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Formulation Development

The leading laboratory for solving complex stability and formulation challenges using world-class science to speed products to market.

Why Work With FreeThink’s Formulation Team

Many one-stop shop CDMOs select technologies based on their existing equipment and specific experience, not based on your product’s needs. We are different! As a highly technical, creative, and flexible development organization, we provide unbiased solutions aligned with your requirements. We use the best science to get fast results using material-sparing processes. Once developed, we can help secure your intellectual property and successfully transfer the technology (and analytical methods) to an appropriate manufacturer.

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Formulation Development

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ADAP: Accelerated Drug Advancement Process

Target Product Profile

Solubilization Development

Controlled Release Development

Stable Formulation Development

ADAP: Accelerated Drug Advancement Process

Target Product Profile

Solubilization Development

Controlled Release Development

Stable Formulation Development

Target Product Profile

FreeThink develops a project-specific Target Product Profile (TPP) with you to align on product musts and wants, identify gaps in current knowledge, and catalyze brainstorming. Our scientists have extensive experience in all stages of product development and understand which parameters are critical.

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Solubilization Development

Selecting an appropriate solubilization technology can be complex for drug substances needing solubility enhancement. FreeThink uses an unbiased assessment to propose and demonstrate which technology best meets your needs. Among the options evaluated: amorphous solid dispersions (spray dried, hot melt), complexation, self-emulsifying systems, pH modifiers, particle size reduction.

Controlled Release Development

FreeThink scientists identify suitable controlled release technologies based on the drug properties and the TPP. Oral extended release technologies include matrices, beads/multiparticulates, and osmotics. Our proprietary OzmoCAP® platform enables factors affecting extended release viability including gastrointestinal solubility, absorption, efflux, and metabolism to be rapidly assessed in canine studies. We have expertise in enteric and taste-masking options and can develop depot systems for long-acting injectables.

Stable Formulation Development

FreeThink can develop a stable formulation in less than eight weeks using a material-sparing process. We use a tiered formulation process which is faster and more accurate than traditional excipient compatibility methods. Our approach uses realistic full formulations rather than binary combinations. The stability assessment uses our ASAPprime® which quickly determines formulation viability, including packaging considerations.

FAQs

Q: What makes tiered formulation better than the traditional excipient compatibility approach?

Unlike the traditional binary drug-excipient testing, which examines 1:1 ratios, tiered formulation skips intermediate steps and directly tests full formulations with realistic ratios. This approach:

  • Reduces unnecessary exclusions of excipients.
  • Yields a stable final formulation faster, often within a few weeks.
  • Minimizes drug substance usage.

Contact us to learn more about our tiered formulation approach [here]

Q: What types of formulations and processes does FreeThink have experience with?

FreeThink has developed a wide range of formulations, including:

  • Solubilized Drug Forms: Amorphous solid dispersions (spray drying, hot melt extrusion), self-emulsifying dispersions, and cyclodextrin complexes.
  • Oral Solids: Tablets, beads, capsules, enteric-coated dosages, and controlled-release forms.
  • Injectable Products: Depots and multiparticulates.

We work with both standard technologies and custom-built laboratory-scale equipment for human and animal health applications.

Contact us to discuss your formulation needs [here].

Q: How much drug substance and time does FreeThink need to develop a typical formulation?

For simple formulations, we typically require:

  • Minimum Drug Substance: 100–2000 mg are typically adequate.
  • Timeframe: About eight weeks for an immediate-release tablet formulation.

Interested in formulation development options? Reach out to our team [here].

Q: Does FreeThink develop sterile formulations?

Yes, FreeThink can develop some types of sterile formulations, though we do not have terminal sterilization capabilities.

Contact us to explore your sterile formulation needs [here].

Q: Does FreeThink have experience developing products for Zone IVb countries?

Yes, we specialize in adapting formulations and packaging to meet the challenging conditions of Zone IVb (30°C/75% RH). Our expertise ensures acceptable shelf life in these regions.

Contact us to learn more about our Zone IVb solutions [here].

Q: Can you make supplies for animal studies or human clinical studies?

FreeThink can produce small-scale supplies for animal studies. However, we are not equipped to produce GMP materials for human clinical studies.

Discuss your drug product development needs with our team [here].