Apparatus and method for delivering a lyophilized active with a needle-less injector

An apparatus for mixing a fluid and a dry reagent and for filling an ampoule of a needle-less injector suitable for injecting a mixture of the fluid and the dry reagent, the apparatus comprising:

• the ampoule containing the dry reagent;
• and
• a needle-free fluid holder containing the fluid, and having a fluid plunger rod, said fluid plunger rod having a longitudinal axis,
• wherein the ampoule is matingly attached to the needle-free fluid holder to provide fluid communication between the ampoule and the needle-free fluid holder, and
• the fluid plunger rod is configured to be slideably depressed, upon application of pressure along the longitudinal axis of the fluid plunger rod, to load the fluid into the ampoule to mix with the dry reagent to produce the mixture in the ampoule of the needle-less injector.

An apparatus for mixing a fluid with a dry reagent in an ampoule of a needle-less injector, the apparatus comprising:

• a needle-free fluid holder containing the fluid;
• an attachment mechanism disposed on said needle-free fluid holder;
• and
• a fluid plunger rod disposed within the needle-free fluid holder and having a longitudinal axis, the fluid plunger rod configured to be slideably depressed, upon application of pressure along the longitudinal axis,
• wherein when the needle-free fluid holder is matingly attached directly to the ampoule of a needle-less injector by the attachment mechanism, fluid communication is provided between the needle-free fluid holder and the ampoule, and
• when the fluid plunger rod is depressed, the fluid and the dry reagent are mixed in the ampoule.

In combination, an ampoule adapted for use with a needle-less injector and an apparatus for filling an ampoule of a needle-less injector suitable for injecting a mixture of a fluid and a dry reagent, the combination comprising:

• the ampoule containing a dry reagent;
• and
• a fluid holder containing a fluid,
• wherein the fluid holder has a fluid plunger rod, said rod having a longitudinal axis,
• the ampoule is matingly attached to the fluid holder to provide fluid communication between the ampoule and the fluid holder, and
• the fluid plunger rod is configured to be slideably depressed, upon application of pressure along the longitudinal axis of the fluid plunger rod, to load the fluid into the ampoule of the needle-less injector thereby creating the mixture of the dry reagent and the fluid;
• wherein the ampoule has an ampoule plunger rod, said rod being configured to be depressed to expel air or gas from the ampoule.

A method of filling an ampoule of a needle-less injector suitable for injecting a mixture of a fluid and a dry reagent, the method comprising the steps of:

• providing a fluid holder containing a fluid;
• providing the fluid holder with a fluid plunger rod having a longitudinal axis;
• adapting the fluid holder to be matingly attached directly to an ampoule to provide fluid communication between the ampoule and the fluid holder;
• slideably depressing the fluid plunger rod in a rotation-free manner by applying pressure along the longitudinal axis thereof to load the fluid into an ampoule containing a dry reagent thereby creating a mixture of the dry reagent and the fluid;
• providing an ampoule containing a dry reagent;
• providing an ampoule plunger rod for the ampoule;
• and
• after the fluid is loaded into the ampoule thereby creating the mixture of the dry reagent and the fluid, depressing the ampoule plunger rod to expel air or gas from the ampoule.