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Composition for injectable solution

A composition and medicament technology, applied in the field of injection compositions, can solve problems such as poor solubility, strong irritation of painful bladder, etc.

Active Publication Date: 2018-06-15
MICROBIOPHARM JAPAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Pirarubicin preparations currently on sale (excipient: lactose) are injections of anthracycline carcinogens, and their solubility in normal saline is poor
Therefore, it is administered after dissolving it in distilled water for injection, but compared with physiological saline, there are disadvantages such as pain and strong irritation to the bladder.

Method used

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  • Composition for injectable solution
  • Composition for injectable solution
  • Composition for injectable solution

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0037] Example 1: Production example of pirarubicin preparation

[0038] use raw materials

[0039] ・Pirarubicin hydrochloride (also referred to as THP) was prepared by adding hydrochloric acid to pirarubicin (manufactured by Japan Microbio Pharma Co., Ltd.).

[0040] ・With regard to maltose, sucrose and lactose, the products marketed as Japanese Pharmacopoeia products were used as they were.

[0041] ・For trehalose, trehalose produced by Hayashibara Biochemical Research Institute was used as it was.

[0042] 1-1: Lactose 250mg THP 10mg titer The volume of the drug solution (also called the filling amount of the drug solution) at the time of freeze-drying Preparation method of 3mL preparation

[0043]Dissolve 100 mg of pirarubicin hydrochloride (titer) and 2.5 g of lactose in water, adjust the pH to 6 with sodium hydroxide, and after making the total amount to 30 mL, perform sterile filtration and fill each vial with 3 mL Put into a glass vial with a capacity of 15 mL, free...

example 2

[0054] Example 2: Dissolution test of freeze-dried products in physiological saline

[0055] 10 mL of physiological saline was added to the freeze-dried product obtained as in Example 1, shaken, and the time until the solid matter in the vial was completely measured was measured. The results are shown in Tables 1 to 5 below. The types and amounts of additives contained in 10 mg of pirarubicin hydrochloride constituting the freeze-dried product were used in the amounts shown in the table, respectively.

[0056] [Table 1]

[0057]

[0058] [Table 2]

[0059]

[0060] [table 3]

[0061]

[0062] [Table 4]

[0063]

[0064] [table 5]

[0065]

[0066] In all the test products prepared under the respective conditions in Tables 1 to 5 above, freeze-dried products were obtained without any problem.

example 3

[0067] Example 3: Stability test of freeze-dried products under severe conditions

[0068] Injections (containing 270 mg of maltose) manufactured in freeze-dried products manufactured as described in Example 1 were stored at 60°C and 40°C, and the residual ratio of pirarubicin during the storage periods shown in the table was measured. In addition, as a control substance, the residual rate was measured similarly using the conventional formulation containing 90 mg of lactose per 10 mg of THP. The results are shown in Table 6.

[0069] [Table 6]

[0070]

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PUM

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Abstract

Disclosed is a composition for an injectable solution, which comprises pirarubicin that acts as an active medicinal agent and an additive, wherein pirarubicin has the form of pirarubicin hydrochlorideand the additive is maltose and / or white soft sugar.

Description

[0001] This application is a divisional application of an invention patent application with an application date of April 5, 2013, an application number of 201380018749.2, and an invention title of "composition for injection". technical field [0002] The present invention relates to a composition for injection of an anthracycline-based carcinogen, and more specifically, to a composition for providing an injection with improved solubility of pirarubicin as the carcinogen. Background technique [0003] The currently marketed pirarubicin preparation (excipient: lactose) is an injection of an anthracycline-based carcinogen, and has poor solubility in normal saline. Therefore, it was dissolved in distilled water for injection and administered, but it had the disadvantages of pain and strong bladder irritation compared with physiological saline. In order to improve this disadvantage, attempts have been made to improve the solubility in physiological saline (see Patent Document 1 a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K31/7048A61P35/00
CPCA61K9/0019A61K31/7048A61K47/26A61P35/00
Inventor 神田泰寿金子桂福井伸治
Owner MICROBIOPHARM JAPAN CO LTD
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