WO2020072568A1

WO2020072568A1 - Medication packaging and dose regimen system

Info

Publication number: WO2020072568A1
Application number: PCT/US2019/054178
Authority: WO
Inventors: Jeffrey Warden; Joanna TERHUNE; John GAFNEY; Eric Richardson
Original assignee: Mylan Inc
Priority date: 2018-10-03
Filing date: 2019-10-02
Publication date: 2020-04-09

Abstract

Medication packaging includes a body defining a cavity for disposal of medication. A closure member is disposable with the body and includes a medication accessible configuration and a closed configuration. The closure member includes a first cap, a second cap and a third cap. The third cap includes at least one first circumferential arm and at least one second circumferential arm. A ramp of the first arm is oriented in a first direction and a ramp of the second arm is oriented in a second opposing direction. The ramp of the second arm is engageable with the second cap in the closed configuration to incrementally advance indicia of a medication dosage regimen. Systems, containers and methods of use are disclosed.

Description

MEDICATION PACKAGING AND DOSE REGIMEN SYSTEM

TECHNICAL FIELD

[0001] The present disclosure generally relates to medicament packaging and more particularly to a dispensing device and system that provides a medication regimen and/or tamper resistance and a method for treatment of a medical condition.

BACKGROUND

[0002] Retail customers and/or patients can be engaged in a medical therapy, which may include diet, exercise and/or a prescription and/or a non-prescription medication dosing regimen, which may be employed to treat an illness. In some cases, hospitalized patients are often discharged and instructed by one or more medical practitioners to comply with a medical therapy.

[0003] Such medication dosing regimen can include one or a plurality of medications administered over a regimen, which may include one or more medications. The medication dosing regimen can require administration of medications simultaneously, at different times and/or according to days of a week or time of day. Such medication regimens may be administered in addition to existing medication regimens that a user may take for nutritional, therapeutic and/or illness treatment.

[0004] Such medication regimens, however, often suffer from poor patient compliance. In fact, many patients fail to comply with their medication regimens. In some cases, life-style related medications may also suffer from poor user compliance. Factors that contribute to non-compliance may include complexity of medication regimen, patient failure in filling prescriptions, incorrect order and/or prescription, cost, adverse side effects, patient reluctance, lack of motivation, non-reconciliation with existing medication and/or patient physiological issues.

[0005] Various medications of a medication regimen can be dispensed from a medication container such as single dose and/or multiple dose blister packaging to a user with or without tamper resistance. Multiple dose blister packaging can dispense a single medication according to a regimen including day, e.g., Monday, Tuesday, etc. and/or time of day. This disclosure describes an improvement over these prior technologies.

SUMMARY

[0006] In one embodiment, medication packaging is provided. The medication packaging includes a body defining a cavity for disposal of medication. A closure member is disposable with the body and includes a medication accessible configuration and a closed configuration. The closure member includes a first cap, a second cap and a third cap. The third cap includes at least one first circumferential arm and at least one second circumferential arm. A ramp of the first arm is oriented in a first direction and a ramp of the second arm is oriented in a second opposing direction. The ramp of the second arm is engageable with the second cap in the closed configuration to incrementally advance indicia of a medication dosage regimen. Systems, containers and methods of use are disclosed.

[0007] In one embodiment, the medication packaging incudes a body defining a cavity for disposal of medication. A closure member is disposable with the body and includes a medication accessible configuration and a closed configuration such that the closure member is rotatable to incrementally advance indicia of a medication dosage regimen. The closure member includes an inner cap, an outer cap, a ring cap and an over cap. The ring cap includes at least one first circumferential arm and at least one second circumferential arm. A ramp of the first arm is oriented in a first direction and a ramp of the second arm is oriented in a second opposing direction. The ramp of the second arm is engageable with the outer cap in the closed configuration to incrementally advance indicia of the medication dosage regimen. The outer cap has at least one lug and the inner cap has at least one slot configured for disposal of the at least one lug such that the outer cap and the inner cap are simultaneously rotatable.

[0008] In one embodiment, the medication packaging incudes a body defining a cavity for disposal of medication. A closure member is disposable with the body and includes a medication accessible configuration and a closed configuration such that the closure member is rotatable to incrementally advance indicia of a medication dosage regimen. The closure member includes a first cap, a second cap, a third cap and a fourth cap. The third cap includes at least one first circumferential arm and at least one second circumferential arm. A ramp of the first arm is oriented in a first direction and a ramp of the second arm is oriented in a second opposing direction. The ramp of the second arm is engageable with the second cap in the closed configuration to incrementally advance indicia of the medication dosage regimen. The second cap has at least one lug and the fourth cap has at least one slot configured for disposal of the at least one lug such that the second cap and the fourth cap are simultaneously rotatable. A bias element is disposed between the second cap and the fourth cap to space the at least one lug from the at least one slot such that the second cap is rotatable relative to the fourth cap.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which:

[0010] FIG. 1 is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure;

[0011] FIG. 2 is a perspective view of the components shown in FIG. 1 with parts separated;

[0012] FIG. 3 is a side view of components of the system shown in FIG. 1 ;

[0013] FIG. 4 is a top view of components of the system shown in FIG. 1 ;

[0014] FIG. 5 is a perspective view of components of the system shown in

FIG. 1 :

[0015] FIG. 6 is a bottom view of components of the system shown in FIG.

