CLIAMS:1. A foldable compliance blister package (1) comprises two planar surfaces (5,6); planar surfaces are joined by a strip (7); the planar surfaces (5) comprise a matrix of blisters (2) arranged in a plurality of columns and plurality of rows for containing fixed dosage form (4) for once a day administration; the planar surface (6) comprise blisters (3) arranged in parallel rows and parallel columns towards the periphery of the planar surface (6) containing fixed dosage form (4) for once a day administration; the fixed dosage form (4) comprises a therapeutically active ingredient; the planar surfaces (5,6) further comprises backing strip; the blister package (1) is characterized in that the planar surface (5) blister (2) comprises dosage form (4) for a week’s administration and the planar surface (6) blister (3) comprises dosage form (4) for a month’s administration on alternate days.
2. The compliance package of claim 1 wherein planar surface (5) blister (2) is identifiable by start date, week, calendar day of the week, morning.
3. The compliance package of claim 1 wherein planar surface (6) blister (3) is identifiable by starting day, calendar day and end date.
4. The compliance package of claim 1 wherein the therapeutically active ingredient of the dosage form (4) in the blisters (2, 3) of the planar surfaces (5, 6) is methylprednisolone.
5. The compliance package of claim 4 wherein planar surface (5) columns blisters (2) are loaded with 164 mg methyl prednisolone.
6. The compliance package of claim 4 wherein planar surface (6) alternate blisters (3) are loaded with 64 mg methyl prednisolone. ,TagSPECI:Field of the invention
A foldable compliance blister package may comprise two planar surfaces; planar surfaces may be joined by a strip; one of the planar surfaces may comprise a matrix of blisters arranged in a plurality of columns and plurality of rows for containing fixed dosage form for once a day administration; the other planar surface may comprise blisters arranged in parallel rows and parallel columns towards the periphery of the planar surface containing fixed dosage form for once a day administration; the planar surfaces further may comprise backing strips; the blister package may be characterized in that the one of the planar surface blister may comprise dosage form for a week’s administration and the other planar surface blister may comprise dosage form for a month’s administration on alternate days.
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 design which may cater to administration of fixed dosage form of medrol (Methylprednisolone) for treating multiple sclerosis.
Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. MEDROL Tablets contain methylprednisolone which is a glucocorticoid.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. 5
Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
MEDROL Tablets are indicated in the following conditions: disorders of endocrine and rheumatic, collagen diseases, dermatolocic diseases, allergic states, opthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, gastrointestinal diseases and nervous system.
In view of the various indications, the available strengths and packages of Medrol vary in sizes such as 2 mg (bottles of 100); 4 mg (bottles of 100 and 500); unit dose packages of 100; 8mg (bottle of 25); 16 mg (bottle of 50); 32 mg (bottle of 25).
In nervous system for treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone (200*0.8 = 160 methyl prednisolone) for a week followed by 80 mg (80*0.8 = 64 methyl prednisolone) every other day for 1 month have been shown to be effective (4 mg of Methylprednisolone is equivalent to 5 mg of prednisolone).
Since the Methylprednisolone tablets are supplied in various strengths 2mg, 4mg, 8mg, 16mg and 32 mg, non availability of 32 mg tablets in pharmacies when in need may pose the problem of compliance. Suppose if the lower strengths tablets may be available, the patient may have to purchase not only more tablet bottles but also needs to calculate the correct dosage posing the problem of non compliance. The non compliance may also result as a consequence of the need to remember the days of the week, the calendar days, the start date and the end date.
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
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functioning who will have to administer this additional dosage forms in case of affliction with specific disease such as multiple sclerosis.
