CA2148456A1 - Capsule cap - Google Patents
Capsule capInfo
- Publication number
- CA2148456A1 CA2148456A1 CA002148456A CA2148456A CA2148456A1 CA 2148456 A1 CA2148456 A1 CA 2148456A1 CA 002148456 A CA002148456 A CA 002148456A CA 2148456 A CA2148456 A CA 2148456A CA 2148456 A1 CA2148456 A1 CA 2148456A1
- Authority
- CA
- Canada
- Prior art keywords
- end portion
- capsule
- cap
- open end
- domed
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
- A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
Abstract
2148456 9409744 PCTABScor01 A cap (8) for fitting to the body (6) of a capsule for delivering a dose of pharmaceutically active material has a tubular open end portion (20) and a domed closed end portion (26). To avoid jamming of the caps one-inside-another whilst being fed within a capsule filling machine, the external diameter of the domed end portion exceeds the internal diameter of the mouth (22) of the tubular open end portion. The taper of the cap may be reduced compared to conventional caps, and the wall thickness may be increased. An inwardly extending ring (28) may be provided near the mouth of the tubular portion. The domed end portion is preferably flattened and non-hemispherical.
Description
WO ~4/05~744 21~ ~ g ~ 6 PCI`/GB93/02269 CAPSULE CAP ~ -1, .`.'`'`
TECHNICAL FIELD t--The present invention relates to a cap ~or fitting to the body of a capsule for containing a pharmaceutically ~;
active material. In particular, though not exclusively, the cap i5 for use with a controlled release capsule construction which comprises a male plug engaged within a neck of a female body; the male plu~ being formed of a water-swellable material which swells 50 as to disengage the female boày upon ex~osure to an aaueous medium. -,.
BACKGROUND ~-International Patent Specification WO 90/0~168 discloses a capsule of this type which comprises a water swella~le male plug engaged withln a female body. A
pharmaceu~ically active material is~contained ~ithin t.~_ device. When the capsule is exposed to water, the male hydrogel plug swells and eventually disengages itself from the remale body, thereby allowing the pharmaceutically active material contained within the capsule to be released. It has been found that the tlme taken to ! :
release the pharmaceutical materi_ is predictable and reproducible, so that the device may be used to release pharmaceutically active material within the body of a patient after a predeter~._ned time interval. .:~is may, , ' for example, be useful in the treatment of medical , ';
W094/09744 PCT/GB93/0226~ ~
TECHNICAL FIELD t--The present invention relates to a cap ~or fitting to the body of a capsule for containing a pharmaceutically ~;
active material. In particular, though not exclusively, the cap i5 for use with a controlled release capsule construction which comprises a male plug engaged within a neck of a female body; the male plu~ being formed of a water-swellable material which swells 50 as to disengage the female boày upon ex~osure to an aaueous medium. -,.
BACKGROUND ~-International Patent Specification WO 90/0~168 discloses a capsule of this type which comprises a water swella~le male plug engaged withln a female body. A
pharmaceu~ically active material is~contained ~ithin t.~_ device. When the capsule is exposed to water, the male hydrogel plug swells and eventually disengages itself from the remale body, thereby allowing the pharmaceutically active material contained within the capsule to be released. It has been found that the tlme taken to ! :
release the pharmaceutical materi_ is predictable and reproducible, so that the device may be used to release pharmaceutically active material within the body of a patient after a predeter~._ned time interval. .:~is may, , ' for example, be useful in the treatment of medical , ';
W094/09744 PCT/GB93/0226~ ~
2 ~ i !,-- ~ ~ ' --conditions where it is desirable to administer a pharmaceutically active material to the patient sometime through the night while the patient is asleep, so as to 1~5 . ';' provide a desired level~of the drug in the patient in accordance with his needs, for Pxamp e during the night or when he awa~es. It may also be useful to allow dosing of ~ `-materials at a predetermined point as the capsule passes through the gastro-intestinal tract, for example in the colon.
Conventional hard gelatin capsules are produced and filled in large numbers using high speed automatic ;~
machinery. Such capsules comprise a body and a cap.
Normally the cap is pre-fitted to the capsule body during manufacture of the capsule. During filling, the rilling machine removes the cap, fills the capsule with pha~maceutical material, and then replaces the cap - often in a manner such that the cap is locked onto the capsule body. Patent Specification U~S. 3,399,803 discloses a self-loc~ing medicament capsule wherein the body has a .
groove near its open end, and the cap has a corresponding ridge which snaps into the groove so as to lock the cap and body together. U.S. 4,442,g41 discloses a bayonet-type arrangement whereby a rais~d portion on the . -cap is engaged into a groove on the body.
