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US 11,026,906 B2Granted
Pharmaceutical quality strontium L-lactate
OwnerDeanna J. Nelsoninventor
Life of this patent
Estimating the term…
Abstract
The present application relates to strontium L-lactate compositions and methods of use. The methods and compositions disclosed herein are particularly useful for providing bioavailable strontium to mammals and treating or preventing symptoms of bone and/or cartilage disorders.
Claims10
A method of preparing a pharmaceutical quality strontium L-lactate composition comprising:
- a. selecting an L-lactic acid having at most trace concentrations of metals selected from the group consisting of aluminum, arsenic, barium, calcium, cadmium, chromium, lead, mercury, and thallium;
- b. selecting a strontium carbonate, strontium oxide, or strontium hydroxide having at most trace concentrations of metals selected from the group consisting of aluminum, arsenic, barium, calcium, cadmium, chromium, lead, mercury, and thallium;
- c. dissolving the L-lactic acid in water to obtain a homogeneous 0.1 M solution;
- d. adding portions of strontium carbonate, strontium oxide, or strontium hydroxide to the vessel containing the solution of L-lactic acid until a mass of said strontium salt equal to 0.45-0.55 mole equivalents of L-lactic acid has been added and agitating the reaction mixture until a homogeneous solution is obtained;
- e. removing particulate from the reaction mixture by filtration or centrifugation to provide a clarified solution;
- f. diluting the clarified solution with a water-miscible, aprotic organic solvent to form a precipitate;
- and
- g. isolating the precipitate and drying to constant mass to provide a pharmaceutical quality strontium L-lactate composition, wherein said strontium L-lactate composition is characterized in having a strontium D-lactate content of less than about 3 weight percent strontium D-lactate.
5 more elements
A method of preparation of a pharmaceutical quality strontium L-lactate composition comprising:
- a. selecting a water-soluble salt of L-lactic acid having at most trace concentrations of metals selected from the group consisting of aluminum, arsenic, barium, calcium, cadmium, chromium, lead, mercury, and thallium;
- b. selecting a water-soluble strontium salt having at most trace concentrations of metals selected from the group consisting of aluminum, arsenic, barium, calcium, cadmium, chromium, lead, mercury, and thallium;
- c. dissolving one mole equivalent of the water-soluble L-lactate in the minimum volume of water needed to obtain a homogeneous solution;
- d. dissolving 0.45-0.55 mole equivalents of the water-soluble strontium salt in the minimum volume of water needed to obtain a homogeneous solution;
- e. adding the strontium salt solution to the vessel containing the L-lactate solution and agitating until a homogeneous solution is obtained;
- f. controlling the reaction temperature, solution pH, and reaction time to ranges sufficiently low to prevent racemization;
- h. removing particulate from the reaction mixture by filtration or centrifugation to provide a clarified solution;
- i. diluting the clarified solution with a sufficient volume of a water-miscible, aprotic organic solvent to form a precipitate;
- and
- j. isolating the precipitate and drying to constant mass to provide a pharmaceutical quality strontium L-lactate composition, wherein said strontium L-lactate composition is characterized in having a strontium D-lactate content of less than about 3 weight percent strontium D-lactate.
7 more elements
A method of preparing a pharmaceutical quality strontium L-lactate composition comprising:
- a. selecting an L-lactic acid having at most trace concentrations of metals selected from the group consisting of aluminum, arsenic, barium, calcium, cadmium, chromium, lead, mercury, and thallium;
- b. selecting a strontium oxide having at most trace concentrations of metals selected from the group consisting of aluminum, arsenic, barium, calcium, cadmium, chromium, lead, mercury, and thallium;
- c. dissolving the L-lactic acid in water to obtain a homogeneous 0.1 M solution;
- d. adding portions of strontium oxide to the vessel containing the solution of L-lactic acid until a mass of strontium oxide equal to 0.45-0.55 mole equivalents of L-lactic acid has been added and agitating the reaction mixture until a homogeneous solution is obtained;
- e. controlling the reaction temperature, solution pH, and reaction time to ranges sufficiently low to prevent racemization;
- f. removing particulate from the reaction mixture by filtration or centrifugation to provide a clarified solution;
- g. diluting the clarified solution with a sufficient volume of a water-miscible, aprotic organic solvent to form a precipitate;
- and
- h. isolating the precipitate and drying to constant mass to provide a pharmaceutical quality strontium L-lactate composition, wherein said strontium L-lactate composition is characterized in having a strontium D-lactate content of less than about 3 weight percent strontium D-lactate.
6 more elements
Dependencies are inferred from the claim text.