U.S. patent application number 15/698851 was filed with the patent office on 2017-12-28 for multicomponent and multilayer compacted tablets.
The applicant listed for this patent is Bio-Lab, Inc.. Invention is credited to Edward Santorella, Curtis Sayre, Alan Yeoman.
Application Number | 20170367326 15/698851 |
Document ID | / |
Family ID | 56024372 |
Filed Date | 2017-12-28 |
United States Patent
Application |
20170367326 |
Kind Code |
A1 |
Yeoman; Alan ; et
al. |
December 28, 2017 |
Multicomponent and Multilayer Compacted Tablets
Abstract
Horizontally layered tablets, methods of making the horizontally
layered tablets, and tableting equipment capable of producing the
horizontally layered tablets are described. The horizontally
layered tablets can be produced by simultaneously feeding a
segregated flow of different compositions that form the respective
layers of the tablet.
Inventors: |
Yeoman; Alan; (Duluth,
GA) ; Sayre; Curtis; (Atlanta, GA) ;
Santorella; Edward; (Canton, GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bio-Lab, Inc. |
Lawrenceville |
GA |
US |
|
|
Family ID: |
56024372 |
Appl. No.: |
15/698851 |
Filed: |
September 8, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14687955 |
Apr 16, 2015 |
|
|
|
15698851 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A01N 43/66 20130101;
A01N 25/34 20130101; B30B 11/04 20130101; A61K 9/2086 20130101;
B30B 15/306 20130101 |
International
Class: |
A01N 25/34 20060101
A01N025/34; B30B 11/04 20060101 B30B011/04; B30B 15/30 20060101
B30B015/30; A01N 43/66 20060101 A01N043/66 |
Claims
1. A method of making a tablet, the method comprising:
simultaneously feeding a segregated flow of a first composition and
a second composition to a tablet die defining a volume, the first
composition forming a first section and the second composition
forming a second section, the first section and the second section
being oriented side-by-side in the tablet die; and simultaneously
compressing the first section and the second section in the tablet
die with sufficient pressure to form a single tablet body.
2. The method of claim 1, wherein the segregated feed is
simultaneously fed from a reciprocating feed device.
3. The method of claim 1, wherein the segregated feed provides an
interface between the first section and the second section, the
interface generally divides the tablet die volume.
4. The method of claim 1, wherein the first composition is a dry
powder and the second composition is a dry powder.
5. The method of claim 1, wherein the method further comprises
ejecting the single tablet body from the tablet die.
6. The method of claim 1, wherein the single tablet body has a
hardness in a range between about 10 to about 500 lb.sub.f.
7. The method of claim 1, wherein at least one from a group
comprising the first composition and the second composition
independently comprises a disinfectant, sanitizer, pH adjuster,
buffer, hardness modifier, algaecide, corrosion inhibitor, scale
inhibitor, dispersant, flocculent, clarifier, oxidizer/shock,
sequestrant, chelant, emulsifier, demulsifier, or any combination
thereof.
8. The method of claim 1, wherein at least one from a group
comprising the first composition and the second composition
independently comprises a sanitizing composition, a shock
composition, a clarifier composition, an algaecide composition, a
pH or water hardness balancer composition, a corrosion control
composition, a scale control composition, a cleaning composition,
or any combination thereof.
9. The method of claim 1, wherein the first composition comprises
trichloroisocyanuric acid, and the second composition comprises
sodium dichloroisocyanuric acid.
10. The method of claim 1, wherein the first composition comprises
trichloroisocyanuric acid, and the second composition comprises
trichloroisocyanuric acid and a sodium or potassium salt of
cyanuric acid.
11. The method of claim 1, wherein the feeding step and the
compressing step are performed under ambient temperature.
12. The method of claim 1, wherein the segregated flow is oriented
along a vertical axis and the first section and the second section
are oriented side-by-side along a horizontal axis.
13. A method of making a tablet, the method consisting of:
simultaneously feeding a segregated flow of a first composition and
a second composition to a tablet die defining a volume, the first
composition forming a first section and the second composition
forming a second section, the first section and the second section
being oriented side-by-side in the tablet die; and simultaneously
compressing the first section and the second section in the tablet
die with sufficient pressure to form a single tablet body.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/687,955, filed Apr. 16, 2015, which is
entirely incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention is generally directed to horizontally
layered tablets, methods of making the horizontally layered
tablets, and tableting equipment capable of producing the
horizontally layered tablets.
BACKGROUND
[0003] Traditional multilayer compacted tablets often are produced
by the sequential addition of the separated components into a
tablet die cavity using separate component gravity feed or force
feed delivery devices to form the separate layers. Punch position
changes may be required to form the desired layer at each component
delivery device. In addition, there may be pre-compression of
previously introduced layers, prior to the addition of subsequent
layers, until a final compression is used to form a single
multilayer tablet in which the separated components are arranged
into vertical layers. Hence, such conventional tableting techniques
are directed to vertically layered tablets, and the use of multiple
compression or compaction steps results in reduced production
rates.
[0004] The production of vertically layered tablets requires the
use of tablet presses which have been purposely designed to produce
multilayer tablets, or single layer tablet presses that have been
significantly modified. Either option increases manufacturing
complexity and equipment costs compared to single layer tablet
presses. In addition to equipment complexity and cost, the
production rate of multilayer tablets, as mentioned above, is often
significantly slower than the production rate of single layer
tablets.
[0005] Therefore, there is a need to develop processes to
manufacture combined, separated components into a single compacted
tablet form without the increased complexity, increased equipment
cost, and reduced production rates associated with conventional
multilayer tablet production. There is also a need to develop
processes to manufacture combined, separated components into a
single compacted tablet form (that is distinct from tablets with
vertically arranged layers) in which horizontally arranged layers
are formed in order to add aesthetic options to the products being
produced, as well as to provide product performance enhancements
associated with horizontal layer orientation.