European Patent Specification 246804 also discloses a >
capsule body having a groove near its mouth for the purposes of pre~enting the capsule distorting from its '`~,' ~ 3 cylindrical form, which may cause difficulty in fitting -~
the cap onto the capsule body. ~-U.S. patent specification 4,4~7,327 discloses ~ `~
number of capsule configurations wherein the cap is intended to be Iocked onto the body in a tamper-proof manner. Whilst not addr2ssing the same problem as the present invention, some of the cap shapes have a mouth which is narrower than the hemispherical end of the cap.
However, in the type of controlled release capsule construction disclosed in WO 90/09168 it may be inconvenient to employ pre-locked capJbody assemblies, since in a filling machine a numb~r of steps are required :~
to be carried out between the disengagement of the -pre-locked assemblies and their reassembly. It would therefore he convenlent to provide the caps and the bodies separately within the filling machine for subsequent assembly as part of the filling process. However, conventional caps have a tendency to nest and jam one inside another during storage, and more particularly as the caps are directed sequentially down a chute in a ~illing machine. One reason for this is that the caps are not truly cylindrical but taper slightly (i.e. are frustro-conical) from a wider open end to a narrower ---hemispherical end. The degree of taper is slight and is intended to asslst removal of the cap from its mould ~
during production. Typically the taper is about 0.012 ~ :
inch (304 microns), that is to say =he radius at the upper AMEN~ S~
i`` ` . .. ... ~ .
en~ of the frustro-conical section adjacent the ~:
. .
hemispherical end is 0.012 inch less than the radius at ~.
the open end of the cap. However, this taper may b~e -.
sufficient to allo~ the hemispherical end of one cap to get jammed inside the open end of an adjacent cap.
It is an object of the present invention to mitigate ~
this problem by providing a cap construc~ion wherein .~
jamming together of the caps is minimised. ~
SUMMARY OF THE INVENTION ~-,.
Thus, the present invention provides a cap for '-fitting to a ~ody of a capsule, the cap having a tubular open end portion for engaging the capsule body and a domed closed end portion, the domed closed end portion having an external diameter greater than the internal diametPr of .
the mouth of the tubular open end portion and wherein the domed closed end portion is ~lattened, such as to be ,~:
non-hemispherical, and have a major radius extending .
substantially transversely to a longitudinal axis of the tubular open end~portion, and a minor radius extending ~`
:;
substantially along said longitudinal axis,.such as to `:
substantially avoid interlocking of nested caps.
The domed closed end portion has an external diameter ' greater than the internal diameter of the tubular open end portion. Generally speaklng, this may be achieved in one .`
of a number o~ ways; or some or all of them in combination. Firstly, the taper of the cap can be reduced ~:
compared to conventional caps. Secondlyl the wall `. ,'',.
~E~ D S~fET
. ,',~.
thickness of the cap can be increased. Thirdly, an inwardly extending protrusion or protrusions may be provided adjacent the mouth of the open end portion. `-According to the first provision the taper may be reduced. Conventional substantially cylindrical caps generally have a taper such that the radial width of the ;~
cap reduces slightly from the open end to the closed end.
This taper assists removal of the cap from its moulding pin during production of the cap. Usually, this taper is of the order of 300 microns. In an embodiment of the invention, the taper is reduced to no more than 250 microns. This has the effect of increasing the external radius of the domed portion relative to the internal ;~
radius of the tubular end portion. The taper is the ` ;
difference between the radius of the domed end portion and ;-the radius of the mouth of the tubular portion.
Secondly, the wall thicXness may be increased. In order to increase the difference between the internal `-diameter of the mouth of the tubular open end portion and l-~
the external diameter of the domed portion, it is ^
preferred to increase the wall thic~ness (over that conventionally used) such that ~he wall thickness is at least 200 microns, (e.g. 220 to 280 microns). A
conventional hard gelatin cap has a wall thickness of approximately 0.005" (127 microns).
According to a third provision, an inwardly extPnding protrusion or protrusions may be provided adjacent the ~M~N~D ~HEET
-6` .
.; ., .
- 5a -:
mouth of the open end portion, such as to further minimise ~
any tendency to nesting and jamming. The protruslons may ~;
be individual protrusions or the protrusions may together form a continuous inwardly extending ridge.
