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Patent 2362633 Summary

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(12) Patent Application: (11) CA 2362633
(54) English Title: METHOD AND APPARATUS FOR FORMING AN ENCAPSULATED PRODUCT MATRIX
(54) French Title: PROCEDE ET DISPOSITIF SERVANT A PREPARER UNE MATRICE DE PRODUIT ENCAPSULEE
Status: Dead
Bibliographic Data
(51) International Patent Classification (IPC):
  • B01J 2/30 (2006.01)
  • A23G 3/20 (2006.01)
  • A23G 4/00 (2006.01)
  • A61K 9/16 (2006.01)
  • A61K 9/50 (2006.01)
  • B01J 2/00 (2006.01)
  • B01J 2/04 (2006.01)
  • B01J 13/02 (2006.01)
  • B01J 13/04 (2006.01)
(72) Inventors :
  • CHERUKURI, SUBRAMAN R. (United States of America)
  • SIRIS, SUPAPONG (United States of America)
(73) Owners :
  • BIOVAIL INTERNATIONAL LTD. (United States of America)
(71) Applicants :
  • BIOVAIL INTERNATIONAL LTD. (United States of America)
(74) Agent: PIASETZKI & NENNIGER LLP
(74) Associate agent:
(45) Issued:
(86) PCT Filing Date: 1999-05-19
(87) Open to Public Inspection: 1999-12-02
Examination requested: 2000-11-21
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): Yes
(86) PCT Filing Number: PCT/US1999/010949
(87) International Publication Number: WO1999/061145
(85) National Entry: 2000-11-21

(30) Application Priority Data:
Application No. Country/Territory Date
980395 Ireland 1998-05-22
09/309,224 United States of America 1999-05-10

Abstracts

English Abstract




A method and apparatus provides for the formation of an encapsulated feedstock
product matrix. A solid product matrix additive is spray ejected in a free-
flow condition. The matrix additive is encapsulated in its free-flow condition
with a matrix encapsulant. The encapsulant additive substantially solidifies
in its free-flow condition to form the feedstock product matrix.


French Abstract

Procédé et dispositif servant à préparer une matrice encapsulée contenant une charge de produit. On éjecte par pulvérisation un additif de matrice de produit solide à l'état coulant. On encapsule cet additif de matrice dans son état coulant au moyen d'un agent d'encapsulation de matrice. L'additif encapsulé se solidifie dans son état coulant, ce qui permet d'obtenir la matrice de produit.

Claims

Note: Claims are shown in the official language in which they were submitted.





WHAT IS CLAIMED IS:
1. A method of forming a product matrix comprising the steps of:
ejecting a substantially solid matrix additive into a free-flow condition;
encapsulating said ejected solid matrix additive at said free-flow condition
with a
matrix encapsulant; and
allowing said encapsulated additive to substantially solidify in said free-
flow
condition to form said product matrix.
2. A method of claim 1 wherein said ejecting step further includes:
delivering an additive in substantially fluid form to a spray nozzle; and
ejecting said
additive upwards from said spray nozzle in substantially solid form.
3. A method of claim 1 wherein said encapsulating step includes:
heating an encapsulating material to induce internal flow thereof;
extruding said heated encapsulating material; and
ejecting said heated encapsulating material upwards to contact said additive
so as to
form said matrix encapsulant in free-flow condition.
4. A method of claim 3 wherein said ejecting step includes;
ejecting said heated encapsulating material from an extruding device; and
subjecting said ejected heated encapsulating material to disruptive fluid
shear force
which forms said matrix encapsulant.
5. A method of clam 1 wherein said solidification step further includes;
applying an air stream to said encapsulated additive in said free-flow
condition to
form said product matrix.
16




6. A method of claim 5 wherein said air stream is applied at a temperature of
about
between 5°C and 10°C.

7. A method of claim 6 wherein said air stream is applied at a relative
humidity of
about 10% or less.

8. A method of forming encapsulated matrix particle material comprising the
steps of:
spraying a first feedstream of first particles in a free-flow condition; and
ejecting a second feedstream of second particles in a free-flow condition into
said
first feedstream to cause said first particles to become encapsulated by said
second particles
and continue in said free-flow condition to form said matrix particles.

9. A method of claim 8 further including:
cooling said matrix particles in said free-flow condition.

10. A method of claim 8 wherein said spraying step includes:
dry spray upwardly ejecting a substantially solid material defining said first
particles.
11. A method of claim 8 wherein said ejecting step includes;
extruding a heated encapsulating material; and
subjecting said heated encapsulating material to a disruptive flash shear
force which
forms said second particles, said particles then being ejected upwardly.

