CA2064959C - Unit dose packaging - Google Patents
Unit dose packaging Download PDFInfo
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- CA2064959C CA2064959C CA 2064959 CA2064959A CA2064959C CA 2064959 C CA2064959 C CA 2064959C CA 2064959 CA2064959 CA 2064959 CA 2064959 A CA2064959 A CA 2064959A CA 2064959 C CA2064959 C CA 2064959C
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- card
- medication
- packaging system
- packaging
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- Legal status (The legal status 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 status listed.)
- Expired - Lifetime
Links
- 238000004806 packaging method and process Methods 0.000 title claims abstract description 111
- 230000003442 weekly effect Effects 0.000 claims abstract description 46
- 239000002552 dosage form Substances 0.000 claims abstract description 27
- 239000007787 solid Substances 0.000 claims abstract description 17
- 239000007909 solid dosage form Substances 0.000 claims abstract description 5
- 239000003814 drug Substances 0.000 claims description 95
- 229940079593 drug Drugs 0.000 claims description 82
- 238000012544 monitoring process Methods 0.000 claims description 18
- 238000012360 testing method Methods 0.000 claims description 16
- MTKNGOHFNXIVOS-UHFFFAOYSA-N ticlopidine hydrochloride Chemical compound [H+].[Cl-].ClC1=CC=CC=C1CN1CC(C=CS2)=C2CC1 MTKNGOHFNXIVOS-UHFFFAOYSA-N 0.000 claims description 10
- 229960002961 ticlopidine hydrochloride Drugs 0.000 claims description 10
- 238000009534 blood test Methods 0.000 claims description 5
- 229940126532 prescription medicine Drugs 0.000 claims description 5
- 206010067484 Adverse reaction Diseases 0.000 claims description 4
- 230000006838 adverse reaction Effects 0.000 claims description 4
- 239000003292 glue Substances 0.000 claims description 3
- 239000004480 active ingredient Substances 0.000 claims 1
- 238000012423 maintenance Methods 0.000 description 7
- 239000011888 foil Substances 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- SGUAFYQXFOLMHL-UHFFFAOYSA-N 2-hydroxy-5-{1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl}benzamide Chemical compound C=1C=C(O)C(C(N)=O)=CC=1C(O)CNC(C)CCC1=CC=CC=C1 SGUAFYQXFOLMHL-UHFFFAOYSA-N 0.000 description 4
- 238000010276 construction Methods 0.000 description 4
- 229960001632 labetalol Drugs 0.000 description 4
- 238000009115 maintenance therapy Methods 0.000 description 4
- AQHHHDLHHXJYJD-UHFFFAOYSA-N propranolol Chemical compound C1=CC=C2C(OCC(O)CNC(C)C)=CC=CC2=C1 AQHHHDLHHXJYJD-UHFFFAOYSA-N 0.000 description 4
- LOUPRKONTZGTKE-LHHVKLHASA-N quinidine Chemical compound C([C@H]([C@H](C1)C=C)C2)C[N@@]1[C@H]2[C@@H](O)C1=CC=NC2=CC=C(OC)C=C21 LOUPRKONTZGTKE-LHHVKLHASA-N 0.000 description 4
- 238000002560 therapeutic procedure Methods 0.000 description 4
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- 230000000747 cardiac effect Effects 0.000 description 3
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- METKIMKYRPQLGS-GFCCVEGCSA-N (R)-atenolol Chemical compound CC(C)NC[C@@H](O)COC1=CC=C(CC(N)=O)C=C1 METKIMKYRPQLGS-GFCCVEGCSA-N 0.000 description 2
- TWBNMYSKRDRHAT-RCWTXCDDSA-N (S)-timolol hemihydrate Chemical compound O.CC(C)(C)NC[C@H](O)COC1=NSN=C1N1CCOCC1.CC(C)(C)NC[C@H](O)COC1=NSN=C1N1CCOCC1 TWBNMYSKRDRHAT-RCWTXCDDSA-N 0.000 description 2
- SGTNSNPWRIOYBX-UHFFFAOYSA-N 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile Chemical compound C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC=C(OC)C(OC)=C1 SGTNSNPWRIOYBX-UHFFFAOYSA-N 0.000 description 2
- JIVPVXMEBJLZRO-CQSZACIVSA-N 2-chloro-5-[(1r)-1-hydroxy-3-oxo-2h-isoindol-1-yl]benzenesulfonamide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC([C@@]2(O)C3=CC=CC=C3C(=O)N2)=C1 JIVPVXMEBJLZRO-CQSZACIVSA-N 0.000 description 2
- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 description 2
- GJSURZIOUXUGAL-UHFFFAOYSA-N Clonidine Chemical compound ClC1=CC=CC(Cl)=C1NC1=NCCN1 GJSURZIOUXUGAL-UHFFFAOYSA-N 0.000 description 2
- LTMHDMANZUZIPE-AMTYYWEZSA-N Digoxin Natural products O([C@H]1[C@H](C)O[C@H](O[C@@H]2C[C@@H]3[C@@](C)([C@@H]4[C@H]([C@]5(O)[C@](C)([C@H](O)C4)[C@H](C4=CC(=O)OC4)CC5)CC3)CC2)C[C@@H]1O)[C@H]1O[C@H](C)[C@@H](O[C@H]2O[C@@H](C)[C@H](O)[C@@H](O)C2)[C@@H](O)C1 LTMHDMANZUZIPE-AMTYYWEZSA-N 0.000 description 2
- GOEMGAFJFRBGGG-UHFFFAOYSA-N acebutolol Chemical compound CCCC(=O)NC1=CC=C(OCC(O)CNC(C)C)C(C(C)=O)=C1 GOEMGAFJFRBGGG-UHFFFAOYSA-N 0.000 description 2
- 229960002122 acebutolol Drugs 0.000 description 2
- BZKPWHYZMXOIDC-UHFFFAOYSA-N acetazolamide Chemical compound CC(=O)NC1=NN=C(S(N)(=O)=O)S1 BZKPWHYZMXOIDC-UHFFFAOYSA-N 0.000 description 2
- 229960000571 acetazolamide Drugs 0.000 description 2
- XSDQTOBWRPYKKA-UHFFFAOYSA-N amiloride Chemical compound NC(=N)NC(=O)C1=NC(Cl)=C(N)N=C1N XSDQTOBWRPYKKA-UHFFFAOYSA-N 0.000 description 2
- 229960002576 amiloride Drugs 0.000 description 2
- 229960002274 atenolol Drugs 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 210000001772 blood platelet Anatomy 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- FAKRSMQSSFJEIM-RQJHMYQMSA-N captopril Chemical compound SC[C@@H](C)C(=O)N1CCC[C@H]1C(O)=O FAKRSMQSSFJEIM-RQJHMYQMSA-N 0.000 description 2
- 229960000830 captopril Drugs 0.000 description 2
- 229960001523 chlortalidone Drugs 0.000 description 2
- LOUPRKONTZGTKE-UHFFFAOYSA-N cinchonine Natural products C1C(C(C2)C=C)CCN2C1C(O)C1=CC=NC2=CC=C(OC)C=C21 LOUPRKONTZGTKE-UHFFFAOYSA-N 0.000 description 2
- 229960002896 clonidine Drugs 0.000 description 2
- 229960005156 digoxin Drugs 0.000 description 2
- LTMHDMANZUZIPE-PUGKRICDSA-N digoxin Chemical compound C1[C@H](O)[C@H](O)[C@@H](C)O[C@H]1O[C@@H]1[C@@H](C)O[C@@H](O[C@@H]2[C@H](O[C@@H](O[C@@H]3C[C@@H]4[C@]([C@@H]5[C@H]([C@]6(CC[C@@H]([C@@]6(C)[C@H](O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)C[C@@H]2O)C)C[C@@H]1O LTMHDMANZUZIPE-PUGKRICDSA-N 0.000 description 2
- LTMHDMANZUZIPE-UHFFFAOYSA-N digoxine Natural products C1C(O)C(O)C(C)OC1OC1C(C)OC(OC2C(OC(OC3CC4C(C5C(C6(CCC(C6(C)C(O)C5)C=5COC(=O)C=5)O)CC4)(C)CC3)CC2O)C)CC1O LTMHDMANZUZIPE-UHFFFAOYSA-N 0.000 description 2
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 description 2
- 229960004166 diltiazem Drugs 0.000 description 2
- ZZUFCTLCJUWOSV-UHFFFAOYSA-N furosemide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC(C(O)=O)=C1NCC1=CC=CO1 ZZUFCTLCJUWOSV-UHFFFAOYSA-N 0.000 description 2
- 229960003883 furosemide Drugs 0.000 description 2
- 229960002003 hydrochlorothiazide Drugs 0.000 description 2
- 239000000463 material Substances 0.000 description 2
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- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical compound COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 description 2
- 229960002237 metoprolol Drugs 0.000 description 2
- 208000010125 myocardial infarction Diseases 0.000 description 2
- 229960004255 nadolol Drugs 0.000 description 2
- VWPOSFSPZNDTMJ-UCWKZMIHSA-N nadolol Chemical compound C1[C@@H](O)[C@@H](O)CC2=C1C=CC=C2OCC(O)CNC(C)(C)C VWPOSFSPZNDTMJ-UCWKZMIHSA-N 0.000 description 2
- HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 description 2
- 229960001597 nifedipine Drugs 0.000 description 2
- 229960002508 pindolol Drugs 0.000 description 2
- PHUTUTUABXHXLW-UHFFFAOYSA-N pindolol Chemical compound CC(C)NCC(O)COC1=CC=CC2=NC=C[C]12 PHUTUTUABXHXLW-UHFFFAOYSA-N 0.000 description 2
- REQCZEXYDRLIBE-UHFFFAOYSA-N procainamide Chemical compound CCN(CC)CCNC(=O)C1=CC=C(N)C=C1 REQCZEXYDRLIBE-UHFFFAOYSA-N 0.000 description 2
- 229960000244 procainamide Drugs 0.000 description 2
- 229960003712 propranolol Drugs 0.000 description 2
- 229960001404 quinidine Drugs 0.000 description 2
- 229960004605 timolol Drugs 0.000 description 2
- 229960001722 verapamil Drugs 0.000 description 2
