EP2109570A1 - Emballage comprenant des capsules souples - Google Patents

Emballage comprenant des capsules souples

Info

Publication number
EP2109570A1
EP2109570A1 EP07856517A EP07856517A EP2109570A1 EP 2109570 A1 EP2109570 A1 EP 2109570A1 EP 07856517 A EP07856517 A EP 07856517A EP 07856517 A EP07856517 A EP 07856517A EP 2109570 A1 EP2109570 A1 EP 2109570A1
Authority
EP
European Patent Office
Prior art keywords
container
soft capsules
soft
absorbent
channel
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Withdrawn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
EP07856517A
Other languages
German (de)
English (en)
Inventor
Stefan Henke
Holger Peitz
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.)
Procter and Gamble Co
Original Assignee
Merck Patent GmbH
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 Merck Patent GmbH filed Critical Merck Patent GmbH
Priority to EP07856517A priority Critical patent/EP2109570A1/fr
Publication of EP2109570A1 publication Critical patent/EP2109570A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • 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
    • B65D2585/00—Containers, packaging elements or packages specially adapted for particular articles or materials
    • B65D2585/56—Containers, packaging elements or packages specially adapted for particular articles or materials for medicinal tablets or pills

Definitions

  • the invention relates to a package comprising a packaging material and soft capsules, a method for stabilizing soft capsules and a method for producing the package.
  • Soft capsules are capsules due to in the capsule shell additives contained in plasticizers such.
  • plasticizers such as glycerol, sorbitol, maltitol and polyethylene glycols have a certain elasticity and suppleness and for the administration of various substances such.
  • drugs nutritional supplements and / or functional ingredients are used.
  • Soft capsules can be prepared, for example, on gelatin or starch basis.
  • Gelatin-based soft capsules have long been known as soft gelatin capsules and are commercially available from various suppliers.
  • Soft capsules based on starch are a relatively new development, an example of which are soft capsules that are sold by Swiss Caps, Switzerland, under the trade name VegaGels ®.
  • soft capsules liquid or semi-solid substances are to be administered, these can be encapsulated directly, solids are previously in liquid or semi-solid bases, such as. As greases, oils, wax mixtures or polyethylene glycols, possibly dissolved or suspended in combination with emulsifiers. Depending on the application path, such. As oral, rectal or vaginal, soft capsules may have different shapes, they may, for. B. round, oval, oblong or torpedo-shaped. Soft capsules can be prepared by the methods known in the art, such as. Example by the Scherer method, the Accogel method or the dripping or blowing process.
  • the softening effect of the amount of plasticizer contained in the casings of soft capsules is based essentially on its hygroscopicity and the associated incorporation of water the capsule shell.
  • the object could surprisingly be achieved by the soft capsules was introduced into a packaging, in the réellewandung / s at least partially an absorbent and at least one channel former is embedded.
  • the invention thus relates to a package comprising a resealable container, in / at the inner wall / s at least part of at least a part Channel former is embedded together with at least one absorbent, and at least one soft capsule, wherein the soft capsule / s contained in the container is / are.
  • the introduction of the soft capsules leads to an increase in storage stability, although the container with an absorbent is an agent which has a drying effect.
  • For drying of soft capsules leads via dehydration just embrittlement and fragility of the capsule shell to cracking, so exactly to the state which is avoided by the invention.
  • the pack according to the invention contains soft gelatine capsules as soft capsules.
  • the subject of the invention is therefore a pack which is characterized in that the soft capsule (s) contained herein is / are a soft gelatin capsule (s).
  • the pack according to the invention contains starch-based soft capsules.
  • the invention therefore relates to a pack which is characterized in that the soft capsule (s) contained herein is / are starch-based soft capsule (s).
  • the container is resealable and can all forms of space, such. B. that of a cylinder or cuboid, provided that it is large enough to accommodate the soft capsules in itself.
  • Reclosable means that the container can be repeatedly, ie at least once, preferably several times, more preferably at least as often opened and closed again, as it corresponds to the number of soft capsules contained in the container.
  • the container is closed so tightly after each opening and closing process, that penetration of moisture and gases into the container interior is effectively prevented.
