GB1579284A - Pharmaceutical unit dose package for use in a single unit dose pharmaceutical delivery system - Google Patents

Description

(54) A PHARMACEUTICAL UNIT DOSE PACKAGE FOR USE IN A SINGLE UNIT DOSE PHARMACEUTICAL DELIVERY SYSTEM (71) We, WARNER-LAMBERT COM- PANY, of 201, Tabor Road, Morris Plains, New Jersey, United States of America, a corporation organised under the laws of the State of Delaware, United States of America, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particulary described in and by the following statement:- This invention relates to a pharmaceutical unit dose package for use in a single unit dose pharmaceutical delivery system.

The subject of the present invention has been divided from co-pending application No.

9240/77 (Serial No. 1579282) in which there is described and claimed a single use, unit dose pharmaceutical delivery system, comprising a hollow cylindrical tube adapted to contain a unit dose of a pharmaceutically active material and having sealing means at each end of the tube, and a single use liquid container made of a pharmaceutically inert material which is deformable upon squeezing by the user and which is adapted to contain a pharmaceutically acceptable diluent, and wherein the container has a hollow neck through which the diluent is expressed and has a rupturable closure means whereby the container is antiseptically sealed from its environment, the outside diameter of the neck in relation to the inside diameter of the cylindrical tube is such as to provide a friction fit liquid seal when the neck, after rupturing the closure means, is inserted into either end of the tube after removing the sealing means at that end, the thus assembled container and tube being ready for dispensing the unit dose of the active material mixed with the diluent by removing the remaining sealing means of the tube and squeezing the container to express the diluent through the hollow neck into the tube to discharge the diluted active material therefrom.

Reference is also made to co-pending Application No. 7934492, (Serial No. 1579283) the subject of which has also been divided from co-pending Application No. 9240/77 (Serial No. 1579282), and in which there is described and claimed a single use liquid container for antiseptic application of a pharmaceutically accepted liquid, the container comprising a moulded deformable translucent bottle generally oval in cross section and having a flat closed bottom portion and a closed top portion, said top portion having a hollow neck extending upwardly therefrom and offset from the centre of the top portion whereby the hollow portion of said neck communicates with the hollow interior of said bottle, said neck having closure means whereby the container may be antiseptically sealed from its environment, and wherein the closure means is a disc of greater diameter than the hollow neck and which is attached to the opened end of said neck along a weakened portion at the junction of said neck and disc, said disc further having an integral lever arm parallel to said bottom portion and extending along a plane passing through the long axis of the generally oval cross section, said container further having a tab extending downwardly from the bottom portion and extending completely across the bottom portion along the long axis of the generally oval cross section.

The aim of bronchodilation therapy is to reduce abnormally high airway resistance which is most often accomplished by the administration of adrenergic drugs among which are isoproterenol, phenylephrine, racemic ephinephrine, and ephedrine. Generally, these drugs are given as aerosols in powdered nebulizers or intermittent positive pressure breathing apparatus (IPPB). The usual dose is 0.5 - 1.0 ml of 1: 200 isoperterenol or 2.25% racemic epinephrine is diluted in enough saline or water (2-5 ml) to assure aerosol therapy for 5-10 minutes.

Most hospitals utilize a multi-dose method of IPPB therapy in which multi-dose vials of sterile saline or water are carried by the technician to the administration site. A prescribed amount of liquid is then withdrawn from the multi-dose vial by use of a presterilized disposable syringe. In theory, a new syringe and needle are used for each patient. The liquid is withdrawn from the container into the syringe and then expressed into the nebulizer reservoir. The active ingredient, such as isoproternol, Bronkosol (Registered Trade Mark), is added to the reservoir by means of a measuring dropper supplied with the drug bottle or drawn up from the drug bottle by a single sterile syringe. In any case, the same bottles are taken from. a hospital room enhancing the possibility of cross contamination and loss of sterility.

It is an object of the present invention to provide a convenient unit dose package for use in a single dose pharmaceutical system.

The invention consists in an open ended pharmaceutical unit dose package comprising a hollow cylindrical tube containing a unit dose of a bronchodilator selected from the group consisting of isoproternol, phenylephrine, racemic epinephrine, and ephedrine within a cavity and having sealing means at each end of the tube, both sealing means being removable to enable flushing of the tube contents by flowing a liquid diluent through the tube, both sealing means having portions not contained within the tube, for enabling gripping of the sealing means for removal thereof from the tube at least one of the two sealing means having a portion extending into the tube a predetermined distance so that the two sealing means form with the tube a cavity of a predetermined volume equal to the desired unit dose of the bronchodilator to the exclusion of an air space and wherein the said one sealing means is in intimate frictional contact between the interior of the tube and the entire portion of the said one sealing means extending into the tube, said contact comprising an airtight seal, the other sealing means being of similar construction to the said one sealing means, or being in the form of a cap in airtight sealing contact with the outside of the tube.

In order that the invention may be more readily understood, reference is made to the accompanying drawings which are given by way of example and in which: Figure 1 is a front view of a liquid diluent container Figure 2 is a side view of the container of Figure 1; Figure 3A is a perspective view of a drug containing tube of the present invention; Figure 3B is a modification of the tube shown in Figure 3A; and Figure 4 is a perspective view of the tube of Figure 3A or 3B attached to the neck of the container of Figure 1.