- 230000000007 visual effect Effects 0.000 description 2
- RKWGIWYCVPQPMF-UHFFFAOYSA-N Chloropropamide Chemical compound CCCNC(=O)NS(=O)(=O)C1=CC=C(Cl)C=C1 RKWGIWYCVPQPMF-UHFFFAOYSA-N 0.000 description 1
- JLRGJRBPOGGCBT-UHFFFAOYSA-N Tolbutamide Chemical compound CCCCNC(=O)NS(=O)(=O)C1=CC=C(C)C=C1 JLRGJRBPOGGCBT-UHFFFAOYSA-N 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
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- 239000008280 blood Substances 0.000 description 1
- 238000004820 blood count Methods 0.000 description 1
- 229960001761 chlorpropamide Drugs 0.000 description 1
- QZUDBNBUXVUHMW-UHFFFAOYSA-N clozapine Chemical compound C1CN(C)CCN1C1=NC2=CC(Cl)=CC=C2NC2=CC=CC=C12 QZUDBNBUXVUHMW-UHFFFAOYSA-N 0.000 description 1
- 229960004170 clozapine Drugs 0.000 description 1
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- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002934 diuretic Substances 0.000 description 1
- 229940030606 diuretics Drugs 0.000 description 1
- 229960004580 glibenclamide Drugs 0.000 description 1
- ZNNLBTZKUZBEKO-UHFFFAOYSA-N glyburide Chemical compound COC1=CC=C(Cl)C=C1C(=O)NCCC1=CC=C(S(=O)(=O)NC(=O)NC2CCCCC2)C=C1 ZNNLBTZKUZBEKO-UHFFFAOYSA-N 0.000 description 1
- 239000005555 hypertensive agent Substances 0.000 description 1
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- 239000003112 inhibitor Substances 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
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- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 description 1
- 229960003105 metformin Drugs 0.000 description 1
- -1 mindoxil Chemical compound 0.000 description 1
- 239000003538 oral antidiabetic agent Substances 0.000 description 1
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- 229960005371 tolbutamide Drugs 0.000 description 1
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Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Packages (AREA)
Abstract
The present invention provides for a unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval. The packaging comprises a series of blister packs, each of the blister packs containing the solid pharmaceutical dosage form for one weekly interval.
The solid dosage form is arranged in individual pockets on the blister pack to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
The solid dosage form is arranged in individual pockets on the blister pack to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
Description
zos49~~
UNIT DOSE PACKAGING
The present invention relates to a unit dose packaging for a pharmaceutical dosage to be taken in a dosage regimen continuously for more than one weekly interval.
Pharmaceuticals or medicines are generally utilized to correct disease states or other physiological abnormalities. In use it is quite common that the medicine be given to a patient in a treatment regimen over a multi day period which may also involve the use of divided daily dosages of the pharmaceutical. For most acute conditions, the treatment regimen usually covers one or two weeks, however, for chronic conditions, it is quite common for a patient to be on a maintenance dose of the medicine for an extended period of time. Such chronic conditions include, for example, diabetes and high blood pressure and other ~_.. 20~49~9 conditions contributing to an increased risk to heart attack or strokes. Examples of such medicines for treating such chronic conditions include oral antidiabetic agents such as acetylhexamide, chloropropamide, glyburide, metformin and tolbutamide, cardiac drugs such as as atenolol, digoxin, diltiazem, labetalol, metoprolol, nadolol, nifedipine, pindolol, procainamide, propranolol, quinidine, ticlopidine hydrochloride, timolol and verapamil, hypertensive drugs such as acebutolol, captopril, clonidine, furosemide, labetalol and mindoxil, diuretics such as acetazolamide, amiloride, chlorthalidone and hydrochlorothiazide.
Frequently, such patients, particularly the elderly or those patients being treated for cardiac problems, have difficulty following the proper dosage regimen due to a tendency to fail to remember whether the medicine was taken at a particular time or on a particular day. This difficulty is compounded by the fact that most medicines are dispensed to the patient in a bulk container making it extremely difficult for a patient to determine whether they have in fact missed taking one of the doses of medicine. In order to help with the compliance of the dosage regimen, containers divided into seven compartments to correspond with the days of the week have been developed. These containers are utilized by patients on such maintenance medicines by placing into each compartment the medicine required for the daily dosages of their treatment regiments. On the particular day of the week, the patient then takes the medicine as required from each of the individual compartments.
Additionally, many of the medications utilized in maintenance therapy and, in particular, those used in treating cardiac conditions, have either narrow therapeutic ranges or have an increased incidence of side effects so that it is necessary for the patient to be monitored on a wH-8365 - 3 -regular basis during the maintenance therapy utilizing the medication. Such monitoring generally is conducted on a fairly frequent basis during the initial stages of the maintenance therapy. Once the patient has been stabilized on the maintenance dose, while the monitoring may be less frequent, it still occurs on a regular basis.
The present invention provides for a unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval. The packaging comprises a series of blister packs, each of the blister packs containing the solid pharmaceutical dosage form for one weekly interval.
The solid dosage form is arranged in individual pockets on the blister pack to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
In an aspect of the invention, there is provided a unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval and requiring a specific act by the patient during at least one of the weekly intervals.
The packaging comprises a series of connected cards, each of the cards having the solid pharmaceutical dosage form for one weekly interval. The card for the weekly interval requiring the specific act by the patient has means thereon for alerting the patient to the specific act. The solid dosage forms are arranged on the cards in a manner to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen and immediate visual feedback as to the compliance with the dosage regimen and compliance with the specific act to be carried out.
In another aspect of the invention, there is provided a packaging system for a prescription medication to be taken daily for more than one weekly interval. The packaging system comprises a series of cards with each card having the required medication for a weekly period located in a blister pack, the blister pack having a series of pockets corresponding to a daily dosage of the prescription medicine with the pockets being positioned to form a closed loop configuration about an open center region. Each card has at least a front cover applied over one of the blister packs and secured thereto, the cover including openings therein for receiving the pockets of the blister pack and presenting the pockets forwardly of the front cover. The front cover includes a unique day of the week associated with the pockets corresponding to a daily dosage of the prescription medicine with the days of the week being in sequence about the loop configuration. The face of each card is customized for the particular weekly period and at least some of the faces of the cards are different.
