[go: up one dir, main page]

EP0692956A1 - Capuchon de capsule - Google Patents

Capuchon de capsule

Info

Publication number
EP0692956A1
EP0692956A1 EP93924694A EP93924694A EP0692956A1 EP 0692956 A1 EP0692956 A1 EP 0692956A1 EP 93924694 A EP93924694 A EP 93924694A EP 93924694 A EP93924694 A EP 93924694A EP 0692956 A1 EP0692956 A1 EP 0692956A1
Authority
EP
European Patent Office
Prior art keywords
capsule
end portion
cap
open end
mouth
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.)
Withdrawn
Application number
EP93924694A
Other languages
German (de)
English (en)
Inventor
Howard Norman Ernest Stevens
James Leonard Mackie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Catalent Pharma Solutions Inc
Original Assignee
Catalent Pharma Solutions Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Catalent Pharma Solutions Inc filed Critical Catalent Pharma Solutions Inc
Publication of EP0692956A1 publication Critical patent/EP0692956A1/fr
Withdrawn legal-status Critical Current

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

Definitions

  • the present invention relates to a cap for fitting to the body of a capsule for containing a pharmaceutically active material.
  • the cap is for use with a controlled release capsule construction which comprises a male plug engaged within a neck of a female body; the male plug being formed of a water-swellable material which swells so as to disengage the female body upon exposure to an aqueous medium.
  • WO 90/09168 discloses a capsule of this type which comprises a water swellable male plug engaged within a female body.
  • the male hydrogel plug swells and eventually disengages itself from the female body, thereby allowing the pharmaceutically active material contained within the capsule to be released. It has been found that the time taken to release the pharmaceutical materi ⁇ .1 is predictable and reproducible, so that the device may be used to release pharmaceutically active material within the body of a patient after a predetermined time interval.
  • This may, for example, be useful in the treatment of medical 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 provide a desired level of the drug in the patient in accordance with his needs, for example during the night or when he awakes. 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.
  • European Patent Specification 246804 also discloses a capsule body having a groove near its mouth for the purposes of preventing the capsule distorting from its cylindrical form, which may cause difficulty in fitting the cap onto the capsule body.
  • the caper is about 0.012 inch (304 microns) , that is to say the radius at the upper end of the frustro-conical section adjacent the hemispherical end is 0.012 inch less than the radius at the open end of the cap.
  • this taper may be sufficient to allow the hemispherical end of one cap to get jammed inside the open end of ar. adjacent cap.
  • the present invention provides a cap for fitting to a body 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 diameter of the tubular open end portion, such as to substantially avoid interlocking of nested caps.
  • this may be achieved in one of a number of way ⁇ ; or some or all of them in combination.
  • the taper of the cap can be reduced compared to conventional caps.
  • the wall thickness of the cap can be increased.
  • an inwardly extending protrusion or protrusions may be provided adjacent the mouth ⁇ f the open end portion.
  • 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.
  • this taper is of the order of 300 microns.
  • 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.
  • the wall thickness may be increased.
  • the wall thickness In order to increase the difference between the internal diameter of the mouth of the tubular open end portion and the external diameter of the domed portion, it is preferred to increase the wall thickness (over that conventionally used) such that the 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).
  • an inwardly extending protrusion or protrusions may be provided adjacent the mouth of the open end portion, such as to further minimise any tendency to nesting and jamming.
  • the protrusions may be individual protrusions or the protrusions may together form a continuous inwardly extending ridge.
  • -he 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 of the open end portion, usually by up to 5% of the diameter.
  • 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 on the domed end where the domed end meets an adjacent cap, and the inside wall of the adjacent cap when nested thereto.
  • 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 similar non-geometrically defined shape.
  • the terms "radius” and "diameter” as used herein are not used in a strict geometrical sense but in a general sense.
  • a capsule comprising the cap fitted to a capsule body.
  • the capsule body has a reduced diameter neck region adjacent the open mouth of the body, and the cap has an inwardly extending ridge between the tubular open end portion and the domed portion, the ridge being engaged within the ⁇ . ⁇ c 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;
  • the method may further comprise the step of introducing a plug of a water swellable material into a neck of the filled capsule body prior to fitting the cap thereto.
  • the capsule body has a flared outwardly extending open mouth and the cap has inwardly extending protrusions
  • the method 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 comprises a male plug engaged within a neck portion of a female bc y; the male plug being substantially cylindrical and formed from a water-swellable material which swells so as to disengage the female body upon exposure to an aqueous medium.
  • the water swellable material is preferably as disclosed i -. W090/09168.
  • Figure 1 is a cross sectional elevation of a first 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 construction; and 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 1 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.
  • a size "0" capsule size is employed.
  • the body 6 comprises a cylindrical main portion 10 and closed end 12.
  • the main body narrows to the neck portion 4 which is substantially 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 24 for locating the cap on the body.
  • the cap has a domed closed end 26 which is flattened relative to a hemisphere.
  • the upstanding radius (along the longitudinal axis of the tubular open end portion) is approximately 70% of the transverse radial direction. This flattening helps avoid jamming of the 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.
  • the domed portion extends outwardly slightly beyond the tubular open end portion.
  • the male plug 2 is formed of a hydrogel material (such as disclosed in WO 90/09168) 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 formed of a water soluble material, such as gelatin.
  • the capsule body is formed of a water insoluble material, which may be a water insoluble plastics material or may be gelatin coated with a water-impermeable coating.
  • the capsule body is 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 coatir.g (e.g. by dip-coating) after the capsule body is stripped from the mould pin and trimmed to size.
  • the water-impermeable coating may JC3 applied by spray coating or vapour deposition onto the capsule body.
  • the walls of the female body may be formed from a wide variety of materials. They may be of homogenous constructions or they may be laminated. Examples of materials suitable for use in the construction of the body include polyethylene, polypropylene, poly(methylmethacrylate) , polyvinyl chloride, polystyrene, polyurethanes, polytetrafluoroethylene, nylons, polyformaldehydes, polyesters, cellulose acetate and nitro cellulose.
  • a preferred construction uses an impermeable coating to cover the exterior of a body which has been formed from a water soluble material. The coating may conveniently be formed by dipping the body in a solution of a material which forms a layer which is impermeable to water.
  • the body might be spray-coated.
  • a preferred class of capsule bodies are conventional hard gelatin or starch capsule bodies coated with a solution of polyvinyl chloride or a polyvinyl acetate copolymer or an ethyl cellulose solution.
  • Figure 2 shows three nested caps 8 travelling down a delivery chute 30 in a filling machine, prior to being fitted onto the capsule body.
  • the capsule body is first filled with pharmaceutically active material.
  • the hydrogel plug is positioned in the neck cf the body and inserted into the body so as to be locate! correctly (usually either flush with the top of the body or slightly recessed) .
  • the cap is fitted over the mouth of the capsule body to form the assembled capsule as shown in Figure 1.
  • Figure 3 shows a second embodiment which is generally similar to the first embodiment, analogous 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 helps further assist prevention of jamming together of the nested caps in the filling chute.
  • the ring 28 locates at the lower end of the neck 4 (see Figure 1) when the cap is fitted onto the body.
  • the cap may be enteric coated to prevent dissolution in the stomach.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)

