U.S. patent application number 12/537092 was filed with the patent office on 2010-04-15 for chewable softgel capsules.
This patent application is currently assigned to VIVA PHARMACEUTICALS INC.. Invention is credited to Chien-Kuang Ko, Jason Jiang-Chung Ko, Yu-Lung Ko, Xueju Xie.
Application Number | 20100092548 12/537092 |
Document ID | / |
Family ID | 41665773 |
Filed Date | 2010-04-15 |
United States Patent
Application |
20100092548 |
Kind Code |
A1 |
Xie; Xueju ; et al. |
April 15, 2010 |
CHEWABLE SOFTGEL CAPSULES
Abstract
A chewable softgel capsule configured for encasing orally
ingestible articles. The chewable soft capsule is provided with an
outer shell composition which comprises at least one gelatin in a
range of 20% to 60% of the total weight of the shell composition,
at least one plasticizer in an amount selected to render flexible
the outer shell composition, an anti-tacking agent in an amount
selected to render the outer shell composition non-sticky, and
water. In one embodiment the chewable soft capsule further
comprises at least one starch in a range of 0.1% to 35% of the
total weight of the shell composition. The chewable softgel capsule
is suitable for encasing therein medicines, pharmaceutical
compositions, nutraceuticals, vitamins, nutritional supplements,
and the like.
Inventors: |
Xie; Xueju; (Richmond,
CA) ; Ko; Yu-Lung; (Richmond, CA) ; Ko;
Chien-Kuang; (Richmond, CA) ; Ko; Jason
Jiang-Chung; (Richmond, CA) |
Correspondence
Address: |
FASKEN MARTINEAU DUMOULIN LLP
2900 - 550 Burrard Street
VANCOUVER
BC
V6C 0A3
CA
|
Assignee: |
VIVA PHARMACEUTICALS INC.
Richmond
CA
|
Family ID: |
41665773 |
Appl. No.: |
12/537092 |
Filed: |
August 6, 2009 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12200850 |
Aug 28, 2008 |
|
|
|
12537092 |
|
|
|
|
Current U.S.
Class: |
424/452 ;
514/774 |
Current CPC
Class: |
A23P 10/30 20160801;
A23L 27/72 20160801; A61K 9/0056 20130101; A61K 9/4816
20130101 |
Class at
Publication: |
424/452 ;
514/774 |
International
Class: |
A61K 9/64 20060101
A61K009/64; A61K 47/42 20060101 A61K047/42 |
Claims
1. A chewable softgel capsule for encasing therein orally
ingestible articles, the chewable soft capsule having an outer
shell composition with a moisture content of about 3% to about 25%,
said outer shell composition comprising: at least one gelatin
incorporated thereinto, said at least one gelatin selected from the
group consisting of an animal-derived gelatin, a chemically
modified gelatin, a physically modified gelatin, and combinations
thereof, the amount of said gelatin selected from the range of
about 30% to about 47% of the total weight of the shell
composition; at least one plasticizer incorporated thereinto, said
at least one plasticizer in an amount sufficient to render said
outer shell composition flexible, said plasticizer selected from a
group consisting of glycerin, mannitol, polyethylene glycol,
sorbitol, sorbitol special, propylene glycol, maltitol, sucrose,
corn syrup, fructose, cellulose, disodium sulfosuccinate, triethyl
citrate, tributyl citrate, 1-2-propylene glycol, natural gum,
isomerized sugar, xylitol, polyglycerol, glucose syrups, glucose,
sugar alcohol, and combinations thereof, the amount of said
plasticizer selected from the range of about 25% to about 45% of
the total weight of the shell composition; at least one starch
incorporated thereinto, said at least one starch selected from a
group consisting of native starches, physically modified starches,
chemically modified starches selected from a group consisting of
starch succinate, starch phosphate, etherified starches, esterified
starches, cross-linked starches, cationized starches, enzymatically
digested starches, and combinations thereof, the amount of said
starch selected from the range of about 10% to about 20% of the
total weight of the shell composition; and an anti-tacking and
softening agent incorporated thereinto in an amount sufficient to
render said outer shell composition non-sticky and soft
therethrough, said anti-tacking and softening agent selected from a
group consisting of lecithin, polysorbate, biologically derived
waxes, chemically derived waxes, fats, oils, and combinations
thereof, the amount of said anti-tacking agent selected from the
range of about 0.2% to about 3% of the total weight of the shell
composition.
