CROSCARMELLOSE SODIUM

Croscarmellose Sodium was first used as a stabilizer in horse supplements.
Croscarmellose Sodium, or sodium CMC, is a cross-linked polymer of carboxymethylcellulose sodium. 
Croscarmellose Sodium appears as white, fibrous, free-flowing powder, and is used commonly as an FDA-approved disintegrant in pharmaceutical manufacturing. 

CAS Number: 74811-65-7
EINECS Number: 1312995-182-4

Synonyms: Carboxymethylcellulose sodium salt, Croscarmellose sodium, 9085-26-1, Edifas B, 9004-32-4, Carboxymethyl cellulose, sodium salt, Carmellose sodium, Aquaplast, Sodium carboxymethylcellulose, Carboxymethyl Cellulose Sodium, Aquacel, Carmethose, Cellofas, Cellpro, Cellufresh, Cellugel, Celluvisc, Collowel, Ethoxose, Lovosa, Sarcell tel, Carboxymethylcellulose sodium [USP], Cellofas B, Cellofas C, Cellogel C, Cellogen PR, Glikocel TA, CMC sodium salt, Nymcel S, Tylose C, Blanose BWM, Nymcel slc-T, Lovosa TN, Tylose CB series, Tylose CR, Unisol RH, Cellofas B5, Cellofas B6, Cellogen 3H, Sodium CMC, Tylose DKL, Carbose 1M, Cellogen WS-C, Majol PLX, Cellofas B50, Courlose F 4, Courlose F 8, Tylose CBR series, Avicel RC/CL, NaCm-cellulose salt, Sodium CM-cellulose, Courlose F 20, Copagel PB 25, Sanlose SN 20A, Cellufix FF 100, Courlose A 590, Courlose A 610, Courlose A 650, Courlose F 370, Modocoll 1200, Nymcel ZSB 10, Nymcel ZSB 16, Tylose CBS 30, Tylose CBS 70, Tylose CR 50, Blanose BS 190, Tylose 666, Tylose C 30, AC-Di-sol. NF, Tylose CBR 400, Courlose F 1000G, Tylose C 300, Tylose C 600, Tylose CB 200, Daicel 1150, Daicel 1180, Tylose C 1000P, CM-Cellulose sodium salt, Cellulose sodium glycolate, Sodium cellulose glycolate, Sodium glycolate cellulose, CMC 7MT, CMC 7H, CMC 7H3SF, CMC 7M, Sodium carboxmethylcellulose, CMC 3M5T, 7H3SF, CMC 2, Aku-W 515, KMTs 212, KMTs 300, KMTs 500, KMTs 600, CMC 41A, CMC 4H1, CMC 4M6, CMC 7L1, Lovosa 20alk., CCRIS 3653, Cellulose carboxymethyl ether sodium salt, S 75M, UNII-E0DNV5JJHX, Cellulose glycolic acid, sodium salt, Sodium salt of carboxymethylcellulose, UNII-6ZQ8V6YVNK, UNII-6YYV7VRE59, UNII-72QQR5RYU4, UNII-D7SXM450NR, UNII-FC40A8XAJ3, UNII-M8VP63K8FU, UNII-RYZ9SHL900, UNII-Y3R0RA1Q8S, UNII-YGX74DKE74, UNII-0Z2R7OG99L, UNII-8UX21M67IJ, UNII-8W25JI0G3V, UNII-M9J9397QWS, UNII-R05Y0B55JY, UNII-S5517JT8YS, UNII-V5U74HSL76, UNII-X075FT70UI, UNII-ZY4732LP1O, B 10, UNII-0891BL4S3D, UNII-1RD48779FJ, UNII-379M03VC9O, UNII-4J4P6L645M, UNII-75KU4500GF, UNII-97W605BIK0, UNII-99H65D77XY, UNII-K679OBS311, UNII-93O70285VH, UNII-KX442849T5, Carmellose sodium, low-substituted, Cellulose carboxymethyl ether, sodium salt, E0DNV5JJHX, 6ZQ8V6YVNK, UNII-0F4M8SIS5K, 0F4M8SIS5K, 6YYV7VRE59, 72QQR5RYU4, D7SXM450NR, FC40A8XAJ3, M8VP63K8FU, RYZ9SHL900, Y3R0RA1Q8S, YGX74DKE74, SCHEMBL454741, 0Z2R7OG99L, 8UX21M67IJ, 8W25JI0G3V, M9J9397QWS, R05Y0B55JY, S5517JT8YS, V5U74HSL76, X075FT70UI, ZY4732LP1O, Refresh Plus, Cellufresh Formula, DPXJVFZANSGRMM-UHFFFAOYSA-N, 0891BL4S3D, 1RD48779FJ, 379M03VC9O, 4J4P6L645M, 75KU4500GF, 97W605BIK0, 99H65D77XY, Cellulose, carboxymethyl ether, sodium salt, low-substituted, K679OBS311, CARBOXYMETHYLCELLULOSESODIUMSALT, AKOS015915206, 93O70285VH, KX442849T5, NS00013438, A843419, CARBOXYMETHYLCELLULOSE SODIUM, LOW-SUBSTITUTED, Sodiumcroscarmellose;CROSCARMELLOSE SODIUM;MODIFIED CELLULOSE GUM;PRIMELLOSE(R);Crosscarmelosesodium;Croscarmellose natrium;Cross-linked carboxymethylcellulose sodium;Unii-m28ol1hh48

