FR2771924A1 - Instrument for indicating time for taking or administering substance - Google Patents

Abstract

Instrument for indicating time for taking or administering substance comprises two components, one for days and one for hours, from which time can be read off. An instrument consists of two components (1, 2) which can be moved relative to one another, the first with graduations (3, 4) to indicate the days of the week, and the second with graduations to indicate the hours of the day. The day markings on opposite sides of the first component are offset relative to one another by four days, and the hour markings on the second are offset by twelve hours, so that when a day marking is set against a given hour on one side of the instrument, a time three and a half days later can be read off on the opposite side. The instrument can be made in the form of a slide ruler or concentric discs.

Description

DEVICE FOR IMPROVING THE REGULARITY OF TAKING OR
ADMINISTRATION OF A PRODUCT
The subject of the invention is a device intended to improve the regularity of taking or administering a pharmaceutical, dietetic or cosmetic product.

 Certain products, in particular certain drugs, require very regular taking or administration, in order to fulfill the functions which are attached to them.

 If certain products can be taken or administered on a frequency of number of days (every morning, every other day, once a week), others require taking or administration at a frequency different from a specific number of days. , this taking or administration can be carried out by any mode whatsoever: transdermal, oral, topical, rectal, injectable, sublingual or percutaneous. It has thus been established, in particular by the Applicant Company, that certain female hormones used in hormone replacement therapy require optimal administration every 84 hours, that is to say every three and a half days, in order to fully perform their function and not cause inconvenience to the patient. This is particularly the case for patches based on female hormones.

 In these cases, the patient must memorize for taking or administering the product, both days and times, which makes compliance difficult. Respect for this observance is very desirable.

 Indeed, if we take the example of female hormones, and more particularly estradiol, associated or not with a progestogen, considered in hormone replacement therapy, preferably by transdermal route (patch or combi-patch) , estradiol or the estradiol-progestogen combination should be administered or taken optimally every 84 hours or so.

 However, the dosages currently provided for such products generally prescribed in the form of patches are one patch every three to four days or every three or four days. To help comply with these dosages, which are therefore not very precise, there was to date no device which made it possible to indicate at what time and on what day the next dose or administration of the product should take place according to the time and day of the first take or administration.

In the case of a dosage of the kind indicated by way of example above, the patient therefore administers the patches according to a 3-day / 4-day schedule.
t1 = to + 3 days, then t2 = t1 + 4 days, then t3 = t2 + 3 days, and so on,
or according to a 4-day / 3-day schedule
t1 = to + 4 days, then t2 = t1 + 3 days then t3 = t2 + 4 days, and so on.

 Thus, it can elapse within 2 schedules 4 full days between taking or administering 2 patches.

 However, it generally appears that there is a drop in the estradiol delivered between the third day (72nd hour) and the fourth day (96th hour). This fall can be limited between the 84th hour (3 and a half days) and the 96th hour (4 days) with certain new generation matrix patches.

 Figure 1 illustrates these decreases in estradiol and more generally the fluctuations in estradiol over 4 days (96 hours) for two types of commercial patches P1 (reservoir patch) and P2 (new generation matrix patch). The ordinate indicates the plasma estradiol concentration, expressed in picograms per milliliter of blood, and the abscissa indicates the time.

 For the two patches, a peak is observed in the first hours and then a significant drop in estradiol from the 73rd hour for the P1 patch and from the 84th hour for the P2 patch.

 Over 8 days of treatment, there is clearly a decrease in the hormone level for the two types of patches P1 and P2.

 The graphs in Figures 2 and 3 show this decrease over time, which is more marked between the evening of the 4th and the morning of the 5th day if the administration follows a schedule 4 days / 3 days or between the evening of the 7th and the morning from the 8th day if the scheme is 3 days / 4 days, whether for the P1 or P2 patches. The plasma estradiol concentration, expressed in picograms per milliliter of blood, is indicated on the ordinate, and the time, in days, is indicated on the x-axis.

