Liposomal ciprofloxacin formulations with encapsulated ciprofloxacin nanocrystals
AssigneeAradigm Corporation
InventorsIgor Gonda, James Blanchard, David C. Cipolla
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Abstract
Methods of treatment of NTM lung infections using formulations of liposomal ciprofloxacin. Specific liposome formulations and delivery of such for treatment of respiratory tract infections and other medical conditions, and devices and formulations used in connection with such are described.
Claims28
An aerosolized dose of a formulation comprised of aerosolized particles having an aerodynamic diameter in a range of from 1 micron to 12 microns;
- wherein the aerosolized formulation comprises:
- a liquid carrier comprising ciprofloxacin at a concentration of 20 mg/mL to 80 mg/mL of ciprofloxacin in solution,
- liposome unencapsulated ciprofloxacin in solution;
- and ciprofloxacin as nanocrystals encapsulated inside the liposomes, wherein nanocrystals in the liposomes have a dimension of 10 nanometers.
A pharmaceutical formulation, comprising:
- a pharmaceutically acceptable carrier;
- and
- liposomes in the carrier wherein the liposomes comprise:
- a lipid bilayer;
- a cryopreservative;
- and
- nanocrystals precipitated out of a solution of a pharmaceutically active anti-infective drug, and the nanocrystals are surrounded by the lipid bilayer wherein the nanocrystals have dimensions of 100 nm or less.
An aerosolized dose of a formulation comprised of aerosolized particles having an aerodynamic diameter in a range of from 1 micron to 12 microns;
- wherein the aerosolized formulation comprises:
- a liquid carrier comprising ciprofloxacin at a concentration of 20 mg/mL to 80 mg/mL of ciprofloxacin in solution,
- liposome unencapsulated ciprofloxacin in solution;
- and ciprofloxacin as nanocrystals encapsulated inside the liposomes;
- wherein the liposomes are comprised of a cryopreservative and a surfactant, and
- wherein the liposomes are characterized such that 95% or more of the liposomes maintain structural integrity and continue to encapsulate nanocrystals of ciprofloxacin in the aerosolized formulation.
An aerosolized dose of a formulation comprised of aerosolized particles having an aerodynamic diameter in a range of from 1 micron to 12 microns;
- wherein the aerosolized formulation comprises:
- a liquid carrier comprising ciprofloxacin at a concentration of 20 mg/mL to 80 mg/mL of ciprofloxacin in solution,
- liposome unencapsulated ciprofloxacin in solution;
- and ciprofloxacin as nanocrystals precipitated out of a solution of ciprofloxacin which nanocrystals are encapsulated inside the liposomes.
An aerosolized dose of a formulation comprised of aerosolized particles having an aerodynamic diameter in a range of from 1 micron to 12 microns;
- wherein the aerosolized formulation comprises:
- a liquid carrier comprising ciprofloxacin at a concentration of 20 mg/mL to 80 mg/mL of ciprofloxacin in solution,
- liposome unencapsulated ciprofloxacin in solution;
- and ciprofloxacin as nanocrystals encapsulated inside the liposomes;
- wherein the liposomes are comprised of cholesterol and hydrogenated soy phosphatidyl-choline (HSPC) of about 30 to 70 (plus or minus 10%);
- and
- wherein the formulation further comprising an excipient suitable for pulmonary delivery comprised of sodium acetate and an isotonic buffer;
- and
- further wherein the liposomes are characterized such that 90% or more of the liposomes maintain integrity when aerosolized and after contacting lung tissue provide a ciprofloxacin release rate of 0.5% to 10% per hour.
Dependencies are inferred from the claim text.