Functional Category
Diluent; lubricant.
Applications in Pharmaceutical Formulation
Sterilizable maize starch is a chemically or physically modified corn (maize) starch that does not gelatinize on exposure to moisture or steam sterilization. Sterilizable maize starch is primarily used as a lubricant for examination and surgeons’ gloves, although because of safety concerns unlubricated gloves are now generally recommended; see Section 14. It is also used as a vehicle for medicated dusting powders
Description
Sterilizable maize starch occurs as an odorless, white, free-flowing powder. Particles may be rounded or polyhedral in shape.
Stability and Storage Conditions
Sterilizable maize starch may be sterilized by autoclaving at 1218C for 20 minutes, by ethylene oxide, or by irradiation.(2)
Safety
Sterilizable maize starch is primarily used as a lubricant for surgeons’ gloves and as a vehicle for topically applied dusting powders. Granulomatous reactions, peritonitis and inflammation at operation sites have been attributed to contamination with surgical glove powders containing sterilizable maize starch. In addition, glove powder may be a risk factor in the development of latex allergy. As a consequence, it has been suggested that the use of sterilizable maize starch in latex gloves should be prohibited.(3–12) See also Starch.