 However, hormonal drops, or more generally hormonal fluctuations, are likely to cause many harmful effects.

 Some of these effects are direct and include serious mood disorders and catamenial migraines.

 It thus appears that fluctuations in blood estradiol levels (estradiolemia), in particular increases and especially decreases, have an impact on female mood (B. de Lignères and M.

Vincent, "differential effects of exogenous oestradiol and progesterone on mood in post-menopausal women: individual dose / effect relationship", in Maturitas, 4 (1982), page 67, Elsevier Biomedical Press), which can go as far as suicide attempt (V. Fouresté and B. de Lignères et al, "suicide attempts in hypooestroegenic phases of the menstrual cycles", The Lancet, December 13, 1986, page 1357).

These behaviors are explained by the concentration of brain estrogen receptors in the areas of emotional management (J. Demots
Mainard, C Henry, Humors and Hormones: the dimorphic brain, interfaces, 1997, page 11).

Fluctuations in estradiolemia are also involved in triggering the so-called catamenial migraine (B. de Lignères, La Migraine cataméniale,
Prat review. Paris, 1990, 40.5, page 395; A. Pradalier, J.

 Belaïsch, La Catraine migraine, Fertile contraception.

Sex., 1995, Volume 23, N "6, page 361), the prevention of which is demonstrated by the administration of estrogen by percutaneous route (Mc Gregor EA, Menstrual migrains: towards a definition, Cephalalgia 16, 1996 , page 11).

As we know, the migraine field is, as in Raynaud's syndrome, and more generally in acrosyndromes (commonly called cold extremity syndromes), a field of vascular lability also called vasospastic field. However, this field is present in around 14 to 20% of women (IHS Group,
Cephalalgia, 1988, 8, suppl. 7; PH Carpentier et al.

Franco-American epidemiological study, 1996). Thus, 14 to 20% of women are prone to these migraines during falls of estradiolemia.

 Besides, besides the direct consequences of this hormonal drop, there are also indirect consequences which prove to be harmful.

 Indeed, the mood disorders and migraines caused by this fall in hormones can lead the doctor to believe that his patient is under-dosed with hormones. it therefore makes him logically increase the daily dose of estrogens and is then confronted with the opposite symptoms, linked to hyperestrogenism and in particular to painful tension in the breasts.

 In addition, the mood disorders and migraines caused by the hormonal fall can demotivate the patient, because she can attribute these disorders to her hormonal treatment, whereas they are attributable to the lack of regularity of taking or administration of his medicine. The consequence is sometimes then the abandonment of the treatment, which deprives the patient of long-term benefits, that is to say of the prevention of osteoporosis and cardiovascular diseases.

 Regarding estrogen-progestational imbalances, these cause the same disorders as the estradiol imbalance, but they also cause other, even more annoying effects, such as bleeding, with greater probability.

 Thus, there are many disadvantages, whether direct or indirect, with the too vague dosages currently proposed for hormone replacement therapy based on a patch, that is to say a patch every 3 to 4 days, or every 3 or 4 days, which leads to 3-day / 4-day or 4-day / 3-day intake patterns.

 It would therefore be highly desirable to remedy all of these drawbacks.

 The Applicant Company has determined that one of the best ways to achieve this would be to be able to ensure, in a simple and effective manner, the taking or administration of a patch with a frequency as close as possible to 3 and a half days. On the one hand, this rhythm of administration presents a considerable advantage for the management of the adaptation of the treatment by the practitioner, who is no longer hampered by the symptomatic background noise.

On the other hand, it allows a stability of the plasma estradiol levels in the patient, avoiding the harmful effects described above. The significant improvement in the stability of plasma estradiol levels is perfectly visible on the curves in FIG. 4, whether for the P1 or P2 type patches, these curves indicating the evolution of the plasma concentration of estradiol, expressed in picograms per milliliter of blood, as a function of time in days.