  • the container is opened and closed by a tight-fitting closure adapted to the container. It can be used all types of closures, as long as they ensure even after repeated opening and closing of the container that gases and / or moisture in the closed state can not or only in extremely small amounts penetrate into the container interior.
  • lids are used as the closure.
  • lids are screw caps, caps which are slipped over the top of the vessels, or inserted into the interior of the vessel.
  • caps which are slipped over the top of the vessels, or inserted into the interior of the vessel.
  • the corners of the opening and the matching lid can also be slightly rounded to increase the tightness of the container to gases and moisture.
  • the container has a cuboidal shape, rounded corners and is well stackable. Such an embodiment is shown by way of example in FIG.
  • the container comprises walls (2), the inwardly directed sides of which at least partially contain at least part of at least one channel former together with at least one absorbent, has rounded corners (7) and has a lid (1) as closure.
  • absorbents and channel formers contained in the container can either be contained directly in the inner wall (s) of the polymer forming the container or applied as a layer to the inner wall (s) of the container made of polymers.
  • absorbents and channel formers can be embedded in an inlay, which is introduced as an insert into the container, so that at least a part of the inner walls of the container are thereby lined.
  • Possible materials for the container are polymers.
  • Polymers which can be used in admixture with absorbent and channel former are in particular thermoplastics such as e.g. Polyolefins such as polyethylene and / or polypropylenes, polyisoprenes, polybutadienes, polybutenes, polysiloxanes, polyamides, ethylene-vinyl acetate copolymers, ethylene-methacrylate copolymers, polystyrenes, polyesters, polyanhydrides, polyacrylate nitriles, polysulfonates, polyester amides, polyacrylate esters, propylene maleic anhydride, polyethylene Maleic anhydride, polyethylene urethanes, polyethylene-ethylvinyl alcohols, polyethylene-nylon and / or polyurethanes.
  • the walls provided on their inner surface with absorbent and channeling agent have a polymer content of 10-90% by weight, based on the total weight of the mixture of polymer, channel
  • any type of desiccant d. H. moisture-binding binder, be included.
  • Three groups of desiccants can be considered:
  • the first group contains chemicals that form hydrates with water.
  • chemicals that form hydrates with water.
  • examples of such chemicals are anhydrous salts which tend to absorb water or moisture to form a stable hydrate. The moisture is bound and their release is prevented by a chemical reaction.
  • the second group of desiccants contains substances that are reactive.
  • the substances react with water or moisture by forming a new substance.
  • the newly formed materials are usually stable at low temperatures, which is reversible only with the use of high energy.
  • This type of desiccant is mainly used for drying solvents and as a water-absorbing material in polymers that yourself in a moisture-reduced state, used.
  • the third group of desiccants binds moisture through physical adsorption.
  • the desiccant contains particles with fine capillaries into which the moisture is drawn.
  • the pore size of the capillaries and their density in the drying agent determine the absorption properties.
  • desiccants are molecular sieves, silica gels, certain synthetic polymers, such as e.g. Such as those used in baby diapers and starches.
  • Desiccants of the third group are preferably contained in the container, since they are largely inert and insoluble in water. Particular preference is given to molecular sieves having a pore size of from 3 to 15 angstroms and / or silica gels having a pore size of 24 angstroms.
  • Suitable channeling agents are hydrophilic substances such.
  • polyglycols ethylvinyl, glycerol, polyvinyl alcohols, polyvinylpyrrolidone, vinylpyrrolidone, N-methylpyrrolidone, polysaccharides, saccharides and / or sugar alcohols.
  • polyglycols polyethylene glycol and / or polypropylene glycol are preferred.
  • saccharides e.g. Glucose, mannose, galactose and / or fructose.
  • Suitable sugar alcohols are e.g.
  • Mannitol Mannitol, sorbitol, hexitol, dulcitol, xylitol, ribitol and / or erythrol.
  • polysaccharides are meant e.g. Dextrins and / or hydrolyzed starch.
  • the channel formers In the inner walls equipped with absorbents and channel formers, the channel formers, based on the total weight of the mixture of polymer, channel former and absorbent, can have a proportion of 10 to 40% by weight.
  • Absorbents and channel formers are embedded in the inner wall (s) of the container over part of the area or over the whole area.
  • Partial area means that at least a portion of the entire surface of the container forming the inner wall (s) contains absorbent and channel-forming agent.
  • Whole-area means that the entire, the inner walls forming surface of the container contains absorbent and channel former.
