Parenteral Product Development
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.
Parenteral Product Development Services
Backed by a talented analytical group, our
parenteral team is prepared to address all aspects of product
development, including:
- Physical and chemical characterization
- Formulation development
- Assessing the chemical and physical stability of drug
in formulation
- Manufacturing process development
- Sterilization process development (heat, filtration)
- Filter compatibility studies
- Container/closure and delivery component compatibility
studies
- Lyophilization
- Drug product stability testing
- Scale-up and technical transfer
Parenteral Tests and Services
A variety of tests and services are offered
to help the client characterize and select the drug candidate,
such as:
- Solubility profile
- Partition coefficient
- Chemical stability evaluation
- Salt selection
- Impurity degradation pathway identification
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).
Early Stage Formulation Feasibility
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.
Parenteral Formulation Development
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.
Parenteral Product Manufacturing
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:
- Blending/homogenization
- Filtration
- Filling
- Container/closure components
- Terminal Sterilization
- Lyophilization
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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