |
PH |
5.0 to 7.0 |
5.5 to 7.0 |
5.0 - 7.5 |
5.8 to 6.5 |
Loss on Drying |
NMT 5% |
NMT 5% |
NMT 6% |
3.5 - 4.0 |
Water Soluble Substances |
Max. 0.16% |
Max. 0.16% |
Max. 0.2% |
Max. 0.12% |
Residue on ignition |
NMT 0.2% |
NMT 0.05% |
NMT 0.1% |
Max. 0.05% |
Heavy metals |
NMT 10ppm |
NMT 10ppm |
NMT 10ppm |
Max. 10ppm |
Starch |
Negative |
Negative |
Negative |
Negative |
Arsenic |
NMT 2ppm |
NMT 2ppm |
NMT 2ppm |
NMT 2ppm |
Assay |
97 - 102% |
91 - 102% |
91 - 102% |
98.5 - 100% |
|
|
Quality Control
At Libraw, we believe in offering quality products
at affordable prices. Precautions are taken right from the sourcing of raw
material to the final packaging. The procurement of raw material is
subjected to intense quality check before being accepted. We have an inbuilt
system of analyzing the quality at various levels of production to ensure a
consistent superior product. We have a very elaborate modern sophisticated
laboratory where the final product is analysed for the detailed
specification before it is cleared for despatch.
Microbiological Laboratory
Libraw Pharma has a modern Micro Biological
Laboratory to conduct micro biological tests essential to make hygienic
products.
Packing
Packing is done in pre laminated HDPE bags. Any
modifications in packing can be suited to the customer need. Librawcel is
developed for the pharmaceutical industry where it has found extensive use
as an excipient and diluent. It has replaced competitive products because of
its uniqueness. For instance - In tableting, Starch is a good disintegrate
but a poor binder; Lactose is a good binder but a poor disintegrant. Spray
Dried Micro Crystalline Cellulose is an excellent binder and a good
disintegrant.
Non Spray Dried Micro Crystalline Cellulose, though less expensive than
Spray Dried Micro Crystalline Cellulose, is less pure and has poor flow
properties. In some pharmaceutical tablet products, traces of inorganic
impurities can markedly reduce drug stability and shelf life.
Librawcel - 102 Microcrystalline Cellulose, IP (Spray
Dried)
|
Parameters |
Specification |
Result |
Description |
Fine or Granular, White or almost
White, Free flowing Powder, Odorless |
Free flowing, White powder
Odorless |
Solubility |
Insoluble in water slight soluble
in dil. Sodium Hydroxide solution. It is insoluble in dil. Acids and
most organic solvents. |
Complies |
Identification |
A |
Should comply |
Complies |
B |
Should comply |
Complies |
C |
Should comply |
Complies |
pH |
5 to 7.5 |
6.21 |
Starch and Dextrins |
Absent |
Absent |
Organic Impurities |
Should Comply |
Complies |
Water Soluble Substances % |
NMT 0.2 |
0.14 |
Arsenic, ppm |
NMT 2 |
Passes |
Heavy Metal, ppm |
NMT 10 |
Passes |
Sulphated Ash, % |
NMT 0.2 |
0.063 |
Loss on Drying % |
NMT 6 |
4 |
Assay, % Cellulose |
97 - 102 |
99.42 |
In-House
Specification* |
Particle Size % |
Wt. + 60 mesh |
NMT 8 |
Passes |
Wt. +200 mesh |
NLT 45 |
Passes |
|
|
Librawcel - W Microcrystalline Cellulose, IP (Bulk
Dried)
|
Parameters |
Specification |
Result |
Description |
Fine or Granular, White or almost
White, Odorless |
Fine, White, Odorless Powder
Complies |
Solubility |
Insoluble in water slight soluble
in dil. Sodium Hydroxide solution,insoluble in dil. Acids and most
organic solvents & soluble in ammoniacal solution of copper
tetra mine. |
|
Indentification A, B & C |
Should comply |
Complies |
B Degree of Polymerizatoin |
NMT 350 |
195 |
pH |
5 to 7.5 |
6.39 |
Starch and Dextrins |
Absent |
Absent |
Organic Impurities |
Should Comply |
Complies |
Water Soluble Substances % |
NMT 0.2 |
0.1 |
Ether Soluble Sbustances |
NMT0.05 |
0.02 |
Arsenic, ppm |
NMT 2 |
Passes |
Heavy Metal, ppm |
NMT 10 |
Passes |
Sulphated Ash, % |
NMT 0.1 |
0.072 |
Loss on Drying % |
NMT 6 |
3.6 |
Assay, % Cellulose |
97 - 102 |
99.7 |
In-House
Specification* |
Particle Size % |
Wt. + 60 mesh |
NMT 1 |
Passes |
Wt. +200 mesh |
NLT 30 |
Passes |
|
|