Chemical Properties
Polacrilin potassium occurs as a cream-colored, odorless and
tasteless, free-flowing powder. Aqueous dispersions have a bitter
taste.
Uses
Pharmaceutic aid (tablet disintegrant).
Production Methods
Polacrilin resin (Amberlite IRP-64) is prepared by the copolymerization
of methacrylic acid with divinylbenzene (DVB). Polacrilin
potassium (Amberlite IRP-88) is then produced by neutralizing this
resin with potassium hydroxide.
Other resins are similarly produced by copolymerization
between styrene and divinylbenzene (Amberlite IRP-69, Amberlite
IRP-67, Amberlite IR-120, and Amberlite IRA-400). Phenolicbased
polyamine condensates (Amberlite IRP-58) may also be
produced.
The homogeneity of the resin structure depends on the purity,
nature, and properties of the copolymers used as well as the controls
and conditions employed during the polymerization reaction. The
nature and degree of crosslinking have significant influence on the physicochemical properties of the resin matrix. The functional
groups introduced on the matrix confer the property of ion
exchange. Depending upon the acidity or basicity of the functional
groups, strongly acidic to strongly basic types of ion-exchange
resins may be produced.
Brand name
Amberlite IRP88 Resin (Rohm and Haas).
Pharmaceutical Applications
Polacrilin potassium is a cation-exchange resin used in oral
pharmaceutical formulations as a tablet disintegrant Concen-trations of 2–10% w/w have been used for this purpose, although
2% w/w of polacrilin potassium is usually sufficient. Other
polacrilin ion-exchange resins have been used as excipients to
stabilize drugs, to mask or modify the taste of drugs, and in the
preparation of sustained-release dosage forms and drug carriers.
Polacrilin resins are also used in the analysis and manufacture of
pharmaceuticals and food products.
Safety
Polacrilin potassium and other polacrilin resins are used in oral
pharmaceutical formulations and are generally regarded as
nontoxic and nonirritant materials. However, excessive ingestion
of polacrilin resins may disturb the electrolyte balance of the body.
storage
Polacrilin potassium and other polacrilin resins are stable to light,
air, and heat up to their maximum operation temperature. Excessive heating can cause thermal decomposition of the resins
and may yield one or more oxides of carbon, nitrogen, sulfur, and/or
amines.
Polacrilin resins should be stored in well-closed containers in a
cool, dry place.
Incompatibilities
Incompatible with strong oxidizing agents, amines, particularly
tertiary amines, and some other substances that interact with
polacrilin resins.
Regulatory Status
Included in the FDA Inactive Ingredients Database (oral capsules
and tablets). Included in non-parenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
