Formulation
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Introduction on business and technologies of Pharmaceutical Technology R&D Division
Pharmaceutical Technology R&D Division of SPERA PHARMA develops the formulation design that is highly value-added (speed, cost, differentiation, novelty of formulation) based on the technologies and experiences cultivated in R&D at leading Japanese pharmaceutical company. We are engaged in the pharmaceutical research and development which depends on the developing stages and the service for high quality & cost competitive manufacturing, the development of robust cost-effective manufacturing process considering the scaling up to production scales, and documentation for new drug application (CTD Modules 3)
Click on each item below for more details.
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Oral formulation: Development & Manufacturing
- Tablets, capsules
- Pediatric formulation
- Immediate Release (IR) formulation
- Fixed Dose Combination (FDC) formulation
- Oral Disintegrating Tablet (ODT) formulation
- Modified Release (MR) formulation
- Solubilized formulation for absorption enhancement
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Sterile injection: Development & Manufacturing
- Vials (Ampules)
- Lyophilized formulation, solution / powder fillers
- High dosing formulation
- Device development
- Solubilized formulation
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Primary and secondary packaging: Design & Manufacturing
- Moisture proof package
- Light resistant package
- CR-Package, blister card package, sachet
- Environmentally friendly package
- Innovative package (Desiccant-integrated Al blister)
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Optimization of manufacturing process
- Manufacturing based on Quality by Design
- Manufacturing based on Process Analytical Technology
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CTM manufacturing & supply
- Agile manufacturing and supply for IND for oral drug products
- Single-use system for sterile drug products
- High-level containment control
Technologies and Achievements
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