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TOPICAL & TRANSDERMAL
Scientists at Cirrus Pharmaceuticals, Inc. have the experience to lead the characterization, formulation and development of water-soluble or water-insoluble drugs and have experience with a wide range of formulation approaches to topical and transdermal product development. Project scope ranges from rapid formulation screening to full development programs.
Topical and Transdermal Dosage Forms include:
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Gels
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Creams
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Patches
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Ointments
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Lotions
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Novel delivery methods
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A variety of preformulation tests and services are offered to understand the physical and chemical characteristics of the drug and dispersed system. These tests may include:
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Solubility
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Partition Coefficient
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Particle Size Distribution
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Surface Area
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Polymorphism
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Surface Tension / Interfacial Tension
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Wettability
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Zeta Potential
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Rheology
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Drug Stability (chemical)
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Backed by a talented analytical group, our topical product development team is prepared to address all aspects of product development, including:
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Physical & Chemical Characterization
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Formulation Development
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Addressing Stability of Drug in Formulation
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Chemical Stability
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Physical Stability
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Manufacturing Process Development
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Container/Closure and Delivery Component Compatibility Studies
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Drug Product Stability Testing
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Scale-up and Technical Transfer
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Services include feasibility studies to assist in dosage form selection and compatibility studies of active ingredients with excipients and delivery components. Formulation selection and optimization are aided by the extensive use of statistical experimental design and response surface methodology. Short-term and accelerated stability studies are typically employed to challenge the candidate formulations.
Cirrus provides topical and transdermal drug formulation expertise:
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Solubilizing Water-insoluble Drugs
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Bioavailability Enhancement
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Excipient Selection & Compatibility
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Improving Product Stability
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Particle Size Reduction
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Product Performance Evaluation
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Enhancing Product Performance
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Novel Delivery System Development
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Manufacturing Process Development
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Services for passive and active energy assisted transdermal and topical delivery of small molecules, proteins and peptides are available. The enhancement approaches include:
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Iontophoresis
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Microneedles
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Ultrasound
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Electroporation
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Iontophoresis can be utilized to deliver peptide molecules while ultrasound can be utilized for proteins. Optimization services to customize and test these skin transport technologies for a pulsatile or programmed drug delivery are available.
Services for release testing and short- and long-term stability testing are available. The following are among the key release and stability tests routinely performed for topical and transdermal products:
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Visual Evaluation
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pH
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Chromtographic Assay
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Particle Size Analysis
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In vitro Diffusion Testing across synthetic membranes and human
dermatomed skin.
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Submission-ready documents will be generated.
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 and batch records. Elements of the process may include:
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Blending/Homogenization
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Filling
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Container/Closure Components
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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. Cirrus can also perform release testing, if needed.
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