DESC:BLISTER PACKAGE FOR IMPROVED PATIENT COMPLIANCE

RELATED PATENT APPLICATIONS

This application claims the priority to and benefit of Indian Provisional Patent Application No. 201921029668 filed on July 23, 2019; the disclosures of which are incorporated herein by reference in its entirety as if fully rewritten herein.

Field of the invention

The present invention relates generally to a packaging system for pharmaceutical products. More particularly, the present invention relates to a medication blister pack for error free dosing, thus improving patient compliance with a recommended dosing regimen.

Background of the invention

Medication adherence – or the rate at which patients take all of their medicines at the proper dosage, and at the correct times is very important. Educating patients about the drugs they take is important, but it may not be enough to ensure they take their medication properly. Convenience can be a critically important factor in medicine adherence.
There are many reasons patients do not take their medication as directed:
i. Patients are human, which means they forget.
ii. Keeping track of multiple pills or a complex medical regimen every day can be difficult and confusing.
iii. Prescriptions can be expensive, particularly for individuals on a limited income.
iv. Patients who have high cholesterol or other conditions that lack outward symptoms may stop taking their medication because they cannot see or feel it working.

Non-compliance is generally associated with patients having chronic illness or illnesses such as hypertension, diabetes, psychotics, hypercholesterolemia etc. The reasons for noncompliance 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. Medication compliance is a serious problem, especially in the elderly. Twenty percent of all prescriptions that are written are never filled and up to sixty percent of all medication prescribed is taken incorrectly or not at all. Solutions aimed at improving medication compliance are needed.

Blister packs are a type of pre-formed plastic packaging commonly used for distributing small consumer goods, including medication. Blister packs provide a cheaper but less robust alternative for distributing medication than other types of personal medication dispensing devices. Blister packaging, commonly referred to as multi-dose blisters, compliance packaging, bingo cards, DisPill®, Distrimedic, Manrex or ECO-PILL™ branded blister packages are the best way to safely dispense solid medications. They commonly hold between 5 and 15 medications per dose and are conveniently organized by time of day: morning, noon, evening and bedtime. Typically, each package contains 1 week supply of medications.

US Patent No. 9,408,777 provides a Blister package for patient compliance. 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.

The blister packages are usually delivered to the senior at their home, their residence or long-term care facility. Those capable of self-managing medications, simply tear off the blister at the appropriate time, and take all their medications contained in 1 blister.

Complex medication regimens are difficult enough for millennial to handle, but for seniors they are near impossible. Blister packages have grown in popularity around the world because they simplify an otherwise complicated process. One blister package replaces up to 15 standard medication vials making it easy for a senior to take the right medications at the right time. Blister packaging is the best solid medication packaging solution, particularly for senior, chronic care patients, veterans or those with complex medication regimens. For Pharmacists, the low start-up costs, error-reduction and increased customer loyalty are enticing. For patients, the ease of taking pre-packaged, pre-organized medications, at no additional cost, is welcome. As our society continues to age, the need for blister packaging will grow. Patients who may have started with a single medication, single vial, may likely transition to pouch and then blister packaging as they age and the number and complexity of medications increase. Blister packaging is a big help.

However, there remains the need for pharmaceutical packaging systems that will further improve patient compliance. Applicant proposes an improved medication blister pack for error free dosing of a twice a day administration of a medication or therapeutically active ingredient.

Summary of the invention

The present inventors have found a need for a suitable compliance enabling blister package which satisfies an error free dosing of a twice a day administration of a medication or therapeutically active ingredient.

The present inventors while working on a compliance blister package have surprisingly designed a simple, cost effective, and simple to use blister pack design. The blister pack design of the present invention aids in increasing patient compliance by easy to use, enhance patient comfort, promote independent living, help people who forget if they have taken their medications or not (avoids double-dosing), are advantageous for vision-impaired people, are easy for caregivers to make sure medications are being taken correctly.

In one of the aspects of the invention is provided a compliance facilitating blister package for patient compliance with the dosage of medication over a period of time; the package comprising a base having a matrix of blister (3); said matrix includes two columns separated by perforation (7); Each column of blister (3) has two dosage of medication of same strength, to be taken at one time; the blister (3) comprises dosage forms for twice a day administration of the medication; one column of blister (3) has morning medications together and second column of blister (3) has evening medications together; Each blister (3) has times of the day printed on its backing strip on peel region, in each peel region peel to get two tablets is printed in one side in each column and in one half of the blister on peel region Morning is printed and another half of the blister on peel region Evening is printed; the blister package is identifiable by the product name, the product strength, the lot number, the manufacturing date and the expiry date. Figure 1 illustrates an embodiment of one day blister package comprising 4 tablets for a twice a day administration.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each dosage form in a set comprises a common dose of medication.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each dosage form in a set comprises a common dose of medication comprising Levonadifloxacin tablet.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein Levonadifloxacin tablet is a film-coated tablet comprising Ala-levonadifloxacin mesylate equivalent to 500mg of Levonadifloxacin.