[0006] Accordingly, it is to these ends, as well as other benefits,
that the various aspects and embodiments consistent with this
invention are directed.
SUMMARY
[0007] This summary is provided to introduce a selection of
concepts in a simplified form that are further described below in
the detailed description. This summary is not intended to identify
required or essential features of the claimed subject matter. Nor
is this summary intended to be used to limit the scope of the
claimed subject matter.
[0008] The present invention is generally directed to compacted,
horizontally layered tablets containing two more layers. In one
aspect, a horizontally layered tablet can comprise a first layer, a
second layer, and an interface between the first layer and the
second layer. This tablet can be characterized, for example, by a
density of at least about 1.2 g/cc. In another aspect, a
horizontally layered tablet can comprise a first layer comprising a
first composition, a second layer comprising a second composition,
and an interface between the first layer and the second layer.
Typically, the first composition and the second composition can be
different. In these and other aspects, the width (or horizontal
dimension, e.g., diameter if circular) of the tablet can be greater
than the height (or vertical dimension) of the tablet, such as, for
example, by a ratio of the width of the tablet to the height of the
tablet ranging from about 1.2:1 to about 10:1, or from about 1.5:1
to about 5:1.
[0009] Other aspects of this invention are directed to methods of
making a horizontally layered tablet, the horizontally layered
tablet having a first layer and a second layer. One such method can
comprise providing a first composition and a second composition,
simultaneously feeding (not sequentially feeding) a segregated flow
of the first composition and the second composition to a tablet
die, and compressing the first composition and the second
composition under sufficient pressure in the tablet die to form the
horizontally layered tablet. In this method, the first layer
comprises the first composition and the second layer comprises the
second composition.
[0010] Further aspects of this invention are directed to suitable
multilayer tableting equipment. For instance, an apparatus for
forming a horizontally layered tablet having a first layer
comprising a first composition and a second layer comprising a
second composition is provided herein. This apparatus can comprise
a tablet die, a first feed chamber containing the first composition
and a second feed chamber containing the second composition, a
reciprocating and segmented feed device for simultaneously
directing a segregated flow of the first composition from the first
feed chamber and the second composition from the second feed
chamber to the tablet die, and a compaction device for compressing
the first composition and the second composition in the tablet die
under sufficient pressure to form the horizontally layered tablet
having the first layer and the second layer.
[0011] Both the foregoing summary and the following detailed
description provide examples and are explanatory only. Accordingly,
the foregoing summary and the following detailed description should
not be considered to be restrictive. Further, features or
variations may be provided in addition to those set forth herein.
For example, certain aspects and embodiments may be directed to
various feature combinations and sub-combinations described in the
detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The accompanying drawings, which are incorporated in and
constitute a part of this disclosure, illustrate various aspects
and embodiments of the present invention. In the drawings:
[0013] FIG. 1 is a top/front perspective view of a multilayer
tablet in an aspect of the present invention.
[0014] FIG. 2 is a top/front perspective view of a multilayer
tablet in another aspect of the present invention.
[0015] FIG. 3A is a top/front perspective view of a segmented feed
device, with the top cover removed, in an aspect of the present
invention.
[0016] FIG. 3B is a side perspective view of the feed device of
FIG. 3A with a clear top cover.
[0017] FIG. 3C is a bottom view of the feed device of FIG. 3A.
[0018] FIG. 4A is a side view of a tableting apparatus in the
filling step.
[0019] FIG. 4B is a side view of the tableting apparatus of FIG. 4A
at the beginning of the compacting step.
[0020] FIG. 4C is a side view of the tableting apparatus of FIG. 4A
during the compacting step.
DETAILED DESCRIPTION
[0021] The following detailed description refers to the
accompanying drawings. Wherever possible, the same or similar
reference numbers are used in the drawings and the following
description to refer to the same or similar elements. While aspects
and embodiments of the invention may be described, modifications,
adaptations, and other implementations are possible. For example,
substitutions, additions, or modifications may be made to the
elements illustrated in the drawings, and the methods described
herein may be modified by substituting, reordering, or adding
stages to the disclosed methods. Accordingly, the following
detailed description does not limit the scope of the invention.
[0022] The terms "a," "an," and "the" are intended to include
plural alternatives, e.g., at least one. For instance, the
disclosure of "a layer," "a tablet die," etc., is meant to
encompass one or more than one layer, tablet die, etc., unless
otherwise specified.
[0023] All publications and patents mentioned herein are
incorporated herein by reference for the purpose of describing and
disclosing, for example, the constructs and methodologies that are
described in the publications, which might be used in connection
with the presently described invention. The publications discussed
throughout the text are provided solely for their disclosure prior
to the filing date of the present application. Nothing herein is to
be construed as an admission that the inventors are not entitled to
antedate such disclosure by virtue of prior invention.
[0024] Applicants disclose several types of ranges in the present
invention. When Applicants disclose or claim a range of any type,
Applicants' intent is to disclose or claim individually each
possible number that such a range could reasonably encompass,
including end points of the range as well as any sub-ranges and
combinations of sub-ranges encompassed therein. For example, in an
aspect of the invention, the density of the multilayer tablet can
be in a range from about 1.2 to about 2 g/cc. By a disclosure that
the density is in a range from about 1.2 to about 2 g/cc,
Applicants intend to recite that the density can be any density in
the range and, for example, can be about 1.2, about 1.3, about 1.4,
about 1.5, about 1.6, about 1.7, about 1.8, about 1.9, or about 2
g/cc. Additionally, the density can be within any range from about
1.2 to about 2 g/cc (for example, the density is in a range from
about 1.3 to about 1.9 g/cc), and this also includes any
combination of ranges between about 1.2 and about 2 g/cc. Likewise,
all other ranges disclosed herein should be interpreted in a
similar manner.