In yet another aspect of the invention, there is provided a packaging system for a prescription medication to be taken daily for an initial trial period during which period the user is to be monitored on a regular basis for efficacy of the medication and/or adverse reactions. The packaging system includes a series of cards, each card having associated therewith one week of medication divided into separate and distinct medication for a particular day identified by the day of the week and an indication whether the card is for the week of the medication during which the monitoring is to be conducted. The card for the week during which the monitoring is to be conducted including specific instructions printed thereon reminding the user of wH-8365 - 5 -the requirement for monitoring to be conducted after a specified number of days of medication in the week sufficient to allow the results of the monitoring to be known prior to completing the medication for the week, whereby a doctor will have the results of the monitoring prior to renewing the prescription providing the user with a further supply of medication contained within the packaging system.
Preferred embodiments of the present invention are illustrated in the drawings, in which:
Figure 1 is a perspective view of a packaging of the present invention;
Figure 2 is a perspective view of a blister pack for use in the packaging of Figure 1;
Figure 3 is a cross-section along line 3-3 of the blister pack of Figure 2;
Figure 4 is a perspective view of the packaging of Figure 1 in use during the first week;
Figure 5 is a perspective view of the packaging of Figure 1 in use during the second week;
Figure 6 is a perspective view illustrating the method of construction of the packaging of Figure 1;
Figure 7 is a perspective view of a second embodiment of the packaging of the present invention;
Figure 8 is a cross-section of the embodiment of Figure 7; and Figure 9 is a perspective view illustrating the inter-relationship of the components of the packaging system of Figure 7.
.. 20fi49~9 The present invention provides for a unit dose packaging for weekly supplies of a solid pharmaceutical dosage form to be taken in a maintenance dosage regimen.
The packaging comprises a blister pack having the solid pharmaceutical dosage form arranged on the blister pack in a manner to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
To further enhance compliance each daily dosage is preferably provided with a day of the week designation so that the user may confirm their compliance with a particular day of the week.
The packaging of the present invention may be provided as a series of blister packs packaged together with each blister pack having the solid pharmaceutical dosage form for one weekly interval.
The blister packs may also be attached to a card having at least a front cover applied over one of the blister packs and secured thereto, the cover being provided with openings therein for receiving the pockets of the blister pack and presenting the pockets forwardly of the front cover. The front cover also preferably includes a unique day of the week associated with the pockets corresponding to a daily dosage of the prescription medicine with the days of the week being in sequence about the loop configuration. The face of each card is preferably customized for the particular weekly period and at least some of the faces of the cards may be different.
This packaging is particularly useful in dosage regimens which require a specific act by the patient during at least one of the weekly intervals. Such specific acts 20fi~9~9 wH-8365 may include regular monitoring or testing to identify adverse reactions or efficacy of the medication. With this packaging, the card for the weekly interval requiring the specific act by the patient may be provided with means thereon for alerting the patient to the specific act. The means for alerting the patient to the specific act may be indicia not directly associated with the dosage for any specific day. Alternatively, the means may be provided by a indicia associated with the dosage a specific day if it is necessary that the specific act be performed on a specific day of the weekly dosage cycle. The indicia may be printed directly on the card such as written instructions for the specific act or may be provided as a stick on label which is placed on the appropriate location on the card either by the pharmacist when dispensing the medicine or by the user of the drug.
The unit dose packaging is also useful for dosage regimens which require multiple daily doses of the medicine, in particular divided daily doses. The packaging may have the solid pharmaceutical dosage form arranged in a manner to present and identify each daily dosage separately by day and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen. For example, the dosages for a particular day could be associated together with a contrasting colour visually tying the dosages together and the daily dosages could be arranged in the closed loop pattern.
The unit dose packaging of the present invention is particularly useful for medicines used in maintenance therapy for treating hypertension or high blood pressure and other conditions contributing to an increased risk to heart attack or strokes. Such medicines include atenolol, digoxin, diltiazem, labetalol, metoprolol, nadolol, nifedipine, pindolol, procainamide, propranolol, quinidine, ticlopidine hydrochloride, timolol, verapamil, acebutolol, 2os49~~
captopril, clonidine, clozapine, furosemide, labetalol, mindoxil, acetazolamide, amiloride, chlorthalidone and hydrochlorothiazide. When a patient is on a maintenance dose of such medicine it is important that the individual dosages are taken when required. If a dosage is missed then the effect of the medicine is reduced which in certain cases may lead to the onset of symptoms. Additionally, certain of the medicines also require further specific acts by the patients at varying times during the dosage regimen.
Such acts may include consulting with their physician or having certain clinical tests performed to monitor the effectiveness of the medicine or the onset of side effects from the therapy. The unit dose packaging of the present invention allows for ease of compliance with the dosage regimen as well as allowing for alerting the patient when it is necessary to perform a specific act such as consulting with their physician or having a clinical test conducted.
Preferred embodiments of the packaging of the present invention for a dosage regimen of divided daily doses will now be described with reference to the attached figures.
Figure 1 illustrates one preferred embodiment of the unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval. The unit dose packaging, generally indicated by the numeral 10, is particularly suitable for an introductory period where testing and/or specific monitoring is required. The packaging 10 comprises a cover 16 and a series of related cards which in the embodiment illustrated in Figure 1 includes two cards 12 and 14. Each card 12 and 14 contains the solid pharmaceutical dosage form for one weekly interval, the dosage form being arranged on the card in a manner to present and identify each dosage separately and to form a 20fi49~~
patterned sequence of dosages. This is most preferably accomplished by providing the solid dosage form in a blister pack for insertion in the card. A typical blister pack is illustrated in Figures 2 and 3 generally indicated by the numeral 20. The blister pack 20 includes a top 22 which is generally constructed of a clear plastic having a series of pockets 24 for containing of the dosage forms 26.
The dosage forms are maintained in the pockets by a bottom 28 which is generally a foil material heat sealed to the top 22 to seal the dosage forms in the individual pockets 24.
In the embodiment illustrated in Figure 2, the blister pack is set up for a medication which is taken in a divided daily dose, namely twice daily over the weekly time interval. Each of the two dosages for a daily period are arranged together in side by side relationship in the blister pack while the dosages for the individual days are arranged in a generally circular closed loop pattern around the blister pack.
Figure 4 illustrates the unit dose packaging 10 being utilized during the first weekly interval. In this case, the weekly interval starts on a Tuesday and the dosages are taken in a clock-wise direction until the card is completed on the following Monday. Owing to the generally circular pattern of the presentation of the dosage forms on the card, the weekly interval may commence on any day and is easily followed in the clock-wise pattern. The card 12 for the first weekly interval has inserted therein a blister pack as described above. The card front 12A is provided with openings 17 to locate pockets 24 forward of the card front 12A. Associated with the openings 17 for receiving the paired pockets 24 is a day of the week indicia 32. A contrasting color indicia 30 is imprinted on the card front 12A associated with the openings for the dosages for a particular day. These 20fi~9~9 indicia 30 and 32 provide a quick reference and immediate visual feedback as to whether one or both of the dosages for a particular day has been taken and whether the user is complying with the dosage regimen. To remove the medication, the patient pushes the medication through the foil at the back of the blister pack and through openings 17 and 18 provided in the card front 12A and card back 12B.
This is accomplished in conventional fashion by pushing on the pocket containing the medication until the medication pushes through the foil at the back of the blister pack.
The medication is taken continuously throughout the weekly interval until the card has been completed. At the completion of the first week, the patient then continues with the second week of medication provided on card 14. A
perforation 42 may be provided between cards 12 and 14 whereby once the medication for the first week is completed, the now empty card 12 may be separated from the remainder of the packaging 10 and discarded.