2. A chewable softgel capsule according to claim 1, wherein said
starch is a native starch selected from a group consisting of
native potato starches, native corn starches, native wheat
starches, native oat starches, native barley starches, native rice
starches, native sorghum starches, and tapioca starches.
3. A chewable softgel capsule according to claim 1, wherein said
chemically modified starch selected from a group consisting of
chemically modified potato starches, chemically modified corn
starches, chemically modified wheat starches, chemically modified
rice starches, chemically modified sorghum starches, chemically
modified oat starches, chemically modified barley starches, and
chemically modified tapioca starches.
4. A chewable softgel capsule according to claim 1, wherein said
starch is a physically modified starch selected from a group
consisting of pre-gelatinized starches and heat-moisture treated
starches.
5. A chewable softgel capsule according to claim 4, wherein the
physically modified starch selected from a group consisting of
physically modified potato starches, physically modified corn
starches, physically modified wheat starches, physically modified
rice starches, physically modified sorghum starches, and physically
modified tapioca starches.
6. A chewable softgel capsule according to claim 1, further
comprising one of flavorants, colorants, and preservatives.
7. A process for making the chewable softgel capsules of claim 1,
the process comprising the steps of: (a) selecting a gelatin; (b)
selecting a plasticizer; (c) selecting a starch; (d) selecting an
anti-tacking and softening agent; (e) placing predetermined amounts
of said selections for a gelatin, a plasticizer, a starch and an
anti-tacking and softening agent into a cooking tank and
intermixing thereinto a predetermined amount of water cookies
thereby preparing a mixture therefrom; (f) cooking said mixture for
at least 2 hours at a temperature selected from the range of about
65.degree. C. to about 90.degree. C.; (g) applying a vacuum to the
mixture to remove air bubbles therefrom; (h) reducing the
temperature of said cooking tank to a temperature selected from the
range of about 55.degree. C. to about 65.degree. C. until all air
bubbles are removed therefrom said mixture; (i) transferring the
mixture to a machine configured for producing therein a plurality
of chewable softgel capsules from said contents; (j) producing a
plurality of chewable softgel capsules with said machine; and (k)
drying said chewable softgel capsules to a final moisture content
from about 3% to about 20%.
8. A process according to claim 7, wherein the starch is a native
starch selected from a group consisting of native potato starches,
native corn starches, native wheat starches, native oat starches,
native barley starches, native rice starches, native sorghum
starches, and tapioca starches.
9. A process according to claim 7, wherein the starch is a
chemically modified starch selected from a group consisting of
esterified starches, etherified starches, cross-linked starches,
cationized starches, enzymatically digested starches.
10. A process according to claim 9, wherein the chemically modified
starch is selected from a group consisting of chemically modified
potato starches, chemically modified corn starches, chemically
modified wheat starches, chemically modified oat starches,
chemically modified barley starches, chemically modified rice
starches, chemically modified sorghum starches, and chemically
modified tapioca starches.
11. A process according to claim 7, wherein the starch is a
physically modified starch selected from a group consisting of
pre-gelatinized starches and heat-moisture treated starches.
12. A process according to claim 11, wherein the physically
modified starch is selected from a group consisting of physically
modified potato starches, physically modified corn starches,
physically modified wheat starches, physically modified oat
starches, physically modified barley starches, physically modified
rice starches, physically modified sorghum starches, and physically
modified tapioca starches.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of our prior
application Ser. No. 12/200,850 filed Aug. 28, 2008 currently
pending.
FIELD OF THE INVENTION
[0002] The present invention relates generally to soft gelatin
capsules and in particular, to soft gelatin capsules having a
chewable consistency.
BACKGROUND OF THE INVENTION
[0003] Common routes for the administration of pharmacologically
active agents, nutraceuticals, and vitamins are exemplified by a
variety of oral dosage forms such as tablets, pills, and capsules.
