DESC:FIELD OF THE INVENTION
[0001] The present disclosure pertains 5 to the field of capsules, in particularly,
to odour masking capsule banding composition.
BACKGROUND OF THE INVENTION
10 [0002] Advancement in product development studies involving deeper insights
of absorption, solubility, bioavailability & pharmacodynamics stem to newer
delivery systems. Predominant oral delivery system involving capsules have
brought a newer dimension to the delivery of complex molecules in the field of
pharma and nutra and dietary segment by expanding the range of possible
15 formulations & further facilitating individualized dosage regimes.
[0003] Capsules are generally prepared from an edible natural substance such
as gelatin or celluloses, synthetically hydroxypropyl methylcellulose. Hard
capsules can offer a significant advantage over soft gel capsules for the
encapsulation of liquids and semisolids. The shell of such hard capsule consists of
20 two prefabricated, cylindrical sections (a cap and a body). The body has a slightly
lower diameter than the cap and fits inside the cap. The two pieces are telescopically
joined so that they have a partial overlap of the cap-side wall with the body-side
wall. The fabricated hard capsule shells are filled with formulation in a separate
manufacturing operation, most critical factor of which is to avoid the propensity for
25 leakage of the formulation through the gap between the cap and body of the capsule.
The leakage can be minimized and eliminated by band sealing the two capsule parts
together by sealing the junction between the cap and body by using a sealing liquid
of banding material, the process commonly termed as band sealing.
[0004] The band sealing of hard capsules is a process, wherein the capsules are
30 first rectified and then passed once or twice over a wheel that revolves in a banding
3
bath. A quantity of polymer is picked up by the serrated wheel and applied to the
junction of the cap and body. The capsules remain in individual carriers for drying.
It is generally accepted that the industrial banding operation is the best practice to
seal the capsule as it offers several advantages such as (1) prevents leakage of liquid
5 encapsulation formulation, 4 (2) reduces oxygen permeability, (3) provides tamper
evident band, (4) ensures capsules separation of capsule body and cap during
swallowing preventing esophageal injuries (5) branding of nutraceuticals for
identification to consumers.
[0005] Active ingredients designed to offer the best of therapeutic advantage to
10 the patient can, at times, fail to elicit the requisite response due to non-compliance
to the dosage regimes by the patients. The predominant factor for such nonadherence
to the regimes is the unpleasant taste and/or odour of the formulation that
is in fact the intrinsic property of the drug. The unpalatable flavor and/or odour of
the formulation can thwart the benefits of even the most powerful of active
15 ingredients, raising the need for better patient compliant delivery forms.
[0006] Odour is an important and critical parameter in administering
formulations which meet the taste buds. Unpleasant odours are a common issue for
pharmaceutical and nutraceutical manufacturers, in terms of both the active
themselves and the conditions they are called on to treat, thereby decreasing patient
20 compliance and thus compromising their curative efficacies in clinical application.
The success of any product depends on its formulation that appeals to the patient.
Therefore, the developments of odour-masking techniques are of great significance
in improving organoleptic properties of the formulation.
[0007] In case of orally administered products, odour and taste are one of the
25 priority factors for achieving patient compliance. The difficulty in administration
of such supplements or drugs becomes more challenging especially if the
drug/medicine has similar obnoxious odour. Therefore, there remains a huge need
in the art to develop an odour masking capsule banding composition.
SUMMARY OF THE INVENTION
4
[0008] Accordingly, the present invention discloses an odour masking capsule
banding composition. The composition comprises at least one odor-masking agent
in an amount in the range of 0.2-25%, at least one base in an amount in the range
of 0.2-25% by weight based of the weight of the banding composition, at least one
flavor and fragrance complex polymer 5 in an amount in the range of 0.2-25% by
weight based of the weight of the banding composition, isopropyl alcohol in an
amount in the range of 5-80% by weight based of the weight of the banding
composition, ethanol in an amount in the range of 5-80% by weight based of the
weight of the banding composition, potable water in an amount in the range of 2-
10 80% by weight based of the weight of the banding composition.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Figure 1 depicts a capsule comprising the odour masking capsule
banding composition in accordance with an embodiment of the present invention.
15
DETAILED DESCRIPTION OF THE INVENTION
[00010] The following is a detailed description of embodiments of the present
disclosure. The embodiments are in such detail as to clearly communicate the
disclosure. However, the amount of detail offered is not intended to limit the
20 anticipated variations of embodiments; on the contrary, the intention is to cover all
modifications, equivalents, and alternatives falling within the spirit and scope of the
present disclosure as defined by the appended claims.