 The Applicant Company therefore endeavored to find a simple, efficient and precise device making it possible to ensure this optimal compliance with this 84 hour cycle.

 The device according to the invention makes it possible to optimize the regularity of taking or administering a pharmaceutical, dietetic or cosmetic product whose optimal frequency of taking or administration is 84 hours (every three and a half days), and it is characterized by the fact that it comprises two elements linked to one another so as to be able to undergo relative to one another relative displacements, the first of these two elements called "day element" carrying two graduations each representing the days of the week, these two graduations being offset one with respect to the other by half a week (the "Thursday" of one of the graduations which begins on a "Monday" corresponding to "Monday" of the other graduation), the second of these two elements says "hour element" carrying two graduations each representing a time slot for taking or administering the product, these two time slots being of equal importance and being offset one by compared to the other of twelve hours (the index "9H" of the graduation which begins at "6H" corresponding to the index "21H" of the graduation which begins at "18H"), thanks to which, during the day of first taking or administration of the product, it suffices to coincide this day read on one of the graduations of element days "with the time of taking or administration to read next to the other corresponding graduation of element days "the next hour of taking or administration.

 The device may advantageously further comprise a third element, called "cursor element", linked to day element "or to hour element" so as to be able to undergo relative displacement, this "cursor element" being arranged to materialize the correspondence between the graduations of day element "and of hour element" brought next to each other.

 Preferably, blocking means are then provided to temporarily immobilize between them the three elements, "day element", "hour element" and "cursor element" of the device in their relative positions corresponding to the biweekly moments of taking or administration of product.

 According to a first embodiment of the invention, the constituent elements of the device, that is to say the "day element", the "hour element" and the "cursor element", are mechanically arranged to undergo between them relative linear displacements thanks to a mounting by slide.

 According to another embodiment of the invention, the constituent elements of the device, ie the "day element", hour element "and the" cursor element ", are mechanically arranged to undergo movements between them angular relative thanks to a mounting around a central axis.

By way of example, the device is characterized in that - the "days element" is constituted by a disc (1) whose
the graduations (3,4) are concentric, the "hour element" (2) consists of two rings
(2a, 2b) carried by a set of arms (L, 1) carrying
each a graduation (3) or (4), the "cursor element" (7) is constituted by a needle,
these three elements being mounted on the central axis (9).

 Preferably, the device is provided with a locking means (8) constituted by a brake mounted on the central axis (9) and which makes it possible to immobilize angularly between them the three elements, "day element" 1, "element hours "(2) and" cursor element "(7) of the device.

 In any exemplary embodiment of the invention whatsoever, the days and hours of taking or administration are alternately always the same since the period of 3 and a half days corresponds exactly to half a week and this frequency of administration or taking of the product therefore makes it easy to materialize these days and times of taking. For example, if the patient undergoes a taking or administration of the product on Monday at 8 am, the device according to the invention indicates to her that she will have to undergo a second taking or administration on Thursday at 8 pm, then a third on Monday at 8 am hours, and so on.

 The optimal frequency of taking or administration of 3 and a half days can be easily respected and there is thus, thanks to the invention, a very simple device making it possible to avoid all the drawbacks caused by an inaccurate taking or administration. every 3 or 4 days or every 3 to 4 days.

 The invention may in any case be well understood with the aid of the additional description which follows, as well as of the appended drawings, which supplements and drawings relate to preferred embodiments of the invention and of course do not include any limiting character.

 Figure 1 of these drawings is a graph representing the plasma concentration of estradiol as a function of time, over 96 hours, for two types of patches. Figures 2 and 3 are graphs representing the plasma concentration of estradiol as a function of time, over 8 days, for two types of patches and according to whether the administration schedule is 4 days / 3 days (Figure 2) or 3 days / 4 days (figure 3). FIG. 4 is a graph representing the plasma concentration of estradiol as a function of time, over 8 days, for two types of patch, and according to an administration schedule every 3 and a half days. Figure 5 is a plan view showing a first embodiment of the invention. Figure 6 is a plan view showing another embodiment of the invention. Figure 7 is a plan view showing yet another embodiment of the invention.

