WO2020072582A1 - Emballage de médicament et système de régime posologique - Google Patents

Emballage de médicament et système de régime posologique

Info

Publication number
WO2020072582A1
WO2020072582A1 PCT/US2019/054201 US2019054201W WO2020072582A1 WO 2020072582 A1 WO2020072582 A1 WO 2020072582A1 US 2019054201 W US2019054201 W US 2019054201W WO 2020072582 A1 WO2020072582 A1 WO 2020072582A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
medication
recited
indicia
closure member
Prior art date
Application number
PCT/US2019/054201
Other languages
English (en)
Inventor
Jeffrey Warden
Bradley Philip
John GAFNEY
Eric Richardson
Original Assignee
Mylan Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mylan Inc. filed Critical Mylan Inc.
Publication of WO2020072582A1 publication Critical patent/WO2020072582A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076—Medicament distribution means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/20—Colour codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076—Medicament distribution means
    • A61J7/0084—Medicament distribution means for multiple medicaments

Definitions

  • 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.
  • 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.
  • 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.
  • hospitalized patients are often discharged and instructed by one or more medical practitioners to comply with a medical therapy.
  • 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.
  • Such medication regimens 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.
  • 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.
  • 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 having at least one rib and a second cap having a plurality of spaced apart protrusions being engageable with the at least one rib in the closed configuration to incrementally advance indicia of a medication dosage regimen.
  • the medication packaging incudes a body that defines 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 further includes an over cap, an outer cap having at least one lug and an 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.
  • a bias element is disposed between the outer cap and the inner cap to space the at least one lug from the at least one slot such that the second cap is rotatable relative to the inner cap.
  • 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.
  • the closure member includes an over cap having at least one rib and an outer cap having a plurality of spaced apart protrusions being engageable with the at least one rib such that the closure member is rotatable to incrementally advance indicia of a medication dosage regimen in the closed configuration.
  • the closure member further includes an inner cap having at least one slot configured for disposal of at least one lug of the outer cap such that the outer cap and the inner cap are simultaneously rotatable.
  • a bias element is disposed between the outer cap and the inner cap to space the at least one lug from the at least one slot such that the outer cap is rotatable relative to the inner cap.
  • FIG. 1 is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure
  • FIG. 2 is a side view of components of one embodiment of a system in accordance with the principles of the present disclosure
  • FIG. 3 is a top view of the components shown in FIG. 2;
  • FIG. 4 is a perspective view of the components shown in FIG. 2;
  • FIG. 5 is a bottom view of the components shown in FIG. 2;
  • FIG. 6 is a perspective view of the components shown in FIG. 2;
  • FIG. 7 is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure.
  • FIG. 8 is a bottom view of the components shown in FIG. 7;
  • FIG. 9 is a top view of the components shown in FIG. 7;
  • FIG. 10 is a perspective view of the components shown in FIG. 7;
  • FIG. 11 is a perspective view of components of one embodiment of a system in accordance with the principles of the present disclosure.
  • FIG. 12 is a side view of the components shown in FIG. 11 ;
  • FIG. 13 is a perspective view of the components shown in FIG. 11 ;
  • FIG. 14 is a bottom view of the components shown in FIG. 11 ;
  • FIG. 15 is a cross section view of components of one embodiment of a system in accordance with the principles of the present disclosure.
  • FIG. 16 is a break away, cross section view of components of one embodiment of a system in accordance with the principles of the present disclosure
  • FIG. 17 is a break away, cross section view of components of one embodiment of a system in accordance with the principles of the present disclosure.
  • FIG. 18 is a break away, cross section view of components of one embodiment of a system in accordance with the principles of the present disclosure.
  • 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 and more particularly.
  • 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.
  • 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.
  • 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.
  • 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.
  • the systems and methods of the present disclosure include a medicament dispensing device that provides child-resistance while being easily accessed by an adult.
