Latitude Case Studies

A new first-in-class therapeutic

A specialty pharma client needed a formulation to locally counteract the effect of another locally applied drug.

Within two weeks, Latitude developed a new formulation with the needed release and bioavailability parameters.

Latitude’s novel formulation resulted in a first-in-class therapeutic for the client that for which marketing approval was recently granted by the US FDA  

Rapid development strategy for insoluble cytotoxic cancer compounds

Latitude’s IV nanoemulsion platform technology is ideal for formulating a wide variety of insoluble and difficult-to-formulate compounds.

A key benefit of this formulation is the reduction of injection site toxicity for a wide variety of compounds When Latitude formulated a widely-used cytotoxic cancer compound in the nanoemulsion, the new formulation retained the same bioavailability but now had significantly less injection site toxicity in animal models.

In human studies, a client recently showed the new formulation was bioequivalent to the existing commercial product yet had significantly reduced injection site adverse events. The client is now seeking marketing approval for the formulated compound under a 505(b)(2) NDA.

Improving the safety of an animal tox formulation

A client needed a new formulation for a toxicity evaluation because the intrinsic toxicity of a co solvent in the original formulation potentially could confound the study.

Much time had been lost with the old formulation and time was of the essence Within 2 weeks, Latitude devised a new cremophor-free/polysorbate-80-free formulation that allowed the toxicological assessment of client’s API without using these toxic co-solvents.

Sustained release depot gel

A major marketing advantage for subcutaneously/intramuscularly injected peptides, proteins and small molecule would be to change from multiple injections per day or per week to a once/day or once/week format.

To address this opportunity, Latitude developed a proprietary gel depot system, made from GRAS excipients, that has near first-order release kinetics and no burst release
In several animal models, the depot has demonstrated proof of concept as a sustained release delivery system for various large and small molecules.

Several clients have licensed or are now planning feasibility studies for applications of the gel technology encompassing cardiovascular, pain management, and hospital therapeutics.