Embodiment 1
The device is made of plastic. it consists of two external parts constituting respectively the graduations (5) and (6) of the hours element "(2) and an internal part constituting the days element" (1). These three parts are parallel to each other, the elements "days" and "hours" being able to move relatively linearly thanks to a mounting by slide. The two graduations (5) and (6) constituting the hours element "each represent a time range, the time range of the graduation 5 being between 5 pm and midnight and the time range of the graduation (6) being between (5) hours and noon. The graduation (5) is in the plane above the graduation (6). day element "
(1) is constituted by a plastic strip separated in two longitudinally, and thus defining the graduations (3) and (4), the graduation (3) being greater in the plane than the graduation (4). The graduation (3) indicates the days of the week from Monday to Sunday and the graduation (4) indicates the days of the week from Friday of one week until Thursday of the following week (see Figure 5). If the patient puts on her first patch on a Monday at 7 p.m., she introduces the plastic strip constituting the day element "between the two parts constituting the hour element" so as to match the Monday indicated at the top of the third strip with the schedule. 7 p.m. and reads that she will have to take her second patch on Friday at 7 a.m. It can then draw a vertical line connecting the data 7 p.m. Monday and Friday - 7 a.m.

 She thus knows, as shown in Figure 5, that she should ideally take a patch every Monday at 7 p.m. and every Friday at 7 a.m.

Embodiment 2
The device is made of cardboard and consists of 3 strips. Two bands are pre-glued and represent the hour element "(2). These two bands each carry time slots offset by 12 hours, these time slots spanning between 4 pm and 11 pm for the graduation (6) of the hour element" which constitutes the upper strip and between 4 hours and 11 hours for the graduation (5) of the hours element "which constitutes the lower band. Between the two bands, a space is left allowing the bonding in parallel of a third self-adhesive band representing the days element" ( 1), the upper part of the third strip representing the graduation (3) of element days "and mentioning the days of the week from Monday to Sunday and the lower part of the strip representing the graduation (4) of element days "and mentioning the days of the week from Friday of one week to Thursday of the following week (see Figure 6). If the patient applies her first patch on a Tuesday at 6 p.m., she sticks the third self-adhesive strip representing the "days element" between the two pre-glued bands constituting the hours element "so as to match the Tuesday indicated with the upper part of the third tape with the 6 p.m. schedule and read that she will have to take her second patch on Saturday at 6 a.m. She can then draw a vertical line connecting the data at 6 p.m. - Tuesday and Saturday - 6 a.m. For convenience patient cuts the part of the "days element" which exceeds the "hours element".

 The patient thus knows, as shown in Figure 6, that she should ideally take a patch every Tuesday at 6 p.m. and every Saturday at 6 a.m.

Embodiment 3
The device is made of cardboard. The "days element" consists of a disc (1) and hours element "
(2) consists of two concentric rings (2a and 2b), one of which (2a) is of smaller diameter than the other
(2b). cursor element "(7) consists of a needle.

 The two rings are arranged on a plane higher than that of the disc and are interconnected so as to be immobilized relative to each other by tongues (L), the ring of smaller diameter being itself connected by tongues (1) to an axis common to the rings and to the support around which the rings and the support are mutually rotatable.

The rings (2a and 2b) are dimensioned so as not to cover the majority of the disc and constitute time dials. The 5 hour element graduation "
(2) is shown on the smaller diameter ring (2a) and the times are staggered from 6 am to noon. The graduation 6 of the hour element "(2) is shown on the larger diameter ring (2b) and the times are staggered from 6 p.m. to midnight. The graduations 5 and 6 are immobilized so that the times face each other are separated by 12 o'clock, so 6 o'clock is positioned opposite 6 o'clock, 7 o'clock opposite 7 o'clock, 8 o'clock opposite 8 o'clock, and so on.