Multilayer Tablets
[0025] Disclosed herein are multilayer and multicomponent tablets,
with the layers of the tablet oriented horizontally, as opposed to
vertically layered tablets that predominate in the marketplace. In
one aspect of this invention, a horizontally layered tablet is
provided, and in this aspect, the tablet can comprise a first
layer, a second layer, and an interface between the first layer and
the second layer; moreover, the tablet can be characterized by a
density of at least about 1.2 g/cc. Importantly, in this aspect,
the horizontally layered tablet has a density of greater than 1
g/cc and, therefore, the tablet sinks in water. In some aspects,
the density of the tablet can be in a range from about 1.2 to about
2.4, from about 1.2 to about 2, from about 1.3 to about 2, from
about 1.4 to about 2, from about 1.2 to about 1.9, from about 1.2
to about 1.8, from about 1.3 to about 1.9, from about 1.3 to about
1.8, from about 1.4 to about 1.9, or from about 1.4 to about 1.8
g/cc, and the like. Other appropriate ranges for the density of the
horizontally layered tablet are readily apparent from this
disclosure. Furthermore, multilayered tablets consistent with the
present invention also can have any of the features, properties, or
characteristics provided below and in any combination.
[0026] In accordance with particular aspects of this invention, the
tablet can have a width (i.e., the horizontal dimension; diameter
if a circular cross-section) of the tablet that is greater than the
height (i.e., the vertical dimension) of the tablet. This
dimensional relationship is illustrated in FIG. 1, which shows a
multilayer tablet 100 having a width (diameter) that is greater
than the height H of the tablet 100. In reference to FIG. 1, the
tablet 100 can have a top surface 110 and a bottom surface 120 (not
visible in FIG. 1), a first layer 130, a second layer 140, an
interface 150 between the layers, and a side surface 160.
[0027] In circumstances where the width is greater than the height,
the ratio of these dimensions can vary over a fairly wide range,
such as from about 1.2:1 to about 10:1. Alternatively, the ratio of
the width of the tablet to the height of the tablet can be in a
range from about 1.2:1 to about 8:1; alternatively, from about
1.2:1 to about 5:1; alternatively, from about 1.5:1 to about 7:1;
alternatively, from about 1.5:1 to about 5:1; alternatively, from
about 1.5:1 to about 4:1; alternatively, from about 1.5:1 to about
3:1; alternatively, from about 1.8:1 to about 6:1, or
alternatively, from about 2:1 to about 5:1. Other appropriate
ranges for the width:height ratio of the horizontally layered
tablet are readily apparent from this disclosure.
[0028] In accordance with certain aspects of this invention, the
tablet can be configured such that the major axis of the interface
is greater than the height of the tablet. For instance, if the
interface is elliptical in shape, the major axis is the longest
diameter than runs through the center of the ellipse. As another
example, if the interface is rectangular, the major axis is the
longer of the width and the height; in FIG. 1, the width is the
greater dimension, and is greater than the height of the
tablet.
[0029] The multilayer tablet is not limited to any particular
geometry. However, certain geometric features and shapes are
specifically contemplated herein. In one aspect, for instance, the
interface between the layers can be substantially perpendicular to
the top of the tablet and/or substantially perpendicular to the
bottom of the tablet. As used herein, "substantially perpendicular"
is meant to indicate an angle of about 90.degree., for example,
from about 75.degree. to about 105.degree., between the interface
and the top of the tablet and/or between the interface and the
bottom of the tablet. In another aspect, a cross-section
perpendicular to the interface of the multilayer tablet can be of
any suitable geometric shape, non-limiting examples of which can
include circular, elliptical or oval, rectangular, or square, and
the like. In yet another aspect, the tablet can be in the shape of
a disk or puck, for example, similar to a hockey puck.
[0030] Often, the interface between layers is generally linear,
however, this is not a requirement. For instance, the interface can
be non-linear, such as a curvilinear shape or S-shape.
[0031] While not being limited thereto, the volume of the first
layer, based on the volume of the tablet, typically can be in a
range from about 10 to about 90%; alternatively, from about 25 to
about 75%; alternatively, from about 30% to about 70%;
alternatively, from about 35% to about 65%; or alternatively, from
about 40 to about 60%.
[0032] The first layer and the second layer can appear the same
(e.g., but with a different composition), or can have a different
visual appearance. For instance, the first layer can have a first
color, and the second layer have a second color, and the first
color and the second color can be different.
[0033] In accordance with alternative aspects of this invention,
multilayer tablets are contemplated in which the ratio of the width
of the tablet to the height of the tablet is from about 0.33:1 to
about 0.8:1, such as, for example, from about 0.4:1 to about 0.8:1,
from about 0.4:1 to about 0.75:1, or from about 0.45:1 to about
0.7:1. Other appropriate ranges for the width:height ratio of a
multilayer tablet in this aspect of the invention are readily
apparent from this disclosure.
[0034] Tablets of this invention often can have a hardness (or
break strength) in a range from about 10 to about 500, from about
10 to about 475, from about 15 to about 500, from about 10 to about
50, or from about 150 to about 500 lb.sub.f. The hardness is the
force required to break the tablet when the tablet is placed on its
side surface and the force applied to the directly opposing side
surface. Unlike extruded or molded tablets, the tablets disclosed
herein have a distinct break in aspects of this invention.
Additionally or alternatively, the tablets disclosed herein, in
particular aspects of this invention, do not have a vicat softening
point or a glass transition temperature. These characteristics are
typically related to extruded or molded tablets, which have a
polymeric or plastic component in the tablet matrix. Thus, as
distinguished from extruded tablets and molded tablets, the
multilayer tablets disclosed herein can be categorized as compacted
tablets (or compressed tablets). The tablet hardness (or break
strength) depends upon the size of the tablet: a 3-inch diameter
tablet can have a break strength that is 10-20 times that of a
1-inch diameter tablet.
