Agar

Basic Information

Name: Agar

CAS No: Agar [9002-18-0]

Functional Categories

Emulsifying agent Stabilizing agent Suspending agent Sustained-release agent Tablet binder Thickening agent Viscosity-increasing agent suppository base

1. Nonproprietary Names

JP: Agar PhEur: Agar USP-NF: Agar

2. Synonyms

Agar-agar; agar-agar flake; agar-agar gum; Bengal gelatin; Bengal gum; Bengal isinglass; Ceylon isinglass; Chinese isinglass; E406; gelosa; gelose; Japan agar; Japan isinglass; layor carang.

3. Chemical Name & CAS Registry

Agar [9002-18-0]

4. Empirical Formula & Molecular Weight

See Section 5.

5. Structural Formula

Agar is a dried, hydrophilic, colloidal polysaccharide complex extracted from the agarocytes of algae of the Rhodophyceae. The structure is believed to be a complex range of polysaccharide chains having alternating a-(1!3) and b-(1!4) linkages. There are three extremes of structure noted: namely neutral agarose; pyruvated agarose having little sulfation; and a sulfated galactan. Agar can be separated into a natural gelling fraction, agarose, and a sulfated nongelling fraction, agaropectin

6. Applications

Agar is widely used in food applications as a stabilizing agent. In pharmaceutical applications, agar is used in a handful of oral tablet and topical formulations. It has also been investigated in a number of experimental pharmaceutical applications including as a sustained-release agent in gels, beads, microspheres, and tablets.(1- 4) It has also been reported to work as a disintegrant in tablets.(5) Agar has been used in a floating controlled-release tablet; the buoyancy in part being attributed to air entrapped in the agar gel network.(6) It can be used as a viscosity-increasing agent in aqueous systems. Agar can also be used as a base for nonmelting, and nondisintegrating suppositories.(7) Agar has an application as a suspending agent in pharmaceutical suspensions.(8)

7. Description

Agar occurs as transparent, odorless, tasteless strips or as a coarse or fine powder. It may be weak yellowish-orange, yellowish-gray to pale-yellow colored, or colorless. Agar is tough when damp, brittle when dry.

8. Pharmacopeial Specifications

See Table I.

9. Typical Properties

NIR spectra see Figure 1. Solubility Soluble in boiling water to form a viscous solution; practically insoluble in ethanol (95%), and cold water. A 1% w/v aqueous solution forms a stiff jelly on cooling.

10. Stability & Storage

Agar solutions are most stable at pH 4–10. Agar should be stored in a cool, dry, place. Containers of this material may be hazardous when empty since they retain product residues (dust, solids).

11. Incompatibilities

Agar is incompatible with strong oxidizing agents. Agar is dehydrated and precipitated from solution by ethanol (95%). Tannic acid causes precipitation; electrolytes cause partial dehydration and decrease in viscosity of sols.

12. Method of Manufacture

Agar is obtained by freeze-drying a mucilage derived from Gelidium amansii Lamouroux, other species of the same family (Gelidiaceae), or other red algae (Rhodophyta).

13. Safety

Agar is widely used in food applications and has been used in oral and topical pharmaceutical applications. It is generally regarded as relatively nontoxic and nonirritant when used as an excipient. LD50 (hamster, oral): 6.1 g/kg(10) LD50 (mouse, oral): 16.0 g/kg LD50 (rabbit, oral): 5.8 g/kg LD50 (rat, oral): 11.0 g/kg

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of the material handled. When heated to decomposition, agar emits acrid smoke and fumes.

15. Regulatory Status

GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (oral tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK.

16. Related Substances

17. Comments

The drug release mechanism of agar spherules of felodipine has been studied and found to follow Higuchi kinetics.(11) Agar has also been used to test the bioadhesion potential of various polymers.(12) The EINECS number for agar is 232-658-1.