12. An apparatus for forming an encapsulated product matrix comprising:
at least one product additive delivery device for ejecting a product additive
into a
feedstream of substantially solid particles; and
at least one extruding device for ejecting a product encapsulant into said
feedstream
of said substantially solid particles to encapsulate said particles.

17




13. An apparatus of claim 12 further comprising:
a cooling device for allowing said encapsulated substantially solid particles
to cool
and attain free-fall conditions.
14. An apparatus of claim 13 wherein said product additive delivery device
includes:
delivery conduit for delivering heated fluid product additive; and
a spray nozzle in communication with said conduit for receiving said heated
fluid
product and ejecting said feedstream of solid particles.
15. An apparatus of claim 14 further including:
an elongate processing tower;
said tower supporting at an upper end thereof said spray nozzle, said spray
nozzle
being positioned to eject said solid particles into a free-flow condition;
said tower further supporting said extruding device at a location down stream
from
said spray nozzle so as to eject said encapsulant into said particles during
said free-flow
condition.
16. An apparatus of claim 15 wherein said tower supports said cooling device
at a
location down stream from said extruding device.
17. An apparatus of claim 15 wherein said device includes;
an encapsulant extruder; and
an ejection nozzle located with said tower.
18. An apparatus of claim 17 wherein said ejection nozzle is positionable
within said
tower at plural spaced apart locations with respect to said spray nozzle.
18




19. An apparatus of claim 18 wherein said ejection nozzle is positioned so as
to eject
said product encapsulant upwardly into said feedstream of said solid particles
to
encapsulate said particles.
20. An apparatus for forming an encapsulated product matrix comprising:
at least one dry spray device for upwardly ejecting a product additive into a
feedstream of substantially solid particles;
at least one extruding device for upwardly ejecting a product encapsulant into
said
feedstream of said solid particles to encapsulate said particles; and
at least one entry port for each of said dry spray device and said extruding
device;
and wherein the relative heights of said dry spray device and said extruding
device are
adjustable, and further wherein the ejecting direction of at least one of said
dry spray
device and said extruding device is adjustable with respect to one another.
19

Description

Note: Descriptions are shown in the official language in which they were submitted.




CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
METHOD AND APPARATUS FOR FORMING
AN ENCAPSULATED PRODUCT MATRIX
FIELD OF THE INVENTION
The present invention relates generally to a process and apparatus for forming
a
feedstock product matrix. More particularly, the present invention is directed
to an
improved method and apparatus for forming an encapsulated product matrix. The
invention further relates to equipment and a process for forming an
encapsulated product
matrix utilizing two or more encapsulating materials, as well as combining two
or more
products in the encapsulated matrix.
BACKGROUND OF THE INVENTION
In certain material processing technologies such is those used in
pharmaceutical
and food processing, particulate feedstock material is formed as an
intermediate product for
use in further processing. The particles may be formed by various techniques.
One
technique is to spray dry eject product particles from a spray nozzle. This
technique
employs a spray nozzle supported within a tower. The spray nozzle converts
liquid
emulsions to dry powder at elevated temperatures. Conventional heated liquid
emulsion is
transported to the spray nozzle where it is ejected therefrom as a dry powder
into a free-
flow feedstream. As the heated dry powder falls in a free-flow condition, it
cools and
solidifies into particles. The particles may then be used for further
processing in
conventional material handling applications for the formation of food stuffs
and
pharmaceutical products.
In certain applications, there is a need to encapsulate certain feedstock
products
during the material handling process so as to form a product matrix. In the
food processing
industry, it is typically desirable to encapsulate food and bioaffecting
additives such as
pharmaceuticals, nutraceuticals, flavorings, colors and sugars in dissimilar
food substances
such as oleaginous material like fats or oils such as flavor oils. In the
pharmaceutical



