Commercial Approvals for NanoCrystal® Technology
The NanoCrystal® Technology has now been incorporated into four commercialized products, with over 70 other compounds at various stages of development. 

Rapamune®    
The first United States approval of a product produced incorporating the 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 Collidal Dispersion™ of sirolimus enabled the preparation of a solid dose formulation.

Emend® (aprepitant, MK 869) 
Emend® (aprepitant, MK 869) was approved by the FDA in March 2003 and launched in the United States 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 utilized NanoCrystal® Technology (Rapamune) was a reformulation of an already marketed drug, Emend was developed as an NCE in a NanoCrystal® Formulation. 

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

Megace® ES (megestrol acetate) 
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 utilizes Elan’s 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 reduced 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.)

If you would like to discuss with us a product you have which you think may benefit from our NanoCrystal® Technology,  contact us.

Rapamune® is a registered trademark owned by Wyeth Pharmaceuticals
Emend® is a registered trademark owned by Merck Inc
TriCor® is a registered trademark owned by Abbott Laboratories Corporation.
Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.