Patent GB-813896-A (GB)
Title: Stable aqueous preparations of calcium amphomycin
IPC: A61K47/26
Filed: 1957-10-28
Abstract: Calcium amphomycin is stabilized in the presence of water (suspension, solution or water containing ointment) by incorporating therein at least one non-toxic water-soluble calcium salt.  The salt is used in quantities of 0.1 to 20 and preferably 1.0 to 4.0 per cent by weight.  Suitable salts are calcium chloride, calcium gluconate, calcium citrate and calcium lactate. It is preferred to dissolve the calcium salt in water and to use this solution to prepare the suspension or solution of calcium amphomycin.  The stabilized calcium amphomycin is used medicinally (see Group VI).  Specification 736,325 is referred to.ALSO:A stable aqueous preparation for pharmaceutical use comprises calcium amphomycin and at least one non-toxic water-soluble calcium salt.  The calcium salt is used in quantities of 0.1 to 20 and preferably 1.0 to 4.0 per cent by weight.  Specified calcium salts are the chloride, gluconate, citrate and lactate.  The calcium amphomycin is used in quantities of 1.0 to 40.0 and especially 5.0 mg. per gram or per mil. of the pharmaceutical preparation which may be in the form of a solution, suspension or oil-in-water emulsion such as vanishing cream type ointment, nasal solution, lotion, eye and ear drops, solutions or suspensions for topical use, suppositories, impregnated gauze dressings, dental pastes and cones and aqueous gels.  It is preferred to dissolve the calcium salt in sterile water and to use this solution to prepare the suspension or solution of calcium amphomycin, which may then be incorporated into an ointment base.  Optional ingredients are (a) buffers such as sodium citrate, (b) preservatives such as phenol, cresol and the methyl-, ethyl-, propyl-or butyl-ester of p-hydroxybenzoic acid; (c) suspending or dispersing agents such as sodium carboxymethylcellulose, methyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, gum tragacanth, gelatin, pectin, cholersterol, urea, dextran, gum karaya, lecithin, partial esters of long chain fatty acids with hexitol anhydride and polyoxyalkylene derivatives thereof, sodium or ammonium alginates, alginic acid, propylene glycol alginate and sterol products effective as non-ionic emulsifiers; and (d) compatible drugs such as antihistamines, sulpha drugs, anaesthetics (e.g. procaine), antibiotics (e.g. penicillin, streptomycin, dihydrostreptomycin, neomycin, bacitracin, tyrothricin, erythromycin, tetracycline, oxytetracycline, chlortetracycline, polymyxin, carbomycin, novobiocin, bryamycin, vancomycin, oleandomycin, nystatin, amphotericin, chloramphenicol, cycloserine, synnematin, viomycin, ristocetin and nucleocidin), spreading agents (e.g. hyaluronidase), vitamines (e.g. Vitamins A, A1, B1, B2, B6, B12, folic acid, C, D2, D3 and E) and hormones (e.g. cortisone, hydrocortisone, prednisone, prednisolone and their fluor derivatives).  Examples describe (a) an oil-in-water vanishing cream prepared with calcium chloride or calcium gluconate and containing 0.1 to 1.0 per cent calcium amphomycin alone or with the further addition of neomycin; (b) an aqueous lotion containing calcium amphomycin, calcium citrate, sodium bisulphite and wetting and suspending agents; (c) aqueous nose drops containing calcium amphomycin, calcium citrate, lactose, chlorbutanol and 1-(m-hydroxy phenyl)-2-methyl aminoethanol. Specification 736,325, [Group IV (b)], is referred to.