Ecopol L 100

Description

ECOPOL™ L 100 – is a co-polymer derived from methacrylic acid and methyl methacrylate (1:1). It is a fine free flowing dry powder. It contains recommended surfactants. It is soluble in most commonly used organic solvents and hydro-alcoholic systems containing 10 – 20% water. This is soluble at pH 6 and works best as an alcohol or hydro-alcoholic aqueous based enteric film coating material. This can be further reconstituted with the addition of plasticizer, glidant & colorants.

Application

Its major application is for Enteric/Delayed release coating and for drug delivery in small intestine.

Regulatory Status

The material has monographs in major internationally recognized pharmacopoeias namely Ph. Eur., USPNF and JPE.

On the regulatory front Ideal Cures has filed Type IV USDMF (No. 25645) for this material.

Product Availability, Reevaluation and Storage

Commercial packing is available in 20 kg HDPE drums.

Recommended reevaluation period is 36 months form the date of manufacturing.

It is recommended to store the properly closed containers below 25 deg. C in light resistant and tightly closed containers.