Figure 5 illustrates the commencement of the second week of taking of the medication. In this case, the card for the first week 12 has been opened up thereby exposing the card back 12B illustrating the openings 18 in the card back which expose the foil 28 of the blister pack 20 and allow for removal of the medication by pushing it through the foil backing of the blister pack and through opening 18. The card back 12B is also provided with a further opening 34 through which, for example, a lot number or other information imprinted on the foil 28 of the blister pack 20 is visible.
The card 14 for the second weekly interval of medication is constructed in similar fashion to the card 12 for the first weekly medication. Moreover, if the taking of the medication by the patient requires a specific act by the patient during one of the weekly intervals such as for example, making an appointment with his physician or having a blood test conducted, the card may be provided with means such as indicia for alerting the patient of the specific act such as, for example, the information 38 imprinted on the card 14. This provides a direct association of a particular step in the monitoring of the effects of the medication with the appropriate time in the regimen of the medication to remind the user to arrange for this particular step to be carried out. This direct association of the timing of a particular step with a particular point in time within the treatment regimen is more reliable and easier for the user. To further assure compliance, a separate test sticker may be included and placed by the doctor, the pharmacist or by the user adjacent the particular day when the desired step should be arranged or carried out. Any of these approaches are of particular benefit with introductory packaging where monitoring is often more critical. In many cases, it is preferred to have the specific act carried out at a point in time that will allow the results to be known prior to renewal of medication. For example, if a test is conducted on the fourth day of the second week, the doctor will have the results prior to renewing of the prescription. A system such as described encourages compliance with any testing requirements and reminds the patient of their responsibility to comply with the desired monitoring function. As can be appreciated with the packaging as illustrated, the user commencing the second week of medication is reminded of the need to carry out a particular step and is continued to be reminded when the medication is taken each day of the second week.
The cover 16 may be provided with a pocket opening 40 in the cover back 16B for receiving a leaflet 43 containing specific information or instructions for the patient. This information would also include details of any particular step to be carried out by the patient such as any testing requirements.
Figure 6 illustrates the construction of the packaging as described in Figures 1 through 5. Figure 6 displays the inside surfaces of the cards and cover prior to being folded to form the packaging. The packaging is preferably formed by die-cutting a blank from a single piece of suitable material such as cardboard to form the various portions of the packaging. The packaging is formed by scoring the blank in the appropriate location to produce fold lines which after insertion of the blister pack and folding of the blank on the fold lines forms the final packaging. In order to provide for the folding of the blank to produce the packaging as described above, the packaging is laid out with the fronts and backs of the cards alternating. Thus, as shown in Figure 6, the lower half of the blank for the packaging shows the cover front 16A, the second week card back 14B and the first week card front 12A. The upper half of the packaging has the cover back 16B, second week card front 14A and first week card back 12B.
A first hinge region 50 is preferably provided between the first week card front 12A and second week card back 14B and a second hinge region 52 is also preferably provided between second week card back 14B and cover front 16A. To provide for easier folding of the completed packaging, portions of the blank between the first week card back 12B and second week card front 14A (indicated by the numeral 54) and between the second week card front 14B
and the cover back 16B (indicated by the numeral 56) corresponding in size to hinge regions 50 and 52 are removed. However, depending upon the weight of the card stock utilized to form the packaging this may not be necessary. Hinge region 50 is formed of a width corresponding generally to the height of the pocket 24 of wH-8365 - i3 -the blister pack to permit the card for the first week 12 and the card for the second week 14 to lie in generally parallel relationship when the card for the first week 12 is folded over on top of the card for the second week 14 in the final packaging 10. Similarly, hinge region 52 between the cover front 16A and the second week card back 14B is of a width to allow the cover 16 to lie in generally parallel relationship to the first and second week cards 12 and 14, when the cover is folded over the cards in the final packaging 10. As described above, the separation between the first week and the second week cards 12 and 14 may be provided with a perforation 42 to allow for the first week card 12 to be discarded once the treatment regimen for that week has been completed.
To form the packaging the blank for the packaging is die-cut from suitable printed card stock and score lines for the folding are pressed into the card stock. Blister packs 20 are placed on the inside of the first week card front 12A and the second week card front 14A to allow the pockets 24 to protrude through the openings provided in the card fronts. For ease of handling, the blister packs may be secured to the card fronts by suitable means such as glue. Thereafter, the packaging is formed by folding the first week card along the score lines in the direction of the arrows and securing it to the back of the blister pack 20 and the first week card front 12A by suitable means such as gluing.
Similarly, the second week card front 14A is folded over along the score lines and secured to the second week card back 14B and the cover back 16B is folded along the score lines and secured to the cover front 16A. The packaging is then completed by folding the first week card 12 along the score lines forming the hinge region 50 to overlay the second week card 14 and the cover 15 is folded along the 206~~~9 score lines forming hinge region 52 to overlay the first week card 12 and second week card 14.
While the packaging has been described for a two-week supply of medication, packaging for more than two weeks may easily be produced by the same methods of construction. If additional cards are provided they would be provided at the edge of the card for the first week 12 and would have the alternating relationship of the fronts and backs of the cards. Thus, the back of the further card would be next to the front of the card for the first week 12A and similarly, the front of the further card would be next to the back of the card 12B illustrated in Figure 6.
In a packaging such as this for a three-week supply, the card for the first week would be the additional card, the card for the second week would be the card 12 and the card for the third week would be the card 14 illustrated in the figures. An additional hinge region would be provided between the extra card and card 12 and hinge regions 50 and 52 would be adjusted in width to compensate for the extra card.
A further embodiment of a packaging system of the present invention is illustrated in Figure 7 generally indicated by the numeral 60. The packaging system 60 includes a wallet holder 62 which as shown in Figure 8 and 9 is adapted to hold blister pack 64 and instruction booklet 66. The wallet is provided with pockets 68 and 69 of a size to allow insertion of the blister pack 64 or instruction booklet 66. The wallet may be provided with a closure flap 70 with a closure means 72 complementary to a closure means 74 provided on the surface of the wallet.
Enclosure means 72 and 74 may be a snap-type closure or as illustrated in Figure 7 may be a VelcroTM closure.
As illustrated in Figure 9, the wallet has pockets 68 and 69 for holding patient instruction booklet 66 and blister pack 64. Blister pack 64 may be provided of 2(?649~9 similar construction as the individual cards described above with respect to the first embodiment or alternatively, the blister pack may itself be provided with the indicia normally associated with the cards such as for example the day of the week indication 76 and the contrasting color indicator 78 associated with the dosages for a particular day. In certain applications it may also be possible to provide for a second weekly blister pack to fit in the pocket 69 along with a patient information booklet 66 or to replace the patient information booklet 66 completely by a second weekly dosage blister pack.
The packaging of the present invention provides a further advantage in that after an initial trial period has been completed, the use of the cards may be adjusted to correspond with a regular weekly cycle. By coordinating the dosage schedule with the regular weekly cycle, compliance of the patient with the therapy may be easier to monitor. In the event that the patient commences the medication on a day of the week other than a Sunday, such as for example on a Tuesday as shown in the figures, the patient would take the medication for the Tuesday through Saturday of the first week's card. Thereafter, on the Sunday, he would commence taking the medication on the second week card. In this way, the card usage is synchronized to the regular weekly cycle of Sunday to Saturday which would provide for further ease of compliance with the dosage regimen. This synchronization to the regular weekly cycle is accomplished with minimal wastage of the pharmaceutical dosage form especially when it is considered that on a maintenance medication, the patient will be taking the medication continuously for an extended period of time.
