Pharmaceutical Drug Formulation and Analytical Method Development

cGMP Manufacturing of OSD & SS

Whether your product is oral-solid or semi-solid dose, establishing the appropriate analytical framework and formulation design is vital to ensuring optimal production at clinical and commercial scale. UPM’s R&D and formulation experts have advanced several complex compounds from concept to commercialization, applying multidisciplinary expertise to develop the best processing conditions and formulation solutions for each unique product.

Formulation Development

Through decades of experience in formulation evaluation, UPM has fostered both the experience and passion to optimize complex formulations for a range of dosage forms. With semi-solids especially, we understand the importance of homogeneity, distribution and spreadability to the quality and efficacy of your product.

Over 25-plus years, it’s likely we’ve developed a time-tested approach to overcome your formulation challenges, but if not, we have the agility and desire to create a bespoke solution that meets the specific needs of your development program and market strategy.

Formulation Development Capabilities

  • Formulation development for tablets and capsules:
    • Immediate Release
    • Modified Release
    • Oral Disintegrating Tablets
  • Modified releases via:
    • Matrix Tablets
    • Delayed or sustained Release Tablet
    • Coating
    • Particle Coating for Capsule Fill
    • Coated Pellets for Compressed tablets
  • Combined technologies
  • Development by QBD principles, with formal DOE
  • Clinical Batch Manufacturing, for IND, Phase I, II, III Studies; Manufacturing of Generic Bio-Studies
  • Registration batch manufacturing
  • Content Uniformity Evaluation
  • Potency
  • Dissolution Testing
  • Stability Assessment
  • In-vitro Dissolution Profile Evaluation
  • Powder Flow Determination
  • Compressibility Evaluation
  • Disintegration Testing
  • Friability Testing
  • Tap density Testing
  • Particle size Testing
  • Micro Testing

Analytical Development

Across all development stages, we approach every project with a commercial mindset—and analytical development is no exception. Working with you to gain a deep understanding of your project goals and challenges, we design detailed protocols for method development, validation and technology transfer based on your product profile and development phase.

UPM offers a full range of analytical services—including elemental impurities testing, analytical testing services for raw materials and drug products—from our nearly 15,000 square-foot state-of-the-art R&D lab.

We offer elemental impurity analysis services according to USP <232>/<233> and ICH Q3D which are Good Manufacturing Practice (GMP) compliant to support your elemental impurity risk assessment and GMP batch release testing.

We have designed a calculated approach including options for semi-quantitative screening to support risk assessments, and fully-quantitative method development and validation along with routine analysis when appropriate. Our GMP facilities are equipped with triple-quadrupole, universal cell inductively coupled plasma – mass spectrometry (ICP-MS) and microwave digestion technologies.

UPM offers a full risk assessment report as required by ICH Q3D guidelines. 

We usually complete the risk assessment report and then perform testing based on the risk assessment and the client’s decision.

Analytical Development Capabilities

  • Dissolution Testing
  • Full ICH Stability Conditions
  • Microbial Testing
  • Purity Testing
  • Impurity Identification
  • Particle Size Determination (by laser)
  • Excipient Compatibility Testing
  • Solubility Screening
  • Hygroscopicity Studies
  • Methods Qualification and Validation
  • Controlled Drug Substances Testing (CI–CV)
  • GC / Headspace Analysis
  • Elemental Impurities
  • Thermal Analysis