Abstract

Capuchon (8) destiné à être fixé sur le corps (6) d'une capsule distribuant une dose d'une matière pharmaceutiquement active, comprenant une partie (20) d'extrémité tubulaire ouverte et une partie (26) d'extrémité fermée en forme de dôme. Pour empêcher les capuchons de se bloquer les uns dans les autres lors de l'introduction dans une machine de remplissage de capsules, le diamètre externe de la partie d'extrémité en forme de dôme est supérieur au diamètre interne de l'ouverture (22) de la partie d'extrémité tubulaire ouverte. La conicité du capuchon peut être réduite par rapport aux capuchons classiques et l'épaisseur de la paroi peut être augmentée. Une bague (28) s'étendant à l'intérieur peut être prévue près de l'ouverture de la partie tubulaire. La partie d'extrémité en forme de dôme est de préférence aplatie et non hémisphérique.
EP93924694A 1992-11-05 1993-11-04 Capuchon de capsule Withdrawn EP0692956A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB929223148A GB9223148D0 (en) 1992-11-05 1992-11-05 Capsule cap
GB9223148 1992-11-05
PCT/GB1993/002269 WO1994009744A1 (fr) 1992-11-05 1993-11-04 Capuchon de capsule

Publications (1)

Publication Number Publication Date
EP0692956A1 true EP0692956A1 (fr) 1996-01-24

Family

ID=10724556

Family Applications (1)

Application Number Title Priority Date Filing Date
EP93924694A Withdrawn EP0692956A1 (fr) 1992-11-05 1993-11-04 Capuchon de capsule

Country Status (7)

Country Link
EP (1) EP0692956A1 (fr)
JP (1) JPH08505370A (fr)
KR (1) KR950703924A (fr)
AU (1) AU5426094A (fr)
CA (1) CA2148456A1 (fr)
GB (1) GB9223148D0 (fr)
WO (1) WO1994009744A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119174704A (zh) * 2024-11-26 2024-12-24 宁波佳康生物科技有限公司 一种胶囊智能生产设备

Family Cites Families (4)

* Cited by examiner, † Cited by third party
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
GB2230442B (en) * 1989-02-16 1992-11-25 Nat Res Dev Controlled release device

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
DE-A- 2 232 236 *
FR-A- 2 204 541 *
See also references of WO9409744A1 *
US-A- 4 487 327 *
US-A- 4 667 498 *
WO-A-90/09168 *

Also Published As

Publication number Publication date
GB9223148D0 (en) 1992-12-16
KR950703924A (ko) 1995-11-17
CA2148456A1 (fr) 1994-05-11
JPH08505370A (ja) 1996-06-11
WO1994009744A1 (fr) 1994-05-11
AU5426094A (en) 1994-05-24

Similar Documents

Publication Publication Date Title
EP0768859B1 (fr) Dispositif a liberation regulee
AU674715B2 (en) Capsule construction
WO1994009743A1 (fr) Capsule a event
JP2552647B2 (ja) 密封カプセル
EP1457431A2 (fr) Contenants solubles dans l'eau moules par injection
EP0572942B2 (fr) Préparations pharmaceutiques orales à délivrance spécifique dans le colon
US20190076353A1 (en) Process for making controlled release medical implant and non-implant products
AU672754B2 (en) Methods for making and administering a blinded oral dosage form and blinded oral dosage form therefor
KR101235951B1 (ko) 통기구를 구비한 개선된 캡슐
IE64761B1 (en) Dispensing device
PL197867B1 (pl) Formowany wtryskowo, rozpuszczalny w wodzie pojemnik
EP0692956A1 (fr) Capuchon de capsule
GB2283912A (en) Enteric coated capsule
AU734740B2 (en) Improvements in or relating to capsules
JP3566291B2 (ja) 薬液容器における改良
AU739031B2 (en) Pharmaceutical dosage form for colonic delivery
AU2005202337A1 (en) Injection-moulded water-soluble container

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 19950425

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IE IT LI LU MC NL PT SE

17Q First examination report despatched

Effective date: 19960401

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Withdrawal date: 19961107