Different dosage forms and manufacturing process may face different situations and problems in product development. A proper formulation and process should be employed to make sure the formulation and the scaled up process are reasonable and dependable and all the in process steps could be controlled effectively.
NDA Formulation Strategy
- Suspensions (Microsuspensions & Nanosuspensions)
- API Filling into Bottles (Powder in Bottles)
- API Encapsulation / Vial Filling Using Xcelodose 120S & 600S
- Dry Blending and Encapsulation
- Liquid Fill into Hard Gelatin Capsules (Enabling Technology)
- Spray Drying (Enabling Technology)
- Granulation (Dry & Wet) and Encapsulation / Tableting
- Direct Compression
- Sachets
ANDA Formulation Strategy
- Select of RLD, Overall Profile of RLD
- Formulation Development by Screen Critical Factors
- Process Development based on QbD
- Package
- Scale Up and Technical Transfer
- Stability
Life Cycle Management – New Formulation Development Support:
- Enable and impart late stage NCE or “Marketed Compounds” with new product attributes
- Improve Safety Profile
- Enhance Efficacy and or Afford New Treatments
- Improve Compliance and Usage
- Rapid onset, taste masking, new route delivery, etc.
- Controlled or sustained release to reduce dosing frequency
- Extend Market Exclusivity
- Create Product Differentiation and Enhance Product Performance Through Formulation Innovation
- Enable New Product Extension
- Potential Market Protection Through New IP Generation
Enabling Formulation Technology Support:
- Solubilization Improvement
- Micronization Using Air Jet Mill
- Nanosuspension or Microsuspension Followed by Granulation
- Spray Dried Amorphous Solid Dispersion
- Hot Melt Extrusion
- Liquid Filled Hard Gelatin Capsules
- Modified release tablet formulations with one or two layers
- Sustained release or delayed release pellets in capsules
