Expertise
Accomplishments  
Apex Pharmaceuticals, Inc has various Oral Solid Dosage formulation developed and filed with the US FDA. This includes two BCS class IV drug products met Bioequivalent for both fed and fasted studies and two immediate release products that were bioequivalent to the reference listed drug. One extended release formulation that met BA/BE studies and are schedule to file with the US FDA in early 2015.
Apex Pharmaceuticals, Inc has two Oral Solution that have been scaled up and are scheduled to file with the US FDA in 2015. In addition, five formulations are in development.
     
Technologies    
     
Oral Solid Dosage - Tablets & Capsules Immediate release formulations utilizing matrix, dry granulation, MUPS, mini tablets, multi-particulate, ODT and sublingual.    
     
Modified Release Dosage - Tablets & Capsules Delay Release (DR), Extended release (ER), Sustained Release (SR) utilizing matrix, multi-particulates, mini tablets, MUPS, etc.    
     
Poorly soluble compounds - BCS II and IV category drugs - Lipid formulation, nanoparticles, and amorphous formulations, utilizing Solid SMEDDS and Liquid SMEDDS.    
     
Liquid Dosage - Oral solution, syrups, suspensions, and pediatric formulation; Ophthalmic solution and suspensions.