1 ;

[0016] FIG. 7 is a perspective view of components of the system shown in

FIG. 1

[0017] FIG. 8 is a perspective view of components of the system shown in

FIG. 1

[0018] FIG. 9 is a perspective view of components of the system shown in

FIG. 1 [0019] FIG. 10 is a perspective view of components of the system shown in

FIG. 1 ;

[0020] FIG. 1 1 is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure;

[0021] FIG. 12 is a bottom view of the components shown in FIG. 1 1 ;

[0022] FIG. 13 is a break away, cross section view of components of one embodiment of a system in accordance with the principles of the present disclosure; and

[0023] FIG. 14 is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure.

DETAILED DESCRIPTION

[0024] The exemplary embodiments of a medicament packaging system and related methods of use disclosed are discussed in terms of dispensing devices for a medication dosing regimen for treatment of various diseases, illness and/or ailments. In some embodiments, the present system is employed with a method for distribution of medication packaging to a patient for treatment of one or more diseases, illness and/or ailments. In some embodiments, the present system is employed with a method such that a patient is discharged from a health care facility, for example, short term discharge and/or long term discharge.

[0025] In some embodiments, the present system comprises a medicament dispensing system and methods of use for storage, transportation and discharge of medications for the treatment of a medical condition. In one embodiment, the systems and methods of the present disclosure are employed to aid a person with a dosing regimen that can include one or a plurality of medications administered over a regimen, which may include one or more medications. In one embodiment, the systems and methods of the present disclosure include a medicament dispensing device that provides child-resistance while being easily accessed by an adult. In some embodiments, the present system comprises a medicament dispensing system and methods of use for storage, transportation and discharge of medications including those for treating illnesses, such as, for example, hypothyroidism, myocardial infarction, elevated blood pressure, dyslipidemia (high cholesterol), diabetes, metabolic syndrome, heart failure, pneumonia, cardiac deficiencies, arthritis, illnesses in which pain is part of an on-going treatment plan, and/or life-style related medications such as, for example, birth control pills, hormone replacement pills and nutritional supplements, such as, for example, neutraceuticals, for example, having vitamin A, D, and E with a calcium supplement.

[0026] In some embodiments, the present system includes a medicament dispensing system that includes a medication container having a threaded screw top to engage a child-resistant lid. In some embodiments, the container body includes a neck portion having threads to engage the lid. In some embodiments, the medicament dispensing system is partially or entirely filled by a pharmacist. In some embodiments, the medicament dispensing system provides child-resistance and is easily accessible by an adult. In some embodiments, a method for accessing the medicaments held within the medicament dispensing system is provided. The method requires consecutive and/or simultaneous motions difficult for children to perform and simple for an adult to perform.

[0027] In some embodiments, the present system includes a medicament dispensing system comprising a bottle and a lid. In some embodiments, the lid includes an inner cap, an outer cap, a ring cap and an over cap. In some embodiments, the medicament dispensing system includes child resistant features. In some embodiments, the outer cap includes increment ramps. In some embodiments, the increment ramps include ramps oriented in a first direction and ramps oriented in a second, opposite direction. In some embodiments, the outer cap includes a flange configured to facilitate connection with the ring. In some embodiments, the ring includes day increment ramps configured for engagement with the ramps of the outer cap.

[0028] In some embodiments, the over cap includes a minimum clearance of a bottle shoulder. In some embodiments, the over cap includes a reduced diameter. In some embodiments, the over cap extends with a radius extending relative to the shoulder of a bottle. In some embodiments, the outer cap includes spring arms configured to facilitate engagement and disengagement of child resistant elements.

[0029] In some embodiments, the present medicament dispensing system includes a medication container having a lid that includes an advancement mechanism. In some embodiments, the advancement mechanism includes ramps disposed on a top surface of an outer cap. In some embodiments, the advancement mechanism includes arms and ramps disposed with the ring. In some embodiments, the advancement mechanism includes teeth disposed with the over cap. The teeth are configured for translation relative to the arms and ramps to facilitate advancement of indicia of a medicament dosing. In some embodiments, the over cap includes a clear window to facilitate viewing indicia of medicament dosing.

[0030] In some embodiments, the present medicament dispensing system includes a medication container having a lid that is fastened by rotating the lid clockwise to engage a thread of an inner cap and a bottle. An advancement mechanism advances to the next indicia of dosage. The user will hear an audible click indicating the advancement to the next indicia of dosage. The lid is fastened with the bottle. The indicia is visible in the window of the over cap. In some embodiments, to reset or advance any number of days, the user continues to rotate the outer cap against the fastening torque. In some embodiments, the over cap is rotated until the required day is shown in the window. In some embodiments, the lid provides an easier and more predictable advancement.

[0031] In some embodiments, the ramps disposed between the ring cap and the over cap provide a torque resistance while the lid is rotated into the closed orientation followed by an audible click as the ramps relatively translate. The audible click indicates that the day is advanced and the lid is closed tight enough to ensure proper function, for example, day advancement, in the next removal and closure cycle of the lid. The ramps and arms are tuned and/or selectively flexible to a selected torque level.

[0032] In some embodiments, the ramps between the ring cap and the outer cap provide a torque resistance while the lid is rotated to the open orientation followed by an audible click as the ramps relatively translate. In some embodiments, the ramps and arms are tuned and/or selectively flexible at a low torque setting to ensure resetting of the lid before the lid is removed from the bottle. After reset and removal of the lid, the day indicator will advance in the next step. In some embodiments, engagement of the ramps resists and/or prevents inadvertent advancement of more than one day.

[0033] The present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. In some embodiments, as used in the specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from“about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent“about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references“upper” and“lower” are relative and used only in the context to the other, and are not necessarily“superior” and“inferior”.

