Chemical Properties
white powder
Uses
ACCEL-101 is most widely used for direct compression tableting and wet granulation.
ACCEL-102 has similar compression properties to ACCEL-101. However, it has larger particle size and therefore, may be of value in improving the flow if fine powders.
ACCEL
Uses
High purity cellulose powders for partition chromatography.
General Description
Odorless, white powdery fibers. Density 1.5 g cm-3. The biopolymer composing the cell wall of vegetable tissues. Prepared by treating cotton with an organic solvent to de-wax Cellulose microcrystalline and removing pectic acids by extration with a solution of sodium hydroxide. The principal fiber composing the cell wall of vegetable tissues (wood, cotton, flax, grass, etc.). Technical uses depend on the strength and flexibility of its fibers. Insoluble in water. Soluble with chemical degradation in sulfuric aicd, and in concentrated solutions of zinc chloride. Soluble in aqueous solutions of cupric ammonium hydroxide (Cu(NH3)4(OH)2).
Reactivity Profile
Cellulose microcrystalline is combustible. Incompatible with strong oxidizing agents including bromine pentafluoride, sodium nitrate, fluorine, perchlorates, perchloric acid, sodium chlorate, magnesium perchlorate, F2, zinc permanganate, sodium nitrite, sodium nitrate, sodium peroxide. Nitration with a mixture of nitric and sulfuric acids produces Cellulose microcrystalline nitrates (celluloid pyroxylin, soluble pyroxyline, guncotton) which are flammable or explosive.
Occurrence
The fiber in typical paper can be called “cellulosic”, meaning that cellulose is its most prominent component. Cellulose is present not only in wood, but also in various non-woody plants, such as straw, sugarcane (bagasse), reeds, and hemp.
Production Methods
Microcrystalline cellulose and carboxymethylcellulose sodium is a
spray- or bulk-dried blend of microcrystalline cellulose and sodium
carboxymethylcellulose. It is prepared by the chemical depolymerization
of highly purified wood pulp. The original crystalline areas
of the pulp fibers are combined with sodium carboxymethylcellulose,
which serves as a protective colloid and also facilitates
dispersion of the product; it is then either spray- or bulk-dried.
Production Methods
Microcrystalline cellulose is manufactured by controlled hydrolysis
with dilute mineral acid solutions of α-cellulose, obtained as a pulp
from fibrous plant materials. Following hydrolysis, the hydrocellulose
is purified by filtration and the aqueous slurry is spraydried
to form dry, porous particles of a broad size distribution.
Health Hazard
Cellulose is inert and is classified
as a nuisance dust.
It has little, if any, adverse effect on the
lung, and there are no reports of organic
disease or toxic effect. The health effects
attributed to wood, cotton, flax, jute, and hemp
are not attributable to their cellulose content
but rather to the presence of other substances.
Cellulose fibers were found in the blood
and urine of human volunteers fed dyed cellulose;
there were no ill effects.
Pharmaceutical Applications
Microcrystalline cellulose and carboxymethylcellulose sodium is
used to produce thixotropic gels suitable as suspending vehicles in
pharmaceutical and cosmetic formulations. The sodium carboxymethylcellulose
aids dispersion and serves as a protective colloid.
Concentrations of less than 1% solids produce fluid dispersions,
while concentrations of more than 1.2% solids produce thixotropic
gels. When properly dispersed, it imparts emulsion stability, opacity
and suspension in a variety of products, and is used in nasal sprays,
topical sprays and lotions, oral suspensions, emulsions, creams
and gels.
Industrial uses
Cellulose is the main constituent of the structureof plants (natural polymer) that, whenextracted, is employed for making paper,plastics, and in many combinations. Celluloseis made up of long-chain molecules inwhich the complex unit C6H10O5 is repeatedas many as 2000 times. It consists of glucose molecules with three hydroxyl groups foreach glucose unit.
One of the simplest forms of cellulose usedindustrially is regenerated cellulose, in whichthe chemical composition of the finished productis similar to that of the original cellulose. Itis made from wood or cotton pulp digested ina caustic solution. Cellophane is a regeneratedcellulose in thin sheets for wrapping and otherspecial uses include windings on wire andcable.
Biochem/physiol Actions
Cellulose helps in maintaining the structural stability of plant cell walls. It is an important component of paper and fabrics made from cotton, and linen.
Safety
Microcrystalline cellulose is widely used in oral pharmaceutical
formulations and food products and is generally regarded as a
relatively nontoxic and nonirritant material.
Microcrystalline cellulose is not absorbed systemically following
oral administration and thus has little toxic potential. Consumption
of large quantities of cellulose may have a laxative effect, although
this is unlikely to be a problem when cellulose is used as an excipient
in pharmaceutical formulations.
Deliberate abuse of formulations containing cellulose, either by
inhalation or by injection, has resulted in the formation of cellulose
granulomas.
storage
Microcrystalline cellulose and carboxymethylcellulose sodium is
hygroscopic and should not be exposed to moisture. It is stable over
a pH range of 3.5–11. Store in a cool, dry place. Avoid exposure to
excessive heat.
Incompatibilities
Microcrystalline cellulose is incompatible with strong oxidizing
agents.
Regulatory Status
Microcrystalline cellulose and carboxymethylcellulose sodium is a mixture of two materials both of which are generally regarded as nontoxic:
Microcrystalline cellulose GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (inhalations; oral capsules, powders, suspensions, syrups, and tablets; topical and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients.
Carboxymethylcellulose sodium GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Database (dental preparations; intra-articular, intrabursal, intradermal, intralesional, and intrasynovial injections; oral drops, solutions, suspensions, syrups and tablets; topical preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Nonmedicinal Ingredients.
