CoreRx™ offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size, and multinational companies, CoreRx™ offers customized formulation development and clinical material manufacturing solutions.
Our solutions optimize client investments, shorten development time and reduce overall costs. From first-in-man drug development to full cGMC manufacturing support, CoreRx™ combines 200+ years of combined pharmaceutical development expertise to produce safe, effective, and innovative drug products, on time, and on budget.
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Compatibility studies, prototype evaluations and chemical property determinations performed to support your pre-clinical platforms including: pH solubility profiles, pKa determinations, polymorphism studies, API-excipient interactions, salt selection, hygroscopicity studies, and determination of distribution/partition coefficients.
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Our process allows for timely execution of formulation development from lab scale prototypes to clinical trial materials. This process ensures speed to the market with proven results for the following: API in capsules or bottles, tablets, capsules, oral liquids, parenterals (solutions, suspensions, and lyophilization), semi-solids, etc.
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| The CoreRx Facility was designed to provide pharmaceutical and biopharmaceutical companies with a quality resource for the cGMP manufacture of oral liquids, topical oral solids and other Clinical Trial Materials (CTM) for Phase I / II studies. The CoreRx facility also offers primary and secondary packaging services for solid, semi-solid, and oral liquid dosage forms, including over encapsulation. > Learn More |
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| Analytical methods can be developed and validated for drug substances and finished product. We support development and validation of methods for stability-indicating properties, purity, potency, dissolution, cleaning verification, impurity profile, and others. > Learn More |
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| To support your fast-track clinical programs, CoreRx can produce API/drug substance in bottle supplies, as well as blended API in capsules. CoreRx can move quickly and efficiently to meet your clinical timelines. > Learn More |
Expertise & Problem Solving to Contract Drug Development Support
CoreRx™ offers complete contract drug development support and analysis, from formulation feasibility studies for proof-of-principal, to excipient compatibility evaluation, final product formulation optimization, cGMP clinical batch manufacture and complete analytical testing.
Additionally, CoreRx™ has the facilities and expertise to work on the most challenging drug formulation issues, including solubility concerns, unstable compounds, innovative delivery options, low dose formulations, controlled drugs, and cytotoxic/high potency compounds.
Our Services Include:
 Development of small molecule NDA and ANDA Products
Development of Immediate, Modified, and Sustained Release dosage forms
Fixed dosage combination product development
Cytotoxic/Potent Compound Development
Feasibility Studies to assist in dosage form selection
Compatibility studies (drug-drug, drug-excipient, drug-package)
Dosage form selection
Formulation optimization
Taste masking/flavoring
Container/closure selection
Full Analytical Development
Stability Studies (short & long term)
Specification Development
cGMP Clinical Manufacturing
Full Release Testing
Facilities Validation
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