[0035] Optionally, tablets disclosed herein can contain more than
two layers. As shown in FIG. 2, a multilayer tablet 200 can have a
third layer 270 (an intermediate layer, a barrier layer, etc.)
between a first layer 230 and a second layer 240. The tablet 200
illustrated in FIG. 2 has a width (diameter) that is greater than
the height H of the tablet 200. Similar to FIG. 1, the tablet 200
in FIG. 2 can have a top surface 210 and a bottom surface,
interfaces between the layers, and side surface 260.
[0036] If desired, any of the tablets disclosed herein also can
have a have an additional layer (a top layer) covering at least a
portion of the top surface of the tablet. Additionally or
alternatively, any of the tablets disclosed herein, optionally, can
further comprise a coating layer (e.g., an enteric coating) on at
least a portion of the outer surfaces of the tablet. This coating
layer can cover the top surface, the bottom surface, the side
surface, or all outer surfaces of the tablet.
[0037] In accordance with another aspect of this invention, tablets
disclosed herein (e.g., horizontally layered tablets) can be
characterized by a first layer comprising a first composition, a
second layer comprising a second composition, an interface between
the first layer and the second layer, and wherein the first
composition and the second composition are different. In further
aspects, such tablets can have any of the features, properties, or
characteristics provided above (e.g., density, width:height ratio,
hardness, layer ratio, etc.) and in any combination.
[0038] In aspects of this invention, the first composition and/or
the second composition independently can comprise any suitable
water treatment chemical, non-limiting examples of which can
include a disinfectant, a sanitizer, a pH adjuster, a buffer, a
hardness modifier, an algaecide, a corrosion inhibitor, a scale
inhibitor, a dispersant, a flocculent, a clarifier, an
oxidizer/shock, a sequestrant, a chelant, an emulsifier, a
demulsifier, and the like, as well as combinations thereof.
Accordingly, illustrative multilayer tablets can include: a tablet
with a first layer containing a sanitizer, and a second layer
containing an oxidizer/shock; a tablet with a first layer
containing a sanitizer and a flocculent, and a second layer
containing an oxidizer/shock and a flocculent; a tablet with a
first layer containing a sanitizer and a flocculent, and a second
layer containing an oxidizer/shock and a pH adjuster; a tablet with
a first layer containing a sanitizer, a second layer containing an
oxidizer/shock, and a third layer (intermediate layer) containing a
flocculent; a tablet with a first layer containing a sanitizer, a
second layer containing an oxidizer/shock, and a third layer
(intermediate layer) containing a pH adjuster and a flocculent; a
tablet with a first layer containing a corrosion inhibitor, and a
second layer containing a scale inhibitor; a tablet with a first
layer containing a corrosion inhibitor and a dispersant, and a
second layer containing a scale inhibitor and a dispersant; and a
tablet with a first layer containing a corrosion inhibitor, a
second layer containing a scale inhibitor, and a third layer
(intermediate layer) containing a dispersant. Hence, the first
composition and/or the second composition independently can
comprise, for example, a sanitizing composition, a shock
composition, a clarifier composition, an algaecide composition, a
pH or water hardness balancer composition, a corrosion control
composition, a scale control composition, a cleaning composition,
and the like, as well as any combination thereof. Information on
such materials and compositions, as well as other suitable layer
compositions, can be found, for example, in U.S. Pat. No.
6,426,317, which is incorporated herein by reference in its
entirety (e.g., TCCA and a sodium or potassium salt of cyanuric
acid). Other appropriate layer and composition selections for the
multilayer tablet are readily apparent from this disclosure.
[0039] In another aspect, the first composition and/or the second
composition independently can comprise any suitable halogenated
(e.g., with active halogens such as chlorine and/or bromine)
biological control agent, such as provided in U.S. Pat. Nos.
6,426,317, 6,852,238, and 8,492,419, the disclosures of which are
incorporated herein by reference in their entirety. Illustrative
compounds that can be used in the first layer and/or the second
layer can include, but are not limited to, trichloroisocyanuric
acid (TCCA), sodium dichloroisocyanurate (anhydrous, dihydrate
salt), 1-bromo-3-chloro-5,5-dimethylhydantoin,
1-chloro-3-bromo-5,5-dimethylhydantoin,
1-bromo-3-chloro-5-methyl-5-ethylhydantoin,
1-chloro-3-bromo-5-methyl-5-ethylhydantoin, 1-bromo-3-chloro-5,
5-diethylhydantoin, 1-chloro-3-bromo-5,5-diethylhydantoin,
1-bromo-3-chloro-5-ethyl-5-methylhydantoin,
1-chloro-3-bromo-5-ethyl-5-methylhydantoin,
1,3-dichloro-5-ethyl-5-methylhydantoin,
1,3-dibromo-5-ethyl-5-methylhydantoin,
1,3-dichloro-5-methyl-5-ethylhydantoin,
1,3-dibromo-5-methyl-5-ethylhydantoin,
1,3-dichloro-5,5-dimethylhydantoin,
1,3-dibromo-5,5-dimethylhydantoin,
1,3-dichloro-5,5-diethylhydantoin,
1,3-dibromo-5,5-diethylhydantoin, calcium hypochlorite, lithium
hypochlorite, and the like, as well as combinations thereof. Solid
chlorine donors and other strong oxidizers also are suitable
ingredients.
[0040] The layered tablets of invention are not limited
compositionally to the materials and components noted hereinabove.
