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Hazardous Reagent Injection System

A technology for injectors and syringes, applied in the direction of syringes, anti-inflammatory agents, auto-injectors, etc., can solve problems such as impracticality

Inactive Publication Date: 2015-09-09
ANTARES PHARMA INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because of the need for these instructions, a number of precautions must be learned and followed for safely injecting hazardous reagents, which are currently considered dangerous for self-injection by patients outside of a healthcare setting or without the assistance of a healthcare worker Especially not for methotrexate

Method used

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  • Hazardous Reagent Injection System

Examples

Experimental program
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Effect test

Embodiment 1

[0210] Described and compared the pharmacokinetics of systemic exposure to the hazardous agent methotrexate achieved in male and female Göttingen minipigs following subcutaneous administration with the automatic injector of the present disclosure or with known hypodermic needle / syringe combinations. Kinetic (pharmacokinetic, PK) analysis.

[0211] Methotrexate and controls were administered. Test and control article administration, blood collection and processing for this study were performed at Charles River Preclinical Services (Spencerville, OH) under non-FDA compliant GLP (Good Laboratory Practice) conditions. The presented plasma concentration data were generated by a research grade Level 3 liquid chromatography tandem mass spectrometry (LC-MS / MS) method.

[0212] Methotrexate was administered subcutaneously in minipigs, and the same group of animals was injected with either an autoinjector or a needle / syringe. Injections were performed on days 1 and 8. Table 3 shows t...

Embodiment 2

[0249] The automatic injector of this disclosure and two known traditional automatic injectors Enbrel SureClick TM Autoinjector (Immunex Corporation, Thousand Oaks, CA, U.S.A.) and HUMIRA A comparison of injections between pens (Abbott Laboratories, Abbott Park, IL, U.S.A.) compared spring force and time required to deliver a full injection of 0.8-1.0 ml of solution.

[0250] A control was administered for this test. The results of two known automatic injectors were averaged. The results of the comparison are shown in Figure 16 . As shown in FIG. 6 , the time required to deliver the full injection is 10 seconds for the known automatic injector, but only 3 seconds for the automatic injector of the present disclosure. Therefore, users of known auto-injectors must hold these auto-injectors at the injection site for the full 10 seconds in order to receive the entire injection. In contrast, the user of the auto-injector of the present disclosure need only hold the auto-in...

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Abstract

Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

Description

[0001] This application claims the benefit of US Provisional Patent Application No. 61 / 162,114, filed March 20, 2009, which is hereby incorporated by reference for all purposes. technical field [0002] This disclosure relates to the injection of hazardous agents. Background technique [0003] Since the 1980s, dangerous agents such as cytotoxic agents have been used in the management and treatment of many diseases such as rheumatoid arthritis (and other autoimmune diseases), juvenile rheumatoid arthritis (juvenile rheumatoid arthritis), psoriatic arthritis (psoriatic arthritis) ), systemic lupus erythematosus, steroid-resistant polymyositis or dermatomyositis, orbital necrotizing granulomatosis (Wegener's granulomatosis), polyarteritis nodosa, and some forms of vasculitis. However, hazardous agents tend to exhibit side effects that are harmful or toxic to the subject. Many of these side effects occur when hazardous agents are administered orally, but due to their ease of us...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61M5/20A61M5/30A61K9/00
CPCA61K9/0019A61M5/178A61M5/3202A61M2005/3247A61M2005/2013A61K31/568A61M5/30A61K9/0087A61M5/2033A61M2005/2073A61M5/326A61K31/519A61P19/02A61P29/00
Inventor 约翰·威廉·海斯保罗·沃顿彼得·L·萨多夫斯基
Owner ANTARES PHARMA INC
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