Additionally, a wide range of foodstuffs and oral hygiene products,
such as breath fresheners are also orally dispensed. Such dosage
forms are generally convenient, stable in storage and transport,
and familiar to the user. However, they are not without problems,
and these problems are often significant. It is extremely difficult
for most people to swallow any of these oral dosage forms without
supplemental water. It is frequently inconvenient or messy to have
to take supplementary water with oral medicaments. Such
difficulties are compounded for those with swallowing difficulties
such as, for example, children and the elderly. Certain medical
conditions, such as Parkinsons' disease and other neurological
states, make it difficult to swallow oral dosage forms, even with
supplemental water.
[0004] Children and the elderly often experience difficulty in
swallowing and ingesting medicines in solid forms such as tablets,
pills, and capsules. Pharmaceuticals in forms which permit easy
ingestion and whose active components are rapidly released in the
oral cavity are desirable in the event of a medical emergency such
as an attack of angina pectoris.
[0005] Recently, with diversification of personal preferences in
food and textures of food within the mouth, the texture of oral
dosage forms of pharmaceuticals is an additional complication in
oral medicaments.
[0006] In conventional soft gelatin capsules, ingredients are
encapsulated in a gelatin shell for consumption. Generally, the
shell of a soft gelatin capsule comprises gelatin and a plasticizer
to control the softness and flexibility of the shell. The shell
further includes water and optionally other additives such as
flavorants. The shells are typically dried until the water content
is decreased to a certain level so as to prevent the capsule from
being deformed or becoming undesirably sticky.
[0007] Conventional soft gelatin capsules commonly available are
often hard and tough because they are designed to dissolve after
reaching the intestines so as to release their contents therein.
Such capsules are not easily broken by teeth and are not suitable
for chewing. In addition, twisting the capsule with the fingers to
open the capsule is often a difficult practice, and generally
opening the capsule requires a tool such as scissors. One measure
to soften a soft gelatin capsule is to increase the plasticizer
content and increase the capsule flexibility. However, this often
makes a soft gelatin capsule more likely to stick to another soft
gelatin capsule or to a container, thereby causing deterioration in
storage stability. Increasing plasticizer content is further
problematic in high-temperature, high-humidity regions. Soft
gelatin capsules with acceptable dosing, stability, and storage and
handling characteristics are typical when a relatively high gelatin
content and a relatively low plasticizer and end water content is
found in the capsules. However, the chewability, texture and mouth
feel, and client acceptance of the capsules are found when a lower
gelatin content and higher plasticizer and end water contents is
used.
[0008] Typically, chewable soft gelatin capsules, or chewable
softgels, are designed such that the user chews upon the capsule to
release the fill into the mouth instead of swallowing the capsule
with the fill still encapsulated within the shell. Furthermore,
these chewable softgels are intended to be completely or nearly
completely dissolved by chewing. Such capsules are distinguished by
particular fabrication problems, such as excessive stickiness
during encapsulation and sticking of the end product to other
capsules during post-encapsulation handling. Further, chewable
softgels with high end water content typically have poor storage
performance, sticking to one another in packaging and often melting
or leaking during storage. In addition to the effects of water
content, chewability of capsules can be affected by the bloom
strength and the melting points of the gelatin used. In general,
gelatins of lower bloom strength and lower melting point have
preferable organoleptic qualities.
[0009] U.S. Pat. No. 4,935,243 to Borkan, et al. discloses a
chewable gelatin capsule composition that comprises less than about
30%, and preferably comprises about 20-26% water, and is directed
to the use of a hydrogenated starch hydrolysate, which allowed a
lower than expected end water content. U.S. Pat. No. 4,532,126 to
Ebert, et al. discloses examples of soft gelatin capsules formed at
as high as 37% water content, but specifies that these capsules
were then subsequently dried to some undisclosed final end water
content, in order to obtain desired chewing characteristics.
