FORM 2
THE PATENT ACT 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION
BLISTER PACKAGE FOR IMPROVED PATIENT
COMPLIANCE
2. APPLICANT
(a). NAME: WOCKHARDT LIMITED
(b). NATIONALITY: INDIAN
(c). ADDRESS: D-4, M. I. D. C INDUSTRIAL AREA,
CHIKALTHANA, AURANGABAD –
431006, MAHARASHTRA, INDIA.
The following specification particularly describes the invention and
the manner in which it is to be performed.
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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.
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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
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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.
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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 doubledosing), 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.
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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.
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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.
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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
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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.
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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
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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.
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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.

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.
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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.