# US 2006/0217350 A1 · Disodium pamidronate formulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2006/0217350 A1 - Document ID: US20060217350A1 - Status: Published application - Kind: A1 - Application number: 11/245,389 - Filed: 2005-10-06 - Published: 2006-09-28 - Earliest claimed: 2005-03-24 - Assignees: Dabur Pharma Limited - Inventors: Dhiraj Khattar; Manish Grover; Mukesh Kumar; Prasanna Kumar Srinivasa Jonnala; Shobhit Singh; Rama Mukherjee; Anand Burman - Web page: https://patentgrep.com/patent/US20060217350A1 ## CPC - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 31/663: Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract A stable pharmaceutical composition comprising a solution of disodium pamidronate in an aqueous solvent and a process for the preparation thereof. The solution of disodium pamidronate is free of particulate matter and has an alkaline pH. The process for preparation of the stable pharmaceutical composition comprises adding disodium pamidronate and optionally a sugar into an aqueous solvent; heating the said mixture at a temperature in the range of 50° C. to 90° C. to obtain a clear solution. It is cooled to ambient temperature, filtered, filled and stored in a conventional and untreated glass container and sealed with normal elastomeric closure. The sealed container is sterilized by steam sterilization. ## Claims ### Claim 1 A stable pharmaceutical composition comprising disodium pamidronate in an aqueous solvent having an alkaline pH of above 8.0, filled and stored in a conventional, untreated glass container, wherein the aqueous solvent is in contact with a glass surface of the container. ### Claim 2 A stable pharmaceutical composition comprising disodium pamidronate in an aqueous solvent having an alkaline pH of above 8.0, filled and stored in a conventional, untreated glass container and sled with an elastomeric closure, wherein the aqueous solvent is in contact with a glass surface of the container. ### Claim at position 3 3-4. (canceled) ### Claim 5 (depends on 1) A stable pharmaceutical composition according to claim 1, further comprising a sugar. ### Claim 6 (depends on 1) A pharmaceutical composition according to claim 1, wherein die conventional, untreated glass container is a USP Type I glass container. ### Claim 7 (depends on 30) A pharmaceutical composition according to claim 30, wherein the conventional, untreated glass container is selected from ampoules, vials, ready-to-use syringes and carpoules. ### Claim 8 (depends on 42) A pharmaceutical composition according to claim 42 wherein the elastomeric rubber closure is a halobutyl rubber closure. ### Claim 9 (depends on 8) A pharmaceutical composition according to claim 8, wherein the halobutyl rubber closure is selected from chlorobutyl and bromobutyl rubber closure. ### Claim 10 (depends on 5) A pharmaceutical composition according to claim 5, wherein the sugar is selected from dextrose, lactose and mannitol. ### Claim 11 (depends on 10) A pharmaceutical composition according to claim 10, wherein the sugar is mannitol. ### Claim 12 (depends on 1) A pharmaceutical composition according to claim 1, wherein the pH of the solution is from about 8.0 to 8.5. ### Claim 13 (depends on 12) A pharmaceutical composition according to claim 12, wherein the pH of the solution is from about 8.0 to 8.2. ### Claim 14 (depends on 1) A pharmaceutical composition according to claim 1, wherein the aqueous solvent is selected from water, ethanol, benzyl benzoate or mixtures thereof. ### Claim 15 (depends on 14) A pharmaceutical composition according to claim 14, wherein the aqueous solvent is water. ### Claim 16 (depends on 15) A stable pharmaceutical composition according to claim 15, wherein the final water content in the solution of disodium pamidronate ranges from 0.01 to 99.99%. ### Claim 17 (depends on 1) A process for preparation of a pharmaceutical composition according to claim 1 comprising the steps of: i) adding disodium pamidronate and optionally a sugar into the aqueous solvent; ii) heating the mixture of step (i) at a temperature in the range of 50° C. to 90° C. to obtain a clear solution, wherein the solution has a pH above 8.0. ### Claim 18 (depends on 17) A process according to claim 17, wherein the clear solution of step (ii) is cooled to ambient temperature and filtered. ### Claim 19 (depends on 18) A process according to claim 18 wherein the filtered solution is filled into the conventional, untreated glass container and sealed. ### Claim 20 (depends on 19) A process according to claim 19 wherein the sealing is made with an elastomeric closure. ### Claim 21 (depends on 20) A process according to claim 20 wherein the sealed container is sterilized by steam sterilization. ### Claim 22 (depends on 17) A process according to claim 17, wherein the aqueous solvent is selected from water, ethanol, benzyl benzoate or mixtures thereof. ### Claim 23 (depends on 22) A process according to claim 22, wherein the aqueous solvent is water. ### Claim 24 (depends on 23) A process according to claim 23, wherein the sugar is selected from dextrose, lactose and manitol. ### Claim 25 (depends on 24) A process according to claim 24, wherein the sugar is mannitol. ### Claim 26 (depends on 17) A process according to claim 17, wherein the conventional, untreated glass container is a USP type I glass container. ### Claim 27 (depends on 17) A process according to claim 17, wherein the elastomeric closure is a halobutyl rubber closure. ### Claim 28 (depends on 17) A process according to claim 17, wherein the sterilization is achieved through autoclaving. ### Claim 29 (depends on 34) A process according to claim 34, wherein autoclaving is performed at a pressure ranging from about 1 to 5 bar. ### Claim 30 (depends on 6) A pharmaceutical composition according to claim 6, wherein the conventional, untreated glass container is tubular or molded. ### Claim 31 (depends on 26) A process according to claim 26, wherein the conventional, untreated glass container is tubular or molded. ### Claim 32 (depends on 26) A process according to claim 26, wherein the conventional, untreated glass container is selected from ampoules, vials, ready-to-use syringes and carpoules. ### Claim 33 (depends on 27) A process according to claim 27, wherein the halobutyl rubber closure is selected from bromobutyl and chlorobutyl rubber closures. ### Claim 34 (depends on 28) A process according to claim 28, wherein the autoclaving is performed at a temperature ranging from about 120° C. to 150° C.; for a time duration ranging from about 15 to 120 minutes; and at a pressure ranging from about 1 to 20 bar. ### Claim 35 (depends on 34) A process according to claim 34, wherein autoclaving is performed at a temperature of about 120° C. to 125° C. ### Claim 36 (depends on 35) A process according to claim 35, wherein autoclaving is performed for at least 15 minutes.