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Polacrilin potassium
پولاکریلین پتاسیم
1Nonproprietary names
- USP–NFPolacrilin Potassium
2Synonyms and trade names
Amberlite IRP88; methacrylic acid polymer with divinylbenzene, potassium salt; polacrilinum kalicum
3Chemical name and CAS Registry Number
Potassium salt of a cross-linked copolymer of methacrylic acid and divinylbenzene · [—]
4Empirical formula and molecular weight
Polymer, mixture or material of variable composition — no single molecular formula applies.
5Functional category
Disintegrant
Typical concentrations: 2–10% · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used mainly as a tablet disintegrant, typically at 2–10% w/w, in both direct compression and wet granulation. Its strong swelling on contact with water gives rapid disintegration without forming a gel. It is not normally used for its ion-exchange properties.
7Description
A cation-exchange resin made from methacrylic acid cross-linked with divinylbenzene, in the potassium salt form. It is supplied as a fine, free-flowing, cream-coloured powder with little or no odour or taste.
8Typical properties
- Physical form
- free-flowing, cream-coloured fine powder; odourless and almost tasteless
- Potassium content
- about 21–25% (dried basis)
- Solubility
- insoluble in water and in most organic solvents; swells rapidly in water
- Type
- weakly acidic cation-exchange resin (carboxylate functional groups)
9Stability and storage conditions
Stable. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents. As an ion-exchange resin it may bind cationic drugs and exchange potassium with other cations, which can affect drug release.
11Method of manufacture
Made by suspension copolymerisation of methacrylic acid with divinylbenzene as the cross-linker; the resin is then neutralised with potassium hydroxide, washed, dried and milled.
12Safety
Used in oral solid dosage forms and regarded as non-toxic; being an insoluble, high-molecular-weight polymer it is not absorbed from the gastrointestinal tract. The potassium it contains should be considered for patients on potassium restriction only when large amounts are taken.
13Handling precautions
Observe normal precautions for the quantity handled. Avoid generating dust; eye protection, gloves and a dust mask are recommended.
14Regulatory status
Included in the FDA Inactive Ingredient Database (oral capsules and tablets).
15Related substances
Polacrilex resin; sodium polystyrene sulfonate; cholestyramine resin.
16Comments
Polacrilin potassium is relatively insensitive to the lubricant and to compression force, but because it is an ion exchanger, compatibility with ionic (especially basic) drugs should be checked. The related hydrogen-form resin (polacrilex) is used to bind and mask the taste of bitter cationic drugs and in nicotine gum.