Case Studies

A new first-in-class therapeutic:  A specialty pharma client needed a formulation to counteract the effect of a 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 which marketing approval was rapidly granted by the FDA.

Rapid development strategy for insoluble cytotoxic cancer compounds:  LATITUDE’s IV nanoemulsion platform technology (Nano-E) 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 irritating 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 it 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 to proceed without the use of 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 to a once-a-day or once-a-week format.  To address this opportunity, LATITUDE has 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, and has been shown to be safe in Phase 1 clinical trials.

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

Topical steroid:  A specialty pharma client needed a topical formulation to substitute a currently marketed solvent-based topical product known to cause dry skin and eczema.  To address the dry skin side effect of the commercial product, LATITUDE developed an equivalent and stable solvent-free aqueous formulation using LATITUDE’s proprietary Nano-E technology platform. The aqueous formulation was evaluated for efficacy with in-vivo animal models and subsequently in humans.

Development of a topical formulation vehicle for combination drugs:   A specialty pharma client needed topical combination drug formulations for two drugs that were incompatible in aqueous and alcoholic solvents.  LATITUDE developed a non-aqueous technology for the topical delivery of water-sensitive active ingredients that does not use alcohols, surfactants or strong solvents, which are known to cause contact dermatitis when used in topical formulations. A leading anti-psoriasis drug molecule was put into this formulation and multiple stability studies showed LATITUDE’s topical formulation was much more stable than the Reference List Drug.  Additionally, the LATITUDE formulation achieved the same skin permeation as the RLD in drug delivery studies.

Change the dosing paradigm and reduce needlesticks with the PG Depot™ formulation:  A pharma company requested LATITUDE to develop an improved formulation for its peptide drug that was being injected once or twice daily to control blood glucose in adults with type 2 diabetes.  To address this challenge, LATITUDE incorporated the peptide into its PG Depot™ to create a new sustained release formulation that reduced the injection frequency from once or twice daily to only once per week.  Reducing the injection frequency created a paradigm shift in the dosing frequency and a potential key competitive advantage over drugs in this category. PK studies in a diabetic rat model confirmed the no-burst, peakless, near zero-order, and sustained release kinetics for this peptide from the PG Depot™.