- Custom manufacturing of chemicals in kilogram quantities.
- Optimization of existing synthetic processes or methods.
- Screening biocatalysts for the resolution or asymmetric synthesis of drug molecules and development of biotransformation process.
Raw Material Sourcing & Qualification
- Excipient-Excipient Compatibility
- API-Excipient Interaction Studies
- pKa/Log P Determination
- Hygroscopicity Studies
- Phase Solubility Determination
- Photostability of API
- Degradation Pathway Determination
- Matrix Stability Evaluations
- Container-API interactions
- Prototype Evaluations
- Particle Size/Solubility Studies
Please contact us for a customized plan for the design and execution of a pre-formulation study, to meet your development objectives.
Analytical Method Development & Validation
- Method development, validation and routine testing.
- Identity, quantitation, potency, content uniformity.
- Process contaminants, impurities, degradants, excipients.
- Lot release and stability assessment.
Formulation Strategies for Pharmaceutical Development
Comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Certain candidates present specific challenges such as: low bioavailability, poor solubility and/or permeability, and poor physical stability. Formulation development can be helpful in overcoming many of these issues. Our approach includes:
- Pre-Formulation Solubility & Stability Evaluations
- Comprehensive Excipient Screening & Vendor Qualification
- Prototype Development
- Formulation Optimization & Finalization
- Identified Specification
- Supporting Documentation & Data Package in CTD/eCTD format meeting QoSr Requirements.
Process Optimization and Manufacturability Design
Based on our commercial production experience, we can provide advice on “Design for Manufacturability” and solutions to provide cost effectiveness in your final product. An optimized formulation assures efficient technical transfer, optimal stability and scalability.
Scale-up and Post Approval Changes – SUPAC
To facilitate process optimization and SUPAC needs, Stason will conduct a comparative study on the various types of supplemental amendments regarding SUPAC modifiers including: SUPAC-Immediate Release solid dosage forms (SUPAC-IR), and SUPAC Modified Release oral dosage forms (SUPAC-MR). Once this study is completed, we will develop strategies for changes that need an approved supplement, but may be submitted as changes being effected, or in the next annual report under the SUPAC terms. We will validate the changes, and with our expert regulatory personnel, provide a mechanism to obtain substantial regulatory acceptance of the post approval changes.