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
industry, active drugs, vitamins and the like can also be encapsulated in fats
and oils. The
encapsulation of product additives has certain benefits. The encapsulating
substances can
act as a taste mask to improve the organoleptic qualities of the food product
and also to
taste mask certain bitter-tasting drugs. Encapsulating can also prevent
unintended
S volatilization of the actives over time. Furthermore, the substances which
encapsulate the
drugs can act to deliver them in a time-release fashion.
One technique to provide an encapsulated product matrix is to form the
encapsulated product in an extrusion process. An encapsulant such as fat is
typically
processed in an extruder under controlled heat and pressure. The fat is
liquefied or molten
and forced through extrusion dies to form round bead or sphere-like particles.
Additives
may be introduced into the fat during the extrusion process so that the small
formed beads
include the additive encapsulated within the fat.
This extrusion process serves adequately for many products in the food and
pharmaceutical industries. However, the method has certain limitations. In an
extrusion
process, it is difficult to obtain high loading of the additive material into
the fat spheres.
The process itself limits the amount of additive which can be introduced into
the
oleaginous material as the product undergoes extrusion. Further, certain
additives which
are desirable to be encapsulated with fat exhibit an extremely low melt point.
Thus, during
the heated extrusion process these low melt additives may have a tendency to
break down,
or degrade. Additionally, certain desirable additives are resistant to melt
flow. Thus these
additives are especially difficult to incorporate into a fat sphere during a
heated extrusion
process. Furthermore, the high heat which must be applied in the extrusion
process may
have a tendency to effect a reduction in the flavor quality of certain
additives. Thus, it may
be appreciated that certain additives are not particularly well-adapted to
being processed in
an extrusion process.
In addition, the necessity of first spraying liquid emulsions, and then
encapsulating
them via an extrusion process often necessitates two or even more separate and
distinct
pieces of equipment. Distinct equipment such as spray dryers, congealers,
fluidizers,
extruders and evaporators translates into additional overhead and processing
costs.
Therefore, it is desirable to provide a process for manufacturing fat
encapsulated additives
2



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
wherein the additives retain desirable product qualities and do not
deteriorate during the
material processing. It is furthermore highly desirable to accomplish this
with one self
contained piece of equipment.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a method and apparatus for
forming a product matrix here a product additive may be efficiently
encapsulated with one
or more encapsulating material.
It is a further object of the present invention to provide a method and
apparatus
where a product additive may be encapsulated with one or more oleaginous
materials and
such process does not result in a deterioration of quality of the additive.
A further object in the present invention to provide an apparatus for
effecting the
encapsulation of a product additive with a sphere or bead of an oleaginous
material such as
fats or oils.
Still another object of the invention is to provide encapsulated material with
increased loading of the additive or active, high content uniformity, enhanced
dispersion of
the encapsulations in various media, improved taste or taste masking of the
encapsulated
material, and no or substantially reduced water and microbial activity.
In the efficient attainment of these other objects, the present invention
provides a
method for forming a product matrix. The method includes the delivery of a
substantially
solid additive into a free-flow condition. The substantially solid matrix
additive is
encapsulated during the free-flow condition with a matrix encapsulant which is
also
supplied to the free-flow condition. The encapsulated additive may also be
cooled during
the free-flow condition to form the product matrix.
The present invention further provides an apparatus for forming an
encapsulated
product matrix. The apparatus includes a delivery device that places a product
additive
into a feedstream of substantially solid particles. A product encapsulant is
also delivered
into the feedstream of the substantially solid particles to encapsulate the
particles. A
cooling device may also be employed for cooling the encapsulated solid
particles in the
feedstream if desired.



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
In a preferred embodiment shown by way of example herein, a processing tower
or
other containment environment which has a sufficient free-flow volume is
employed. The
processing tower accommodates a delivery device at one end thereof so as to
eject, deliver
or otherwise place the product additive into a free-flow condition within the
free-floe
containment volume. An encapsulant delivery device ejects, or otherwise
delivers the
product encapsulant into the free-flow stream so as to encapsulate the
individual particles
therein. The encapsulated particles remain in a free-flow condition for a
sufficient amount
of time to form the product matrix.
In one especially preferred embodiment of the invention, the processing tower
apparatus may be modified to include additional entry ports for inclusion of
double, or
even triple or more, the quantity of material to be encapsulated. The product
additive
delivery device for delivering particles of the product additive into the free-
flow condition
can be located towards either end of the free-flow containment environment or
tower. The
equipment will therefore permit differing types of material to encapsulate or
to be
encapsulated to separately enter the apparatus.
In still another embodiment, it is also desirable to include additional entry
ports for
the inclusion of an increased quantity of oleaginous encapsulating material
entering the
processing tower, as well provide for the entry of differing encapsulating
materials.
Overall, the invention provides an encapsulated product matrix in which both
the
types of material to be encapsulated and the encapsulating materials
themselves can be
optimized according to whatever requirements are necessary in the final
product without
the need to utilize additional apparatus or to stop and clean the instant
inventive apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is schematic representation of the product encapsulating apparatus of
the
present invention.
Figure 2 is a schematic representation of an encapsulant extruder used in
accordance with the present invention.
4



