OptiForm® Solution Suite Bio

FAST MACROMOLECULE SCREENING FOR ORAL DELIVERY

Today, a majority of macromolecule doses are delivered in traditional but invasive injectable formats, which often results in poor patient compliance and therefore is not the most suitable route for long term treatment.  Although oral delivery has always been preferred for any new therapy, there are a variety of development challenges faced by formulation scientists.  

  • Poor absorption due to rigid molecular geometry and flexibility
  • Permeation limitations with tight junctions and limited transcellular pathways
  • Low stability because of proteolytic enzymes of the stomach and lumen, as well as harsh acidic gastric conditions

OptiForm® Solution Suite Bio is an integrated offering designed to rapidly screen biomolecules’ potential for a non-invasive delivery route.  OptiForm® Solution Suite Bio employs advanced formulation technology platforms including OptiGel™ Bio and Zydis® Bio technologies, and utilizes a parallel screening model based on rigorous science and best-in-class formulation expertise.

Today there is no proven technology for biomolecule oral delivery.  A simple screening process with a toolkit of enabling technologies targeting different biological barriers allows quick assessment for biomolecule oral delivery potential.  

EASY: Integrated and parallel screening with 2 enabling technologies – OptiGel™ Bio and Zydis® Bio technologies

FAST: Parallel screening against biological barriers  with animal study material ready in as little as 3 weeks

COST EFFECTIVE: Screen your biomolecule for oral delivery potentials at a minimal price 

The Process

Catalent OptiForm® Solution Suite Bio follows this three step process: 

  • ASSESS: Assess permeability of target molecules against duodenal and sublingual barriers and get material for animal study in as  little as 3 weeks
  • ENHANCE: Formulation technology experts confirm the possibility  of reaching targeted systemic exposure and collect preliminary stability data
  • DELIVER: A dedicated advisor will provide a recommended path forward based on rigorous data and validated PK data in upper animal species.
Assess

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API Selection with Parallel Screening for Duodenal and Sublingual Permeation

DUODENAL BARRIER ASSESSMENT 

  • SUBLINGUAL BARRIER ASSESSMENTAnalytical method assessment
  • API stability assessment with the permeation enhancer
  • Prepare API in solution with the permeation enhancer
  • Review PK baseline study results in dogs
  •  Manufacture of non-optimized lyophilized tablets for API in blisters for animal PK study
  • Review PK baseline study results in dogs
Enhance

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Develop Chemically Stable Formulations with Enhanced Bioavailability

OPTIGEL™ BIO TECHNOLOGY: Lipid Based Formulation Screening Visual API solubility assessment with excipients

  • Lipid based formulation development (up to 3 formulations)
  • Provide softgel formulations for animal PK study

ZYDIS® BIO TECHNOLOGY: Lyophilized Formulation Screening

  • Visual API solubility assessment in prelyophilized solutions
  • Tablet prototypes screening 
  • Provide ODT prototypes for animal PK study  
Deliver

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Scientific Advisor Delivers Formulation Approach Recommendations 

  • Development report showing summary of studies conducted, results, recommended path forward based on rigorous data, and validated PK data in upper animal species
  • Your dedicated scientific advisor will review all the data and provide recommendations for future development
Oral Formulation Technologies
  • OptiGel™ Bio technology incorporates enteric coating and permeation enhancers to first deliver active macromolecules to the absorption site and then allow them to pass through the absorption site to enter circulation.  Click for details
  • Zydis® ODT (orally dissolving tablet) is a freeze-dried oral solid dosage form that disperses almost instantly in the mouth without water required.  Zydis® Bio technology is an advanced ODT formulation designed to deliver biomolecules to the oral mucosa for systemic absorption.  Click for details.
Benefits

When you partner with Catalent you can expect rigorous science, innovative technologies and track record of serving innovators.

  • RIGOROUS SCIENCE, INNOVATIVE TECHNOLOGIES: Data driven parallel screening with advanced technologies
    • Deepest expertise processing thoughts of molecules applying proven formulation technologies
    • One partner from molecule screening to phase I and beyond: accelerate development and eliminate future tech transfers
    • Lead Non-Invasive Macromolecule Delivery Consortium with industry KOLs to foster collaboration and the use of innovative technologies
  • PROVEN TRACK RECORD: Help innovators bring products from early stage to market
    • 100+ molecule candidates for optimal formulations screened every year
    • 100+ new products to market every year
    • 20 R&D centers in a global network of 30+ sites with 1,000+ scientists
    • Serving 1,000+ innovators of all sizes on 7,000+ products
    • Partnering on 75% leading molecules and 50% FDA approvals