Claims
- 1. A method of sterilizing a polymer which comprises the steps of:
- dispersing the polymer in a water-miscible organic liquid;
- mixing the polymer and organic liquid to form a polymer/organic liquid suspension;
- placing the suspension in a sealed, water-vapor proof vessel; and
- heating the suspension for a period of time effective to sterilize the polymer.
- 2. A method according to claim 1, wherein the suspension is heated at a temperature of from 110.degree. to 150.degree. C. for a period of from 0.5 to 8 hours.
- 3. A method according to claim 1, wherein the polymer is a heat-labile polymer.
- 4. A method according to claim 3, wherein the heat-labile polymer is a galactomannan polymer.
- 5. A method according to claim 4, wherein the galactomannan is selected from the group consisting of guar, tara and locust bean gum.
- 6. A method according to claim 4, wherein the galactomannan polymer is HP-guar.
- 7. A method according to claim 1, wherein the water-miscible organic liquid is a polyethylene glycol.
- 8. A method according to claim 7, wherein the polyethylene glycol is selected from the group consisting of PEG 200, PEG 400 and PEG 600.
- 9. A method according to claim 1, wherein the polymer is a galactomannan and the water-miscible organic liquid is a polyethylene glycol.
- 10. A method according to claim 9, wherein the galactomannan is HP-guar and the polyethylene glycol is PEG-400.
- 11. A method according to claim 1, wherein the suspension is heated at a temperature of 125.degree. C. for a duration of at least 40 minutes.
- 12. A method according to claim 9, wherein the suspension is heated at a temperature of 125.degree. C. for a duration of at least 40 minutes.
- 13. A method according to claim 10, wherein the suspension is heated at a temperature of 125.degree. for a duration of at least 40 minutes.
- 14. A method of preparing a sterile composition containing a polymer comprising the steps of:
- sterilizing the polymer by:
- dispersing the polymer in a water-miscible organic liquid;
- mixing the polymer and organic liquid to form a polymer/organic liquid suspension;
- placing the suspension in a sealed, water-vapor proof vessel; and
- heating the suspension for a period of time effective to sterilize the polymer; and
- mixing the sterilized polymer suspension with pre-sterilized excipients to form a sterile composition containing a polymer.
- 15. A method according to claim 14, wherein the composition comprises:
- about 0.20% w/v hydroxypropyl guar gum;
- about 0.40% w/v polyethylene glycol 400;
- about 0.25% w/v tetronic 1304;
- about 1.00% w/v boric acid;
- about 0.90% w/v propylene glycol;
- about 0.01% w/v disodium Edetate; and
- about 0.0015% w/v polyquaternium-1;
- wherein the composition is adjusted to a pH of from 6.5 to 7.5 with sodium hydroxide and hydrochloric acid.
Parent Case Info
The present application claims priority to U.S. provisional Ser. No. 60/054,119 filed Jul. 29, 1997.
US Referenced Citations (6)