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
Figure 3 is a detailed schematic representation of an ejection nozzle of the
extruder
of Figure 2.
Figure 4 is a further embodiment of the apparatus shown in Figure 1.
Figure 5 is still another embodiment of the apparatus shown in Figure 1.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS:
The present invention is directed to method and apparatus for forming an
encapsulated feedstock product matrix. The resultant product matrix is
preferably in the
form of tiny particles in the shape of beads or spheres, though variations
thereof are
certainly within the scope of the invention. Each of the sphere-like particles
includes
particles of a matrix additive (material to be encapsulated) which are enrobed
with spheres
or tiny masses of an encapsulating material.
In the present illustrative embodiment, the product additives may include
flavors,
fibers, colorings, sugars and other additives useful in the manufacture of
food-stuffs, and
especially confectionery products such as gums, candies, lozenges and mints,
etc and
combinations thereof. Also highly suitable are actives, i. e. those materials
which are
intended to produce a biological, chemical or pharmacological, etc. response
once ingested.
Thus, drugs, vitamins, minerals, nutraceutcials and other dietary supplement
material are
within the scope of materials to be encapsulated. Especially suitable are
actives with
undesirable organoleptic qualities such as bitter taste or offensive odor. By
encapsulating
these materials to form a product matrix, their off taste can be successfully
masked, while
their efficacy is preserved until ingestion.
The encapsulating material or materials may include a dissimilar material such
as
an oleaginous material like various fats or oils and including vegetable oils,
soy bean oil,
cannola oil, corn oil, cocoa butter, sunflower oil, animal fats, tallows,
lards, fish oils,
crustation oils, and mixtures thereof. Also useful are medium chain
triglycerides, and other
substances with fatty moieties. Materials with emulsifying capabilities are
also highly
desirable. Particularly preferred may be natural and synthetic flavor oils,
including without
limitation, such oils as a spearmint, peppermint, menthol, wintergreen,
cinnamon and citrus
5



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
oils. This encapsulating material can also have incorporated thereinto other
additives such
as bioaffecting agents, dyes, fragrances, crystallization modifiers,
surfactants, control
agents, sweeteners, flavors and mixtures thereof. Certain of these additional
additives,
which are directly introduced into the oleaginous material, are typically of
the type which
may be subjected to fairly high temperature environments without degradation
of product
qualities. It is also within the scope of the invention that the encapsulating
material in fact
be substantially or wholly a proteinaceous substance or carbohydrate-based.
Thus, while it
is preferred that the encapsulating material be oleaginous, it is certainly
expected that other
types of material available to the skilled artisan be employed as well. For
the purposes
herein, the term "oleaginous" is intended to cover all such materials.
The present invention permits the incorporation of certain other additives of
the
type described above which would be subject to product degradation if combined
with
oleaginous material in a conventional high-heat extrusion process. Thus, the
present
invention is directed to the incorporation of certain product additives into
extruded
oleaginous spheres without degradation of the beneficial attributes of the
additive.
Refernng now to Figure 1, a schematic representation of the method and
apparatus
of the present invention is shown. A product encapsulating apparatus 10 of the
present
invention is shown. Encapsulating apparatus 10 includes a free flow
containment device
12. The free flow containment device is preferably a tower apparatus 12, but
those skilled
in the art will recognize that any device which can contain, suspend, fluidize
and/or
separate the additives and encapsulating material may be utilized. As shown in
Fig. 1, the
preferred tower 12 is generally an elongate enclosure container having
cylindrical side wall
14 in communication with a lower frustro-conical end wall 16. Frustro-conical
end wall 16
has a lower open end 18 which is in communication with a collection hopper 20.
The
upper end 22 of tower 12 may be closed by a cap 24 to provide a substantially
seated tower
interior 26. While an elongate generally cylindrical tower is shown in the
present
illustrative embodiment, it may be appreciated that any enclosure of suitable
dimension my
be employed in combination with the present invention. In the present
embodiment, tower
12 has a cylindrical wall 14 of an extended length (approximately 5 ft.) for
purposes which
will be discussed in further detail hereinbelow.
6