In another aspect of the invention is provided a compliance blister package for patient compliance is stored at room temperature.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein the backing strip is a peel away strip.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein the backing strip is a multilayer backing strip.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack comprises tablets of same or different strength to be consumed in one day.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack comprises 4 tablets of 500 mg strength to be consumed in one day with twice a day administration.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack of one day is provided in a separate carton cover or carton box.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein the dosage of medication is taken over a period of one week.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack shown in Figure 1 comprises a bottom film and a top film for forming a plurality of film containers (1), which through perforations (7) can be separated from one another, each having one accommodating chamber (2) for a filling, the accommodating chambers (2) being arranged around the peripheral boundary of the blister pack (3), wherein an opening region, a peel able leading foil (5) is available for opening the accommodating chamber (2); the blister pack (3) containing a plurality of film containers (1) comprises a bottom film with cavities (4) and a top film, which is attached to the bottom film in suitable manner, preferably using a heat-seal lacquer, to form closed accommodating chambers (2) in the region of the cavities (4), each for at least one filling, particularly a pharmaceutical active substance formulation in the form of tablet; Restraint means (6) for preventing the medicament from moving from one accommodating chamber (2) to another accommodating chamber (2).

In another aspect of the invention is provided a compliance blister package for patient compliance may be any known child resistant or non child resistant one.

Detailed description of the drawings

Figure 1 Illustrate an embodiment of one day blister package comprising 4 tablets for a twice a day administration;

Detailed description of the invention

The following terminologies will have the meanings as defined below.

The term “medication” as used herein refers to a medicine or pharmaceutical drug, or simply drug; which is used to diagnose, cure, treat, or prevent disease. The term “medication” can also be refereed as the administration of a drug or medicine.

The term "active ingredient" refers to a therapeutically active compound contained in medicine, as well as any prodrugs thereof and pharmaceutically acceptable salts, hydrates and solvates of the compound and the prodrugs. The term "active ingredient" also refers to as therapeutically active ingredients or pharmaceutically active ingredients.

The term “blister” as used herein refers to a reservoir or pocket or cell of the compliance package which accommodates the active ingredient in any of the dosage form as defined under “dosage form”.

The “dosage form” as defined here is in the form of a tablet or capsule of any geometrical shape.

“Administration” as used herein refers to twice a day administration of a single drug.

"Room temperature" as used herein refers to normal storage conditions, which means storage in a dry, clean, well-ventilated area at room temperatures between 1°C to 30°C or up to 45°C, depending on climatic conditions. "Room temperature" can also refer to a temperature prevailing in a work area.

In one of the aspects of the invention is provided a compliance blister package for patient compliance with the dosage of medication over a period of time; the package comprising a base having a matrix of blister (3); said matrix includes two columns separated by perforation (7); Each column of blister (3) has two dosage of medication of same strength, to be taken at one time; the blister (3) comprises dosage forms for twice a day administration of the medication; one column of blister (3) has morning medications together and second column of blister (3) has evening medications together; Each blister (3) has times of the day printed on its backing strip on peel region, in each peel region peel to get two tablets is printed in one side in each column and in one half of the blister on peel region Morning is printed and another half of the blister on peel region Evening is printed; the blister package is identifiable by the product name, the product strength, the lot number, the manufacturing date and the expiry date. Figure 1 illustrates an embodiment of one day blister package comprising 4 tablets for a twice a day administration.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each dosage form in a set comprises a common dose of medication.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each dosage form in a set comprises a common dose of medication comprising Levonadifloxacin tablet.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein Levonadifloxacin tablet is a film-coated tablet comprising Ala-levonadifloxacin mesylate equivalent to 500mg of Levonadifloxacin.

In another aspect of the invention is provided a compliance blister package for patient compliance is stored at room temperature.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein the backing strip is a peel away strip.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein the backing strip is a multilayer backing strip.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack comprises tablets of same or different strength to be consumed in one day.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack comprises 4 tablets of 500mg strength to be consumed in one day with twice a day administration.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack of one day is provided in a separate carton cover or carton box.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein the dosage of medication is taken over a period of one week.

