FORMULATION DEVELOPMENT SERVICES

By offering an extensive array of services, Cirrus Pharmaceuticals is contributing to the development of a wide range of pharmaceutical products. The services offered by our formulation development group include feasibility studies to assist in dosage form design, excipient compatibility studies to aid in selection of excipients, product/process optimization through batch manufacture, physicochemical testing, process scale-up, technology transfer and batch manufacture for GLP Tox support. Our scientists have experience formulating small molecules, peptides and proteins.

Cirrus scientists work closely with clients to ensure they are well prepared in advance for the regulatory submission process so that topics such as formulation optimization, scale-up feasibility, and product performance are well substantiated.

DOSAGE FORMS

A wide variety of dosage forms can be developed at Cirrus, and our scientists work to develop novel technologies when requested. Dosage forms that can be developed at Cirrus include:

Inhalation

• Metered dose inhaler (MDI)
• Dry powder inhaler (DPI)
• Nebulizer

Nasal

• Spray (solution, suspension, emulsion and dry powder)
• Wash
• Gel
• Drops

Parenteral

• Stable and unstable compounds
• Water-soluble and - insoluble compounds
• Solution
• Suspension
• Emulsion
• Semi-aqueous, non-aqueous
• Micellar dispersion
• Inclusion complex (cyclodextrins)
• Liposome

Oral

• Solution
• Emulsion
• Suspension
• Capsule
• Tablet

Topical and Transdermal

Gel

• Cream
• Patch
• Ointment
• Lotion
• Aerosol

Peptide and Protein Delivery

• Intranasal
• Topical
• Parenteral
• Nebulized Solution
• Intrauterine Catheter
• Oral

FORMULATION DEVELOPMENT SERVICES

Services include:

• Feasibility studies to assist in dosage form selection
• Compatibility studies of active ingredients with excipients, delivery components and packaging components
• Dosage form design
• Formulation Optimization
• Taste Masking/Flavoring
• Formulation Characterization
• Process Scale-Up
• Technology Transfer
• GLP Tox Batch Manufacture
• Container/closure selection
• Short-term and Accelerated Stability Studies

Formulations and optimizations are aided by the extensive use of statistical design of experiments.

FORMULATION DEVELOPMENT EXPERTISE

The scientists at Cirrus have years of experience developing a wide range of dosage forms. With this experience they are well equipped to provide the following areas of expertise:

• Solubilizing water-insoluble drugs
• Stabilizing unstable molecules through formulation and excipient selection
• Taste Masking
• Bioavailability enhancement
• Excipient Selection and Compatibility
• Particle Size Reduction
• Formulation Screening (Microformulation)
• Product Performance Evaluation
• Enhancing Product Performance
• Novel Delivery System Development
• Manufacturing Process Development