Formulation Development Services
Pre-formulation Development
At Dalton Pharma Services we recognize the importance of our clients’ requirement to develop robust and compliant formulations. Starting with comprehensive pre-formulation services, Dalton helps its customers to determine optimal dosage forms they can use for preclinical or clinical applications. With our analytical development services supporting our preformulation work, Dalton can perform full physico-chemical characterization using modern analytical techniques in-house for rapid turnaround times.
Dalton evaluates and determines a variety of parameters to help you arrive at the right formulation using your API.
These may include:
- Solubility of API in different media and solvents
- Excipient compatibility studies
- Dissolution of the active pharmaceutical ingredient (API)
- Accelerated Stability Services under various conditions
- Solid state analysis (polymorphs, particle size, particle shape etc.)
Formulation Development
Dalton has the right equipment, facilities and highly dedicated formulation development specialists to help you arrive at the optimal dosage form for your API and application. We ensure any forms we develop are scalable, compliant and commercializable for our customers.
We can formulate a wide range of sterile and non-sterile dosage forms including:
- Oral Immediate Release – Solutions, Emulsions, Suspensions
- Sterile Liquids – Solutions, Suspensions and nanoemulsion
- Powders – Sterile and non-sterile powder filling
- Injectable drugs (intravenous, and intramuscular, subcutaneous injectables)
- Lyophilized formulations
Formulation Services and Capabilities
- Formulation development for new chemical entities (NCE)
- Optimization of existing formulations
- Feasibility Studies
- Excipient Compatibility selection and optimization
- Physico-Chemical Testing
- Process Scale-Up
- Technology Transfers
- Batch manufacture
Our formulation development services can be utilized independently or with our fully integrated services to accelerate your drug development program.