MEDICATION CONTAINER

BACKGROUND OF THE INVENTION

1. Field of the Invention

[0001] The invention relates generally to medication containers and more particularly to medication containers specifically adapted to improve compliance of patients suffering from mental diseases.

2. Description of the Related Art

[0002] Medication compliance is a complex and severe subject, causing reduced personal prospects for patients and also considerable financial costs. All kinds of patients experience difficulties in staying adherent to medication, including the old and mentally infirm. The reasons for non-compliance are varied and include forgetfulness, unwillingness, over-complex dosing schedules etc. In particular schizophrenic patients have heightened problems staying adherent to medication, due at least partially to their mistrust of any form of imposed regime. Medical practitioners are concerned about compliance in order to improve their patients' well being. Pharmaceutical companies have a focus on the well being of people in general and also seek to maximize the acceptance and success of their medication. To be able to put a new drug to its full potential the packaging in which it is marketed is often of critical importance and is generally subject to similar regulatory approval.

[0003] To support patients in taking prescribed medication several aids have been utilized. The aids offer support particularly for the organization, control and remembering of medication. Many aids have been developed for patients with a particular illness or disability e.g. diabetic patients and the elderly. One branch of the medical world in which compliance receives immense attention and is considered to be of great importance is contraception. In this particular field pharmaceutical companies go to great lengths to improve their products and additional services to support their users in staying adherent to medication. Not only do women have the option to choose the form of contraception but they can also be supported by SMS text messages services and alarms and the packaging is developed to fit their situation.

[0004] A simple form of reminder is the pillbox. Pillboxes are used to make it easier for patients to take their medication with them in their every day life. Pillboxes can be decorated

in various ways. Also they may be combined with other products people often carry with them, for instance keys, jewelry or a wallet. Some pillboxes have a timer or reminder integrated. The reminder may provide the patient with an indication of time since a previous usage of the medication as in GB 2306707. Alternative devices may be used when it is desired to prevent over dosage by providing a patient with an indication of when it is safe to take a further dosage. Examples of such arrangements are shown in US5625334 and in US6335692 in which a permissive indicator is given once a minimum dosage period has passed. Hitherto, such devices have been employed for non-mandatory dosage i.e. cases where it is merely desired to indicate to a patient that a further dosage id available if desired. [0005] Organizers are similar to pillboxes yet a distinction may be made in that the function is focused primarily on support in organizing medication and providing an overview. Organizers are available in different forms and for a range of time periods. Organizers may be in the form of boxes or trays containing dosages for a day, a week or a month and may be filled by the patient, caregiver or pharmacist. An organizer type device is known from EP 1344514 which includes a tray having compartments to receive medication. An alarm is provided to warn the user when it is time to take the medication. Alternatively, organizers may be integrated as part of the original packaging. This is commonly used with blister packs of medication or contraceptives e.g. assigned to the days of the month.

[0006] For mandatory dosage regimes, i.e. those in which it is important that the patient adheres to a strict procedure, devices are provided having an alarm that can sound or otherwise actively remind the patient of the time for medication. A dispenser is known from WO2003/092575 in which a time since a last dose is monitored. When a next dose becomes due, the dispenser may give an audible alarm that becomes greater in frequency or volume. The dispenser additionally provides considerable additional information to a user in the form of icons and figures. A further device is known from US6149029 in which an alarm is given after a predetermined dosage period has passed. After a given period, a dosage blocking device is inactivated so that a further dosage may be taken. In this manner the patient is prevented from accessing more than one dose at a time or at least until a next dosing period commences. WO2005/004787 discloses a device providing a display representing time since a

previous dosage, which may also give an alarm. The device is arranged to accurately count the number of dosages given.

[0007] Despite the considerable selection and variation in dosage and dispensing devices presently available, little attention has been paid to the specific requirements of patients affected by mental disorders. In the case of schizophrenia patients, non-compliance appears to be a combination of several factors which are closely related and enhance one another. These are in addition to problems of medication usage experienced in common by patients of other disorders. The most prominent additional problems to staying adherent for patients with schizophrenia include: cognitive dysfunctions (difficulties with memory, structure and decision making); adhenonia (lack of pleasure); avilition (lack of initiative); and stigmal shame. In addition to these problems, the noncompliant behavior may cause a reaction from the environment (for example in the form of higher dosages) which can also create negative influences on the future medication compliance. Furthermore, non compliance is also generally considered as a symptom of schizophrenia and not merely the cause of recidivism. All of these factors in combination severely deteriorate compliance and create a vicious circle. The problems surrounding this issue differ from patient to patient yet there are also enormous variations over time in relation to the medication regime for a single patient.

