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
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
  • A61J1/035—Blister-type containers
• • 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
  • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets

Definitions

• the present invention is directed to the packages and methods for dispensing pills and particularly packages for dispensing calendar-oriented drugs.
• drugs are taken over a variety of days in varying amounts in order to provide for their effective administration.
• Packages have been developed for aiding the user of such drugs to comply with proper administration of those drugs over a period of days.
• Typical of such drugs are birth control pills which are taken over a period of days corresponding to a woman's menstrual cycle and the administration of anti-inflammatory drugs such as -cortisone and cortisone-like drugs for the treatment of various ailments.
• None of the dispensing apparatus associated with such multiple day administered drugs is geared to administration of drugs on a calendar day basis; rather they are geared to the administration of drugs irrespective of the particular day of the month and indeed are typically administered so as to be timed to a body cycle.
• the present invention is directed to the administration of the drugs in pill form whose administration is based upon the actual calendar date and thus are geared to initial administration on the first day of a given month.
• the patient continues to take the pill or pills on a daily basis, corresponding to the days of the month. If the patient fails to take the pill or pills for a given day, he or she merely takes the pill or pills for the following day leaving those for the previous day in the dispensing package. In this way, a complete verifiable record of patient compliance is available to the attending physician, thereby allowing the physician to be better able to determine what course of action to take depending upon the nature of this compliance.
• the present invention is particularly suited for the administration of drugs for the treatment of menopausal symptoms. It is known that during the natural course of a woman's life she will experience a decrease in estrogen production normally between the ages of 45 and 55. Such decrease in estrogen production can also be caused by surgical removal of the ovaries. In either case, when the amount of estrogen in the blood begins to decrease, a woman may develop various symptoms including the feelings of warmth in the face, neck, chest, or sudden intense episodes of heat and sweating throughout the body (typically known as "hot flashes") with the severity of these symptoms varying from woman to woman. Some women also may develop atrophic vaginitis which can cause discomfort. In order to treat these symptoms, estrogens may be prescribed by the attending physician for a period of a few months or longer while the woman's body begins to adjust to her lower estrogen production levels.
• the present invention presents a calendar-oriented prescriptive drug dispenser which can provide estrogen, progesterone, and calcium to a patient under the care of a gynecologist or other physician.
• the present invention provides a dispenser in which the days of the month are associated with pill-containing enclosures having a one-to-one correspondence to each day of a calendar month. The patient is typically instructed to begin the medication on the first day of the next succeeding month and if a day is missed, to simply skip that pill-containing enclosure and continue with those for the remainder of the month.
• the physician if he or she desires, can by examining the dispenser, ascertain the amount of patient compliance with the prescriptive drugs.
• a dispenser for containing pills for administration ove a period of days associated with a calendar month is disclosed.
• the dispenser comprises a plurality of pill- containing enclosures, each enclosure containing one or mor pills associated with a prescriptive regimen to be taken by a patient over the course of a calendar month.
• Each pill- containing enclosure has a number associated with it corresponding to one of the calendar days.
• the reverse side of the enclosure is preferably relatively smooth and contains a plurality of areas associated with each pill- containing enclosure through which the pill or pills within the enclosure may be removed by rupturing thereof.
• Each rupture area includes the same number corresponding to the calendar day that appears on the front side of the dispenser, thereby facilitating ease and assurance of proper pill(s) removal by the patient. If the patient forgets to take the pill or pills associated with a pill-containing enclosure for one or more days, these enclosures are left in their sealed state and thereby provide a visual means to inform the attending physician to determine the amount of compliance by the patient to the prescriptive drug regimen.
• the pill-containing enclosures are made from a clear blister-pack plastic material so that the patient can readily see the pill(s) contained within the enclosure.
• the remainder of the dispenser is preferably formed from a flat stiff material, such as an aluminum foil laminated sheet, so as to provide the necessary rigidity to allow the patient to easily use the dispenser.
• the calendar indicia on the front surface of the dispenser may be placed above the co resonding pill-containing enclosure, or may be placed in any other location where there is a one-to-one relationship between each number and one pill-containing enclosure.
• the dispenser is for the administration of post-menopausal prescriptive drugs for the treatment of menopausal symptoms and osteoporosis.
• two rows each comprise nine pill enclosures, wherein each enclosure contains an estrogen replacement pill; while the next seven enclosures are positioned in a third row and contain both estrogen and progesterone pills; while a fourth row has six enclosures containing calcium replacement pills.
• This dispenser thus comprises thirty-one enclosures corresponding to the maximum number of days in any given month. The particular calendar month may also be indicated on the dispenser.
• the patient begins the prescriptive drug regimen on the first day of the next succeeding month and continues taking the pills from the enclosures corresponding to the days of the month. If the month has fewer than thirty-one days, those enclosures corresponding to days which do not exist are simply not used by the patient. The attending physician can then observe the dispenser after completion of a month's use.
• Objects of the Invention therefore it is the principal object of the present invention to provide a dispenser for pills to be administered on a calendar oriented basis, wherein the dispenser comprises a plurality of rupturable pill enclosures, each enclosure having an indicia associated with it on both its front and reverse sides corresponding to one of the days of the month so as to make a one-to-one correlation between each calendar date and a pill enclosure containing one or more pills to be taken on that calendar date.
• Another object of the present invention is to provide a dispenser of the above description in which the pill- containing enclosures are formed from a transparent material so that the user can easily ascertain the pill or pills contained therein.
• a still further object of the present invention is to provide a dispenser of the above description in which the pill-containing enclosures are arranged in a plurality of rows, each row corresponding to a uniform pill regimen.
