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Nextar’s case studies   

Nextar demonstrated successful and efficient repositioning and /or reformulation of generic API’s for 505 (b)(2) products. The followings are a few examples for reformulation projects which were carried out at Nextar. Work included formulation development,  GMP production and analyses. 

 

  • Coeruleus- sublingual spray of Flumazenil to restore wakefulness
  • Sterile topical formulation of a local anesthetic drug belonging to the aminoamide group
  • OticPharma - topical foam for ophatlmological drugs
  • Barkan Farma- injectable Raviten and  Immediate release Ravimig tablets
  • Ophthalmic emulsion of cyclosporine for a US company 



Successful case studies at reduced costs and short timelines:  
 

  • Lyophilized peptide formulation with increased stability
  • Formulation development and GMP manufacturing of freeze-dried vaccine formulation with a very limited amount of API
  • Repositioning of a generic drug as a slow release tablet formulation with improved pharmacokinetic profile for new indication
  • Formulation of water-insoluble anticancer drug with maximal bioavailability
  • Process development, up scaling and GMP manufacturing of sterile implantable protein gel for cartilage regeneration
  • Formulation optimization and GMP clinical supply in prefilled syringes of a phospho lipid-based sustained release gel formulation  to provide a sub-dermal depot for local anesthetics