The graduation (3) of days element "constituted by the disc is located between the central axis (9) and the ring of smaller diameter (2a). This graduation (3) is divided into 7 angular segments each representing a day of the week. The graduation 4 of element days "is located between the ring of smaller diameter
(2a) and the larger diameter ring (2b). This graduation (4) is divided into 7 angular segments also each representing a day of the week. The graduations (3) and (4) are arranged so that each day D of the graduation (4) is associated with a day
D '= D + 3 days of graduation (3). Thus, Monday of graduation 4 is associated with Thursday of graduation 3, Tuesday of graduation 4 is associated with Friday of graduation 3, Wednesday of graduation 4 is associated with Saturday of graduation 3 and so on ( see
Figure 7).

 If the patient places her first patch on a Sunday at 8:30 a.m., she then manipulates the rotary axis so as to make these two data coincide and then reads the day and time when her second patch was taken. is to say here on Wednesday at 8:30 p.m.

 A needle attached to the rotary axis and angularly movable around this axis allows the patient to match Sunday 8:30 a.m. and Wednesday 8:30 p.m.

 The patient thus knows, as shown in Figure 7, that she should ideally take a patch every Sunday at 8:30 a.m. and every Wednesday at 8:30 p.m.

Claims (7)

 1. Device making it possible to optimize the regularity of taking or of administration of a pharmaceutical, dietetic or cosmetic product whose optimal frequency of taking or of administration is 84 hours (every three and a half days), characterized by the fact that it has two elements (1,2) linked to each other so that they can undergo relative displacement relative to each other, the first of these two elements (1) says "element days "bearing two graduations (3, 4) each representing the days of the week, these two graduations (3,4) being offset one from the other by half a week (the" Thursday "of the graduation (3) which begins on a "Monday" corresponding to the "Monday" of the graduation (4)), the second of these two elements (2) says "hour element" carrying two graduations (5, 6) each representing a time range taking or administering the product, these two time periods being of equal importance and being offset one compared to the other of twelve hours (the index "9H" of the graduation which begins at "6H" corresponding to the index "2lH" of the graduation which begins at "18H"), which is what, during from the day of the first taking or administration of the product, it suffices to make this day read on one of the graduations of element days "coincide with the time of taking or administration to read next to the other corresponding graduation of days element "the next take or administration time.  2. Device according to claim 1 characterized in that it further comprises a third element  (7) called "cursor element" linked to day element "(1) or to hour element" (2) so as to be able to undergo a relative displacement, this "cursor element" (7) being arranged to materialize the correspondence between the graduations of day element "(1) and of hour element" (2) brought opposite each other.  3. Device according to claim 2 characterized in that blocking means (8) are provided for temporarily immobilizing between them the three elements "day element" (1), "hour element" (2) and "cursor element" ( 7) of the device in their relative positions corresponding to the biweekly moments of taking or administering the product.  4. Device according to claim 2 or 3 characterized in that its constituent elements, "day element" (1), "hour element" (2) and "cursor element" (7) are mechanically arranged to undergo movements between them linear relative thanks to a slide mounting.  5. Device according to claim 2 or 3 characterized in that its constituent elements, "day element" (1), "hour element" (2) and "cursor element" (7) are mechanically arranged to undergo movements between them angular relative by mounting around a central axis (9).  6. Device according to claim 5 characterized in that - the "days element" (1) consists of a disc,  the graduations (3,4) are concentric, - the "hours element" (2) consists of two rings  (2a, 2b) carried by a set of arms (L, 1) carrying  each a graduation (3) or (4), the "cursor element" (7) is constituted by a needle, these three elements being mounted on the central axis (9).  7. Device according to claim 6 characterized in that the locking means (8) are constituted by a brake mounted on the central axis (9) and which allows to immobilize angularly between them the three elements, "day element" 1, "hour element" (2) and "cursor element" (7) of the device.