Driving Speed, Stability, and Compliance in Oral Solid Dosage Manufacturing
While the industry’s focus often leans toward biologics and injectables, oral solid dosage (OSD) forms remain the workhorse of global pharmaceutical production. Among these, hard gelatin capsules have gained renewed attention—not just for patient-centric delivery, but as a strategic format that enables resilient, flexible, and GMP-aligned manufacturing.
Hard gelatin capsules provide advantages in formulation flexibility, stability, and rapid tech transfer, especially for multi-product sites and CDMOs managing high variability.
Why Hard Gelatin Capsules Enhance Manufacturing Resilience
- No need for granulation or drying steps—faster development timelines
- Lower thermal and moisture sensitivity during processing
- Simplified cleaning and changeover between products
- Suitable for encapsulating APIs, pellets, mini-tabs, and combination fills
Technical Design Considerations
- Compatibility with high-speed encapsulation lines
- Control over fill weight, tamping force, and capsule size
- Materials aligned with pharmacopoeial standards (gelatin, HPMC)
- Real-time weight control and reject systems integrated with SCADA
GMP and Compliance Alignment
- Minimal contact surface area reduces cleaning burden
- Rapid cleaning validation and reduced cross-contamination risk
- MES-ready batch records and capsule serialization capabilities
Applications Driving Demand
- Early-phase clinical supply where speed-to-manufacture is critical
- Oncology, hormonal, or high-potency drugs requiring low-dose control
- Lifecycle extensions with combination or modified release fills
Strategic Benefits
- Accelerated tech transfer and scale-up across sites
- Flexible manufacturing platforms for low-to-medium volume products
- Risk reduction through shorter cleaning and validation cycles
In a manufacturing environment increasingly defined by agility, quality, and compliance, hard gelatin capsules offer an optimal balance between formulation freedom and operational control—making them a vital element in building pharmaceutical resilience.
