Accelerating Oral Formulation Development for Poorly Soluble Compounds

Bioavailability Enhancement

Many drug candidates struggle to achieve adequate oral exposure because of poor solubility, limited absorption, or restricted API availability. BioDuro’s Solution Engine (SE) combines computational modeling, formulation screening, and in vivo pharmacokinetic evaluation to rapidly identify amorphous solid dispersion (ASD) formulations that can improve oral bioavailability and support progression toward development.

Using as little as 1–10 mg of API, SE helps teams quickly evaluate formulation strategies and advance optimized candidates with greater confidence.

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Polymer–API Combinations Evaluated
1-10 mg
Typical API Required for Early Screening
4-6 weeks
In Vitro and In Vivo Screening Timeline
8-12 weeks
IND-Ready Formulation Timeline

Improving Bioavailability Through Integrated Formulation Science

Poor solubility remains one of the most common barriers to successful drug development, particularly for BCS Class II and IV compounds. Traditional formulation approaches often require significant material, lengthy development timelines, and multiple rounds of optimization before a suitable formulation is identified.

BioDuro’s Bioavailability Enhancements platform integrates in silico modeling, in vitro formulation screening, and in vivo PK studies within a coordinated workflow. This approach enables rapid evaluation of drug-polymer combinations, accelerates formulation selection, and supports development decisions with minimal API requirements.

Solving Common Formulation Challenges

Poor Bioavailability

Improve dissolution and oral exposure for challenging compounds through optimized amorphous solid dispersion formulations.

Limited API Availability

Generate meaningful formulation and pharmacokinetic data using milligram quantities of material during early development.

Accelerated Development Timelines

Move from formulation screening to IND-ready development candidates in as little as 8–12 weeks through integrated scientific and manufacturing support.

In Silico Formulation Modeling

Computational approaches help prioritize promising formulation candidates before laboratory evaluation begins.

  • Flory-Huggins-based miscibility modeling
  • Drug-polymer interaction assessment
  • Polymer screening
  • Solvent screening
  • Prediction of formulation compatibility
  • Rapid evaluation of multiple formulation approaches

API Characterization

Generate foundational physicochemical data to guide formulation strategy.

  • Melting point analysis (DSC)
  • Thermal stability assessment (DSC/TGA)
  • Crystallinity evaluation (PXRD)
  • Aqueous solubility testing
  • Solvent solubility profiling
  • Minimal API requirements (1–10 mg)

In Vitro Formulation Screening

Evaluate formulation performance using efficient screening workflows designed to conserve API.

  • Polymer and surfactant screening
  • Drug-to-polymer ratio optimization
  • MicroEvap and re-dissolution studies
  • ASD characterization by DSC and XRD
  • Kinetic solubility assessment
  • Stability evaluation

In Vivo PK Assessment

Confirm formulation performance through pharmacokinetic studies that support candidate selection.

  • Prototype formulation manufacturing
  • Rodent PK studies
  • Exposure comparison across formulations
  • In vitro and in vivo performance assessment
  • Formulation selection support

ASD Stability, Scale-Up & Manufacturing

Following formulation selection, BioDuro supports progression into development and manufacturing through integrated ASD scale-up capabilities.

Spray Dried Dispersion (SDD)

Development and scale-up of spray dried dispersion processes supporting formulation optimization and manufacturing readiness.

Hot Melt Extrusion (HME)

Process development and scale-up of hot melt extrusion formulations for challenging compounds.

Clinical Manufacturing Support

  • Engineering batch manufacturing
  • Process development
  • Oral solid dosage form manufacturing
  • Tablet and capsule production
  • Packaging and labeling support
  • Clinical trial material supply

From Screening to IND-Ready Formulation

A streamlined workflow connects formulation development, pharmacokinetic evaluation, scale-up, and manufacturing within a single organization.

  1. API Characterization
  2. ASD Screening
  3. In Vitro Evaluation
  4. In Vivo PK Studies
  5. Formulation Optimization
  6. Prototype Scale-Up
  7. Engineering Manufacturing
  8. Clinical Batch Manufacturing

This integrated approach helps reduce technology transfer challenges while accelerating progression toward IND-enabling studies and clinical development.

Frequently Asked Questions

Frequently Asked Questions

Improve Bioavailability

Helping poorly soluble compounds achieve better oral exposure.