The unit dose packaging as described above is of particular utility with respect to ticlopidine hydrochloride, an inhibitor of platelet function which 2064~~g reduces the ability of blood platelets to stick to each other and to the walls of blood vessels. This action reduces the tendency of blood to clot in unwanted places such as narrowed blood vessels. This medication has been found to be especially suitable for therapy in patients who have undergone a stroke or are at increased risk of undergoing a stroke as ticlopidine hydrochloride has been shown to decrease both stroke mortality and the occurrence of first or repeat strokes in such patients. While the medication has been found to be particularly useful it has also been found that in a certain small percentage of the population, the medication may affect the formation of white blood cells which could result in the patient having an increased susceptibility to infection. It has been found that this side effect of the medicine occurs within the first 3 months of the patient being placed on the medication. If the condition does not show up in the first 3 months, then it has been found that the patient is unlikely to develop the condition. Thus, during the initial 3 month therapy utilizing ticlopidine hydrochloride, it is necessary to perform blood cell counts on a regular basis, most preferably at least once every two weeks. In order to alert the patient to this fact, packaging such as described above is used. This packaging 10 contains the two-week dosages of ticlopidine hydrochloride and has on the card for the second week supply, the indication to alert the patient to have the blood test conducted after 3 to 4 days of week two. With this testing procedure the test results will be available to the doctor prior to renewing the prescription for a further two-week period. These packages are preferably used during the initial 3-month period and thereafter maintenance packages such as the second embodiment described above consisting of individual weekly blister packs containing the dosages for the week may be utilized.
2os49~o wH-8365 - 17 -The direct association of a particular day of the week with a particular daily dosage and the lay-out of a weekly amount of the medication on a card provides the user with a simplified format to make compliance easier and to provide a record that the user has been complying. For example, if on Wednesday there is still one pill left for Tuesday and Monday's medication has been properly taken, the user recognizes that he did not comply with the regimen and additional care should be exercised. Furthermore, the packaging allows other people helping the user to evaluate whether the medication is being taken as directed.
Although various preferred embodiments of the present invention have been described herein in detail, it will be appreciated by those skilled in the art, that variations may be made thereto without departing from the spirit of the invention or the scope of the appended claims.
UNIT DOSE PACKAGING
The present invention relates to a unit dose packaging for a pharmaceutical dosage to be taken in a dosage regimen continuously for more than one weekly interval.
Pharmaceuticals or medicines are generally utilized to correct disease states or other physiological abnormalities. In use it is quite common that the medicine be given to a patient in a treatment regimen over a multi day period which may also involve the use of divided daily dosages of the pharmaceutical. For most acute conditions, the treatment regimen usually covers one or two weeks, however, for chronic conditions, it is quite common for a patient to be on a maintenance dose of the medicine for an extended period of time. Such chronic conditions include, for example, diabetes and high blood pressure and other ~_.. 20~49~9 conditions contributing to an increased risk to heart attack or strokes. Examples of such medicines for treating such chronic conditions include oral antidiabetic agents such as acetylhexamide, chloropropamide, glyburide, metformin and tolbutamide, cardiac drugs such as as atenolol, digoxin, diltiazem, labetalol, metoprolol, nadolol, nifedipine, pindolol, procainamide, propranolol, quinidine, ticlopidine hydrochloride, timolol and verapamil, hypertensive drugs such as acebutolol, captopril, clonidine, furosemide, labetalol and mindoxil, diuretics such as acetazolamide, amiloride, chlorthalidone and hydrochlorothiazide.
Frequently, such patients, particularly the elderly or those patients being treated for cardiac problems, have difficulty following the proper dosage regimen due to a tendency to fail to remember whether the medicine was taken at a particular time or on a particular day. This difficulty is compounded by the fact that most medicines are dispensed to the patient in a bulk container making it extremely difficult for a patient to determine whether they have in fact missed taking one of the doses of medicine. In order to help with the compliance of the dosage regimen, containers divided into seven compartments to correspond with the days of the week have been developed. These containers are utilized by patients on such maintenance medicines by placing into each compartment the medicine required for the daily dosages of their treatment regiments. On the particular day of the week, the patient then takes the medicine as required from each of the individual compartments.
Additionally, many of the medications utilized in maintenance therapy and, in particular, those used in treating cardiac conditions, have either narrow therapeutic ranges or have an increased incidence of side effects so that it is necessary for the patient to be monitored on a wH-8365 - 3 -regular basis during the maintenance therapy utilizing the medication. Such monitoring generally is conducted on a fairly frequent basis during the initial stages of the maintenance therapy. Once the patient has been stabilized on the maintenance dose, while the monitoring may be less frequent, it still occurs on a regular basis.
The present invention provides for a unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval. The packaging comprises a series of blister packs, each of the blister packs containing the solid pharmaceutical dosage form for one weekly interval.
The solid dosage form is arranged in individual pockets on the blister pack to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
In an aspect of the invention, there is provided a unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval and requiring a specific act by the patient during at least one of the weekly intervals.
The packaging comprises a series of connected cards, each of the cards having the solid pharmaceutical dosage form for one weekly interval. The card for the weekly interval requiring the specific act by the patient has means thereon for alerting the patient to the specific act. The solid dosage forms are arranged on the cards in a manner to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen and immediate visual feedback as to the compliance with the dosage regimen and compliance with the specific act to be carried out.
In another aspect of the invention, there is provided a packaging system for a prescription medication to be taken daily for more than one weekly interval. The packaging system comprises a series of cards with each card having the required medication for a weekly period located in a blister pack, the blister pack having a series of pockets corresponding to a daily dosage of the prescription medicine with the pockets being positioned to form a closed loop configuration about an open center region. Each card has at least a front cover applied over one of the blister packs and secured thereto, the cover including openings therein for receiving the pockets of the blister pack and presenting the pockets forwardly of the front cover. The front cover includes a unique day of the week associated with the pockets corresponding to a daily dosage of the prescription medicine with the days of the week being in sequence about the loop configuration. The face of each card is customized for the particular weekly period and at least some of the faces of the cards are different.
In yet another aspect of the invention, there is provided a packaging system for a prescription medication to be taken daily for an initial trial period during which period the user is to be monitored on a regular basis for efficacy of the medication and/or adverse reactions. The packaging system includes a series of cards, each card having associated therewith one week of medication divided into separate and distinct medication for a particular day identified by the day of the week and an indication whether the card is for the week of the medication during which the monitoring is to be conducted. The card for the week during which the monitoring is to be conducted including specific instructions printed thereon reminding the user of wH-8365 - 5 -the requirement for monitoring to be conducted after a specified number of days of medication in the week sufficient to allow the results of the monitoring to be known prior to completing the medication for the week, whereby a doctor will have the results of the monitoring prior to renewing the prescription providing the user with a further supply of medication contained within the packaging system.
Preferred embodiments of the present invention are illustrated in the drawings, in which:
Figure 1 is a perspective view of a packaging of the present invention;
Figure 2 is a perspective view of a blister pack for use in the packaging of Figure 1;
Figure 3 is a cross-section along line 3-3 of the blister pack of Figure 2;
Figure 4 is a perspective view of the packaging of Figure 1 in use during the first week;
Figure 5 is a perspective view of the packaging of Figure 1 in use during the second week;
Figure 6 is a perspective view illustrating the method of construction of the packaging of Figure 1;
Figure 7 is a perspective view of a second embodiment of the packaging of the present invention;
Figure 8 is a cross-section of the embodiment of Figure 7; and Figure 9 is a perspective view illustrating the inter-relationship of the components of the packaging system of Figure 7.
.. 20fi49~9 The present invention provides for a unit dose packaging for weekly supplies of a solid pharmaceutical dosage form to be taken in a maintenance dosage regimen.
The packaging comprises a blister pack having the solid pharmaceutical dosage form arranged on the blister pack in a manner to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
To further enhance compliance each daily dosage is preferably provided with a day of the week designation so that the user may confirm their compliance with a particular day of the week.
The packaging of the present invention may be provided as a series of blister packs packaged together with each blister pack having the solid pharmaceutical dosage form for one weekly interval.
The blister packs may also be attached to a card having at least a front cover applied over one of the blister packs and secured thereto, the cover being provided with openings therein for receiving the pockets of the blister pack and presenting the pockets forwardly of the front cover. The front cover also preferably includes a unique day of the week associated with the pockets corresponding to a daily dosage of the prescription medicine with the days of the week being in sequence about the loop configuration. The face of each card is preferably customized for the particular weekly period and at least some of the faces of the cards may be different.
