STERILIZATION OF CIPROFLOXACIN COMPOSITION

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100° C. to about 120° C.; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.

Sterilization of ciprofloxacin composition

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100° C. to about 120° C.; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.

CIPROFLOXACIN OTIC COMPOSITION AND KITS AND METHOD FOR USING SAME

Disclosed herein are otic product kits for administration of a sterilized formulation. In some embodiments, the otic product kit comprises: an aseptic container containing the sterilized formulation; a syring; and an administration needle connectable to the syringe, wherein the sterilized formulation comprising: from about 5.5 wt % to about 6.5 wt % multiparticulate ciprofloxacin; from about 15 wt % to about 17 wt % poloxamer 407; and water. Also disclosed herein are methods of preparing and administrating the sterilized formulation. In some embodiments, the method comprising (1) transferring the sterilized otic formulation from an aseptic container to a syringe through a preparation needle; (2) replacing the preparation needle with an administration needle; and (3) injecting the sterilized otic formulation from the syringe through the administration needle into the ear of a patient. 1. An otic product kit for administration of a sterlized formulation , comprising:an aseptic container containing the sterilized formulation;a syring; andan administration needle connectable to the syringe, wherein the sterilized formulation comprising: from about 5.5 wt % to about 6.5 wt % multiparticulate ciprofloxacin; from about 15 wt % to about 17 wt % poloxamer 407; and water.2. The otic product kit of claim 1 , wherein the aseptic container is sealed with a cap.3. The otic product kit of claim 2 , wherein the cap comprises a metal frame having a top wall and a side wall.4. The otic product kit of claim 3 , wherein the metal frame is made of aluminum.5. The otic product kit of claim 4 , wherein the cap further comprises a septum secured against the aseptic container by the aluminum frame.6. The otic product kit of claim 1 , wherein the administration needle is from 20 gauge to 24 gauge.7. The otic product kit of claim 1 , wherein the administration needle is flexible.8. The otic product kit of claim 1 , wherein the administration needle has a blunt tip.9. The otic product kit of ...

Sterilization of ciprofloxacin composition

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100° C. to about 120° C.; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.

Sterilization of ciprofloxacin composition

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100 °C to about 120 °C; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.

Compositions comprising pedf-derived short peptides (pdsp) and uses thereof

An aqueous formulation includes a PEDF-derived short peptide (PDSP) having the sequence of one of SEQ ID NO: 1, 2, 3, 5, 6, 8, or 9; boric acid at a concentration of 0.01 mM – 923 mM; and a non-ionic tonicity agent. The pH value is around 5.5–8.4. The non-ionic tonicity agent is glycerin, sucrose, mannitol, or sorbitol. A concentration of the PDSP is 0.01% - 1% w/v.

Method for preparation of pharmaceutical-grade dithiocarbamate

Method for preparation of pharmaceutical-grade dithiocarbamate

The present invention provides methods for producing pharmaceutical-grade particulate dithiocarbamates from secondary amines by vigorously contacting at least one secondary amine and a pharmaceutically acceptable diluent that is a solvent for the carbon disulfide, but not for the secondary amine in an inert gas atmosphere, cooling the mixture so as to precipitate the dithiocarbamate therefrom, and separating the precipitated dithiocarbamate from the cooled mixture. The preferred solvent contains absolute ethanol. In alternative embodiments, the invention further provides methods for purifying a dithiocarbamate to obtain a pharmaceutical-grade dithiocarbamate particulate from a dithiocarbamate feed and methods for producing a sterile pharmaceutical-grade dithiocarbamate from a dithiocarbamate feed.

Compositions comprising pedf-derived short peptides (pdsp) and uses thereof

An aqueous formulation includes a PEDF-derived short peptide (PDSP) having the sequence of one of SEQ ID NO: 1, 2, 3, 5, 6, 8, or 9; boric acid at a concentration of 0.01 mM – 923 mM; and a non-ionic tonicity agent. The pH value is around 5.5–8.4. The non-ionic tonicity agent is glycerin, sucrose, mannitol, or sorbitol. A concentration of the PDSP is 0.01% - 1% w/v.

Method for preparation of pharmaceutical-grade dithiocarbamate

The present invention provides methods for producing pharmaceutical-grade particulate dithiocarbamates from secondary amines by vigorously contacting at least one secondary amine and a pharmaceutically acceptable diluent that is a solvent for the carbon disulfide, but not for the secondary amine in an inert gas atmosphere, cooling the mixture so as to precipitate the dithiocarbamate therefrom, and separating the precipitated dithiocarbamate from the cooled mixture. The preferred solvent contains absolute ethanol. In alternative embodiments, the invention further provides methods for purifying a dithiocarbamate to obtain a pharmaceutical-grade dithiocarbamate particulate from a dithiocarbamate feed and methods for producing a sterile pharmaceutical-grade dithiocarbamate from a dithiocarbamate feed.

Method for preparation of pharmaceutical-grade dithiocarbamate

Method for preparation of pharmaceutical-grade dithiocarbamate

Compositions comprising pedf-derived short peptides (pdsp) and uses thereof

An aqueous formulation includes a PEDF-derived short peptide (PDSP); a blend of PVP/PVA in different ratios around 8/2 – 2/8; and a tonicity agent, which is preferably non-ionic. The PDSP is preferably 14-39 amino acids long and has the sequence of one of SEQ ID NO: 1, 2, 3, 5, 6, 8, or 9. The non-ionic tonicity agent is glycerin, sucrose, mannitol, or sorbitol. A concentration of the PDSP is 0.01% - 1% w/v.

Compositions comprising pedf-derived short peptides (pdsp) and uses thereof

An aqueous formulation includes a PEDF-derived short peptide (PDSP) having the sequence of one of SEQ ID NO: 1, 2, 3, 5, 6, 8, or 9; boric acid at a concentration of 0.01 mM – 923 mM; and a non-ionic tonicity agent. The pH value is around 5.5–8.4. The non-ionic tonicity agent is glycerin, sucrose, mannitol, or sorbitol. A concentration of the PDSP is 0.01% - 1% w/v.

Method for preparation of pharmaceutical-grade dithiocarbamate

Sterilization of ciprofloxacin composition

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100 °C to about 120 °C; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions.

Sterilization of ciprofloxacin composition

Disclosed herein are methods of making sterilized ciprofloxacin compositions. In some embodiments, the method includes the steps of: (a) forming an aqueous suspension comprising ciprofloxacin particles; (b) heating the aqueous suspension comprising ciprofloxacin particles at a temperature range of from about 100 °C to about 120 °C; and (c) allowing the aqueous suspension comprising ciprofloxacin particles to cool down. Also described herein are otic formulations containing ciprofloxacin formed by the disclosed methods, and therapeutic use of such otic formulation for providing sustained release of ciprofloxacin into the ear for treating various otic disorders and conditions. - 67-

Composition comprising pedf-derived short peptide, preparation method thereof, and use thereof

The present invention relates to a composition, a preparation method therefor, and a use thereof. The composition comprises a PEDF-derived short peptide (PDSP), a stabilizer, and a buffer agent. The pH of the composition ranges from 4 to 9. The stabilizer is a copolymer of vinyl pyrrolidone and vinyl acetate. The buffer agent is selected from a citric acid buffer system, a phosphoric acid buffer system, a boric acid buffer system, a histidine buffer system, or a combination thereof. The composition has improved stability, small irritation to eyes, and/or high bioavailability.