FreeThink Formulation & Product Development
FreeThink Pharma Laboratories will help you develop the best formulation and process solution:
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FreeThink is a leader in developing formulations and dosage forms for complex product requirements including, for example, such needs as high dose actives, low solubility drugs, oil-based formulations, controlled drug delivery, regional drug delivery, gastroretentive dosage forms, depot formulations, multiple drug dosage forms, and many more.
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FreeThink’s tiered development approach allows for fast development of simpler dosage forms (tablets, capsules). This approach is combined with ASAPprime® stability testing to generally achieve a usable formulation in under 4 months.
The details:
FreeThink develops formulations and analytical methods which are owned by the sponsor companies. This provides flexibility to bid the manufacturing operation with multiple CMOs, often reducing long-term costs.
FreeThink can assist in finding an appropriate CMO and manage the technology transfer process.
FreeThink’s pharma laboratory scientific experts will work to find the best formulation and process solution for the project and are not constrained by a specific manufacturing approach or technology, providing the best formulation by design.
Contact a Formulation Expert
Unbeatable Expertise in Product and Method Development
FreeThink scientists are leaders in the adoption of a “tiered” approach to formulation development, with an emphasis on stability enabled by ASAPprime®:
- Traditional excipient compatibility studies correlate poorly with final product stability and require a significant investment of time and resources.
- In the tiered approach, FreeThink’s scientists prepare two to three standard formulations of actives in tablets, capsules, or other dosage forms.
- These formulations are evaluated using ASAPprime® to see if one or more of the formulations is acceptable for stability –not just rank-ordered.
- Analytical method development and validation is used in this process to ensure reliability and consistency.
- If deemed acceptable, the formulations can be developed rapidly. If none of the formulations reach the desired stability targets, a second-tier study is initiated.
- These second-tier formulations may include such stabilizers as antioxidants or pH modifiers.
- A final formulation is generally achieved in less than four months.
- For all formulation development, FreeThink brings its knowledge of stability to the process, enabling stable liquid and solid formulations even for unstable actives.
FreeThink scientists can establish the maximum absorbable dose (MAD) for oral absorption and use this to determine the most appropriate technology to provide adequate drug absorption.
- FreeThink can help facilitate the development of appropriate technologies through our partner companies, including:
- Particle size reduction (for drugs that are dissolution limited rather than solubility limited)
- Salt formation and amorphous drug forms (using spray dried dispersions, SDDs, or hot melt extrusions, HMEs).
- Our scientists have experience in product development for very lipophilic drugs in the form of oils and emulsified dispersions (e.g., self-emulsifying dispersion systems, SEDDS and self-emulsifying microdispersion systems, SMEDDS).
- These formulation options can be combined with hard (gelatin or HPMC) or soft gelatin capsules, when appropriate.
FreeThink has particular expertise in the development of oral controlled release dosage forms.
- Working with the sponsor company, a dosage form Target Product Profile (TPP) is established and used to select the primary dosage form to be developed.
- For many technologies, FreeThink scientist can develop appropriate formulations and dosage forms internally.
- In some cases, FreeThink will coordinate work through one of its partner companies.
- When the TPP requires a very high dose, FreeThink has expertise in complex tablet and chewable formulations and processes (including external
lubrication technology).