[0008] As described above, although there are many differences between individuals, noncompliant behavior can be divided into two main groups: intentional and unintentional noncompliant behavior. Unintentional behavior is often referred to as inadvertent noncompliant behavior and occurs when signs or symptoms get in the way of taking medication. The present invention is directed primarily to inadvertent noncompliant behavior where patients do have a certain intrinsic level of motivation to stay adherent. Nevertheless, it is believed that it can also be effective in improving the intentional form of non-compliance. [0009] One medication that has been effective in assisting patients with mental illness is asenopine. This product and its use are described in WO1995/023600, US2007/0027134 and WO2006/040314, the contents of all of which are included herein by reference in their entirety. The medication may be provided in the form of a kit with a dispenser designed to dispense the daily doses one at a time. It is suggested that the dispenser may have a memory- aid to read out the date that the last daily dose has been taken or provide an audible reminder

when the next dose is to be taken. It has however now been found that specifically this type of medication reminder may be a major factor in causing non-compliance. In particular, the use of an active reminder is perceived as a statement of lack of trust in the patient. Furthermore, complicated systems that store (or appear to store) data relating to usage are generally not readily accepted by such patients. Thus, there is a particular need for a device that can more comprehensively meet the specific requirements of patients suffering from mental illnesses.

BRIEF SUMMARY OF THE INVENTION

[0010] The present invention addresses these problems by providing a medication organizer, comprising a medication container having a plurality of compartments in which a user may arrange a plurality of units of a medication, a housing in which the medication container is received, a timing arrangement arranged to record a timed period from a reset time to a time that corresponds to a dosage period, a display indicative of the timed period and a reset arrangement for resetting the timing arrangement. The medication container and housing are moveable with respect to one another to allow access to the container whereby a single dosage of medication is presented. For patients suffering from mental disorders, in particular bipolar disorders and schizophrenia, it has been found extremely important that they are perceived to be in charge of their medication. This feeling of control and trust is increased by providing an organizer that can involve the patient in arranging the medication and that gives a passive feedback of the time since the last intake of medication. In this context, it is preferred that the organizer gives no active indication or other form of alarm regarding the failure to take medication. In particular, the timing arrangement and display are arranged to do no more than register and display the progress of timed period. The patient knows that they can thus easily "cheat" the system by not actually taking the medication or by taking it earlier or later than recommended. Nevertheless, this symbolic trust is understood to reduce the desire to cheat. [0011] According to a preferred embodiment the reset arrangement acts to delete the timed period, without retaining or otherwise transmitting a record of the duration of that time period. Co-operation of patients may be reduced in cases where they believe that there actions are somehow being recorded or monitored.

[0012] In a further preferred embodiment the medication container is slideable with respect to the housing and the reset arrangement is operable by such movement. In a convenient arrangement the reset arrangement deletes a current timing period on sliding the container out of the housing and starts a new timing period on sliding it into the housing. [0013] According to a most preferred embodiment of the invention, the interior space within the container is separated into individual compartments, each compartment being for receiving one or more units of medication. On initially arranging the medication within the container, the patient may place one or more units of the medication into each compartment. The compartments may be labeled or otherwise marked or the patient may mark them as desired. Alternatively, the medication may itself be marked. On filling, the compartments are initially all covered over and uncovered sequentially each time the container is accessed.

[0014] In certain embodiments, it may be required or desirable that the units of medication comprise an additional protective packaging. This may serve to prevent e.g. degradation of the product or may serve as required labeling. The plurality of units may be individually packaged or may be packaged in groups. One preferred form of packaging is the blister pack comprising a number of units that may be individually removed from the package, leaving the other units unopened. Particularly in the case of freeze dried medication, such protective packaging is highly desirable.

[0015] It has also been found highly desirable that the container comprises noise reduction arrangements for reducing noise caused by movement of the units of medication within the container. Patients with mental disorders are often highly sensitive to other persons becoming aware of their need for medication. Additionally, they usually prefer not to be reminded of their medication when walking or moving. Preferably the interior space in which the medication is contained is sufficiently resilient or appropriately lined to prevent rattling of the medication units. It has also been found preferable that the outer part of the container is at least partially formed of a resilient or soft material. This may reduce noise caused by movement of the container and is especially advantageous in providing a comfortable feel when held.

