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28 Pages·2013·2.29 MB·English

US 20070193 894Al
(19) United States
(12) Patent Application Publication (10) Pub. No.: US 2007/0193894 A1
Macken et al. (43) Pub. Date: Aug. 23, 2007
(54) CONTAINER FOR CONSTITUTING A Publication Classi?cation
FORMULATION IN LIQUID FORM
(51) Int. Cl.
(75) Inventors: Michael Joseph Macken, Athlone (IE); B65D 25/08 (2006.01)
Brendan Joseph O’Mara, Meelick (IE) (52) US. Cl. ............................................................ .. 206/219
Correspondence Address: (57) ABSTRACT
BIRCH STEWART KOLASCH & BIRCH A container (70) for constituting a formulation in liquid
PO BOX 747 form, comprises an elongate outer body (71) split into a ?rst
FALLS CHURCH’ VA 22040-0747 (Us) section (72) and a second section (73), along the longitudinal
_ _ axis thereof, The container (70) has an inner chamber (77)
(73) Asslgnees' ERING CCOM_ divided into a ?rst compartment (78) and a second compart
R E _ iDDtEilllJe ’PA 191??? ment (79) by a seal (80). Seal (80) is movable in use betWeen
Hiiicgilggl (C())’MPAB_IY LIMITED a closed position, Wherein the ?rst compartment 78 and the
hl ’ second compartment are sealed thereby, to an open position,
At one’ County Roscommon (IE) Wherein the ?rst compartment (78) and the second compart
ment (79) are unsealed and any contents therein are free to
mix together in the inner chamber (77) to form the formu
(2l) Appl. No.: 11/547,709 1 at1. on. The seal (80) i. s movable from the closed pos1. t1. on to
the open position by rotation of the ?rst section (72) relative
- _ to the second section (73) and the volume of the inner
22 PCTFl d. A . 7 2005 ’
( ) 1 e Pr ’ chamber (77) remains unchanged following unsealing. Once
the seal (80) has been moved to the open position it is
(86) PCT NO; PCT/IE05/00039 retained in that position. Reversal of the rotational move
ment causes an outer cover (74) to become detached from a
§ 371(c)(1)’ tear strip (75), permitting the outer cover (74) to be removed
(2)’ (4) Date; Mar_ 26, 2007 and the formulation to be capable of being delivered from
the container (70). A formulation administered from the
(30) Foreign Application Priority Data container (70) can ensure, for example, that a precise dose
of an active ingredient is delivered to a patient, Where the
Apr. 8, 2004 (IE) ................................ .. PCTIE0400053 formulation is a pharmaceutical product.
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Patent Application Publication Aug. 23, 2007 Sheet 1 0f 7 US 2007/0193894 A1
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Patent Application Publication Aug. 23, 2007 Sheet 2 0f 7 US 2007/0193894 A1
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Patent Application Publication Aug. 23, 2007 Sheet 3 0f 7 US 2007/0193894 Al
Patent Application Publication Aug. 23, 2007 Sheet 4 0f 7 US 2007/0193894 A1
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Patent Application Publication Aug. 23, 2007 Sheet 5 0f 7 US 2007/0193894 A1
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Patent Application Publication Aug. 23, 2007 Sheet 6 0f 7 US 2007/0193894 A1
Patent Application Publication Aug. 23, 2007 Sheet 7 0f 7 US 2007/0193894 A1
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US 2007/0193894 A1 Aug. 23, 2007
CONTAINER FOR CONSTITUTING A to cake in the closure, such that the full complement of
FORMULATION IN LIQUID FORM active ingredient is not released into the liquid When
required, With the attendant consequence of inadequate
dosing.
TECHNICAL FIELD
[0001] This invention relates to liquid formulations Which [0011] Pharmaceutical formulations of the above type are
just one example of formulations Which require constitution
are formed of constituents Which are constituted prior to use
because, for example, the constituents do not have the prior to the point of use. HoWever, there are many other
types of formulations in the beverage, food, domestic and
requisite activity or stability if stored in constituted form.
other sectors Where one requires to use a formulation in a
[0002] In one aspect the invention relates to pharmaceu liquid state, but Where the constituent parts thereof must
tical formulations for oral administration and, in particular, remain unmixed until required for use as indicated above.
pharmaceutical formulations Which can be imbibed directly
[0012] A formulation for feeding to a baby is an example
from a container in Which they are sold.
of one of these other types of formulations. A number of
containers are knoWn in Which components of such a
BACKGROUND ART
formulation can be stored for subsequent mixing together
[0003] Medicines for oral administration are typically in When required.