Notably, the first composition and/or the second composition
independently can comprise any active pharmaceutical ingredient
(API) or nutraceutical ingredient suitable for tableting, and this
includes any suitable prescription or over-the-counter (e.g.,
acetaminophen, aspirin) pharmaceutical ingredient, as well as
vitamins and other nutritional supplements that are suitable for
tableting. As would be recognized by those of skill in the art, any
of the tablets and the respective layers and compositions described
herein can further contain suitable tablet excipients, such as
binders, lubricants, disintegrators, and the like, as well as
combinations thereof.
[0041] A potential benefit of the multilayer tablets can be a
tailoring of different release profiles of the respective layers
for different end-use applications. In one aspect, for example, the
first layer can be a quick release layer (or immediate release, or
fast dissolving). Additionally or alternatively, the second layer
can be a slow release layer (or delayed release, or slow
dissolving). As disclosed herein, the tablet can contain an
intermediate layer (or third layer) between the first layer and the
second layer; this intermediate layer can be an inert layer or a
barrier layer, if desired, to prevent any reaction or interaction
between components of the first layer with components of the second
layer.
Producing Multilayer Tablets
[0042] Methods of making multilayer tablets also are provided
herein. One such method for making a horizontally layered tablet
having a first layer and a second layer can comprise (a) providing
a first composition and a second composition; (b) simultaneously
feeding a segregated flow of the first composition and the second
composition to a tablet die; and (c) compressing the first
composition and the second composition under sufficient pressure in
the tablet die to the form the horizontally layered tablet. In this
method, the first layer comprises the first composition and the
second layer comprises the second composition. The tablets
producing in accordance with this method can have any of the
features, properties, materials, or characteristics of the tablets
described hereinabove and in any combination.
[0043] In step (b), the segregated flow of the first composition
and the second composition can be simultaneously fed to the tablet
die. In one aspect, the segregated flow can be gravity fed, while
in another aspect, the segregated flow can be force fed.
[0044] Advantageously, in particular aspects of this invention, the
method for making the horizontally layered tablet can comprise a
single compression step. Hence, in such aspects, the method does
not comprise a pre-compression step in order to form the tablet.
While not wishing to be bound to theory, Applicants believe that
this method, which can involve only a single compression in step
(c), can result in an increase in the production rate of the
multilayer tablets.
[0045] In step (c), the first composition and the second
composition are compressed under sufficient pressure in the tablet
die to form the horizontally layered tablet. Typically, though not
required, this step is conducted using mechanical or hydraulically
driven compression. The amount of pressure needed to form the
tablet can be readily determined by those of skill in art, and
generally, the pressure to form the tablet is uniform between the
first layer and the second layer (e.g., within specifications based
on percent variability of a particular press when operated in
single layer mode).
[0046] This method also can further comprise, after step (c), a
step of ejecting the (compressed or compacted) tablet from the
tablet die. Typically, the interface between the first layer and
the second layer is generally perpendicular to the bottom of the
tablet die, for example, an angle of about 90.degree., or from
about 75.degree. to about 105.degree., between the interface and
the bottom of the tablet die.
[0047] Advantageously, in aspects of this invention, the method of
making the horizontally layered tablet does not include an
extrusion step, and/or a molding step, and/or an external heating
step. For example, the tablet die can be at ambient temperature,
where no external heating or cooling of the tablet die is either
utilized or required.
Tableting Equipment
[0048] An apparatus suitable for forming the multilayer tablets
disclosed and described herein also is provided. For instance, an
apparatus for forming a horizontally layered tablet (the tablet
having a first layer comprising a first composition and a second
layer comprising a second composition) can comprise (i) a tablet
die, (ii) a first feed chamber containing the first composition and
a second feed chamber containing the second composition, (iii) a
reciprocating and segmented feed device for simultaneously
directing a segregated flow of the first composition from the first
feed chamber and the second composition from the second feed
chamber to the tablet die, and (iv) a compaction device for
compressing the first composition and the second composition in the
tablet die under sufficient pressure to form the horizontally
layered tablet having the first layer and the second layer. The
tablets produced using this apparatus can have any of the features,
properties, materials, or characteristics of the tablets described
hereinabove and in any combination.
[0049] FIGS. 3A-4C illustrate various components and views of the
tableting apparatus. Referring first to FIGS. 3A-3C, in which
different views of a feed device 305 (also referred to a feed shoe)
are provided for a two-tablet (side-by-side) feed device. FIG. 3A
is a top view of the feed device 305 in which the top cover is
removed. The feed device 305 can have a first feed chamber 315, a
second feed chamber 325, and dividers 335 for segmenting the flows
from the feed chambers. A flow path of a first composition 345 from
the first feed chamber 315 and a flow path of a second composition
355 from the second feed chamber 325 also are illustrated in FIG.
3A. The flows of the first composition and the second composition
exit the bottom of the feed device and enter a tablet die,
discussed further hereinbelow.
[0050] FIG. 3B is a side view of the feed device 305 with a clear
top cover 365 (which can be any suitable plastic or metal
material), and the respective locations are shown for the first
feed chamber 315, the second feed chamber 325, the dividers 335 for
segmenting the flows from the feed chambers, the flow path of the
first composition 345 from the first feed chamber 315, and the flow
path of the second composition 355 from the second feed chamber
325. FIG. 3C is a bottom view of the feed device 305, illustrating
the dividers 335 for segmenting the flows from the feed chambers,
the flow path of the first composition 345, and the flow path of
the second composition 355.
[0051] Referring now to FIGS. 4A-4C, which illustrate a side view
of a tableting apparatus 400 during various stages of the cycle
used to produce the multilayer tablets. In FIG. 4A, a compaction
device 485 (or top punch) is retracted, and the feed device 405
(viewed from the side, with a metal top cover) is positioned over
tablet dies (two side-by side, not shown in FIG. 4A), where the
segmented flow of the first composition and the second composition
fills each of the two tablet dies simultaneously, for example, to
produce two tablets similar to the design and layout shown in FIG.
