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Expert Solutions in Drug Formulation Development

Expert Solutions to these Challenging Scenarios

Challenge:

Client #1 required a common formulation for a family of four compounds that employed a clear, water-based vehicle to increase topical bioavailability.

Velesco Solution:

• Within two days, Velesco developed a common formulation applicable to all five compounds to be dosed at three strengths each.
• All four compound formulations demonstrated significant improvement versus control.
• Timely delivery of the formulation allowed the client to meet their tight timelines for an animal study.

Challenge:

Client #2 had a poorly soluble compound which they needed in a vehicle acceptable for oral, intraperitoneal, and intravenous use.

Velesco Solution:

• Within one week, Velesco successfully developed a formulation that met the client's target concentration, was isotonic, well tolerated by the target animal species, and was acceptable for all three routes of administration.
• The formulation was simple to prepare and demonstrated 2 week stability at ambient storage.

Challenge:

Client #3 had a poorly soluble compound which they wanted formulated as a clear solution/microemulsion at high concentration for oral use in tox studies.

Velesco Solution:

• Within one day, Velesco developed a formulation that met the client's target concentration, was a lipid-based self-emulsifying drug delivery system (SEDDS), stable for three weeks at ambient storage, and had potential for further development as a soft-gel formulation.
• Client requested development of additional oil/water microemulsion formulations at high concentration.  Velesco quickly developed two additional formulations to meet these requirements.  The oil/water microemulsion also demonstrated good stability.

Challenge:

Client #4 had a poorly soluble, non-ionizable compound and required a high dose injectable formulation for animal studies.

Velesco Solution:

• Regular solvent mixtures were unable to achieve the required dose, but the precipitation characteristics suggested nucleation inhibitors may work.
• A successful non-toxic formulation containing anti-nucleation polymers was developed.
• A successful animal study was performed.