CA 02362633 2000-11-21
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As shown in Figure 1, encapsulating apparatus 10 includes a source 28 of
product
additive to be encapsulated. This source 28 can include any device capable of
delivering
material into the tower 12. For example, the delivery source 28 may be a
supply ejector, or
a spinning head apparatus, such as that described in U.S. Patent No.s
5,427,811, 5,445,769,
5,447,423, 5,458,823 and most recently, U.S. Patent No. 5,834,033. In a
preferred
embodiment shown in Figure 1, the product source 28 is a spray dry device. Dry
spray
device 28 includes a dry spray nozzle 30 supported within the interior 26 of
tower 12
adjacent the upper end 22 thereof using any means known in the art. Dry spray
nozzle 30
is in communication with a product conduit 32 for delivering liquid or semi-
liquid product
(in one embodiment liquid product emulsion) to the spray nozzle 30. The
conduit 32 may
be formed of an insulated pipe which delivers the liquid material from a
location where the
liquid material is prepared (not shown) to the spray nozzle 30 within interior
26 of tower
12. Entry port 34 is provided at the upper end of tower 12 through cylindrical
side wall 14
so as to permit delivery of the liquid product to the spray nozzle 30 within
tower 12.
Dry spray apparatus 28 can be of conventional construction and is desirably
used to
dry out excess moisture in the liquid product and convert the liquid product
to a dry
powder at relatively high temperatures. Those skilled in the art will discover
that the
product does not have to be dry upon entering the tower via conduit 32,
however (the
material may be wet and subsequently be either partially or wholly dried upon
exposure to
the air or other gaseous medium inside the tower 12, or in some instances may
even remain
in a liquid or semi-liquid state upon entering the interior of the tower). Dry
spray
apparatus 28 may be operational under electrical power and may heat the
emulsion by gas,
steam or electrical energy. Conventional feeding pumps (not shown) are used to
deliver
the liquid from a location adjacent the lower end of tower 12 to the spray
nozzle 30 located
interior of the upper end of tower 12. The emulsion which is delivered by
conduit 32
includes an emulsion of a product additive as above-described.
The dry spray nozzle 30 operates in a conventional fashion to convert the
liquid
product to a dried power and spray eject solid powered particles 31 into a
feedstream of
such particles in a free-flow condition. The dried particles 31 drop under the
influence of
gravity through the tower interior 26 in such free-flow condition. It is also
within the
7



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scope heretofore described that the additive material contain a "drying"
material
recognized by those skilled in the art. For example, cellulosic material may
be utilized to
imbibe and absorb excess moisture which might otherwise contaminate the
product
additive. In this way, any drying action of the dry spray apparatus 28 may be
augmented
or even replaced.
Encapsulating apparatus 10 of the present invention further includes an
encapsulation extruding device 40. Extruding device 40 delivers an extruded
liquid or
semi-liquid encapsulating material, preferably oleaginous material such as one
or more fats
or oils, to an extrusion nozzle 42 which is supported within the interior 26
of tower 12
adjacent the lower end 23 thereof. Preferably, the encapsulating material is
at an elevated
temperature. The extruder serves to eject extruded oleaginous beads or spheres
41 into the
interior 26 of tower 12. Formation of such fat or oil spheres with extruding
device 40 may
be accomplished preferably in accordance with a method and apparatus disclosed
in
commonly assigned U.S. Patent No. 5, 380,473 entitled "Process For Making
Shear Form
Matrix". The process and apparatus disclosed therein forms a shear-form matrix
by raising
the temperature of the oleaginous material to a point where the material
undergoes internal
flow upon application of a fluid shear force, but at a temperature typically
below the
melting point of the material. The material is advanced and ejected while in
this internal
flow condition and subjected to a disruptive fluid shear force to form
multiple parts or
masses which have a sphere or bead-like configuration. The multiple masses are
cooled
substantially immediately after contact with the disruptive shear force and
are ejected into
a feedstream into a free-flow condition and solidified. The disruptive force
is applied to
the oleaginous material abruptly over a short period of time so that the
duration of the
disruptive force can be considered instantaneous. The oleaginous material can
be subjected
to a stream of fluid, gas or liquid impacting the material at a velocity which
creates the
flash disruptive shear force. In the present embodiment, the preferred fluid
is air.
However, other types of fluids may be used to create the fluid shear force. In
a specific
embodiment, air is ejected against the material as a continuous high velocity
jet. The pat
of the material is abruptly disrupted into discrete continuous masses or
spheres due to the
shear acting on the material while it has internal flow.
8