[0034] As used in the specification and including the appended claims, “treating” or“treatment” of a disease or condition may include administering one or more medications to a patient (human or other mammal). Alleviation can occur prior to signs or symptoms of the disease or condition appearing, as well as after their appearance. Thus, treating or treatment includes preventing or prevention of disease or undesirable condition (e.g., preventing the disease from occurring in a patient, who may be predisposed to the disease but has not yet been diagnosed as having it). In addition, treating or treatment does not require complete alleviation of signs or symptoms, does not require a cure, and specifically includes procedures that have only a marginal effect on the patient. Treatment can include inhibiting the disease, e.g., arresting its development, or relieving the disease, e.g., causing regression of the disease. For example, treatment includes, but is not limited to, reducing acute or chronic inflammation, inducing an anti-platelet effect, reducing hypertension, and lowering cholesterol.

[0035] In some embodiments, a biologically-active substance includes any substance or substances comprising a medicament, medication or drug including an active therapeutic substance, metabolite, hormone, steroid, vitamin, fatty acid, amino acid, sugar, carbohydrate, polypeptide or mineral. In some embodiments, a biologically- active substance includes any substance used for treatment, prevention, diagnosis, cure or mitigation of disease or illness. In some embodiments, a biologically-active substance includes any substance that affects anatomical structure or physiological function. In some embodiments, a biologically-active substance includes any substance that alters the impact of external influences on an animal, or metabolite thereof. In some embodiments, a complex dosing regimen includes a systematic administration of multiple dosage units at designated times during the day. In some embodiments, a dose includes each individual release of substance into body tissue.

[0036] The following discussion includes a description of a medicament dispensing system including medicament packaging, a medicament dispensing container, related components and methods of employing the medicament dispensing system. Alternate embodiments are also disclosed. Reference is made in detail to the exemplary embodiments of the present disclosure, which are illustrated in the accompanying figures. Turning to FIGS. 1 -13, there are illustrated components of a medicament dispensing system 10.

[0037] The components of medicament dispensing system 10, individually or collectively, can be fabricated from materials suitable for storage and dispensing of medication. In some embodiments, such materials include metals, ceramics, synthetic polymers such as thermoplastics, semi-rigid and rigid materials, elastomers, fabric and/or their composites. Various components of medicament dispensing system 10 may have material composites, including the above materials, to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, and durability. The components of medicament dispensing system 10, individually or collectively, may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials. The components of medicament dispensing system 10 may be monolithically formed, integrally connected or include fastening elements and/or instruments, as described herein.

[0038] In some embodiments, as shown in FIGS. 1 -13, medicament dispensing system 10 includes a medication container, such as, for example, medication bottle 12. Bottle 12 includes an opening at a top end 14 and an oppositely positioned base 16. In some embodiments, bottle 12 includes a circular cross-section. In some embodiments, bottle 12 may include cross-section shapes, such as, for example, round, partially cylindrical, oval, rectangular, polygonal, irregular, tapered, offset, staggered, uniform and non-uniform.

[0039] Bottle 12 defines an inner cavity configured to receive medications, such as, for example, dosage units as part of a medication dosage regimen. In some embodiments, the cavity is divided into a number of compartments by partitions. For example, the cavity may be divided into two, three, four, or more compartments that are radially arrayed in the cavity. In some embodiments, the compartments can be variously and/or differently sized and configured for disposal of one or more medications. In some embodiments, bottle 12 is transparent or semi-transparent to allow a patient to monitor the remaining amount of medications in the cavity.

[0040] Bottle 12 includes a surface 20 that is configured to be handled by a patient to access the medications stored therein. In some embodiments, surface 20 may have alternate surface configurations, such as, for example, rough, arcuate, undulating, mesh, porous, semi-porous, dimpled and/or textured to facilitate gripping by a patient. In some embodiments, surface 20 includes ergonomic features, such as, for example, rubberized inserts or grooves to conform to a user’s grip. In some embodiments, bottle 12 may comprise indicia on surface 20 in the form of a label 22. In some embodiments, label 22 provides the time and order in which the medications are to be taken by the patient. In one embodiment, bottle 12 is labeled to indicate the day of the dosage regimen the medication should be taken. Label 22 may include graphics to indicate the time of day the medication should be taken. Label 22 may indicate the name and/or nature of the medication held in the cavity. Label 22 may include a list of possible side effects of the medication held in the cavity. Label 22 may provide instructions on how long a patient should take the medication held in the cavity. In some embodiments, label 22 may provide color coding to differentiate the medications held within the various compartments of the cavity. In various embodiments, the indicia of label 22 are screen printed on bottle 12. In some embodiments, the indicia may be hand written. In some embodiments, label 20 may comprise a sticker containing the indicia to be adhered to a portion of bottle 12. [0041] Bottle 12 includes a neck portion 24 positioned opposite base 16. Neck portion 24 extends from bottle 12 and includes an outer surface 26 having threads 28. In some embodiments, threads 28 may include a single thread turn or a plurality of discrete threads. In some embodiments, threads 28 comprise child-resistant features, such as, for example, a gap in threads 28 to correspond with a tab in the threads of a lid, as discussed herein.

[0042] In some embodiments, medicament dispensing system 10 includes a closure member, such as, for example, a lid 30. Lid 30 is disposable with bottle 12 between an open configuration and a closed configuration, which includes one or more advance positions to incrementally advance indicia of a medication dosage regimen, as described herein. In the open configuration, medication disposed within bottle 12 is accessible. In the closed configuration, lid 30 is fixed with bottle 12. In the advance position, lid 30 is incrementally advanced to a next indicia of a medication dosage regimen. Lid 30 is configured to aid a user in maintaining compliance with a dosage regimen. Lid 30 includes closure elements, such as, for example, an inner cap 40, an outer cap 42, a ring cap 44 and an over cap 46, as shown in FIG. 2.