One of the aspects of the invention may relate to a foldable compliance blister package comprises two planar surfaces; planar surfaces are joined by a strip; the planar surfaces comprise a matrix of blisters arranged in a plurality of columns and plurality of rows for containing fixed dosage form for once a day administration; the planar surface comprise blisters arranged in parallel rows and parallel columns towards the periphery of the planar surface containing fixed dosage form for once a day administration; the fixed dosage form comprises a therapeutically active ingredient; the planar surfaces further comprises backing strip; the blister package is characterized in that the planar surface blister comprises dosage form for a week’s administration and the planar surface blister comprises dosage form for a month’s administration on alternate days.
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 comprising a therapeutically active ingredient for a week followed by every other day for 1 month;
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
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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 may comprise a therapeutically active ingredient.
“Administration” or “Ingestion” as used herein may refer to once a day administration of a dosage form.
“Alternate day” or “every other day” may refer to day1, day3, day5, day7, etc., i.e. skipping every second day - one day on, one day off, and so on
Figure 1 shows a planar foldable compliance blister package (1) for patient compliance provided with a fixed dosage form (4) over a period of time; the planar foldable blister package (1) may comprise two halves known as planar surfaces (5, 6) which may be joined together at the centre by a small strip (7) of the same material as that of blister package (1); one of the planar surfaces (5) may comprise a matrix of blisters (2) arranged in a plurality of columns and plurality of rows for containing fixed dosage form for once a day administration.; the other planar surface (6) may comprise blisters (3) arranged in parallel rows and parallel columns towards the periphery of the planar surface containing fixed dosage form for once a day administration; Each half of the planar blister package (1) may comprise same fixed dosage forms (4) for administration daily for a week
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followed by alternate days for a month. The two parallel edges of the small strip (7) joining the planar surfaces (5,6) 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 (7) would act as a link and support between the two planar surfaces (5, 6) to extend the shape of a foldable pack. The planar surfaces (5, 6) and small strip (7) may be integrally formed or also may be 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 (5) may correspond to that half of the blister pack (1) which may comprise a week’s administration of fixed dosage form (4); there are five blisters against each of the seven days of the week forming five columns comprising a fixed dosage form (4); the blisters pack (1) planar surface (5) may be identifiable by start date, week 1 against the columns, the month and the word morning (represented in abbreviated form “M”) above the five columns signifying once a day administration of five 32 mg fixed dosage forms (160 mg) all together at time in the morning. The planar surface (5) may also be identifiable by days against rows on one side and calendar days on the other side.
The other planar surface (6) may comprise blisters (3) arranged in parallel rows and parallel columns towards the periphery of the planar surface containing fixed dosage form (4) for once a day administration on alternate days for one month. The alternate blisters (3) starting from the day 1 of the month for compliance purpose immediately after the ingestion of Day 7 fixed dose of the week 1 may be also be divided in two halves (3a,3b) by a partition to contain two 32 mg strengths of the blisters. In Figure 1, the blisters (3) of the planar surface (6) where in the two partitions have been shown signify the days of the compliance month. For example Day 7 of the week 1 falls on 25th day of the November month i.e. Thursday, then the starting day 1 of the month for the compliance purpose for ingestion on alternate days falls on 26th day of November. The day 1 of the planar surface (6) of the compliance pack (1) would Friday, 26th November. In figure 1, though only numerals 1 to 30 have been indicated for the days, it needs to be understood that the numeral 1 refer to Day 1, numeral 2 refer to Day 2, etc. In Figure 1, though calendar days have been shown against the Day 3 and Day 13 representation of
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calendar days have been understood to have been shown on all odd number days. The blisters pack (1) of the planar surface (6) may be identifiable by the month, the day, the calendar day and the end date. Against the day 3, in the planar surface (6) the numerals 32 and the word morning (represented in abbreviated form “M”) signifies once a day administration of two 32 mg fixed dosage forms (64 mg) all together at time in the morning. Though for representation purpose the numerals 32 and “M” have been shown against the day 3, it may be understood that they have been shown against all odd days of the month.
The blister package may be any known child resistant or non child resistant one. The blister package may be 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.