Hydroxypropyl cellulose, low-substituted

• BPHydroxypropylcellulose, Low-Substituted
• JPLow Substituted Hydroxypropylcellulose
• Ph. Eur.Hydroxypropylcellulose, Low-Substituted
• USP–NFLow-Substituted Hydroxypropyl Cellulose

L-HPC; LH-11; LH-21; LH-31; LH-B1; NBD-021; low-substituted hydroxypropylcellulose; hyprolose, low-substituted

Cellulose, 2-hydroxypropyl ether (low-substituted) · [9004-64-2]

Polymer, mixture or material of variable composition — no single molecular formula applies.

Disintegrant, Binder

Typical concentrations: — · Dosage forms: Solid

Used in oral solid dosage forms as a tablet and capsule disintegrant, usually at a few per cent up to about 10% w/w, and also as a binder because it compacts well; it can therefore serve as a combined binder–disintegrant in wet granulation and direct compression. Grades differ in particle size and substitution and are chosen for direct compression, wet granulation or orally disintegrating tablets. It is also used as an extrusion–spheronisation aid.

A white to yellowish-white, odourless and tasteless, fibrous or granular powder. Its low degree of hydroxypropyl substitution makes it insoluble in water, in which it swells.

Hydroxypropoxy content

5.0–16.0% (pharmacopoeial range)

pH

5.0–7.5 (1% w/v aqueous dispersion)

Solubility

practically insoluble in water and ethanol, in which it swells; dissolves in 10% sodium hydroxide solution

Particle size

grade-dependent; fine grades (mean about 20 µm) to coarser fibrous grades (mean about 50 µm or more)

Stable, although hygroscopic. Store in a well-closed container in a cool, dry place.

Alkaline substances may interact with it, and tablets containing such materials may show slower disintegration after storage.

Made by reacting alkali cellulose with a limited amount of propylene oxide. The crude product is neutralised, washed, dried and milled to the required particle size and shape.

Used in oral products and regarded as non-toxic and non-irritant; it is not absorbed from the gastrointestinal tract.

Observe normal precautions for the quantity handled; eye protection, gloves and a dust mask are recommended.

Included in the FDA Inactive Ingredient Database (oral capsules and tablets) and in non-parenteral medicines licensed in Europe and Japan.

Hydroxypropyl cellulose; croscarmellose sodium; crospovidone; sodium starch glycolate; microcrystalline cellulose.

L-HPC acts mainly by swelling rather than by wicking alone, and its disintegrant action is less affected by tablet hardness than that of some starches. Because it is non-ionic, it is less likely than ionic superdisintegrants to interact with cationic drugs.