[0043] Inner cap 40 includes a circumferential sidewall 50 extending from the periphery of a top 52, as shown in FIGS. 3-7. Top 52 includes a surface 54 that includes child-resistant elements 56 that define slots 58 engageable with child resistant structure disposed with outer cap 42, as described herein, to prevent a child from opening medicament dispensing system 10. Sidewall 50 includes an outer surface sized to facilitate a friction fit with the inner surface of outer cap 42. Sidewall 50 includes inner threads 59 configured to engage threads 28 of neck portion 24 of bottle 12, as described herein.

[0044] Outer cap 42 includes a circumferential sidewall 60 extending from the periphery of a top 62, as shown in FIGS. 8 and 9. Top 62 includes an inner surface 64 that includes child-resistant features. In some embodiments, the child resistant features include protrusions, such as, for example, lugs 66. Lugs 66 are configured to engage a surface of slots 58 to prevent a child from opening medicament dispensing system 10, as described herein. Sidewall 60 includes an inner surface sized to facilitate a friction fit with the outer surface of inner cap 40. [0045] In some embodiments, removal of lid 30 requires a patient to push down and rotate lid 30 relative to bottle 12. Surface 64 includes an element, such as, for example, a pair of spring arms 68. Arms 68 each include a protuberance 69 oriented to extend between outer cap 42 and inner cap 40 to space lugs 66 from slots 58 such that outer cap 42 is rotatable relative to inner cap 40. In some embodiments, surface 64 can include one or a plurality of arms 68.

[0046] Arms 68 are flexible and/or resiliently biased to engage inner cap 40. Protuberances 69 extend between outer cap 42 and inner cap 40 such that outer cap 42 is spaced from inner cap 40. Lugs 66 are spaced from slots 58 and caps 40, 42 are permitted to relatively rotate. A force applied to top 62 overcomes the spring bias of arms 68 such that arms 68 and protuberances 69 elastically deform allowing surface 64 to deform. As surface 64 deforms, lugs 66 are moved into slots 58 for engagement with elements 56. Engagement of lugs 66 with elements 56 fixes outer cap 42 with inner cap 40 such that rotation of outer cap 42 simultaneously rotates caps 40, 42 to dispose lid 30 and bottle 12 in an open configuration. If the force applied to lid 30 is not adequate to engage lugs 66 with slots 58, outer cap 42 will rotate freely relative to inner cap 40 and inner cap 40 and outer cap 42 are not engaged to release the child resistant features, as described herein.

[0047] Outer cap 42 includes a surface 70 disposed circumferentially about top 62. Surface 70 includes a plurality of protrusions, such as, for example, ramps 72. Ramps 72 are configured for engagement with ring cap 44, as described herein. Ramps 72 are positioned about outer cap 42 such that movement of ring cap 44 between ramps 72 advances lid 30 a single dose and displays indicia 102, as described herein.

[0048] Top 62 includes one or more stops 82. Stops 82 are configured for engagement with a portion of over cap 46. Stops 82 are configured to resist and/or prevent rotation of over cap 46 to advance indicia 102. In some embodiments, stops 82 comprise a unit of advance and/or increment of indicia for one or more components of a dosage regimen.

[0049] Outer cap 42 includes a surface 90 that defines an opening 92. Outer cap 42 includes an extension, such as, for example, a flexible arm 94. Arm 94 extends into opening 92. Arm 94 includes an angled portion, such as, for example, a finger 96. A surface of finger 96 is configured for engagement with a surface of over cap 46 to provide audible indicia of advancement of lid 30, as described herein. Arm 94 is moveable between a closed orientation, an opened orientation and an advanced orientation, as described herein.

[0050] Ring cap 44 includes an outer surface 100 that includes indicia 102. Indicia 102 are disposed circumferentially about surface 100. Ring cap 44 includes an outer surface configured to receive over cap 46 having a window for viewing indicia 102, as described herein. In some embodiments, indicia 102 are printed onto an outer circumferential sidewall of ring cap 44. In some embodiments, indicia 102 are presented to represent days of the week and are radially arrayed and spaced evenly about the sidewall of ring cap 44. In some embodiments, indicia 102 are presented to represent times of the day in which a medication is to be taken by a user. In some embodiments, indicia 102 are presented as a combination of time and day in which a medication is to be taken by a user. Ring cap 44 includes an opening 104. Opening 104 is configured for disposal of outer cap 42.

[0051] Lid 30 includes an advancement mechanism configured to advance an increment of indicia 102 to a sequential increment of indicia 102 representing a reminder for the next dosage to be taken, to facilitate compliance with a dosage regimen. In some embodiments, the advancement mechanism includes an engagement between ring cap 44 and over cap 46 and an engagement between ring cap 44 and outer cap 42. Ring cap 44 includes a plurality of circumferential arms 106. Arms 106 each include a ramp 108 oriented in a direction, for example, towards a selected surface of over cap 46. Ramps 108 provide a torque resistance while lid 30 is rotated into the closed orientation followed by an audible click as ramps 108 translate over ramps 190 on over cap 46. The audible click indicates that the day is advanced and lid 30 is closed tight enough to ensure proper function, for example, day advancement, in the next removal and closure cycle of lid 30. In some embodiments, ramps 108, 190 and arms 106 are tuned and/or selectively flexible to a selected torque level.

