Oral Drugs Formulation
and Development
Water-Soluble, Water-Insoluble,
Liquids, Capsules and Tablets
Scientists at Cirrus have the expertise
to characterize, formulate and develop water-soluble and water-insoluble
drugs and have experience with a wide variety of formulations
including liquids (syrups and suspensions), capsules and tablets.
Services include feasibility studies to assist in dosage form
selection and compatibility studies of excipients, active
ingredients and delivery components. Formulation selection
and optimization are aided by the extensive use of statistical
experimental design.
Oral Drugs Formulation and Development
– Tests and Services Offered
A variety of tests and services are offered
to help our clients characterize and select the drug candidate,
such as:
- Solubility profile
- Partition coefficient
- Thermal analysis
- Hygroscopicity
- Chemical stability evaluation
- Salt selection
- Impurity degradation pathway identification
Oral Product Development –
Range of Services
Supported by a talented analytical group,
our oral product development team is prepared to address all
aspects of product development, including:
- Physical and chemical characterization
- Assessing the chemical and physical stability of drug
in formulation
- Formulation development
- Flavoring/taste masking
- Bioavailability optimization
- Container/closure selection
- Manufacturing process development
- Drug substance and drug product stability testing
- Scale-up and technical transfer to clinical or commercial
manufacturing
- Release testing
Cirrus provides all method development
and validation for regulatory submission-required tests. Full
release testing, as well as short- and long-term stability
testing are available. We can provide services to meet all
testing requirements for regulatory submissions of oral products.
Regulatory submission-ready documents will be generated.
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