  • 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.
  • 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
  • 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
  • the present system includes a medicament dispensing system that includes a medication container having a threaded screw top to engage a child-resistant lid.
  • the container body includes a neck portion having threads to engage the lid.
  • the medicament dispensing system is partially or entirely filled by a pharmacist.
  • the medicament dispensing system provides child-resistance and is easily accessible by an adult.
  • 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.
  • the present system includes a medicament dispensing system comprising a bottle and a lid.
  • the lid includes an inner cap, an outer cap and an over cap.
  • the medicament dispensing system includes child resistant features.
  • the medicament dispensing system includes features, such as, for example, flanges disposed with the outer cap.
  • the flanges are configured to engage the inner cap such that the inner cap and the outer cap simultaneously rotate to facilitate fastening the lid with the bottle.
  • the medicament dispensing system includes spring bumps configured to facilitate disengagement of the child resistant features.
  • the present medicament dispensing system includes a medication container having a lid that includes an advancement mechanism.
  • the advancement mechanism includes ramps disposed on a top surface of an outer cap.
  • the advancement mechanism includes ribs disposed with an inner surface of an over cap. The ribs are configured for translation relative to the ramps to facilitate advancement of indicia of a medicament dosing.
  • the over cap includes a clear window to facilitate viewing indicia of medicament dosing.
  • 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.
  • flanges facilitate simultaneous clockwise rotation of the inner cap and an outer cap.
  • an over cap drives the outer cap causing the flanges to engage.
  • 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.
  • the user continues to rotate the outer cap against the fastening torque.
  • the over cap is rotated until the required day is shown in the window.
  • the present medicament dispensing system includes a medication container opened by applying a downward force to a lid against spring bumps.
  • the applied force engages protrusions of an outer cap with slots of an inner cap.
  • the lid is rotatable counter clockwise to remove the lid from a bottle.
  • the outer cap rotates freely providing three audible clicks per revolution as flanges pass over each other so that the lid will not unscrew from the bottle.
  • the over cap will not advance the indicia during counter clockwise rotation.
  • the present medicament dispensing system includes a medication container with a lid having an increased rotational torque to advance the advancement mechanism.
  • the lid provides an easier and more predictable advancement.
  • the medication container includes a mechanism for resisting and/or preventing torque drop off and/or levelling off.
  • the lid includes an outer cap having a portion with an increased thickness.
  • the lid includes an outer cap having a portion with a rounded edge to provide an increased bearing chamfer between the outer cap and the over cap.
  • the outer cap portion with an increased thickness includes a cut out to provide a vent.
  • the outer cap includes a circumferential rib.
  • the circumferential rib includes a height configured to provide a gap between an inner top surface of the over cap and the circumferential rib. In some embodiments, the circumferential rib includes a height configured to contact an inner top surface of the over cap. In some embodiments, an increased height is configured to limit engagement of the ramps with the ribs when the lid is compressed. In some embodiments, an increased height is configured resist and/or prevent an increased torque from engagement of the ramps and the ribs during opening.
  • 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”.
  • 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.
  • 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).
  • 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.
  • treatment includes, but is not limited to, reducing acute or chronic inflammation, inducing an anti-platelet effect, reducing hypertension, and lowering cholesterol.
  • 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.
  • a biologically- active substance includes any substance used for treatment, prevention, diagnosis, cure or mitigation of disease or illness.
  • 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.
  • FIGS. 1 -15 there are illustrated components of a medicament dispensing system 10.
  • the components of medicament dispensing system 10, individually or collectively, can be fabricated from materials suitable for storage and dispensing of medication.
  • 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.
  • 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.
  • bottle 12 includes a circular cross-section.
  • 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.
