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Softgels

SoftgelsWith more than a decade of softgel experience, Pii has established a strong reputation in the pharmaceutical industry as a high quality softgel dosage form development and cGMP manufacturer.  We have supported the development of softgel capsules from feasibility and prototype development to commercial launch.  Our deep scientific understanding of and experience with softgels provides you with an opportunity to shorten development time, improve product performance, and extend intellectual property position.

Softgels are widely used in prescription and OTC pharmaceuticals for their improved bioavailability, ease of swallowing, positive consumer response, reduced odors/flavors, extended shelf life and flexible product formulation options.

A proven delivery technology with multiple prescription and OTC products on the market, softgels are an ideal delivery solution for complex development challenges, including:

  • Solve formulation challenges for compounds characterized by:
    • Poor solubility
    • Low melting point
    • High oxidation susceptibility
    • UV degradation
  • Improve clinical profiles and patient compliance
    • Controlled release or  rapid onset of action
    • Improved dosage accuracy
    • Taste masking
    • Enteric coating
  • Provide market differentiation:
    • Product life cycle opportunities
    • Intellectual property positioning
    • Longer shelf-life, product security and stability
  • Improve handling for hormonal, potent and cytotoxic drugs

Pii’s softgel experience is grounded in our understanding of and experience with lipid based drug delivery. From bench to launch, Pii has the experience and capabilities to support your softgel development project. Our softgel capabilities include:

  • Feasibility studies and prototype formulations
  • Pilot scale and CTM production
  • Gel shell design studies to optimize finished product performance
  • Commercial manufacturing
  • Analytical services to support product development

 

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