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Core Differences Between Hard Gelatin Capsules and Soft Gelatin Capsules
Content
1. Structural Design and Production Principles
Hard Gelatin Capsules:
Two-section structure: The capsule cap and body are produced separately and mechanically fitted together after filling with the drug.
Cold impregnation and shaping: A stainless steel needle mold is impregnated with gelatin solution, dried at low temperature, and then demolded.
Soft Gelatin Capsules:
Integrated sealing: Liquid drug is directly encapsulated within a gelatin membrane, and a rotating mold is used for hot pressing to seal into a single capsule.
Hot-melt dripping method: Gelatin solution and drug solution are extruded simultaneously through dual pipelines, achieving instant shaping.
2. Content Adaptability
| Property | Hard Gelatin Capsules | Soft Gelatin Capsules |
|---|---|---|
| Physical Form Compatibility | • Powders• Granules• Mini-tablets | • Oils (e.g., fish oil, vitamin E)• Suspensions• Pastes/semi-solids (e.g., ointments) |
| Encapsulation Limits | • Hygroscopic materials prohibited (e.g., herbal extracts) → causes shell brittleness• Low-moisture content only (<5%) | • Compatible with high-moisture/volatile actives (e.g., essential oils)• Sealed construction prevents evaporation |
| Dosing Precision | • ±5% weight variation• Dependent on powder flow properties | • ±1% accuracy• Liquid piston pumps enable exact volumetric filling |
| Viscosity Range | • Dry fills only | • Handles 5,000–100,000 cP liquids (e.g., thick emulsions) |
3. Fundamental Differences in Gelatin Formulation
Hard Gelatin Capsules:
High gel strength: Gelatin concentration >30%, ensuring shell rigidity.
Low Plasticizer: Glycerin content <5% to prevent shell adhesion.
Soft Gelatin Capsules:
High Flexibility Formula: Glycerin/sorbitol content 20-40% to maintain elasticity.
Imperfection Layer: Added gum arabic to reduce the risk of oily drug penetration.
4. Direct Comparison of Performance and Defects
Disintegration Rate:
Hard Gelatin Capsules disintegrate in gastric juice within 10-15 minutes.
Soft Gelatin Capsules dissolve within 5 minutes of contact with gastric acid.
Stability Issues:
Hard Gelatin Capsules are prone to deformation at high temperatures (>40℃).
Soft Gelatin Capsules are prone to hardening and cracking at low temperatures (<10℃).
Oxygen Barrier:
Hard Gelatin Capsules have higher oxygen permeability (>100 cc/m²·day).
Soft Gelatin Capsules have 3 times better oxygen barrier properties (<30 cc/m²·day).
5. Commercial and Compliance Costs
Production Costs:
Hard Gelatin Capsules require lower equipment investment, making them the preferred choice for small and medium-sized pharmaceutical companies.
Soft capsule production lines are expensive and rely on fully automated packaging systems.
Religious Compliance:
Hard Gelatin Capsules use animal gelatin for better traceability.
Soft Gelatin Capsules have a higher additive content, resulting in a doubled failure rate for halal certification.
