Note: Descriptions are shown in the official language in which they were submitted.
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B A C K G R 0 U N D A ~ D S U M M A R Y
O F T ~I E I ~ V E N T I 0 N
The present procedure for the encapsulation of
medicament in a gelatin shell is to use two sheets or rib'bons
of gelatin'between which discrete amounts of medicament are
deposited. The sheets of gelatin are then cohered about each
unit of medicament to define a capsule. For identification
purposes, it is common that the two sheets of gelatin are of
different colors so that the resulting capsule is two-toned
in those colors. This procedure of using gelatin sheets has
a number of disadvantages.
First and foremost~ there is a substantial amount of
wasted gelatin. While those parts of the gelatin sheets, re-
maining after the portions used to actually form the capsules
have'been removed, can'be salvaged, it is not reusable as all
or a part of a product to be ingested. There is danger that
these remaining parts may have been contaminated by the medica-
ment and thus ingested by a person not needing the medicament
or for whom the medicament might'be dangerous. Furthermore,
when it is salvaged the colors are mixed. The result is that
the gelatin can 'be sold only for use in a product, e.g. glue,
which is not to'be ingested. Such other gelatin products are
normally made of a much lower quality gelatin and thus gelatin
sold for that use has a substantially lower price tag. To sum
it up, while the salvaged gelatin can be sold, there is a sub-
stantial loss in value of the salvaged gelatin. The amount of
gelatin subject to the value loss is in the range of about
ten to thirty percent.
Secondly, this conventional process necessitates the
use of gelatin having a relatively high water content, for
example, about forty percent. A~ter the capsules are formed
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this water must be removed by drying. The drying process
is slow, requiring from thirty-six to nine-ty-six hours
depending on the thickness of the gela-tin shell, the
humidity conditions, etc. There are substantial costs
in this drying, such as the cost of factory space (which
is substantial), the direct costs, etc. Efforts to
accelerate the drying have proven futile because the
resulting capsules are likely to be deformed.
With some medicamen-ts, the requirement that the
lG gelatin have a relatively high water content has an
additional disadvantage. This is that the medicamen-t
may tend to absorb water from the gelatin. This can have
a deleterious effect on the medicament, the dosage, etc.
According to the present invention, there is
provided a method of orming capsules or sticks including
a core of ingestable substance with a shell of ingestable
material, the method including the steps of forming a
fluid ingestable substance and a fluid ingestable
material, extruding a rod having a core of the substance
and a sheath of the material. Successive portions of
the rod is used, molding the sheath about the ends of
each portion while severing the portion from the rods.
The material is then hardened on the served rods.
In the apparatus of the present invention
which is used or making units including an ingestable
substance with a coating of ingestable material, there is
provided first means forming a source of the substance
in fluid form under pressure and second means forming a
source of the material in fluid form under pressure.
~n extruder means includes a body having a vertical
passageway open at the bottom, the extruder means being
connected to the first and second means for extruding a
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rod including a continuous core of the substance with
a continuous coating of the material along a vertically
downward path from the bottom open:ing. Unit molding
means is provided for forming the rod into individual
units and includes two endless devices each positioned
at a respective side of the path below the opening. Each
device has a surface with a sequence of half-unit-cavities
therein which move past the path in a downward direction
in timed relationship such that the half-unit-cavities
of the two devices meet at the path to define a whole-
unit-cavity. Each half-unit-cavity includes walls defining
a pocket having sides and ends, the molding means
sequentially receiving the lowermost part of the rod
between the half-unit-cavities with the half-unit-cavities,
as they move together pinching off the part and molding
the material of the part about the ends of the substance
of the part to form a unit in which the substance thereof
is encased in the material thereof. Means is positioned
below the molding means for receiving the individual
-~ 20 units descending by gravity from the molding means and
for hardening the material.
According to specific features of the invention,
there are provided a method and apparatus for extruding
a rod or column of medicament (edible substance) having
an annular gelatin (edible material~ shell and then -
pinching off that column into individual capsules con-
sisting of the medicament encased in the gelatin from
the annular shell of the column. The annular shell of
gelatin of ~he column can be half one color and half a
second color, whereby the resulting capsule is two-toned
. .
for identification purposes. If desired, ad~itional colors
can be produced.
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The present invention substantially overcomes
the disadvantages discussed above wi-th respec-t to the
conventional process for forming capsules. There is
practically no waste gelatin which results in a
significant monetary saving. The water content of
the gelatin extruded to form the annular shell of the
column can be relatively low, e.g. in the neighborhood
of three to ten percent. This greatly reduces the
problem of water removal after the capsules are formed
and before they are packaged.