1. In FIG. 4B, the reciprocating feed device 405 retracts from the
tablet dies 475 and the compaction device 485 proceeds in a
downward motion toward the entrance of the tablet dies 475. The
compaction device can be a mechanical compaction device or a
hydraulic compaction device, as desired. In FIG. 4C, the compaction
device 485 proceeds into the tablet dies to compress and compact
the segmented first composition and second composition to form
compacted horizontally layered tablets. Subsequently, the
compaction device retracts, and the tablets are ejected from the
tablet dies. For example, tablet ejection can be accomplished by an
upward movement of a bottom punch.
[0052] The above-described figures illustrate an apparatus designed
with 2 tablet dies. However, the apparatus can be configured with
any suitable number of tablet dies, such as from 1 to 30, from 1 to
15, from 2 to 30, from 2 to 15, or from 2 to 10, and so forth. The
depth of the tablet die(s) also is not particularly limited, and
can be configured based on the desired height of the finished
tablet(s). Typically, the tablet die(s) has/have a depth ranging
from about 1/8'' to about 10 inches, or from about 1/4'' to about 6
inches.
[0053] As shown and described herein, the tableting apparatus in
aspects of this invention is not a rotary tablet press, in which
multilayer tablets are typically formed in a vertical and
sequential fashion (i.e., one layer or composition on top of
another layer or composition). Beneficially, however, due to the
segregated and simultaneous flow of the respective compositions
(and layers) in accordance with this invention, multilayer tablets
can be formed at relatively high output rates. Generally, the
tableting apparatus is capable of forming (horizontally layered)
tablets in a output rate range, based on each tablet die, of from
about 30 to about 70, from about 35 to about 65, or from about 40
to about 60 tablets/minute, and the like.
[0054] Also advantageously, the tableting apparatus does not
require a heating or cooling system, as would be the case for
extruded or molded tablets, in contrast with the compacted tablets
produced in aspects of this invention.
[0055] The invention is further illustrated by the following
examples, which are not to be construed in any way as imposing
limitations to the scope of this invention. Various other aspects,
embodiments, modifications, and equivalents thereof which, after
reading the description herein, may suggest themselves to one of
ordinary skill in the art without departing from the spirit of the
present invention or the scope of the appended claims.
EXAMPLES 1-2
[0056] Horizontally layered tablets were produced using a Baldwin
mechanical press with a reciprocating gravity feed shoe device to
fill two tablet die cavities simultaneously. This feed shoe device
was modified such that the two (2) separate feed streams could be
fed simultaneously to the tablet die cavities in a fashion to
produce a horizontally layered tablet where each layer received
approximately equal amounts of the respective feed streams (50% in
each layer). The horizontally layered tablets had a diameter of 3
inches, a height of 11/4 inches, and weighed about 8 ounces.
Representative equipment used to produce the tablets is illustrated
in FIGS. 3A-4C, and the tablet produced is generally illustrated by
FIG. 1.
[0057] Two tablet combinations were produced. In Example 1, the
same sanitizing, slow dissolving, formula designed to maintain
oxidizing chlorine levels over a period of time was fed, except
that one layer of the tablet was supplied an un-dyed (white) feed
and the other layer was supplied a dyed (blue) feed to yield a
horizontally layered tablet differentiated by appearance. The
density of the tablets in Example 1 was 1.6 g/cm.sup.3 and the
tablet hardness (or break strength) was 430 lb.sub.f. In Example 2,
the un-dyed (white) sanitizing, slow dissolving feed used in
Example 1 was fed simultaneously with a dyed (blue) shock, fast
dissolving, feed intended for rapid delivery of oxidizing chlorine
to yield a horizontally layered tablet differentiated by
multi-functional delivery of incompatible components to
recirculating water systems such as pools and spas. The density of
the tablets in Example 2 was 1.55 g/cm.sup.3 and the tablet
hardness (or break strength) was 192 lb.sub.f. The shape and design
of the tablet products of Examples 1-2 are generally represented by
the tablet illustration of FIG. 1. The compositions of the
respective layers of the tablets of Examples 1-2 are provided in
Table 1 below.
[0058] Unexpectedly, these tablets were manufactured at the same
rate (48-49 tablets per minute, for each tablet die) as single
component tablets of the same size and nominal composition, but
with a clearly defined interface between the two layers. Moreover,
this was accomplished on a tablet press designed only for single
layer production without any loss of production rate. The tablets
produced did not exhibit weakness along the layer interface and had
similar mechanical properties (such as break strength) to single
layer tablets produced on the same equipment having the same size
and nominal composition.
TABLE-US-00001 TABLE 1 Examples 1-2. Example Layer 1 Layer 2 Number
Layer 1 Composition Layer 2 Composition 1 White 99% TCCA-95.2% Blue
99% TCCA-95.0% Sanitizing SHMP-3.8% Sanitizing SHMP-3.8% Layer
Boric Acid-1.0% Layer Boric Acid-1.0% Blue Dye-0.2% 2 White 99%
TCCA-95.2% Blue DCCA-60.0% Sanitizing SHMP-3.8% Shock Sodium
Sulfate-19.8% Layer Boric Acid-1.0% Layer Alum 10.0% Borax-5.5%
Boric Acid-4.5% Blue Dye-0.2% Notes on Table 1: 99% TCCA is 99%
trichlorocyanuric acid, SHMP is sodium hexametaphosphate, Blue Dye
is Pigment Blue 29, DCCA is sodium dichloroisocyanuric acid, Alum
is aluminum sulfate (hydrated), and Borax is sodium tetraborate
pentahydrate.
EXAMPLES 3-6
[0059] Horizontally layered tablets having a 1'' diameter (and a
height of 5/8'') and weighing approximately 20 grams were produced
using a laboratory press, where each layer received approximately
equal amounts of the respective components (50% in each layer).