  • Bottle 12 defines an inner cavity configured to receive medications, such as, for example, dosage units as part of a medication dosage regimen.
  • the cavity is divided into a number of compartments by partitions.
  • the cavity may be divided into two, three, four, or more compartments that are radially arrayed in the cavity.
  • the compartments can be variously and/or differently sized and configured for disposal of one or more medications.
  • bottle 12 is transparent or semi-transparent to allow a patient to monitor the remaining amount of medications in the cavity.
  • Bottle 12 includes a surface 20 that is configured to be handled by a patient to access the medications stored therein.
  • 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.
  • surface 20 includes ergonomic features, such as, for example, rubberized inserts or grooves to conform to a user’s grip.
  • bottle 12 may comprise indicia on surface 20 in the form of a label 22.
  • label 22 provides the time and order in which the medications are to be taken by the patient.
  • 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.
  • label 22 may provide color coding to differentiate the medications held within the various compartments of the cavity.
  • the indicia of label 22 are screen printed on bottle 12.
  • the indicia may be hand written.
  • label 20 may comprise a sticker containing the indicia to be adhered to a portion of bottle 12.
  • 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.
  • threads 28 may include a single thread turn or a plurality of discrete threads.
  • 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.
  • 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 an inner cap 40, an outer cap 42 and an over cap 44, as shown in FIGS. 2-15.
  • Inner cap 40 includes a circumferential sidewall 50 extending from the periphery of a top 52, as shown in FIGS. 2-6.
  • 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.
  • Sidewall 50 includes a flange 130.
  • Flange 130 is configured to engage a flange 132 of outer cap 42, as described herein. Engagement of flanges 130, 132 facilitates simultaneous clockwise rotation of inner cap 40 and outer cap 42 for fastening of lid 30 with bottle 12.
  • Outer cap 42 includes a circumferential sidewall 60 extending from the periphery of a top 62, as shown in FIGS. 7-10.
  • Top 62 includes an inner surface 64 that includes child-resistant features.
  • 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 inner cap 40.
  • 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, protuberances 68.
  • Protuberances 68 are disposed 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.
  • surface 64 can include one or a plurality of protuberances 68.
  • Protuberances 68 are flexible and/or resiliently biased to engage inner cap 40. As such, outer cap 42 is spaced from inner cap 40 such that lugs 66 are spaced from slots 58 and caps 40, 42 are permitted to relatively rotate. Flanges 130, 132 provide an audible indication of spacing and disengagement of lugs 66 from slots 58. A force applied to top 62 overcomes the spring bias of protuberances 68 such that protuberances 68 elastically deform. 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 to dispose lid 30 and bottle 12 in an open configuration.
  • outer cap 42 will rotate freely relative to inner cap 40 and flanges 130, 132 will provide an audible click upon engagement during rotation. The audible clicks indicate that inner cap 40 and outer cap 42 are not engaged to release the child resistant features.
  • Sidewall 60 includes a surface 70.
  • Surface 70 includes indicia 72.
  • indicia 72 may represent days of the week and are radially arrayed and spaced evenly about sidewall 60.
  • indicia 72 are presented to represent times of the day in which a medication is to be taken by a user.
  • indicia 72 are presented as a combination of time and day in which a medication is to be taken by a user.
  • indicia 72 may include information presented on various surfaces of outer cap 42.
  • indicia 72 may be positioned on a surface that extends diagonally between top 62 and sidewall 60.
  • Lid 30 includes an advancement mechanism configured to advance an increment of indicia 72 to a sequential increment of indicia 72 representing a reminder for the next dosage to be taken, to facilitate compliance with a dosage regimen.
  • the advancement mechanism includes an engagement between outer cap 42 and over cap 44, as described herein.
  • the advancement mechanism includes a plurality of protrusions 82 of outer cap 42 disposed with a surface 80 of top 62, as shown in FIG. 9.
  • protrusions 82 includes a U-shaped configuration.
  • Protrusion 82 includes a ramp 84 having a surface 85 and a ramp 86 having a surface 89. Surfaces 85 of protrusions 82 are disposed in circumferential alignment. Surfaces 89 of protrusions 82 are disposed in circumferential alignment. Ramps 86 are radially spaced apart from ramps 84.
  • Ramps 84, 86 are connected by a wall 88 having a surface 90.
  • a channel 92 is formed between wall 88 and adjacent ramps 84, 86, as shown in FIG. 9.
  • outer cap 42 includes a circumferential rib 87 disposed about surface 80, as shown in FIG. 9.
  • circumferential rib 87 includes a height configured to provide a gap between over cap 44 and circumferential rib 87, as shown in FIG. 15.