In another aspect of the invention is provided a compliance blister package for patient compliance wherein each blister pack shown in Figure 1 comprises a bottom film and a top film for forming a plurality of film containers (1), which through perforations (7) can be separated from one another, each having one accommodating chamber (2) for a filling, the accommodating chambers (2) being arranged around the peripheral boundary of the blister pack (3), wherein an opening region, a peel able leading foil (5) is available for opening the accommodating chamber (2); the blister pack (3) containing a plurality of film containers (1) comprises a bottom film with cavities (4) and a top film, which is attached to the bottom film in suitable manner, preferably using a heat-seal lacquer, to form closed accommodating chambers (2) in the region of the cavities (4), each for at least one filling, particularly a pharmaceutical active substance formulation in the form tablet; Restraint means (6) for preventing the medicament from moving from one accommodating chamber (2) to another accommodating chamber (2).

In another aspect of the invention is provided a compliance blister package for patient compliance may be any known child resistant or non child resistant one.

In one of the aspects of the invention the medication or therapeutically active ingredient in the compliance blister package may be antibiotics, antivirals, antifungals, anti-osteoporosis agents, antithrombotic agents, anticholinergic agents, antihypertensive, platelet aggregation inhibitors, antidiabetics and anti psychotic, anti-inflammatory agents, sedatives, hypnotics, anxiolytic agents, adrenergics, anti-parkinsonism agents, anticonvulsants, antiepileptics, CNS stimulants, antianginal agents, antiarrhythmics, antihyperlipidemic drugs, diuretics, antiasthmatics, anticoagulants, antianemia agents, vitamins, hormones, antihistaminics, anticancer agents, antiallergics, antiarthritis agents, antialzheimers’ agents, vasopressin antagonists, anticonvulsants, steroids, anesthetics, thrombolytics, antacids, proton pump inhibitors, protease inhibitors, mucolytics, antimalarials, antiemetics, laxatives, expectorants, enzymes, contraceptives, bronchodilators, antitussives, antimigraine agents, anthelmintics, antidepressants, and anorexiants within the scope of the invention.

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.
,CLAIMS:We Claim:

1. A compliance blister package for patient compliance with the dosage of medication over a period of time; the package comprising a base having a matrix of blister (3); said matrix includes two columns separated by perforation (7); Each column of blister (3) has two dosage of medication of same strength, to be taken at one time; the blister (3) comprises dosage forms for twice a day administration of the medication; one column of blister has morning medications together and second column of blister has evening medications together; Each blister has times of the day printed on its backing strip on peel region, in each peel region peel to get two tablets is printed in one side in each column and in one half of the blister on peel region Morning is printed and another half of the blister on peel region Evening is printed; the blister package is identifiable by the product name, the product strength, the lot number, the manufacturing date and the expiry date.

2. The compliance blister package as claimed in Claim 1, wherein each dosage form in a set comprises a common dose of medication comprising Levonadifloxacin tablet.

3. The compliance blister package as claimed in Claim 2, wherein Levonadifloxacin tablet is a film-coated tablet comprising Ala-levonadifloxacin mesylate equivalent to 500mg of Levonadifloxacin.

4. The compliance blister package as claimed in Claim 1 is stored at room temperature.

5. The blister package as claimed in Claim 1, wherein the backing strip is a peel away strip.

6. The blister package as claimed in Claim 1, wherein each blister pack comprises 4 tablets of 500mg strength to be consumed in one day with twice a day administration.

7. The blister package as claimed in Claim 1, wherein each blister pack of one day is provided in a separate carton cover or carton box.

8. The blister package as claimed in Claim 1, wherein the dosage of medication is taken over a period of one week.

9. The blister package as claimed in Claim 1, wherein each blister pack comprising a bottom film and a top film for forming a plurality of film containers (1), which through perforations (7) can be separated from one another, each having one accommodating chamber (2) for a filling, the accommodating chambers (2) being arranged around the peripheral boundary of the blister pack (3), wherein an opening region, a peel able leading foil (5) is available for opening the accommodating chamber (2); the blister pack (3) containing a plurality of film containers (1) comprises a bottom film with cavities (4) and a top film, which is attached to the bottom film in suitable manner, preferably using a heat-seal lacquer, to form closed accommodating chambers (2) in the region of the cavities (4), each for at least one filling, particularly a pharmaceutical active substance formulation in the form of tablet; Restraint means (6) for preventing the medicament from moving from one accommodating chamber (2) to another accommodating chamber (2).

10. The compliance blister package as claimed in Claim 1, wherein the blister package is child resistant or non child resistant.