I am aware that it has previously been suggeste~
that capsules could be formed by extruding a tube of
gelatin into
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which is injected amounts of a medicament, with the tube being
pinched off -to form capsules (e.g. U. S. Paten-t 2,449,139).
However~ to the best of my knowledge no capsules have been
commercially manufactured by any such process and the process
discussed initially herein is the one being used commercially
at the present time. The principal object of the present in- -
vention i5 to provide a machine which is suitable for commer-
cial use in the manufacture of capsules comprising a medicament
encased in gelatin. The machine includes a number of features
which permit the manufacturer to produce capsules to his
individual requirements and/or desiresO
Further objects and advantages will become apparent
from the following description and the drawings herein.
D E S C R I P T I O N O F T H E D R A W I N G S
Figure 1 is a front elevational view of an embodiment
of the invention, with portions broken away;
Figure 2 is a section as viewed at line 2-2 of Figure
l; .. .....
Figure 3 is a partial rear elevational view, with a
porkion broken away to show a section as seen at line 3-3 of
~ Figure 2;
; Figure 4 is an enlarged partial front view, as seen
in Figure 1, with portions broken away;
Figure 5 is a further enlarged partial section of the
e~truder head as viewed in Figure 4;
Figure 6 is a partial section as seen at lines 6-6 of
Figure 5;
Figure 7 is a partial section as viewed at line 7-7
` of Figure 5;
30Figure 8 is an enlarged developed view of the peri-
phery of one of the capsule forming wheels showing the action
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of the wheels in forming the tube into capsules; and
Figure 9 is a partial section as seen at line 9-9
of Figure 4.
D E S C R I P T I 0 ~ O F S P E C I F I C
E M B 0 D I M E N T
The following disclosure is offered for public dis-
semination in return for the grant of a patent. Although it
is detailed to ensure adequacy and aid understanding, this is
not intended to prejudice that purpose of a patent which is to
cover each new inventive concept therein no matter how others
may later disguise it by variations in form or additions or
further improvements.
GE~ERAL ORGA~IZ~TIO~
In the illustrated embodiment there are three supply
means, generally 10-12, for supplying streams of a gelatin
material and medicament substance under pressure. The terms
"gelatin material" and "medicament substance" are used herein
to signify that they incorporate all or principal quantities
of gelatin and medicament. Supply means 10 and 12 force gelatin ~ -
material under pressure through conduits 13 and 14, respectively,to an extruder head, generally 15. Supply means 11 forces the
medicament substance through a conduit 16-to the extruder head.
Fro~l the extruder head these issue as a rod consisting of a
continuous core 17 of medicament substance encased in a tubular
shell 18 of gelatin material. When gelatln o~ different colors
are put in supply means 10 and 12, respectively~ the shell 18 ;~
will have one color on one side and the other color on the other ;
side. This rod is divided into individual capsules or units 19
by a capsule molding means comprising two molding wheels, gener~
ally 20 and 21. Each wheel has a plurality of half-capsule-
~ :
cavities (or half-unit-cavities) 22 therein. Each cavity 22
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has a rim 23 extending about both sides and both ends of the
cavity. The rims 23 of these half-capsule-cavities meet at a
pinch-point, which is on a line extendiny between the axes of
wheels 20 and 21, to thereby pinch the rod to form the individual
capsules or units. The peripheries oE the wheels both move
downwardly at the pinch-point.
From the molding means the capsules are cooled to
promptly set up the gelatin. The cooling means, ~enerally 26,
is in the form of a conveyor extending transversely to the
10 path of the capsules falling by gravity from the molding means.
After the capsules are cooled they go to a dryer, generally 27,
for removal of water from the gelatin substance. This dryer
could be in the form of a tumbling dryer through which an air
stream is passed.
GELATIN A2~D MEDICAMEl~T SUPPLY rqEA~lS
Supply means 10, best seen in Figures 2 and 3, is
representative of the three supply means. It includes a posi-
tive displacement pump in the form of a worm 29 in a casing 30.
A thermostatically controlled heater 31 about the casing main-
20 tains the proper temperature for keeping the gelatin materialat the proper fluid consistency. The worm is driven by a
variable speed motor 32. The motor may be electric or hydrau-
lico S ince naptha will be present, at least at times, an
electric motor should be explosion-proof. The output shaft 33
of the motor is coupled to the shaft of an input worm 34 of a
gear box 35. In turn the worm drives a worm wheel 36 mounted
on an output shaft 37. A coupling 38 connects shaft 37 with
worm 29.
