Method for recovering the contents of filled pharmaceutical capsules

A practice for recovering the contents of filled pharmaceutical capsules wherein the capsules are supported and a cutting blade cuts the supported capsules to allow egress of the capsule contents.

BACKGROUND OF THE INVENTION 
This invention pertains to the recovery of pharmaceutical substances and, 
in particular, to the recovery of pharmaceutical substances carried in two 
component, hard gelatin capsules. 
In the manufacture of encapsulated pharmaceuticals, a certain number of 
capsules are rejected for one reason or another during the manufacturing 
process. As the number of rejected capsules grows and the cost of the 
encapsulated pharmaceutical increases, it becomes increasingly important 
to recover the pharmaceutical product from the rejected capsules. In order 
for the recovery process to be acceptable, however, it must be carried out 
such that the physical integrity--bulk density, particle size, etc.--of 
the pharmaceutical product is not significantly altered. 
Prior art procedures for the recovery of encapsulated pharmaceuticals have 
been mainly directed to the recovery of pharmaceutical product in powdered 
form. One practice presently employed is to subject the capsules to a 
milling procedure wherein the capsules are ground to produce a mixture of 
hard capsule fragments and powdered pharmaceutical. The mixture is then 
screened to separate the capsule fragments from the powdered 
pharmaceutical. 
Another procedure which has been proposed for the recovery of 
pharmaceutical powder is disclosed in U.S. Pat. No. 3,800,399. In this 
procedure a pressure differential is created between the capsule interior 
and the surrounding area. This pressure differential causes separation of 
the capsule cap from the capsule body or rupturing of the capsule in cases 
wherein the cap and body are tightly fastened. Removal of the 
pharmaceutical powder is then carried out by blowing same through a screen 
which inhibits passage of the capsules. 
In present day pharmaceuticals, it is often the case that the encapsulated 
product is in pellet or bead form, rather than in powdered form. Recovery 
of such pharmaceutical beads using the prior milling procedure is, 
however, undesirable, as the grinding action of this procedure is 
detrimental to bead integrity. Furthermore, present day capsules are 
usually provided with a strong locking mechanism. Use of the pressure 
differential procedure would thus require a high pressure to break this 
locking mechanism which again could be detrimental to bead integrity. 
Additionally, it is usually the case that expensive filling equipment has 
been employed to fill the capsules. Use of further specialized milling or 
pressurizing equipment to recover the pharmaceutical product adds to this 
expense and, furthermore, reduces any gains achieved by the recovery. 
It would thus be advantageous if a recovery procedure could be developed 
for both bead filled and powder filled capsules. It would be further 
advantageous if a procedure could be developed which could make use of 
some or all of the existing filling equipment. 
It is therefore an object of the present invention to provide a method and 
apparatus for the recovery of encapsulated pharmaceutical product. 
It is also an object of the present invention to provide a method and 
apparatus for the recovery of encapsulated pharmaceutical product which is 
adaptable to present capsule filling equipment. 
It is further object of the present invention to provide a method and 
apparatus for the recovery of pharmaceutical beads in a manner which 
substantially preserves bead integrity. 
SUMMARY OF THE INVENTION 
The above and other objects are realized in accordance with the principles 
of the present invention in a practice wherein a capsule containing a 
pharmaceutical product is supported by a support means and wherein a 
cutting means is provided to cut the supported capsule so as to enable 
egress of the product from the capsule. 
In the preferred embodiment of the invention to be disclosed hereinafter 
the support means comprises the spaced upper and lower capsule support 
members of a conventional capsule filling apparatus. These members have 
upper and lower bores, respectively, and are adapted such that these bores 
are maintained in alignment in moving from a capsule receiving station 
whereat a capsule is inserted from above into the upper bore, through a 
capsule cutting station whereat a cutting means is located which cuts the 
capsule body at a point accessible through the space between the upper and 
lower members. In this preferred embodiment a capsule ejection station 
immediately follows the cutting station and the support members are moved 
to maintain the bores in alignment into the ejection station whereat a jet 
of air is applied to the bottom of the lower bore causing the cut capsule 
parts to be expelled upwardly out of the bores.

DETAILED DESCRIPTION OF THE INVENTION 
In FIG. 1, a capsule cutting apparatus or assembly 1 in accordance with the 
principles of the present invention is shown. The illustrated assembly has 
been realized by modifying a conventional capsule filling machine and, in 
particular, a capsule filling machine sold by Eli Lilly and Co. under the 
name Rotofil.RTM. Automatic Filling Machine Type P. 