In one embodiment the cap is wider at its domed end `-~
than its open end; the transverse external diameter of the -;
domed end portion exceeding the transverse external ~ .
diameter o~ the open end portion, usually by up to 5% of -the diameter.
Advantageously, the domed end of the cap may be flattened relative to conventional hemispherical caps so ~`
as to increase the angle between a tangent at a position `~
' .
,." ~
'1"`' ~, . .
, . .
, ' , ,', .. "
! . .
, ;~.
' ..':' ~MEN~ SHEE7 ~, '' "`-"
':'~''':
W094/0~744 2 ~ PCT/GB93/02269 ;,~-;
.;`, 1-, , ,,,. 1.
on the domed end where the domed end meets an adjacent cap, and the inside wall of the adjacent cap when nested thereto. In particular, the minor radius of the flattened dome may be from 60 to 80~ of the major transversely extending radius (i.e. in the direction transverse to the longitudinal axis of the tubular open end portion). The flattened dome may be substantially hemi-ovoid in shape or it may be a slmilar non-geometrically defined shape.
Thus, the terms "radius" and "diameter" as used herein are~;
not used in a strict geometrical sense but in a general sense.
Another aspect of the invention relates to a capsule comprising the cap fitted to a capsule body. In a preferred arrangement, the capsule body has a reduced ~-diameter neck regior. adjacent the open mouth of the body, and the cap nas an inwardly extending ridge between the tubula, open end portion and the domed portion, the ridge ;
being engaged within the -eck region of the body to lock the cap to the body.
A further aspect of the invention provides a method of filling the capsule, which comprises, ~i) providing a supply of the caps and a separate su~ly of capsule bodies;
(ii) fee~ing a body to a filling location and introducing a unit dose of phar~a~eutically. ~ ,~
actlve material into the body; and (iii) closing the capsule by fitting a cap over an open end of the capsule. -W094/09744 PCT/GB93/022~9 ~ ~
2~ 36 "~
.. i. .. .
The method may rurther comprise the step of -~
introducing a plug of a water swellable material into~a neck of the l^illed capsule body prior to fitting the cap thereto. Preferably the capsule body has a flared outwardly extending open mouth and the cap has inwardly extending protrusions, and the methcd comprises the further step of pressing the cap onto the body such that the inwardly extending protrusions clip over the flared -.
mouth of the body to lock the cap in~place on the body.
The present invention is particularly applicable to a : .
controlled release capsule which c_mprises a male plug engaged ~ithin a neck portion of a female k-iy; the male ,-.
plug belng substantially cylindrical and formed from a ~-water-swellable mater.ial which swells so as to disengage .~
the female body upon exposure to an aqueous medium. The l~ :
water swellable material is preferably as disclosed W090/0916~. :
DETAILED DESCRIPTION OF PREFERRED EM~`DIMENTS
Embodiments of the present inYention will now be j ~-~
described by way of example only with reference to the drawings wherein;
Figure 1 is a cross sectional elevation oî a firs~ l-embodiment;
Figure 2 is a schematic elevation of a series of caps in the chute of a capsule filling machine; ~.
Figure 3 is an elevation of a second cap i ~
construction; and `~:
2,!L(s~ t5~ pCI'/C;1~93/02~6Y ~, ~ - 8 -Figure 4 is a part cross sectional elevation of a series of caps according to the second construction in a filling machine chute.
The capsule shown in Figure l comprises a male plug 2 formed of a hydrogel material inserted in neck 4 of female body 6. The capsule is closed with a cap 8. Typically, a -~
size "0" capsule size is employed.
The body 6 comprises a cylindrical maln portion 10 and closed end 12. The main body narrows to the neck portio.~ ~ which is substantlally cylindrical so as to receive the male plug 2 with a close tolerance. The neck portion then flares out to a flared mouth portion 14 of a diameter substantially the same as the diameter of the ;~
main body portion 10. ~-The cap 8 comprises a tubular (substantially cylindrical) open end portion 20 having a mouth 22, and at its inner end a ridge 18 or series of detents for locking the cap onto the body and a stop ring 2~ for locating the cap on the body. The cap has a domed closed end 26 which is flattened relative to a hemisphere. In the embodiments shown, the upstanding radius (along the longitudinal axis of the -ubular open end portion) is approximately 70% of ' -~
the transverse radial direction. This flattening helps avoid jamming of th~ nested caps by increasing the angle between the dome and the mouth of an adjacent cap when , nested thereto. The cap wall thickness is substantially 250 microns.
