Method for the manufacture of pharmaceutical cellulose capsules

Details Method for the manufacture of pharmaceutical cellulose capsules Method for the manufacture of pharmaceutical cellulose capsules

1997-04-21

2002-01-08

Ortiz, Angela (Department: 1732)

Plastic and nonmetallic article shaping or treating: processes

Direct application of electrical or wave energy to heat the...

C264S405000, C264S305000, C264S310000, C264S327000, C264S297800, C264SDIG003, C425S174600, C425S272000, C425S804000

Reexamination Certificate

active

06337045

ABSTRACT:

TECHNICAL FIELD
The invention relates generally to methods and apparatus used in the manufacture of pharmaceutical capsules.
BACKGROUND OF THE INVENTION
Pharmaceutical capsules presently in general use are made of gelatin and the techniques for the manufacture of gelatin capsules are well developed. Compositions for cellulose capsules are also well known, but the first cellulose composition that was used commercially to manufacture cellulose capsules did not reliably break down in the user's digestive system. When this fact was discovered, the commercial manufacture of cellulose capsules was discontinued. An improved cellulose composition was later patented by Sarkar and several patents disclose methods for manufacturing cellulose capsules from the improved cellulose composition. However, in the fifteen years since the Sarkar patent issued, and in spite of many attempts, none have succeeded in manufacturing cellulose capsules in quantity, using the improved composition, with sufficient uniformity to be suitable for filling in modern high-speed filling machines. Until the present invention was made, cellulose capsules manufactured in quantity from the improved composition suffered imperfections such as wrinkles, starred ends and corrugations. These imperfections result in capsules either breaking, failing to separate, or jamming in the high-speed filling machine.
Prior Art Gelatin Capsules
Prior art gelatin capsules, as shown in
FIGS. 1A
,
1
B and
1
C, are made in a range of sizes including sizes listed in the first column of each of Tables 1 and 2. These tables are copied from the February, 1987 Specification Sheet of the CAPSUGEL Division of Warner-Lambert Company for its PRE-FIT™, SNAP-FIT™ and CONI-SNAP™ series of hard gelatin capsules. Table 1 shows the external diameter, obtained by optical measurements, of a body and a cap of each size of CAPSUGEL capsule. (Diameter is difficult to measure precisely because of the slightly tapered shape and the flexibility of the gelatin capsule parts.) Table 2 shows the target wall thickness of a body and a cap of each type and size of CAPSUGEL capsule. Table 3, copied from the Scherer LOX-IT™ specification sheet, gives the external diameter of the Scherer LOX-IT™ capsule caps and bodies in a range of sizes.
TABLE 1
CAPSUGEL CAPSULE PART, EXTERNAL DIAMETER
PRE-FIT ™ SNAP-FIT ™ or CONI-SNAP ™
Body
Cap
Sizes
Inches
mm
Inches
mm
000
0.378
9.60
0.394
10.00 
 00
0.324
8.23
0.339
8.60
 0 el
0.291
7.38
0.300
7.70
 0
0.291
7.38
0.303
7.70
 1
0.263
6.68
0.275
6.98
 2
0.241
6.13
0.252
6.41
 3
0.221
5.61
0.231
5.88
 4 el
0.201
5.11
0.212
5.38
 4
0.201
5.11
0.212
5.38
 5
0.185
4.70
0.193
4.89
Tolerance: ±0.001 (±0.03 mm)
TABLE 2
CAPSUGEL CAPSULE PART, SINGLE WALL THICKNESS
SNAP-FIT ™ or
PRE-FIT ™
CONI-SNAP ™
Body
Cap
Body
Cap
Size
Inches
mm
Inches
mm
Inches
mm
Inches
mm
000
0.0042
0.107
0.0044
0.112
—
—
—
—
±
±
±
±
0.0009
0.023
0.0012
0.030
 00
0.0041
0.104
0.0042
0.109
0.0042
0.107
0.0043
0.109
±
±
±
±
±
±
±
±
0.0009
0.023
0.0012
0.030
0.0009
0.023
0.0012
0.030
0 el
—
—
—
—
0.0041
0.104
0.0042
0.107
±
±
±
±
0.0008
0.020
0.0010
0.025
0
0.0040
0.102
0.0042
0.107
0.0041
0.104
0.0042
0.107
±
±
±
±
±
±
±
±
0.0008
0.020
0.0010
0.025
0.0008
0.020
0.0010
0.025
1
0.0039
0.099
0.0041
0.104
0.0040
0.102
0.0041
0.104
±
±
±
±
±
±
±
±
0.0008
0.020
0.0010
0.025
0.0008
0.020
0.0010
0.025
2
0.0038
0.096
0.0040
0.102
0.0039
0.099
0.0040
0.102
±
±
±
±
±
±
±
±
0.0008
0.020
