Drug Delivery Systems and Formulation Platforms
LATITUDE offers its clients proprietary drug delivery technologies derived from our many years of experience as drug formulators. These innovative dosage forms, which have patents issued or pending, can solve your formulation challenges as well as provide new intellectual property for your API.
LATITUDE’s latest drug delivery technology is a powerful yet safe, broad-spectrum solubilizer called ClearSol™. The ClearSol™ vehicle forms stable, one-phase aqueous solutions with about 80% of insoluble APIs tested, which is much greater than achieved by other solubilizers such as cyclodextrins (e.g., sulfobutyl ether beta-cyclodextrin), polysorbates, and organic solvents. Furthermore, ClearSol™ formulations can be freely diluted in water or IV infusion fluids without any precipitation of the API, and can be sterile-filtered through standard 0.2-micron filters. ClearSol™ is made up of three Generally Regarded As Safe (GRAS) excipients that are FDA-approved for injection, and safety of the ClearSol™ technology has been demonstrated in several animal models and a U.S. Phase 1 human clinical trial under an FDA-approved IND. Details on the ClearSol™ technology can be found here.
Table chart: Common formulation challenges = LATITUDE’s formulation platform solutions
Individual summary of LATITUDE’s Formulation Platforms and Drug Delivery Systems
Nano-E : Nanoemulsion, a versatile solubility-enhancing platform for injectable, ophthalmic, topical and oral formulations ideal for highly insoluble APIs or “brick dusts”
PG Depot : Phospholipid Gel Depot, allows a customizable release profile of a drug following an injection into soft tissue or body cavity over 1-7 days. Injectable through fine needles up to 28 g, for easy administration by autoinjector or pen injector
ARTSS : Aqueous Room Temperature-Stable Solutions, a platform for the transformation of lyophilized powders or 2-8°C solutions into RT-stable aqueous solutions
RFAP : Rapidly-dissolving, Free-flowing Amorphous Powders, creates stable, amorphous, water-soluble powders that provide rapid dissolution and enhanced absorption for insoluble APIs
RTTF : Rapid Tox Templates Formulations, enable a smooth tox evaluation for highly insoluble oral drugs
24H ER : ALLDAY 24H ER Tablets, a tablet platform for increased dosage and linear, extended release of drugs for up to 24 hrs
MiniSpheres : novel delivery format for high/bulky dose oral drugs requiring taste masking and/or controlled release
GelPatch : novel transdermal spray/rub-on gel that dries as durable patch to provide multiday drug delivery
FEEDLETs : pellet formulation with superior taste-masking and controlled-release properties ideally suited for veterinary drugs
For more information, or to learn how LATITUDE can optimize the successful development of your drug, contact us.