[0010] U.S. Pat. No. 3,851,051 to Miskel et al. discloses numerous
embodiments of a soft gelatin capsule that has an initial capsule
shell water content of between 28.3 and 36.6%, but further
discloses that the capsules are then dried to be in equilibrium
with the internal gel-lattice composition, which has a water
content of 15-20%. In U.S. Pat. No. 6,258,380 to Overholt, capsules
are fabricated from a wet mass that is initially as much as 30%
water by weight, but is then subsequently dried to 6%-8% water.
[0011] U.S. patent application Ser. No. 10/456,450 to Makino;
accomplished a high degree of hydration using fish gelatin having a
low sol-gel transition temperature, that is, a relatively low
melting point. However, such formulations can be problematic when
stored at high temperatures or high humidity. For example, it is
very difficult to formulate a fish gelatin capsule that will be
stable at a storage temperature above 35.degree. C. Capsules made
with such low melting point gelatins tend to become sticky during
storage, and may even burst or melt, releasing their contents. On
the other hand, it is known that mammalian gelatins, some of which
have melting temperatures above 60.degree. C., tend to be much more
stable at higher storage temperatures, but too often have poorer
organoleptic qualities.
[0012] There is a need for chewable softgel compositions having
commercially acceptable properties at the time the capsules are
packaged and made available for sale. Additionally, these chewable
capsules should exhibit stability under reasonably expected storage
times and conditions. Further, these capsules need to exhibit a
soft, pleasant chewing texture and low stickiness.
BRIEF SUMMARY OF THE INVENTION
[0013] The exemplary embodiments of the present invention relate to
chewable softgel capsules suitable for encasing orally ingested
articles, and to processes for producing such chewable softgel
capsules.
[0014] An exemplary embodiment of the present invention relates to
a chewable soft capsule having an outer shell composition
comprising at least one gelatin in an amount selected from the
range of 20% to 60% of the total weight of the shell composition,
at least one plasticizer in an amount selected to render flexible
said outer shell composition, an anti-tacking and softening agent
in an amount selected to render said outer shell composition
non-sticky and soft, and water.
[0015] According to one aspect the outer shell composition of the
chewable softgel capsule may optionally comprise at least one
starch in an amount selected from the range of 0.1% to 35% of the
total weight of the shell composition.
[0016] According to one aspect, the gelatin is selected from the
group consisting of an animal-derived gelatin, a chemically
modified gelatin, a physically modified gelatin, and combinations
thereof.
[0017] According to another aspect, the anti-tacking and softening
agent is selected from the group consisting of lecithin,
polysorbate, biologically derived waxes, chemically derived waxes,
fats, oils and combinations thereof.
[0018] According to another aspect, the oil is selected from the
group consisting of palm oil, coconut oil, vegetable oil, middle
chain triglycerins and mixtures thereof.
[0019] According to yet another aspect, the plasticizer is selected
from the group consisting of glycerin, mannitol, polyethylene
glycol, sorbitol, sorbitol special, propylene glycol, maltitol,
sucrose, corn syrup, fructose, cellulose, disodium sulfosucciante,
triethyl citrate, tributyl citrate, 1-2-propylenglycol, natural
gum, isomerized sugar, xylitol, polyglycerol, glucose syrups,
glucose, sugar alcohol, and combinations thereof.
[0020] According to a further aspect, the starch is selected from
the group consisting of native starches, modified starches,
polysaccharides, and combinations thereof.
[0021] According to another further aspect, the outer shell
composition of the chewable softgel capsule may optionally comprise
at least one of a flavorant, a colorant, a preservative, and
optionally, combinations thereof.
[0022] Another exemplary embodiment of the present invention is
relates to a process for making the chewable softgel capsules. The
process generally comprises the steps of selecting a suitable
amount of gelatin, selecting a suitable amount of plasticizer,
selecting a suitable amount of starch, selecting a suitable amount
of anti-tacking and softening agent, placing predetermined amounts
of said selections into a cooking tank and adding a predetermined
amount of water, mixing selections for at least 2 hours at
80-90.degree. C., reducing the temperature of the mixture in the
cooking tank to 55-65.degree. C. until all air bubbles are removed
from the mixture, transferring the mixture from the cooking tank to
a machine configured for producing chewable softgel capsules from
the mixture, and then producing chewable softgel capsules from the
mixture with the machine.
