Claims for Patent: 5,454,786

Summary for Patent: 5,454,786

Title:	Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
Abstract:	A cartridge assembly for holding a lyophilized product, forming a disposable portion of a pen injector includes a cylindrical glass cartridge adapted to receive the product, a closure cap, a cartridge case, and a plunger mechanism. The closure cap is adapted to retain an elastomeric disc seal during lyophilization and includes diametrically opposed ledges. The closure cap and seal are adapted to cover a neck portion of the ampule, the neck portion having on its end a radially extending circumferential flange. The ledges of the closure cap and the flange of the neck portion allow the closure cap to remain open during lyophilization, oxygen purge and nitrogen overlay. An oval-shaped indentation formed on the inside of the closure cap aids in snapping the closure cap about the flange without crimping to retain the closure cap underneath the flange. Reconstitution of the lyophilized drug is accomplished without foaming by use of an obliquely angled connector which causes the diluent to indirectly impinge on the drug. The injection pen and cartridge assembly cooperate such that the length of travel of the plunger rod during retraction is less than the axial length of a recess in the rod tip.
Inventor(s):	Harris; Dale C. (Fairland, IN)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	08/218,653
Patent Claims:	1. A method for reconstituting a lyophilized compound, comprising: providing a lyophilized compound contained within an interior space defined by an inner wall of a cartridge having an inlet at one end thereof and a plunger at an opposite end thereof; attaching a connector to the inlet end of the cartridge, the connector having a neck portion coaxial with a longitudinal axis of the cartridge and a tubular first portion connected to said neck portion, said first portion having an interior space and defining an axis along a longitudinal length thereof, the axis of the first portion forming an oblique angle relative to the axis of the cartridge; placing a syringe having a needle and containing the diluent into the interior space of the first portion, such that the needle is oriented toward the inner wall of the cartridge; and injecting a diluent from the syringe into the cartridge via the inlet such that the diluent impinges on and runs down the inner wall of the cartridge before contacting the lyophilized compound whereby foaming of the compound is prevented. 2. A method of reconstituting a lyophilized compound comprising: providing a lyophilized compound contained within an interior space defined by an essentially annular inner wall of a cylindrical cartridge, the cartridge including an inlet on one end thereof and a plunger on an opposite end thereof and defining an axis extending through the inlet along the longitudinal length thereof; removably attaching a connector on the inlet end of the cartridge, the connector defining an open-ended cavity for receipt of a syringe containing the diluent, the connector including a tubular angled portion for receiving and angularly positioning the diluent syringe relative to the cartridge, the angled portion defining an axis along a longitudinal length thereof, the axis of the angled portion forming an oblique angle relative to the axis of the cartridge; placing the syringe containing the diluent into the tubular angled portion such that a needle of the syringe extends through the inlet at the oblique angle; and injecting the diluent into the cartridge through the needle whereby the diluent is caused to impinge upon and run down the inner wall of the cartridge before contacting the lyophilized compound. 3. An apparatus for reconstituting a lyophilized drug contained within an inner space of a cartridge comprising: a cartridge having an inlet on one end thereof, a plunger on the opposite end and containing a lyophilized drug, said cartridge defining a longitudinal axis extending through the inlet, a connector releasably secured to the inlet end of the cartridge and adapted to receive and hold a syringe containing a diluent, the connector having a neck portion coaxial with the axis of the cartridge and having a tubular first portion defining a longitudinal axis which forms an oblique angle with the longitudinal axis of the cartridge, the syringe adapted to be supported by the connector at the oblique angle whereby the diluent is injected into the cartridge via the inlet at the oblique angle. 4. The apparatus of claim 3, wherein said neck portion is received on the inlet end of the cartridge, the connector further including a tubular second portion eccentric with said first portion, said second portion having a larger diameter than the diameter of said first portion and adapted to retain and support the syringe. 5. The apparatus of claim 4 including a lid on said tubular second portion for sealing the interior of said connector.

Details for Patent 5,454,786

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	06/23/1987		2013-03-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10/16/1986		2013-03-15
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	02/04/1999		2013-03-15

International Patent Family for US Patent 5,454,786

Country	Patent Number	Estimated Expiration
South Africa	941801
World Intellectual Property Organization (WIPO)	9421213
United States of America	5334162