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PharmaSolv Consulting

Pharmaceutical Solutions From Discovery Through Development

Helping you improve the druggability and formulability of your drug compound

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What Can PharmaSolv Consulting Do For You?

1

Select the right form/phase of the API

• What salt form of the drug substance or active pharmaceutical ingredient should I choose?
• Does my salt disproportionate in the formulation (solution, suspensions, parenteral formulations, solid oral dosage forms…)?
• What polymorph?
• Should I select an amorphous phase?

2

Select the right preclinical safety toxicology formulation

• What formulation should I select to maximize exposures?
• What vehicle should be used when dosing rodents/non-rodents orally, parenterally (injectable)?

3

Maximize bioavailability

• What formulation should be used in pre-clinical tox studies?
• Can formulation solve my exposure issues?
• Can changing the form of the drug compound help?

4

Troubleshoot

• How can I maximize plasma exposures?
• How can I reduce variability in plasma exposures?
• What is happening to the drug substance during formulation development?
• What excipients should I avoid in my formulations?
• Why do the plasma concentrations decrease?
• Does my API crystallize from the amorphous solid dispersion formulations?
• Does it convert to a new polymorph?
• Does the salt disproportionate in the dosage form?

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