Croscarmellose Sodium is prepared by steeping cellulose, obtained from wood pulp or cotton fibers, in sodium hydroxide solution. 
The alkali cellulose is then reacted with sodium monochloroacetate to obtain carboxymethylcellulose sodium. 
After the substitution reaction is completed and all of the sodium hydroxide has been used, the excess sodium mono chloroacetate slowly hydrolyzes to glycolic acid. 

Croscarmellose Sodium changes a few of the sodium carboxymethyl groups to the free acid and catalyzes the formation of cross link stop roduce croscarmellose sodium.
The Croscarmellose Sodium is then extracted with aqueous alcohol and any remaining sodium chloride or sodium glycolate is removed. 
After purification, croscarmellose sodium of purity greater than 99.5% is obtained. 

Croscarmellose Sodium may be milled to break the polymer fibers into shorter lengths and hence improve its flow properties.
The cross-linking reduces water solubility while still allowing the material to swell (like a sponge) and absorb many times its weight in water. 
As a result, it provides superior drug dissolution and disintegration characteristics, thus improving formulas′ subsequent bioavailability by bringing the active ingredients into better contact with bodily fluids.

Croscarmellose Sodium also resolves formulators′ concerns over long-term functional stability, reduced effectiveness at high tablet hardness levels, and similar problems associated with other products developed to enhance drug dissolution. 
Croscarmellose Sodium is a very commonly used pharmaceutical additive approved by the U.S. Food and Drug Administration. 
Croscarmellose Sodium purpose in most tablets – including dietary supplements – is to assist the tablet in disintegrating in the gastrointestinal tract promptly. 

If a tablet disintegrating agent is not included, the tablet could disintegrate too slowly, in the wrong part of the intestine or not at all, thereby reducing the efficacy and bioavailability of the active ingredients.
Croscarmellose Sodium is made by first soaking crude cellulose in sodium hydroxide, and then reacting the cellulose with sodium monochloroacetate to form sodium carboxymethylcellulose. 
Excess Croscarmellose Sodium slowly hydrolyzes to glycolic acid and the glycolic acid catalyzes the cross-linkage to form sodium croscarmellose.

Chemically, it is the sodium salt of a cross-linked, partly O-(carboxymethylated) cellulose.
Disintegrants facilitate the breakup of a tablet in the intestinal tract after oral administration. 
Cross-linking allows enhanced bioavailability of the drug through superior drug dissolution. 

Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness.
Croscarmellose Sodium is a chemically modified form of cellulose, a naturally occurring polymer, which is commonly used as a disintegrant in pharmaceutical formulations. 
Croscarmellose Sodium is a crosslinked sodium salt of carboxymethylcellulose, and it is specifically designed to help tablets and capsules disintegrate more efficiently after ingestion, enabling the active ingredients to be released and absorbed by the body. 