Tablets were compressed for 30 sec at 10 kpsi, producing stable and
robust multilayer tablets. The tablets produced are generally
illustrated by FIG. 1. The compositions of the respective layers of
the tablets of Examples 3-6 are provided in Table 2 below.
TABLE-US-00002 TABLE 2 Examples 3-6. Example Layer 1 Layer 2 Number
Composition Composition 3 Alum and Blue Dye MgSO.sub.4*7H.sub.2O 4
Alum and Blue Dye CaCl.sub.2 5 Alum and Blue Dye Na.sub.2CO.sub.3 6
Alum and Blue Dye NaHSO.sub.4
Embodiments
[0060] The invention is described above with reference to numerous
aspects and embodiments, and specific examples. Many variations
will suggest themselves to those skilled in the art in light of the
above detailed description. All such obvious variations are within
the full intended scope of the appended claims. Other embodiments
of the invention can include, but are not limited to, the following
(embodiments are described as "comprising" but, alternatively, can
"consist essentially of" or "consist of"):
[0061] Embodiment 1. A horizontally layered tablet comprising a
first layer; a second layer; and an interface between the first
layer and the second layer; wherein the tablet is characterized by
a density of at least about 1.2 g/cc.
[0062] Embodiment 2. The tablet defined in embodiment 1, wherein
the density of the tablet is in any range disclosed herein, e.g.,
from about 1.2 to about 2.4, from about 1.2 to about 2, from about
1.3 to about 2 g/cc, etc.
[0063] Embodiment 3. The tablet defined in embodiment 1 or 2,
wherein the width (horizontal dimension; diameter if circular) of
the tablet is greater than the height (vertical dimension) of the
tablet.
[0064] Embodiment 4. The tablet defined in any one of the preceding
embodiments, wherein a ratio of the width of the tablet to the
height of the tablet is in any range disclosed herein, e.g., from
about 1.2:1 to about 10:1, from about 1.5:1 to about 5:1, etc.
[0065] Embodiment 5. The tablet defined in any one of the preceding
embodiments, wherein the major axis of the interface is greater
than the height of the tablet.
[0066] Embodiment 6. The tablet defined in embodiment 1 or 2,
wherein a ratio of the width of the tablet to the height of the
tablet is in any range disclosed herein, e.g., from about 0.33:1 to
about 0.8:1, from about 0.4:1 to about 0.75:1, etc.
[0067] Embodiment 7. The tablet defined in any one of the preceding
embodiments, wherein the interface is substantially perpendicular
to the top of the tablet and/or the bottom of the tablet.
[0068] Embodiment 8. The tablet defined in any one of embodiments
1-6, wherein the interface is generally linear.
[0069] Embodiment 9. The tablet defined in any one of embodiments
1-6, wherein the interface is a curvilinear shape (S-shape).
[0070] Embodiment 10. The tablet defined in any one of the
preceding embodiments, wherein a cross-section perpendicular to the
interface is any geometric shape disclosed herein, e.g., circular,
elliptical/oval, rectangular, square, etc.
[0071] Embodiment 11. The tablet defined in any one of the
preceding embodiments, wherein the tablet is in the shape of a disk
or puck.
[0072] Embodiment 12. The tablet defined in any one of the
preceding embodiments, wherein the tablet has a hardness in any
range disclosed herein, e.g., from about 10 to about 500, from
about 10 to about 50, from about 150 to about 500 lb.sub.f,
etc.
[0073] Embodiment 13. The tablet defined in any one of the
preceding embodiments, wherein the tablet has a distinct break.
[0074] Embodiment 14. The tablet defined in any one of the
preceding embodiments, wherein the tablet does not have a vicat
softening point or a glass transition temperature.
[0075] Embodiment 15. The tablet defined in any one of the
preceding embodiments, wherein the volume of the first layer, based
on the volume of the tablet, is in any percentage range disclosed
herein, e.g., from about 10 to about 90%, from about 25 to about
75%, from about 40 to about 60%, etc.
[0076] Embodiment 16. The tablet defined in any one of the
preceding embodiments, wherein the first layer has a first color,
and the second layer has a second color, and the first color and
the second color are different.
[0077] Embodiment 17. The tablet defined in any one of the
preceding embodiments, wherein the tablet further comprises a third
layer (intermediate layer, barrier layer, etc.) between the first
layer and the second layer.
[0078] Embodiment 18. The tablet defined in any one of the
preceding embodiments, wherein the tablet further comprises a top
layer on at least a portion of the top surface of the tablet.
[0079] Embodiment 19. The tablet defined in any one of the
preceding embodiments, wherein the tablet further comprises a
coating layer (e.g., an enteric coating) on at least a portion of
the outer surfaces of the tablet.
[0080] Embodiment 20. The tablet defined in any one of the
preceding embodiments, wherein the tablet is a compacted tablet,
e.g., not an extruded tablet, not a molded tablet, etc.
[0081] Embodiment 21. A horizontally layered tablet comprising a
first layer comprising a first composition; a second layer
comprising a second composition; and an interface between the first
layer and the second layer; wherein the first composition and the
second composition are different.
[0082] Embodiment 22. The tablet defined in embodiment 21, wherein
the tablet is further characterized as defined in any one of
embodiments 1-20.
[0083] Embodiment 23. The tablet defined in embodiment 21 or 22,
wherein the first composition and/or the second composition
independently comprise any suitable water treatment chemical or any
water treatment chemical disclosed herein, e.g., disinfectant,
sanitizer, pH adjuster, buffer, hardness modifier, algaecide,
corrosion inhibitor, scale inhibitor, dispersant, flocculent,
clarifier, oxidizer/shock, sequestrant, chelant, emulsifier,
demulsifier, etc., or combinations thereof.
