Formulation Development




EXPERT FORMULATION TAILORED TO YOUR API AND INVESTIGATIVE NEEDS

  • Multiple dosage forms
  • Container/Closure compatibility
  • Fill-finish of drug product
  • CMC section preparation
  • Technology in-process transfer to CMO

Irvine's formulation team has over 100 cumulative years of small and large molecule formulation development experience. Our in-depth knowledge covers a diverse range of products, from generics to opthalmics, as well as a wide variety of dosage forms and routes of delivery. Irvine's preformulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Our formulation experts unite a thorough understanding of your needs along with the data on the physicochemical properties of the compounds to ensure the delivery of a stable, high quality product.

In addition to our formulation capabilities and complete CMC support, Irvine also conducts the necessary analyses, container/closure compatibility studies and pilot batch studies required to move your product through the regulatory process.

PRE-FORMULATION EXPERTISE

  • Solubility/solubilization                                  
  • LogD/LogP
  • Polymorph screening by DSC
  • Stability evaluation
  • Effect of pH
  • Arrhenius kinetics
  • Excipient compatibility

COMPREHENSIVE FORMULATION OF STERILE INJECTABLE PRODUCTS

  • Parenteral dosage forms
  • Liquid and lyophilized dosage forms
  • Emulsions/suspensions, semi solids
  • Liposome and microsphere encapsulation
  • Lyophilization cycle development
  • Admixture and container/closure compatibility
    studies
  • Pilot batch production and stability analysis
  • Toxicology supply manufacturing/dosing solutions
  • Fill-finish of drug product
  • Development report in support of CMC

DISCIPLINED TECHNOLOGY TRANSFER

  • Batch record development
  • Method transfer, development and validation    
  • Scale-up studies



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INSTRUMENTATION

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