[00011] Unless the context requires otherwise, throughout the specification
which follow, the word “comprise” and variations thereof, such as, “comprises” and
25 “comprising” are to be construed in an open, inclusive sense that is as “including,
but not limited to.”
[00012] Reference throughout this specification to “one embodiment” or “an
embodiment” means that a particular feature, structure or characteristic described
5
in connection with the embodiment is included in at least one embodiment. Thus,
the appearances of the phrases “in one embodiment” or “in an embodiment” in
various places throughout this specification are not necessarily all referring to the
same embodiment. Furthermore, the particular features, structures, or
characteristics may be 5 combined in any suitable manner in one or more
embodiments.
[00013] As used in the description herein and throughout the claims that follow,
the meaning of “a,” “an,” and “the” includes plural reference unless the context
clearly dictates otherwise. Also, as used in the description herein, the meaning of
10 “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00014] In some embodiments, the numbers expressing quantities of ingredients,
properties such as concentration, and so forth, used to describe and claim certain
embodiments of the invention are to be understood as being modified in some
instances by the term “about.” Accordingly, in some embodiments, the numerical
15 parameters set forth in the written description are approximations that can vary
depending upon the desired properties sought to be obtained by a particular
embodiment. In some embodiments, the numerical parameters should be construed
in light of the number of reported significant digits and by applying ordinary
rounding techniques. Notwithstanding that the numerical ranges and parameters
20 setting forth the broad scope of some embodiments of the invention are
approximations, the numerical values set forth in the specific examples are reported
as precisely as practicable.
[00015] The recitation of ranges of values herein is merely intended to serve as
a shorthand method of referring individually to each separate value falling within
25 the range. Unless otherwise indicated herein, each individual value is incorporated
into the specification as if it were individually recited herein.
[00016] All methods described herein can be performed in suitable order unless
otherwise indicated herein or otherwise clearly contradicted by context. The use of
any and all examples, or exemplary language (e.g., “such as”) provided with respect
6
to certain embodiments herein is intended merely to better illuminate the invention
and does not pose a limitation on the scope of the invention otherwise claimed. No
language in the specification should be construed as indicating any non-claimed
element essential to the practice of the invention.
5 [00017] The headings and abstract of the invention provided herein are for
convenience only and do not interpret the scope or meaning of the embodiments.
[00018] Various terms are used herein. To the extent a term used in a claim is
not defined below, it should be given the broadest definition persons in the pertinent
art have given that term as reflected in printed publications and issued patents at the
10 time of filing.
[00019] In accordance with an aspect of the present invention, disclosed is an
odour masking capsule banding composition. The composition comprises at least
one odor-masking agent, at least one base, at least one flavor and fragrance
complex, isopropyl alcohol, ethanol and potable water. In an exemplary
15 embodiment of the present invention, the odour masking capsule banding
composition comprises:
- at least one odor-masking agent in an amount in the range of 0.2-25%
- at least one base in an amount in the range of 0.2-25% by weight based
of the weight of the banding composition;
20 - at least one flavor and fragrance complex polymer in an amount in the
range of 0.2-25% by weight based of the weight of the banding
composition;
- isopropyl alcohol in an amount in the range of 5-80% by weight based
of the weight of the banding composition;
25 - ethanol in an amount in the range of 5-80% by weight based of the
weight of the banding composition; and
- potable water in an amount in the range of 2-80% by weight based of
the weight of the banding composition.
7
[00020] In an embodiment of the present invention, the composition further
comprises at least one predetermined colour imparting additive. Typically, the at
least one predetermined colour imparting additive is present in an amount in the
range of 0.01-5% by weight based of the weight of the banding composition.
[00021] In another embodiment 5 of the present invention, the at least one odormasking
agent is at least one of a synthetic, natural or naturally identical flavouring
agent.
[00022] In yet another embodiment of the present invention, the at least one
odor-masking agent is selected from the group consisting of, but not limited to,
10 mint, lemon, orange, vanilla, strawberry, chocolate and coffee.
[00023] In still another embodiment of the present invention, the at least one
base is selected from the group consisting of hydroxypropyl methylcellulose
(HPMC) and gelatin.
[00024] EXAMPLES:
15 Aroma Profiling Study:
The capsules banded with the composition of the present invention were used along
with non-banded capsules (capsules without any odour masking banding). This
was done to get an understanding of sensory profile and also to check the intensity
of odour after certain period.
