International Numbering System (INS) for Food Additives: 405
Food additives Europe numbers: E405
Functional Category
Emulsifying agent; foam stabilizer; stabilizing agent; suspending agent; viscosity increasing agent.
Applications in Pharmaceutical Formulation
Propylene glycol alginate, propane-1,2-diol alginate is used as a stabilizing, suspending, gelling, and emulsifying agent in oral and topical pharmaceutical formulations. Typically, a concentration of 0.3–5% w/v is used, although this may vary depending upon the specific application and the grade of propylene glycol alginate used. Propylene glycol alginate is also used in cosmetics and food products.
Description
Propylene glycol alginate occurs as a white to yellowish colored, practically odorless and tasteless, fibrous or granular powder.
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; see Sodium Alginate The bulk material should be stored in an airtight container in a cool, dry place
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.(1) 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.(2) LD50 (hamster, oral): 7.0 g/kg(3) LD50 (mouse, oral): 7.8 g/kg LD50 (rabbit, oral): 7.6 g/kg LD50 (rat, oral): 7.2 g/kg