Speed to Market

For decades, Bilcare has helped packaging engineers and formulators of global pharmaceutical companies overcome the time and resource crunch they face when attempting to achieve successful stability studies.

Bilcare's Services

  • Reduce risk of delays of FDA approval and product launches due to stability failures
  • Reduce wasteful and costly over-packaging
  • Expedite formulation and packaging development processes, thereby increasing R&D output
  • Align the drug stabilization process to the QbD approach recommended by FDA
  • Make post-approval changes easy and scientifically correct
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BilcareOptima

Enhanced formulation analysis leads to optimum packaging solutions

  • Provides ideal, product-specific packaging recommendations within six weeks
  • Documentation supports the QbD approach recommended by the FDA
  • Assures market launch of products in customized, "just right" packaging
  • Stability is conducted on the selected package only, saving time and cost for multi-pack stability studies
  • Leads to deeper understanding of the product's sensitivity and stability challenges
  • Enables the design of customized packaging solutions for specific climatic conditions
  • Identifies stability issues of products at non ICH/ tropical/ real life conditions and their solutions
  • Evaluates three fresh batches, taking batch-to-batch variation into account
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FastPack®

Enhanced formulation analysis leads to optimum packaging solutions

  • Scientifically streamlined process identifies the two most optimal packaging materials in terms of cost and barrier protection in just 15 business days
  • Provides the tools and support needed by packaging engineers and formulators to shorten the timeframe of successful stability studies
  • Provides ideal blister design and tool drawing

Eliminate "Over-Packaging"

The BilcareOptima™ and FastPack® solutions help eliminate over-packaging by placing your product through rigorous evaluation examinations, including a Forced Degradation Study, which:

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  • Measures effects of temperature, relative humidity, and light
  • Evaluate Critical Quality Attributes (CQA) of the product impacted
  • Determines a product’s threshold values
  • Determines optimum barrier properties required for product stability
  • Designs the ideal blister cavity using SolidWorks 3D Software
  • Simulates cavity thinning and moisture permeation through FEA software
  • Selects optimum film and foil for blister packaging of the product
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Bilcare Modelling

Solid and cost-effective shape for solid dose products

The Bilcare Modelling Program boosts the productivity of packaging engineers by providing information required for final blister pack, including tool drawing and/or dosage sizes data. The program comprises a thermoforming simulation and barrier determination of the formed cavity. Benefits include:

  • Converts a tool drawing to a virtual thermoformed cavity in just in few hours
  • Determines barrier properties (WVTR, O2TR) of blister without even physically making it
  • Determines the stability suitability of same packaging film should the dosage be changed or shelf life extended
  • Optimizes blister dimensions for best-possible “post-formed” barrier protection
  • Reduces process development time by accurately sizing the cavities and improving material utilization
  • Determines the film thickness requirement to make a sturdy blister
  • Determines the thickness profile of the formed cavity

Any Blister Challenges? Contact us!

Bilcare Research AG

GLOBAL PHARMA
PACKAGING LOCATIONS

  • Bötzingen, Germany
    Bötzingen, Germany
  • DELAWARE, US
    DELAWARE, US
  • SINGAPORE
    SINGAPORE