CoreRx is a Contract Development Manufacturing Organization (CDMO), based out of Clearwater, FL with a focus on clinical phase drug product development. We offer state of the art facilities to support your supply chain needs throughout the entire clinical trial process. Our comprehensive services include Preformulation (API Characterization, excipient compatibility, stability etc.) and formulation development, GMP manufacturing and analytical (cGMP compliant and in-house labs) testing of solid, liquid and semi-solid dosage forms.
While, our strength is in developing and Manufacturing Solid Oral dose, Solutions and Semi-solid (including topicals) formulations. We also have some novel capabilities for solubility/bioavailability enhancements, including a proprietary particle size reduction technology for creating nano-particles down to the 100nm range.
Our capabilities include the following -
Besides providing Solid Dose Formulation support such as Solubilizing water-insoluble drugs, Stabilizing unstable molecules, Enhancing bioavailability, Taste masking/flavoring, Creating modified/controlled release delivery of, API, Creating fixed dose combination products.
Our Solid dose Formulation Technologies include, Blending, Dry Granulation/Roller Compaction, Wet Granulation, Fluid Bed Drying, Spray Drying, Extrusion/Spheronization, Encapsulation, Tableting (Micro and Multi-Layer), Pan Coating/Drying.
Semi-solid formulation technologies include the standard Mixing, Homogenizing and Filling – however, we believe the difference maker is in the expertise of the formulation chemists.
Particle sizing technologies include the Dry Jet-Mill, Wet Microfluidization and the proprietary MicroJet Reactor to produce nano-particles with a very narrow standard deviation.
MANUFACTURING AND PACKAGING
We currently support a variety of dosage forms, with the scale to support Phase I – niche commercial manufacturing. We support manufacturing of DEA scheduled CII – V substances as well as high potency compounds.
Our full range of Manufacturing services provide the following solid Dose manufacturing support -
Tablets: Immediate to Modified Release, Orally Disintegrating (ODT), Multi-Layer Tablets, Micro-Tablets, Multi-API Combination Products (via multiple approaches).
Capsules: Neat API in capsule, Immediate to Modified Release, Powder Blends, Multi-particulates (beads & granules), Tablet in capsule, Over-encapsulation (for comparator blinding), Multi-API Combination Products via multiple approaches
Coating: Experience with coating of functional excipients, non-functional excipients, and secondary APIs, Experience in coating granules, beads, tablets, hard shell capsules and soft gel capsules
Semi-Solids: Include Gels, Creams, Ointments and Lotions filled in bottles and tubes.
We offer comprehensive primary and secondary packaging, labeling and distribution options linked with our manufacturing services to meet the needs of our customers.
Our full range of packaging options include thermoform and coldform blister packs as well as sachets and bottles for solid medications from tablets to capsules. With our bottle line, we can provide manual packaging or fully automated.