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Refernng now to Figure 2, in the extruding device 40 of the preferred
embodiment,
shear is provided to the extruded encapsulating material 40a while in the
internal flow
condition by directing a stream of high velocity air against the coherent
stream exiting the
nozzle 42. The high velocity air can be provided by air stream 43 which can
pass through
a filter and pressure/flow regulator 44 to an in-line heater 45 and a thermo-
couple 46 to
control the temperature of the air. The in-line heater 45 can be used to raise
the
temperature of the air to enhance the free-flow feature of the sheared masses
separated
from the feedstock stream. Preferably, the air is heated to a temperature of
about 75 to
90°C. Those skilled in the art will appreciate that this temperature
will vary, depending
upon the particular material to be extruded. Any pre-extrusion additives can
be introduced
with a static mixer 47.
The stream of air is directed against the extruded encapsulant exterior by the
nozzle
42 to provide discontinuities in the encapsulant and basically transform the
morphology of
the original encapsulant to a new morphology achieved by free-flow
solidification as
discontinuous masses such as spheres or beads. Referring to Figure 3, air
stream 43 is seen
as being in fluid communication with annular channel 50 which surrounds the
internal
nozzle device 52. Extruded encapsulant material 40a is shown being fed to the
nozzle
device 52 and exiting as a coherent feedstream 54 where it is subjected to
high-velocity air
stream 56 which is created by the combination of tortuous path exits provided
by air cap 58
and retaining ring 59. In the present embodiment, the coherent feedstream is
formed of
beads of spheres 41 of encapsulating material. As shown in Figure 1, such
spheres 41 are
preferably ejected upwardly in a free-flow condition. In other embodiments,
the spheres 41
may be ejected sideways or even downwards from nozzle 42, should such
conditions
optimize the formation of encapsulated product additive matrices according to
the needs of
the person skilled in the art.
When air is used to create the shear force, it is applied in a two-fluid
nozzle at a
pressure of from about 1.5 to about 20 atmospheres. Preferably, the pressure
is applied at
about 4 - 6 atmospheres. As previously mentioned, the temperature of the air
used to
create the shear force should preferably be controlled to a temperature at
least about 0.1°C
about the temperature of the feedstock being ejected for every atmosphere of
pressure.
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Referring again to Figure 1, the extruding device 40 is arranged with respect
to
tower 12 such that the nozzle 42 is positioned below the dry spray nozzle 30.
Thus, the
extrusion nozzle 42 is positioned within the feedstream of the ejected solid
particles 31 in
free-flow condition. The extruding device 40 is arranged so that the extrusion
nozzle 42 is
directed preferably upwardly so as to eject spheres 41 directly into the
gravity fed free-flow
feedstream of particles 31 ejected from dry spray nozzle 30. By directing the
nozzle 42
upwards, it has been found that the solid particles 31 are often better
encapsulated.
Preferably, the nozzle will be directed at about 90 degrees upwards (as shown
in Figure 1),
with variations thereof of less than about +/- 45 degrees, more preferably +/-
25 degrees,
and even more preferably about +/- 10 degrees or even less. Further
optimization is
attainable according to the particular needs of the skilled technician.
The extruding nozzle 42 may also be positioned at a desirable spaced apart
location
with respect to nozzle 30. In that regard, tower 12 provides multiple entry
ports 60 along
the length of cylindrical side wall 14. The location of the extruding nozzle
42 with respect
to the dry spray nozzle 30 may be adjusted depending upon the types) of
materials) being
processed. The position of the extruding nozzle 42 may be varied to control
the contact
between particles 31 in the free-flow and the ejected spheres 41. Factors such
as time of
free-flow, temperature and the like are considered when positioning nozzle 42
of extruding
device 40 with respect to nozzle 30 of dry spray device 28. In addition, the
multiple entry
ports 60 can accommodate more than one extruding nozzle 42 at a time. Two or
more
extruding nozzles may therefore be positioned within the tower 12 at spatially
optimal
locations (horizontally (x), vertically (y) and laterally(z)) according to the
needs of the
skilled artisan.
As the fat spheres 41 are ejected so as to come into contact with the dry
spray
particles 31 in the free-flow condition, the fat spheres are caused to
encapsulate the dry
spray particles so as to form an encapsulated product matrix 61 of product
particles
encapsulated with fat spheres. The encapsulated product matrix continues in a
free-flow
condition under gravity through the lower end 23 of tower 12 and into the
frustro-conical
wall 16 which funnels the encapsulated product matrix to opening 18 for
collection within
a hopper 20.