The gelatin material flows by gravity from a feed
hopper 41 through an opening 42 into the interior of casing 30.
The gelatin material in feed hopper 41 is maintained at ~he
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proper fluidic temperature by a heater 43. In turn, the gelatin
material for the feed hopper 41 comes from a supply hopper 44.
Feed hopper 41 is comparative]y small and supply hopper 44 is
comparatively large. Supply hopper 44 is not fixedly mounted
but is movable, as by means of an overhead track, etc~ Thus~
when it is desired to change the color of the gelatin material
being furnished by supply means 10, there is only relatively
little gelatin material in feed hopper 41 which must then be
cleaned out. The previous supply hopper 44 is moved away and
a new supply hopper 44 containing gelatin material of the sub-
stituted color is positioned in its stead. Upon making a color
change, there is no necessity for cleaning out a large container
such as is represented by supply hopper 44.
The two hoppers include an automatic control for
maintaining the quantity of gelatin material in feed hopper
41 between predetermined maximum and minimum limits. In the
illustrated embodiment this includes a float 46 in the feed
hopper 41. This float is mounted on one end of an arm 47. This
arm extends through and is secured to a pivot pin 48 journaled
in a support 49 attached to feed hopper 41. The arm has a
counterweight 50 adjustably mounted thereon. The other end of
the arm is positioned to engage actuators 51 and 52 of a switch --
53. ~s indicated by dashed line 54, switch 53 is connected (as
by means of a plug-in connection) to a motor operated valve 55
in the discharge line 56 of supply hopper 44. Depending upon
the type of valve motor operation, switch 53 may be electrical,
fluid, etc. As the level of gelatin in feed hopper 41 reaches
the desired minimum, arm 47 pivots clockwise sufficiently to
move switch actuator 51 and open valve 55. When the feed
hopper 41 has been filled to the desired maximum extent, the
arm 47 pivots counterclockwise sufficiently to engage switch
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actuator 52 and close valve 55.
EXTRUDER EE~D
Referring particularly to Figures 4 and 5, the
extruder head 15 is a three-part unit. It comprises a main
- 'body part 59 secured to the machine frame. In this main body
part are electric heaters 60 to maintain the required fluidic
temperature. The main body part has a vertically positioned
cylindrical opening into which e~tends the nose 61 of a head
part 62. The head part is held in place by cap screws 63.
The upper portion 64 of nose 61 closes the top of the opening
in the main body partO ~" '
The lower end of nose 61 is smaller than the opening
in the main'body part and has two diametrically opposed
partitions 65. Thus~ it divides the opening into two chambers
66 and 67. Chamber 66 communicates with conduit 13 and chamber
67 communicates with conduit 14. Below the partition 65 there
is an annular opening 68 of truncated conical configuration
between the lower or distal end of nose 61 and the top of the
third body part 69. The third'body part is threaded into the
main body part as seen at 70. Thus~ the width or thickness of
the truncated conical opening 68 can be adjusted and thereby
adjust the thic~ness of the gelatin shell 18. To maintain the
desired adjustment, the exterior of the third body part 69 has
a plurality of spaced teeth 71 thereabout. A spring retainer
72 secured to main body part 59 ~its between these teeth. By
moving the retainer outward, the third'body part 69 can'be
rotated. An 0-ring 73 maintains a seal between the main body
~ part and t'he third body part.
:: The upper portion of head part 62 has a relati~ely
large diameter opening 76 and the~ lower portion has a smaller
opening within which is recei~ed an annular tube 77. The upper
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end of the tube has an annular enlargement 78 which seats on a
shoulder 79 at the juncture of the two openings. The bottom
of tube 77 extends below the distal end of nose 61. The third
body part 69 has an opening 80 which is the same diameter as
that of the exterior of tube 77. The tube is of stainless
steel and has a wall thickness of 0.015 to 0.020 inches (0.381
to 0.508 m.m.). The gelatin material issuing from annular
opening 68 initially forms a cylindrical shell about tube 77.
At the bottom of the tube this shell will have an internal
diameter greater than the external diameter of the rod of
medicament substance issuing from the bottom of the internal
opening 81 in the tube, the dif:Eerence being the wall thickness
of the tube. While this difference in size may not be maintained
completely, there will be a size difference between the gelatin
shell and the medicament core which facilitates the forming of
the rod 17, 18 into capsules or units, since at the time of
capsule formation there must be provision to permit the gelatin
to be closed over the ends of the medicament.
If tri-colored capsules were desired, partitions 65
would be arranged to divide the opening into three chambers
rather-than the two 66, 67. A third gelatin supply means identi-
cal to 10, 12 would communicate with the third chamber and each
of the three would hold gelatin of a different color. Obviously,
the described apparatus can thus be used to produce capsules of
the number and variety of colors desired.