  • the advancement mechanism includes a plurality of spaced apart ribs 1 12 disposed with over cap 44. Ribs 1 12 are configured for engagement with ramps 84, 86, as described herein. Ribs 1 12 extend in a radial orientation from a center of over cap 44. In a closed configuration of lid 30 and bottle 12, over cap 44 is rotatable relative to outer cap 42 such that ribs 1 12 are engageable with and along each protrusion 82 between a start position and an advanced position. For example, in the start position, ribs 1 12 are disposed with a channel 92.
  • ribs 1 12 slide over ramps 84, 86 and wall 88 to a successive channel 92 in circumferential rotation to incrementally advance indicia 72 to window 104 in connection with a medication dosage regimen.
  • Ribs 1 12 engage surface 90 of wall 88 to provide audible indicia of advancement of lid 30.
  • the audible indicia include an audible click feature and/or a tactile click feature.
  • each protrusion 82 defines an arc length AL.
  • Arc length AL is a measure of the distance along a curved portion of protrusion 82, such as, for example, along ramp 86, as shown in FIG. 10.
  • Each arc length AL defines a unit of advance and/or increment of indicia 72 for one or more components of a dosage regimen.
  • Ribs 1 12 are circumferentially spaced a distance equal to arc length AL. Ribs 1 12 rotating relative to protrusion 82 indicates a next indicia position.
  • Ribs 1 12 include a leading edge 1 14 and a trailing edge 1 16.
  • leading edge 1 14 includes an angled surface configured to facilitate translation over ramps 84, 86.
  • trailing edge 1 16 is configurated to facilitate engagement of ribs 1 12 with wall 88 to resist and/or prevent rotation in the counter clockwise direction, as described herein.
  • Over cap 44 is configured to aid a user in maintaining compliance with a dosage regimen.
  • Over cap 44 includes a circumferential sidewall 100 extending from the periphery of a top surface 102, as shown in FIGS. 1 1 -14.
  • Over cap 44 includes an inner diameter that is configured to fit snugly over outer cap 42. In some embodiments, over cap 44 attaches to outer cap 42 by a pressure fit or a friction fit.
  • over cap 44 allows a user to view indicia 72 to aid a user in complying with a dosage regimen.
  • Over cap 44 includes window 104 in sidewall 100 which is sized to align with indicia 72.
  • Window 104 is advanced by the advancement mechanism relative to indicia 72, as described herein.
  • Window 104 may be variously configured, and have a variety of shapes.
  • window 104 is square shaped, circular, oval, trapezoidal, rhomboid, polygonal, kidney shaped, regular, or irregular.
  • Window 104 is sized to allow visibility of indicia 72. As shown in FIG. 1 , window 104 is sized to provide visibility for at least one letter representing a day of the week.
  • over cap 44 includes an indicator to aid in directing a user’s attention to window 104.
  • the indicator may include, such as, for example, a dash or a line pointing in the direction of window 104.
  • over cap 44 is transparent or semi-transparent to allow a user to view indicia 72 in the context of surrounding indicia.
  • window 104 is rotated to align with “Su” of indicia 72, 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 100 on either side of window 72.
  • the entirety of over cap 44 is transparent or semi-transparent such that all indicia 72 disposed around sidewall 60 is visible through sidewall 100.
  • gripping ridges 106 are disposed around the circumference of sidewall 100. Ridges 106 project from the surface of sidewall 100 to aid a user in rotating lid 30 or over cap 44.
  • ridges 106 are transparent or semi-transparent to allow a user to see indicia 72 therethrough.
  • ridges 106 distort the visibility of indicia 72 to obscure portions of indicia 72 that are not aligned with window 104.
  • over cap 44 is opaque or translucent to prevent visibility of indicia 72 that are not aligned with window 104.
  • bottle 12 comprises a disposable dispensing device that provides therapeutic and/or nutritional support to an animal by increasing compliance with a dosing regimen.
  • 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.
  • 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.
  • 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.
  • indicia may include each separate row or column on bottle 12 indicating a time of day, such as AM doses and PM doses.
  • bottle 12 may be color coded for time indicia.
  • one or more components of medicament dispensing system 10 may include a key defining or explaining color coding.
  • 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.
  • 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 glucon
  • a dose of medicament, medication or drug may be prescription and/or non-prescription substances.
  • 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.
  • 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,
  • the non-prescription substance can be a vitamin or derivative thereof, and/or a mineral compound or derivative thereof.
  • 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, naphth
  • bottle 12 having lid 30 is disposed in a closed configuration, is portable such that the user/patient transports and/or carries bottle 12 upon discharge.