W094tO9744 ~1 4 ~ PCT~GB93/02269 ',`!,'", 9 _ ' In the embodiments shown, the domed portion extends `~
outwardly slightly beyond the tubular open end portion.
I'he male plug 2 is formed of a hydrogel material (such as disclosed ~n WO 9C/09168) and is usually inserted so that the upper end of the plug is level with or below the upper end of the capsule body.
The cap is ~ormed of a water soluble ma~erial, such as gelatin. The capsule body is formed of a water i~-insoluble material, which may be a water insoluble ~;
plastics material or may be ~elatin coated with a f water-impermeable coating.
The capsule body i5 formed in conventional manner by dipping a mould pin into a gelatin solution and allowing to dry. The gelatin is then coated with a ~-water-impermeable coati-.g (e.g. by dip-coating) after the capsule body is stripped from ~he mould pin and trimmed ~o j~
size. ~l_ernatively, the water-impermeable coa-~g may ^- ~-applie~ by spray coatlng or vapour deposit~_n o~.-o the ;, capsule body. ;~
The walls of the female body may be formed from a wide varietv of materials. They may be of homogenous 3 ;.
construc~ions or they may be laminated. Examples of mater~ls suitable for use in the construction of the body include polyethylene, polypropylene, poly(methylmethacrylate), polyvinyl chloride, polystyrene, polyurethanes, polytetrafluoroethylene, nylons, polyformaldehydes, polyesters, oellulose aceiate ~nd nitro cellulose.
W094/097~ PCT/GB93/0226~ ~
Z ~ 5 ~; - 10 However, a ~-eferred construction uses an impermeable coating to cover the exterior of a body which has been formed fxom a water soluble material. The coating may conveniently be formed by dippin~ the body in a solution ---of a material which forms a layer which is impermeable to water. Alternatively, the hody might be spray-coated. A ;~
preferred class of capsule bodies are conventional hard gelatin or starch capsule bodies coated with a solution of polyvinyl chlorlde or a polyvinyl acetate copolymer or an ethyl cellulose solution.
Figure , shows three nested caps 8 travelling down a delivery chute 30 in a filling machine, prior to being fitted onto the capsule body. During assembly, the capsule body is first filled with pharmaceutically active material. Then, the hydrogel plug is positioned in the neck c~ the body and inserted into the body 50 as to be -;~
locat~ correctly (usually either flush with the top or the bcdy or slightly recessed). Finally, the cap is fitted over the mouth of the capsule body to fo~m the assembled capsule as shown in Figure 1.
Figure 3 shows a second embodiment which is generally similar to the first embodiment, analo~ous parts being labelled with the same reference numerals, but with the addition of a further ring 28 adjacent the open mouth 22 of the open ended portion 20 of the cap. As can be seen in Figure 4, this help~ further assist prevention of ja~-ng together of the nested caps in the filling chute.
'` ' W094/09744 ~ PCT/GB93/02269 ,~
- 11 - i The ring 28 locates at the lower end of the neck 4 (see Figure 1) when the cap is fitted onto the body.
Depending on the intended application, the cap may be enteric coated to prevent dissolution in the stomach. In ;~
the higher pH of the intestine the enteric coating dissolves exposing the water soluble cap, which in turn ;
dissolves in the aqueous medium. The enteric coating may be any coating material known in the art, such as those disclosed in WO 90/09168.
As used herein, the term enteric coating includes all coatings (whether pH dependent or not) which are able to pass through the stomach and dissolve in the intestine.
This includes coating materials, such as fats, which dissolve preferentially under the enzymatic regime prevailing in the intestine.
';', i `~:
. .
,,
Conventional hard gelatin capsules are produced and filled in large numbers using high speed automatic ;~
machinery. Such capsules comprise a body and a cap.
Normally the cap is pre-fitted to the capsule body during manufacture of the capsule. During filling, the rilling machine removes the cap, fills the capsule with pha~maceutical material, and then replaces the cap - often in a manner such that the cap is locked onto the capsule body. Patent Specification U~S. 3,399,803 discloses a self-loc~ing medicament capsule wherein the body has a .
groove near its open end, and the cap has a corresponding ridge which snaps into the groove so as to lock the cap and body together. U.S. 4,442,g41 discloses a bayonet-type arrangement whereby a rais~d portion on the . -cap is engaged into a groove on the body.
