MJR PharmJet GmbH

Formulation Development

MJR PharmJet provides formulation services for pharmaceuticals with a special focus on low soluble substances. We are your reliable development partner for all dosage forms including solid, liquid and semi solids. 

Our Formulation Development Services:

  • Development of solid, semi-solid and liquid formulations

  • Reformulation services and value added formulations for your existing products

  • Formulation screening services

  • Formulation optimization with QbD

  • Innovative formulations for low soluble APIs

  • CTM production

  • Clinical studies/ Pilot clinical studies

  • Stability studies

 

We understand the challenges in formulation development and use them for our advantage

We evaluate different innovative technologies such as hot melt extrusion, spray drying, nanoparticles, complexation for APIs with low solubillity and stability. We take the physicochemical properties of the API, excipient compatibilities, application route in consideration for the determination of lead technology and drawing the road map. This leads to superior formulations custom designed from the very first stages of development. 

 

 

MJR PharmJet ensures solution for your formulation challenges with innovative technologies, where we combine our expertise with high quality standards. Thanks to our wide range of services we accompany the whole way from conceptual approach over development to manufacturing. We set the user requirement specifications via functional design starting from the early stages of the solubilization development which is fed by interactions with end formulation process development at later stages, and finally combined to implementation of technology transfer. If required, we also offer our expertise for preparation of regulatory and business strategies, as well as risk asessments based on the experience/data that we gathered throughout the development phase. 

 

 

Our formulation and process development strategies are based six main pillars:

  • Ease of scale up via Quality-by-Design approach in accordance with the requirements of ICH Q8, Q9 and Q10
  • Early establishment of Process Analytical Technology (PAT) technique by integrating on-line, in-line or at-line process control specifications by determining the critical quality attributes from the very beginning of the development phase.
  • Early establishment quality control methods and identification of batch release strategy to ensure quality of the product and reduce batch-to-batch variation.
  • Compliant documentation under the light of regulatory requirements starting from the early development phase.
  • Reduced cost by affordable process protocols which are relevant for the optimization of the production methods by using your existing technologies without need of equipment invesment
  • Reduced Time-to-Market period owing to years of experience on life-cycle-assesment of particulate products<