Highly efficient superdisintegrant with rapid and uniform tablet disintegration in aqueous media.
Consistent performance across varying formulation pH and ionic strength conditions.
Low substitution degree ensures excellent compatibility with active pharmaceutical ingredients (APIs) and excipients.
Optimized particle size distribution for improved blend uniformity and flowability in direct compression processes.
Pharmaceutical-grade material manufactured under strict cGMP conditions and compliant with USP/NF, EP, and JP monographs.
Immediate-release oral solid dosage forms, including tablets and capsules.
Fast-dissolving tablets (FDTs) and orally disintegrating tablets (ODTs).
Direct compression formulations requiring high disintegration efficiency without excessive lubricant sensitivity.
Effervescent tablet systems where rapid water penetration and structural breakdown are critical.
Controlled-release matrix tablets as a secondary disintegrant to support dose dumping prevention.
| Chemical Type | Croscarmellose Sodium (Cross-linked Sodium Carboxymethylcellulose) |
| Product Form | White to off-white fine powder |
| Appearance | Free-flowing, odorless, tasteless powder |
| Primary Applications | Pharmaceutical superdisintegrant for oral solid dosage forms |
| Key Features | High swelling capacity, low substitution, pH-independent disintegration |
| Compliance | USP/NF, Ph. Eur., JP, and cGMP-compliant manufacturing |
| Microbial Limits | Meets USP <61>: Total aerobic microbial count ≤10³ CFU/g; absence of E. coli, Salmonella, and S. aureus |
| Residue on Ignition | 15–25% (as Na₂O equivalent) |
Q1: What is the primary functional role of ND-200 in solid dosage forms?
A: ND-200 functions primarily as a superdisintegrant, rapidly absorbing water and swelling to promote efficient tablet disintegration and enhance drug dissolution in oral solid dosage forms.
Q2: How does ND-200 differ from other croscarmellose sodium grades in terms of particle morphology?
A: ND-200 is specifically engineered with a uniform, low-dust granular structure that improves flowability and blend uniformity compared to conventional powdered croscarmellose sodium, supporting robust high-speed tableting processes.
Q3: Is ND-200 suitable for direct compression formulations?
A: Yes — ND-200’s optimized granular form and consistent density make it well-suited for direct compression, where it contributes to both disintegration performance and blend homogeneity without requiring additional milling or sieving.
Q4: What are typical usage levels of ND-200 in tablet formulations?
A: ND-200 is typically used at low concentrations, generally ranging from 0.1% to 2% by weight of the total formulation, depending on tablet composition, desired disintegration time, and manufacturing process parameters.
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