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OptiDose® Design Solution

DRUG DEVELOPMENT & FORMULATION IS SCIENCE.
DOSE DESIGN TO CREATE SUCCESSFUL TREATMENTS IS ART.

Achieving development milestones is critical to progressing your molecule to the clinic, but this doesn’t always translate to successful medicines or better outcomes for patients and stakeholders.

Put our experience to work for you.

Catalent has helped innovators launch thousands of products for over 80 years, so we know what it takes for a therapy to succeed in an increasingly competitive market. We help your molecule progress from oral drug candidate to clinic quickly and efficiently with OptiForm® Solution Suite, solving it’s most complex bioavailability, solubility, and permeability challenges – but we don’t stop there.

We help seamlessly guide your drug through its path to success with OptiDose® Design Solution to help deliver a comprehensive assessment of your molecule, patient, and market.

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A DATA-DRIVEN COLLABORATIVE APPROACH

To determine the optimal dose form, Catalent’s team of scientific advisors collaborate with you to review your program background and utilize a set of structured tools to perform a comprehensive evaluation.

By assessing the physicochemical properties of the molecule, ADME/PK/PD characteristics, patient considerations, manufacturability, stability, and market considerations, our team of advisors provide recommendations for a dose form strategy that can help differentiate your product, improve patient acceptance, and turn your science into commercially successful medicine.

Physiochemical – Captures information on material properties of a drug and technology/dose form compatibility

Pharmacokinetics – Captures key pharmacokinetic properties of a drug that deliver efficacy

Patient Considerations – A vision for a product that will meet the needs of the patient

Dose Form Selection & Manufacturability – Recommendations that considers dose form evolution, product differentiation, and speed to market. Plus, a stable drug product and manufacturing process that is efficient and scalable

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FEATURES & BENEFITS

Our scientific advisors help you maximize your drug development investment, by identifying risk factors that could affect long-term commercial success and satisfy the needs of your stakeholders and achieve success in the market.

12
FEATURES
  • An agnostic evaluation of your molecule, technology dose form, and manufacturing path
  • Identification of development & manufacturing challenges
  • Tailored recommendations with options for optimal dose form selection
BENEFITS
  • Increase patient initial acceptance and adherence
  • Drive faster development timelines
  • Enable a differentiated dose form to help develop a successful treatment in the marketplace

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ADDRESSING PATIENT NEEDS & CHALLENGES

With a wide range of advanced drug delivery technologies able to overcome a variety of drug delivery challenges including dose loading, taste masking, drug release, food effects, and others, Catalent matches stakeholder considerations with these solutions.

Improved API performance

  • Solid form screening
  • Broadest range of proven solutions to improve bioavailability

Formulation flexibility

  • GLP and GMP formulations and test materials for early stage testing
  • Seamless transition to stable, scalable finished dose forms

Enhanced therapeutic profiles

  • Better absorption
  • Faster onset
  • Extended release
  • Targeted delivery
  • Improved therapeutic adherence
  • Minimized food effects
  • Reduced dose burden
  • Reduced dose frequency

Patient experience

  • Taste masking
  • Better dosing experience for special patient groups (e.g. pediatric, geriatric, psychiatric, veterinary)
  • Easier administration

Product differentiation

  • Unique technologies to attract prescribers and patient

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INTEGRATED SOLUTIONS

OptiDose Design builds on Catalent’s extensive expertise and integrated offerings in accelerating the scale up of promising compounds into success treatments including, OptiForm® Solution Suite, OneXpress™ Solution and OptiForm® Total Supply.

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BROAD TECHNOLOGY TOOLKIT

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WHY PARTNER WITH CATALENT?

As a global leader in drug delivery solutions we have the deepest expertise, the broadest offerings, and the most innovative technologies to improve the performance of your products from discovery to market and beyond.