UNIT DOSE MEDICATION COMPLIANCE

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Serial No. 61/719,750, filed October 29, 2012, which is incorporated herein by reference in its entirety.

SUMMARY OF INVENTION

Embodiments of the disclosure are directed to medication compliance systems. According to various implementations, a substrate includes an array of apertures arranged in rows and columns, and a multiplicity of vial sets each of which comprises a predefined number of separable individual vials configured to contain a unit dose of a therapeutic fluid. Each of the vials includes a body and a distal end, and the predefined number of separable individual vials corresponding to a number of the rows or the columns. At least a portion of a distal end of each vial is dimensioned to be received by one of the apertures of a particular row or column. The substrate preferably includes a retention feature configured to retain the distal ends of the vials, such that the body of each vial extends outwardly from the substrate when positioned within a respective aperture. A support structure includes an upper surface, a lower surface, and a volume defined between the upper and lower surfaces, wherein the support structure either integrally incorporates the substrate or is configured to detachably receive the substrate.

According to some embodiments, the support structure is configured to detachably receive the substrate, which may be implemented as a plastic tray. In various embodiments, the substrate is configured to be snap-fitted to the upper surface of the support structure. According to some implementations, each of the vials includes an outwardly tapering section proximal to the distal end portion and having a width greater than that of the distal end portion. In some embodiments, the volume of the support structure is sufficient to accommodate passage of the distal end portion of the vials to a depth limited by contact between the tapering section and the substrate surrounding an aperture of the substrate. The distal end portion of the vials may terminate in a substantially flat portion.

In various embodiments, apertures of the substrate comprise a series of spaced-apart openings of the substrate, wherein each of the openings is dimensioned to receive one of the vials. In some embodiments, the substrate includes indicia disposed adjacent the rows and columns, the indicia indicating days of a predefined period of time. According to various aspects, the indicia indicates days of a predetermined period of time. In some implementations, the predefined number of separable individual vials of a single vial set corresponds to a predetermined number of the days indicated for each individual row or each individual column.

According to some embodiments, the substrate includes indicia disposed adjacent the rows and columns, the indicia indicating dates of a month. In some implementations, the predefined number of separable individual vials of a single vial set corresponds to a predetermined number of the days indicated for each individual row or each individual column. For example, the substrate can include indicia disposed adjacent the rows and columns and indicating days of a week repeated for each of five weeks adjacent each row or each column. In some embodiments, the substrate includes a first planar surface and a second planar surface. According to various implementations, indicia indicating days of a month is disposed on the first planar surface adjacent the rows and columns, and indicia indicating days of a week is repeated at a first edge and a second edge on the second planar surface adjacent each row or each column. According to various embodiments, the retention feature of the substrate includes the apertures separated from one another by a predetermined distance. In some implementations, each vial set may be configured to be received by the apertures of one row or column of the substrate without individual vials being separated from one another, such that the distal ends of the vials of each non-separated vial set align relative to the apertures.

In some embodiments, the therapeutic fluid includes a therapeutic fluid for treating glaucoma. According to various aspects, the therapeutic fluid includes a therapeutic fluid selected from the group consisting of Lumigan, Travatan, Xalatan, Duotrav, Xalacom, Azopt, Azarga, Trusopt, Cosopt, Alphagan, Alphagan P, Zioptan, Saflutan, Tafluprost, brimonidine, Combigan, latanoprost, Ganfort, and beta blockers.

Some embodiments of the present disclosure include the following:

1 . An apparatus, comprising:

a substrate comprising an array of apertures arranged in rows and columns;

a plurality of vial sets each of which comprises a predefined number of separable individual vials configured to contain a unit dose of a therapeutic fluid, each of the vials comprising a body and a distal end, and the predefined number of separable individual vials corresponding to a number of the rows or the columns, at least a portion of a distal end of each vial dimensioned to be received by one of the apertures of a particular row or column;

a retention feature of the substrate configured to retain the distal ends of the vials such that the body of the vials extend outwardly from the substrate when positioned within the apertures, and

a support structure comprising an upper surface, a lower surface, and a volume defined between the upper and lower surfaces, wherein the support structure either incorporates the substrate or is configured to detachably receive the substrate. 2. The apparatus according to paragraph 1 , wherein the support structure is configured to detachably receive the substrate.