[0084] Embodiment 24. The tablet defined in embodiment 21 or 22,
wherein the first composition and/or the second composition
independently comprise any suitable halogenated biological control
agent or any halogenated biological control agent disclosed
herein.
[0085] Embodiment 25. The tablet defined in embodiment 21 or 22,
wherein the first composition and/or the second composition
independently comprise a sanitizing composition, a shock
composition, a clarifier composition, an algaecide composition, a
pH or water hardness balancer composition, a corrosion control
composition, a scale control composition, a cleaning composition,
or any combination thereof.
[0086] Embodiment 26. The tablet defined in embodiment 21 or 22,
wherein the first composition and/or the second composition
independently comprise any active pharmaceutical ingredient or
nutraceutical ingredient suitable for tableting or any active
pharmaceutical ingredient or nutraceutical ingredient disclosed
herein.
[0087] Embodiment 27. The tablet defined in any one of embodiments
21-26, wherein the tablet further comprises any suitable tablet
excipient or any tablet excipient disclosed herein, e.g., binder,
lubricant, disintegrator, etc.
[0088] Embodiment 28. The tablet defined in any one of embodiments
21-27, wherein the first layer is quick release layer, e.g.,
immediate release, fast dissolving, etc.
[0089] Embodiment 29. The tablet defined in any one of embodiments
21-28, wherein the second layer is a slow release layer, e.g.,
delayed release, slow dissolving, etc.
[0090] Embodiment 30. The tablet defined in any one of embodiments
21-29, wherein the tablet further comprises an intermediate layer
between the first layer and the second layer, e.g., a barrier
layer, an inert layer, etc.
[0091] Embodiment 31. A method of making a horizontally layered
tablet having a first layer and a second layer, the method
comprising providing a first composition and a second composition;
simultaneously feeding a segregated flow of the first composition
and the second composition to a tablet die; and compressing the
first composition and the second composition under sufficient
pressure in the tablet die to the form the horizontally layered
tablet; wherein the first layer comprises the first composition and
the second layer comprises the second composition.
[0092] Embodiment 32. The method defined in embodiment 31, wherein
the tablet is further characterized as defined in any one of
embodiments 1-30.
[0093] Embodiment 33. The method defined in embodiment 31 or 32,
wherein the method comprises a single compressing step.
[0094] Embodiment 34. The method defined in any one of embodiments
31-33, wherein the method does not comprise a pre-compression
step.
[0095] Embodiment 35. The method defined in any one of embodiments
31-34, wherein the segregated flow is gravity fed.
[0096] Embodiment 36. The method defined in any one of embodiments
31-34, wherein the segregated flow is force fed.
[0097] Embodiment 37. The method defined in any one of embodiments
31-36, wherein the compressing step comprises mechanical or
hydraulically driven compression.
[0098] Embodiment 38. The method defined in any one of embodiments
31-38, further comprising a step of ejecting the tablet from the
tablet die.
[0099] Embodiment 39. The method defined in any one of embodiments
31-38, wherein the method does not comprises an extrusion step
and/or a molding step and/or an external heating step.
[0100] Embodiment 40. The method defined in any one of embodiments
31-39, wherein the tablet die is at ambient temperature, e.g., no
external heating or cooling of the tablet die.
[0101] Embodiment 41. The method defined in any one of embodiments
31-40, wherein the sufficient pressure in the compressing step is
uniform between the first layer and the second layer, e.g., within
specifications based on percent variability of a particular press
when operated in single layer mode.
[0102] Embodiment 42. The method defined in any one of embodiments
32-41, wherein the interface between the first layer and the second
layer is generally perpendicular to the bottom of the tablet
die.
[0103] Embodiment 43. An apparatus for forming a horizontally
layered tablet having a first layer comprising a first composition
and a second layer comprising a second composition, the apparatus
comprising a tablet die; a first feed chamber containing the first
composition and a second feed chamber containing the second
composition; a reciprocating and segmented feed device for
simultaneously directing a segregated flow of the first composition
from the first feed chamber and the second composition from the
second feed chamber to the tablet die; and a compaction device for
compressing the first composition and the second composition in the
tablet die under sufficient pressure to form the horizontally
layered tablet having the first layer and the second layer.
[0104] Embodiment 44. The apparatus defined in embodiment 43,
wherein the tablet is further characterized as defined in any one
of embodiments 1-30.
[0105] Embodiment 45. The apparatus defined in embodiment 43 or 44,
wherein the apparatus is not a rotary tablet press.
[0106] Embodiment 46. The apparatus defined in any one of
embodiments 43-45, wherein the compaction device is a mechanical
compaction device or a hydraulic compaction device.
[0107] Embodiment 47. The apparatus defined in any one of
embodiments 43-46, wherein the compaction device comprises a
downward movement of a top punch and/or an upward movement of a
bottom punch.
[0108] Embodiment 48. The apparatus defined in any one of
embodiments 43-47, wherein the apparatus is further configured to
eject the tablet from the tablet die by upward movement of a bottom
punch to eject the tablet.
[0109] Embodiment 49. The apparatus defined in any one of
embodiments 43-48, wherein the apparatus does not comprise a
heating or cooling system.
[0110] Embodiment 50. The apparatus defined in any one of
embodiments 43-49, wherein the apparatus comprises 2 or more tablet
dies, e.g., from 2 to 30, from 2 to 15, from 2 to 10, etc.
[0111] Embodiment 51. The apparatus defined in any one of
embodiments 43-50, wherein the tablet die has a depth of from about
1/8'' to about 10 inches.
[0112] Embodiment 52. The apparatus defined in any one of
embodiments 43-51, wherein the apparatus is capable of forming
tablets in any output rate range disclosed herein, based on each
tablet die, e.g., from about 30 to about 70, from about 40 to about
60 tablets/minute, etc.
* * * * *