Pharmaceutical development is a long journey and pre-formulation in most important step towards ensuring development milestone.
How does Callidus help in pre-formulation development?
Callidus’s formulation and analytical scientists include years of experience accelerating the optimization and development of life-changing large and small molecule formulations. It includes formulations with poor bioavailability, stability and solubility, short half-life, gastric intolerability, and lower permeability.
Our scientists can assist with API characterization and develop correct formulation strategies and a detailed pre-formulation study report.
What are Callidus’s Pre-formulation services?
Whether you are a leading multinational company or a virtual organization, Callidus’s client-centric and collaborative approach will always benefit you. Our extensive skills in CMC (Manufacturing and Controls), Chemistry, regulatory and scientific expert network, state-of-the-art equipment, and industry-leading pre-formulation services enhance the product development life cycle.
Our flexible services will assist you in formulation development and optimal manufacturing.
The pre-formulation services of Callidus include:
- Sourcing of raw material
- Characterization of materials
- Analysis of solid state
- Selection and screening of salt
- Morphology analysis of particle size
- Polymorph study and screening
- Thermometric properties like TGA, HSM, and DSC
- Level of moisture content & Hygroscopicity Study
- Solubility profiles like kinetic, intrinsic, and equilibrium in different pH, solvents, and media
- Compatibility study and selection of excipients
- API stability testing through forced degradation like heat, oxidative stress, pH, and light
- Testing of powder flow
- Intrinsic drug dissolution
- Biorelevant dissolution and solubility testing
- Precipitation and supersaturation evaluation
- Analytical method development for product stability testing and release
Why select the Pre-formulation services of Callidus?
Callidus provides effective pre-formulation services to understand the cost optimization and times for drug development. Recognizing the potentially difficult issues early during development can help to achieve desired drug product quality in stipulated time.
Pre-formulation reduces the chances of expensive delays in the drug formulation development. It also allows rapid progression into the subsequent drug development stages. In other words, Callidus pre-formulation services help to speed up delivery of life-saving medicines to the doorstep of patients.
Reasons why large or small pharmaceutical companies are selecting pre-formulation services of Callidus include:
- Experience with different characterization techniques
- Understanding various pharmacopeial and regulatory requirements
- Development of analytical methods
- In-depth compound knowledge
- Controlling the quality attribute of the product
- Delivering a full spectrum of analytical tools and techniques
For value-added and customized drug development that will help it to get to market rapidly, Callidus is here to help you succeed!