European Patent Specification 246804 also discloses a >
capsule body having a groove near its mouth for the purposes of pre~enting the capsule distorting from its '`~,' ~ 3 cylindrical form, which may cause difficulty in fitting -~
the cap onto the capsule body. ~-U.S. patent specification 4,4~7,327 discloses ~ `~
number of capsule configurations wherein the cap is intended to be Iocked onto the body in a tamper-proof manner. Whilst not addr2ssing the same problem as the present invention, some of the cap shapes have a mouth which is narrower than the hemispherical end of the cap.
However, in the type of controlled release capsule construction disclosed in WO 90/09168 it may be inconvenient to employ pre-locked capJbody assemblies, since in a filling machine a numb~r of steps are required :~
to be carried out between the disengagement of the -pre-locked assemblies and their reassembly. It would therefore he convenlent to provide the caps and the bodies separately within the filling machine for subsequent assembly as part of the filling process. However, conventional caps have a tendency to nest and jam one inside another during storage, and more particularly as the caps are directed sequentially down a chute in a ~illing machine. One reason for this is that the caps are not truly cylindrical but taper slightly (i.e. are frustro-conical) from a wider open end to a narrower ---hemispherical end. The degree of taper is slight and is intended to asslst removal of the cap from its mould ~
during production. Typically the taper is about 0.012 ~ :
inch (304 microns), that is to say =he radius at the upper AMEN~ S~
i`` ` . .. ... ~ .
en~ of the frustro-conical section adjacent the ~:
. .
hemispherical end is 0.012 inch less than the radius at ~.
the open end of the cap. However, this taper may b~e -.
sufficient to allo~ the hemispherical end of one cap to get jammed inside the open end of an adjacent cap.
It is an object of the present invention to mitigate ~
this problem by providing a cap construc~ion wherein .~
jamming together of the caps is minimised. ~
SUMMARY OF THE INVENTION ~-,.
Thus, the present invention provides a cap for '-fitting to a ~ody of a capsule, the cap having a tubular open end portion for engaging the capsule body and a domed closed end portion, the domed closed end portion having an external diameter greater than the internal diametPr of .
the mouth of the tubular open end portion and wherein the domed closed end portion is ~lattened, such as to be ,~:
non-hemispherical, and have a major radius extending .
substantially transversely to a longitudinal axis of the tubular open end~portion, and a minor radius extending ~`
:;
substantially along said longitudinal axis,.such as to `:
substantially avoid interlocking of nested caps.
The domed closed end portion has an external diameter ' greater than the internal diameter of the tubular open end portion. Generally speaklng, this may be achieved in one .`
of a number o~ ways; or some or all of them in combination. Firstly, the taper of the cap can be reduced ~:
compared to conventional caps. Secondlyl the wall `. ,'',.
~E~ D S~fET
. ,',~.
thickness of the cap can be increased. Thirdly, an inwardly extending protrusion or protrusions may be provided adjacent the mouth of the open end portion. `-According to the first provision the taper may be reduced. Conventional substantially cylindrical caps generally have a taper such that the radial width of the ;~
cap reduces slightly from the open end to the closed end.
This taper assists removal of the cap from its moulding pin during production of the cap. Usually, this taper is of the order of 300 microns. In an embodiment of the invention, the taper is reduced to no more than 250 microns. This has the effect of increasing the external radius of the domed portion relative to the internal ;~
radius of the tubular end portion. The taper is the ` ;
difference between the radius of the domed end portion and ;-the radius of the mouth of the tubular portion.
Secondly, the wall thicXness may be increased. In order to increase the difference between the internal `-diameter of the mouth of the tubular open end portion and l-~
the external diameter of the domed portion, it is ^
preferred to increase the wall thic~ness (over that conventionally used) such that ~he wall thickness is at least 200 microns, (e.g. 220 to 280 microns). A
conventional hard gelatin cap has a wall thickness of approximately 0.005" (127 microns).
According to a third provision, an inwardly extPnding protrusion or protrusions may be provided adjacent the ~M~N~D ~HEET
-6` .
.; ., .
- 5a -:
mouth of the open end portion, such as to further minimise ~
any tendency to nesting and jamming. The protruslons may ~;
be individual protrusions or the protrusions may together form a continuous inwardly extending ridge.
In one embodiment the cap is wider at its domed end `-~
than its open end; the transverse external diameter of the -;
domed end portion exceeding the transverse external ~ .
diameter o~ the open end portion, usually by up to 5% of -the diameter.
