CoreRx™ Pharmaceuticals - Pre-Formulation / Formulation Development, Analytical Development, and Clinical Manufacturing

CoreRx™ offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size and multinational companies, CoreRx offers traditional, as well as customized formulation development and clinical material manufacturing solutions; solutions that maximize client investments, shorten development time and reduce overall costs. From 'first-in-man' drug development to full CMC support, CoreRx combines over 200 years of pharmaceutical development expertise to produce safe, effective and innovative drug products – on time and on budget.

CoreRx offers complete contract drug development support, 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 and high potency compounds.

• Over-encapsulation and powder-in-bottle studies
• Development of NDA and ANDA products
• Development of immediate, modified and sustained release product
• 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 and long term)
• Specification development
• cGMP clinical manufacturing
• Full release testing
• Facilities validation

Dosage formulation development

CoreRx offers comprehensive formulation development services for virtually every dosage form, catering to the needs of our clients and their specific drug delivery requirements.

CoreRx scientists have extensive expertise in drug formulation development, allowing innovative solutions and speed to market. Areas of expertise include:

• Solubilizing water-insoluble compounds
• Fixed dosage combination products
• Multi-layer tablets
• Taste masking
• Bioavailability enhancement
• Excipient selection
• Product stability enhancement
• Particle size reduction
• Formulation screening
• Modified and controlled release development
• Innovative delivery system development
• Clinical manufacturing process development
• Cytotoxic / potent compound development
• First-in-man studies (API in capsule / bottle)

CoreRx supports early and late stage development of solids (IR tablets, MR tablets and SR tablets), capsules, semi-solids (creams, gels, ointments, lotions), solutions, ophthalmics, parenterals and nasals. CoreRx has specific expertise in developing fixed dosage combination products, including bi-layer, tri-layer and multi-layer tablets, as well as multi-particulate delivery in capsule combination products. Additionally, CoreRx has extensive expertise in orally disintegrating tablets (ODT), taste masking and modified release delivery.

Clinical manufacturing of dosage forms

CoreRx offers diversified technical resources, capacity and flexibility to develop and manufacture virtually any clinical dosage form with strict quality compliance, speed and overall value.

CoreRx has innovative manufacturing capabilities for challenging products and the ability to customize manufacturing to client demands. Other services include:

• GMP manufacturing, packaging and labeling
• First-in-man studies (API in capsule / bottle)
• Tablets, capsules, semi-solids, suspensions and solutions manufacturing
• Blinding for clinical studies (over encapsulation)
• Process development, scale-up and technical transfer of various dosage forms
• Manufacture matching placebo for clinical studies
• Manufacturing semi-solids (gels, ointments, creams, lotions), process qualification and cleaning verification
• Cytotoxic / potent compound capability

Analytical development and small molecule analysis

At CoreRx our services center on small molecule analysis, including pre-formulation, method development, method qualification, method validation, drug substance testing, finished product release, and ICH stability storage and testing.

We can perform experimental design and execution for separation, isolation and analysis of pharmaceutical compounds, and HPLC, GC method development and validation for assay and related substances dissolution. We follow standard protocol for all development studies and can offer full document traceability. Other services include:

• Method development and validation for identity, potency, quality and purity of drug substances and finished products
• Impurity profiles
• Photostability determination
• Specification testing
• Release testing
• Cleaning validation
• Specification development
• Stability testing via ICH guidelines
• Forced degradation studies