CA 02362633 2000-11-21
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During the free-flow condition, the encapsulated product matrix 61 is
preferably
subjected to a stream of gaseous fluid so as to solidify the encapsulated
product matrix 61.
The gaseous fluid is preferably air, but may also comprise any other
substantially inert
gas. In a preferred embodiment, the gaseous fluid is an air stream. The
gaseous fluid may
be heated or cooled, or may also be at room temperature, depending upon the
type of
drying and free-fall conditions required within the tower 12. An air flow
pattern may also
be utilized to recirculate the encapsulated particles to another part of the
tower 12 or to a
location outside the tower. A preferred embodiment is set forth in Figure 1.
Cold air
stream 65 is introduced into the interior 26 of tower 12 through an air entry
port 66 through
the frustro-conical wall 16. The entry port 66 is desirably located near the
bottom of the
tower 12, but it is also within the scope of the invention to optimize
location at or near the
midpoint or even the top of the tower to take full advantage of fluid
dynamics. The air is
generated by an air generating device 67 which maintains a cool dry air stream
through the
entry port. The air stream is preferably supplied within a temperature range
of between
about 5° to 10°C and a relatively dry humidity, preferably that
of about 25% relative
humidity or less, more preferably about 10% relative humidity or less, and
even more
desirably about 5% or less. In this way, there is less water and consequently
less microbial
activity in the encapsulated product matrix 61.
Once the encapsulated matrix 61 is cooled and solidified, the matrix particles
61
fall through the frustro-conical wall 16 to the lower open end 18. The air
pattern heretofore
described can optimize the free-fall conditions of the encapsulated matrices
through
creation of positive or negative pressure flows, or merely through assistance
of the natural
forces of gravity. After passing through the lower open end 18, the
encapsulated particles
are collected within collection hopper 20 for further processing. The
encapsulated matrix
material may be in solid form, but may also be in semi-solid form, and is
preferably in the
shape of tiny spheres, beads or solloids.
Referring now to Figure 4, there is shown a variation of the device set forth
in
Figure 1. Encapsulating apparatus 10 is shown with optional additional entry
ports 70. In
one embodiment, these entry ports allow for introduction of additional
particles 31 via
components 28 and 32. The various levels of entry of the additional ports 70
shown in
11



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
Figure 1, as well as their respective orientations, may be adjusted by the
skilled artisan to
account for variations in the physical properties of the material 31 itself,
e.g. weight,
density, thickness, etc. In another embodiment of the invention, the entry
ports 70 may
also be utilized to admit material 31 to the apparatus 10 from another source
28a, 30a and
32a shown in Figure 4. In this way, double or even triple the amount of
material may be
added to the apparatus 10 at the same time, or two or more separate and
distinct materials
may be added for encapsulation. The materials 31 may be added simultaneously
or in
sequence. The various heights of the additional entry ports 70 may be utilized
so that one
material is encapsulated first, and a second material (which is introduced at
a lower or
higher level) is next encapsulated. This procedure may be especially relevant
when the
materials to be encapsulated are particularly reactive with one another. The
oleaginous
material encapsulates both materials during free fall, and at the same time,
can keep them
physically apart from one another. It is within the skilled artisan's judgment
to decide how
many additional entry ports 70 to utilize, as well as their relative
locations. It is also
possible to adjust the direction of the nozzles) 30. For example, one or more
could be
directed upwards (as shown in the Figures), but one or more could also be
directed
sideways or downwards as well, to thereby operate in the most efficient way
with respect
to one another. In this way, the skilled artisan may be further able to
regulate and
maximize optimal conditions for encapsulation according to his or her needs.
A still further aspect of the invention is set forth in Figure 5. As shown in
Figure 5,
there are additional entry ports 70 provided for entry of oleaginous
encapsulating material
41 via components 40 and 42. In this way, it is possible to double or even
triple etc. the
amount of encapsulating material 41 entering the apparatus 10, or take full
advantage of
two differing angles for entry to further ensure complete encapsulation. It is
also within
the scope of the invention that two or more distinct oleaginous encapsulating
materials be
added at the same time via additional components 40a and 42a shown in Figure
5, for
example. It is further possible to add one type of oleaginous encapsulating
material
through one entry port 70, and a second (or third, etc.) oleaginous
encapsulating material
thereafter through another entry port, whether simultaneously or in
succession. As
12