This packaging is particularly useful in dosage regimens which require a specific act by the patient during at least one of the weekly intervals. Such specific acts 20fi~9~9 wH-8365 may include regular monitoring or testing to identify adverse reactions or efficacy of the medication. With this packaging, the card for the weekly interval requiring the specific act by the patient may be provided with means thereon for alerting the patient to the specific act. The means for alerting the patient to the specific act may be indicia not directly associated with the dosage for any specific day. Alternatively, the means may be provided by a indicia associated with the dosage a specific day if it is necessary that the specific act be performed on a specific day of the weekly dosage cycle. The indicia may be printed directly on the card such as written instructions for the specific act or may be provided as a stick on label which is placed on the appropriate location on the card either by the pharmacist when dispensing the medicine or by the user of the drug.
The unit dose packaging is also useful for dosage regimens which require multiple daily doses of the medicine, in particular divided daily doses. The packaging may have the solid pharmaceutical dosage form arranged in a manner to present and identify each daily dosage separately by day and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen. For example, the dosages for a particular day could be associated together with a contrasting colour visually tying the dosages together and the daily dosages could be arranged in the closed loop pattern.
The unit dose packaging of the present invention is particularly useful for medicines used in maintenance therapy for treating hypertension or high blood pressure and other conditions contributing to an increased risk to heart attack or strokes. Such medicines include atenolol, digoxin, diltiazem, labetalol, metoprolol, nadolol, nifedipine, pindolol, procainamide, propranolol, quinidine, ticlopidine hydrochloride, timolol, verapamil, acebutolol, 2os49~~
captopril, clonidine, clozapine, furosemide, labetalol, mindoxil, acetazolamide, amiloride, chlorthalidone and hydrochlorothiazide. When a patient is on a maintenance dose of such medicine it is important that the individual dosages are taken when required. If a dosage is missed then the effect of the medicine is reduced which in certain cases may lead to the onset of symptoms. Additionally, certain of the medicines also require further specific acts by the patients at varying times during the dosage regimen.
Such acts may include consulting with their physician or having certain clinical tests performed to monitor the effectiveness of the medicine or the onset of side effects from the therapy. The unit dose packaging of the present invention allows for ease of compliance with the dosage regimen as well as allowing for alerting the patient when it is necessary to perform a specific act such as consulting with their physician or having a clinical test conducted.
Preferred embodiments of the packaging of the present invention for a dosage regimen of divided daily doses will now be described with reference to the attached figures.
Figure 1 illustrates one preferred embodiment of the unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval. The unit dose packaging, generally indicated by the numeral 10, is particularly suitable for an introductory period where testing and/or specific monitoring is required. The packaging 10 comprises a cover 16 and a series of related cards which in the embodiment illustrated in Figure 1 includes two cards 12 and 14. Each card 12 and 14 contains the solid pharmaceutical dosage form for one weekly interval, the dosage form being arranged on the card in a manner to present and identify each dosage separately and to form a 20fi49~~
patterned sequence of dosages. This is most preferably accomplished by providing the solid dosage form in a blister pack for insertion in the card. A typical blister pack is illustrated in Figures 2 and 3 generally indicated by the numeral 20. The blister pack 20 includes a top 22 which is generally constructed of a clear plastic having a series of pockets 24 for containing of the dosage forms 26.
The dosage forms are maintained in the pockets by a bottom 28 which is generally a foil material heat sealed to the top 22 to seal the dosage forms in the individual pockets 24.
In the embodiment illustrated in Figure 2, the blister pack is set up for a medication which is taken in a divided daily dose, namely twice daily over the weekly time interval. Each of the two dosages for a daily period are arranged together in side by side relationship in the blister pack while the dosages for the individual days are arranged in a generally circular closed loop pattern around the blister pack.
Figure 4 illustrates the unit dose packaging 10 being utilized during the first weekly interval. In this case, the weekly interval starts on a Tuesday and the dosages are taken in a clock-wise direction until the card is completed on the following Monday. Owing to the generally circular pattern of the presentation of the dosage forms on the card, the weekly interval may commence on any day and is easily followed in the clock-wise pattern. The card 12 for the first weekly interval has inserted therein a blister pack as described above. The card front 12A is provided with openings 17 to locate pockets 24 forward of the card front 12A. Associated with the openings 17 for receiving the paired pockets 24 is a day of the week indicia 32. A contrasting color indicia 30 is imprinted on the card front 12A associated with the openings for the dosages for a particular day. These 20fi~9~9 indicia 30 and 32 provide a quick reference and immediate visual feedback as to whether one or both of the dosages for a particular day has been taken and whether the user is complying with the dosage regimen. To remove the medication, the patient pushes the medication through the foil at the back of the blister pack and through openings 17 and 18 provided in the card front 12A and card back 12B.
This is accomplished in conventional fashion by pushing on the pocket containing the medication until the medication pushes through the foil at the back of the blister pack.
The medication is taken continuously throughout the weekly interval until the card has been completed. At the completion of the first week, the patient then continues with the second week of medication provided on card 14. A
perforation 42 may be provided between cards 12 and 14 whereby once the medication for the first week is completed, the now empty card 12 may be separated from the remainder of the packaging 10 and discarded.
Figure 5 illustrates the commencement of the second week of taking of the medication. In this case, the card for the first week 12 has been opened up thereby exposing the card back 12B illustrating the openings 18 in the card back which expose the foil 28 of the blister pack 20 and allow for removal of the medication by pushing it through the foil backing of the blister pack and through opening 18. The card back 12B is also provided with a further opening 34 through which, for example, a lot number or other information imprinted on the foil 28 of the blister pack 20 is visible.
The card 14 for the second weekly interval of medication is constructed in similar fashion to the card 12 for the first weekly medication. Moreover, if the taking of the medication by the patient requires a specific act by the patient during one of the weekly intervals such as for example, making an appointment with his physician or having a blood test conducted, the card may be provided with means such as indicia for alerting the patient of the specific act such as, for example, the information 38 imprinted on the card 14. This provides a direct association of a particular step in the monitoring of the effects of the medication with the appropriate time in the regimen of the medication to remind the user to arrange for this particular step to be carried out. This direct association of the timing of a particular step with a particular point in time within the treatment regimen is more reliable and easier for the user. To further assure compliance, a separate test sticker may be included and placed by the doctor, the pharmacist or by the user adjacent the particular day when the desired step should be arranged or carried out. Any of these approaches are of particular benefit with introductory packaging where monitoring is often more critical. In many cases, it is preferred to have the specific act carried out at a point in time that will allow the results to be known prior to renewal of medication. For example, if a test is conducted on the fourth day of the second week, the doctor will have the results prior to renewing of the prescription. A system such as described encourages compliance with any testing requirements and reminds the patient of their responsibility to comply with the desired monitoring function. As can be appreciated with the packaging as illustrated, the user commencing the second week of medication is reminded of the need to carry out a particular step and is continued to be reminded when the medication is taken each day of the second week.
The cover 16 may be provided with a pocket opening 40 in the cover back 16B for receiving a leaflet 43 containing specific information or instructions for the patient. This information would also include details of any particular step to be carried out by the patient such as any testing requirements.
Figure 6 illustrates the construction of the packaging as described in Figures 1 through 5. Figure 6 displays the inside surfaces of the cards and cover prior to being folded to form the packaging. The packaging is preferably formed by die-cutting a blank from a single piece of suitable material such as cardboard to form the various portions of the packaging. The packaging is formed by scoring the blank in the appropriate location to produce fold lines which after insertion of the blister pack and folding of the blank on the fold lines forms the final packaging. In order to provide for the folding of the blank to produce the packaging as described above, the packaging is laid out with the fronts and backs of the cards alternating. Thus, as shown in Figure 6, the lower half of the blank for the packaging shows the cover front 16A, the second week card back 14B and the first week card front 12A. The upper half of the packaging has the cover back 16B, second week card front 14A and first week card back 12B.