[0052] Ring cap 44 includes a plurality of circumferential arms 120. Arms 120 each include a ramp 122 oriented in an opposite direction relative to the direction of ramp 108, for example, towards a selected surface of outer cap 42. Ramps 122 provide a torque resistance while lid 30 is rotated to the open orientation followed by an audible click as ramps 122 translate over ramps 72 of outer cap 42. In some embodiments, ramps 122 are configured to translate over ramps 72 and are tuned and/or selectively flexible at a low torque setting to ensure resetting of lid 30 before lid 30 is removed from bottle 12. After reset and removal of lid 30, the day indicator will advance in the next step.

[0053] Arms 106, 120 define a channel 124 therebetween, as shown in FIG. 10. Channel 124 is configured for disposal of ramps 72 and teeth 190 in a medication accessible configuration. In some embodiments, arms 106, 120 are disposed in an alternating orientation and/or direction configuration. In some embodiments, arms 106, 120 includes seven arms to facilitate a daily dose regimen advancement. Arms 106, 120 are positioned about ring cap 44 such that movement of over cap 46 advances over cap 46 a single dose and displays indicia 102. In some embodiments, engagement of ramps 108 with over cap 46 and ramps 122 with outer cap 42 resists and/or prevents inadvertent advancement of more than one day.

[0054] Over cap 46 is configured to aid a user in maintaining compliance with a complex dosage regimen. Over cap 46 includes a circumferential sidewall 140 extending from the periphery of a top surface 142. In some embodiments, surface 142 is solid and continuous. Over cap 46 includes an inner diameter that is configured to fit snugly over cap 42 and ring cap 44. In some embodiments, over cap 46 attaches to cap 42 and ring cap 44 by a pressure fit or a friction fit.

[0055] In some embodiments, over cap 46 allows a user to view indicia 102 to aid a user in complying with a dosage regimen. Over cap 46 includes a window 144 in sidewall 140 which is sized to align with indicia 102 disposed on ring cap 44. Window 144 may be variously configured and have a variety of shapes. For example, in various embodiments, window 144 is square shaped, circular, oval, trapezoidal, rhomboid, polygonal, kidney shaped, regular, or irregular. Window 144 is sized to allow visibility of indicia 102, as shown in FIG. 1 . In some embodiments, window 144 is sized to provide visibility for at least one letter representing a day of the week. In some embodiments, over cap 46 includes an indicator to aid in directing a user’s attention to window 144. In some embodiments, the indicator is shown as an arrow printed onto surface 142. In some embodiments, the indicator may include, such as, for example, a dash or a line pointing in the direction of window 48. In some embodiments, over cap 46 is transparent or semi- transparent to allow a user to view indicia 102 in the context of surrounding indicia. In some embodiments, as shown in FIG. 1 , window 144 is turned to align with“Su” of indicia 102, representing a reminder for a medication to be taken on Sunday. The indicia surrounding“Su” are“Mo” and“Sa” representing a reminder for a medication to be taken on Monday and Saturday. The surrounding indicia are viewable through sidewall 140 on either side of window 144. In some embodiments, the entirety of over cap 46 is transparent or semi-transparent such that all indicia 102 is visible through sidewall 140. In some embodiments, gripping ridges are disposed around the circumference of sidewall 140. The ridges project from the surface of sidewall 140 to aid a user in rotating lid 30 or over cap 46. In some embodiments, the ridges are also transparent or semi-transparent to allow a user to see indicia 102. In some embodiments, the ridges may distort the visibility of indicia 102 to obscure portions of indicia 102 that are not aligned with window 144. In other embodiments, over cap 46 is opaque or translucent to prevent visibility of indicia 102 that are not aligned with window 144.

[0056] In some embodiments, over cap 46 includes a surface 150 that defines a plurality of ribs 152. Ribs 152 are configured for engagement with stops 82 to facilitate advancement of indicia 102. Over cap 46 and ring cap 44 rotate together and/or simultaneously such that ribs 152 rotate between stops 82 in a counter-clockwise direction to a limit of travel at ribs 152. Ribs 152 engage stops 82 such that lid 30 rotates in the counter-clockwise direction and lid 30 is removed from bottle 12. In some embodiments, lid 30 is unthreaded from bottle 12.

[0057] In conjunction with ribs 152 and stops 82, lid 30 includes a locking element 160 configured to facilitate indication of opening, closing and advancement of lid 30. Locking element 160 includes a lateral ramp 162 having a surface 164 and a lateral ramp 168 having a surface 170. Ramps 162, 168 are connected by a surface 172. Locking element 160 includes a surface 174 that defines a recess 176. In a closed configuration of bottle 12, finger 96 is initially disposed adjacent surface 164 of ramp 162. To remove lid 30, over cap 46 is rotated counter clockwise relative to cap 42 and ring cap 44, causing arm 94 to flex inward. Flexing of arm 94 inward allows finger 96 to translate along surface 172. As arm 94 flexes back, finger 96 translates along surface 170 of ramp 168 into a bottle open orientation such that lid 30 can be removed from bottle 12.

[0058] Lid 30 is replaced by positioning finger 96 adjacent ramp 168. Lid 30 is rotated clockwise causing finger 96 to translate over ramp 168 into recess 176 into a closed configuration of bottle 12. In some embodiments, translation of finger 96 over ramp 168 causes a tactile click. In some embodiments, translation of finger 96 over ramp 168 causes an audible click. Lid 30 is further rotated clockwise such that finger 96 translates out of recess 176 along a surface 178 into a position adjacent ramp 162, returning to a bottle advanced and closed orientation. In some embodiments, translation of finger 96 over surface 178 and onto ramp 162 causes a tactile click. In some embodiments, translation of finger 96 over surface 178 and onto ramp 162 causes an audible click.