An orientating mechanism 2 receives pharmaceutical capsules 3 and provides 
at its output capsules oriented with their axes aligned in the vertical 
direction and with the caps 3a of the capsules upward. An orientating 
mechanism of this type, in addition, to being provided with the 
Rotofil.RTM. machine is also disclosed in U.S. Pat. No. 3,817,423. 
The oriented capsules are delivered from the orientating mechanism 2 to a 
capsule support mechanism comprising lower and upper spaced rotatably 
mounted support assemblies 4 and 5. The lower support assembly 4 is in the 
form of a ring and is provided with through bores 6 (See, FIG. 2) 
distributed around the ring periphery. These through bores are each 
adapted to slidably receive the tip end 7 of a hollow punch 8. The latter 
punches are slidably mounted in a bottom rotatably mounted ring 9. The 
side wall of ring 9 includes passages 11, each communicating with the 
interior of a different punch. 
The upper support assembly 5 comprises an inner ring 12 provided about its 
periphery with radial slots 13. These slots provide guides for cam 
followers 14 of radially directed fingers 15. Fingers 15 (See, FIG. 3) 
include bushings 44 held by snap rings 45. Bushings 44 define through 
bores 16 for the fingers 15, which through bores at the outermost radial 
position of cam followers 14 align with respective through bores 6 in the 
ring 4. 
In usual operation of the aforesaid assembly to fill capsules with 
pharmaceutical product and, in particular, beads or pellets, unfilled 
capsules 3 are first delivered to the hopper of the orienting mechanism 2. 
The mechanism 2 orients the capsules, as above described, and delivers 
each oriented capsule at delivery station 17 to a through bore 16 in a 
radial finger 15. Simultaneously with or immediately after such delivery 
at an immediately adjacent vacuum station 18, a vacuum is applied, via a 
vacuum block (not shown) adjacent the ring 9, to the radial bore 11 
communicating with the bore 6 in the support 4 aligned with the capsule 
receiving bore 16. This vacuum causes the cap 3a and body 3b of the 
received capsule 3 to separate and the body becomes lodged in the bore 6 
and the cap remains held in the bore 16, which is shaped in its interior 
to prevent through passage of the cap. 
As the support rings 4 and 5 rotate, the cam follower 14 of the finger 15 
is forced radially inwardly by a cam track of a cam (not shown) which is 
attached to the central fixed cam guide plate 19. Movement of the follower 
14 inwardly causes like movement of the finger 15 so that the bore 16 
holding the capsule cap 3a is now located radially inwardly of the bore 6 
holding the capsule body 3b, thereby exposing the body. With this relative 
position of the bores maintained, the rings traverse a capsule filling 
station 21 at which is located a filling mechanism (not shown) wherein 
pharmaceutical product in pellet form is introduced into the capsule body 
3a filling same. 
Upon leaving the filling station 21, the cam track now urges the finger 15 
radially outwardly to a point where the bore 16 carrying the capsule cap 
3a now aligns with the bore 6 carrying the filled capsule body 3b. With 
this positioning maintained, the rings enter a capsule closing station 22 
at which the punch tip 7 aligned with the through bore 6 carrying the 
filled capsule body 3b is urged upwardly by the punch body 8 as a result 
of the body riding upon a cam surface 23 of a lower fixed ring 24. 
Movement of the tip upwardly urges the capsule body 3b into the bore 16 
and into locking engagement with the capsule cap 3a, this engagement being 
ensured by a closing plate (not shown) which is positioned at station 22 
and acts to buttress the cap 3a against movement as the body is moved 
upwardly and locked thereto. 
The rings 4, 5 and 9 then move from the closing station to an ejection 
station 25 whereat the cover plate terminates and the punch tip 7 
continues to be urged upwardly by the cam surface 25. This brings the 
filled locked capsule upwardly out of the bore 16 at which time a jet of 
air is directed at the capsule blowing same into a discharge conduit. 
The above explanation has described how the assembly 1 could be operated as 
a capsule filling assembly. In accordance with the principales of the 
present invention, however, the assembly 1 is adapted to recover 
pharmaceutical product and, in particular, pharmaceutical pellets, from 
already filled capsules. More particularly, the assembly 1 is modified as 
shown by removing the filling and closing station equipment and by 
removing the cam which moves the fingers 15 inwardly. The ejection station 
25 is also modified and a capsule cutting station 26 is added. 
Additionally, a separating assembly 27, shown as separate from the basic 
assembly 1, is also added. 