capsule, granule, poWder, tablet or other solid dosage unit
[0013] For example, U.S. Pat. No. 5,419,445 describes a
form Which are not readily sWalloWed Without a drink of
baby bottle With tWo compartments for storage of poWdered
Water or beverage.
baby formula and Water. The Water is stored in a bottle
[0004] In the case of medicines administered as liquids, portion and the poWdered formula is stored in a cartridge
syrups and the like, a spoon or other means of delivering the assembly. A nipple assembly is located at one end of the
required amount of medicine to the mouth must be used and, cartridge assembly, the other end of Which cartridge assem
indeed, must be to hand. bly is located in the bottle portion. A seal is located betWeen
the cartridge assembly and the bottle portion, and this seal
[0005] Elderly patients or individuals With special needs
can be released by rotation of the nipple assembly. This
and children frequently experience problems in taking medi
activation of the mixing procedure, by rotation of the nipple
cation. For example, such persons may be reluctant to
assembly, causes the seal to be unscreWed from the cartridge
sWalloW or have dif?culty in sWalloWing conventional oral
assembly resulting in the release of the poWdered formula
dosage forms.
and the seal into the Water. The released seal acts as a means
[0006] Those caring for the elderly, in particular health for mixing the poWder and Water While the bottle is shaken.
professionals, are legally prohibited from tampering With
[0014] The rotation of the nipple assembly during activa
medication and are obliged to administer it in accordance
tion causes the separate internal compartments to merge
With the manufacturer’s instructions. HoWever, for the rea
together resulting in a smaller container. Thus, this feature
sons indicated above, such health professionals may be
limits the amount of storage space available in the pre
obliged to modify medication, for example, by breaking or
activated bottle.
crushing tablets, With the attendant legal consequences, in
order to ensure that their patients receive their prescribed [0015] Such a bottle could be used for the constitution of
medication in an amount to ensure effective therapy. formulations other than baby feeds. HoWever, the fact that
the seal is released into the bottle on activation could cause
[0007] Another problem With conventional medication is
problems With more viscous formulations as the seal might
that it generally has an unpleasant taste. Although coatings,
block the space betWeen the tWo compartments resulting in
such as sugar coatings, can be applied to mask the taste of incomplete mixing of the formulation.
the active ingredient(s) or excipient(s), elderly and other
patients often cheW such medication exposing the unpleas [0016] It is an object of the present invention to overcome
ant active agent or excipient Which can result in medication the problems of containers of the type hereinbefore
being expelled from the mouth and thus the required dose is described.
not received by the patient.
DISCLOSURE OF INVENTION
[0008] In many countries in the World it is di?icult to ?nd
a clean Water supply. Accordingly, if medication must be [0017] Accordingly, the invention provides a container for
taken With a liquid, frequently the person taking the medi constituting a formulation in liquid form, Which container
cation Will need Water in order to sWalloW the medication or, comprises an elongate outer body split into sections along
indeed, to solubilise the medication. the longitudinal axis thereof, an inner chamber divided into
tWo or more compartments, a seal movable, in use, from a
[0009] Also in the case of natural disasters such as earth
closed position, Wherein all the compartments are sealed
quakes and ?oods, Water supplies can be temporarily inter
thereby, to an open position, Wherein all the compartments
rupted and again there is a need for medication Which does
are unsealed and any contents therein are free to mix
not require one to have a clean Water supply to hand.
together in the inner chamber to form the formulation, the
[0010] A system has been proposed Wherein an active seal being movable from the closed position to the open
ingredient in poWder form is housed in a closure mechanism position by rotation of one section of the outer body relative
of a container for storage purposes and is released into a to another section thereof, such that the volume of the inner
liquid medium in the container When it is desired to consume chamber remains unchanged folloWing unsealing of the
the active ingredient in liquid form. HoWever, a problem that compartments, and means for retaining the seal in the open
arises With such a system is that the active ingredient tends position.
US 2007/0193894 A1 Aug. 23, 2007
[0018] An advantage of having a container With a seal [0028] Further, preferably, the seal is a circular partition
Which is retainable in the open position is that, following and is attached by a threaded section at the periphery
unsealing, mixing of the contents in the inner chamber thereof, in the closed position, to an inner threaded surface
cannot be impeded by the seal. If, folloWing unsealing, the of one of the sections, such that the rotation of the one
seal Were free to move about Within the inner chamber, it section relative to the other section unscreWs the seal off the
might partially or totally block transfer of the contents of the threaded surface from the closed position to the open
inner chamber betWeen the compartments. position.