  • a user rotates lid 30 from the closed configuration to an open configuration.
  • Protuberances 68 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.
  • 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.
  • a user applies a downward force, in a direction shown by arrow A in FIG. 15, onto lid 30 to overcome the resilient spring bias of protuberances 68, 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 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.
  • lid 30 Upon engagement of lugs 66 with slots 58, lid 30 is rotated relative to bottle 12 in a counter clockwise rotation to dispose lid 30/bottle 12 in an open configuration.
  • over cap 44 is prevented from advancing by ribs 1 12.
  • ribs 1 12 are disposed with channels 92 in a start position such that engagement of trailing edge 1 16 with wall 88 resists and/or prevents counter clockwise rotation of over cap 44 relative to outer cap 42 to maintain position of window 104 relative to indicia 72.
  • a user takes a dosage of medication as required by a dosage regimen.
  • 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 44 is rotatable relative to outer cap 42 subject to the advancement mechanism, as described herein. For example, in the start position, ribs 1 12 are disposed with a channel 92 representing a start channel or position. As over cap 44 is rotated relative to outer cap 42, ribs 1 12 slide over ramps 84, 86 and wall 88 to a successive channel 92 representing an advance channel or position in circumferential rotation to incrementally advance indicia 72 to window 104 in connection with a medication dosage regimen. Ribs 1 12 engage surface 90 of wall 88 to provide audible indicia of advancement of lid 30.
  • ribs 1 12 and protrusions 82 allows for rotation of over cap 44 relative to outer cap 42 in a clockwise direction for advancement of window 104 into alignment with indicia 72, as described herein.
  • Rotation of over cap 44 rotates window 104 from an increment of indicia 72 representing a dosage taken to a sequential increment of indicia 72 representing a reminder for a next dosage to be taken, to facilitate compliance with a dosage regimen.
  • window 104 is initially aligned with“Su” of indicia 72, representing a reminder for a medication to be taken on Sunday.
  • Window 104 is rotated to“Mo” representing a reminder for a medication to be taken on Monday.
  • medicament dispensing system 10 similar to the systems and methods described herein, includes a lid 30, described herein, which includes an outer cap 342, similar to outer cap 42 described herein and over cap 44 described herein.
  • Outer cap 342 includes a portion 346 with an increased thickness.
  • Portion 346 includes a rounded edge to provide an increased bearing chamfer between outer cap 342 and over cap 44.
  • portion 346 includes a cut out 348 to provide a vent.
  • medicament dispensing system 10 similar to the systems and methods described herein, includes a lid 30, described herein, which includes an outer cap 442, similar to outer cap 42 described herein and over cap 44.
  • Outer cap 442 includes a circumferential rib 487, similar to rib 87 described herein.
  • Rib 487 includes a height configured to engage an inner top surface of over cap 44. The height of rib 487 is configured to limit engagement of the advancement mechanism, as described herein, when lid 30 is compressed. In some embodiments, the height of rib 487 is configured to resist and/or prevent an increased torque from engagement of the components of the advancement mechanism during opening of bottle 12.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un emballage de médicament qui comprend un corps définissant une cavité pour le dépôt de médicament. Un élément de fermeture est jetable avec le corps et comprend une configuration accessible au médicament et une configuration fermée. L'élément de fermeture comprend un premier capuchon ayant au moins une nervure et un second capuchon ayant une pluralité de saillies espacées pouvant venir en prise avec la ou les nervures dans la configuration fermée pour avancer progressivement les indices d'un régime posologique de médicament. L'invention concerne des systèmes et des méthodes d'utilisation.
PCT/US2019/054201 2018-10-03 2019-10-02 Emballage de médicament et système de régime posologique WO2020072582A1 (fr)

Applications Claiming Priority (2)

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US201862740746P 2018-10-03 2018-10-03
US62/740,746 2018-10-03

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100580810B1 (ko) * 2003-07-14 2006-05-16 최정구 열림방지용 마개구조
US20180178955A1 (en) * 2013-06-20 2018-06-28 Rennie West Reusable Rotating Bottle Cap Markers for Bottles and Containers
US20180250196A1 (en) * 2015-09-02 2018-09-06 Mylan Inc Medication packaging and dose regimen system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100580810B1 (ko) * 2003-07-14 2006-05-16 최정구 열림방지용 마개구조
US20180178955A1 (en) * 2013-06-20 2018-06-28 Rennie West Reusable Rotating Bottle Cap Markers for Bottles and Containers
US20180250196A1 (en) * 2015-09-02 2018-09-06 Mylan Inc Medication packaging and dose regimen system

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