0.0010
0.025
0.0008
0.020
0.0010
0.025
3*
0.0034
0.086
0.0036
0.092
0.0035
0.089
0.0036
0.092
±
±
±
±
±
±
±
±
0.0008
0.020
0.0010
0.025
0.0008
0.020
0.0010
0.025
4 el
—
—
—
—
0.0037
0.094
0.0038
0.096
±
±
±
±
0.0008
0.020
0.0010
0.025
4
0.0034
0.086
0.0036
0.089
0.0034
0.086
0.0035
0.091
±
±
±
±
±
±
±
±
0.0008
0.020
0.0010
0.025
0.0008
0.020
0.0010
0.025
5
0.0034
0.086
0.0036
0.092
—
—
—
—
±
±
±
±
0.0008
0.020
0.0010
0.025
3* SNAP-FIT ™ Body Target - 0.0034 ± 0.0008
TABLE 3
SCHERER LOX-IT ™ CAPSULE PART DIAMETER
Size
0
1
2
3
4
CAP
0.301″
0.272″
0.250″
0.230″
0.210″
DIAMETER*
(±0.003)
BODY
0.289″
0.262″
0.240″
0.220″
0.200″
DIAMETER*
(±0.003)
*DETERMINED AT CUT EDGE
U.S. Pat. No. 3,399,803 to Oglevee et al. is directed to a hard-shell self-locking pharmaceutical capsule having a cap part and a body part, the parts adapted for machine filling. Oglevee discloses mold pins having a uniform taper or candle-shape such as to avoid suction when the part is removed from the pin and to provide a wedging fit between the capsule cap and the capsule body. Oglevee also discloses the shaping of the cap and body to provide a semi-locked position and a locked position. A single groove in the cap and a matching single groove in the body provide a mechanical lock.
U.S. Pat. Nos. 3,508,678 and 3,664,495 both to Graham et al. disclose a capsule cap having an indent, in addition to a locking groove, which defines a prelock position by providing either an elastic friction fit with the capsule body (U.S. Pat. No. 3,664,495) or a mechanical lock between the indent of the cap and the groove in the body (U.S. Pat. No. 3,508,678).
U.S. Pat. No. 4,247,006 to Bodenmann et al. discloses a capsule body having a reduced diameter in the area of its open end, and further the capsule cap and the capsule body each having an indentation to provide for a positive engagement of the body and the cap.
Prior Art Process for Gelatin Capsules
U.S. Pat. No. 1,787,777 to Colton describes the “Colton” machine used in the manufacture of gelatin capsules. Key elements in the prior art manufacture of gelatin capsules are illustrated in
FIGS. 1-7
.
FIG. 1A
shows the parts of a capsule having a body
1
and a cap
2
. The parts are shown in
FIG. 1B
in a prelock position
3
held in position by prelock dimples
4
. The parts are also shown in
FIG. 1C
in a filled position
5
held in position by locking rings
6
.
FIG. 2
shows elements of the traditional “Colton” capsule manufacturing machine. The elements are a greaser section
21
, a dipper section
22
, spinners
23
, upper drying kiln
24
, lower drying kiln
26
, table section
27
and automatics
28
. A pinbar, having thirty pins
31
mounted to a bar
32
, is shown in FIG.
3
.
FIG. 4
shows gel
41
formed around a pin
31
to a dip line
42
. Also shown is the trim line (cut-point)
43
and the area
44
on the pin above the dip line.
FIG. 5
shows a prior art stripper
51
about to push a capsule part
53
off a pin from the area
44
above the dip line with pushing face
52
. A side view of a prior art stripper having a pivot
61
and a spring
62
is shown in FIG.
6
.
FIG. 7
shows a knife
71
trimming a capsule part to remove the rough edge
72
and create a clean edge
73
.
U.S. Pat. Nos. 1,978,829 (to Wilkie), 3,632,700 (to Oglevee), 3,794,453 (to Padilla et al.), 4,705,658 (to Lukas) and 4,997,359 (to Lebrun) are all directed to processes for manufacturing gelatin capsules. The Wilkie patent discloses an apparatus for drying capsules by directing a stream of air at the part of the capsule that contains the most moisture. A fine stream of air passing through a hole in a plate is directed to the closed end of the capsule so that a greater drying effect is experienced on the closed ends of the capsule than on the sides of the capsule. A plate is provided having multiple holes spaced to match the position of the pins. The Oglevee patent discloses a method for insuring capsule wall thickness uniformity by measuring the visco

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