[0059] Over cap 46 includes a protrusion, such as, for example, a plurality of teeth 190. Teeth 190 are disposed circumferentially about over cap 46, as shown in FIG. 12. Teeth 190 are configured to translate over arms 106, 120 and ramps 108 to facilitate incremental rotation of over cap 46 relative to outer cap 42 and ring cap 44. In some embodiments, over cap 46 may include one or more teeth 190.

[0060] In some embodiments, over cap 46 includes an end 200 that extends a minimum clearance of a shoulder of bottle 12, as shown in FIG. 13. In some embodiments, over cap 46 extends with a radius R along the shoulder of bottle 12.

[0061] In some embodiments, bottle 12 comprises a disposable dispensing device that provides therapeutic and/or nutritional support to an animal by increasing compliance with a dosing regimen. In some embodiments, a dose of medicament, medication or drug can include, such as, for example, a chewable tablet, quick dissolve tablet, effervescent tablet, reconstitutable powder, elixir, liquid, solution, suspension, emulsion, tablet, multi-layer tablet, bi-layer tablet, capsule, soft gelatin capsule, hard gelatin capsule, caplet, lozenge, chewable lozenge, bead, powder, granules, dispersible granules, cachets, douche, suppository, cream, topical, inhalant, aerosol inhalant, patch, particle inhalant, implant, depot implant, dragee, ampoule, ingestible, injectable, infusion, health bar, liquid, food, nutritive food, functional food, yogurt, gelatin, cereal, cereal coating, animal feed and/or combinations thereof. [0062] In some embodiments, indicia of a medication regimen, direction, instruction and/or prescription for administration of a medication regimen may include dosage day indicia, a specific day of the week, such as Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday or an abbreviation of said day, a specific date or a general succession of days, such as day 1 , day 2, day 3. In some embodiments, indicia may include time indicia that may be, such as, for example, a general time of the day or a specific time of the day, such as, for example, AM, PM, morning, afternoon, evening, day, night, daytime, nighttime and combinations thereof. In some embodiments, indicia may include each separate row or column on bottle 12 indicating a time of day, such as AM doses and PM doses. In some embodiments, bottle 12 may be color coded for time indicia. In some embodiments, one or more components of medicament dispensing system 10 may include a key defining or explaining color coding.

[0063] In some embodiments, a dose of medicament, medication or drug may comprise vitamin A, B vitamins, vitamin C, vitamin D, vitamin E, vitamin K, essential fatty acids, folic acid, iron, calcium, magnesium, potassium, copper, chromium, zinc, molybdenum, iodine, boron, selenium, manganese, derivatives thereof and/or combinations thereof. In some embodiments, biologically-active substances may include thiamin, thiamin pyrophosphate, riboflavin, flavin mononucleotide, flavin adenine dinucleotide, niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine dinucleotide, tryptophan, biotin, pantothenic acid, ascorbic acid, retinol, retinal, retinoic acid, beta-carotene, 1 ,25-dihydroxycholecalciferol, 7-dehyrdocholesterol, alpha- tocopherol, tocopherol, tocotrienol, menadione, menaquinone, phylloquinone, naphthoquinone, calcium, calcium carbonate, calcium sulfate, calcium oxide, calcium hydroxide, calcium apatite, calcium citrate-malate, calcium gluconate, calcium lactate, calcium phosphate, calcium levulinate, phosphorus, potassium, sulfur, sodium, docusate sodium, chloride, magnesium, magnesium stearate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium sulfate, copper, iodine, zinc, chromium, molybdenum, carbonyl iron, ferrous fumarate, polysaccharide iron, and/or combinations and derivatives thereof.

[0064] In some embodiments, a dose of medicament, medication or drug may be prescription and/or non-prescription substances. In some embodiments, the prescription substance may be a hormone replacement agent, a contraceptive agent, an osteoporotic agent, a chemotherapeutic agent, an anti-infective agent, analgesic, a steroid, an appetite suppressant, a weight loss agent, a tobacco antagonist, a cholesterol reducer and/or combinations thereof.

[0065] In some embodiments, the prescription substances may include, such as, for example, erythromycin, penicillins, cephalosporins, theophylline, albuterol, terbutaline, diltiazem, propranolol, nifedepine, clonidine, thioridazine, diazepam, meclizine, ergoloid mesylates, chlorpromazine, carbidopa, levodopa, beclomethasone diproprionate, budesonide, dexamehasone, flunisolide, fluticasone proprionate, mometasone furoate, triamcinolone acetonide, beconase, pulmicort, rhinocort, decadron, aerobid/nasolide, flovent/flonase, azmacort, amprenavir, adefovir dipivoxil, zidovudine, azidothymidine, AZT, paclitaxel, cyclophosphamide, teniposide, taxol, cytoxan, vumon, methotrexate, methotrexate, cisplatin, carboplatin, oxaliplatin, platinol, paraplatin, adriamycin, bleomycin, dactinomycin, daunorubicin, doxorubicin, indarubicin, mitomycin, blenoxane, cosmegen, cerubidine, rubex, indamycin, mutamycin, BCNU, streptozocin, vinblastine, thiotepa, conjugated estrogens, esterified estrogens, estropipate, estradiol, ethinyl estradiol, medroxyprogesterone, meprobamate, desogestrel, levonorgestrel, norethindrone, norethindrone acetate, norgestimate, norgestrel, raloxifene, tamoxifen, methyltestosterone, quinapril, losartan, sotalol, alendronate, atorvastatin, colestipol, clofibrate, and/or combinations thereof.

