Method of preparing multiple doses of a pharmaceutical solution from a single-dose

a technology of ranibizumab and single dose, which is applied in the field of preparing multiple individual doses of a pharmaceutical solution, can solve the problems of significant portion of the drug being unused and wasted, and achieve the effect of reducing the cost of treatmen

Active Publication Date: 2010-11-18
THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE DEPT OF VETERANS AFFAIRS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007]Another aspect of the present invention is to provide a method which prepares multiple doses of ranibizumab from a single-use vial that are sterile, stable and effective for up to three months after refrigeration. In particular, the present invention utilizes a sterile procedure to extract multiple 0.5 mg/0.05 ml ranibizu

Problems solved by technology

However, due to the dead space in the tuberculin syringe

Method used

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  • Method of preparing multiple doses of a pharmaceutical solution from a single-dose
  • Method of preparing multiple doses of a pharmaceutical solution from a single-dose
  • Method of preparing multiple doses of a pharmaceutical solution from a single-dose

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Embodiment Construction

[0017]The present invention is based, in part, on the discovery that due to the dead space in a syringe, particularly a tuberculin syringe, a significant portion of the drug is unused and wasted. In particular, the present inventors discovered that ranibizumab is supplied by the manufacturer in a single-dose vial with a 30G needle and a filter needle. However, due to the dead space, much of the drug is not used is therefore wasted. The present invention provides an extraction method which produces multiple doses of ranibizumab from a single-dose vial. The doses produced are sterile, stable and effective for up to three months, less painful to the patient, and easier to use by a retinal specialist. The method described herein is not limited to ranibizumab and can be used for other drugs that have established stability under these conditions such as bevacizumab.

[0018]The following is a preferred embodiment for carrying out the method of the present invention.

[0019]Supply List (FIG. 1)...

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Abstract

A method of preparing multiple doses of a pharmaceutical solution, such as ranibizumab, from a single-dose container, includes providing a sterile enclosed area with a plurality of unused sterile syringes, a decapper, and a plurality of sterile bags, opening a single-use container of a pharmaceutical solution in the enclosed area, withdrawing a first portion of the pharmaceutical solution using one of the sterile syringes, withdrawing a second portion of the pharmaceutical solution using a second of the sterile syringes, repeating the previous step for the remaining pharmaceutical solution using the remaining sterile syringes, and placing the sterile syringes containing portions of the pharmaceutical solution individually in the sterile bags.

Description

FIELD AND BACKGROUND OF THE INVENTION[0001]The present invention is generally directed to a method of preparing multiple individual doses of a pharmaceutical solution, and more specifically to preparing multiple doses of ranibizumab from a single-dose vial.[0002]Opthalmic solution, such as ranibizumab is available from the manufacturer in a single-dose vial intended to be used one time per procedure. The drug is supplied with a tuberculin syringe, 30G needle, and a filter needle to extract it from the vial, which contains 0.26 ml of ranibizumab by volume. However, due to the dead space in the tuberculin syringe, a significant portion of the drug is unused and wasted.ASPECTS OF THE INVENTION[0003]The present disclosure is directed to various aspects of the present invention.[0004]One aspect of the present invention is to provide a method which eliminates or significantly reduces wastage of a pharmaceutical solution, suspension, mixture, composition, or the like in any form (collectiv...

Claims

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Application Information

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IPC IPC(8): B65B3/04
CPCA61F9/0017A61M5/1782A61M5/002
Inventor MALMSTROM, ROBERT A.MEIER, JOY L.CARMICHAEL, JANNET M.
Owner THE GOVERNMENT OF THE UNITED STATES OF AMERICA AS REPRESENTED BY THE DEPT OF VETERANS AFFAIRS
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