CLIAMS:1. A foldable compliance blister package (1) comprises two planar surfaces (6,7); planar surfaces are joined by a strip (8) ; the planar surfaces (6,7) comprise a matrix of blisters (2,5) arranged in a plurality of columns and plurality of rows for containing disease treating dosage form 1 (3) and disease relapse dosage form 2 (4); the planar surfaces (6,7) further comprises backing strip; the planar surface (6) comprises blisters (2) containing disease treating dosage form 1 (3) for two weeks; the planar surface (7) comprises blisters (5) containing disease relapse dosage form 2 (4) for two weeks; the blister package (1) is characterized in that the (i) planar surface (6) comprising disease treating dosage form 1 (3) is identifiable by start date; the planar surface (7) comprising disease relapse dosage form 2 (4) is identifiable by end date.
2. The compliance package of claim 1 wherein the disease treating dosage form 1 (3) therapeutically active ingredient is any one or combinations of chloroquine, doxycycline, mefloquine.
3. The compliance package of claim 1 wherein the disease relapse 1 dosage form 2 (4) is primaquine phosphate.
4. The compliance package of claim 1 wherein the backing strip of the planar surface (6) is identifiable by yellow, blue or green.
5. The compliance package of claim 1 wherein the backing strip of the planar surface (7) is identifiable by orange, violet and indigo.
6. The compliance package of claim 1 wherein the disease treating dosage form 1 (3) is once a day fixed dose.
7. The compliance package of claim 1 wherein the disease treating dosage form 2 (4) is once a day fixed dose.

,TagSPECI:Field of the invention
This invention may relate to a foldable compliance blister package comprising a matrix of blisters arranged in a plurality of columns and plurality of rows in each of its folded planar portions; matrix of blisters in one of the folded planar portions may comprise a fixed disease treating dosage form 1 which may comprise a therapeutically active ingredient for treating an ailment for once a day administration for two weeks; matrix of blisters in the other folded planar portion may comprise a fixed disease relapse dosage form 2 comprising a different therapeutically active ingredient than in the other for once a day administration for two weeks; the administration of the dosage form 2 for prevention of relapse of the ailment necessarily may follow the administration of dosage form 1.
Background of the invention
Non-compliance is generally associated with patients having chronic illness or illnesses such as hypertension, diabetes, psychotics, hypercholesterolemia, malaria etc. The reasons for non compliance are many which include multiple medication administration, complex treatment regimens, frequent dose regimens, increasing numbers of medication prescribed and the increase in side effects and/ or drug interactions associated with multiple drug regimens.
Besides the above reasons for non compliance even wherein only two different fixed dosage forms have to be ingested/administered, each one of them once a day for two weeks sequentially, other non compliance extraneous factors such as availability of each one of the fixed dosage forms in different volumes in bottles in large quantities, difficulties in carrying them if the patient is mobile, wastage of available excess fixed dosage forms than the requisite dosages to be ingested/administered, tendency to ingest wrong dosage forms, prevention of procurement of loose dosage forms due to regulatory aspects etc prevent adherence to non compliance. In case even if loose dosage forms are
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available, finding suitable hygienic storage means for the patient at his residence would act as a deterrent for non compliance.
Medication compliance aids have been developed to enhance compliance. In medicine, compliance (also adherence, concordance, or capacitance) describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but may also mean use of medical appliances such as compression stockings, chronic wound care, self-directed physiotherapy exercises, or attending counseling or other courses of therapy. One example is a compliance package. A compliance package may be defined as "a prepackaged unit that provides one treatment cycle of the medication to the patient in a ready-to-use package”
US Patent No. 7,328,802 provides a child resistant blister packages utilizing walled structures enclosing medicament therein.
US Application No. 20080190801 relates to pharmaceutical packaging systems or improved patience compliance.
US Application No. 20070093497 relates to methotrexate compliance package.
WO98/22072 relates to compliance package and method of improving or aiding patient compliance for complex drug regimens.
Some of the prior art compliance packages are; For example, OvconX 35 and 50 (Bristol-Meyers Squibb), Ortho-Novum Dialpak 1/35, 1/50, 10/11 and 7/7/7 (Ortho Pharmaceutical Corp.), Loestrin (D Fe 1/20 and 1.5/30 (Parke-Davis), etc. are oral contraceptives packaged in blister cards. These packages are generally a single blister card, with 21 or 28 day regimens; RheumatrexQ) Dose Packs made by Lederle Laboratories, containing four blister-pack cards each containing either 2, 3, 4, 5, or 6 tablets (for 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per week, respectively) for l-week's therapy of methotrexate; Medrol Dosepak (Upjohn Company), is a packaging designed
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for the administration of steroids, (i.e. methylprednisolone) which require staggered dosing. For each day of drug treatment the number of tablets (and total dose) that the patient must take, decreases. For example, the Medrol Dosepak contains 21, 4mg tablets for 6 days of treatment where for each day of treatment, the total daily dose decreases by one tablet; ZithromaxX Z-Pak made by Pfizer Laboratories, contains a single medication blister card with 6, 250mg capsules. Each blister medication card is labeled with "Day 1 to Day 5" for each dose, the first dose being two, 250 mg capsules labeled "Day 1." Each subsequent capsule is labeled with "Day 2" to "Day 5.”
