Product

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

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