Sai recently expanded its services to now offer an extensive suite of pre-formulation and formulation expertise and capabilities. The formulation team works in a state-of-the-art facility that is equipped with high-end analytical instruments including HPLCs, DSC/TGA, moisture sorption analyzer, dissolution testers, particle size analyzers. The labs are further equipped with a broad range of instruments to develop tablet, capsule or injectable formulations.
Pre-formulation services offered by Sai include:
- Characterization of physical properties and form including particle size, pH solubility, pKa, vapor sorption analysis, solid state stability, forced degradation
- Excipient compatibility studies
- Salt selection
- Polymorph screening
Formulation services for tablets, capsules and injectibles include
- Formulation development for DMPK studies.
- Identification of suitable dosage form.
- Prototype formulation development.
- Selection of suitable excipients and process.
- Stability studies of prototype formulations.
Formulation services of interest for generics include:
- Developing products with NI strategy.
- Developing ER and CR products.
- Development of injectable formulations.
- Development of lyophilized injectable products
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