WO1988002266A1

WO1988002266A1 - Liquid medicine container and method

Info

Publication number: WO1988002266A1
Application number: PCT/US1987/002397
Authority: WO
Inventors: Jeffrey Wenig
Original assignee: Nastech Pharmaceutical Company, Inc.
Priority date: 1986-09-23
Filing date: 1987-09-21
Publication date: 1988-04-07

Abstract

A container (10) for the delivery of medicines especially through the nasal membrane. The container (10) includes a cap (20), a body member (11), and a disk member (25). The body member (11) has a flexible bottom wall (23) and a top wall (12) connected to the bottom wall (23). The top wall (12) has an orifice (19) through which a liquid is propelled when the bottom wall (23) is squeezed to eject the liquid.

Description

LIQUID MEDICINE CONTAINER AND METHOD

RELATED APPLICATION

Background of the Invention

This application is a continuation in part of copending application serial number 910,925 filed September 23, 1986. (Attorney's Docket 17974).

The present invention relates to containers for the delivery of liquids, especially liquid medicines in which the medicament may be dissolved, suspended or emulsified in a liquid vehicle which may be a gel or may manifest various viscosities. More particularly, it relates to containers from which the medicine is ejected when the container is squeezed.

At the present time, there are a number of commercially available methods and devices used to deliver liquid medicine to a patient. For example, the liquid may be encapsulated in a capsule which is ingested orally. However, generally the delivery time, before it is taken up in the bloodstream, may be prolonged, as the capsule must first pass into the digestive tract. In addition, it is difficult, or may be impossible, to provide medicine orally to those patients who are unable to swallow capsules, for example, because of throat medical problems or senility. An alternative method is to inject the medicine directly into the bloodstream of the patient. However, the injection, if a needle is

SUBSTITUTE SHEET used, may be objectionable to the patient as it may be painful and may be objectionable to the medical personnel as it is inconvenient and time-consuming to give injections. iWhen a,, number of.liquid medicines B_re -to t>e given the same patient each day, and when the patient has difficulty in swallowing capsules, the use of a number of injections each day may be both costly and inconvenient.

It has been suggested that a liquid medicine may be delivered through the nasal membrane by spraying or otherwise injecting the liquid either mixed with air or other gas or as a gel of selected viscosity near the membrane by a tube inserted throught he nose. This is a highly efficient and preferred method in many circumstances.. ^"Compared,to*.a-^~capsule, -.the nasal spray is relatively a rapid means of providing medicine to the bloodstream and does not require either voluntary or involuntary swallowing by the patient. On the other hand, it has proven difficult to provide an exact predetermined measured dose of liquid to a patient by means of a nasal spray. Generally liquid is retained in a squeeze container such as a collapsible plastic or metal foil tube. Some of the liquid may be retained on the wails o - e tube,-'especially when the liquid is in a thick viscous gel-like form, so that an exact and measured dose of the liquid is not provided to the patient.

The containers of this invention are especially useful or- nasal delivery ^'nd' will be principally described with respect thereto. However, the devices are not limited to nasal delivery. They may also be used for the delivery of ophthalmic or otic delivery to the eye or ear. Objectives and Features of the Invention

It is an objective of the present invention to provide a liquid medicine delivery system which will provide a substantially uniform measured dosage of liquid medicine to a patient.

It is a further objective of the present invention to provide a device for delivering such dosage to the nose so that it may be absorbed readily and speedily into the bloodstream of a patient or into the eye or ear for local administration.

It is a further objective of the present invention to provide such a measured dosage to the patient at the patient's nasal membrane so that the patient need not swallow the medicine or be inconvenienced by having the medicine injected.

It is a still further objective of the present invention to provide a liquid container for a measured dose of medicine, which container, upon operation, may be uniformly and substantially completely emptied of the medicine so that the dosage of the liquid may be predetermined.

It is a feature of the invention that the devices of the invention can be designed to deliver amounts which are plus or minus ten percent or even closer to desired, exact predetermined amounts. Summary of the invention

In accordance with the present invention, a container delivers-_a selecte .dosage of liquid; for example, the liquid may be a gel. The container includes a cap means, a body member and a disk member.

The body member, preferably a one-piece plastic member, has a flexible bottom wall forming a closed gas- tight chamber with a quantity of gas, such as air, trapped therein. A top wall is connected to the botton wall and forms a liquid-tight chamber for the liquid.

