INDUSTRY COMPONENT

Disintegrant

A pharmaceutical excipient that promotes tablet disintegration in the gastrointestinal tract for drug release.

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Component Specifications

Definition
Disintegrants are essential pharmaceutical excipients incorporated into tablet formulations to facilitate rapid breakdown of the compressed tablet into smaller particles or granules upon contact with gastrointestinal fluids. This mechanical disruption increases surface area, accelerating drug dissolution and bioavailability. They function through mechanisms like swelling, wicking, deformation recovery, or gas production to overcome tablet bonding forces.
Working Principle
Disintegrants work primarily through capillary action (wicking) where they absorb liquid and swell, creating internal pressure that fractures the tablet matrix. Secondary mechanisms include deformation recovery (where compressed particles return to original shape) and chemical reaction (e.g., effervescent disintegrants producing gas). The disruption of interparticulate bonds allows rapid penetration of dissolution media to the drug core.
Materials
Common materials include: superdisintegrants like crospovidone, sodium starch glycolate, croscarmellose sodium; natural disintegrants like starch, microcrystalline cellulose; and effervescent combinations like citric acid-sodium bicarbonate. Materials must meet pharmacopeial standards for purity, particle size (typically 50-200 μm), and swelling capacity.
Technical Parameters
  • Bulk Density 0.3-0.6 g/mL
  • Swelling Volume 4-10 mL/g
  • Moisture Content <10%
  • Disintegration Time <5 minutes (USP standard)
  • pH Range Compatibility 1.2-7.4
  • Particle Size Distribution D50: 50-150 μm
Standards
ISO 8871, USP <701>, EP 2.9.1, JP 6.09

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Disintegrant.

pharmaceutical disintegrant tablet excipient drug dissolution crospovidone sodium starch glycolate tablet formulation USP disintegration test Disintegrant Disintegrant in Chemical Manufacturing

Parent Products

This component is used in the following industrial products

Pharmaceutical Tablets

A pharmaceutical tablet is a solid dosage form produced by compressing a mixture of active pharmaceutical ingredients and excipients into a uniform shape and size.

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Engineering Analysis

Risks & Mitigation
  • Over-swelling causing tablet cracking
  • Moisture sensitivity affecting shelf life
  • Incompatibility with certain APIs
  • Variable performance with formulation changes
FMEA Triads
Trigger: Inadequate disintegrant concentration or improper distribution
Failure: Prolonged disintegration time (>30 minutes)
Mitigation: Optimize concentration (2-8% w/w), use granulation techniques for uniform distribution, conduct disintegration testing during formulation development
Trigger: Moisture absorption during storage
Failure: Premature disintegration or reduced tablet hardness
Mitigation: Use moisture-resistant packaging, incorporate desiccants, select low-hygroscopic disintegrants like crospovidone
Trigger: Chemical interaction with API or other excipients
Failure: Reduced drug potency or altered dissolution profile
Mitigation: Conduct compatibility studies, select chemically inert disintegrants, adjust formulation pH

Industrial Ecosystem

Compatible With

Interchangeable Parts

Compliance & Inspection

Tolerance
Disintegration time must meet pharmacopeial limits (typically <15-30 minutes depending on monograph). Tablet weight variation ≤5%, friability <1%
Test Method
USP <701> Disintegration Test: Six tablets tested in basket-rack assembly immersed in 37±2°C fluid, observed for complete disintegration without residue

Buyer Feedback

★★★★☆ 4.5 / 5.0 (25 reviews)

"As a professional in the Chemical Manufacturing sector, I confirm this Disintegrant meets all ISO standards."

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Frequently Asked Questions

What is the difference between superdisintegrants and traditional disintegrants?

Superdisintegrants (e.g., crospovidone) provide faster disintegration at lower concentrations (1-5% w/w) through superior swelling or wicking, while traditional disintegrants (e.g., starch) require higher concentrations (5-15% w/w) and work primarily through swelling.

How does disintegrant concentration affect tablet properties?

Excessive disintegrant (>10% w/w) can reduce tablet hardness and increase friability, while insufficient amounts (<1% w/w) may prolong disintegration. Optimal concentration balances disintegration time with mechanical strength.

Can disintegrants affect drug stability?

Yes, some disintegrants may interact with APIs through moisture absorption or chemical incompatibility. Proper selection and moisture-controlled environments are critical for stability.

Can I contact factories directly?

Yes, each factory profile provides direct contact information.

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