EP0587957A1 - Emballage pour suppositoires - Google Patents

Emballage pour suppositoires Download PDF

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Publication number
EP0587957A1
EP0587957A1 EP92810703A EP92810703A EP0587957A1 EP 0587957 A1 EP0587957 A1 EP 0587957A1 EP 92810703 A EP92810703 A EP 92810703A EP 92810703 A EP92810703 A EP 92810703A EP 0587957 A1 EP0587957 A1 EP 0587957A1
Authority
EP
European Patent Office
Prior art keywords
approximately
cavity
packaging
packaging according
edge
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Withdrawn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
EP92810703A
Other languages
German (de)
English (en)
Inventor
Giovanni Dr. Bonavia
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.)
Novartis AG
Original Assignee
Ciba Geigy AG
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 Ciba Geigy AG filed Critical Ciba Geigy AG
Priority to EP92810703A priority Critical patent/EP0587957A1/fr
Publication of EP0587957A1 publication Critical patent/EP0587957A1/fr
Withdrawn legal-status Critical Current

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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
    • A61J3/08—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of suppositories or sticks
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/321—Both sheets being recessed
    • B65D75/323—Both sheets being recessed and forming several compartments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments

Definitions

  • the invention relates to packaging for suppositories according to the preamble of patent claim 1.
  • Suppositories or suppositories are shaped preparations which are usually essentially torpedo-shaped, conical or cylindrical in appearance for the rectal or vaginal administration of one or more active substances. For the most part, they consist of a suppository mass, in which one or more mostly powdered active ingredients are embedded. Semisynthetic fats are usually used as the suppository mass, more rarely also water-soluble masses, for example mixtures of polyethylene glycols.
  • the advantage of suppositories is, among other things, that many active ingredients are absorbed from them to approximately the same extent as from an oral dosage form, but the plasma level curve is often flatter and lower maximum plasma values are achieved. In addition, suppositories often have a prolonged effect compared to conventional oral dosage forms. The digestive tract is spared and the problems that many people have with swallowing tablets or capsules, for example, are completely avoided.
  • the suppositories are usually manufactured using a molding and casting process. Pressing and casting processes are also used less frequently.
  • the casting process uses metal molds, preformed plastic films or machines in which the films are drawn into molds.
  • the preformed suppositories are placed in a so-called primary packaging and sealed airtight. Suppositories are produced particularly advantageously by first pre-deforming the primary packaging and pouring the suppositories directly into the primary packaging. The primary packaging is then sealed airtight. In this way a disadvantage of the preformed suppositories is avoided; these show a relatively low melting point of approximately 32 ° C to approximately 38 ° C depending on the application, can therefore deform easily at elevated temperatures and often cannot be applied as desired after cooling.
  • the primary packaging which also serves as casting molds, has an oblong shape with an approximately circular cross-section.
  • they comprise two half-shells made of coated plastic or plastic-aluminum laminate, which are welded or in love at the edges.
  • the cross section of the mold cavity of each half shell is approximately semicircular.
  • the materials of the two half-shells are usually identical and have approximately the same wall thickness and rigidity.
  • Opening these primary packaging often requires special skill or even the use of tools such as scissors or knives.
  • At the ends of the packaging there are usually only short pieces of material that are difficult to grasp.
  • the pulling off one arched half-shell from the other is also associated with considerable effort. So far, attempts have been made to reduce the effort required and ensure correct opening by attaching tear lines, but it can happen that a suppository is jerked out of the packaging and falls onto the floor.
  • One approach to eliminating this problem is to specifically enlarge the grip area at one end of the primary packaging. In this way, the two half-shells can be gripped better, for example those with rheumatism can also grip the packaging better.
  • greater effort is required to separate the two half-shells at the handle ends of the primary packaging than later when separating along the longitudinal edges.
  • the packaging is oversized due to the enlargement of the grip area.
  • the opening of the primary packaging should also be easy, for example for people with rheumatism, without the use of aids be feasible.
  • a jerky opening process in which a suppository located in the packaging could be ejected should be avoided.
  • the primary packaging should allow the suppositories to be produced by pouring them directly into the packaging.
  • the shape cavity in the packaging is intended to ensure that the suppository is as ergonomic as possible, which on the one hand allows the suppository to be easily removed from the packaging and on the other hand facilitates its handling and administration, for example also with protective gloves.
  • the shape of the suppositories defined by the primary packaging should make it possible to simply divide them in the longitudinal direction if required, if a lower dose of an active ingredient or an active ingredient mixture is required.
  • the materials that are used for the primary packaging should be as homogeneous as possible in order to allow easy recycling and thus the disposal by the customer or patient can be carried out as environmentally friendly as possible.
  • FIGS. 1 and 4 show four examples of the shape of suppositories S *.
  • the shapes in FIGS. 1 and 2 are referred to as torpedo-shaped.
  • the shape in FIG. 3 is essentially conical, while the shape shown in FIG. 4 is referred to as cylindrical. All four of the shapes shown, for example, have the essentially oblong shape in common.
  • the suppositories S * previously known from the prior art have an essentially rotationally symmetrical and in particular circular cross section (not shown). It is understood that such suppositories S * can only be divided very inaccurately either along their longitudinal extension or transversely thereto if smaller amounts of active substance are required. In addition, because of their essentially rotationally symmetrical shape, the suppositories S * are often difficult to handle, especially for patients suffering from rheumatism.
  • FIG. 5 shows a number of suppository packs P * of the prior art which are combined into a strip.
  • the individual packages each comprising two preformed half-shells of approximately semicircular cross-section and welded and / or glued to one another, are separated by a gap G, which is a result of the manufacturing process.
  • predetermined breaking points are provided in the form of tear lines L, which open the packs P *, which is relatively due to the bulged shape of the half-shells requires great effort, should facilitate.
  • the packaging P comprises a container part 1 and a cover part 2.
  • the container part 1 and the cover part 2 in the assembled state, delimit a cavity 3 for receiving a suppository mass S.
  • the container part 1 and the cover part 2 are together welded and / or glued such that the cavity 3 is sealed airtight. However, this ensures that the two parts 1, 2 can be detached from one another again by applying a tensile force.