A first hinge region 50 is preferably provided between the first week card front 12A and second week card back 14B and a second hinge region 52 is also preferably provided between second week card back 14B and cover front 16A. To provide for easier folding of the completed packaging, portions of the blank between the first week card back 12B and second week card front 14A (indicated by the numeral 54) and between the second week card front 14B
and the cover back 16B (indicated by the numeral 56) corresponding in size to hinge regions 50 and 52 are removed. However, depending upon the weight of the card stock utilized to form the packaging this may not be necessary. Hinge region 50 is formed of a width corresponding generally to the height of the pocket 24 of wH-8365 - i3 -the blister pack to permit the card for the first week 12 and the card for the second week 14 to lie in generally parallel relationship when the card for the first week 12 is folded over on top of the card for the second week 14 in the final packaging 10. Similarly, hinge region 52 between the cover front 16A and the second week card back 14B is of a width to allow the cover 16 to lie in generally parallel relationship to the first and second week cards 12 and 14, when the cover is folded over the cards in the final packaging 10. As described above, the separation between the first week and the second week cards 12 and 14 may be provided with a perforation 42 to allow for the first week card 12 to be discarded once the treatment regimen for that week has been completed.
To form the packaging the blank for the packaging is die-cut from suitable printed card stock and score lines for the folding are pressed into the card stock. Blister packs 20 are placed on the inside of the first week card front 12A and the second week card front 14A to allow the pockets 24 to protrude through the openings provided in the card fronts. For ease of handling, the blister packs may be secured to the card fronts by suitable means such as glue. Thereafter, the packaging is formed by folding the first week card along the score lines in the direction of the arrows and securing it to the back of the blister pack 20 and the first week card front 12A by suitable means such as gluing.
Similarly, the second week card front 14A is folded over along the score lines and secured to the second week card back 14B and the cover back 16B is folded along the score lines and secured to the cover front 16A. The packaging is then completed by folding the first week card 12 along the score lines forming the hinge region 50 to overlay the second week card 14 and the cover 15 is folded along the 206~~~9 score lines forming hinge region 52 to overlay the first week card 12 and second week card 14.
While the packaging has been described for a two-week supply of medication, packaging for more than two weeks may easily be produced by the same methods of construction. If additional cards are provided they would be provided at the edge of the card for the first week 12 and would have the alternating relationship of the fronts and backs of the cards. Thus, the back of the further card would be next to the front of the card for the first week 12A and similarly, the front of the further card would be next to the back of the card 12B illustrated in Figure 6.
In a packaging such as this for a three-week supply, the card for the first week would be the additional card, the card for the second week would be the card 12 and the card for the third week would be the card 14 illustrated in the figures. An additional hinge region would be provided between the extra card and card 12 and hinge regions 50 and 52 would be adjusted in width to compensate for the extra card.
A further embodiment of a packaging system of the present invention is illustrated in Figure 7 generally indicated by the numeral 60. The packaging system 60 includes a wallet holder 62 which as shown in Figure 8 and 9 is adapted to hold blister pack 64 and instruction booklet 66. The wallet is provided with pockets 68 and 69 of a size to allow insertion of the blister pack 64 or instruction booklet 66. The wallet may be provided with a closure flap 70 with a closure means 72 complementary to a closure means 74 provided on the surface of the wallet.
Enclosure means 72 and 74 may be a snap-type closure or as illustrated in Figure 7 may be a VelcroTM closure.
As illustrated in Figure 9, the wallet has pockets 68 and 69 for holding patient instruction booklet 66 and blister pack 64. Blister pack 64 may be provided of 2(?649~9 similar construction as the individual cards described above with respect to the first embodiment or alternatively, the blister pack may itself be provided with the indicia normally associated with the cards such as for example the day of the week indication 76 and the contrasting color indicator 78 associated with the dosages for a particular day. In certain applications it may also be possible to provide for a second weekly blister pack to fit in the pocket 69 along with a patient information booklet 66 or to replace the patient information booklet 66 completely by a second weekly dosage blister pack.
The packaging of the present invention provides a further advantage in that after an initial trial period has been completed, the use of the cards may be adjusted to correspond with a regular weekly cycle. By coordinating the dosage schedule with the regular weekly cycle, compliance of the patient with the therapy may be easier to monitor. In the event that the patient commences the medication on a day of the week other than a Sunday, such as for example on a Tuesday as shown in the figures, the patient would take the medication for the Tuesday through Saturday of the first week's card. Thereafter, on the Sunday, he would commence taking the medication on the second week card. In this way, the card usage is synchronized to the regular weekly cycle of Sunday to Saturday which would provide for further ease of compliance with the dosage regimen. This synchronization to the regular weekly cycle is accomplished with minimal wastage of the pharmaceutical dosage form especially when it is considered that on a maintenance medication, the patient will be taking the medication continuously for an extended period of time.
The unit dose packaging as described above is of particular utility with respect to ticlopidine hydrochloride, an inhibitor of platelet function which 2064~~g reduces the ability of blood platelets to stick to each other and to the walls of blood vessels. This action reduces the tendency of blood to clot in unwanted places such as narrowed blood vessels. This medication has been found to be especially suitable for therapy in patients who have undergone a stroke or are at increased risk of undergoing a stroke as ticlopidine hydrochloride has been shown to decrease both stroke mortality and the occurrence of first or repeat strokes in such patients. While the medication has been found to be particularly useful it has also been found that in a certain small percentage of the population, the medication may affect the formation of white blood cells which could result in the patient having an increased susceptibility to infection. It has been found that this side effect of the medicine occurs within the first 3 months of the patient being placed on the medication. If the condition does not show up in the first 3 months, then it has been found that the patient is unlikely to develop the condition. Thus, during the initial 3 month therapy utilizing ticlopidine hydrochloride, it is necessary to perform blood cell counts on a regular basis, most preferably at least once every two weeks. In order to alert the patient to this fact, packaging such as described above is used. This packaging 10 contains the two-week dosages of ticlopidine hydrochloride and has on the card for the second week supply, the indication to alert the patient to have the blood test conducted after 3 to 4 days of week two. With this testing procedure the test results will be available to the doctor prior to renewing the prescription for a further two-week period. These packages are preferably used during the initial 3-month period and thereafter maintenance packages such as the second embodiment described above consisting of individual weekly blister packs containing the dosages for the week may be utilized.
2os49~o wH-8365 - 17 -The direct association of a particular day of the week with a particular daily dosage and the lay-out of a weekly amount of the medication on a card provides the user with a simplified format to make compliance easier and to provide a record that the user has been complying. For example, if on Wednesday there is still one pill left for Tuesday and Monday's medication has been properly taken, the user recognizes that he did not comply with the regimen and additional care should be exercised. Furthermore, the packaging allows other people helping the user to evaluate whether the medication is being taken as directed.
Although various preferred embodiments of the present invention have been described herein in detail, it will be appreciated by those skilled in the art, that variations may be made thereto without departing from the spirit of the invention or the scope of the appended claims.
Claims (38)
1. A unit dose packaging for a solid pharmaceutical dosage form to be taken in a dosage regimen continuously for more than one weekly interval, said packaging comprising a series of blister packs, each of said blister packs having the solid pharmaceutical dosage form for one weekly interval, the solid dosage form being arranged in individual pockets in a generally closed loop configuration on the blister pack to present and identify each dosage separately and to form a patterned sequence of dosages to allow for ease of compliance with the dosage regimen whereby non-compliance is immediately visually identifiable by reviewing the dosages remaining on the blister pack.
2. A unit dose packaging as claimed in claim 1 for a weekly supply of a solid pharmaceutical dosage form to be taken in a dosage regimen of multiple daily doses wherein the pockets containing the dosage forms for a daily dose of the dosage regimen are associated together on the blister pack.
3. A unit dose packaging as claimed in claim 1 wherein a unique day of the week is associated with each pocket with the days of the week being in sequence.
4. A unit dose packaging as claimed in claim 1 or 2 wherein a unique day of the week is associated with the pocket containing the dosage forms for a daily dose of the dosage regimen with the days of the week being in sequence about said loop configuration.
5. A unit dose packaging as claimed in claim 3 wherein the dosage form is taken twice daily.
6. A unit dose packaging as claimed in any one of claims 1 to 8, wherein the blister pack has a separate colour field about the dosage forms for any particular day.
7. A unit dose packaging as claimed in any one of claims 1 to 6, wherein the solid pharmaceutical dosage form is a tablet.
8. A unit dose packaging as claimed in any one of claims 1 to 7, wherein the solid pharmaceutical dosage form contains ticlopidine hydrochloride as the active ingredient.