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
heretofore described as well, one or more of the nozzles 42 may be directed
upwards, while
at the same time one or more may be directed sideways or even downwards as
well.
It is further within the scope of the invention that the embodiments shown in
Figures 4 and 5 be utilized in conjunction with one another. Optimization of
the particular
embodiments is possible, depending upon the type and quantity of materials) to
be
encapsulated, as well as the type and quantity of encapsulating material to be
utilized.
Additional entry ports 70 may also be utilized to adjust the relative
positions of the
components 30 and 42 with respect to one another. When one or more of the
entry ports
70 is not in use, it may simply be covered.
By virtue of the invention according to the embodiments herein described, it
is
possible to provide encapsulated material without the need for several
distinct pieces of
equipment. The method herein described provides excellent product which can be
utilized
in a wide range of applications. The encapsulated material as a result of the
novel process
is a matrix in which there is intimate mixing of dissimilar ingredients such
as sugars and
oils. It is also possible to attain increased loading of the additives which
are encapsulated
compared to other processes known in the art such as standard spray drying and
spray
congealing techniques. Thus, it is possible to attain about 40 - 60% loading
of additives or
actives without any adverse effects. A conventional spray dryer many times can
attain
only about 20% loading. A further advantage of the invention is enhanced
product
uniformity; there is often considerably less variance in content within the
same batch and
even after several batches of processed material. Enhanced dispersion of the
encapsulated
product matrix in further media such as, for example, standard chewing gum
bases is also
attainable. The drying process of the invention is fiuthermore unique in that
the
encapsulated product also exhibits a lowered water activity and microbial
activity as
compared to other encapsulations available today. In addition, the
encapsulated product
matrix exhibits excellent taste-masking in certain embodiments and improved
taste in
others.
As heretofore described, other embodiments of the device of the invention are
possible. In one such embodiment, the tower 12 may be replaced with a sideways
T-
shaped tube in which air is circulated via the two stems of the "T" and both
additive
13



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
material and encapsulating material enter via the main portion of the "T" and
are brought
together by the action of the air flow. In another embodiment, a tube-within-a-
tube design
permits air circulation and introduction of material into the interior tube.
Upon mixing
under the force of the circulating air, the encapsulated product matrices exit
into the
exterior tube for collection.
EXAMPLES
The following examples illustrate various preferred embodiments of the
invention.
These should not be construed as limiting the scope thereof, however.
Example 1
In this example, the device set forth in Figure 1 was utilized to form an
encapsulated product matrix. A peppermint/spearmint flavor combination and
sucrose
mixture was encapsulated using peppermint oil (an oleaginous material). The
resultant
1 S product matrix was a substantial quantity of large spheres that were dry
to the touch.
When sampled, the spheres revealed an intense mint taste. Little of the mint
sensation
could be detected, however, with the nostrils, indicating that the
peppermint/spearmint
flavors were well encapsulated and preserved within the matrix. The product
matrix
spheres were then combined with gum base in a traditional manner, along with
other
chewing gum additives. The final chewing gum product provided a sweet minty
chewing
sensation, which due to the encapsulated product matrix throughout the gum
base, was
intense and long-lasting for over 30 minutes.
Example 2
For this example, a bitter tasting medicament (ibuprofen) was successfully
encapsulated using spearmint oil. When combined into a confectionery base
having a soft
and chewy consistency, the resultant product yielded a delivery system in
which medicine
could be palatably administered without off taste, thereby substantially
increasing patient
compliance.
14



CA 02362633 2000-11-21
WO 99/61145 PCT/US99/10949
Various changes to the foregoing described and shown structures would now be
evident to those skilled in the art. Accordingly, the particularly disclosed
scope of the
invention is set forth in the following claims.

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Administrative Status

Title Date
Forecasted Issue Date Unavailable
(86) PCT Filing Date 1999-05-19
(87) PCT Publication Date 1999-12-02
(85) National Entry 2000-11-21
Examination Requested 2000-11-21
Dead Application 2003-05-20

Abandonment History

Abandonment Date Reason Reinstatement Date
2002-05-21 FAILURE TO PAY APPLICATION MAINTENANCE FEE

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Request for Examination $400.00 2000-11-21
Registration of a document - section 124 $100.00 2000-11-21
Application Fee $300.00 2000-11-21
Maintenance Fee - Application - New Act 2 2001-05-22 $100.00 2001-05-22
Registration of a document - section 124 $0.00 2002-01-17
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
BIOVAIL INTERNATIONAL LTD.
Past Owners on Record
CHERUKURI, SUBRAMAN R.
FUISZ INTERNATIONAL LTD.
SIRIS, SUPAPONG
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Representative Drawing 2002-01-18 1 8
Abstract 2000-11-21 1 49
Claims 2000-11-21 4 124
Drawings 2000-11-21 4 90
Description 2000-11-21 15 799
Cover Page 2002-01-21 1 38
Fees 2001-05-22 1 36
PCT 2000-11-21 17 668
Assignment 2000-11-21 10 388