Polyacrylic Resin Ⅳ

Category

Binder Excipients

Molecular Formula

(C29H52O6)n

Molecular Weight

150000

Grade

Pharmceutical Excipients

UNII

905HNO1SIH

Chemical Name

Poly(butyl methacrylate, (2-dimethylaminoethyl) methacrylate, methyl methacrylate) 1 : 2 : 1

CAS Number

24938-16-7

Administration route

Oral

Dosage Form

Oral capsules and tablets

Stability and Storage Conditions

The polymer in dry powder state is stable at temperatures below 30°C. Above this temperature, the powder is easy to agglomerate, but this phenomenon does not affect the quality of the material, and the lumps are easy to crush. The polymer in dry powder state is stable for 3 years when stored in a sealed container at a temperature below 30°C. Aqueous dispersions are very sensitive to temperature and delamination occurs below 0°C. Therefore, the water dispersion should be transported and stored in a sealed container at a temperature of 5-25°C, and it is stable for at least 19 months after delivery from the manufacturer's warehouse.

Source and Preparation

Polymerized from acrylic and methacrylic acid or their various esters.

Applications

It can be used as film coating material; tablet binder; tablet diluent. Polyacrylic resins are mainly used as film coating materials for oral tablets and capsules. Films of different types of polymers have different dissolution characteristics. Eudragit L and S types are used as enteric-coated materials because they are insoluble in gastric juice. Different models dissolve at different pHs. Eudragit L30D-55 is used as an enteric coating material for solid preparations, which cannot be tolerated in the stomach, but is easily dissolved when the pH is above 5.5. Eudragit L100-55 can replace Eudragit L30D-56, and the commercially available product is redispersible powder.

Safety

Acrylic resins are widely used as film coating materials for oral pharmaceutical dosage forms. Non-toxic, non-irritating, also used in topical preparations. Taking 2mg of Eudragit per kilogram of body weight per day (equivalent to about 151mg for adults) is basically safe for humans.

Incompatibilities

The incompatibility of polymer aqueous dispersion mainly depends on the ionization and physical properties of polymer and solvent. For example, coagulation can be caused by electrolyte solution, pH change, some organic solvents, too high or too low temperature, etc. The aqueous dispersion of Eudragit L100-56 is not compatible with magnesium stearate. Although solutions of solid acrylic resins and organic solvents are compatible with more drugs than their aqueous dispersions, reactions with some drugs may still occur.