9. A packaging system for a prescription medication to be taken daily for more than one weekly interval, said packaging system comprising a series of cards with each card having the required medication for a weekly period located in a blister pack, said blister pack having a series of pockets corresponding to a daily dosage of said prescription medicine with said pockets being positioned to form a closed loop configuration about an open center region, each card having at least a front cover applied over one of said blister packs and secured thereto, said cover including openings therein for receiving the pockets of the blister pack and presenting said pockets forwardly of said front cover, said front cover including a unique day of the week associated with the pockets corresponding to a daily dosage of said prescription medicine with the days of the week being in sequence about said loop configuration, and wherein the face of each card is customized for the particular weekly period and at least some of the faces of the cards are different.
10. A packaging system as claimed in claim 9 for a two week interval and wherein said series of cards is two cards each identified for a particular week,, the card identified for the second week having on the front cover thereof specific instructions for having a test carried out after a certain number of days of medication in the second week.
11. A packaging system as claimed in claim 10 wherein each card has a front and back cover each having aligned openings corresponding to the location of the pockets of the blister pack.
12. A packaging system as claimed in claim 11 wherein said blister pack is secured by glue between said front and back covers.
13. A packaging system as claimed in claim 12 wherein said cards are connected along one side edge by a hinge connection.
14. A packaging system as claimed in claim 13 wherein said cards include a cover card the same size as said series of cards hingedly connected to the card for the second week and designed to cover the cards for the first and second week when stacked one above the other.
15. A packaging system as claimed in claim 14 wherein said cover card further includes a pocket therein containing a patient package insert.
16. A packaging system as claimed in claim 15 wherein each card has a separate colour field about each paired pocket.
17. A packaging system for a prescription medication to be taken twice daily for more than one weekly interval, said packaging system comprising a series of cards with each card having the required medication for a weekly period located in a blister pack, said blister pack having a series of paired pockets corresponding to one daily dosage of said prescription medication with said paired pockets being positioned to form a closed loop configuration about an open center region, each card having at least a front cover applied over one of said blister packs and secured thereto, said cover including openings therein for receiving the pockets of the blister pack and presenting said pockets forwardly of said front cover, said front cover including a unique day of the week associated with each paired pocket with the days of the week being in sequence about said loop configuration, and wherein the face of each card is customized for the particular weekly period and at least some of the faces of the cards are different.
18. A packaging system as claimed in claim 17 for a two week interval and wherein said series of cards is two cards each identified for a particular week, the card identified for the second week having on the front cover thereof specific instructions for having a test carried out after a certain number of days of medication in the second week.
19. A packaging system as claimed in claim 18 wherein said medication is ticlopidine hydrochloride.
20. A packaging system as claimed in claim 19 wherein said certain number of days is three or four and said test is a blood test.
21. A packaging system as claimed in claim 21 wherein each card has a front and back cover each having aligned openings corresponding to the location of the pockets of the blister pack.
22. A packaging system as claimed in claim 21 wherein said blister pack is secured by glue between said front and back covers.
23. A packaging system as claimed in claim 22 wherein said cards are connected along one side edge by a hinge connection.
24. A packaging system as claimed in claim 23 wherein said cards include a cover card the same size as said series of cards hingedly connected to the card for the second week and designed to cover the cards for the first and second week when stacked on above the other.
25. A packaging system as claimed in claim 24 wherein said cover card further includes a pocket therein containing a patient package insert.
26. A packaging system as claimed in claim 25 wherein each card has a separate colour field about each paired pocket.
27. A packaging system for a prescription medication to be taken daily for an initial trial period during which period the user is to be monitored on a regular basis for efficacy of the medication and/or adverse reactions, said packaging system including a series of cards, each card has associated therewith one week of medication divided into separate and distinct medication for a particular day identified by the day of the week and an indication whether the card is for the week of the medication during which the monitoring is to be conducted, the card for the week during which the monitoring is to be conducted including specific instructions printed thereon reminding the user of the requirement for monitoring to be conducting after a specified number of days of medication in the week sufficient to allow the results of the monitoring to be known prior to completing the medication for the week, whereby a doctor will have the results of the monitoring prior to renewing the prescription providing the user with a further supply of medication contained within the packaging system.
28. A packaging system as claimed in claim 27 wherein the blister pack of each card is common.
29. A packaging system as claimed in claim 28 wherein said prescription medication is ticlopidine hydrochloride.
30. A packaging system as claimed in claim 29 wherein said specified number of days is three of four and said monitoring is a blood test.
31. A packaging system as claimed in claim 30 wherein each card has a separate colour field about medication for any particular day.
32. A packaging system as claimed in claim 31 wherein the daily medication is two separate tablets contained in paired pockets of the blister pack.
33. A packaging system for a prescription medication to be taken daily for an initial trial period during which period the user is to be tested on a regular basis for adverse reactions, said packaging system including two cards, each card has associated therewith one week of medication divided into separate and distinct medication for a particular day identified by the day of the week and an indication whether the card is for the first or second week of the medication, the card for the second week including specific instructions printed thereon reminding the user of the requirement for a test to be conducted after a specified number of days of medication in the second week sufficient to allow the results of the test to be known prior to completing the medication for the second week, whereby a doctor while have the results of the test prior to renewing the prescription providing the user with a further two week supply of medication contained within the packaging system.
34. A packaging system as claimed in claim 33 wherein the blister pack of each card is common.
35. A packaging system as claimed in claim 34 wherein said prescription medication is ticlopidine hydrochloride.
36. A packaging system as claimed in claim 35 wherein said specified number of days is three or four and said test is a blood test.
37. A packaging system as claimed in claim 36 wherein each card has a separate colour field about medication for any particular day.
38. A packaging system as claimed in claim 37 wherein the daily medication is two separate tablets contained in paired pockets of the blister pack.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA 2064959 CA2064959C (en) | 1992-04-02 | 1992-04-02 | Unit dose packaging |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA 2064959 CA2064959C (en) | 1992-04-02 | 1992-04-02 | Unit dose packaging |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2064959A1 CA2064959A1 (en) | 1993-10-03 |
CA2064959C true CA2064959C (en) | 2000-09-19 |
Family
ID=4149563
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA 2064959 Expired - Lifetime CA2064959C (en) | 1992-04-02 | 1992-04-02 | Unit dose packaging |
Country Status (1)
Country | Link |
---|---|
CA (1) | CA2064959C (en) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005019061A1 (en) * | 2003-08-21 | 2005-03-03 | Duchesnay Inc. | Micronutrient supplement dispensing package |
WO2005018652A1 (en) * | 2003-08-21 | 2005-03-03 | Duchesnay Inc. | Micronutrient supplement |
USD607750S1 (en) | 2007-03-27 | 2010-01-12 | The Procter & Gamble Company | Dispensing package |
USD607749S1 (en) | 2007-03-27 | 2010-01-12 | The Procter & Gamble Company | Dispensing package |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5755462A (en) * | 1996-03-12 | 1998-05-26 | Lupi; Louis A. | Medication sample and medication prescription device |
US6056322A (en) * | 1998-08-03 | 2000-05-02 | Lupi; Louis A. | Combination sample medication payment check and medication prescription device |
-
1992
- 1992-04-02 CA CA 2064959 patent/CA2064959C/en not_active Expired - Lifetime
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2005019061A1 (en) * | 2003-08-21 | 2005-03-03 | Duchesnay Inc. | Micronutrient supplement dispensing package |
WO2005018652A1 (en) * | 2003-08-21 | 2005-03-03 | Duchesnay Inc. | Micronutrient supplement |
CN1835870B (en) * | 2003-08-21 | 2010-07-21 | 达切斯内公司 | Micronutrient supplement dispensing package which is safe to children |
USD607750S1 (en) | 2007-03-27 | 2010-01-12 | The Procter & Gamble Company | Dispensing package |
USD607749S1 (en) | 2007-03-27 | 2010-01-12 | The Procter & Gamble Company | Dispensing package |
Also Published As
Publication number | Publication date |
---|---|
CA2064959A1 (en) | 1993-10-03 |
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