Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay

Definitions

• Amino acid in solutions suitable for injection are used with critically ill patients to provide nu- trition.
• the injectable amino acid solutions are sold without certain electrolytes which may be needed by a patient. In that circumstance, it becomes desirable for the doctor to add appropriate electrolytes to the container of amino acid solution immediately prior to intravenous administration to the patient.
• electrolytes often added are phos ⁇ phate and calcium, as well as other physiologica] elec- trolytes.
• Amino acid solutions have been provided in glass bottles, where they may have a relatively low pH.
• small amounts of phosphate and calcium may be added to the amino acid solution without the risk of forming a precipitate, because the pH of amino acid solutions currently sold in bottles is sufficiently low to prevent the precipitation of, for example, dibasic calcium phosphate.
• a supplemental calcium addition unit for administering dissolved calcium to a container of phosphate-containing intravenous amino acid solution.
• the unit comprises an ampule, plus means carried on the ampule for facilitatingsubstantially aseptic fluid flow connection with the interior of said container.
• This may constitute any of various conventional means for transferring an ampule of material in aseptic manner to a larger container.
• the ampule may carry a needle-pierceable latex wall, which may be penetratedin conventional manner with a needle and syringe.
• the ampule contains a solution of intravenously metabolizable calcium compound at a pH of 2 to 5.5. Accordingly, sufficient acidity may be provided by the contents of the ampule, so that when the calcium c ⁇ pound is added to phosphate-containing intravenous amino acid solution, no precipitation takes place.
• the solution inside the ampule may typically con- tain from 5 to 25 weight percent of calcium gluconate, a known metabolizable calcium compound, plus sufficient gluconic acid to provide to the solution a preferredpH of 3 to 4.
• the solution may also contain from 4 to 6 mg. of calcium d-saccharate per ml. of solution whichis present, as a precipitation inhibitor as well as a source of added calcium and as a stabilizer.
• metabolizable calcium which may be used in the supplemental calcium addition unit include calcium chloride, calcium acetate, calcium lactate, cal ⁇ cium ascorbate, or calcium succinate.
• acids besides gluconic acid may also be used to provide a pH within the desired range, for example acetic acid, hydrochloric acid, ascorbic acid, lactic ac- id, succinic acid, or any other desired acid which would be suitable for use in an injectable solution at the appropriate pH.
• the solution may be prepared by adding the desired amount of calcium gluconate (preferably 10 to 20 percent by weight) to rapidly boiling water for in ⁇ jection, which may be present in about 80 percent of the total volume of solution required, with constantstirring.
• the desired amount of calcium gluconate preferably 10 to 20 percent by weight
• the desired amount of calcium gluconate preferably 10 to 20 percent by weight
• the desired amount of calcium gluconate preferably 10 to 20 percent by weight
• the desired amount of calcium gluconate preferably 10 to 20 percent by weight
• rapidly boiling water for in ⁇ jection which may be present in about 80 percent of the total volume of solution required, with constantstirring.
• calcium d-saccharate may be added. Twice this amount of calcium d-saccharate may be added for a 15 percent solution of calcium gluconate.
• the solution becomes clear after 2 or 3 minutes of continuous boiling.
• the solution is then allowed to cool to room temperature.
• 50 percent gluconic acid may be added incrementally until the pH of the solution is, preferably, 3.4-3.5.
• gluconic acid For 10 percent calcium gluconate solution, about 56 mg./ml. of gluconic acid is required to obtain this pH.
• the resulting solution is then adjusted tothe total volume required by the addition, if necessary, of up to about 10 or 20 percent of its volume of water for injec ⁇ tion.
• the solution is then filtered through a 0.2 micron filter to prevent nucleation by crystallites or contam- inants in the solution.
• the solution is then filled into 50 ml. glass ampules, stoppered with a conventional ampule closure, and autoclaved for 35 minutes.
• ampules may be trans ⁇ ferred by injection needle using normal aseptic technique into a flexible, collapsible container of amino acid injection solution containing dissolved phosphate and other electrolytes, the amino acid injection solution typically having a pH of 6 to 8, without formation of any precipitate.
• a typical pH value for such amino acid injection solutions is 7.5.
• a typical glass ampule 10 containing a solution of this invention is shown.
• the ampule is closed with a conventional latex needle-piercable dia ⁇ phragm 12, and is autoclaved before use.

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• Health & Medical Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Inorganic Chemistry (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicinal Preparation (AREA)
• Materials For Medical Uses (AREA)
• Treating Waste Gases (AREA)

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• 1986
  • 1986-03-24 AU AU56283/86A patent/AU5628386A/en not_active Abandoned
  • 1986-03-24 WO PCT/US1986/000593 patent/WO1986005688A1/en not_active Ceased
  • 1986-03-24 JP JP61501901A patent/JPS62502261A/ja active Pending
  • 1986-03-24 EP EP19860902230 patent/EP0215925A4/de not_active Withdrawn
  • 1986-03-27 ZA ZA862326A patent/ZA862326B/xx unknown

Non-Patent Citations (2)

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