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Alginic acid
اسید آلژینیک
1Nonproprietary names
- BPAlginic Acid
- Ph. Eur.Alginic Acid
- USP–NFAlginic Acid
2Synonyms and trade names
Acidum alginicum; E400; Kelacid; L-gulo-D-mannoglycuronan; polymannuronic acid; Protacid
3Chemical name and CAS Registry Number
Alginic acid (linear copolymer of D-mannuronic and L-guluronic acid) · [9005-32-7]
4Empirical formula and molecular weight
(C6H8O6)n · ≈ 10 000–600 000
5Functional category
Disintegrant, Binder, Gelling agent, viscosity modifier
Typical concentrations: 1–5% · Dosage forms: Solid
6Applications in pharmaceutical formulation
Used in oral and topical products as a tablet binder and disintegrant, as a thickening and suspending agent, and in modified-release matrices. Combined with sodium bicarbonate and antacids it forms a floating gel raft in reflux-suppressant products. Typical concentrations: tablet binder 1–5%; tablet disintegrant 1–5%.
7Description
A white to yellowish-white, fibrous powder, odourless or almost odourless and practically tasteless. It is a linear polyuronide made of blocks of β-(1→4)-D-mannuronic acid and α-(1→4)-L-guluronic acid in varying proportions and sequence, depending on the seaweed source.
8Typical properties
- Acidity
- pH 1.5–3.5 (3% w/v aqueous dispersion)
- pKa
- ≈ 3.4 (mannuronic acid) and ≈ 3.7 (guluronic acid) units
- Loss on drying
- not more than 15% w/w (pharmacopoeial limit)
- Solubility
- soluble in alkali hydroxide solutions, giving viscous solutions; practically insoluble in water (swells) and in ethanol and other organic solvents
9Stability and storage conditions
Hydrolyses slowly at warm temperatures, with a fall in molecular weight and viscosity. Store in a well-closed container in a cool, dry place.
10Incompatibilities
Incompatible with strong oxidising agents. With calcium and other polyvalent cations it forms insoluble, gelled salts, and it reacts with alkaline drugs and excipients.
11Method of manufacture
Extracted from brown seaweeds (Phaeophyceae), such as Laminaria, Macrocystis and Ascophyllum species, with dilute alkali; the alginate solution is clarified and alginic acid is precipitated by acidification, then washed and dried.
12Safety
Widely used in oral products and food and regarded as non-toxic and non-irritant. It is not absorbed to a significant extent after oral administration. JECFA has allocated an ADI 'not specified' to alginic acid and its salts.
13Handling precautions
Observe normal precautions for the quantity handled. Eye protection and a dust mask are recommended; the dust may irritate the eyes and respiratory tract.
14Regulatory status
GRAS listed. Accepted as a food additive in Europe (E400). Included in the FDA Inactive Ingredient Database (oral preparations) and in non-parenteral medicines licensed in Europe.
15Related substances
Ammonium alginate; calcium alginate; potassium alginate; propylene glycol alginate; sodium alginate.
16Comments
The ratio and arrangement of guluronic and mannuronic blocks control gel behaviour: alginates rich in guluronic acid form stronger, more rigid calcium gels, whereas mannuronic-rich alginates give softer, more elastic gels.