[0016] According to a preferred embodiment of the invention, the medication container is generally elongate in shape. According to present thinking, it is understood that patients

suffering from the above mentioned mental disorders are generally more receptive to devices and arrangements with a clear direction. By using an elongate container, the medication may be arranged sequentially e.g. in a line. Use of the medication may then proceed in the same manner, giving a clear indication of the progress through the dosage regime. In such an arrangement the container is preferably slideable with respect to the housing in the elongate direction.

[0017] According to a most preferred embodiment, the display comprises a visual quantification of the timed period with respect to the dosing period. Preferably this part of the display comprises no letters or numbers and is based on easily understood symbols. One preferred display is an hour-glass representation in which sand appears to flow until the dosing period is complete. Alternatively, a series of bars may be provided indicating progress. The display may use any appropriate technology, such as LED, LCD, plasma screens and the like. One embodiment of a display that has been found particularly appropriate comprises a slider moveable across the display. Movement of the slider causes dispensing of medication and resetting of the timer. This can be made to have the appearance of a "magic slate" arrangement. Wiping of the slider one way across the display appears to erase the previous timing period. On returning the slider, a new image appears and timing recommences. The slider may be linked to the opening of the container e.g. it may be directly linked to a tray containing the medication units. Alternatively other mechanisms may be provided e.g. where movement of the slider and tray are reversed by a pulley or band such that movement of the slider in one direction causes the tray or container to move out in the opposite direction. Preferably the display also includes a reference to the last time medication was taken i.e. that the container was accessed. In certain embodiments, a child resistant closure may be desirable. This may preferably be of a simple nature e.g. based merely on the relative size of an adult's hand to grip and squeeze across the width of the slider.

[0018] The invention also relates to a medication organizer, comprising a housing, a plurality of units of a medication effective for use in the treatment of a mental disorder, the units being associated with a dosage period for their sequential administration to a patient, a timing arrangement and arranged to time a period since a previous reset, a display comprising a visual quantification of the timed period with respect to the dosing period, and a reset

arrangement for resetting the timing arrangement, the reset arrangement comprising a slider moveable across the display wherein movement of the slider causes dispensing of medication and resetting of the timer. In this embodiment of the invention it will be understood that as an alternative to individual medication units, packaged doses including multiple dose blister packs and the like may also be provided in or on a tray or the like.

[0019] Most preferably, the medication is effective in relation to schizophrenia and or bipolar disorders. These psychiatric disorders and conditions are known to those of skill in the art and are defined in art-recognized medical texts such as the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, American Psychiatric Association, 1994 (DSM - IV), which is incorporated herein by reference in its entirety. Medication that is prescribed for use by such patients is susceptible to be used in a container or organizer as described above.

[0020] A preferred form of medication comprises asenapine. The term "asenapine", as used herein, encompasses the free base of the compound asenapine and all pharmaceutically acceptable salts, solvates, hydrates, and optical isomers thereof. Asenapine is also known in the art as Org 5222. Pharmaceutically acceptable addition salts include, but are not limited to maleate, mesylate, esylate, and hydrochloride and may also include polymorphic forms of such salts.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Further features and advantages of the invention will be appreciated upon reference to the following drawings, in which:

[0022] FIG. 1 is a perspective view of an embodiment of the invention;

[0023] FIG. 2 is a perspective view of the device of FIG. 1 with an upper part of the shell removed;

[0024] FIG. 3 is a perspective view of the device of FIG. 1 prior to opening; [0025] FIG. 4 is a perspective view of the device of FIG. 1 being opened;

[0026] FIGS 5 A to 5H are plan views of the device of FIG. 1 during use;

[0027] FIG. 6 is a perspective view of the device of FIG. 1 on removing medication; and

[0028] FIG. 7 is a perspective view of the device of FIG. 1 during closing.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0029] The following is a description of certain embodiments of the invention, given by way of example only and with reference to the drawings. Referring to FIG. 1, a medication organizer 1 according to a first embodiment of the invention is shown. The organizer 1 comprises a housing or shell 2 having elongate slots 10 extending along opposed edges and an opening 12 formed at one end. A slider 6 is located around and encircles the shell 2. On an upper surface 14 of the shell 2, there is a display 4. Display is an integrated LCD display of the type found in mobile telephones and music players. The shell 2 is moulded of a rigid plastics material such a polycarbonate, PET or polypropylene. It is covered over its outer surface by a resilient layer which in the illustrated case may be made of polyurethane. This may be achieved by a process of dual injection moulding or by a subsequent coating procedure.

