Soybean Oil

Category

Carrier Excipients

Molecular Weight

/

Grade

Pharmceutical Excipients

Description

Soybean oil as the refined fixed oil obtained from the seeds of the soya plant Glycine max Merr. (Fabaceae); if an antoxidant is added, the name and quantity must be specified on the label.

UNII

241ATL177A

Chemical Name

Soybean oil

CAS Number

8001-22-7

Synonyms

Aceite de soja; Calchem IVO-114; Lipex 107; Lipex 200; Shogun CT; soiae oleum raffinatum; soja bean oil; soyabean oil; soya bean oil.

Administration route

IV, oral and topical

Dosage Form

IV injections, oral capsules, and topical preparations; chewable tablets; oral lozenges; topical bath additives

Stability and Storage Conditions

Soybean oil is a stable material if protected from atmospheric oxygen.The formation of undesirable flavors in soybean oil is accelerated by the presence of 0.01 ppm copper and 0.1 ppm iron, which act as catalysts for oxidation; this can be minimized by the addition of chelating agents. Prolonged storage of soybean oil emulsions, particularly at elevated temperatures, can result in the formation of free fatty acids, with a consequent reduction in the pH of the emulsion; degradation is minimized at pH 6-7. However, soybean oil emulsions are stable at room temperature if stored under nitrogen in a light-resistant glass container. Plastic containers are permeable to oxygen and should not be used for long-term storage since oxidative degradation can occur.The stability of soybean oil emulsions is considerably influenced by other additives in a formulation. Soybean oil should be stored in a well-filled, airtight, lightresistant container at a temperature not exceeding 25℃.

Source and Preparation

Obtained by solvent extraction using petroleum hydrocarbons, or to a lesser extent by expression using continuous screw-press operations, of the seeds of either Glycine max (Leguminosae) or Glycine soja (Leguminosae). The oil is refined, deodorized, and clarified by filtration at about 0℃. Any phospholipids or sterols present are removed by refining with alkali.

Applications

In pharmaceutical preparations, soybean oil emulsions are primarily used as a fat source in total parenteral nutrition (TPN) regimens. Although other oils, such as peanut oil, have been used for this purpose, soybean oil is now preferred because it is associated with fewer adverse reactions. Emulsions containing soybean oil have also been used as vehicles for the oral and intravenous administration of drugs; drug substances that have been incorporated into such emulsions include amphotericin, diazepam, retinoids, vitamins, poorly water-soluble steroids, fluorocarbons, ibuprofen, and insulin. In addition, soybean oil has been used in the formulation of many drug delivery systems such as liposomes, microspheres, dry emulsions, self-emulsifying systems, microemulsions, nanoemulsions and nanocapsules, solid-in-oil suspensions, and multiple emulsions. Soybean oil may also be used in cosmetics and is consumed as an edible oil. As soybean oil has emollient properties, it is used as a bath additive in the treatment of dry skin conditions.

Safety

Soybean oil is widely used intramuscularly as a drug vehicle or as a component of emulsions used in parenteral nutrition regimens; it is also consumed as an edible oil. Generally, soybean oil is regarded as an essentially nontoxic and nonirritant material. However, serious adverse reactions to soybean oil emulsions administered parenterally have been reported. These include cases of hypersensitivity, CNS reactions, and fat embolism.Interference with the anticoagulant effect of warfarin has also been reported. Anaphylactic reactions have also been reported following the consumption of foods derived from, or containing, soybeans.Recently there has been concern at the concentration of phytoestrogens in some soy-derived products. Administration of soy protein to humans has resulted in significantly decreased serum lipid concentrations.
LD50 (mouse, IV): 22.1 g/kg
LD50 (rat, IV): 16.5 g/kg

Incompatibilities

Soybean oil emulsions have been reported to be incompatible at 25℃ with a number of materials including calcium chloride, calcium gluconate, magnesium chloride, phenytoin sodium, and tetracycline hydrochloride.Lower concentrations of these materials, or lower storage temperatures, may result in improved compatibility. The source of the material may also affect compatibility; for example, while one injection from a particular manufacturer might be incompatible with a fat emulsion, an injection with the same amount of active drug substance from another manufacturer might be compatible. Amphotericin B has been reported to be incompatible with soybean oil containing fat emulsions under certain conditions. Soybean oil emulsions are also incompatible with many other drug substances, IV infusion solutions, and ions (above certain concentrations).When plastic syringes are used to store soybean oil emulsion, silicone oil may be extracted into the emulsion; swelling of the syringe pump also occurs, resulting in the necessity for increased forces to maintain the motion of the plunger.