Coupling syringe system and methods for obtaining a mixed composition

Inactive Publication Date: 2012-07-24
TOLMAR THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]In the most simplistic embodiment, the '786 patent discloses a four part system: diluent holder, support brushing, reagent holder, and the needleless injector; while the '029 patent discloses a four part system: injector, plunger vial, adaptor and charging vial. The presence of multiple (e.g., four) components increases the likelihood of human error when mixing and administering a drug. Additionally, the presence of multiple components increases the likelihood of an occurrence of sample loss (e.g., leakage).
[0009]Thus, there is a need for a syringe system wherein components of a composition can be easily mixed by the end user without losing a significant amount of mixed composition during the mixing process and wherein the mixed composition can be easily and rapidly administered to a patient. Such a syringe system will have a relatively few number of interconnecting parts, to minimize human error and to minimize sample loss. Additionally, the syringe system will effectively mix the contents located therein without sample loss, such that it will be approved by the FDA when used with drugs that must be administered in a known, discrete and precise amount (e.g., leuprolide acetate).
[0010]The present invention provides a syringe system wherein components of a composition can be easily mixed by the end user without losing a significant amount of mixed composition during the mixing process and wherein the mixed composition can be easily and rapidly administered to a patient. The syringe system has a relatively few number of interconnecting parts, to minimize human error and to minimize sample loss. Additionally, the syringe system effectively mixes the contents located therein without sample loss, such that it can be approved by the FDA when used with drugs that must be administered in a known, discrete and precise amount (e.g., leuprolide acetate).

Problems solved by technology

However, this process is often cumbersome, a significant amount of the drug may be lost, and the time between the mixing and the application is often too long with sensitive compositions (i.e., compositions that, upon mixing, must be immediately administered).
However, with this type of arrangement, control over the degree of mixing does not exist and the degree of mixing, therefore, may be inadequate.
The contents, therefore, do not mix well.
Additionally, when the syringes are uncoupled (i.e., disengaged), the contents have to be aspirated out of the independent coupling means or they will be lost.
Since the '029 patent explicitly discloses that the system is made for one-way transfer, without recharging the charging vial, it would not be suitable for the recombination of materials between two syringes.
This is so because a system not contemplated for multiple-pass use, that is nonetheless employed for multiple-pass use, can result in an appreciable amount of sample loss (e.g., leakage).
This is especially troublesome when the drug is expensive (e.g. leuprolide acetate).
This is also troublesome since the U.S. Food and Drug Administration (FDA) requires that the health care professionals administer an active ingredient in a precise and known amount.
Obviously, this requirement cannot be met when there is an appreciable amount of sample loss due to the syringe assembly.
Moreover, the engagement disclosed by the '786 cannot be locked, as the threaded engagement has no means of locking.
The presence of multiple (e.g., four) components increases the likelihood of human error when mixing and administering a drug.
Additionally, the presence of multiple components increases the likelihood of an occurrence of sample loss (e.g., leakage).

Method used

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  • Coupling syringe system and methods for obtaining a mixed composition
  • Coupling syringe system and methods for obtaining a mixed composition
  • Coupling syringe system and methods for obtaining a mixed composition

Examples

Experimental program
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Effect test

Example

Example 1

[0047]The LA-2575 30.0 mg drug product when injected subcutaneously forms a biodegradable implant that delivers 30.0 mg of leuprolide acetate (LA) over a four-month period. The drug product is composed of two separate syringes. Syringe A with a female Luer Lok fitting contains the drug delivery vehicle, and Syringe B with a male Luer Lok fitting contains lyophilized LA. To constitute the product for injection, Syringe A and Syringe B are connected, and the contents are passed back and forth until blended. After mixing, the two syringes are separated, a hypodermic needle is attached to Syringe B, and the constituted drug product is administered subcutaneously to the patient.

[0048]A fraction of the constituted drug product is trapped in the hub of Syringe A after the mixing process and in the hub and needle of Syringe B after injection. To meet the targeted delivery values, this retained drug product must be accounted for when calculating the fill weights for both syringes. Also

Example

Example 2

[0053]The 6-Month ELIGARD 45.0 mg drug product when injected subcutaneously forms a biodegradable implant that delivers 45.0 mg of leuprolide acetate (LA) over a six-month period. The drug product is composed of two separate syringes. Syringe A with a female Luer Lok fitting contains the drug delivery vehicle, and Syringe B with a male Luer Lok fitting contains lyophilized LA. To constitute the product for injection, Syringe A and Syringe B are connected, and the contents are passed back and forth until blended. After mixing, the two syringes are separated, a hypodermic needle is attached to Syringe B, and the constituted drug product is administered subcutaneously to the patient.

[0054]A fraction of the constituted drug product is trapped in the hub of Syringe A after the mixing process and in the hub and needle of Syringe B after injection. To meet the targeted delivery values, this retained drug product must be accounted for when calculating the fill weights for both syringe

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Abstract

The present invention relates generally to medical devices for mixing, preparing and administering therapeutic compositions, and more particularly to a system comprising two syringes and a locking ring wherein two compositions are mixed between the two syringes immediately prior to administration.

Description

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Claims

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Application Information

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Owner TOLMAR THERAPEUTICS
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