DETAILED DESCRIPTION OF THE INVENTION
[0023] Some exemplary embodiments of the present invention relate
to a chewable softgel capsule exhibiting extended storage
stability, a soft chewing texture and low stickiness. Further, the
chewable softgel capsule exhibits excellent manufacturing
properties and can be produced using conventional encapsulation
machinery known in the art.
[0024] Some exemplary embodiments of the present invention relate
to a chewable softgel capsule encasing an orally ingestible
article, where the capsule having an outer shell composition
comprising: at least one gelatin; at least one plasticizer in an
amount sufficient to render the outer shell flexible; at least one
starch; an anti-tacking and softening agent sufficient to render
said outer shell non-sticky during manufacturing processes; and
purified water. The capsule outer shell may optionally further
include at least one of flavorants, colorants, and
preservatives.
[0025] Surprisingly, it has been found that the chewable softgel
capsule of the present invention may be produced by mixing an
anti-tacking and softening agent, for example lecithin and or
beewax, with gelatin, plasticizer, and starch. The softgel capsules
produced from this mixture are non-sticky at a high moisture
content of about 20% thereby facilitating their processing and
production. In addition, the softgel capsule remains very soft and
pliable, even at low moisture contents of about 3%. Moreover, the
softgel capsules remain non-sticky and soft during extended
storage, for example, in conditions of 40.degree. C., 75% RH.
[0026] The composition of the present chewable softgel capsule
utilizes the starch component, when mixed with the gelatin and
plasticizer, to form a matrix in which the anti-tacking agent is
trapped so as to produce the chewable softgel capsule of the
present invention. The starch does not act as a moisture retention
agent as understood in the prior art. This anti-tacking agent when
used in the formulations disclosed by the present invention enables
the production of a softgel capsule which: is non-sticky under
storage conditions of high temperature and humidity for example,
40.degree. C., 75% RH; and is non-sticky and soft at both low e.g.
3%, and high e.g. 24%, capsule moisture content.
[0027] Some exemplary embodiments of the present invention related
to a softgel capsule encasing an orally ingestible article, the
capsule having an outer shell composition comprising at least (a)
at least one gelatin, preferably between about 20 to 60% weight,
more preferably between about 20 to 50% weight, even more
preferably between about 30 to 45% weight; (b) at least one
plasticizer in an amount sufficient to render said outer shell
flexible, preferably between about 25 to 40% weight; (c) an
anti-tacking and softening agent sufficient to render the outer
shell non-sticky and soft, preferably 0.2 to 15% weight, more
preferably between about 0.4 to 10% weight, even more preferably
0.6 to 5% weight; and (d) purified water, preferably between about
3 to 25% weight, more preferably between about 3 to 20% weight. The
capsule outer shell further includes (e) at least one starch,
preferably between about 0.1 to 35% weight, more preferably between
about 2 to 20% weight, even more preferably between about 10 to 18%
weight. The capsule outer shell may optionally further include (f)
at least one of flavorants, colorants, and preservatives.
[0028] Some exemplary embodiments of the present invention relate
to at least one plasticizer selected from the group consisting of
glycerin, mannitol, polyethylene glycol, sorbitol, sorbitol
special, propylene glycol, maltitol, sucrose, corn syrup, fructose,
cellulose, disodium sulfosucciante, triethyl citrate, tributyl
citrate, 1-2-propylenglycol, natural gum, isomerized sugar,
xylitol, polyglycerol, glucose syrups, glucose, sugar alcohol, and
combinations thereof.
[0029] Some exemplary embodiments of the present invention relate
to at least one gelatin selected from the group consisting of
animal-derived gelatin, chemically modified gelatin, physically
modified gelatin, and combinations thereof. A particularly suitable
animal-derived gelatin may be derived from pigskin.
[0030] Some exemplary embodiments of the present invention relate
to incorporation into the present chewable soft gelatin capsule
composition of at least one starch exemplified by native starches
and modified starches. Suitable native starches are exemplified by
potato starches, corn starches, wheat starches, oat starch, barley
starch, rice starches, sorghum starches, and tapioca starches.