As shown, a cutting assembly 28 is located at cutting station 26 and 
comprises a flat circular cutting blade 29. The blade 29 is mounted from 
above by a mounting block 31 which is supported on a shaft 32 which 
extends upwardly from a weighted stand 33. The mounting is such that the 
cutting edge of the blade extends into the space between the fingers 15 
and the upper surface of the support 4 and radially inwardly to a point 
beyond the peripheral location of the bores 6. 
The ejection station 25 follows the cutting station 26 and comprises a 
block 34 communicating with the radial bores 11 in the ring 9. Block 34 is 
held by a T-shaped support 35 mounted on a stand 36. Compressed air is fed 
to block 34 via a conduct 37 attached to an inlet port 38 of the support 
35. 
A collection funnel 39 is situated above the bores 16 of the fingers 15 at 
the ejection station 25. A conduit 41 leads from the funnel 39 to the 
separating station 27 which includes a vibratory screening mechanism 42 
supported on a collection receptacle 43. 
Forward of the cutting station 26 is a pressure plate 44 supported slightly 
above the fingers 15. The fingers 15 are positioned by the guide plate 19 
so that the bores 16 of the fingers are aligned with the bores 6 of the 
lower support and the removal of the cam ring from the guide plate ensures 
that this alignment is maintained through rotation of the rings 4 and 5 
from the filling station 17 through the ejection station 25. 
In operation, filled capsules are fed into the orienting mechanism 2 which 
again aligns the axes of the capsules vertically with the caps 3a upward. 
Each oriented capsule is delivered by the mechanism 2 to a bore 16 of a 
finger 15 at the delivery station 17, at which time the capsule is also 
subjected to a vacuum via the vacuum block at the vacuum station 18. This 
vacuum ensures proper seating of the filled capsule in the bore 16, but is 
insufficient to separate the cap 3a and body 3b of the capsule due to the 
strong locking engagement imparted to these parts during filling. 
As shown in FIG. 3, the body 3b of the capsule 3 in the bore 16 extends 
into the aligned bore 6 of the ring 4 with the body portion 3c between the 
lower surface of the finger 15 and the upper surface of ring 4 being 
situated in the space between these members. As the rings 4 and 5 rotate, 
the cap 3a of the capsule is engaged by the pressure plate 44 so as to 
right the capsule if the capsule is skewed. 
As rotation continues, the capsule 3 is carried into the cutting station 
whereat the cutting blade 29 cuts through the circumferential area of the 
exposed capsule body portion 3c, thereby providing a means of egress for 
the pharmaceutical product. By suitable selection of the speed of rotation 
of the members 4 and 5 and the number of fingers 15 the cut capsule 
preferably remains in essentially the same position in bores 16 and 6 
after cutting and upon arrival at the ejection station 25. At this 
station, compressed air passes from the block 34 into the bore 11 and from 
there through the punch and punch tip 7 to the lower end of bore 6. This 
air acts as a jet and shoots the cut capsule parts upwardly into the 
funnel 39 and carries them through conduit 41 to vibrating screen assembly 
42. 
The screen assembly 42 segregates the cut capsule parts from the 
pharmaceutical product by its vibratory action and the product passes 
through the screen of the assembly which inhibits passage of the larger 
capsule parts. The pharmaceutical product is then collected in receptacle 
43 for reuse in filling empty capsules. 
As presently illustrated, the blade 29 is situated to cut entirely through 
the capsules 3, but the blade could be adjusted so as to cut the capsule 
around less than its entire circumference. The degree of circumference cut 
must be such as to allow egress of the encapsulated product therethrough 
and will be dictated, amongst other things, by the product type (pellet, 
powder, etc.), product size, capsule resiliency and screening method. A 
preferable cutting range is from about 300 to 360.degree. of the capsule 
circumference. 
It also should be noted that the position at which the cut is made on the 
capsule body is preferably at or above the cupped shape end of the body. 
This again facilitates product egress. 
As can be appreciated from the above, the present recovery assembly 
requires only relatively inexpensive and uncomplicated adaptation of 
existing capsule filling equipment. Furthermore, recovery is dependent 
upon simple cutting and pressure differentials and equipment for creating 
same are not needed. Finally, pharmaceutical product integrity is 
substantially ensured, particularly for product in pellet form. 
In all cases, it is understood that the above-described arrangements are 
merely illustrative of the many possible specific embodiments which 
represent applications of the present invention. Numerous and varied other 
arrangements can readily be devised without departing from the spirit and 
scope of the invention.