CAPS ULE MOLI) ING MEA~S
The molding wheels 20, 21 are diven by a common motor
85. A drive shaft 86 is connected by a coupling to the output
shaft of the motor. This drive shaft extends through gear boxes
87 and 88. The molding wheel 21 extends from a shaft in gear
box 87 while molding wheel 20 extends from a shaft in gear box
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88. Gear box 87 is fixedly mounted on the ~rame of the machine.
Gear box 88 is on ways 89 so that it may be moved toward and
away from gear box 87. The shaft 90 of an adjusting wheel 91
is threaded through the machine frame. A spring 92 is in com-
pression between a cap 93 rotatably mounted on the end of shaf-t
90 and a socket 94 on gear box 88. This arrangement permits
the spring pressure to be applied against gear box 88 so as to
control the contact pressure between the molding wheels 20 and
21. Bearing 95 for shaft 86 is movable in gear box 88 to permit
the described gear box movement.
Figure 9 illustrates the structure within gear box 88.
There is a shaft 97 rotatably mounted in bearings 98. The end
play of the shaft is strictly limited. Adjacent its outer end
the shaft has a flange 99 about which is a seal 100. The wheel
20 is secured to the shaft by a pin 101 extending into the
flange and cap screws 102 which extend through a cover plate
103 and are threaded into the end of the shaft.
A worm wheel 105 is mounted on the inner end of shaft
97 and engages a worm 106 formed on shaft 86. ~ conically
tapered cap 107 is secured to the end of shaft 97 by a bolt 108.
It is also held against rotation with respect to the shaft by
a pin 109. The adjacent encl of the hub of worm wheel 105 has
a corresponding conical taper 110. When bolt 108 is tightened
the frictional engagement between the conical surfaces of cap
- 107 and the worm wheel 105 causes the rotation of the wheel to
produce a corresponding rotation of shaft 97. However, by
loosening bolt 108 the worm wheel 105 can be rotated on shaft
97 to a different position with respect to the shaft. When
bolt 108 is again retightened~ the wheel and shaft are locked
in the new alignment. This permits the alignment of wheel 20
with respect to the angular alignment of wheel 21. A cover
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plate 111 may be removed from the gear box to permit this
adjustment to'be made.
The structure within gear box 87 is for all practical
purposes identical with tha-t just descri'bed with respect to
gear box 88. ~Iowever, the worm wheel (not shown) in gear box
87 and in engage.ment with worm 112 on shaft 86 is keyed to the
shaft that supports wheel 21 rather than being adjustably
mounted thereon as just described with respect to shaft 97 and
worm wheel 105.
The molding wheels 20, 21 have a plurality of radial
bores each of which intersects the center of the'bottom of each
half-capsule-cavity 2Z respectively. Within each bore is a
knock-out pin 115. At its inner end each pin has a head 116
which forms a stop controlling the positioning of the pin. A
sleeve 117 within the wheel holds the knock-out pins in place.
' The sleeve is held within the wheel by a retainer ring 118.
The knock-out pins operate primarily by the pull of
gravity, although they are not completely free of centrifugal
force~ When the pin is at the top of the wheel it is in the
~0 position illustrated in Figure 9. When the pin approaches, or
is at, the'bottom of the wheel it is pulled down'by gravity so
that it extends out into the respective half-capsule-cavity
22 Thus, if a capsule 19 has improperly stuck in the cavity
the action of the pin as that cavity approaches the bottom of
the wheel will push the capsule out of the cavity.
As a further aid to preventing the capsules from stick-
ing in the cavities 22, the cavities may be coated with mineral
oil. To this end there is a conduit 120 which connects to a
source of mineral oil 121. The conduit has nozzles 122 and
123 over wheels 20 and 21, respectively, to permit a drop of
mineral oil to be deposited in each cavity. When mineral oil
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is used, it will be necessary to subsequently wash it Erom the
finished capsules.
At the periphery of the wheels 20, 21 there is a re-
lief cut into the surface of the wheel which relief defines
the rim 23 surrounding each half-capsule-cavity or pocket 22.
In addition, this relief forms grooves l25 extending annularly
about the periphery of the wheel. The remainder of the wheel
surface is uncut leaving a pair of rims 126 about the periphery
of the wheel. Since the rims 126 have the same radius as rims
23 surrounding the pockets 22 the latter are protected so as to
prevent damage to them when pressure is supplied through the
use of hand wheel 91 and spring ~2.
