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Sustained-release Formulations 


Sustained-release EUDRAGIT® formulations are employed for many oral dosage forms to enable time-controlled release of active ingredients. Drug delivery can be controlled throughout the whole gastro-intestinal tract for increased therapeutic effect and patient compliance. Different polymer combinations of EUDRAGIT® RL and RS grades allowing custom-tailored release profiles enable a wide range of alternatives to achieve the desired drug delivery performance.The EUDRAGIT® NE polymer is a neutral ester dispersion which requires no plasticizer and is particularly suitable for granulation processes in the manufacture of matrix tablets and sustained release coatings.

There are two formulation options:

  • EUDRAGIT® is employed as a coating material,usually for the coating of pellets or particles that are filled into capsules or compressed into tablets. These pellets or particles act as diffusion cells in the digestive tract and release a constant drug quantity per unit of time (multi-unitdosage forms).
  • EUDRAGIT® serves as a matrix by which the active ingredient is embedded. The matrix structure is obtained by direct compression,granulation, or melt techniques.


Applications

EUDRAGIT® Grades

Availability

Functionality

Dissoltion Properties

Monographs + DMFs

Sustained release formulations

EUDRAGIT® RL 30 D

EUDRAGIT® RL PO

EUDRAGIT® RL 100

Aqueous dispersion 30%

Powder

Granules

Meth-/ acrylates copolymers with trimethyl-ammonioethylmethacrylate as a functional group

Insoluble

High permeability

pH independent swelling

USP/NF, DMF 1242

Ph.Eur., USP/NF, JPE, DMF 1242

Ph.Eur., USP/NF, JPE, DMF 1242

Sustained release formulations

EUDRAGIT® RS 30 D

EUDRAGIT® RS PO

EUDRAGIT® RS 100

Aqueous dispersion 30%

Powder

Granules

Insoluble

Low permeability

pH independent swelling

USP/NF, DMF 1242

Ph.Eur., USP/NF, JPE, DMF 1242

Ph.Eur., USP/NF, JPE, DMF 1242

Sustained release formulations,
suitable for matrix structures and miscible with other EUDRAGIT® grades

EUDRAGIT® NE 30 D

EUDRAGIT® NM 30 D

 

EUDRAGIT® NE 40 D

Aqueous dispersion 30%

 

Aqueous dispersion 40%

Neutral polymer of meth-/ acrylates

Insoluble

Low permeability

pH independent swelling

Ph.Eur., JPE, DMF 2822

DMF 2822



Application benefits of EUDRAGIT® coatings with sustained drug release:

  • Time-controlled release of activeingredient
  • Therapeutically customized releaseprofiles
  • Higher patient compliance dueto reduced number of doses tobe taken
  • Cost-effective processing