International Numbering System (INS) for Food Additives : 404
Food additives Europe numbers: E404
Functional Category
Emulsifying agent; stabilizing agent; tablet disintegrant; thickening agent
Applications in Pharmaceutical Formulation
In pharmaceutical formulations, calcium alginate and calciumsodium alginate have been used as tablet disintegrants.(1) The use of a high concentration (10%) of calcium-sodium alginate has been reported to cause slight speckling of tablets.(1) A range of different types of delivery systems intended for oral administration have been investigated. These exploit the gelling properties of calcium alginate.(2) Calcium alginate beads have been used to prepare floating dosage systems(3–6) containing amoxicillin,(7) furosemide,(8) meloxicam,(9) and barium sulfate,(10) and as a means of providing a sustained or controlled-release action for sulindac,(11) diclofenac,(12,13) tiaramide,(14) insulin,(15) and ampicillin.(16) The effect of citric acid in prolonging the gastric retention of calcium alginate floating dosage forms has been reported.(17,18 Impregnating meloxicam in calcium alginate beads may reduce the risk of ulceration and mucosal inflammation following oral adminstration.(19) The use of calcium alginate beads, reinforced with chitosan, has been shown to slow the release of verapamil,(20) and may be useful for the controlled release of protein drugs to the gastrointestinal tract.(21) The bioadhesive properties,(22) swelling and drug release(23) of calcium alginate beads have also been investigated. A series of studies investigating the production,(24) formulation,(25) and drug release(26) from calcium alginate matrices for oral administration have been published. The release of diltiazem hydrochloride from a polyvinyl alcohol matrix was shown to be controlled by coating with a calcium alginate membrane; the drug release profile could be modified by increasing the coating thickness of the calcium alginate layer.(27) The microencapsulation of live attenuated Bacillus Calmette–Gue´rin (BCG) cells within a calcium alginate matrix has also been reported.(28) It has been shown that a modified drug release can be obtained from calcium alginate microcapsules,(29) pellets,(30,31) and microspheres.(32) When biodegradable bone implants composed of calcium alginate spheres and containing gentamicin were introduced into the femur of rats, effective drug levels in bone and soft tissue were obtained for 30 days and 7 days, respectively.(33) The incorporation of radioactive particles into calcium alginate gels may be useful for the localized delivery of radiation therapy to a wide range of organs and tissues.(34) Therapeutically, the gelling properties of calcium alginate are utilized in wound dressings in the treatment of leg ulcers, pressure sores, and other exuding wounds. These dressings are highly absorbent and are suitable for moderately or heavily exuding wounds. Calcium alginate dressings also have hemostatic properties, with calcium ions being exchanged for sodium ions in the blood; this stimulates both platelet activation and whole blood coagulation. A mixed calcium–sodium salt of alginic acid is used as fibers in dressings or wound packing material. Sterile powder consisting of a mixture of calcium and sodium alginates has been used in place of talc in glove powders. In foods, calcium alginate is used as an emulsifier, thickener, and stabilizer
Description
Calcium alginate is an odorless or almost odorless, tasteless, white to pale yellowish-brown powder or fibers
Stability and Storage Conditions
Calcium alginate can be sterilized by autoclaving at 1158C for 30 minutes or by dry heat at 1508C for 1 hour. Calcium alginate should be stored in airtight containers
Incompatibilities
Calcium alginate is incompatible with alkalis and alkali salts. Propranolol hydrochloride has been shown to bind to alginate molecules, suggesting that propranolol and calcium ions share common binding sites in the alginate chains; the formation of the calcium alginate gel structure was impeded in the presence of propranolol molecules.(35
Safety
Calcium alginate is widely used in oral and topical formulations, and in foods. In 1974, the WHO set an estimated acceptable daily intake of calcium alginate of up to 25 mg, as alginic acid, per kilogram bodyweight.(36) When heated to decomposition, it emits acrid smoke and irritating fumes. LD50 (rat, IP): 1.41 g/kg(37) LD50 (rat, IV): 0.06 g/kg