Title:
PERFUSION DOSAGE FORM
Document Type and Number:
Japanese Patent JP2021038223
Kind Code:
A
Abstract:
To provide a method for enabling hospitals or clinics to administer a dose of a drug to patients in need thereof while avoiding steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous administration.SOLUTION: A perfusion dosage form comprises a flexible perfusion container containing from 50 ml to 500 ml of a ready-to-infuse aqueous perfusion solution comprising irinotecan hydrochloride at a concentration in a range from 0.2 mg/ml to 2.0 mg/ml, tonicity adjusting agent, water for injection, and lactic acid. The solution has a pH in a range from 3.0 to 4.5. The flexible perfusion container has a single outlet configured to provide a single outward flow of the solution. The flexible perfusion container is terminally sterilized by autoclaving. The flexible perfusion container comprises a secondary packaging designed to protect the solution from light, the secondary packaging surrounding said flexible perfusion container.SELECTED DRAWING: Figure 1
Inventors:
KUMAR SAMARTH
KANE PRASHANT
BHOWMICK SUBHAS BALARAM
KIRTI GANORKAR
PATEL NISHIT
ANILRAO ASHISH DUBEWAR
MUKESHBHAI UMESHKUMAR PATEL
KANE PRASHANT
BHOWMICK SUBHAS BALARAM
KIRTI GANORKAR
PATEL NISHIT
ANILRAO ASHISH DUBEWAR
MUKESHBHAI UMESHKUMAR PATEL
Application Number:
JP2020176766A
Publication Date:
March 11, 2021
Filing Date:
October 21, 2020
Export Citation:
Assignee:
SUN PHARMACEUTICAL IND LTD
International Classes:
A61K31/4745; A61J1/00; A61K9/08; A61K47/12; G16H20/17; G16Z99/00
Domestic Patent References:
JP2013231029A | 2013-11-14 | |||
JP2004188039A | 2004-07-08 | |||
JP2007505861A | 2007-03-15 |
Foreign References:
CN102885765A | 2013-01-23 |
Attorney, Agent or Firm:
Yukitaka Nakamura
Satoru Asakura
Mari Asano
Hiroshi Sorimachi
Satoru Asakura
Mari Asano
Hiroshi Sorimachi