• Another object of the present invention is to provide a dispenser of the above ' description in which the pill- containing enclosures are formed onto a backing sheet formed from a relatively stiff planar material having easily rupturable zones placed beneath each p:11-containing enclosure; and further wherein the indicia on the reverse side of this backing sheet are placed on these rupturable zones so as to facilitate the determination of which enclosure to dispense for a particular calendar date.
• a still further object of the present invention is to provide a dispenser of the above description for use in the administration of calendar-oriented menopausal therapy drugs in which the first two rows of the pill-containing enclosures comprise nine pill-containing enclosures each corresponding to the first eighteen calendar days of a month for which estrogen replacement pills are stored, wherein a third row of the pill-containing enclosures comprises seven pill-containing enclosures for storing up to two pills associated with such menopausal therapy, and wherein a fourth row of pill-containing enclosures comprises six enclosures for the storage of a third drug to be administered for the retardation of osteoporosis in menopausal therapy.
• Figure 1 is a top plan view of a dispenser for the administration of calendar oriented drugs illustrating a plurality of rows, with pill-containing enclosures, each enclosure for the storage of one or more pills to be administered on a given calendar date further showing numerical indicia for the calendar date positioned in proximity to the pill-containing enclosure whose pill or pills are to be taken on that calendar date.
• Figure 2 is a side cross-sectional view taken along line 2-2 of Figure 1 illustrating the arner in which the pill or or pills within a pill-containiny enclosure are removed by rupturing the lower surface of the enclosure forming part of the backing she'et of the dispenser.
• Figure 3 is a bottom plan view of the dispenser shown in Figures 1 and 2 showing in phantom the zones on the rear surface of the backing sheet which correspond to the pill- containing enclosures and forming the lower surface of the pill-containing enclosures which are ruptured when the pills within the enclosures are removed, and further showing that e such zone has a number associated therewith which corresponds to the number shown on the front surface of the dispenser sheet corresponding to the calendar date for which the pills within the corresponding enclosure are to be taken by the patient.
• a dispenser 20 for calendar oriented drugs has a generally rectangular backing sheet 22 onto which are positioned a plurality of pill-containing enclosures 24.
• the backing sheet 22 has a relatively thin cross-section and is preferably made from a relatively stiff sheet material, such as a reinforced aluminum foil sheet.
• the pill-containing enclosures are preferably fabricated from a clear thermal plastic material, forming part of an overall thermal plastic sheet 26 which can be sealingly attached to the underlying backing sheet. In the packaging art, this is commonly referred to as a blister-pack type packaging procedure.
• each pill-containing enclosure is dimensioned to house a single pill for some enclosures or two pills or larger pills for other enclosures.
• the pills in rows A and B of the embodiment shown in Figure 1 are dimensioned to house a single pill, while those in row C are dimensioned to house two pills, and those in row D are dimensioned to house a pill relatively larger than those in rows A, B, or C.
• the front surface 28 of the backing sheet 22 has a plurality of numerals ranging from 1 to 31, each numeral or numeral pair corresponding to a particular calendar date, and each number positioned on the front surface of the backing sheets so as to be in proximity to a specific pill-containing enclosure.
• the dispenser is thus particularly designed for the administration of a pill regimen to a user where the user takes one or more pills on a specific calendar date.
• the front surface may optionally include indicia 34 indicating the particular month of the year for which the pills are to be taken.
• the rear surface 30 of backing sheet 22 has a plurality of zones 32, shown in phantom, which correspond to the area lying directly beneath the pill-containing enclosure caps 24.
• Each zone has a numerical indicia placed thereon, corresponding to the calendar date associated with the same pill-containing enclosure on the front surface. By placement of the number on each zone, the user can quickly ascertain if the pills for the correct date are being removed from the dispenser package.
• Each zone 32 thus forms a rupturable region for the removal of the pills within the corresponding enclosure by merely pressing the corresponding pill-enclosure dome 24 as shown in Figure 2 for dome 24'.
• the user is instructed to take the pill or pills in the enclosure corresponding to the specific calendar date on only that date, and if the user forgets to take those pills on a particular date they are left intact in the dispenser- In this manner, the attending physician can readily determine the degree of patient compliance to a specific drug regimen.
• the user may be instructed to begin use of the dispenser on the first day of a particular calendar month, for example August. In this case, the user for the first day of August would remove the pill or pills in the enclosure identified by the indicia "1" and for the second day of August would remove the pills for the indicia enclosure identified by the numeral "2", and so on.
• the pill or pills are simply left in the dispenser. If, for example, the user was taking calendar oriented drugs for the month of September, then the pill or pills in the enclosure identified by the numeral "31" would be left in the dispenser. In this way, the attending physician can quickly ascertain the patient compliance with the drug regimen and can insure that extra pills were not taken for extra days exceeding those of a particular calendar month.
• the present invention provides a unique approach to maximizing patient compliance and providing the means for ascertaining this compliance. It has been recently discovered, as mentioned above, that post-menopausal women experience a decrease in estrogen and progesterone production whic ' i causes various physiological symptoms including sudden feelings of warmth in the face, neck, chest, and sudden intense episodes of heat and sweating throughout the body, commonly referred to as " hot flashes" or " hot flushes.” These symptoms can be alleviated to a great extent by the administration of estrogen and progesterone.
• the present invention when used for the administration of post-menopausal therapeutic purposes, therefore, provides estrogen over a period of 18 days, followed by 7 days of both estrogen and progesterone treatment, followed by from 3 to 7 days of calcium replacement during the days that the patient does not take estrogen or progesterone/estrogen combination.
• the present invention has been found to provide an effective means for the proper administration of calendar oriented drug regimens since it provides the user with a direct one-to-one correlation between the pill or pills to be taken on a particular date and the date as shown by the calendar for the given month. It also provides an easily verifiable record of the patient's compliance with the calendar oriented prescription drug regimen.
• the dispenser through the use of rupturable pill- containing enclosures having indicia on both the front and rear surfaces of the dispenser provides an effective and easy-to-use device for both storing drugs and for their administration when directed to a calendar oriented regimen.

