AAIPharma’s Formulation Development team can guide your development program every step of the way – from Compound to Clinic®.  Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing a variety of dose forms.    We offer early phase accelerated programs for new chemical entities (NCEs) and generic drug development for human and veterinary applications (ANDA and ANADA).

AAIPharma’s formulation development scientists provide full chemistry, manufacturing and controls (CMC) services for drug candidates that encompass all biopharmaceutical classification system schemes (BCS class I through class IV) including the more challenging not freely soluble, unstable or poorly bioavailable. Our formulation and analytical experts provide creative solutions to these and other pharmaceutical challenges, such as extremely low or high drug loads, poor flow or homogeneity problems.

Our team’s extensive experience with the development of small and large molecules for administration by injection includes solutions, suspensions, emulsions, and lyophilized products. All of these product types have been successfully transferred for clinical and commercial use.

Our formulation development services include:

  • Drug substance preformulation studies
    • API salt form selection
    • API polymorph screening
    • API structural chemistry
  • Preclinical formulation development
    • Drug-excipient compatibility studies
    • Solid oral dose prototype development
    • Injectable prototype development
    • Bioavailabilty enhancement
    • Matching placebo development
  • Clinical formulation development
    • Accelerated first-in-human clinical trial materials
    • Powders for reconstitution
    • Blinding and over-encapsulation
    • Quality by design (QbD)
    • Pharmaceutical process development
    • Technology transfer and process scale-up
    • Drug candidate selection
    • Commercial dosage form design
  • Pediatric formulation development
  • Drug product life-cycle management

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Contact us for more information about our Formulation Development services.