Dispensing – Resilient wall – With flow controllers or closures
Reexamination Certificate
2002-10-22
2004-06-08
Mar, Michael (Department: 3754)
Dispensing
Resilient wall
With flow controllers or closures
C222S212000, C222S562000, C222S563000, C222S420000
Reexamination Certificate
active
06745919
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a container having a nozzle suitable for accurate and problem-free delivery of spill resistant pharmaceutical compositions onto a spoon.
While devices for dispensing a measured amount of a composition have been disclosed, for example in U.S. Pat. No. 3,104,032 issued to Hansen and U.S. Pat. No. 3,383,018 issued to Grimsley, these devices tend to be complicated and are not completely satisfactory for easy delivery and administration of a measured amount of a pharmaceutical composition.
Spill resistant and non-spill pharmaceutical compositions are described in U.S. Pat. No. 6,071,523 issued to Mehta et al., and U.S. Pat. No. 6,102,254 issued to Ross, both of which are incorporated herein by reference. The advantages of the disclosed compositions require easy administration from a squeezable container onto a spoon. With standard containers, it has been found that either too much or too little material may be dispensed, making measurement difficult. Moreover, the container may become fouled by leftover material, requiring a cleaning step to ensure that the nozzle remains hygienic and attractive.
This invention solves a previously unrecognized problem of how to match nozzle size and shape to the typical dimensions of a disposable plastic spoon permitting accurate clean measurement of spill resistant formulations.
SUMMARY OF THE INVENTION
The inventive device makes it particularly easy to measure single dosage units of a pharmaceutical agent useful for systemic treatment and convenient to administer them orally in a semi-solid composition. The device is suitable for administration to children and for self administration by aging adults, and adults with motor problems.
The invention avoids problems of liquid formulations, such as spillage. It is resistant to tampering by young children or individuals with limited mental capacity due to a childproof closure.
It has been discovered that pharmaceutical agents in semisolid form, such as a gel or paste, are much easier to administer to children than liquid and solid dosage forms and are much easier for an aging adult or a adult with motor problems to measure than a liquid and in some cases are easier to swallow than a pill or capsule. It has also been discovered that such compositions can be desirably packaged in a single dosage form or in a multi-dose device which contains or is suitable for use with spoon-like measuring and administration means.
According to the invention, a device is provided for administering a pharmaceutical agent useful for oral administration to treat an illness systemically that is semisolid in gel or suspension form in a composition containing the pharmaceutical agent and a pharmaceutically acceptable vehicle comprising a thickening agent and a liquid base compatible with the pharmaceutical agent and thickening agent in which the pharmaceutical agent is soluble.
In one embodiment of the invention, a single dose of the semisolid pharmaceutical composition is contained in a squeezable container.
In another embodiment of the invention, a device comprises a squeezable bottle with multiple doses with means for administering a single dose of the semisolid composition of the invention and resealing the container thereafter.
The invention provides a device for containing multiple doses and measuring a single dose of the semisolid composition of the invention, including a squeezable container for holding the pharmaceutical composition having an open outlet with exterior threads for attaching a cap thereto, a cap with interior threads suitable to engage the outer threads of the outlet of the squeezable container, the cap having an exterior outer shell and an inner sealing layer, and a dispensing channel formed as a plug having a nipple, a shoulder, and a channel communicating through an orifice in the nipple, the plug being fixed into the interior of the open outlet of the container, such that the nipple of the plug projects outside the open outlet of the container, and the channel projects into the open outlet of the container, the orifice in the nipple providing space for the contents of the container to flow through the channel means into a spoon in response to pressure on the container when the cap is opened, whereby contents of the squeezable container can be squeezed into the bowl-shaped end of the spoon and administered therefrom.
The inventive container can be resealed by replacing the cap onto the open outlet, so that the sealing layer at the interior of the cap provides an airtight seal of the orifice and prevents air from entering or escaping the container.
The invention provides an article of manufacture comprising: a squeezable bottle having an outlet, a plug in the outlet of the bottle, the plug comprising an upper surface with a protruding nipple having a neck and a top and an orifice communicating with a smooth tubular channel sized to permit a semi-solid formulation to be squeezed out of the bottle and through the channel and orifice without dislodging the plug, the neck of the nipple having a protruding height slightly greater than the thickness of a spoon, and the neck of the nipple and the flat upper surface forming a notch which engages with the edge of a spoon, the orifice forming a sharp intersection with the top of the nipple sufficient to cut flow of the formulation cleanly when pressure ceases, and the junction of the top of the nipple with the nipple neck having a bevel, the top of the nipple being flat and wide enough to form a seal with a child resistant cap having a flat inner seal, and without being abraded by the inner seal, and a child resistant cap covering the orifice when the formulation is not in use, the cap sealing the orifice without abrading the nipple, and without being abraded by the top of the nipple.
In particular embodiments, the nipple is centered, the cap covers the orifice without protruding into it, the cap screws onto the squeezable bottle, and the plug fits into the outlet of the bottle, and the bottle may be flattened in cross-section. In commercial embodiments, the bottle contains a spill resistant formulation, in amounts e.g. from 50 to 250 or 500 ml.
In embodiments of the invention the plug is from about 0.3 cm to about 1.5 cm in height and from about 0.9 cm to 3.9 cm in diameter; the nipple is about 0.1 cm to about 0.5 cm in height and about 0.4 cm to about 1.8 cm in width; the neck is from about 0.1 cm to about 0.4 cm in diameter; the orifice is from about 0.1 to about 1.0 cm in diameter. The channel may be from about 0.6 to 2.6 cm in diameter. The shaft may be about 0.6 cm to about 2.6 cm in height and from about 0.1 to about 0.5 cm in diameter.
The upper surface of the nipple may be flat or sloped.
The invention provides a plug sized to fit in the outlet of a squeezable container, the plug comprising an upper surface with a protruding nipple having a neck and a top and an orifice communicating with a smooth tubular channel sized to permit a semi-solid formulation to be squeezed out of the container and through the channel and orifice without dislodging the plug, the neck of the nipple having a protruding height slightly greater than the thickness of a spoon, and the neck of the nipple and the flat upper surface forming a notch which engages with the edge of a spoon, the orifice forming a sharp intersection with the top of the nipple sufficient to cut flow of the formulation cleanly when pressure ceases, and the junction of the top of the nipple with the nipple neck having a bevel, the bevel and nipple being sized to form a seal against a child resistant cap placed on the plug, without abrading the nipple.
The invention provides a method for producing a container for a spill resistant formulation comprising forming a squeezable container, filling the container with the spill resistant formulation, inserting a plug having an orifice in a neck, the height of the neck being at least about the size of a spoon, and capping the container with an airtight, child-resistant cap.
An inventive method of using the bottle c
Asotra Satish
Moros Daniel A.
van den Heuvel Theophilus
Alathari Zayd
Gollin Michael A.
Mar Michael
Nicolas Frederick C
Taro Pharmaceutical Industries Ltd.
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