TECHNOLOGIES & CAPABILITIES

POORLY SOLUBLE DRUGS

Since nearly 70% of NCEs in clinical development, and over 50% of pharmaceutical products approved in the US since 2000, contain poorly soluble drugs, the demand for new and improved formulation approaches continues to increase. Nano-technology is driving the solution for these difficult formulation challenges, providing new options for pharmaceutical products to be developed with improved biopharmaceutical properties. Using these technologies, products with lower doses, reduced food effects, less painful injections, more rapid onset-of-action, improved palatability and many other outcomes are made possible. Serious unmet medical needs can now be addressed with new formulations that enable medicines to be delivered orally or parenterally when such options were not available when the medicine was originally developed. Since 2000, the use of solubilization technologies in pharmaceutical development has significantly accelerated, and this trend is expected to continue.

NANO-TECHNOLOGY

Ascendia specializes in the application of nano-technology approaches to overcome solubility hurdles and develop novel pharmaceutical products. Nano-technology in the pharmaceutical field encompasses many types of formulation approaches, from nano-particles, to self-emulsifying lipid systems, to dispersed amorphous systems, to nano-emulsions - a field that is expected to exceed $100 billion by 2020. Ascendia's suite of state-of-the-art technologies for formulating poorly water soluble compounds provide sophisticated formulation options for our clients, and the unique dosage forms we create can be administered orally, topically, or by injection.

OUR TECHNOLOGIES

Formulating poorly water soluble drugs has traditionally been initially approached by creating new salt forms or co-crystals, micronizing the drug substance, or creating lipidic emulsions. As drugs become more insoluble, more sophisticated approaches are required. The properties of the drug substance often dictate the initial formulation approach, however it is not an exact science. Ascendia provides the parallel investigation of multiple technical solutions to see which one works best for a particular molecule. All of these approaches have one common goal - to improve the solubility and bioavailability of the drug by increasing the rate and extent of its dissolution in biological fluid. Since dissolution in an in-vivo environment is a dynamic system, meta-stable formulations and super-saturated dissolution kinetics often yield the most promising results.





ORAL CONTROLLED RELEASE

Developing long-acting oral medications for poorly soluble drugs is particularly challenging. The formulation design has to take into account the transit time in the gastrointestinal tract, the pH of the stomach and intestine (both with and without food), salinity and interaction with bile salts, and many other considerations. Ascendia has expertise developing matrix tablets, coated pellets, nanoparticles, and molecularly dispersed systems that can overcome these challenges for poorly water soluble drugs. Our dosage forms solubilize the drug in small particles that when disseminated in the GI tract allow the drug to dissolve more readily. The particles contain coatings that are time and pH sensitive so that a controlled release effect is simultaneously achieved as the particles transit the GI tract.
 
EmulSol is a technology for production of oil-in-water nano-emulsions. Nano-emulsions are meta-stable, and a high level of input energy is required to produce a nano-emulsion…

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AmorSol is a technology for the production of amorphous solid dispersions. Formulation of a drug substance in amorphous form greatly improves its dissolution kinetics, and has become a standard formulation technique...

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NanoSol is a technology for the production of nano-sized drug particles. Formulation of a drug substance in nano-particle form significantly increases the surface area available for dissolution…

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