Croscarmellose Sodium is water-soluble and forms a gel-like matrix when it comes into contact with water, facilitating the breakdown of solid dosage forms in the digestive system.
In addition to its use in the pharmaceutical industry, Croscarmellose Sodium also finds application in other industries, such as cosmetics, food processing, and agriculture, owing to its ability to absorb water and swell, improving the texture or consistency of formulations. 
It is generally regarded as safe for use in both food and pharmaceutical products, with a long history of use in these areas. 

However, like other excipients, its use must be carefully regulated to avoid potential adverse reactions, particularly in individuals with allergies or sensitivities to cellulose-based products.
Croscarmellose Sodium is a modified cellulose compound that has become an essential ingredient in many pharmaceutical formulations due to its versatility and effectiveness as a disintegrant. 
Its crosslinked structure allows for enhanced water absorption, which results in rapid swelling and breakdown of tablets or capsules once they are ingested. 

This characteristic not only ensures that the active pharmaceutical ingredient (API) is quickly released into the gastrointestinal tract, but it also helps to improve the overall bioavailability of the medication. 
As a result, Croscarmellose Sodium contributes significantly to the effectiveness of the drug by enhancing its dissolution and absorption rates.

Melting point: >205°C (dec.)
Density: Bulk density (g/cc) 0.48
Storage temp.: Hygroscopic, -20°C Freezer, Under inert atmosphere
Solubility: Practically insoluble in acetone, in anhydrous ethanol and in toluene.
Form: Solid
Color: White to Off-White
Odor: At 100.00%, odorless
pH: 5-7 (20°C, 10g/L in H2O)
Water solubility: 30g/L

The efficacy of disintegrants, such as croscarmellose sodium, may be slightly reduced in tablet formulations prepared by either the wet-granulation or direct-compression process that contain hygroscopic excipients such as sorbitol.
Croscarmellose Sodium is not compatible with strong acids or with soluble salts of iron and some other metals such as aluminum, mercury, and zinc.
Croscarmellose Sodium, NF is an internally crosslinked sodium carboxymethylcellulose. 

Croscarmellose Sodium, NF is used commonly as a FDA-approved disintegrant in pharmaceutical manufacturing. 
The cross linking minimizes its solubility in water while allowing it to absorb many times its weight in water like a sponge.
Croscarmellose Sodium is a chemically modified form of cellulose, a naturally occurring polymer, which is commonly used as a disintegrant in pharmaceutical formulations. 

Croscarmellose Sodium is a crosslinked sodium salt of carboxymethylcellulose, and it is specifically designed to help tablets and capsules disintegrate more efficiently after ingestion, enabling the active ingredients to be released and absorbed by the body. 
Croscarmellose Sodium is water-soluble and forms a gel-like matrix when it comes into contact with water, facilitating the breakdown of solid dosage forms in the digestive system.

In addition to its use in the pharmaceutical industry, Croscarmellose Sodium also finds application in other industries, such as cosmetics, food processing, and agriculture, owing to its ability to absorb water and swell, improving the texture or consistency of formulations. 
Croscarmellose Sodium is generally regarded as safe for use in both food and pharmaceutical products, with a long history of use in these areas. 
However, like other excipients, its use must be carefully regulated to avoid potential adverse reactions, particularly in individuals with allergies or sensitivities to cellulose-based products.

Beyond its role in pharmaceutical products, Croscarmellose Sodium is commonly used in a wide range of personal care and cosmetic applications. 
Croscarmellose Sodium serves as a stabilizer and thickening agent in formulations such as lotions, creams, and gels, helping to improve the product's texture and consistency.
In certain formulations, it also provides moisture retention, preventing the product from becoming too runny or unstable.

Croscarmellose Sodiums biocompatibility with the skin and non-toxic nature makes it a preferred choice for topical applications.
In food technology, Croscarmellose Sodium is used to improve the quality of processed foods, especially gluten-free products. 
Croscarmellose Sodium can act as a binding agent that gives a desired texture, mouthfeel, and moisture retention in baked goods or other food items. 

