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Commercialised Products

Commercial Approvals for NanoCrystal^® Technology
Elan Drug Technologies' NanoCrystal^® technology has now been incorporated into four commercialised products, with over 50 other compounds at various stages of development.


Rapamune^®
The first U.S. approval of a product produced incorporating our NanoCrystal^® technology occurred in August 2000: Wyeth’s first solid-dose formulation of the immunosuppressant Rapamune^® (sirolimus) received marketing approval from the U.S. Food & Drug Administration (FDA). Rapamune^® was previously available only as an oral solution in bottles or sachets. The oral solution requires refrigeration storage, and must be mixed with water or orange juice prior to administration. The new tablet developed using NanoCrystal^® technology provides patients with more convenient administration and storage than Rapamune^® oral solution. The development of a NanoCrystal Colloidal Dispersion^® formulation of sirolimus enabled the preparation of a patient preferred solid dose form.




Emend^®
Emend^® (aprepitant) was approved by the U.S. FDA in March 2003 and was launched by Merck in April 2003. Emend^® is a capsule containing 80 or 125 mg of aprepitant formulated as NanoCrystal^® drug particles. Whereas the first commercial product that utilised NanoCrystal^® technology (Rapamune^®) was an improved formulation of an already marketed drug, Emend^® was developed as an NCE in a NanoCrystal^® formulation.






TriCor^® 145
TriCor^® 145mg and 48mg (fenofibrate) was launched in December 2004 by Abbott in the U.S. following FDA approval. The new formulation of TriCor^® incorporating NanoCrystal^® technology provides the benefits of a lower dose, simplified, flexible dosing regime and allows for administration with or without food. The old formulation had to be taken with food.



Megace^® ES
Megace^® ES (megestrol acetate) 625 mg/5/mL was approved in July 2005 by the FDA and subsequently launched in the U.S. Megace^®  ES utilises Elan Drug Technologies’ NanoCrystal^® technology delivery system to improve the rate of dissolution, increase the rate of absorption and improve on the bioavailability of the original Megace^® Oral Suspension 800 mg/ 20 mL (Megace^® ES Prescribing Information. Par Pharmaceutical, Inc. 2006). Megace^® ES is bioequivalent to Megace^® in the fed condition. However, in the fasting condition, bioavailability of Megace^® ES is minimally affected while bioavailability of Megace^® is substantially reduced. (Megace^® ES Prescribing Information. Par Pharmaceutical, Inc. 2006, Data on File. PAR-MES-014. Par Pharmaceutical, Inc.) Patients taking Megace^® ES are able to take a one-teaspoon daily dose, or one-fourth of the volume of the original product. Megace^® ES also has 1/16th the viscosity of the original formulation, which may make it easier to swallow. Low volume and viscosity may enhance compliance (Megace^® ES Prescribing Information. Par Pharmaceutical, Inc. 2006, Megace^® Oral Suspension Prescribing Information. Bristol-Myers Squibb Company. 2002, Data on File. PAR-MES-006. Par Pharmaceutical, Inc.)
 

 

 

 

Invega® Sustenna™ was approved by the FDA in July 2009 and is marketed by Janssen in the US.  This new once monthly extended release injectable formulation incorporates the NanoCrystal® technology. Major benefits include, monthly dosing using a small bore needle with small volume needle, negating the need for a power injector, which can all help to improve compliance for schizophrenic patients. This is the first injectable product launched using the NanoCrystal® technology. 

In an industry where improved formulation and combination products will account for an increasingly large proportion of sales, applying a commercialised technology as offered by Elan Drug Technologies can provide real patient benefits to compounds often critical for a successful life cycle management strategy.

For more detail on how we can successfully apply our technologies to your compounds or products please contact us.