  • the container part 1 and the lid part 2 are welded and / or glued to one another along a sealing seam 5, which runs along the edge 4 of the cavity 3.
  • the sealing seam 5 has a width w which is smaller than a distance x of the edge 4 of the cavity 3 from the edge of the container part 1.
  • the container part 1 and the cover part 2 are therefore not sealed to one another on their entire contact surfaces, but only on one relatively narrow area that runs along the edge 4 of the cavity. In this way, the required tensile force for releasing the lid part 2 from the container part 1 is significantly reduced and an airtight seal of the cavity 3 is nevertheless ensured.
  • the gluing and / or welding only along the edge of the cavity 3 also ensures that the packaging P is opened by detaching the lid part 2 from the container part 1 and does not tear open at an undefined point.
  • the sealing seam 5 preferably comprises a front and a rear section 6, 7.
  • the front section 6 extends along the edge of the front, preferably approximately tapering region of the cavity 3 and over approximately half to three quarters, preferably two thirds, of the length 1 of the cavity 3.
  • the rear section 7 connects directly to the front section 6 and extends over the remaining edge region of the cavity 3.
  • the division of the sealing seam 5 into two sections 6, 7 allows the widths a and b of the Select sections 6 and 7 differently. This has the advantage that the required tensile force for releasing the lid part 2 from the container part 1 can be controlled in such a way that initially a relatively small tensile force is required, which increases slightly, but then remains constant until the packaging P to a desired extent is open.
  • the ratio of the width a of the front section 6 of the sealing seam 5 to the width b of the rear section 7 of the sealing seam 5 in the connection region of the two sections is preferably from approximately 1: 1 to approximately 1: 8.
  • the width a of the front section 6 of the sealing seam 5 is from approximately 0.5 mm to approximately 4 mm and is essentially constant over the course of the front section 6.
  • the width a can be at the edge of the front tapered area of the cavity 3 may initially be chosen somewhat larger. In this way it is achieved that at the beginning of the opening a certain tension threshold must be exceeded. The required tensile force then decreases again to a lower value and remains constant up to the transition region into the rear section 7 of the sealing seam 5, the width b of which is preferably a maximum of approximately 8 mm.
  • the container part 1 and the lid part 2 are each formed by a half-shell.
  • the half-shells have approximately the same wall thickness t.
  • each half-shell is preferably from approximately 70 ⁇ m to approximately 200 ⁇ m.
  • FIGS. 8 and 9 A further exemplary embodiment of the packaging P according to the invention is shown in FIGS. 8 and 9.
  • the container part 1 is a half-shell with an approximately semicircular cross-section, while the cover part 2 is an essentially flat and flexible cover film.
  • the wall thickness t of the half-shell 1 is greater than the wall thickness s of the cover film 2 and is approximately twice to approximately ten times the wall thickness s of the cover film 2.
  • the wall thickness s of the cover film 2 is from approximately 20 ⁇ m to approximately 100 ⁇ m while the Wall thickness t of the half-shell 1, as before, is a maximum of approximately 200 ⁇ m.
  • the cavity 3 forms the casting cavity for the suppositories S to be produced and essentially defines their shape.
  • suppositories S are produced in this way, which although they still have the known oblong shape (FIGS. 1 to 4), but have an essentially semicircular cross section. Designed in this way, the suppositories S are far easier to grip and have an ergonomic shape. They can now be easily handled by both healthy patients and, for example, rheumatic patients with crippled hands.
  • the largely asymmetrical cross section of the suppositories S significantly reduces the risk of the suppository S sliding out of the hands.
  • the flat top of the suppository S can be used as Support surface can be used if the suppository S is intended to be divided lengthways. This defined contact surface makes it very easy to divide, for example with the help of a knife.
  • the torpedo shape of the suppository is essentially not changed.
  • cover part 2 is formed by an essentially planar flexible film also makes it easier to open the packaging P. It is evident that the effort required to pull off the cover film 2 from the half-shell-shaped container part 1 is significantly less than with the semi-circular bulged and preformed half-shells of the packaging P. Another advantage of the essentially planar cover film 2 is that it is now can be used very well as a carrier for information to the patient. Since it is essentially flat, these can be read off easily, which is difficult with the bulky form of the packaging P.
  • the cover part 2 preferably has a grip tab 8, the length c of which, measured from the sealing seam 5 to the longitudinal edge of the cover part 2, is from approximately 10 mm to approximately 45 mm. In this way, gripping the lid part 2 for opening the packaging P is made even easier.
  • the desire for simple recyclability of the materials from which the packaging P is made is preferably met by the container part 1 and the cover film 2 being made from recyclable materials.
  • Plastics such as polyvinyl chloride PVC, polypropylene PP, polyethylene PE, polyethylene terephthalate PET or polyamide PA are preferably used. These plastics can be present as monofilms or as combinations (laminates, coextruded foils, etc.) of various plastics.
  • the greater flexibility of the cover film 2 has the advantage that it allows the cavity 3 to be filled to different extents, for example in the direct casting process.
  • cover film 2 also makes it possible to take into account the loss of material when the filled-in suppository mass cools down by pouring in a little more material.
  • the volume of the suppository mass and the finished suppository S decrease in turn has the approximately semicircular cross-sectional area, which is predetermined by the shape of the cavity 3.
  • a number of individual packagings P are combined to form a strip M.
  • a number of half-shells 1 are preferably deep-drawn in a first material strip 10.
  • the cover foils 2 of the individual packs P are sections of a second material strip 20.
  • Perforation lines R are provided between the individual packs P, which facilitate the tearing off of individual packaged suppositories S.
  • 11 finally shows two suppository strips M according to the embodiment shown in FIGS. 8 and 9 in a secondary packaging 9, which is preferably a folding box.
  • the semicircular cross-sectional shape of the suppositories in packaging P allows particularly space-saving packaging.
  • an insert text L is also indicated in the secondary packaging.
  • the packaging according to the invention for soup stalls allows simple handling and requires only little effort to open, so that patients with more or less crippled fingers can safely remove suppositories.
  • the suppository produced in the primary packaging as a casting mold has an essentially asymmetrical shape and is even easy to handle with gloves. If necessary, the suppository manufactured in this way can simply be divided lengthways.
  • the production of the packaging and the filling of the suppository masses is possible with the usual technical equipment. Due to the special design of the packaging with only one preferably deep-drawn half-shell and a flat cover film, the manufacturing process is even simplified.
  • the flat cover film can be printed "on-line" during the manufacturing process of the suppositories.

