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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
Application Number:
JP2020176766A
Publication Date:
March 11, 2021
Filing Date:
October 21, 2020
Export Citation:
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Assignee:
SUN PHARMACEUTICAL IND LTD
International Classes:
A61K31/4745; A61J1/00; A61K9/08; A61K47/12; G16H20/17; G16Z99/00
Domestic Patent References:
JP2013231029A2013-11-14
JP2004188039A2004-07-08
JP2007505861A2007-03-15
Foreign References:
CN102885765A2013-01-23
Attorney, Agent or Firm:
Yukitaka Nakamura
Satoru Asakura
Mari Asano
Hiroshi Sorimachi