3. The apparatus according to paragraph 2, wherein the support structure comprises a plastic tray. 4. The apparatus according to paragraphs 1 - 3, wherein:

each of the vials comprises an outwardly tapering section proximal to the distal end portion and having a width greater than that of the distal end portion; and

the volume of the support structure is sufficient to accommodate passage of the distal end portion of the vials to a depth limited by contact between the tapering section and the substrate surrounding the aperture.

5. The apparatus according to paragraph 4, wherein the distal end portion terminates in a substantially flat portion.

6. The apparatus according to paragraph 1 , wherein the substrate is configured to be snap-fitted to the upper surface of the support structure.

7. The apparatus according to paragraphs 1 - 6, wherein the apertures comprise a series of spaced-apart openings of the substrate, each of the openings dimensioned to receive one of the vials.

8. The apparatus according to paragraphs 1 - 7, wherein the substrate comprises indicia disposed adjacent the rows and columns, the indicia indicating days of a predefined period of time.

9. The apparatus according to paragraphs 1 - 7, wherein:

the substrate comprises indicia disposed adjacent the rows and columns, the indicia indicating days of a predetermined period of time; and

the predefined number of separable individual vials of a single vial set may correspond to a predetermined number of the days indicated for each individual row or each individual column. 10. The apparatus according to paragraphs 1 - 7, wherein the substrate comprises indicia disposed adjacent the rows and columns, the indicia indicating dates of a month.

1 1 . The apparatus according to paragraphs 1 - 7, wherein:

the substrate comprises indicia disposed adjacent the rows and columns, the indicia indicating dates of a month; and the predefined number of separable individual vials of a single vial set may correspond to a predetermined number of the days indicated for each individual row or each individual column. 12. The apparatus according to paragraphs 1 - 7, wherein the substrate comprises indicia disposed adjacent the rows or columns, the indicia indicating days of a week printed at a first edge and at a second edge adjacent to the rows or columns.

13. The apparatus according to paragraphs 1 - 7, wherein:

the substrate comprises a first planar surface and a second planar surface;

indicia indicating days of a month is disposed on the first planar surface adjacent the rows and columns; and

indicia indicating days of a week is printed at a first edge and at a second edge on the second planar surface adjacent each row or each column.

14. The apparatus according to paragraph 1 - 13, wherein each of the vial sets comprises five separable individual vials.

15. The apparatus according to paragraphs 1 - 14, wherein:

the retention feature comprises the apertures separated from one another by a predetermined distance; and

each vial set may be configured to be received by the apertures of one row or column of the substrate without individual vials being separated from one another, such that the distal ends of the vials of each non-separated vial set align relative to the apertures. 16. The apparatus according to paragraphs 1 - 15, wherein the therapeutic fluid comprises a therapeutic fluid for treating glaucoma.

17. The apparatus according to paragraphs 1 - 15, wherein the therapeutic fluid comprises a therapeutic fluid selected from the group consisting of Lumigan, Travatan, Xalatan, Duotrav, Xalacom, Azopt, Azarga, Trusopt, Azarga, Cosopt, Alphagan, Alphagan P, Zioptan, Saflutan, Tafluprost, brimonidine, Combigan, latanoprost, Ganfort, and beta blockers.

18. An apparatus, comprising,

a surface having an array of apertures arranged in rows and columns configured to hold a plurality of vials, each vial containing a unit dose of a therapeutic fluid,

a plurality of vial sets each of which comprises a predefined number of separable individual vials configured to contain a unit dose of a therapeutic fluid, each of the vials comprising a body and a distal end, and the predefined number of separable individual vials corresponding to a number of the rows or the columns, at least a portion of a distal end of each vial dimensioned to be received by one of the apertures of a particular row or column; and

a retention feature of the apparatus configured to retain the distal ends of the vials such that the body of the vials extend outwardly from the substrate when positioned within the apertures.

