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Morflex produces a series of esters that perform as excipient plasticizers in pharmaceutical coatings.  These esters include four citrates and one sebacate.  These Morflex pharmaceutical grade plasticizers have excellent compatibility with the resins that are typically used for controlled release of the actives in both solvent based and aqueous based systems.  Customizing the release properties of the dosage form can be achieved by selecting a plasticizer(s) that provides the proper balance of solubility within the specific formulation for the desired release characteristics.  Please click on the bulletins below for for additional technical details*.

Pharmaceutical Coatings Pharmaceutical Coatings 3

Pharmaceutical Coatings 1 Pharmaceutical Coatings 4

Pharmaceutical Coatings 2 Pharmaceutical Coatings 5
Pharmaceutical Coatings 6
     
     

These pharmaceutical grade plasticizers are manufactured in conformance with cGMP guidelines and meet the requirements of their respective monographs in the National Formulary (NF). 

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ATBC, NF

ATBC, NF is Morflex’s trade designation for Acetyl tri-n-butyl Citrate, National Formulary.   ATBC has a current Drug Master File (DMF) submission to the FDA (#7425) for its application in pharmaceutical coatings as well as a current Device Master File submission to the FDA for its use in medical devices.

ATEC, NF

ATEC, NF is Morflex’s trade designation for Acetyltriethyl Citrate, National Formulary.  ATEC, NF has a current Drug Master File (DMF) submission to the FDA (#8000) for its use in pharmaceutical coatings.

DBS, NF

DBS, NF is Morflex’s trade designation for Dibutyl Sebacate, National Formulary.   DBS, NF has an excellent history of use as a pharmaceutical excipient in both aqueous and solvent-based formulations.

TBC, NF

TBC, NF is Morflex’s trade designation for Tributyl Citrate, National Formulary.  TBC, NF has a current Drug Master File submission to the FDA per #7263.  Further, TBC, NF has a recent submission to Australia for the same application.

TEC, NF

TEC, NF is Morflex’s designation for Triethyl Citrate, National Formulary.  TEC, NF  has a current Drug Master File submission to the FDA per #7086 for its use in pharmaceutical coatings.  Additionally, TEC, NF  has a current Master File in Canada and meets the requirements of monographs in the European Pharmacopeia (EP) and the Japanese Pharmacopeia of Excipients (JPE).

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This Page Last Updated Thursday, 10 March 2005 

Citroflex®, VEctomer ®  and Morflex® are registered trademarks of Morflex, Inc.

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