Croscarmellose Sodium also has applications in low-fat and fat-reduced products, where it helps mimic the mouthfeel of fat without the calorie content. 
This makes it a popular choice in functional food products designed for weight management or dietary restrictions.
Despite its widespread use, there are guidelines set by regulatory authorities like the FDA and European Food Safety Authority (EFSA) that specify the maximum allowable concentrations of Croscarmellose Sodium in various products. 

In pharmaceutical formulations, excessive concentrations could potentially lead to issues such as reduced tablet stability or unwanted side effects. 
Therefore, manufacturers are required to adhere to these regulations to ensure the safety, quality, and efficacy of the final product.

Storage
Croscarmellose sodium is a stable though hygroscopic material.
A model tablet formulation prepared by direct compression, wit cros carmel lose sodium asadisintegrant, show edno significant differenceindrugdissolutionafterstorageat30°Cfor14months.
Croscarmellose sodium should be stored in a well-closed container in a cool, dry place.

Uses:
Used as Disintegrant in Capsules, Tablet and Granule Formulations.
Croscarmellose Sodium is a super disintegrant used in pharmaceuticals in the synthesis of tablets for oral administration.
Croscarmellose sodium is used in oral pharmaceutical formulations as a disintegrant for capsules, tablets, and granules.

In tablet formulations, croscarmellose sodium may be used in both direct-compressionand wet-granulation processes.
When used in wet granulations, the croscarmellose sodium should be added in both the wet and dry stages of the process (intra- and extragranularly) so that the wicking and swelling ability of the disintegrant is best utilized. 
Croscarmellose sodium at concentrations up to 5% w/w may be used as a tablet disintegrant, although normally 2% w/w is used in tablets prepared by direct compression and 3% w/w in tablets prepared by a wet-granulation process.

Croscarmellose Sodium is primarily used in the pharmaceutical industry, where it serves as an essential disintegrant in tablet and capsule formulations. 
Croscarmellose Sodium is specifically designed to promote the rapid breakdown of solid oral dosage forms upon contact with water, facilitating the quick release of the active pharmaceutical ingredient (API) in the gastrointestinal tract. 
This accelerates the absorption of the medication, improving its bioavailability and ensuring that the intended therapeutic effects are achieved more efficiently. 

In addition to its disintegrant properties, Croscarmellose Sodium can also be used as a binder in tablet formulations, enhancing the mechanical strength and integrity of the tablets.
In the field of food manufacturing, Croscarmellose Sodium is often employed as a texturizing agent or stabilizer, particularly in gluten-free and low-fat food products. 
Croscarmellose Sodium contributes to the desired consistency and mouthfeel of processed foods such as baked goods, sauces, dressings, and dairy products. 

By acting as a moisture retention agent, it helps maintain the product's moisture content, preventing it from becoming dry or brittle. 
This is particularly important in gluten-free products, where achieving the right texture can be challenging due to the absence of traditional gluten-forming ingredients. 
Additionally, Croscarmellose Sodium helps improve the viscosity of liquid food products, providing a smooth, consistent texture.

The compound also finds use in cosmetic and personal care products, where it acts as a stabilizer and thickening agent in formulations like creams, lotions, gels, and shampoos.
In these products, Croscarmellose Sodium helps to maintain the uniformity and consistency of the formulation, ensuring that the active ingredients are evenly dispersed throughout the product. 
Its ability to retain moisture also contributes to improved skin hydration and the overall sensory experience of the product. 

Croscarmellose Sodium can provide improved spreadability and ease of application, making it a valuable ingredient in various cosmetic formulations.
Another significant application of Croscarmellose Sodium is in the manufacturing of controlled-release or extended-release drug formulations. 
In these applications, the compound helps control the release rate of the active ingredient over time, ensuring a more sustained and prolonged therapeutic effect. 

This is especially useful for drugs that require gradual absorption to maintain steady therapeutic levels in the bloodstream, such as pain relievers, antihypertensive medications, and certain hormone therapies.
Due to its biocompatibility, non-toxicity, and versatility, Croscarmellose Sodium is widely regarded as a safe and effective excipient in both pharmaceutical and non-pharmaceutical industries. 
Its range of applications continues to grow, as research explores its potential for use in various other sectors such as biotechnology, nutraceuticals, and even agriculture.