19. The apparatus according to paragraph 18, wherein the substrate comprises indicia disposed adjacent the rows and columns, the indicia indicating days of a predefined period of time.

20. The apparatus according to paragraphs 18 and 19, wherein the support structure is configured to detachably receive the substrate.

21 . The apparatus according to paragraphs 18 - 20, wherein:

each of the vials comprises an outwardly tapering section proximal to the distal end portion and having a width greater than that of the distal end portion; and the volume of the support structure is sufficient to accommodate passage of the distal end portion of the vials to a depth limited by contact between the tapering section and the substrate surrounding the aperture.

These and other features can be more thoroughly appreciated in view of the following detailed discussion and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1A, 1 B, 1 C, and 1 D illustrate a substrate of a calendaring arrangement that supports unit dose vials of a therapeutic liquid according to various embodiments described herein;

Figures 2A and 2B show a package or kit that contains a tray, vials of a therapeutic liquid, and a compliance card bearing calendaring indicia according to various embodiments;

Figure 3 illustrates a unit dose medication compliance arrangement according to various embodiments;

Figure 4 shows a representative embodiment of a unit dose medication compliance arrangement in which a lid, being part of a unitary structure, is configured to support vials of a therapeutic liquid; and

Figures 5A and 5B illustrate positioning of a vial containing a unit dose of a therapeutic liquid within an aperture provided in a substrate of a unit dose medication compliance arrangement according to various embodiments.

Figures 6-1 1 illustrate perspective, top, bottom, and side views of a calendaring arrangement inserted into a tray.

Figures 12-17 illustrate perspective, top, bottom, and side views of a calendaring arrangement inserted into a tray with unit dose vials inserted therein. Figure 18 illustrates a perspective view of a calendaring arrangement inserted into a tray with one row of unit dose vials inserted therein.

Figure 19 illustrates a perspective exploded view of a calendaring arrangement, a tray, and one row of unit dose vials.

DISCLOSURE

Embodiments of the disclosure are generally directed to compliance systems for drug and unit dose drug delivery systems. Embodiments of the disclosure are directed to calendaring arrangements for supporting unit dose vials containing a therapeutic fluid and enhancing compliance with a medication regimen for treating a chronic or long-term disorder.

According to embodiments of the disclosure, a compliance system is configured for holding vials, wherein each vial contains a single dose (also referred to herein as a unit dose) of a therapeutic fluid. It is well-appreciated by those in health and community services that many patients find it difficult to take medication at regular intervals as prescribed by their physician. It can be harmful to a patient if prescribed medications of specified dosages are skipped. For example, neglecting to take glaucoma medication by a patient at regularly scheduled intervals can lead to increased intraocular pressure and an accelerated progression of the disease. A unit dose compliance card system according to embodiments of the present disclosure enhances patient adherence to a prescribed medication regime.

Turning now to Figure 1 A, there is illustrated a substrate 105 of a medication calendaring arrangement 100 that supports unit dose vials of a therapeutic liquid in accordance with various embodiments. The representative embodiment of Figure 1 A shows the substrate 105 having a multiplicity of apertures 1 10 arranged as rows. According to various implementations, the apertures 1 10 comprise spaced-apart openings 120 of the substrate 105. Each of the openings 120 is dimensioned to receive one vial. Each of the vials is preferably configured to contain a single dose of a therapeutic liquid. In some implementations, such as that shown in Figure 1A, each of the apertures 1 10 defines a slot, with a series of space-apart openings 120 arranged along the length of the slot. According to Figure 1A, the substrate 105 includes seven apertures 1 10, with five openings 120 provided for each aperture 1 10. In various implementations, the substrate 105 may have more or fewer than seven apertures 1 10 and more or fewer than five openings 120 for each aperture 1 10.

