Purdue Pharma L.P.

• R&D
  • Therapeutic Areas & Technologies
  • Reasons to Partner With Purdue
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Therapeutic Areas & Technologies

Discovery Research
Drug Formulation and Delivery
Medical Research and Regulatory Affairs

Pain Management Research

The scientific discovery team within Purdue’s pain management research laboratories employs a range of advanced technologies to find and evaluate thousands of new compounds for their potential to treat nociceptive pain (such as sprains, bone fractures, burns, and inflammation) and neuropathic pain (such as peripheral neuropathy, certain types of cancer pain, and phantom limb pain).

Discovery Research Technologies

Medicinal & Combinatorial Chemistry

• Parallel synthesis & purification systems
• Microwave synthesis
• Peptide synthesis
• Kilo lab

Analytical Chemistry

• NMR Spectroscopy
• IR, LCMS, HPLC

Computation & Informatics

• Protein modeling
• “Risk minimizing” molecule design tools
• Data sharing/mining & visualization

Pharmacology & High-Throughput Screening

• Liquid handlers 96 & 384 wells
• Radioligand-assays
• FLIPR/TETRA
• Electrophysiology

Drug Formulation and Delivery

Purdue is well known for its expertise in drug formulation and delivery systems. The non-clinical development team pioneered the sustained-release formulations of opioid analgesics helping to advance the practice of pain management. We employ a full range of formulation and testing platforms.

Non-Clinical Development Technologies

Drug Safety, Toxicology & PKDM

• 100% CRO supported
• Bioanalytical

Tamper Testing

• Mechanical & thermal
• Extraction, inhalation
• Dissolution
• EtOH dose-dumping

Analytics

• Stability testing
• Method development
• Tech transfer
• Batch release testing
• Solid-state characterization

Pharmaceutics

• PEO, PCL platforms
• Melt extrusion
• In vitro dissolution
• Controlled substance management
• Non-GMP pilot plant

Medical Research and Regulatory Affairs

Purdue medical researchers guide the development of all pipeline projects and conduct clinical trials to study the latest generation of analgesics and new therapeutic products. Purdue’s Medical Research group provides end-to-end clinical development capability with dedicated and experienced staff in all core and supporting disciplines, including:

• Clinical Research
• Clinical Pharmacology
• Statistics and Data Management
• Clinical Operations
• Scientific Communications
• Clinical Systems
• Risk Management and Epidemiology
• Regulatory Affairs
• Drug Safety & Pharmacovigilance

Purdue’s clinical development staff includes a diverse group of clinical research professionals, including medical doctors who collectively possess a tremendous breadth of experience in the analgesic, CNS, and cardiovascular disciplines.

Purdue’s clinical and regulatory team interacts regularly with the FDA on issues pertaining to our products.

Purdue’s drug development teams have been responsible for the design and execution of United States and ex-U.S. (EU, Japan, Canada, Australia, etc.) development plans leading to multiple regulatory submissions and approvals of the company’s sustained-release opioid analgesic products.

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