[0030] FIG. 2 shows a view of an interior of the organizer 1 with an upper part of the shell 2 removed. Within the shell 2 is provided an interior space 20 in which is received a tray 18 that serves as a medication container. The tray 18 is divided into a plurality of compartments 22, some of which contain a unit of medication 24. As can also be seen in FIG 2, tray 18 is connected to slider 6 by pins 26 that protrude through slots 10. The tray 18 is covered by slats 30, one of which is shown in FIG. 2. The slats 30 are slideably engaged with the upper surface of tray 18 and have an upstanding abutment 32 on their upper surface. The abutment 32 is arranged to engage with a moveable stop (not shown) on the underside of an upper surface of the shell 2. The position of the stop may be adjusted by an appropriate dosing mechanism.

[0031] Operation of the organizer 1 will be appreciated by reference to Figures 3 to 7.

[0032] In FIG. 3, a user holds the organizer 1. As can be seen, the display 4 depicts a sand glass in which the time has run out. The display 4 also includes in this case the wording "Monday 20 March 2007" and the depiction of a sun. The empty sand glass indicates that the dosage period since a last dose has passed and that the user may proceed to a further dose.

The wording indicates that the last dose was taken on Monday 20 ^th March 2007 during the day time.

[0033] In FIG. 4, in order to take a following dose, the user takes the organizer 1 with both hands and moves the slider 6 in the direction of the arrow X. FIGS 5 A to D depict the opening of the organizer 1. As the slider 6 is moved towards the left (FIG. 5B), the tray 18 is slid

outwards through opening 12. In FIG. 5C, it may be noted that display 16 is being erased. This appears to be due to the wiping action of the slider 6 as in a child's magic slate type writing block. Erasing of the display in fact takes place electronically by appropriate means linked to the movement of slider 6. Appropriate hardware and software to achieve such a display will be immediately evident to the skilled person in the field of electronic displays and is not the subject of the present invention. As the tray 18 is moved outwards according to FIG. 5C a single dose of medication 24 becomes visible as it is uncovered by retention of one of slats 30 by interaction between the abutment 32 and the stop (not show) on the dosage mechanism. [0034] In FIG. 5D, movement of the slider 6 has continued and it is now fully displaced to the left in slots 10. Display 4 is fully erased. A unit of medication 24 (two tablets) in compartment 22 is exposed. The remaining unused compartments are covered by slats 30 to prevent exposure of further medication. To extract the medication 24, a user inverts the organizer 1 by rotation according to the arrow Y in FIG. 6. The medication may be received in the user's hand.

[0035] The tray 18 may then be returned to the starting position by sliding the slider 6 in the direction Z as shown in FIGS 5E to 5H and in FIG. 7. During this movement, the image in display 4 reappears with the hour glass now indicating the start of a new timing period. The display also now shows a new date illustrative of the time at which the user used the organizer. As will immediately be understood, this in no way reflects the fact of whether the user actually took a unit of medication 24 from the tray 18 or whether the medication was actually ingested or not. The user thus clearly understands that use of the device and actual compliance is based completely on trust. A further particular feature of the device is that it retains no memory of the previous times at which the tray 18 was opened and provides no form of alarm or active warning to the user that a dosage period has passed and that medication is due. It will of course be understood that such possibilities could be provided as optional features, in particular to patients that specifically desire an active warning or for use with other medication where other dosage requirements are of relevance.

[0036] After all doses of medication have been removed from the organizer 1, a user may refill the tray 18 with a new stock of medication. This may be done independently or together

with a pharmacist or care giver as required. Once filled, the slats 30 may be moved forwards once more to cover all of the compartments and reset their mechanism.

[0037] Thus, the invention has been described by reference to certain embodiments discussed above. It will be recognized that these embodiments are susceptible to various modifications and alternative forms. In particular, the slider 6 may be provided with child resistant locking means, e.g. actuated by application of pressure across the slider. Furthermore, while the slider 6 may be directly connected to the tray 18, it may also be connected by a mechanism such as a reversing arrangement such that movement of the slider 6 and the tray 18 are opposed to one another. Other modifications well known to those of skill in the art may be considered, without departing from the spirit and scope of the invention.

Accordingly, although specific embodiments have been described, these are examples only and are not limiting upon the scope of the invention as defined by the appended claims.