Tablet Disintegration & Dissolution Profile Plotter
USP <711> compliant profile analysis with T₅₀, T₉₀, and disintegration time
Profile Data Entry
Add New Time Point
| Time (min) | Disintegration (%) | Dissolution (%) | Actions |
|---|---|---|---|
| 0 | 0% | 0% | |
| 5 | 15% | 5% | |
| 10 | 65% | 25% | |
| 15 | 100% | 60% | |
| 20 | 100% | 85% | |
| 30 | 100% | 98% |
Profile Plot
USP Q Value Assessment
At 30 minutes:
98.0% dissolved
✓ Meets Q=80%
USP <711> acceptance: Q + 5% at S1 [citation:1]
USP <711> Acceptance [citation:1][citation:3]
S1 (n=6)
Each unit ≥ Q + 5%
S2 (n=12)
Average ≥ Q, no unit < Q - 15%
S3 (n=24)
Average ≥ Q, ≤2 units < Q-15%, none < Q-25%
IVIVC Correlation Levels [citation:10]
Level A: Point-to-point relationship
Level B: Statistical moments (MDT vs MRT)
Level C: Single point (T₅₀, T₉₀ vs Cmax, AUC)
Profile Similarity [citation:7]
f₂ similarity factor:
f₂ = 50·log{[1 + (1/n)Σ(Rᵢ - Tᵢ)²]⁻⁰·⁵ × 100}
f₂ ≥ 50 indicates similarity
≥85% dissolved in 15 min → profiles considered similar without f₂ [citation:7]
ODT Requirements [citation:9]
- • Disintegration ≤ 30 seconds
- • Tablet weight ≤ 500 mg
- • No need for water
- • Rapid oral disintegration
Dissolution Requirements by Dosage Form
| Dosage Form | Apparatus | Speed (rpm) | Medium | Q Value | Time Point |
|---|---|---|---|---|---|
| Immediate Release | I or II | 50-100 | 0.1N HCl, buffer | 75-80% | 30-45 min |
| Extended Release | I or II | 50-100 | Multiple pH | Varies | Multiple |
| Enteric Coated | I or II | 50-100 | Acid then buffer | 75% (buffer) | 45-120 min |
| Orally Disintegrating | USP <701> | N/A | Water | N/A | ≤30 sec |
Source:USP <701> FDA Guidance [citation:1][citation:9]