The top wall has an orifice through which the liquid is propelled when the bottom wall is squeezed to eject the liquid.

The disk member is positioned in sealed relationship between the liquid-tight chamber and the gas-tight chamber. The disk is preferably flexible and elastomeric and has at least one opening or passage, often a slit. The slit forms a one-way air valve which prevents the flow of the liquid to the air-tight chamber and permits the flow of air therethrough when the bottom wall is --squeezed- 'The cap 'means closes -.the -orifice. The cap means is removed to open the orifice before the bottom wall is squeezed.

Also in accordance with the present invention is the method of delivery of a selected, predetermined dose of liquid to .a patient through rthe -patient's -nasal .membrane,. This method uses a container including a cap means, a body member and a disk member.

SUBSTITUTE SHEET The first step of the method is to remove the cap means from the body member to uncover an orifice of the body member through which the liquid is propelled. The orifice is then placed into the nose of the patient. Then the flexible bottom wall of the body member is squeezed to compress the gas, such as air, trapped in its gas-tight chamber. The gas is forced through a slit of a one-way valve disk and into the liquid-tight chamber formed by the top wall of the body member. The gas efects the measured dose of liquid held in the liquid- tight chamber through the orifice and into contact with the patient's nasal cavity.

The methods for delivering medicaments to the eye of ear will be apparent from the foregoing description of the method of delivering through the nasal cavity.

Brief Description of the Drawings

Other objectives and features of the present invention will be apparent from the following detailed description, providing a preferred embodiment and the best mode of carrying out the invention.

In the drawings:

Figure 1 is a front plan view of the liquid container of the present invention with its cap on the container body member;

Figure 2 is a front plan view of the liquid container of Figure 1 with its cap removed from the container; Figure 3 is a top plan view of the liquid container of Figure 2, with the cap removed;

Figure -4 is a cross-sectional view taken along lines A-A of Figure 1 , looking in the direction of the arrows;

Figure 5 is an enlarged top plan view of the disk member utilized in the liquid container of the present invention; and

Figure 6 is a side cross-sectional view along the line G-G of Figure 5.

Detailed Description of the Invention

As shown in Figure 1 , the liquid container 10 of the present invention includes the body portion 11. The body portion 11, prior to the container receiving its measured dose of liquid, is in the form of an open tubular member. The liquid is injected, preferably by needle, in a measured dose in the upper liquid-tight chamber 12 of the container 10. The container 10 is then closed at its bottom 13 by pressing together and heat-sealing the end,, forming -the seam 14. A. quantity of air <»gas) is trapped in the bottom chamber 15 of the container.

As best shown in Figure 4, the flexible wall forming the bottom portion 23 has an inward slanting shoulder 16 which forms a shoulder ledge for the one-way valve disk 17. The disk T7 is -pressed- in-an -its-ri ^'25- seals on the inner wall. The pre-measured dose of liquid is injected through the slits of the disk 17 by a needle and forms a pool of liquid 18 in the top chamber of the container. The container has a top orifice 19 through which the liquid .is -propelled, The orifice IS is

SUBSTITUTE SHEET normally closed by the cap 20, which is preferably heat- sealed with an easily broken seal to the container to prevent tampering. The liquid to be delivered can be injected into the chamber 12 before or after placement of the disk 17.

In operation, the user, for example, a nurse, will pull off the cap 20 and break its seal. This exposes the open orifice 19. The user will then squeeze the side walls 21, 22 (see Figure 4), causing the air entrapped within the chamber 15 to flex the membrane of the disk

17. The air will be propelled by the squeezing force on the side walls 20, 21 through the slits of the disk 17 and will force the entire dose of liquid 18 out through the orifice 19, without leaving any objectionable residue of liquid in the chamber 15.

Preferably, as shown in Figures 5 and 6, the disk 17 has four slits 26a-26d arranged at 90 angles about its center. The slits may be v-shaped as shwon in Figure 6, or the walls forming the slits may be parallel or any other convenient geometric configuration. The disk is preferably an elastomeric plastic which may be formed by injection molding or other technique.