[0066] In some embodiments, the non-prescription substance can be a vitamin or derivative thereof, and/or a mineral compound or derivative thereof. In some embodiments, the vitamin or mineral compound may be, such as, for example, thiamin, thiamin pyrophosphate, riboflavin, flavin mononucleoride, flavin adenine dinucleotide, niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine dinucleotide, tryptophan, biotin, folic acid, pantothenic acid, ascorbic acid, retinol, retinal, retinoic acid, beta-carotene, 1 ,25-dihydroxycholecalciferol, 7-dehydrocholesterol, alpha-tocopherol, tocopherol, tocotrienol, menadione, menaquinone, phylloquinone, naphthoquinone, calcium, calcium carbonate, calcium sulfate, calcium oxide, calcium hydroxide, calcium apatite, calcium citrate-malate, calcium gluconate, calcium lactate, calcium phosphate, calcium levulinate, phosphorus, potassium, sulfur, sodium, docusate sodium, chloride, magnesium, magnesium stearate, magnesium carbonate, magnesium oxide, magnesium hydroxide, magnesium sulfate, copper, iodine, zinc, chromium, molybdenum, carbonyl iron, ferrous fumarate, polysaccharide iron, and combinations and derivatives thereof. In some embodiments, the derivatives of vitamin compounds include salts, alkaline salts, esters and chelates of any vitamin compound. In some embodiments, the nonprescription substance can be an herbal compound, herbal extract, derivative thereof and/or combinations thereof.

[0067] In use, bottle 12, having lid 30, is disposed in a closed configuration and portable such that the user/patient transports and/or carries bottle 12 upon discharge. At a time specified by indicia 102 positioned in window 144, a user rotates lid 30 from the closed configuration to an open configuration. Protuberances 69 bias outer cap 42 and inner cap 40 to space lugs 66 from slots 58 such that outer cap 42 is rotatable relative to inner cap 40. As such, lid 30/bottle 12 includes a child resistant configuration to resist and/or prevent lid 30 removal from bottle 12 by a child, as described herein.

[0068] To remove lid 30, a user applies a downward force, in a direction shown by arrow A in FIG. 13, onto lid 30 to overcome the resilient spring bias of arms 68 and protuberances 69, as described herein. Surface 64 deforms and lugs 66 are moved into slots 58 for engagement with elements 56. Engagement of lugs 66 with elements 56 fixes outer cap 42 with inner cap 40 such that rotation of outer cap 42 simultaneously rotates caps 40, 42. Ramps 72 and teeth 190 are disposed with channels 124 such that inner cap 40, outer cap 42, ring cap 44 and over cap 46 simultaneously rotate to dispose lid 30 and bottle 12 in an open configuration. If the force applied to lid 30 is not adequate to overcome the spring bias of protuberances 68, lugs 66 remain spaced and disengaged from elements 56 such that outer cap 42 will continue to rotate freely relative to inner cap 40, as described herein.

[0069] Lid 30 is rotated relative to bottle 12 in a counter clockwise rotation to dispose lid 30/bottle 12 in an open configuration. In the open configuration, over cap 46 is prevented from advancing by arms 106, 120. For example, teeth 190 are disposed with channels 124 in a start position such that arms 120 and engagement of ramps 122 with outer cap 42 resists and/or prevents counter clockwise rotation of over cap 46 relative to ring cap 44 to maintain position of window 144 relative to indicia 102. Bottle 12 is disposed in a medication accessible configuration and a user takes a dosage of medication as required by a dosage regimen.

[0070] To dispose lid 30/bottle 12 in a closed configuration, the user engages lid 30 with neck portion 24 and rotates lid 30 in a clockwise direction. Threads 59 engage threads 28 to fix lid 30 with bottle 12 in the closed configuration. Threads 59, 28 are engaged in a fixed orientation and over cap 46 is rotatable relative to outer cap 42 subject to the advancement mechanism, as described herein. For example, in the start position, teeth 190 are disposed with channels 124 representing a start position. As over cap 46 is rotated relative to outer cap 42 and ring cap 44, teeth 190 slide over arms 106, 120 and ramps 108 to a successive channel 124 representing an advance channel or position in circumferential rotation to incrementally advance indicia 102 to window 144 in connection with a medication dosage regimen. Teeth 190 translate over ramps 108 to provide audible indicia of advancement of lid 30 in a clockwise direction for advancement of window 144 into alignment with indicia 102, as described herein. Rotation of over cap 46 rotates window 144 from an increment of indicia 102 representing a dosage taken to a sequential increment of indicia 102 representing a reminder for a next dosage to be taken, to facilitate compliance with a dosage regimen. For example, window 144 is initially aligned with“Su” of indicia 102, representing a reminder for a medication to be taken on Sunday. Window 144 is rotated to“Mo” representing a reminder for a medication to be taken on Monday.

[0071] In some embodiments, to reset or advance lid 30 to a desired day, over cap 46 is rotated until window 144 is positioned with the desired indicia. The audible click will indicate the increment of indicia 102 during each rotation. Teeth 190 are disposed with channels 124 and returned to a start position such that arms 120 and ramps 122 resist and/or prevent counter clockwise rotation of over cap 64 relative to ring cap 44 to maintain the position of window 144 relative to indicia 102.