Croscarmellose Sodium is also utilized in the development of fast-dissolving dosage forms, which are designed to dissolve quickly in the mouth without the need for water. 
These formulations are particularly beneficial for patients who have difficulty swallowing tablets or capsules, such as the elderly, children, or individuals with dysphagia. 
By aiding in the rapid disintegration of the dosage form, Croscarmellose Sodium ensures that the medication is released promptly, allowing for quicker onset of action, which is especially crucial for treatments like pain relief or emergency medications.

Additionally, Croscarmellose Sodium's versatility extends to its role in the preparation of topical formulations, including ointments and creams. 
In these products, it serves not only as a disintegrant but also helps to stabilize the formulation, ensuring uniform distribution of active ingredients on the skin. 
This stabilization is important to maintain the efficacy of the product over time, preventing separation or degradation of key ingredients. 

Moreover, its ability to bind water and maintain hydration makes it beneficial in formulations designed to treat dry skin conditions or provide moisturization.
In the biotechnology and pharmaceutical sectors, Croscarmellose Sodium has garnered attention for its potential use in creating controlled-release systems for biologic drugs, including proteins and peptides. 
These drugs often require specialized delivery methods due to their instability or rapid degradation in the body. 

Croscarmellose Sodium’s properties make it suitable for use in microencapsulation or other delivery technologies, where it helps protect the biologic drug from degradation while controlling its release over a prolonged period. 
This can improve patient adherence to treatment regimens by reducing the frequency of dosing.
Croscarmellose Sodium is also explored in the context of "orally disintegrating" tablet (ODT) technologies, where it can be integrated into formulations that dissolve in the mouth within seconds, providing patients with a more convenient and effective way to take medication. 

These ODTs are particularly advantageous for patients who are on the go, as they eliminate the need for water and can be easily consumed without the need for swallowing large pills.
In the field of agriculture, Croscarmellose Sodium has shown potential as a coating material for controlled-release fertilizers. 
By controlling the rate at which the fertilizer breaks down, it ensures that nutrients are released gradually over time, reducing the need for frequent applications and promoting more efficient use of resources. 
This has significant environmental benefits, as it minimizes nutrient runoff and ensures that plants receive a steady supply of nutrients for optimal growth.

Moreover, research into the use of Croscarmellose Sodium in drug delivery systems has led to innovative formulations that target specific areas of the gastrointestinal tract, such as the colon. 
This targeted delivery is particularly useful for drugs that need to act in specific regions of the body, such as those used to treat inflammatory bowel diseases (IBD) or colon cancer. 
Croscarmellose Sodium aids in the development of these advanced formulations by ensuring that the drug is released at the right time and location for maximum therapeutic benefit.

As a result of its wide range of applications, Croscarmellose Sodium remains an important excipient and material in the development of novel pharmaceutical products, food formulations, cosmetics, and agricultural products. 
Its role in enhancing the performance and effectiveness of these products underscores its versatility and continued relevance across multiple industries.

Safety Profile:
Croscarmellose sodium is mainly used as a disintegrant in oral pharmaceutical formulations and is generally regarded as an essentially nontoxic and nonirritant material. 
However, oral consumption of large amounts of croscarmellose sodium may have a laxative effect, although the quantities used in solid dosage formulations are unlikely to cause such problems.
In the UK, croscarmellose sodium is accepted for use in dietary supplements.

The WHO has not specified an acceptable daily intake for the related substance carboxymethylcellulose sodium, used as a food additive, since the levels necessary to achieve a desired effect were not considered sufficient to be a hazard to health.
Inhalation of fine dust particles from Croscarmellose Sodium could lead to respiratory irritation, coughing, or difficulty breathing. 
Chronic exposure to dust particles may potentially aggravate pre-existing respiratory conditions, such as asthma, or contribute to the development of respiratory issues. 

Proper ventilation and dust control measures should be in place during handling, especially in large-scale production settings.
Croscarmellose sodium may cause mild irritation upon contact with the skin or eyes, especially if the substance is in a powdered form. 

Direct eye contact may result in redness, watering, or discomfort, while skin contact might cause itching or a rash. 
Although these reactions are generally mild and temporary, it is advisable to use protective equipment like gloves, goggles, and lab coats to minimize exposure during handling.