The container of Figures 1 and 2 is in the form of a bottle moulded from pharmaceutically inert plastics or other deformable material and is of generally oval cross-sectional shape and carries a downwardly extending tab 11 on which a control number, expiration date, or other information may be embossed. The bottle also carries graduations 18 by which to measure the volume of the fluid expressed through the capillary opening of an offset neck 15 at the top of the bottle.

The bottle opening is sealed by a closure seal 13 which comprises a lever arm 14 and an integral flat disc or cover 19 attached to the neck 15 by a weakened portion at the junction.

The neck is offset from the central axis of the bottle in such a manner that one shoulder of the bottle is longer than the other and this longer shoulder defines a downwardly tapered shoulder 12. The taper increases the spacing between the bottle and the lever arm so that when the bottle is grasped in one hand, the users thumb may be inserted in this space and by positioning the lever arm in the direction of the arrow, the closure may be broken at the weakened portion and the arm 14 and disc 19 discarded. The seal-neck junction is so moulded that once the seal is removed, a secondary sealing ring 36 is exposed.

The bottle neck is moulded to comprise a number of ribs 16 which strengthen the neck and aid in guiding the dose capsule 30 over the bottle neck. The midportion of the neck comprises an outwardly extending shoulder sealing system 17 which is suitable for large inner diameter dose capsules. The cylindrical portion 15 immediately adjacent the bottle is adapted to frictionally contact the inner surface of the capsule to form a primary seal 37.

The dose capsule is a hollow cylindrical capillary tube 31 having closure means 32 sealing both ends of the tube. These closures may extend into the tube as shown in Figure 3A to form a central cavity 34 of a predeterrmined volume equal to the desired amount of the active ingredient. Alternatively, the capsule may be prepared as shown in Figure 3B wherein the cavity 35 is under a vacuum and asceptically sealed by the closure means 32 at one end and a resilient cap 33 at the other. The cap 33 has a surface 33A intended to be punctured by a hypodermic needle to fill the capsule. In this embodiment, the technician may prepare an active ingredient other than those listed and inject the ingredient into the cavity 34 and store the preparation in the capsule until it is needed. Withdrawal of the hypodermic needle causes the cap 33 aseptically to close itself.

In use, the bottle containing the premeasured amount of diluent, such as water or saline, is grasped by the technician in one hand, the technician's thumb is inserted between the tapered shoulder 12 and the lever arm 14 and the closure top is positioned away, removed, and discarded. The liquid remains within the bottle since the internal diameter of the neck forms a capillary and requires the bottle to be squeezed in order to express the diluent.

The technician next removes one of the sealing means 32 on the capsule and positions the open end of the tube 31 over the bottle neck to form a friction fit. A primary seal 37 and a secondary seal 36 formed by the friction contact of the neck and capsule prevent liquid loss. By merely removing the remaining sealing means from the capsule, the unit can be inverted, the bottle squeezed and the contents of the capsule flushed into the IPPB nebulizer by the diluent in the bottle.

WHAT WE CLAIM IS: 1. An open ended pharmaceutical unit dose package comprising a hollow cylindrical tube containing a unit dose of a bronchodilator selected from the group consisting of isoproternol, phenylephrine, racemic epinephrine, and ephedrine within a cavity and having sealing means at each end of the tube, both sealing means being removable to enable flushing of the tube contents by flowing a liquid dileunt through the tube, both sealing means having portions not contained within the tube, for enabling gripping of the sealing means for removal thereof from the tube, at least one of the two sealing means having a portion extending into the tube a predetermined distance so that the two sealing means form with the tube a cavity of a predetermined volume equal to the desired unit dose of the bronchodilator to the exclusion of an air space and wherein the said one sealing means is in intimate frictional contact between the interior of the tube and the entire portion of the said one sealing means extending into the tube, said contact comprising an airtight seal, the other sealing means being of similar construction to the said one sealing means, or being in the form of a cap in airtight sealing contact with the outside of the tube.

2. An open ended pharmaceutical unit dose package substantially as hereindescribed with reference to and as shown in Figure 3A or 3B of the accompanying drawings.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (2)

**WARNING** start of CLMS field may overlap end of DESC **. the diluent in the bottle. WHAT WE CLAIM IS:

1. An open ended pharmaceutical unit dose package comprising a hollow cylindrical tube containing a unit dose of a bronchodilator selected from the group consisting of isoproternol, phenylephrine, racemic epinephrine, and ephedrine within a cavity and having sealing means at each end of the tube, both sealing means being removable to enable flushing of the tube contents by flowing a liquid dileunt through the tube, both sealing means having portions not contained within the tube, for enabling gripping of the sealing means for removal thereof from the tube, at least one of the two sealing means having a portion extending into the tube a predetermined distance so that the two sealing means form with the tube a cavity of a predetermined volume equal to the desired unit dose of the bronchodilator to the exclusion of an air space and wherein the said one sealing means is in intimate frictional contact between the interior of the tube and the entire portion of the said one sealing means extending into the tube, said contact comprising an airtight seal, the other sealing means being of similar construction to the said one sealing means, or being in the form of a cap in airtight sealing contact with the outside of the tube.

2. An open ended pharmaceutical unit dose package substantially as hereindescribed with reference to and as shown in Figure 3A or 3B of the accompanying drawings.