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Product |
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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.
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Brand |
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Micro Crystalline Cellulose is offered in ordinary non spray dried &
spray dried directly compressible forms under the brand name LIBRAWCEL.
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Process |
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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
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Spray
Drying |
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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.
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Direct
Compressible Grade |
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Librawcel, Direct Compressible Grade of Micro Crystalline Cellulose can
be compressed into self - binding tablets, a boon for tablets
manufacturers.
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Advantages |
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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 |
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Librawcel Standards |
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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 |
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Comparison chart of Specificatoins |
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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% |
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Quality Control |
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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.
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Microbiological Laboratory |
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Libraw Pharma has a modern Micro Biological Laboratory to conduct
micro biological tests essential to make hygienic products.
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Packing |
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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.
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Librawcel - 102 Microcrystalline Cellulose, IP
(Spray Dried) |
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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 |
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Librawcel - W Microcrystalline Cellulose, IP
(Bulk Dried) |
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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. |
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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 |
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