Propylene Glycol Alginate

Category

Emulsifying Agents; foam Stabilizer; Stabilizing Agents; Suspending Agents; Viscosity Increasing Agents

Grade

Pharmceutical Excipients

Description

Propylene glycol alginate occurs as a white to yellowish colored, practically odorless and tasteless, fibrous or granular powder.

UNII

26CD3J2R0C

Chemical Name

Propylene glycol alginate

CAS Number

9005-37-2

Synonyms

Alginic acid, propylene glycol ester; E405; hydroxypropyl alginate; Kelcoloid; Kimiloid; Manucol Ester; Profoam; Pronova; propane1, 2-diol alginate; Protanal; TIC Pretested

Administration route

Oral

Dosage Form

Oral preparations

Stability and Storage Conditions

Propylene glycol alginate is a stable material, although it will gradually become less soluble if stored at elevated temperatures for extended periods. Propylene glycol alginate solutions are most stable at pH 3-6. In alkaline solutions, propylene glycol alginate is rapidly saponified.Alginate solutions are susceptible to microbial spoilage and should be sterilized or preserved with an antimicrobial preservative.However, sterilization processes may adversely affect the viscosity of propylene glycol alginate solutions. The bulk material should be stored in an airtight container in a cool, dry place.

Source and Preparation

Alginic acid, extracted from brown seaweed, is reacted with propylene oxide to form propylene glycol alginate. Various grades may be obtained that differ in composition according to the degree of esterification and the percentage of free and neutralized carboxyl groups present in the molecule; complete esterification of alginic acid is impractical.

Applications

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Safety

Propylene glycol alginate is used in oral and topical pharmaceutical formulations, cosmetics, and food products. It is generally regarded as a nontoxic and nonirritant material, although excessive oral consumption may be harmful. A study in five healthy male volunteers fed a daily intake of 175 mg/kg body-weight of propylene glycol alginate for 7 days, followed by a daily intake of 200 mg/kg body-weight of propylene glycol alginate for a further 16 days, showed no significant adverse effects. Inhalation of alginate dust may be irritant and has been associated with industrially related asthma in workers involved in alginate production. However, it appears that the cases of asthma were linked to exposure to seaweed dust rather than pure alginate dust. LD50 (hamster, oral): 7.0 g/kg LD50 (mouse, oral): 7.8 g/kg LD50 (rabbit, oral): 7.6 g/kg LD50 (rat, oral): 7.2 g/kg