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.

Read more: Pre-Formulation

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.

Read more: Formulation Development

The CoreRx Facility was designed to provide pharmaceutical and biopharmaceutical companies with a quality resource for the cGMP manufacture of oral liquids, oral solids, topicals, 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.

Read more: Clinical Manufacturing

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.

Read more: Analytical Development

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.

Read more: First-in-Man Studies

CoreRx offers diversified technical resources, capacity, flexibility, and the experience to develop and manufacture virtually any clinical dosage form with strict quality compliance. We partner with you to provide expert scientific resources throughout the manufacturing process.

Read more: Contract Manufacturing

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 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
• 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