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• Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Pharmacology & Pharmacy (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Jellies, Jams, And Syrups (AREA)
• Closures For Containers (AREA)
• Thermotherapy And Cooling Therapy Devices (AREA)
• Medicinal Preparation (AREA)
• Packging For Living Organisms, Food Or Medicinal Products That Are Sensitive To Environmental Conditiond (AREA)
• Packages (AREA)
• Steroid Compounds (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

Family

ID=24249298

Family Applications (1)

Country Status (15)

Cited By (5)

Families Citing this family (48)

Citations (7)

Family Cites Families (3)

• 1983
  • 1983-12-19 US US06/563,148 patent/US4534468A/en not_active Expired - Lifetime
• 1984
  • 1984-12-13 IL IL73819A patent/IL73819A/xx not_active IP Right Cessation
  • 1984-12-13 AU AU37476/85A patent/AU3747685A/en not_active Abandoned
  • 1984-12-13 JP JP60500077A patent/JPS61500709A/ja active Granted
  • 1984-12-13 AT AT85900418T patent/ATE58701T1/de not_active IP Right Cessation
  • 1984-12-13 EP EP85900418A patent/EP0166763B1/en not_active Expired - Lifetime
  • 1984-12-13 DE DE8585900418T patent/DE3483691D1/de not_active Expired - Fee Related
  • 1984-12-13 WO PCT/US1984/002045 patent/WO1985002828A1/en active IP Right Grant
  • 1984-12-18 NZ NZ210596A patent/NZ210596A/xx unknown
  • 1984-12-18 IE IE3242/84A patent/IE56496B1/en not_active IP Right Cessation
  • 1984-12-18 ZA ZA849831A patent/ZA849831B/xx unknown
  • 1984-12-18 CA CA000470433A patent/CA1215689A/en not_active Expired
• 1985
  • 1985-08-13 DK DK367485A patent/DK367485A/da not_active Application Discontinuation
  • 1985-08-16 FI FI853158A patent/FI82821C/fi not_active IP Right Cessation
  • 1985-08-16 NO NO853236A patent/NO165428C/no unknown

Patent Citations (7)

Non-Patent Citations (1)

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