When the liquid is a gel-like thick and viscous liquid, in the range of 4000-6000 CPS (room temperature) the following dimensions (in inches) for the disk 17 have been found to prevent leakage of the liquid and have provided excellent results: Outer diameter of rim 25, dimension B is .370 in.; inner diameter of rim 25, dimension C is .330 in.; width of slit, dimension D is .010 in.; thickness of rim, dimension F is .050 in.; and thickness of flexible membrane of disk, dimension E is .030 in. The dimension of the thickness of the disk membrane and the width of the slits should be adjusted to accord with the viscosity of the liquid. Generally the slit should he less, wide ifrthe. liquid is thinner, In all

5 cases, however, the slits prevent the liquid from flowing into the air-tight chamber.

Preferably the liquid fills the entire liquid-tight chamber. If the amount of liquid in the pre-measured dose is to be reduced, then preferably a smaller size

10 container is used so that the entire liquid-tight chamber is filled with liquid. However, in other cases, the liquid need not fill the liquid-tight chamber. Preferably the size of the air-tight chamber compared to the size of -the liquid?- ight chambe -is --about in-_a 2 to 1

IB ratio; however, preferably that size relationship is in the range of 1.5 - 2.5 to 1 (internal volume of chambers) .

Many apparent variations of this invention will occur to those skilled in the art. For example, disk 17

20 is shown with two slits. Similar results may be achieved with disks having only one slit, or with disks having .more -.than two .slits.-. -.Alternatively, two disks -with one or more slits may be employed superimposed upon each other with their slits offset. One or more holes which

25 may or may not be circular in shape can also be employed.

The cap need not take the form shown, although it is .preferred that ^'it_*So .so to. protect ±he-chamber 12-,. and to assist in maintaining its sterility. The cap may be a simple closure member with a protuberance which serves as 30 a closure for orifice 19. The cap may also be threaded so that it can be screwed on to the chamber 12.

SUBSTIT All such variations are included within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1» A container to deliver a predetermined dosage of liquid including a cap means, a body member and a disk member; the body member having a flexible bottom wall forming a closed gas-tight chamber and having a quantity of gas trapped therein; a top wall connected to said bottom wall and forming a liquid-tight chamber for the liquid, said top wall having an orifice through which the liquid is propelled when the bottom wall is squeezed;

The disk member being positioned between said liquid—tight chamber and said;.gas—tight chamber.having at least one opening therein, forming a one-way air valve which prevents the flow of the liquid to the air-tight chamber and permits the flow of air therethrough when the bottom wall is squeezed; and cap means to close the orifice, said cap means being operated to open the orifice before the bottom wall is squeezed.

2. "A container as in. claim 1 wherein the opening is a slit.

3. A container as in claim 1 or 2 wherein the liquid has a viscosity of between 4000 and 6000 CPS.

4, A container as in. claim 1 or 2 wherein the_,body member is a unitary one-piece heat-sealable plastic resin member.

5. A container as in claim 1 or 2 wherein the bottom edge of the bottom wall is sealed after the liquid is injected into the liquid-tight chamber.

6. A container as in claim 1 or 2 wherein the gas is air.

7. A container as in claim 1 wherein the top wall is a conical tube which is round in cross-section vertical to its imaginary axis.

8. A container as in claim 2 wherein the top wall is a conical tube which is round in cross-section vertical to its imaginary axis.

9. A container as in claim 7 or 8 wherein the cap means is an elongated cap which covers the top wall and seals the orifice.

10. A container as in claim 2 wherein the disk has ffoouurr sslliittss eeqquuaallllyy positioned at angles of 90 around the center of the disk.

11. The method of delivery of a pre-measured dose of liquid to a patient through the patient's nasal membrane, using a container including a cap means, a body member and a disk member, the method comprising the steps of: removing the cap means from the body member to uncover an orifice of the body member through which the liquid is propelled; positioning said orifice into the nose of the patient; and

E SHEET squeezing the flexible bottom wall of the body member to compress the gas trapped in a gas-tight chamber and forcing the gas through an opening of a one-way valve disk and into the.liquid- ight .chamber formed by the. op wall of the body member, thereby ejecting the measured dose of liquid held in the liquid-tight chamber through the orifice and into contact with the patient's nasal cavity.

12. The method of claim 11 wherein the liquid is filled into the liquid-tight chamber by injecting the liquid through a needle which penetrates through the opening, the needle is then removed and the bottom edge of the body member is then sealed entrapping gas in the gas—tig t chamber.

13. A method as in claim 11 wherein the opening in the one way valve is a slit.

14. A method as in claim 11 wherein the gas is air.

SUBSTITUTE SHEET