Croscarmellose Sodium (CAS 74811-65-7) is a crucial pharmaceutical excipient widely used as a superdisintegrant in oral solid dosage forms. This internally cross-linked sodium carboxymethylcellulose plays a vital role in ensuring rapid tablet disintegration and enhanced drug bioavailability.
What is Croscarmellose Sodium?
Croscarmellose Sodium is an insoluble, cross-linked polymer derived from cellulose. With the molecular formula C8H16O8 and E number E468, it is specifically engineered to promote rapid disintegration of tablets upon contact with aqueous fluids in the gastrointestinal tract.
This white to off-white, free-flowing powder is synthesized through internal cross-linking of sodium carboxymethylcellulose, which reduces its water solubility while enhancing its swelling properties. The resulting material exhibits excellent compression characteristics and can be directly compressed into tablets without prior granulation.
What Are the Benefits?
1. Rapid Tablet Disintegration
Croscarmellose Sodium possesses exceptional swelling capacity. Upon contact with water, the particles swell significantly in an omnidirectional manner, creating internal pressure that forces the tablet apart and promotes rapid disintegration into smaller particles.
2. Enhanced Bioavailability
By promoting faster disintegration in the gastrointestinal tract, Croscarmellose Sodium improves the release and absorption of active pharmaceutical ingredients (APIs), leading to better bioavailability and therapeutic efficacy.
3. Versatile Application
This superdisintegrant can be used in various oral solid dosage forms, including tablets, capsules, and granules. It is compatible with a wide range of APIs and excipients.
4. Excellent Compression Properties
Croscarmellose Sodium can be incorporated either intragranularly or extragranularly, offering flexibility in formulation development. Studies show that intragranular incorporation often results in faster dissolution rates.
5. Cost-Effective
As a widely available pharmaceutical excipient, Croscarmellose Sodium offers a cost-effective solution for improving tablet performance without significantly increasing manufacturing costs.
What Are the Uses?
- Tablet Disintegrant: Primary use in immediate-release tablet formulations
- Capsule Formulations: Used in hard and soft gelatin capsules
- Granule Formulations: Incorporated into granules for improved dissolution
- Dietary Supplements: Commonly used in supplement tablets
- Food Industry: Used as emulsifier (E468) in food products
- Biomedical Applications: Researched for preventing postoperative adhesions
Safety and Regulatory Status
Croscarmellose Sodium is considered Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration (FDA) for use in pharmaceuticals and food applications. It has been used in pharmaceutical formulations for decades with a proven safety profile.
Regulatory agencies including the FDA, European Medicines Agency (EMA), and other national pharmaceutical authorities have approved its use in oral solid dosage forms. The compound is manufactured following Good Manufacturing Practice (GMP) guidelines, including ICH Q7 and FDA 21 CFR Parts 210 and 211.
Commonly Reported Considerations:
- Generally well-tolerated with no significant adverse effects reported at typical pharmaceutical concentrations
- As a cellulose derivative, it is essentially inert and does not interact with most APIs
- Not absorbed systemically, making it suitable for a wide range of patient populations
Chemical Specifications
| Property | Valor |
| Número CAS | 74811-65-7 |
| Fórmula molecular | C8H16O8 |
| E Number | E468 |
| Apariencia | White to off-white free-flowing powder |
| Solubilidad | Insoluble in water, but swells significantly |
| pH | Typically 5.0-7.0 (1% suspension) |
| Pérdida por secado | ≤10% |
| Sodium Chloride | ≤1.0% |
Frequently Asked Questions
Q: What is the difference between Croscarmellose Sodium and regular carboxymethylcellulose?
A: The key difference is the internal cross-linking in Croscarmellose Sodium, which gives it superior swelling properties while reducing water solubility. This makes it much more effective as a superdisintegrant compared to regular CMC.
Q: What is the typical usage level in tablet formulations?
A: Typically, Croscarmellose Sodium is used at 0.5-5% w/w of the tablet formulation, with 2-3% being the most common concentration for immediate-release tablets.
Q: Can Croscarmellose Sodium be used in sustained-release formulations?
A: While primarily used in immediate-release formulations, it can be combined with other matrix formers in controlled-release applications. However, for pure sustained-release products, other excipients are typically preferred.
Q: Does it work in both acidic and alkaline conditions?
A: Yes, Croscarmellose Sodium maintains its disintegrant properties across a wide pH range, making it effective throughout the gastrointestinal tract.
Why Choose Our Croscarmellose Sodium?
- High Purity: Our Croscarmellose Sodium meets USP-NF, EP, and JP pharmacopeial standards
- Consistent Quality: Batch-to-batch consistency ensures reliable tablet performance
- Technical Support: Our team provides formulation guidance and technical assistance
- Competitive Pricing: Cost-effective solutions for pharmaceutical manufacturing needs
- Reliable Supply: Stable supply chain ensuring timely delivery
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