Nitto Avecia Pharma Services
Formulation Development

Formulation Development

Nitto Avecia Pharma Services is a cGMP contract development and manufacturing organization. Avecia Pharma's experienced and knowledgeable formulation team can reduce product risk and accelerate the drug development process by providing you with the optimum dosage form selection.

Partner with Avecia Pharma's Formulation Development Team

Avecia Pharma's 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. Avecia Pharma's pre-formulation 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, we also conduct the necessary analyses, container/closure compatibility studies and pilot batch studies required to move your product through the regulatory process.

Expert formulation tailored to your API and investigative needs

  • Multiple dosage forms (suspensions, liquids, lyo)
  • Fill-finish of drug product
  • Container/Closure and solution contact surfaces compatibility
  • CMC section preparation
  • Technology in-process transfer to CMO

Pre-Formulation Expertise

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

Comprehensive Formulation of Sterile Injectables

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

Disciplined Technology Transfer

  • Batch record development
  • Critical process parameters evaluation
  • Method transfer, development and validation
  • Scale-Up from lab to manufacturing

State-of-the-Art Instrumentation

  • VirTis 25L Genesis EL freeze dryer with sample thief and Maestro software
  • TA Instruments Q2000 Differential Scanning Calorimeter with modulated DSC
  • TA Instruments TGA Q500 high resolution thermogravimetric analyzer
  • LYOSTAT2 freeze drying microscope system
  • Microfluidics Microfluidizer Model M-110P high shear homogenizer
  • Malvern Zetasizer Nano Series ZS-90
  • Malvern Mastersizer 2000 with wet and dry modules
  • Mettler Toledo DL39 Karl Fischer Coulometer
  • Brookfield HBDV-II+Pro cone/plate rheometer
  • Agilent 1200 Series HPLCs with a range of detectors
  • UPLC
  • Brookfield CT3 texture analyzer
  • HunterLab ColorQuest XE
  • Ross Dual planetary mixer
  • Dissolution apparatuses
  • Advanced Instrumentation: Micro-osmometer, specialized pH meters, and micro/ analytical top loading balances

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