WO2013030697 discloses a compliance blister package comprising a matrix of blisters arranged in a plurality of columns and plurality of rows which comprises a combination of one of the fixed dose combination dosage form comprising two or more therapeutically active ingredients loaded into blisters of one of the columns and the other dosage form which comprises one or more of therapeutically active ingredient form loaded into the successive column blisters for once a day administration or concurrent administration; and the compliance blister package is identifiable by the product name, the product strength, the lot number, the expiry date and order time for patient compliance.
US 5,788,974 discloses a pharmaceutical dispensing container which holds multiple dosage units for aiding in the compliance in the eradication/treatment for Helicobater pylori and subsequent/related gastric maladies in relation to said bacterial infection using a repetitive dosage regimen for a treatment period of sufficient duration to mitigate said bacterial infection formatted in such a way to gain optimal ease of compliance resulting in improved outcome of treatment. Dosage units may be antibiotic, anti microbial or symptomatic relief agents in any combination. However, this container is capable of dispensing multiple doses of discrete doses of medicines 4 times a day for about a week;
US4039080 discloses a tray having individual compartments for holding pills, capsules, or similar solid medication, each compartment being rectangular in plan view and arranged in a rectangular format or seven columns and a plurality of rows. The tray may
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be loaded with a week's medication for an individual patient with indicia adjacent each column indicating the day of the week
In FR2705886 each column represents a week identifiable by different colors for once a day administration;
DE29913195 discloses nn each blister pack is below the medication in the left lower field of the brand name (eg. B.Heli-Set®) and in the right lower field below the medication is on the one blister pack in red "morning", on the second in blue "evening" for precise treatment instructions. On the back of each blister pack Is Open the foil printed directly on the appropriate medications ranks of the corresponding drug names
All prior art compliance packs discussed above disclose either repetitive or concurrent administration of medicines under any one of the following conditions; once a day administration or concurrent administration of fixed doses over a month or 4 times a day. These prior art compliance packs cater to multiple medicament doses to be administered simultaneously or concurrently.
Summary of the invention
The present inventors while working on a compliance blister package have surprisingly designed a simple, cost effective, and simple to use a foldable blister pack design, easy to carry in pocket. The foldable blister pack design of the present invention aids in increasing patient compliance for easy to use by elderly patient’s declining mental functioning who will have to administer this additional dosage forms in case of affliction with specific disease such as vivax malaria.
Primaquine phosphate may be recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic. Patients suffering from an attack of vivax malaria or having parasitized red blood cells should receive a course of
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chloroquine phosphate, which quickly destroys the erythrocytic parasites and terminates the paroxysm. The course of chloroquine phosphate lasts for 2 weeks.
When chloroquine, doxycycline, or mefloquine may be used for primary prophylaxis, primaquine should be used during the last 2 weeks of post exposure prophylaxis.
Since the suppressive therapy is preceded by the radical cure of vivax malaria, the dosage form 1 may be any one of chloroquine, doxycycline, or mefloquine or combinations thereof and dosage form 2 may be primaquine phosphate. Foldable compliance blister package of the invention may address such sequential once a day administration of fixed dosage forms.
A foldable compliance blister package of the invention may comprise a dosage form 1 comprising a therapeutically active ingredient for treating an ailment for once a day administration in one of the planar blister package folds followed simultaneously with once a day administration of fixed dosage form 2 comprising a different therapeutically active ingredient for treatment of relapse of the ailment in the other planar blister package fold wherein the fold comprising dosage form 1 may be identifiable by start date and the fold comprising dosage 2 may be identifiable by end date.
One of the aspects of the invention may relate to a foldable compliance blister package comprising a matrix of blisters arranged in a plurality of columns and plurality of rows in each of its folded portions; matrix of blisters in one of the planar folded portions may comprise a fixed dosage form 1 which may comprise a therapeutically active ingredient for treating an ailment for once a day administration for two weeks; matrix of blisters in the other planar folded portion may comprise a fixed dosage form 2 comprising a different therapeutically active ingredient than in the other for once a day administration for two weeks; the administration of the dosage form 2 may necessarily follow the administration of dosage form 1 for prevention of relapse of the ailment; the planar folded portion comprising fixed dosage form 1 may be identifiable by start date and the planar folded portion comprising the fixed dosage form 2 may be identifiable by end date.
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In another aspect of the invention may be a planar foldable compliance blister package for patient compliance provided with the dosage of medication over a period of four weeks; each one of the planar folded blister packages may comprise a base having a matrix of blisters for containing either the disease treating dosage form 1 or disease relapse dosage form 2 for two weeks; said matrix including a plurality of columns and a plurality of rows; A plurality of set of dosage form 1 may be provided in the blisters of one of the planar folded blister package portion; each dosage form 1 may be loaded into blister of one of an adjacent row and an adjacent column; the rows and columns i.e. all the blisters in one of the planar folded portions may be identifiable by a unique color provided over the backing strip; the backing strip color may be one or more of yellow, blue, green.
