NanoSol

Nano-Particle Technology

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. A ten-to-twenty-fold increase in surface area can result from reducing particle size from a micronized drug substance to a nanonized drug substance.













As surface area increases, the rate of dissolution increases and bioavailability improvements may result. If a solid dosage form is desired, the nano-particles are stabilized by adsorption onto polymer carriers - a process conducted by fluid bed coating. Alternatively, the nano-particles can be prepared as a suspension and administered as a liquid - either orally or by injection.

Lipid-Based Nano-Particles

In addition, dissolution of poorly soluble drugs can be improved by formulating the nano-particle as a homogenous mixture of the drug and a lipophilic excipient. By combining the drug with a lipid carrier, the energy required for the drug to dissolve in the body is greatly lowered.

Ascendia uses a bead-milling or high-shear homogenization process for production of nano-particles, and can investigate the impact of nanonization with small amounts of drug substance. Ascendia’s nano-particle technology can enable pharmaceutical products with enhanced drug loading, bioavailability, reduced food-effect and more rapid onset-of-action. Ascendia specializes in the application of nano-technology approaches to developing novel pharmaceutical products. Our suite of state-of-the-art technologies for formulating poorly water soluble compounds provides sophisticated formulation options for our clients. Contact us today for more information on how our formulations can enable your pharmaceutical product.

ASD-005: LIPID-BASED NANO-PARTICLE CASE STUDY

ASD-005 is a long-acting, injectable nano-particle formulation of a cardiovascular drug indicated for the treatment of heart failure. The drug substance in nano particle form is stabilized using lipid excipients. The process involves the homogenous mixture of drug and lipids, nano-sizing, and resuspension in an injection vehicle. Three prototype formulations were prepared with different drug loadings (drug weight/solution volume). The first figure shows the morphology of the nano-particles. The table shows the nano-particle size and drug loading for the three formulations. The second figure shows the dissolution at body temperature over a 24 hour period.





Morphology of Nano-particles (via SEM)



In-vitro Dissolution of Nano-particles (at 37°C)
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