According to various aspects, indicia is provided proximate each opening 120 that indicate individual days of a month, for example. According to the representative example of Figure 1A, 31 of the openings 120 are numbered to accommodate the number of days of the longest month of a given year. In some embodiments, the openings 120 are numbered according to a period of more than one month or less than one month. A number of unnumbered openings 120 are provided to receive excess vials for months with fewer than 31 days. These vials are subsequently moved into the appropriate numbered aperture. These unnumbered openings 120 can be included after the last numbered opening 120 (e.g., the opening 120 corresponding to day 31 ).

According to some implementations, on the second planar surface, each aperture on a first edge and each aperature on a second edge-are labeled with a symbol indicating a day of the week. Figure 1 B illustrates a substrate 105 as described in relation to Figure 1A flipped and rotated ninety degrees. Each aperture 1 10 on a first edge and each aperture 1 10 on a second edge is labeled according to a day of the week. Figure 1 B shows that the seven apertures 1 10 are labeled S, M, T, W, Th, F, and S, corresponding to Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, and Saturday, respectively. In some implementations, the days of the week are labeled according to a language other than English. For example, Figure 1 B also illustrates the days of the week labeled D, L, M, Mi, J, V, and S, corresponding to the days of the week in Spanish. A patient can use the numbered openings 120 and/or the openings labeled with a day of the week to keep track of the day each vial of medication is dispensed.

In some embodiments, the openings 120 of the compliance card 105 are labeled according to days of a week and are not labeled according to dates of a month. In other embodiments, the compliance card 105 has one aperture 1 10 with seven openings 120, each opening 120 labeled according to a day of the week. Other arrangements of apertures 1 10, openings 120, and corresponding days are contemplated. For example, a unit dose vial of medication may require dispensing twice per day. In this case, indicia associated with the openings 120 preferably correspond to AM and PM time periods of each day of the week, for example. The number and arrangement of apertures 1 10 and openings 120 are preferably distributed on the substrate 105 in a manner that correspond to the number (1 , 2, ... n) of unit dose vials to be dispensed by the patient per day over a given time period (e.g., week, bi-month, month). Turning now to Figure 1 C and 1 D, there is illustrated a substrate 105 of a medication calendaring arrangement 102 that has the dates of the month and the days of the week labeled on the same planar surface. According to Figures 1 C and 1 D, the substrate 105 may be rotated ninety degrees to display the days of a week. According to various embodiments, a packaged assembly or kit includes a substrate configured as a medication compliance card associated with a package of vials, such as cards of the vials. Figures 2A and 2B illustrate a package 200 containing a tray 215, vials 240 of therapeutic liquid, and at least one compliance card 230. Figure 2A shows the package 200 is its post- manufacture configuration prior to use. Figure 2B shows the package 200 and its constituent parts after being opened by the user.

The compliance card 230 may sit on top of a protective foil layer 210. The package 200 is preferably sealed with the protective foil layer 210. When the package 200 is initially opened by a user, the foil layer 210 is typically pulled back and removed by the user, revealing tray a 215 and a predetermined number of vials each containing a therapeutic liquid prescribed by a physician or clinician. As previously discussed, the vials 240 are preferably packaged in cards, with each card comprising a specified number of vials 240. The number of vials 240 in each card preferably, but not necessarily, corresponds to the number of openings of a given aperture (e.g., slot) provided in the compliance card 230.

Individual vials 240 of a card of vials are preferably connected together using a frangible member or thinned portion of the card of vials that facilitates easy separation of individual vials from the card of vials. For example, the frangible members may be formed as a thinned portion of the plastic material used to form the vials 240 during the molding process, such during a sterile blow-fill-seal (BFS) manufacturing process. A BFS manufacturing process typically involves aseptic fabrication of a vessel which is formed, filled, and sealed in a continuous automated process within a sterile enclosed region within the fabrication machinery. Although many embodiments utilize vials 240 manufactured to contain a sterile therapeutic fluid, other embodiments of vials 240 need not be manufactured to maintain fluid sterility.

