Information

INDiGO™ with Solid State Option

Utilizing our global company, our INDiGO™ service with the solid state study option will substantially reduce time to First In Man clinical trials while improving consistency of results and product knowledge, the two backbones of quality.

INDiGO™ reduces time from API to IND submission to 26 weeks or less for appropriate compounds. These reductions are achieved by merging traditional preformulation, drug substance, drug product, clinical supplies and analytical method development silos into a single unit managed by a veteran, dedicated project manager and staffed by professionals with experience spanning the development process.

The INDiGO™ approach is based on:

  1. Eliminating artificial barriers between drug substance (API) and drug product development, merging these into a single track. This approach streamlines the pre-IND process down to three tracks: (a) Preclinical toxicology; (b) Clinical supplies; and (c) IND preparation. These tracks operate in parallel to reduce time to clinical trials.
  2. Modern formulation approaches to increase the solubility and bioavailability of the drug substance. 
  3. Establishing information for patent filings early. 

General Plan

The diagram below outlines how the Fast-to-IND process works and approximate time frames for various parallel development tracks.



The chart is divided into three tracks: Preclinical, Clinical supplies, and IND preparation. The preclinical program includes a rigorous preclinical study involving 28 day tox studies as well as a complete battery of additional tests, designed and implemented with an eye toward the requirements for successful IND submission – with non GMP material timelines can be further reduced. The clinical supplies module includes a significant planning component where the type of dosage form for clinical supplies is determined based on the solubility of the API, as well as methods development. Finally, there is an IND preparation segment during which the IND will be prepared. All of this is intended to be accomplished in 26 weeks. This plan is based on the assumption that the client is able to provide us with at least 1 kg of GMP drug substance on day one – a capability we are also able to resource.

Formulation Approaches

  • Amorphous dispersion in capsule. This formulation targets increasing exposure for the estimated 80% of NCE’s that have solubility problems.
  • Salt/Cocrystal/Polymorph  (crystals) in capsule. This formulation provides well characterized clinical supplies.
  • Lipid/Liquid formulation in capsules. This formulation is targeted toward insoluble compounds to provide maximum exposure.
  • Wet milled microcrystals. This formulation is targeted toward low solubility compounds to increase exposure.

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Quality Overall Summary

Our approach was developed based on the latest FDA standards for quality. These concepts are briefly summarized in the wheel above. In INDiGO our work on our clients’ behalf focuses on the inner part of the wheel. As shown on the wheel, step 1 is product design as described in the formulation approaches section. A process is then designed to produce the product. Quality by design elements are at the heart of the process design, and extensive measures are taken to ensure stability, for example. The process is monitored using sophisticated analytical equipment including in-line Raman probes. This information will be provided in a report suitable for submission to the FDA.

Intellectual Property

Information needed for patent filings is also provided as a standard part of the INDiGO™ offering with the solid state study option.

Unique Aspects of INDiGO™ with Solid State Study Option

  • Aptuit has been the industry leader in offering this type of integrated program. Our complete scientific platform eliminates the need for 3rd party service providers allowing us to truly manage priorities and delivery milestones.
  • We offer our INDiGO ™ programs for fixed price on a fixed timeline simplifying management of budget and timelines.
  • Aptuit has  an industry leading and proven track record of completing more than 20 INDiGO™ type programs and a long history of progressing candidates through to First In Man and beyond to product launch.
  • Reduce your timeline to IND/CTA submission.
  • Solid state studies can be included in the program to extend and maximize IP coverage and provide further understanding of our molecule.
  • Best possible approaches for poorly soluble drugs including amorphous dispersion in capsule.
  • Intellectual property support elements.

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