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.
Development of Topical and Transdermal
Dosage Forms:
- Gels
- Creams
- Patches
- Ointments
- Lotions
- Novel delivery methods
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:
- Solubility
- Partition Coefficient
- Particle Size Distribution
- Surface Area
- Polymorphism
- Surface Tension / Interfacial Tension
- Wettability
- Zeta Potential
- Rheology
- Drug Stability (chemical)
Topical Product Development –
Range of Services
Backed by a talented analytical group, our
topical product development team is prepared to address all
aspects of product development, including:
- Physical & Chemical Characterization
- Formulation Development
- Addressing Stability of Drug in Formulation
- Chemical Stability
- Physical Stability
- Manufacturing Process Development
- Container/Closure and Delivery Component Compatibility
Studies
- Drug Product Stability Testing
- Scale-up and Technical Transfer
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.
Expertise in Topical and Transdermal
Drug Formulation
Cirrus provides topical and transdermal
drug formulation expertise:
- Solubilizing Water-insoluble Drugs
- Bioavailability Enhancement
- Excipient Selection & Compatibility
- Improving Product Stability
- Particle Size Reduction
- Product Performance Evaluation
- Enhancing Product Performance
- Novel Delivery System Development
- Manufacturing Process Development
Topical and Transdermal Delivery
Approaches
Services for passive and active energy assisted
transdermal and topical delivery of small molecules, proteins
and peptides are available. The enhancement approaches include:
- Iontophoresis
- Microneedles
- Ultrasound
- Electroporation
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.
Release Testing and Stability Testing
for Topical and Transdermal Products
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:
- Visual Evaluation
- pH
- Chromtographic Assay
- Particle Size Analysis
- In vitro Diffusion Testing across synthetic membranes
and human dermatomed skin.
Submission-ready documents will be generated.
Manufacturing Topical and Transdermal
Products
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:
- Blending/Homogenization
- Filling
- Container/Closure Components
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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