Advantageously, the domed end of the cap may be flattened relative to conventional hemispherical caps so ~`
as to increase the angle between a tangent at a position `~
' .
,." ~
'1"`' ~, . .
, . .
, ' , ,', .. "
! . .
, ;~.
' ..':' ~MEN~ SHEE7 ~, '' "`-"
':'~''':
W094/0~744 2 ~ PCT/GB93/02269 ;,~-;
.;`, 1-, , ,,,. 1.
on the domed end where the domed end meets an adjacent cap, and the inside wall of the adjacent cap when nested thereto. In particular, the minor radius of the flattened dome may be from 60 to 80~ of the major transversely extending radius (i.e. in the direction transverse to the longitudinal axis of the tubular open end portion). The flattened dome may be substantially hemi-ovoid in shape or it may be a slmilar non-geometrically defined shape.
Thus, the terms "radius" and "diameter" as used herein are~;
not used in a strict geometrical sense but in a general sense.
Another aspect of the invention relates to a capsule comprising the cap fitted to a capsule body. In a preferred arrangement, the capsule body has a reduced ~-diameter neck regior. adjacent the open mouth of the body, and the cap nas an inwardly extending ridge between the tubula, open end portion and the domed portion, the ridge ;
being engaged within the -eck region of the body to lock the cap to the body.
A further aspect of the invention provides a method of filling the capsule, which comprises, ~i) providing a supply of the caps and a separate su~ly of capsule bodies;
(ii) fee~ing a body to a filling location and introducing a unit dose of phar~a~eutically. ~ ,~
actlve material into the body; and (iii) closing the capsule by fitting a cap over an open end of the capsule. -W094/09744 PCT/GB93/022~9 ~ ~
2~ 36 "~
.. i. .. .
The method may rurther comprise the step of -~
introducing a plug of a water swellable material into~a neck of the l^illed capsule body prior to fitting the cap thereto. Preferably the capsule body has a flared outwardly extending open mouth and the cap has inwardly extending protrusions, and the methcd comprises the further step of pressing the cap onto the body such that the inwardly extending protrusions clip over the flared -.
mouth of the body to lock the cap in~place on the body.
The present invention is particularly applicable to a : .
controlled release capsule which c_mprises a male plug engaged ~ithin a neck portion of a female k-iy; the male ,-.
plug belng substantially cylindrical and formed from a ~-water-swellable mater.ial which swells so as to disengage .~
the female body upon exposure to an aqueous medium. The l~ :
water swellable material is preferably as disclosed W090/0916~. :
DETAILED DESCRIPTION OF PREFERRED EM~`DIMENTS
Embodiments of the present inYention will now be j ~-~
described by way of example only with reference to the drawings wherein;
Figure 1 is a cross sectional elevation oî a firs~ l-embodiment;
Figure 2 is a schematic elevation of a series of caps in the chute of a capsule filling machine; ~.
Figure 3 is an elevation of a second cap i ~
construction; and `~:
2,!L(s~ t5~ pCI'/C;1~93/02~6Y ~, ~ - 8 -Figure 4 is a part cross sectional elevation of a series of caps according to the second construction in a filling machine chute.
The capsule shown in Figure l comprises a male plug 2 formed of a hydrogel material inserted in neck 4 of female body 6. The capsule is closed with a cap 8. Typically, a -~
size "0" capsule size is employed.
The body 6 comprises a cylindrical maln portion 10 and closed end 12. The main body narrows to the neck portio.~ ~ which is substantlally cylindrical so as to receive the male plug 2 with a close tolerance. The neck portion then flares out to a flared mouth portion 14 of a diameter substantially the same as the diameter of the ;~
main body portion 10. ~-The cap 8 comprises a tubular (substantially cylindrical) open end portion 20 having a mouth 22, and at its inner end a ridge 18 or series of detents for locking the cap onto the body and a stop ring 2~ for locating the cap on the body. The cap has a domed closed end 26 which is flattened relative to a hemisphere. In the embodiments shown, the upstanding radius (along the longitudinal axis of the -ubular open end portion) is approximately 70% of ' -~
the transverse radial direction. This flattening helps avoid jamming of th~ nested caps by increasing the angle between the dome and the mouth of an adjacent cap when , nested thereto. The cap wall thickness is substantially 250 microns.
W094tO9744 ~1 4 ~ PCT~GB93/02269 ',`!,'", 9 _ ' In the embodiments shown, the domed portion extends `~
outwardly slightly beyond the tubular open end portion.