Modified starches are native starches that have been partially
degraded by physical treatments or alternatively, by chemical
treatments, and are commonly referred to as physically modified
starches and chemically modified starches.
[0031] Suitable physical treatments are exemplified by
pre-gelatinization and by heat-moisture treatments. Suitable
physically modified starches are exemplified by physically modified
potato starches, physically modified corn starches, physically
modified wheat starches, physically modified oat starch, physically
modified barley starch, physically modified rice starches,
physically modified sorghum starches, and physically modified
tapioca starches.
[0032] Suitable chemical treatments are exemplified by alkali
washes, washes with inorganic acids, enzymatic hydrolysis,
bleaching, oxidation, esterification, etherification,
cross-linking, ionization, and combinations of these modifications
such as acetylation and oxidation. Suitable chemically modified
starches are exemplified by esterified starch, starch phosphate,
etherified starches, cross-linked starches, cationized starches,
enzymatically digested starches, oxidized starch, and combinations
thereof.
[0033] Some exemplary embodiments of the present invention relate
to a softgel capsule where the anti-tacking and softening agent is
preferably between about 0.2 to 15% weight, more preferably between
about 0.4 to 10% weight, and even more preferably between about 0.6
to 5% weight.
[0034] Some exemplary embodiments of the present invention relate
to an anti-tacking agent and softening selected from the group
consisting of: lecithin, polysorbate such as Tween 60 or 80,
biologically derived waxes, chemically derived waxes, fats, oils or
combinations thereof.
[0035] Some exemplary embodiments of the present invention relate
to an anti-tacking and softening agent where it is preferably one
of beeswax, lecithin, palm oil and coconut oil.
[0036] The following Examples illustrate practical formulations of
chewable softgel capsules of the present invention. It is to be
understood these examples should not be considered as limitations,
the experimental data is only for illustration.
Example 1
Softgel Capsules, Formulation A, without Anti-Tacking and Softening
Agent
[0037] Conventional softgel capsules known in the art were prepared
according to the following method. A mixture of gelatin, glycerin,
potato starch, stevia extract, orange flavor and water cookies, in
the proportions as indicated in Table 1 below, up to a weight of
200 kg were placed in a cooking tank with 800 L of capacity. The
cooking tank was heated to 80-85.degree. C. and the temperature was
maintained for a period of 2-3 hours. The temperature of the
cooking tank was then reduced to 55.degree. C. until air bubbles
were about completely removed. Chewable soft capsules of 20-oval
size were produced using conventional soft capsule machinery and
were filled with seal oil.
TABLE-US-00001 TABLE 1 Item Name % weight Gelatin 170-180 Bloom
Pigskin 33.58 Glycerin 99.5% 28.79 Potato Starch 11.5 Stevia
extract 0.0144 Orange Flavor 0.191 Purified Water 26.0
Exemplary embodiments of the softgel capsules of the present
invention disclosed above are detailed in Examples 2-4 below.
Example 2
Improved Softgel Capsule, Formulation B
[0038] A mixture of gelatin, glycerin, potato starch, lecithin,
stevia extract, orange flavor and water cookies, in the proportions
as indicated in Table 2 below, up to a weight of 200 kg were placed
in a cooking tank with 800 L of capacity. The cooking tank was
heated to 80-85.degree. C. and the temperature was maintained for a
period of 2-3 hours. The temperature of the cooking tank was then
reduced to 55.degree. C. until air bubbles were about completely
removed. Chewable soft capsules of 20-oval size were produced using
conventional soft capsule machinery and were filled with seal
oil.
TABLE-US-00002 TABLE 2 Item Name % weight Gelatin 170-180 Bloom
Pigskin 33.58 Glycerin 99.5% 28.79 Potato Starch 11.5 Lecithin 0.96
Stevia extract 0.0144 Orange Flavor 0.191 Purified Water 24.96
Example 3
Improved Softgel Capsule, Formulation C
[0039] A mixture of gelatin, glycerin, potato starch, palm oil,
aspartame, acesulfame-K, orange flavor and water cookies, in the
proportions as indicated in Table 3 below, up to a weight of 200 kg
were placed in a cooking tank with 800 L of capacity. The cooking
tank was heated to 80-85.degree. C. and the temperature was
maintained for a period of 2-3 hours. The temperature of the
cooking tank was then reduced to 55.degree. C. until air bubbles
were about completely removed. Chewable soft capsules of 20-oval
size were produced using conventional soft capsule machinery and
were filled with multi-vitamins paste.