The wheels 20, 21 rotate at a common angular speed.
However, they are not exactly the same diameter. Thus, for
example, wheel 20 is six inches (15.24 centimeters) in diameter
and wheel 21 is six and three-sixteenths inches (15.72 centi-
meters) in diameter. Thus~ the linear speed of the periphery
of the wheels is not identical. This results in a shearing
action between rims 23 of the two wheels when the wheels are
at the pinch-point. This shearing action aids in severing the
gelatin sheath between the adjacent ends of the capsules being
formed.
Referring to Figure ~3, it will be seen that the
width of the half-capsule-cavities 22 is slightly greater than
the width of the exterior of the gelatin sheath 18 of the des-
cending rod. This permits the capsule to grow in width so that
it assumes a somewhat oval shape as distinguished from the
cylindrical configuration of the original rod. This is done,
along with the increasing of the size of the sheath 18 (as
previously described), so as to enable the gelatin coating to
be molded over the ends of the medicament core.
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CAPSULE COOLING MEANS
The cooling means 26 includes a conveyor comprised
of a foramenous belt 130. The belt is trained for movement
along a path defined by pulleys 131. One of the pulleys is
driven by a suitable power means 135 so that the upper,run
of the belt moves to the left in Figure 1. Below this upper
run of the belt is an air chamber 132 which receives cooling
air from a duct 133. The top of the air chamb0r is perforated
with discharge holes 134 so that the cooling air flows out
through the foramenous belt 130 to cool the capsuLes 19 as
they are moving along the upper run of the belt.
MISCELLA~IEOUS
While the formulation of the gelatin material de-
posited in the feed hoppers 41 will,be varied by individual
manufacturers, I contemplate using a formulation such that
fifty pounds (22,68 ~cg.) of glycerin and five to ten pounds
(2.27 to 4.54 kg.) of water are added' to one hundred pounds
(45.36 kg.) of pure gelatin. It is important that the water
,and glycerin are cold when they are added to the gelatin in
order to prevent the gelatin from balling. Any of the various ,~
conv~3ntional coloring materials may 'be incorporated as desired.
In most instances, the medicament substance deposited '
in the feed hopper of supply means 11 will be in a carrie-r. I
prefer an oil based thick paste as a carrier not only for rea-
sons of economy but also so that the oil serves as a water
barrier to prevant migration of the water in the gelatin into
the medicament. Often, it will be possible to include more
active medicament in a paste than in a liquid thereby reducing
the size of the resulting capsule required. A Eluid paste is
more adaptable to the described process of molding capsules
than is an unthickened liquid. S uitable food thic]ceners such as
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gelatin or starch can be employed to achieve the fluid paste
consistency.
SUPPLEME~TARY DISCLOSURE
The present invention can be employed to form capsules
or sticks consisting of materials other than a medicament with a
gelatin coating. For example, the hopper of extruder 11 may be ~-
filled with an extrudable edible substance. This might be a
candy in a liquid or paste form (which is included within the
term "food" as used herein). It could be a liver pate, a pro-
cessed cheese of a flowable (extrudable) consistency, fruit or
vegetable base substances of such consistency or a combination
of such materials. An ingestable material for use as a sheath
as an alternative to the gelatin would be one of well known,
wide variety of dough. Such dough would be put into the hoppers
of extruders 10 and 12 processed as above described except that
instead of using a cooling air stream such as is employed when
the sheath is gelatin, other means of conventionally hardening a
dough after the capsule or stic~ was formed would be employed.
For example, a current of heated air could be substituted for
the refrigerated air entering plenum 132 through opening 133 to
cook and/or dry the dough. Another alternative would be to pass
the discharge conveyor 130 through a tunnel oven to perform the
cooking and/or drying of the dough.
A specific example of a suitable dough formulation
would be as follows
31 gallons (260 pounds) boiling water
8 pounds butter
8 pounds of lard or shortening
15 pounds of sugar
30 12 pounds of salt
125 commercial yeast cakes, or equivalent~
dissolved in
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2 gallons of lukewarm water
375 pounds sifted bread flour
The butter, lard, su~ar and salt are put in a power driven dough
mixer With the mixer operating, the boiling water would be
added. When the solids had dissolved and the water had cooled
to lukewarm, the dissolved yeast and 375 pounds of flour are
added and the mixing continued until a uniform mix was obtained.
As an alternative, only 16 gallons of boiling water would be
employed with the butter~ lard, sugar and salt dissolved as
above described After the solution had cooled to lukewarm, 15
galLons of warm milk and the dissolved yeast are added, followed
by the 375 pounds of sifted bread flour.
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