I'he male plug 2 is formed of a hydrogel material (such as disclosed ~n WO 9C/09168) and is usually inserted so that the upper end of the plug is level with or below the upper end of the capsule body.
The cap is ~ormed of a water soluble ma~erial, such as gelatin. The capsule body is formed of a water i~-insoluble material, which may be a water insoluble ~;
plastics material or may be ~elatin coated with a f water-impermeable coating.
The capsule body i5 formed in conventional manner by dipping a mould pin into a gelatin solution and allowing to dry. The gelatin is then coated with a ~-water-impermeable coati-.g (e.g. by dip-coating) after the capsule body is stripped from ~he mould pin and trimmed ~o j~
size. ~l_ernatively, the water-impermeable coa-~g may ^- ~-applie~ by spray coatlng or vapour deposit~_n o~.-o the ;, capsule body. ;~
The walls of the female body may be formed from a wide varietv of materials. They may be of homogenous 3 ;.
construc~ions or they may be laminated. Examples of mater~ls suitable for use in the construction of the body include polyethylene, polypropylene, poly(methylmethacrylate), polyvinyl chloride, polystyrene, polyurethanes, polytetrafluoroethylene, nylons, polyformaldehydes, polyesters, oellulose aceiate ~nd nitro cellulose.
W094/097~ PCT/GB93/0226~ ~
Z ~ 5 ~; - 10 However, a ~-eferred construction uses an impermeable coating to cover the exterior of a body which has been formed fxom a water soluble material. The coating may conveniently be formed by dippin~ the body in a solution ---of a material which forms a layer which is impermeable to water. Alternatively, the hody might be spray-coated. A ;~
preferred class of capsule bodies are conventional hard gelatin or starch capsule bodies coated with a solution of polyvinyl chlorlde or a polyvinyl acetate copolymer or an ethyl cellulose solution.
Figure , shows three nested caps 8 travelling down a delivery chute 30 in a filling machine, prior to being fitted onto the capsule body. During assembly, the capsule body is first filled with pharmaceutically active material. Then, the hydrogel plug is positioned in the neck c~ the body and inserted into the body 50 as to be -;~
locat~ correctly (usually either flush with the top or the bcdy or slightly recessed). Finally, the cap is fitted over the mouth of the capsule body to fo~m the assembled capsule as shown in Figure 1.
Figure 3 shows a second embodiment which is generally similar to the first embodiment, analo~ous parts being labelled with the same reference numerals, but with the addition of a further ring 28 adjacent the open mouth 22 of the open ended portion 20 of the cap. As can be seen in Figure 4, this help~ further assist prevention of ja~-ng together of the nested caps in the filling chute.
'` ' W094/09744 ~ PCT/GB93/02269 ,~
- 11 - i The ring 28 locates at the lower end of the neck 4 (see Figure 1) when the cap is fitted onto the body.
Depending on the intended application, the cap may be enteric coated to prevent dissolution in the stomach. In ;~
the higher pH of the intestine the enteric coating dissolves exposing the water soluble cap, which in turn ;
dissolves in the aqueous medium. The enteric coating may be any coating material known in the art, such as those disclosed in WO 90/09168.
As used herein, the term enteric coating includes all coatings (whether pH dependent or not) which are able to pass through the stomach and dissolve in the intestine.
This includes coating materials, such as fats, which dissolve preferentially under the enzymatic regime prevailing in the intestine.
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Claims (13)
1. A cap for fitting to a body of a capsule, the cap (8) having a tubular open end portion (20) for engaging the capsule body and a domed closed end portion (26);
the domed closed end portion having an external diameter greater than the internal diameter of the mouth (22) of the tubular open end portion; and wherein the domed closed end portion is flattened, such as to be non-hemispherical, and have a major radius extending substantially transversely to a longitudinal axis of the tubular open end portion, and a minor radius extending substantially along said longitudinal axis; such as to substantially avoid interlocking of nested caps.
the domed closed end portion having an external diameter greater than the internal diameter of the mouth (22) of the tubular open end portion; and wherein the domed closed end portion is flattened, such as to be non-hemispherical, and have a major radius extending substantially transversely to a longitudinal axis of the tubular open end portion, and a minor radius extending substantially along said longitudinal axis; such as to substantially avoid interlocking of nested caps.
2. A cap according to claim 1, wherein the minor radius of the flattened dome is from 60 to 80% of the major transversely extending radius.