[0072] In some embodiments, as shown in FIG. 14, medicament dispensing system 10, similar to the systems and methods described herein, includes a lid 330, described herein, which includes an inner cap 40, a ring cap 42 and an over cap 46, as described herein, and an outer cap 342, similar to outer cap 42 as described herein. [0073] Outer cap 342 includes a circumferential sidewall 360 extending from the periphery of a top 362. Top 362 includes an inner surface 364 that includes child- resistant features, as described herein. Surface 364 includes a pair of spring arms 368, similar to spring arms 68 as described herein, oriented to extend between outer cap 342 and inner cap 40 such that outer cap 342 is rotatable relative to inner cap 40, as described herein.

[0074] Outer cap 342 includes a surface 370 disposed circumferentially about top 362. Surface 370 includes a plurality of ramps 372, similar to ramps 72 as described herein. Ramps 372 are configured for engagement with ring cap 44, as described herein. Top 362 includes one or more stops 382, similar to stops 82 as described herein, configured for engagement with a portion of over cap 46.

[0075] It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

WHAT IS CLAIMED IS:

1 . Medication packaging comprising: a body defining a cavity for disposal of medication; and a closure member disposable with the body and including a medication accessible configuration and a closed configuration, the closure member including a first cap, a second cap and a third cap, the third cap including at least one first circumferential arm and at least one second circumferential arm, and a ramp of the first arm being oriented in a first direction and a ramp of the second arm being oriented in a second opposing direction, the ramp of the second arm being engageable with the second cap in the closed configuration to incrementally advance indicia of a medication dosage regimen.

2. Medication packaging as recited in Claim 1 , wherein the second cap includes ramps configured for engagement with the arms of the third cap.

3. Medication packaging as recited in Claim 2, wherein the ramps are disposed in circumferential alignment.

4. Medication packaging as recited in Claim 1 , wherein the at least one first arm and the at least one second arm are spaced apart to define a channel.

5. Medication packaging as recited in Claim 4, wherein the channel is configured for disposal of a portion of the first cap and a portion of the second cap in a start position and/or an advance position of the closure member.

6. Medication packaging as recited in Claim 1 , wherein the second cap includes at least one stop member.

7. Medication packaging as recited in Claim 6, wherein the first cap includes at least one rib configured to engage the at least one stop member to facilitate advancement of the closure member.

8. Medication packaging as recited in Claim 7, wherein the at least one rib extends in a radial orientation from a center of the first cap.

9. Medication packaging as recited in Claim 7, wherein the at least one rib includes a plurality of spaced apart ribs.

10. Medication packaging as recited in Claim 7, wherein the ribs are spaced apart to define an arc length that defines a unit of advance and/or increment of indicia for the dosage regimen.

11. Medication packaging as recited in Claim 1 , wherein the third cap includes a ring configuration.

12. Medication packaging as recited in Claim 1 , wherein the third cap includes a indicia for the dosage regimen.

13. Medication packaging as recited in Claim 1 , wherein the closure member further includes a fourth cap.

14. Medication packaging as recited in Claim 13, wherein the fourth cap includes at least one slot configured for disposal of at least one lug of the second cap such that the second cap and the fourth cap are simultaneously rotatable.

15. Medication packaging as recited in Claim 14, further including a bias element disposed between the second cap and the fourth cap to space the at least one lug from the at least one slot such that the second cap is rotatable relative to the fourth cap.

16. Medication packaging as recited in Claim 15, wherein the bias element includes at least one spring arm.

17. Medication packaging comprising: a body defining a cavity for disposal of medication; and a closure member disposable with the body and including a medication accessible configuration and a closed configuration such that the closure member is rotatable to incrementally advance indicia of a medication dosage regimen, the closure member including an inner cap, an outer cap, a ring cap and an over cap, the ring cap including at least one first circumferential arm and at least one second circumferential arm, a ramp of the first arm being oriented in a first direction and a ramp of the second arm being oriented in a second opposing direction, the ramp of the second arm being engageable with the outer cap in the closed configuration to incrementally advance indicia of the medication dosage regimen, the outer cap having at least one lug and the inner cap having at least one slot configured for disposal of the at least one lug such that the outer cap and the inner cap are simultaneously rotatable.

18. Medication packaging as recited in Claim 17, wherein the at least one first arm and the at least one second arm are spaced apart to define a channel therebetween.

19. Medication packaging as recited in Claim 18, wherein the channel is configured for disposal of a portion of the outer cap cap and a portion of the over cap in a start position and/or an advance position of the closure member.

20. Medication packaging as recited in Claim 18, wherein the outer cap includes at least one rib configured to engage at least one stop member of the outer cap to facilitate advancement of the closure member.

21 . Medication packaging comprising: a body defining a cavity for disposal of medication; a closure member disposable with the body and including a medication accessible configuration and a closed configuration such that the closure member is rotatable to incrementally advance indicia of a medication dosage regimen, the closure member including a first cap, a second cap, a third cap and a fourth cap, the third cap including at least one first circumferential arm and at least one second circumferential arm, a ramp of the first arm being oriented in a first direction and a ramp of the second arm being oriented in a second opposing direction, the ramp of the second arm being engageable with the second cap in the closed configuration to incrementally advance indicia of a medication dosage regimen; the second cap having at least one lug and the fourth cap having at least one slot configured for disposal of the at least one lug such that the second cap and the fourth cap are simultaneously rotatable; and a bias element disposed between the second cap and the fourth cap to space the at least one lug from the at least one slot such that the second cap is rotatable relative to the fourth cap.