20 Fragrance intensity/Scale of Intensity:
Low intensity: 1 – 30: Fragrance note is present but weak, some might wonder the
existence of the fragrance.
Moderate intensity: 30 – 50: Fragrance note is present at acceptable intensity.
High intensity: 50 – 80: Fragrance note can be perceived immediately after
25 opening of capsule bottle.
8
Very high intensity: 80 – 100: Fragrance note is intense or dominant or near to
extreme level.
10 people were randomly chosen for this test and were asked to smell the aroma of
capsule from the bottle at various time intervals. Two sets of capsules were
considered 5 for the test, fish oil capsule without any odour masking capsule banding
composition and fish oil capsules with odour masking capsule banding composition
of the present invention.
The observations are summarized in the below mentioned table:
Fish oil capsule (without the banding
composition)
Sr.no Fishy smell intensity
Initial 1 month 2 months 3 months
Panellist -1 10 31 51 60
Panellist -2 13 31 60 75
Panellist -3 22 38 49 65
Panellist -4 25 30 48 66
Panellist -5 18 34 64 80
Panellist -6 24 38 50 79
Panellist -7 15 32 51 65
Panellist -8 24 39 58 78
Panellist -9 26 36 62 68
Panellist -10 23 41 57 64
Average 20 35 55 70
Fish oil capsule with the banding composition
Sr.no Fishy smell intensity Fragrance intensity
Initi
al
1
month
2
months
3
months
Initi
al
1
month
2
months
3
months
Panellist -
1
15 7 5 8 67 80 70 57
Panellist -
2
22 16 6 5 77 70 71 55
Panellist -
3
24 12 11 6 79 68 60 68
Panellist -
4
16 10 10 3 70 65 65 58
Panellist -
5
27 17 12 4 66 62 63 63
9
Panellist -
6
17 18 15 8 80 71 75 50
Panellist -
7
23 15 7 2 82 75 58 65
Panellist -
8
14 18 8 6 79 68 61 58
Panellist -
9
28 20 12 7 74 76 70 59
Panellist -
10
14 17 14 1 76 65 57 67
Average 20 15 10 5 75 70 65 60
Further trials were conducted on the capsules with odour masking capsule banding
composition at predetermined time intervals to check the intensity of aroma with
control samples. The results are summarized in the table hereinbelow:
Sr.no Control Sample Fishy smell Intensity
1 Initial 20
2 1 month 35
3 2 months 55
4 3 months 70
5
Sr.no
Sample with
Fragrance Fishy smell Intensity Fragrance intensity
1 Initial 20 75
2 1 month 15 70
3 2 months 10 65
4 3 months 5 60
Thus, it was observed that the intensity of the fishy smell intensity of fish oil capsule
without the odour masking capsule banding composition goes from low intensity to
high intensity in comparison with the intensity of the fish oil capsule with odour
10 masking capsule banding composition, which remains in low intensity.
[00025] While, the foregoing description discloses various embodiments of the
disclosure, other and further embodiments of the invention may be devised without
departing from the basic scope of the disclosure. ,CLAIMS:1.) An odour masking capsule banding composition, said composition
comprising:
- at least one odor-5 masking agent in an amount in the range of 0.2-25%
by weight based of the weight of the banding composition;
- at least one base in an amount in the range of 0.2-25% by weight based
of the weight of the banding composition;
- at least one flavor and fragrance complex polymer in an amount in the
10 range of 0.2-25% by weight based of the weight of the banding
composition;
- isopropyl alcohol in an amount in the range of 5-80% by weight based
of the weight of the banding composition;
- ethanol in an amount in the range of 5-80% by weight based of the
15 weight of the banding composition;
- potable water in an amount in the range of 2-80% by weight based of
the weight of the banding composition.
2.) The composition as claimed in claim 1, wherein said composition also
comprises at least one predetermined colour imparting additive in an amount
20 in the range of 0.01-5% by weight based of the weight of the banding
composition.
3.) The composition as claimed in claim 1, wherein said at least one odormasking
agent is at least one of a synthetic, natural or naturally identical
flavouring agent.
25 4.) The composition as claimed in claim 1, wherein said at least one odormasking
agent is selected from the group consisting of mint. lemon, orange,
vanilla, strawberry, chocolate and coffee.
5.) The composition as claimed in claim 1, wherein said at least one base is
selected from the group consisting of hydroxypropyl methylcellulose
30 (HPMC) and gelatin.