Pharmaceutical development is a massive industry, and in this sector, there is an ignored and vital stage known as pre-formulation. It is the developmental stage that acts like a behind-the-scenes establishment and characterizes the drug’s physicochemical properties. You cannot neglect pre-formulation to shape a drug development into success.
Pharmaceutical development is a massive industry, and in this sector, there is an ignored and vital stage known as pre-formulation. It is the developmental stage that acts like a behind-the-scenes establishment and characterizes the drug’s physicochemical properties. You cannot neglect pre-formulation to shape a drug development into success.
How does Callidus help in pre-formulation development?
Callidus’s formulation analytical chemists and scientists include years of experience accelerating the optimization and development of life-changing large and small molecule formulations. These formulations are for parenteral, topical, ophthalmic, and oral dosage forms and NDSS (Novel Drug Delivery Systems). It also includes formulations with poor bioavailability, stability and solubility, short half-life, gastric intolerability, and lower permeability.
Our highly trained and knowledgeable formulators and scientists are experts in early solving complicated challenges during the drug development lifecycle and process. Our scientists can assist with API molecules characterization and develop correct formulation strategies. They prepare a detailed report of the pre-formulation study resulting in a strong form design of pre-formulation dosage. It will also accelerate the product path of the drug to the clinic and avoid unnecessary delays.
What are Callidus’s Pre-formulation services?
Whether you are a large and leading multinational company or a virtual start-up 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 developing the optimal manufacturing and formulation development. The pre-formulation services of Callidus include:
- Sourcing of raw material
- Characterization of materials
- Analysis of solid state
- Election and screening of salt
- Morphology analysis of particle size
- Polymorph study and screening
- Thermometric properties like TGA, HSM, and DSC
- Distribution and partition of coefficients
- Level of moisture content
- 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
- Dissociation and Ionization constants
- 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 can help the drug manufacturer process the production proactively or alter the formulation. These difficulties can include restricted solubility or poor stability.
Pre-formulation reduces the chances of expensive delays in the drug formulation. It also allows rapid progression into the subsequent drug development stages. In other words, Callidus pre-formulation services help to deliver life-saving medicines to the doorstep of the patients rapidly. The reasons why large or small pharmaceutical companies are selecting the 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 the clinics and the market rapidly, Callidus is here to help you succeed!