TABLE-US-00003 TABLE 3 Item Name % weight Gelatin 170-180 Bloom
Pigskin 34 Glycerin 99.5% 28 Potato Starch 10.0 Palm Oil 1.5
Aspartame 0.190 Acesulfame-K 0.199 Orange Flavor 0.191 Purified
Water 25.92
Example 4
Improved Softgel Capsule, Formulation D
[0040] A mixture of gelatin, glycerin, potato starch, beeswax,
stevia extract, mango flavor and water cookies, in the proportions
as indicated in Table 2 below, up to a weight of 200 kg were placed
in a cooking tank with 800 L of capacity. The cooking tank was
heated to 80.degree. C. and the temperature was maintained for a
period of 2-3 hours. The temperature of the cooking tank was then
reduced to 55.degree. C. until air bubbles were about completely
removed. Chewable soft capsules of 20-oval size were produced using
conventional soft capsule machinery and were filled with seal
oil.
TABLE-US-00004 TABLE 4 Item Name % Gelatin 170-180 Bloom Pigskin 33
Glycerin 99.5% 26 Potato Starch 12 beewax 1.0 Stevia extract 0.0144
Mango Flavor 0.191 Purified Water 27.79
Example 5
Comparison of Improved Softgel Capsules of Formulation B-D with
Softgel Capsules of Formulation A
[0041] Each of the chewable soft capsules described in examples 1-4
were prepared and produced using the same methods. Two samples of
the resulting capsules for each formulation were taken at a
plurality of time points. These time points included: immediately
after production (i.e. encapsulation); following 20-minutes of
drying in a tumbler; after drying overnight in a room at 21.degree.
C., 23% room humidity (RH); and after drying in a room for three
days at 21.degree. C., 23% RH. The capsule samples for each time
point and each formulation were packaged in glass bottles and
sealed. Each sample comprised at least 86 soft capsules. A first
set of samples was tested after being stored for a period of 2
weeks at 40.degree. C. and 75% RH. A second set of samples was
tested after being stored for a period of 3 months at 25.degree. C.
and 35% RH.
[0042] The results of the comparison of samples for each of the
formulations taken at different time points and then stored under
different conditions are shown in Table 5. The samples of the
capsules at each time point had variable degrees of capsule shell
moisture ranging from 3%-24%. Despite the variable in shell
moisture content, each of the formulations (B, C, and D) of the
present invention exhibited no stickiness and softness under either
set of the storage conditions tested. However, the capsule from
formulation A containing no anti-tacking and softening agent showed
stickiness for each sample time-point tested under both sets of
storage conditions. In addition, the capsule formulation A produced
capsules which were significantly harder than the formulations of
the present invention, especially when the shell moisture is lower
than 11%. In Table 5, N represents no sticky, Y represents sticky,
S represents soft, and H represents hard.
TABLE-US-00005 TABLE 5 Formulation A containing no anti-tacking and
soften Formulation B Formulation C Formulation D agent % % % %
Shell 3 Shell 3 Shell 3 Shell 3 Timepoints Moisture 2 weeks months
Moisture 2 weeks months Moisture 2 weeks months Moisture 2 weeks
months Sample 1 Immediately 22% NS NS 23% NS NS 24% NS NS 22% YS YS
following production Sample 2 After drying 11% NS NS 11% NS NS 12%
NS NS 11% YH YH for 30 mins in a tumbler Sample 3 After drying 6%
NS NS 7% NS NS 7% NS NS 6% YH YH overnight 21.degree. C., 23% RH
Sample 4 After drying 3% NS NS 3% NS NS 4% NS NS 3% YH YH for 3
days 21.degree. C., 23% RH
[0043] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
* * * * *