Croscarmellose Sodium Powder

Product Description

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Croscarmellose Sodium Powder is a commonly used excipient in the pharmaceutical, nutraceutical, and food industries. It is a modified form of cellulose, specifically designed to act as a disintegrant in tablet and capsule formulations. Croscarmellose sodium helps tablets and capsules break down efficiently in the digestive system, ensuring that the active ingredients are released for absorption. It is widely used in the production of oral solid dosage forms like tablets, capsules, and powder blends.

Chemical Composition:

Chemical Name: Sodium carboxymethylcellulose

Formula: (C6H7NaO2)n

Croscarmellose sodium is a cross-linked form of sodium carboxymethylcellulose, a derivative of cellulose. The cross-linking structure improves its ability to absorb water and expand, making it an effective disintegrant in solid dosage forms.

Physical Characteristics:

Appearance: White to off-white, free-flowing powder.

Solubility: Insoluble in water but absorbs water rapidly, leading to its swelling and the disintegration of tablets and capsules in the gastrointestinal tract.

Particle Size: Fine, typically a powder that can pass through standard sieves.

Odor: Odorless.

Source:

Croscarmellose sodium is derived from cellulose, a natural polymer obtained from plant cell walls. It is chemically modified to create sodium carboxymethylcellulose, which is further cross-linked to improve its performance as a disintegrant.

Primary Functions and Uses:

Disintegrant in Tablets and Capsules:

Croscarmellose sodium is primarily used in the pharmaceutical industry as a disintegrant in tablet and capsule formulations. When tablets come into contact with moisture (such as in the digestive system), croscarmellose sodium rapidly absorbs water and swells, helping the tablet to break apart and release its active ingredients.

Formulation Stabilizer:

It helps to stabilize the texture and uniformity of tablet formulations by preventing clumping or sticking during the manufacturing process.

Binder in Food Products:

Croscarmellose sodium is used in food products as a binder or stabilizer. It helps to improve texture and consistency in various food formulations, especially in processed or prepackaged foods.

In Drug Formulations:

Besides being used as a disintegrant, it can also assist in the controlled release of drugs, depending on the specific formulation.

Health and Safety Benefits:

Non-Toxic: Croscarmellose sodium is considered safe for use in pharmaceuticals and food products, with minimal risk of toxicity or adverse reactions.

Biocompatible: As a derivative of cellulose, it is biocompatible and does not pose significant risks when used according to recommended guidelines.

Benefits of Croscarmellose Sodium in Pharmaceuticals:

Rapid Tablet Disintegration:

Its ability to absorb water and expand allows tablets to break down quickly in the stomach, enabling the fast release and absorption of the active pharmaceutical ingredients.

Improved Bioavailability:

By enhancing the disintegration of tablets, croscarmellose sodium can improve the bioavailability of the drug, leading to better therapeutic outcomes.

Controlled Drug Release:

In some formulations, it is used to help control the release of the drug, making it useful in extended-release formulations.

Dosage and Usage in Formulations:

Typical Usage: Croscarmellose sodium is typically used in concentrations ranging from 1% to 5% by weight in tablet and capsule formulations. The exact amount depends on the specific requirements of the formulation and the desired disintegration time.

Side Effects and Safety:

Minimal Risk: Croscarmellose sodium is generally considered safe for consumption in the quantities used in pharmaceuticals and food. There are no known serious side effects associated with its use, and it is generally recognized as safe (GRAS) by the U.S. Food and Drug Administration (FDA) for use in food products.

Allergic Reactions: As with any excipient, though rare, some individuals may have allergic reactions to certain ingredients. If any adverse reactions are experienced, it is advised to discontinue use and consult a healthcare provider.

Precautions:

Not for Direct Consumption in Large Amounts: While croscarmellose sodium is safe in food and pharmaceutical applications, it is not intended to be consumed in large quantities independently.

Use in Pharmaceutical Manufacturing: It should be used as directed by pharmaceutical and food manufacturing guidelines to ensure safety and efficacy.

Storage:

Store croscarmellose sodium powder in a cool, dry place, away from direct sunlight and moisture to prevent clumping and degradation of its disintegrant properties. It should be kept in an airtight container to maintain its quality and shelf life.