Croscarmellose Sodium – A First-Choice Superdisintegrant for Tablets, Capsules, and ODT Formulations

1. General introduction to Croscarmellose Sodium

Croscarmellose sodium is a cross-linked polymer of sodium carboxymethyl cellulose, widely used as a superdisintegrant in various dosage forms such as tablets, film-coated tablets, capsules, orally disintegrating tablets (ODTs), and dispersible tablets. Due to its rapid water wicking combined with a strong swelling mechanism, croscarmellose sodium enables fast disintegration of the formulation within seconds to minutes, even in high-load active ingredient formulations.

Featuring characteristics such as fair flowability, moderate compressibility, and optimal particle size, croscarmellose sodium is suitable for multiple manufacturing processes, including wet granulation, dry granulation, and direct compression. In granulation processes, this excipient can be utilized both intra- and extragranularly to optimize water uptake, promote disintegration, and enhance the drug release efficiency of the tablet.

2. Raw Material Information: Croscarmellose Sodium

• Material Name: Croscarmellose sodium or crosslinked carboxymethylcellulose sodium
• Material Category: Excipient / Food Additive
• Function: Disintegrant in tablet and capsule formulations
• Usage Notes:Typically used in tablet formulations at 2 - 5%; however, higher concentrations may lead to partial gelation, increasing disintegration time
• Incompatibilities: Incompatible with strong acids, alkalis, and salts of heavy metal ions
• Physical Form: White or grayish-white powder
• Solubility: Practically insoluble in water, but can swell to 4 - 8 times its volume in water
• Quality Standards: Complies with Pharmacopeial standards (USP / EP / BP / JP)

3. Advantages of Croscarmellose Sodium

• Superior Disintegration Speed: Through a combined mechanism of rapid water wicking, strong swelling, and generating force to disrupt the tablet structure, Croscarmellose sodium enables tablets to disintegrate almost instantaneously upon contact with biological fluids, even in high-compressibility formulations.
• High Efficiency at Low Concentrations: Effective at low concentrations (1 - 3%) to achieve optimal disintegration performance, helping to reduce manufacturing costs.
• Broad Formulation Compatibility: Featuring high chemical inertness and stability across a wide pH range, Croscarmellose sodium minimizes interactions with APIs, other excipients, or active substances, making it suitable for a wide range of formulations.
• Manufacturing Process Flexibility: Effective in various processes ranging from direct compression and wet granulation to dry granulation, allowing manufacturers flexibility in process selection and shortening product development timelines.
• Consistent Performance During Scale-Up: Due to uniform particle size and good flowability, this excipient ensures batch-to-batch uniformity during commercial scale-up, reducing quality variation risks.
• Compliance with International Standards: Meets USP, EP, and JP standards, facilitating seamless product registration in demanding markets such as the EU, US, and Japan.

4. Applications of Croscarmellose Sodium

In Pharmaceuticals and Nutraceuticals

• Orally disintegrating tablets (ODTs)
• Dispersible tablets
• Hard capsules filled with powder or granules

In Cosmetics

• Solid compressed products (facial cleansing tablets, soap tablets)
• Gels and creams: provide consistency and control viscosity

5. Commercial products using Croscarmellose Sodium

6. Commercial Products Containing Croscarmellose Sodium

For more information about Croscarmellose Sodium supply, please contact us:

• Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website: www.biorichgroup.com
• Sample / COA Request: Please contact us via email to receive the latest samples and Certificate of Analysis (COA).