[0019] The avoidance of the potentially blocking action of [0029] HoWever, it Will be appreciated that the container
a released seal means that the thorough mixing of the according to the invention can have a Wide variety of shapes
contents of the inner chamber can take place and that the depending on the use to Which it is to be put. Furthermore,
mixed contents can be delivered from the container When the container can have aesthetic features or features Which
required.
Would appeal to a particular group of users, such as children.
[0020] The volume of the inner chamber of the container [0030] According to a second embodiment of the inven
according to the invention remains unchanged folloWing
tion, the seal is mounted at one end of an elongate connect
unsealing of the compartments, and this has the advantage ing member, Which elongate connecting member is locatable
that this volume is available for mixing of the contents of the Within a ?rst compartment of the inner chamber, the end of
container. the elongate member remote from the seal having forma
tions thereon, Which are engageable With complementary
[0021] The container according to the invention can be
formations on an internal surface of an outer body section
used to maintain the constituents of a liquid formulation in
overlying the compartment.
an active or stable form until they are required for use,
thereby extending their shelf life, While at the same time [0031] Preferably, the outer body is generally cylindrical
providing a convenient and practicable means of dispensing in shape and is split into tWo generally cylindrical sections,
the formulation at the point of use.
the ?rst section having an opening at one end thereof, the
opening being sealed, in storage, by the second section,
[0022] The invention Will principally be illustrated herein
With reference to a pharmaceutical or other liquid formula Which is in the form of a threaded closure, and Wherein the
seal is moved to the open position, in use, by an unsealing
tion in a ready-to-drink form, hereinafter to referred to
collectively and for convenience as a pharmaceutical for movement of the closure.
mulation.
[0032] This arrangement is advantageous in that the
[0023] Thus, a ready-to-drink pharmaceutical formulation unsealing movement does not require much strength on the
administered from a container according to the invention part of the user, as it only requires that the closure be turned.
overcomes the problem of conventional oral dosage forms
[0033] Further, preferably, the opening is in a neck-shaped
mentioned above, as Well as the problem of inadequate or
portion of the ?rst section, the neck-shaped portion having
failed release of an active ingredient from a closure mecha
a thread on the external surface thereof for engaging the
nism of the type hereinabove described.
closure and a thread on the inner surface thereof, the inner
[0024] The container alloWs for a ‘one shot’ administra thread cooperating With a threaded section at the other end
tion of a required dose of pharmaceutical formulation to a of the elongate connecting member, such that the unsealing
subject. Also because of the form of the active ingredient in movement of the closure results in the unscreWing of the
the formulation, the formulation can result in immediate elongate member from the neck-shaped portion and conse
uptake or delayed onset of action of the active ingredient, quent movement of the seal to the open position.
because the formulation comes into immediate contact With
[0034] According to a third embodiment of the invention,
the mouth and upper parts of the gastrointestinal tract. Thus,
the ?rst compartment of the inner chamber in Which the
absorption can commence sublingually, through the Walls of
inner elongate connecting member is locatable is generally
the buccal cavity, in the throat and oesophagus, rather than
cylindrical in shape With an opening at each end thereof,
commencing in the stomach. A formulation administered
With one opening being adapted to seat the seal in the closed
from a container according to the invention can ensure that
position and the other end accommodating the end of the
a precise dose of an active ingredient is delivered to a
subject. elongate member remote from the seal together With the
complementary formations on the internal surface of the
[0025] According to a ?rst embodiment of the invention, outer body section overlying the ?rst compartment.
the outer body is generally cylindrical in shape and is split
[0035] One advantage of this arrangement is that the outer
into tWo generally cylindrical sections, the sections being
body can be rotated and consequently the seal moved to the
butt-joined together to permit relative movement therebe
open position by gripping the outer body at any convenient
tWeen.
position thereon. This rotational movement of the outer body
[0026] By butt-joined herein is meant that the tWo sections is translated through the formations on the elongate member
are joined in such a Way that they are connected together at and the complementary formations on the outer body to
opposing ends of the cylinders and that the rotational provide the unsealing movement of the seal.
movement is betWeen these tWo butt-joined cylindrical
[0036] A further advantage of this arrangement is that it
sections.
alloWs the outer cover to be gripped by the user in order to
[0027] Preferably, the tWo sections are joined together by turn it relative to the inner compartment so as to unseal the
a snap-?t. inner compartment and permit mixing of an active ingredi