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FORMULATION

Comprehensive drug development
for solid oral dosage.

OUR BIG PHARMA EXPERIENCE ALLOWS YOU TO OUTSOURCE WITH CONFIDENCE

Step by step, our experienced technical experts will work with you to establish, develop, scale up and finalize the ideal formulation for your solid oral dosage project. With focus on Quality by Design (QbD) principles, timelines and customer communication, we ensure that your needs are our top priority. Whether single-batch formulation transfer or full-service formulation development, Ropack Pharma Solutions offers cGMP-compliant or non-GMP environments.

FORMULATION DEVELOPMENT

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Ropack Pharma Solutions offers formulation development expertise for products at all stages. From early-stage prototype development, formulation selection, formulation optimization and release profile definition to late-stage formulation troubleshooting and lifecycle management formulations, Ropack Pharma Solutions provides complete development strategies to ensure your requirements are met.

  • Prototype formulation
    • Immediate release
    • Controlled release (extended, sustained, delayed release)
    • PH-dependent release (gastro-resistant)
    • Combination products (505(b)(2))
    • Lifecycle management
    • Bioavailability and solubility improvement
  • Formulation optimization
  • Scale-up
PROCESS DEVELOPMENT 

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Ropack Pharma Solutions offers fully scalable cGMP process operations capabilities from early-stage development to large-scale clinical supplies and registration batches. Our pharmaceutical scientist will work with you to develop a comprehensive scale-up plan with process design and QbD principles included at every manufacturing stage. The technologies and capabilities include:

  • Blending
  • Multilayer tablet compression
  • Tablet coating
  • Wurster coating (coated pellets)
  • Top-spray granulation
  • High-shear wet granulation
  • Encapsulation
  • Micronization
  • Light-sensitive compounds

SPECIALIZED DOSAGE FORMS
  • Bi-layer tablets 
  • Controlled-release tablets
  • Coated pellets
Multilayer tableting

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When our pharmaceutical scientists determine that a multilayer tablet is the optimal form for your solid oral dosage – whether giving it a competitive edge and improving patient compliance or extending a patent – they are supported by the advanced technology of the Korsch XL 400. This state-of-the-art rotary tablet press:

  • Ensures the highest regulatory standards quickly, reliably and flexibly
  • Provides precision weight control at the highest speeds
  • Seamlessly scales up from pilot batches to commercial production
  • Eliminates segregation of powder in the feeding system
OTHER SERVICES

other

  • Internal commercial technology transfer team guiding the scale-up process from clinical to commercial
  • Manufacturing of individual development batches

THE ROPACK PHARMA SOLUTIONS ADVANTAGE

Ropack Pharma Solutions is driven by quality, scientific expertise and customer communication to ensure that your drug candidate is given the best path to market.

  • Scientists experienced with a combined approval of 22 commercial products
  • All scientists experienced in the big pharma industry
  • cGMP-compliant facilities totaling more than 340,000 sq-ft.
  • Ample cGMP cold storage
  • Licensed for controlled substance management
  • Dedicated project manager
  • Seamless drug development process from R&D to commercial manufacturing and packaging