3. A cap according to any preceding claim wherein the transverse external diameter of the domed end portion exceeds the transverse external diameter of the tubular open end portion.
4. A cap according to either of claims 1 and 2 wherein the transverse external radius of the domed end portion is less than the external radius of the mouth of the tubular open end portion by no more than 250 microns.
5. A cap according to any preceding claim wherein the wall thickness of the tubular open end portion is at least 200 microns.
6. A cap according to any preceding claim which further comprises an inwardly extending protrusion or protrusions (28) adjacent the mouth of the tubular open end portion.
7. A cap according to claim 6 wherein the protrusion is in the form of a continuous inwardly extending ring (28).
8. A capsule which comprises a cap according to any preceding claim, fitted to a capsule body (6).
9. A capsule according to claim 8 wherein the capsule body has a reduced diameter neck region (4) adjacent the open mouth (14) of the body, and the cap has an inwardly extending ridge (18) between the tubular open end portion and the domed portion, the ridge being engaged within the necked region of the body to lock the cap to the body.
10. A capsule according to claims 9, 8, 7 and 6 wherein the protrusion(s) (28) adjacent the mouth of the tubular open end portion is/are also engaged within the neck region (4) of the body.
11. A capsule according to claim 9 or 10 which further comprises a plug (2) of a water-swellable material inserted in the neck region (4) of the capsule body.
12. A method of filling a capsule according to claim 8, which comprises;
(i) providing a supply of said caps and a separate supply of said capsule bodies;
(ii) feeding a body to a filling location and introducing a unit dose of pharmaceutically active material into the body; and (iii) closing the capsule by fitting a cap over an open end of the capsule.
(i) providing a supply of said caps and a separate supply of said capsule bodies;
(ii) feeding a body to a filling location and introducing a unit dose of pharmaceutically active material into the body; and (iii) closing the capsule by fitting a cap over an open end of the capsule.
13. A method according to claim 12 which comprises the further step of inserting a plug of a water-swellable material into the neck region of the capsule body, prior to fitting of the cap.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB9223148.9 | 1992-11-05 | ||
| GB929223148A GB9223148D0 (en) | 1992-11-05 | 1992-11-05 | Capsule cap |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2148456A1 true CA2148456A1 (en) | 1994-05-11 |
Family
ID=10724556
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002148456A Abandoned CA2148456A1 (en) | 1992-11-05 | 1993-11-04 | Capsule cap |
Country Status (7)
| Country | Link |
|---|---|
| EP (1) | EP0692956A1 (en) |
| JP (1) | JPH08505370A (en) |
| KR (1) | KR950703924A (en) |
| AU (1) | AU5426094A (en) |
| CA (1) | CA2148456A1 (en) |
| GB (1) | GB9223148D0 (en) |
| WO (1) | WO1994009744A1 (en) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3823843A (en) * | 1972-10-26 | 1974-07-16 | Lilly Co Eli | Locking capsule |
| US4487327A (en) * | 1982-12-21 | 1984-12-11 | Grayson Robert E | Locking capsule |
| US4667498A (en) * | 1984-06-29 | 1987-05-26 | Sauter Manufacturing Corp. | Method and apparatus of making gelatine capsule forming pins having a rounded locking groove |
| ES2043270T3 (en) * | 1989-02-16 | 1993-12-16 | British Tech Group | DISTRIBUTOR DEVICE. |
-
1992
- 1992-11-05 GB GB929223148A patent/GB9223148D0/en active Pending
-
1993
- 1993-11-04 EP EP93924694A patent/EP0692956A1/en not_active Withdrawn
- 1993-11-04 KR KR1019950701788A patent/KR950703924A/en not_active Application Discontinuation
- 1993-11-04 CA CA002148456A patent/CA2148456A1/en not_active Abandoned
- 1993-11-04 WO PCT/GB1993/002269 patent/WO1994009744A1/en not_active Application Discontinuation
- 1993-11-04 AU AU54260/94A patent/AU5426094A/en not_active Abandoned
- 1993-11-04 JP JP6510855A patent/JPH08505370A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| GB9223148D0 (en) | 1992-12-16 |
| WO1994009744A1 (en) | 1994-05-11 |
| AU5426094A (en) | 1994-05-24 |
| JPH08505370A (en) | 1996-06-11 |
| EP0692956A1 (en) | 1996-01-24 |
| KR950703924A (en) | 1995-11-17 |
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Legal Events
| Date | Code | Title | Description |
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| FZDE | Dead |