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  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
EP92810703A 1992-09-14 1992-09-14 Emballage pour suppositoires Withdrawn EP0587957A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP92810703A EP0587957A1 (fr) 1992-09-14 1992-09-14 Emballage pour suppositoires

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP92810703A EP0587957A1 (fr) 1992-09-14 1992-09-14 Emballage pour suppositoires

Publications (1)

Publication Number Publication Date
EP0587957A1 true EP0587957A1 (fr) 1994-03-23

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EP92810703A Withdrawn EP0587957A1 (fr) 1992-09-14 1992-09-14 Emballage pour suppositoires

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EP (1) EP0587957A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0703157A1 (fr) * 1994-08-23 1996-03-27 Alusuisse-Lonza Services AG Emballage du type blister
CN104968315A (zh) * 2012-10-19 2015-10-07 克里斯特科特公司 栓剂插入装置、栓剂和制造栓剂的方法
DE102015218217A1 (de) * 2015-09-22 2017-03-23 Henkel Ag & Co. Kgaa Blisterverpackung mit asymmetrischer Tablette sowie asymmetrische Tablette

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1067307A (fr) * 1954-06-15
US3078986A (en) * 1959-09-24 1963-02-26 Rich Hill Drug Co Inc Combination mold and dispenser
FR2056902A1 (fr) * 1969-07-19 1971-05-07 Pozzi Franco

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1067307A (fr) * 1954-06-15
US3078986A (en) * 1959-09-24 1963-02-26 Rich Hill Drug Co Inc Combination mold and dispenser
FR2056902A1 (fr) * 1969-07-19 1971-05-07 Pozzi Franco

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0703157A1 (fr) * 1994-08-23 1996-03-27 Alusuisse-Lonza Services AG Emballage du type blister
CN104968315A (zh) * 2012-10-19 2015-10-07 克里斯特科特公司 栓剂插入装置、栓剂和制造栓剂的方法
DE102015218217A1 (de) * 2015-09-22 2017-03-23 Henkel Ag & Co. Kgaa Blisterverpackung mit asymmetrischer Tablette sowie asymmetrische Tablette

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