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PARENTERAL
Cirrus Pharmaceuticals, Inc. offers its sponsors a senior scientific staff with over 35 years of combined experience in parenteral product development. Our scientists characterize, formulate and develop water-soluble and water-insoluble drugs and have experience with a wide range of formulation approaches. Project scope ranges from rapid formulation screening to full development programs.
Backed by a talented analytical group, our parenteral team is prepared to address all aspects of product development, including:
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Physical and chemical characterization
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Formulation development
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Assessing the chemical and physical stability of drug in formulation
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Manufacturing process development
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Sterilization process development (heat, filtration)
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Filter compatibility studies
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Container/closure and delivery component compatibility studies
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Lyophilization
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Drug product stability testing
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Scale-up and technical transfer
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A variety of tests and services are offered to help the client characterize and select the drug candidate, such as:
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Solubility profile
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Partition coefficient
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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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Cirrus scientists have successfully formulated numerous water soluble compounds (stable and unstable), water insoluble compounds as well as proteins and peptides. Our parenteral team has experience with essentially all types of parenteral formulations, including solutions, micellar dispersions, emulsions, inclusion complexes (cyclodextrins), liposomes and suspensions (IM or subQ).
In addition to Cirrus' standard parenteral formulation capabilities, we have developed methods for carrying out formulation studies with as little as 2-3 mg of drug substance. These methodologies can be used to formulate new drugs for initial in vivo experiments when only low milligram quantities of the drug have been synthesized and/or purified.
Formulation development 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. Short-term and accelerated stability studies are typically employed to challenge the candidate formulations.
Cirrus provides full method development and validation services for regulatory submission-required tests. Full release testing, as well as short- and long-term stability testing are available. Submission-ready documents will be generated.
For poorly-soluble or highly unstable drugs, the manufacturing process can be as critical as the formulation. Our formulation scientists and process engineers collaborate to develop a manufacturing process which can be optimized for robustness and efficiency, then scaled up through careful evaluation of manufacturing parameters. To facilitate the transfer process, Cirrus typically writes the manufacturing monograph. Elements of the process may include:
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Blending/homogenization
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Filtration
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Filling
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Container/closure components
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Terminal Sterilization
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Lyophilization
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If requested, Cirrus can work with the sponsor to select a manufacturing site for full-scale batch production, transfer the manufacturing process, and oversee batch manufacture.
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