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PHARMACEUTICAL NANOTECHNOLOGY
Drug particles in the nanometer size range have unique characteristics that can lead to enhanced performance in a variety of dosage forms. Formulated correctly, particles in this size range are resistant to settling and can have higher saturation solubility, rapid dissolution, and enhanced adhesion to biological surfaces, thereby providing a rapid onset of therapeutic action and improved bioavailability. Scientists at Cirrus Pharmaceuticals, Inc. use nanotechnology to approach classical and novel drug delivery applications. We provide services for producing, formulating, and characterizing nanoparticles for a wide array of applications including, but not limited to, oral, pulmonary and parenteral delivery.
Applications
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Improving solubility and bioavailability of poorly soluble drugs
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Reducing fed / fasted variability
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Reducing inter-subject variability
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Drug targeting
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Novel formulation opportunities
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Potential for intravenous administration of poorly soluble drugs
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Activity screening of newly developed poorly soluble drugs
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Drug targeting
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Formulation Development
Cirrus has capabilities to generate nanoparticles using size reduction or particle building methods. A variety of specialized liquid milling equipment allows us to generate dispersions of submicron particles or droplets. Conversely, particles can be created through controlled precipitation. The process and formulation are developed together to yield a narrowly distributed, physically stable dispersion of primary particles. Types of dispersions that can be developed include:
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Nanosuspensions
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Nanoemulsions
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Solid lipid nanoparticles
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While suspensions are solid-in-liquid dispersions and emulsions are liquid-in-liquid dispersions, solid lipid nanoparticles are formed as a liquid in liquid dispersion which is transformed to a solid-in-liquid dispersion by solidification of the droplets. This chemically stable alternative to colloidal drug carriers can be tailored to achieve a modulated drug release.
Dosage form selection and formulation optimization are aided by extensive use of statistical experimental design. Short-term accelerated stability studies and physical stress testing are typically employed to challenge the candidate formulations.
Characterization
State of the art methods are used to characterize nanoparticles:
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Particle size distribution
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Dynamic Light Scattering is used to measure particles ranging from a few nanometers to about 3 µm, while Laser Diffraction is used to detect microparticles or possible aggregates of drug nanoparticles.
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Particle charge / zeta potential
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Our highly experienced staff uses zeta potential measurements to optimize formulation parameters and to make predictions regarding the storage stability of the colloidal dispersion.
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Crystalline status
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Differential Scanning Calorimetry and other analytical methods are used to assess any possible changes brought about in the physical form of the drug during processing.
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Saturation solubility and dissolution rate
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Pharmacopoeial methods are used to determine dissolution rate.
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Stability and Release Testing
Cirrus provides full method development and validation for regulatory submission. Full release testing, as well as short- and long- term stability testing are available:
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Particle size analysis
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Dissolution
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Chromatography
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Visual evaluation
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Dose content uniformity
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Drug-related impurities
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Submission-ready documents will be generated. If needed, Cirrus will assist the sponsor with issues regarding FDA regulation.
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