CLIAMS:1. A foldable compliance blister package (1) comprises two planar surfaces (2,3); the planar surfaces (2,3) further comprises a backing strip; the planar surfaces are joined by a strip (4); the planar surfaces (2,3) comprise a matrix of blisters (5,6) arranged in a plurality of columns and plurality of rows; the columns one to four and columns five to eight of the planar surfaces (2,3) comprise three different fixed the dosage forms (9,10,11) for twice a day administration; the rows of the planar surfaces (2,3) represent days of the week 1 and week 2; days of the week 1 and week 2 are marked on the strip (4); the blister package (1) is characterized in that the columns one to four of the planar surface represents morning dosage form and columns five to eight represent evening dosage form of the planar surfaces (2) of the week 1; the columns one to four represents morning dosage form and columns five to eight represent evening dosage form of the planar surfaces (3) of the week 2; the columns one to four and columns five to eight of the planar surfaces (2,3) are separated by demarcation gaps (7,8).
2. The compliance package of claim 1 wherein the demarcation gap (7) is colored blue.
3. The compliance package of claim 1 wherein the demarcation gap (8) is colored green.
4. The compliance package of claim 1 wherein the week 1 and week 2 are identifiable by start date and end date.
5. The compliance package of claim 1 wherein the dosage forms (9) comprises Lansoprazole.
6. The compliance package of claim 1 wherein the dosage forms (10) comprises amoxicillin. 10
7. The compliance package of claim 1 wherein the dosage forms (11) comprises clarithromycin. ,TagSPECI:Field of the invention
A foldable compliance blister package may comprise two planar surfaces; the planar surfaces further may comprise a backing strip; the planar surfaces may be joined by a strip; the planar surfaces may comprise a matrix of blisters arranged in a plurality of columns and plurality of rows; the columns one to four and columns five to eight of the planar surfaces may comprise three different fixed dosage forms for twice a day administration; the rows of the planar surfaces may represent days of the week 1 and week 2; days of the week 1 and week 2 may be marked on the strip; the blister package may be characterized in that the columns one to four of the planar surfaces may represent morning dosage form and columns five to eight of the planar surfaces may represent evening dosage form; the columns one to four and columns five to eight of the planar surfaces may be separated by demarcation gaps.
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
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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 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
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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 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 4
arranged in a rectangular format or seven columns and a plurality of rows. The tray may 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 all in general and especially for elderly patient’s declining mental functioning who will have to administer single/multiple fixed dosage forms twice a day in case of affliction with specific disease such as drug resistant bacteria over an extended duration of two weeks. Ingestion of these dosage forms may be in addition to other dosage forms due to diseases that normally afflict the elderly persons.
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Prevpac may be prescribed for reducing the development of drug-resistant bacteria and maintain the effectiveness of Prevpac and other antibacterial drugs; Prevpac may be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Prevpac consists of a daily administration card containing two prevacid (Lansoprazole) 30 mg delayed release capsules, four amoxicillin 500 mg capsules, USP, and two clarithromycin 500 mg tablets, USP, for oral administration.
According to USFDA label Prepac may be supplied as an individual daily administration card containing two Lansoprazole 30 mg delayed release capsules, four 500 mg amoxicillin capsules and two 500 mg clarithromycin tablets for oral administration. A carton containing 14 or 11 daily administration cards may be supplied. This way of supplying the dosage forms may pose problems for people who may to have travel frequently on outstation duties. Patients whose duties may be at a place which may be far enough to involve 2 to 3 hours travel may prefer to carry a single card with them with the assumption that they would return back home on the same day. It may so happen that they may to have to extend their stay back at the duty place due to exigencies of work. In such situations carton may pose non compliancy. It may always be, easy, preferable and comfortable to carry a foldable blister pack which can be tucked inside the pocket rather than a carton containing a multiple blister packs. Further carton bulkiness associated with tucking inside the pocket prevents the patient to follow this practice but prefer individual cards leading to non compliancy.
A foldable compliance blister package may comprise two planar surfaces; further the planar surfaces may comprise a backing strip; the planar surfaces may be joined by a strip; the planar surfaces may comprise a matrix of blisters arranged in a plurality of columns and plurality of rows; the columns one to four and columns five to eight of the of one the planar surfaces may comprise three different fixed dosage forms for twice a day administration; the columns one to four and columns five to eight of the of the other planar surface may comprise three different fixed dosage forms for twice a day administration; the rows of the planar surfaces may represent days of the week 1 and week 2; days of the week 1 and week 2 may be marked on the strip; the week 1 days may
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be marked as Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and the week 2 days may be marked as Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14. The compliance blister package may be characterized in that the columns one to four in one of the planar surfaces may represent morning dosage form and columns five to eight of evening dosage form; the columns one to four may represent morning dosage form and columns five to eight of evening dosage form in the other planar surface; Columns one to four and columns five to eight of the planar surfaces may be separated by demarcation gaps.
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 a foldable compliance blister package comprising twice daily administration of three different fixed dosage forms comprising three different therapeutically active ingredients for two weeks.
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.
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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 three different dosage forms may comprise three different therapeutically active ingredients.
“Administration” or “Ingestion” as used herein may refer to once a day administration of a dosage form.
A foldable compliance blister package (1) may comprise two planar surfaces (2, 3). The planar surface (2) and planar surface (3) may be joined by a strip (4). The planar surfaces (2, 3) and the strip (4) may be a integrally formed or the two edges (12, 13) may be joined to the planar surfaces (2, 3) by a glue or similar material. The edges (12, 13) may be sufficient thickness so as to withstand the frequent opening and closing operations. the planar surfaces (2,3) may comprise a matrix of blisters (5,6) arranged in a plurality of columns and plurality of rows; the columns one to four and columns five to eight of the planar surfaces (2,3) may comprise three different fixed the dosage forms (9,10,11) for twice a day administration; the column 1 to column 8 may be numbered from left to right of the planar surface (2); Similarly Column 1 to column 8 may be numbered from left to right of the planar surface (3); the column1, column 5 of the planar surface (2) and column 1 and column 5 of the planar surface (3) may comprise the dosage form (9) comprising the therapeutically active ingredient Lansoprazole. The Lansoprazole may be indicated by the letter “L” in the compliance for convenience sake. Column 2, column 3, column 6, column 7 of the planar surface (2) and Column 2, column 3, column 6, column 7 of the planar surface (3) may comprise the dosage form (10) comprising the 8
therapeutically active ingredient amoxicillin. The amoxicillin may be indicated by the letter “M”. Column 4, Column 8 of the planar surface (2) and column 4, column 8 of the planar surface (3) may comprise the dosage form (11) comprising therapeutically active ingredient clarithromycin. The clarithromycin may be indicated by the letter “C”. The rows of the planar surfaces (2,3) may represent days of the week 1 and week 2; days of the week 1 and week 2 are marked on the strip (4); the blister package (1) may be characterized in that the columns one to four of the planar surface may represent morning dosage form and columns five to eight represent evening dosage form of the planar surfaces (2) of the week 1; the columns one to four may represent morning dosage form and columns five to eight may represent evening dosage form of the planar surface (3) of the week 2; the columns one to four and columns five to eight of the planar surfaces (2,3) may be separated by demarcation gaps (7,8).
The demarcation gap (7) of the planar surface (2) of the compliance blister package (1) may be identifiable blue color. The demarcation gap (8) of the planar surface (3) may be identifiable by green color.
The week 1 of the planar surface (2) and week 2 of the planar surface (3) of the compliance blister package (1) may be identifiable start date and end date.
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.