A plurality of set of disease relapse dosage form 2 may be provided in the blisters of the other planar folded blister package portion; the other planar folded blister packages may comprise a base having a matrix of blisters for containing disease relapse dosage form 2 for two weeks; each dosage form 2 may be loaded into blister of one of an adjacent row and an adjacent column; the rows and columns i.e. all the blisters in the other planar folded blister package portions may be identifiable by a unique color provided over the backing strip; the backing strip color may be one or more of orange, violet and indigo.
The details of one or more embodiments of the inventions are set forth in the description below. Other features, objects and advantages of the invention will be apparent from the description and claims.
Detailed description of the drawings
Figure 1 Illustrate an embodiment of foldable blister package comprising a fixed dosage form 1 comprising a therapeutically active ingredient and a fixed dosage form 2 comprising a different therapeutically active ingredient for sequential administration of dosage form 1 and dosage form 2 administration;
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Detailed description of the invention
The following terminologies will have the meanings as defined below. The foldable compliance blister pack may refer to planar foldable sheets with one or more blisters or wells, inside which may be contained an active ingredient, which may be sealed within the well by a second sheet. The construction of the foldable compliance blister pack may be such that the sealing sheet or backing strip may be independently accessible, removable or breakable. The blister pack and the sealing sheet or backing strip may be made of known material of construction in the prior art such as polyvinyl chloride, polyvinylidene chloride, polypropylene, polyethylene, polychlorotrifluoroethylene and combinations thereof.
The term "active ingredient" may refer to a therapeutically active compound, as well as any prodrugs thereof and pharmaceutically acceptable salts, hydrates and solvates of the compound and the prodrugs.
The term “blister” or “well” as used herein may refer to a reservoir or pocket or cell of the compliance package which may accommodate the active ingredient in any of the dosage form as defined under “dosage form”.
The “dosage form” as defined here may be in the form of a tablet or capsule of any geometrical shape. The dosage form 1 and dosage form 2 may comprise different therapeutically active ingredients. The dosage form 1 may also be known as disease treating dosage form. The dosage form 2 may also be known as disease relapse dosage form which acts to prevent the relapse of the disease.
“Administration” or “Ingestion” as used herein may refer to once a day administration of a dosage form.
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“Sequential administration” as used herein may refer to once a day administration of dosage form 1 initially till its completion followed by once a day administration of dosage form 2.
Figure 1 shows a planar foldable compliance blister package (1) for patient compliance provided with either the disease treating fixed dosage form 1 (3) or disease relapse fixed dosage form 2 (4) over a period of time i.e. four weeks comprising two different fixed dosage forms for two weeks of administration in each of its halves; the planar foldable blister package (1) may comprise two halves known as planar surfaces (6, 7) which may be joined together at the centre by a small strip (8) of the same material as that of blister package (1). Each half of the planar blister package (1) may comprise different fixed dosage forms for administration for two weeks. The two parallel edges of the small strip (8) joining the planar surfaces (6,7) of the blister pack (1) may be suitably shaped and of higher thickness than the planar surface to facilitate durability of blister package (1) due to frequent folding and unfolding of the two halves during its usage. The strip (8) would act as a link and support between the two planar surfaces (6, 7) to extend the shape of a foldable pack. The planar surfaces (6,7) and small strip (8) may also be integrally formed or joined together by known adhesion means. The adhesion may be achieved by gum, glue or other known materials of adhesion of polymer based sheets. The planar surface (6) may correspond to that half of the blister pack (1) which may comprise diseasing treating fixed dosage form 1. The blisters pack (1) planar surface (6) may also be identifiable by start date. The planar surface (6) may comprise a base having a matrix of blisters (2) or wells for containing medication for two weeks; said matrix may include a plurality of columns and a plurality of rows; A plurality of set of disease treating fixed dosage form 1 (3) may be provided in the blisters. Each disease treating dosage form 1 (3) may be loaded into blister of one of an adjacent row and an adjacent column; the rows and columns i.e. all the blisters in the planar surface (6) may be identifiable by a unique color provided over the backing strip; the backing strip color may be one or more of yellow, blue and green.
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A plurality of set of disease relapse fixed dosage form 2 (4) may be provided in the blisters (5) or wells of the other planar surface (7) of the blister package (1) containing therapeutically active in gradient for two weeks; each disease relapse fixed dosage form 2 (4) may be loaded into blister of one of an adjacent row and an adjacent column which may be identifiable by an end date; the rows and columns i.e. all the blisters in the other planar surface (7) of the blister package (1) may be identifiable by a unique color provided over the backing strip; the backing strip color may be one or more of orange, violet and indigo.
The blister package may be any known child resistant or non child resistant one. The blister package is provided in a carton cover or carton box.
While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the invention.