Article comprising a diffuser with flow control features

Details Article comprising a diffuser with flow control features Article comprising a diffuser with flow control features

2001-12-10

2003-06-17

Chambers, A. Michael (Department: 3753)

Fluid handling

Flow affected by fluid contact, energy field or coanda effect

Device including linearly-aligned power stream emitter and...

C137S806000, C239S265190, C239SDIG007

Reexamination Certificate

active

06578607

ABSTRACT:

STATEMENT OF RELATED APPLICATIONS
The present invention is related to International Application No. PCT/US99/12772 filed Jun. 8, 1999 entitled “Pharmaceutical Product and Methods and Apparatus for Making Same.”
FIELD OF THE INVENTION
The present invention relates to improvements in an apparatus for the manufacture of pharmaceutical products.
BACKGROUND OF THE INVENTION
In the pharmaceutical industry, pharmaceutical products are typically embodied as tablets, caplets, test strips, capsules and the like. Such products, which include diagnostic products, include one or more “unit dosage forms” or “unit diagnostic forms” (collectively “unit forms”).
Each of the unit forms typically contains at least one pharmaceutically- or biologically-active ingredient (collectively “active ingredient”) and, also, inert/inactive ingredients. Such active and inactive ingredients, typically available as powders, are suitably processed to create the unit forms.
In the above-referenced International Patent Application, which is incorporated herein by reference, applicant discloses an apparatus for manufacturing such unit forms. The apparatus utilizes an electrostatic deposition process whereby powder(s) containing active and/or inactive ingredients are deposited on a substrate at discrete locations thereby producing the unit forms. To provide context for the present invention, the deposition apparatus, its operation, and illustrative unit forms produced thereby are described below.
FIGS. 1-4
depict one embodiment of a unit form
6
produced by the electrostatic deposition apparatus.
FIG. 1
depicts a plurality of such unit forms
6
arrayed on a strip
4
. In the illustrated embodiment, strip
4
comprises a substrate
8
and a cover layer
10
, each of which comprise a substantially planar, flexible film or sheet. In some embodiments, one of either substrate
8
or cover layer
10
include an array of semi-spherical bubbles, concavities or depressions (hereinafter “bubbles”)
12
that are advantageously uniformly arranged in columns and rows.
Unit form
6
comprises active ingredient
14
, a portion of cover layer
10
defining bubble
12
, and a region of substrate
8
within bonds
7
.
FIG. 2
(showing cover layer
10
partially “peeled” back from substrate
8
) and
FIG. 3
(showing a cross section of a portion of strip
4
) depict a deposit of dry active ingredient
14
, in the form of a powder, disposed between substrate
8
and cover layer
10
within bubble
12
. FIG.
3
and
FIG. 4
(showing a top view of a unit form
6
) depict substrate
8
and cover layer
10
attached to one another via bonds
7
that are near to and encircle bubble
12
.
Deposition Apparatus
FIG. 5
depicts, via a high-level block diagram, deposition apparatus
1
suitable for making unit form
6
. Apparatus
1
comprises platform
102
wherein unit forms
6
are produced. Platform
102
performs a variety of operations including the electrostatic deposition of dry powder on defined discrete regions of a substrate, materials handling, alignment operations, measurement operations and bonding operations.
Electrostatically-charged powder is delivered to platform
102
for deposition via powder feed apparatus
402
. In some embodiments, platform
102
and/or powder feed apparatus
402
are isolated from the ambient environment by an environmental enclosure. In such environments, environmental controller EC provides temperature, pressure and humidity control for platform
102
and powder feed apparatus
402
. Further description of platform
102
and powder feed apparatus
402
is provided later in this section.
Processor P and controller C control various electronic functions of apparatus
1
, such as, for example, the application of voltage for the electrostatic deposition operation, the operation of powder feed apparatus
402
, the operation of robots that are advantageously used in conjunction with platform
102
, and dose measurement operations. To facilitate such control functions, memory M is accessible to processor P and controller C.
FIGS. 6 and 7
depict a top view and a front elevational view, respectively, of illustrative platform
102
. In some embodiments, platform
102
comprises bench
214
that incorporates five processing stations that perform various operations used to produce the present product. Briefly, those processing stations include: storage station
220
, which advantageously comprises three substations
220
A,
220
B and
220
C for storing substrates and cover layers; alignment station
230
for assuring that the substrate and cover layer are properly adhered to a transport mechanism (e.g., robotic elements) that delivers them to other processing stations; deposition station
250
where powder is deposited on the substrate; dose measurement station
240
for measuring the amount of powder that is deposited on the substrate; and lamination station
260
where the cover layer is laminated to the substrate.
As depicted in
FIG. 7
, four supports
216
elevate bench
214
above a table or like surface. Additionally, supports
216
advantageously provide a frame or superstructure for optional side-mounted barriers
218
, depicted in FIG.
6
. The side-mounted barriers, in conjunction with a top barrier (not shown) and bench
214
define an environmental enclosure or chamber that isolates the region therein from the ambient environment under air or inert gas.
To facilitate the various processing operations, as well as materials handling between the processing stations, platform
102
advantageously includes a transport means. In the embodiment illustrated in
FIG. 7
, the transport means is a robotic system that includes first robotic transport element
270
and second robotic transport element
280
that are movable along first rail
290
. First rail
290
functions as a guide/support for movement in one direction (e.g., along the x-axis). An additional rail (not shown) movably mounted on first rail
290
functions as a guide/support for movement in a direction orthogonal to but in the same plane (e.g., the y-axis) as first rail
290
. Such rails collectively provide x-y motion. Drive means (not shown), such as x-y stepper motors, move robotic transport elements
270
and
280
along the rails.
Receiver
272
is attached to first robotic transport element
270
and “bonding” head
282
is attached to second robotic transport element
280
. Receiver
272
is operable to retrieve at least the substrate from the substation where it is stored (i.e.,
220
A or
220
B or
220
C) and to move it to at least some of the various operational stations
230
-
260
for processing. Bonding head
282
is operable to join/seal the substrate and cover layer to one another to create the unit forms
6
.
First and second robotic transport elements
270
and
280
have telescoping components under servo control (not shown) that provide movement along the z axis (i.e., normal to the x-y plane). Such z-axis movement allows receiver
272
and bonding head
282
to move “downwardly” toward a processing station to facilitate an operation, and “upwardly” away from a processing station after the operation is completed.
Moreover, robotic transport elements
270
and
280
advantageously include &thgr; control components under servo control (not shown) that allow receiver
272
and bonding head
282
to be rotated in the x-y plane as may facilitate operations at a processing station. Compressed dry air or other gas is suitably provided to operate the robotic transport elements. Robotic transport elements
270
and
280
can be based, for example, on a Yaskawa Robot World Linear Motor Robot available from Yaskawa Electric Company of Japan.
As previously indicated, powder comprising an active ingredient is electrostatically deposited at discrete locations on substrate
8
at deposition station
250
. In the illustrated embodiments, accomplishing such deposition requires that, among other things, substrate
8
is transported to deposition station
250
from some other location, and that an electrostatic charge is developed that c

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