The tray 215 is preferably configured to retentively receive and support the compliance card 230. The tray 215 and compliance card 230 may be fabricated from various materials, such as various plastics, composites, and cardboard. In some implementations, the tray 215 is formed from polypropylene, and the compliance card 230 is formed from cardboard, paperboard, plastic and/or nylon

Figure 2B shows the tray 215, a predetermined number of vials 240, and the compliance card 230 removed from the package 200 after removal of the protective foil layer 210. In some implementations, there may be more than one compliance card 230 included in the package 200, such as two cards 230 for respective first and second halves of a month, or four cards 230 for each week of a month. The compliance card 230 can then be fitted into the tray 215 by the user, and individual vials placed into individual aperture openings provided on the compliance card 230. The user preferably separates individual vials 240 from the vial card(s) and positions individual vials 240 within individual aperture openings of the compliance card 230.

According to various embodiments, the compliance card 230 is fitted to the tray 215 and mechanically captured by a retention feature of the compliance card 230. For example, the compliance card 230 may have slightly larger dimensions than the inside dimensions of the tray 215, and the retention feature may exploit an interference fit between the periphery of the compliance card 230 and a groove or other retention feature 217 provided continuously or discontinuously along an inner surface of the tray 215. In some implementations, the compliance card 230 is manufactured of a material which is deformable, such as plastic, a composite or cardboard.

When deformed by the user, the compliance card 230 can be placed in the tray 215 and situated with its periphery in proximity with the groove or other retention feature(s) 217 of the tray 215. After being properly positioned, the compliance card 230 can be allowed to take its original shape, causing the compliance card 230 to be held in place by the tray 215 (e.g., via a snap-fit retention feature). In some cases, the compliance card 230 has substantially the same dimensions as the inside of the tray 215 and the tray 215 includes a protrusion 217. The compliance card 230, when deformed, can be forced below the protrusion 217 and then allowed to take its original shape. The protrusion 217 then holds the compliance card 230 in place.

Once the compliance card 230 is fitted into the tray 215, the vials 240 can be placed in the openings. Figure 3 illustrates an assembled medication compliance system which includes the tray 215, the compliance card 230 inserted into the tray 215, and some vials 240 shown inserted into aperture openings of the compliance card 230.

In accordance with some embodiments, a medication calendaring arrangement that supports unit dose vials of a therapeutic liquid includes a unitary structure comprising a tray 215 and an integral compliance card 230. In contrast to the physically separable compliance card embodiment shown in Figure 3, the calendaring arrangement shown in Figure 4 is configured as a unitary structure that incorporates the tray 215 as a support arrangement and the compliance card 230 as an exposed surface or lid comprising rows and columns of aperture openings for receiving and supporting unit dose vials 240 of a therapeutic liquid. A number of the vials 240 are shown inserted in aperture openings of the compliance card 230 defining the lid of the unitary structure. The unitary calendaring arrangement shown in Figure 4 can be fabricated using various molding processes, such as injection and/or thermoform, and of any plastic. Indicia, such as days and/or weeks of the month, can be embossed or badged on the lid 230 subsequent to the molding process.

According to various implementations, vials 240 are arranged in groups of five vials, and are configured to be separated upon application of a force as previously discussed. In other embodiments, attached vials 240 of a card may be inserted into the compliance card aperture openings without being separated from one another. A user can place the vials 240 into the calendaring compliance card openings based on the date and/or the day of the week. Figures 6-1 1 illustrate similar views of an embodiment of a calendaring arrangement inserted into a tray. Figures 12-17 illustrate views of an embodiment of a calendaring arrangement with vials 240 forming a vial set inserted therein.

