Title:
REGULATION OF GELATION TEMPERATURE OF FORMULATION INCLUDING POLOXAMER
Document Type and Number:
Japanese Patent JP2018009006
Kind Code:
A
Abstract:
PROBLEM TO BE SOLVED: To provide sustained release formulations including a thermosensitive polymer.SOLUTION: A pharmaceutical formulation which includes an active agent, and a thermosensitive polymer including a copolymer of polyoxyethylene and polyoxypropylene is characterized by a) having a viscosity which is injectable at the time of administration and is suitable for administration with a 25-31 gauge needle; b) having a gelation temperature between about 14°C and about 42°C; c) providing sustained release of a therapeutically effective amount of the active agent for at least three days, preferably for at least five days, particularly preferably for at least seven days, in vivo; and (d) having a microbial factor of less than 50 cfu per g of the formulation. Preferably, the formulation is administered at or near the fenestra rotunda membrane of the ear and the sustained release in vivo occurs in the inner ear. Alternatively, the formulation is administered at or near one or more paranasal sinuses, and the sustained release in vivo occurs at or near the paranasal sinus.SELECTED DRAWING: None
Inventors:
YE QIANG
LUIS A DELLAMARY
FABRICE PIU
LUIS A DELLAMARY
FABRICE PIU
Application Number:
JP2017156133A
Publication Date:
January 18, 2018
Filing Date:
August 10, 2017
Export Citation:
Assignee:
OTONOMY INC
International Classes:
A61K9/08; A61K9/10; A61K31/424; A61K31/43; A61K31/4725; A61K31/496; A61K31/5383; A61K31/573; A61K45/00; A61K47/10; A61K47/12; A61K47/40; A61P31/04
Domestic Patent References:
| JP2006509791A | 2006-03-23 | |||
| JP2001526246A | 2001-12-18 | |||
| JPH07215877A | 1995-08-15 | |||
| JP2002537316A | 2002-11-05 |
Foreign References:
| US20060257488A1 | 2006-11-16 |
Other References:
OCULAR POLOXAMER-BASED CIPROFLOXACIN HYDROCHLORIDE IN SITU FORMING GELS., DRUG DEV IND PHARM, vol. 34, no. 7, JPN6014033553, 2008, pages 744 - 52, ISSN: 0003959563
"Prolonged antifungal effects of clotrimazole-containing mucoadhesive thermosensitive gels on vaginit", J CONTROL RELEAS, vol. 82, no. 1, JPN6014033555, 2002, pages 39 - 50, ISSN: 0003959564
LEE,S.H. ET AL: "Regional delivery of vancomycin using pluronic F-127 to inhibit methicillin resistant Staphylococcus", JOURNAL OF CONTROLLED RELEASE, vol. 96, no. 1, JPN6013010823, 2004, pages 1 - 7, XP004500727, ISSN: 0003959562, DOI: 10.1016/j.jconrel.2003.12.029
"Prolonged antifungal effects of clotrimazole-containing mucoadhesive thermosensitive gels on vaginit", J CONTROL RELEAS, vol. 82, no. 1, JPN6014033555, 2002, pages 39 - 50, ISSN: 0003959564
LEE,S.H. ET AL: "Regional delivery of vancomycin using pluronic F-127 to inhibit methicillin resistant Staphylococcus", JOURNAL OF CONTROLLED RELEASE, vol. 96, no. 1, JPN6013010823, 2004, pages 1 - 7, XP004500727, ISSN: 0003959562, DOI: 10.1016/j.jconrel.2003.12.029
Attorney, Agent or Firm:
Kazuhiro Kiyohara