Formulation Technologies for Drug Products
Source: Siegfried AG
Siegfried offers a broad spectrum of technologies for the development and manufacture of solid dosage forms, ranging from rapid-release tablets to controlled-release formulations.
Based on more than 30 years of experience and application with an extensive range and type of products, our customers gain more knowledge, Innovation and technological expertise through the following services:
- API characterization
- Excipients compatibility
- Pre-formulation for early safety studies
- Small scale formulation work
- Packaging screening for up-front stability
- Up-front stability testing
- Development and validation of analytical methods
- Validation of manufacturing process according to cGMP
- Process optimization
- Production and release of clinical trial material (CTM)
- Stability testing (ICH)
- Compilation of source documents for registration
- Regulatory support and advanced services
- Scale-up and technology transfer to the commercial site
Our state-of-the-art equipment and development department offers a wide range of the following technologies:
- Powder blending
- Wet granulation with high shear mixer
- Fluid bed spray granulation / drying
- Roller compaction
- One-pot granulation
- Pellet extrusion and spheronisation (IR, DR, SR)
- Tablet compression (IR, SR, Oral Disintegrating Tablets, minitablets)
- Coating (granules, pellets, tablets, IR, DR, SF)
- Hard gelatin capsule filling (granules, powder, pellets)
We also offer development of other administration forms (e.g., injection preparations, eye drops, etc.) under non-GMP conditions.
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