As illustrated in Figures 18 and 19, some embodiments may only have vials 240 inserted into one of (or a portion of) the rows 1 10 present on the substrate 105. This could occur, for example, if a user only requires dosage of a medicament for a limited duration of time. Figure 19 shows an exploded view illustrating how the card or substrate 105 may be configured to be insertable into the tray 215. By way of example, and referring back to Figure 1A, suppose a user started using the compliance card on the 17 ^th . The user would break off one vial from a group of five vials and then place the leftover four vials in the compliance card starting on the 17 ^th . The dates after the 17 ^th could hold an entire group of five vials so the user can continue to fill the compliance card until all of the vials are properly placed. Once the user reaches the last day of the month, he/she can continue to place vials starting at the 1 ^st of the next month. It can be appreciated that the calendaring compliance card advantageously allows the user to easily see if a unit dose vial has been skipped, simply by looking at the vials positioned within the calendaring compliance card substrate. The user can also determine if he/she still needs to take medication for the current day. Additionally or alternatively, a user can place vials according to days of the week by flipping calendaring compliance card, exposing the second planar surface, and rotating ninety degrees. Thus, a single compliance card, such as that shown in Figures 1A and 1 B, can be used for medication compliance based visually on individual days of the month (e.g., Figure 1 A) or days of the week (e.g., Figure 1 B).

Turning now to Figure 5A, a vial 510 configured to contain a unit dose of a therapeutic fluid is shown positioned relative to a row of five openings 530 of a calendaring compliance card substrate 515. In the embodiment shown in Figure 5A, the vial 510 has an outwardly tapering section proximal to a distal end portion. The outwardly tapering section has a width that is greater than that of the distal end portion. As illustrated in Figure 5A, the vial 510 has a width, V _w , and the opening 530 has a width, O _w . O _w is greater than V _w so that the distal end portion of the vial 510 can readily fit into the opening 530.

In some implementations, the distal end portion terminates in a substantially flat section 520. The flat section 520 is smaller than the opening 530 so that the distal end portion of the vial 510 can readily be placed in the opening 530. The flat section 520 may be sized and shaped to increase stability when the vial 510 is placed within the substrate opening 530. In some implementations, the vial 510 does not have a flat section 520. As described previously, the vials 510 may be arranged in a set of more than one detachable vial 510. As can be observed from Figure 5A, the openings 530 are arranged along an aperture 525 that is narrower than the openings 530. The aperture 525 allows the vials 510 to be inserted into the calendaring compliance card substrate 515 without detaching the vials 510 from each other.

The opening 530 can be configured to allow passage of the vial 510 to a depth limited by contact between the tapering section of the vial 510 and the substrate 515 surrounding the opening 530. Figure 5B illustrates that the internal volume of the support structure 550 (e.g., tray) is sufficient to accommodate passage of the distal end portion of the vial 510 to a depth limited by contact between the tapering section and the substrate 515 surrounding the aperture 525, such that the distal end of the vial 510 does not touch the bottom 555 of the support structure 550. The vial 510 preferably rests at a depth that is less than the distance of the distal end of the vial 510 to the angle of the vertical plane of the vial 510. The vial 510 is sufficiently secured within the opening 530 to preclude movement to an adjacent opening 530. When it comes to rest, the angle of the vial 510 may vary between 60 and 90 degrees from the plane of the substrate 515. The vial 510 preferably tilts up to 30 degrees to allow the user to read the indicia on the substrate 515. According to various implementations, the vials are configured to enable a user to administer an ophthalmic therapeutic agent to the eyes. The flat section 520 of the vial 510 can be removed to reveal a dispensing tip. A variety of therapeutic agents can be dispensed through the dispensing tip using vials in accordance with embodiments of the disclosure. A non-limiting, non- exhaustive list of such therapeutic agents includes Lumigan, Travatan, Xalatan, Duotrav, Xalacom, Azopt, Azarga, Trusopt, Cosopt, Alphagan, Alphagan P, Zioptan, Saflutan, Tafluprost, brimonidine, Combigan, latanoprost, Ganfort, and beta blockers. The systems implemented in accordance with embodiments of the disclosure are not limited to delivery of ophthalmic therapeutic agents. For example, any topically-delivered therapeutic agent such as dermatological agents, oral liquid medications, wound healing preparations, etc., may be dispensed through the dispensing tip using vials in accordance with embodiments of the disclosure.

The foregoing description of the representative embodiments has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit inventive embodiments to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. Any or all features of the disclosed embodiments can be applied individually or in any combination are not meant to be limiting, but purely illustrative. It is intended that the scope of inventive embodiments be limited not with this detailed description, but rather determined by the claims appended hereto.