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ORAL
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.
A variety of tests and services are offered to help our clients characterize and select the drug candidate, such as:
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Solubility profile
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Partition coefficient
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Thermal analysis
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Hygroscopicity
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Chemical stability evaluation
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Salt selection
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Impurity degradation pathway identification
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Supported by a talented analytical group, our oral product development team is prepared to address all aspects of product development, including:
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Physical and chemical characterization
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Assessing the chemical and physical stability of drug in formulation
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Formulation development
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Flavoring/taste masking
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Bioavailability optimization
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Container/closure selection
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Manufacturing process development
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Drug substance and drug product stability testing
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Scale-up and technical transfer to clinical or commercial manufacturing
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Release testing
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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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