For inquiries please call 1-919-321-4047 email: bizdev@cirruspharm.com

www.cirruspharm.com

Oral Product DevelopmentCirrus Pharmaceuticals, Inc. is a contract product development organization providing services to the pharmaceutical and biotech industries.

Projects range from sample-based services to feasibility studies to full-scale product development.

Cirrus Pharmaceuticals, Inc. is registered with the United States Food and Drug Administration and is a cGMP compliant facility.

Scientists at Cirrus Pharmaceuticals, Inc. characterize, formulate, and develop drugs for oral delivery and have experience with a wide variety of formulations including liquids (syrups or suspensions), capsules, and tablets.

Supported by a talented analytical group, our oral product development team is prepared to address all aspects of product development, including:

•Preformulation •FormulationDevelopment •Flavoring/TasteMasking •BioavailabilityOptimization •Container/ClosureSelection •ManufacturingProcessDevelopment •DrugSubstanceandDrugProductStabilityTesting •Scale-upandTechnicalTransfer

ChemicalandPhysicalCharacterization

A variety of tests and services are offered to characterize and select the drug candidate, such as:

•SolubilityProfile •IntrinsicDissolution •PartitionCoefficient •ParticleSizeandMorphology •Polymorphism

FormulationDevelopment

Cirrus oral formulation scientists have experience formulating:

•Liquids(SyrupsandSuspensions) •Capsules •Tablets

Services include feasibility studies to assist in dosage form selection and compatibility studies with excipients and containers/closures. 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.

StabilityandReleaseTesting

Cirrus provides all method development and validation for regulatory submission-required tests. Full release testing and short- and long-term stability testing are available. We can provide services to meet all testing requirements for regulatory submission of oral products. Key stability tests include:

•Dissolution •Disintegration •Chromatography,includingLCMS •ContentUniformity Regulatory submission-ready documents will be generated.

ProcessDevelopment,Scale-Up,andTechnicalTransfer

Our formulation scientists and process engineers collaborate to develop a manufacturing process that can be optimized forrobustnessandefficiency,thenscaledupthroughcarefulevaluationofmanufacturingparameters.Tofacilitatethe transfer process, Cirrus typically prepares a manufacturing monograph and master batch record.

If requested, Cirrus can work with the sponsor to select a manufacturing site for full-scale batch production. Cirrus can assume responsibility for transferring the manufacturing process, oversee batch manufacture, and can also perform release testing, if needed.

OralBioavailabilityOptimization

Oral bioavailability can be optimized using one or more of the following techniques:

•SaltFormSelection •SolubilityImprovement/Enhancement •ParticleSizeReduction

Oral Product DevelopmentOverv iew

•Hygroscopicity•ChemicalStabilityEvaluation•SaltSelection•ImpurityDegradationPathwayIdentification

•HydrationState•PowderDensityandFlowability•ThermalAnalysis•PartitionCoefficient•MoistureContent

•Friability•Hardness•MicroscopicEvaluation

•pHSensitiveRelease•PermeabilityModulatingExcipients