  • absorbents and channel-forming agents are contained in at least 10%, preferably in at least 50%, particularly preferably in at least 90% of the inner walls.
  • Containers of polymers containing absorbent and channel former and which are suitable as a container for the package according to the invention are known in the art and z. As described in WO 97/32663 A1, EP 1000873 A2 and WO 03/086900 A1, EP 1421991 A1. Containers which can be used in the pack according to the invention are commercially available and are described, for example, by Capitol Specialty Plastics Inc., 2039 McMillan Street Auburn, Alabama, USA, under the trademark Activ-Vial or by Süd Chemie, Ostenrieder Str 15, 85368 Moosburg, Germany, under the brand name 2 AP Multipolymer.
  • the pack according to the invention is produced by filling the soft capsule into a resealable container, in which at least part of its inner wall is embedded with at least one channel former together with at least one absorbent, and the container is then closed.
  • the subject matter of the present invention is therefore also a process for the production of a package, which is characterized in that the soft capsule / s is spent in a resealable container, in / on its inner wall at least partially channeled together with at least one absorbent is embedded, and the container is then closed.
  • the pack according to the invention leads to an increase in the storage stability of the soft capsules contained herein.
  • the invention therefore also provides a process for increasing the storage stability of soft capsules, the characterized in that they are placed in a resealable container, in / on the inner wall / s at least part of the channel at least a channel former is embedded together with at least one absorbent, and the container is then closed.
  • the stabilizing effect of the pack according to the invention is based on the influence of the container on that in soft capsule / s, which can be made available thereby storage-stable. Achieving the effect according to the invention thus requires that the soft capsule / s is / are contained in the container, that is, the soft capsule / s and container are present together as a package.
  • the package of the invention leads in the package of the invention also to a stabilization of the active ingredients and / or auxiliaries contained in these, ie the entire formulation. This is especially true when the active ingredients and / or adjuvants contained are sensitive to moisture.
  • moisture-sensitive agents which are thus preferably contained in the soft capsules in the package are many pharmaceutical agents such as hormones or proteins, vitamins, cells, e.g. probiotic cultures.
  • Multivitamin soft capsules active ingredient composition and capsule shell as described below are separated into a thermoformed PVC 250 ⁇ m + 40 g / m 2 PVDC and sealed with aluminum foil (20 ⁇ m) or in a resealable container, in / on the inner wall / s at least part of the channel at least one channel former is embedded together with at least one absorbent, spent (type: M-3006-16 Activ-Vial), in the inner walls of a molecular sieve with a capacity of 1, 92 g is embedded.
  • spent type: M-3006-16 Activ-Vial
  • the blisters and containers containing the multivitamin soft capsules are stored at 40 0 C and 75% relative humidity (RH), outsourced after predetermined times, visually assessed in terms of their appearance and analyzed analytically with regard to the amounts of active ingredient contained.
  • RH relative humidity
  • composition of the soft capsule shell gelatin 209.76 mg, glycerol 85% 65.83 mg, sorbitol solution 70% 44.21 mg, black iron oxide 1.22 mg, red iron oxide 3.89 mg.
  • composition of the soft capsule shell gelatin 209.76 mg, glycerol 85% 65.83 mg, sorbitol solution 70% 44.21 mg, black iron oxide 1.22 mg, red iron oxide 3.89 mg.
  • Multivitamin soft capsules active ingredient composition and capsule shell as described below are in a resealable container, in / on the inner wall / s at least part of at least part of channel at least one channel former embedded with at least one absorbent, spent (Type: M-3006-16 Activ-Vial) , in whose inner walls a molecular sieve with a capacity of 1, 92 g is embedded.
  • the multivitamin soft capsules are stored at 30 0 C and 65% relative humidity (RH), outsourced after predetermined times, visually assessed in terms of their appearance and in terms of analyzed active ingredient levels.
  • RH relative humidity
  • composition of the soft capsule shell gelatin, glycerol 98-100%,

Landscapes

  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • General Preparation And Processing Of Foods (AREA)

Abstract

La présente invention concerne un emballage comprenant un moyen d'emballage et des capsules souples, un procédé de stabilisation de capsules souples et un procédé de réalisation de l'emballage.
EP07856517A 2007-01-20 2007-12-10 Emballage comprenant des capsules souples Withdrawn EP2109570A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07856517A EP2109570A1 (fr) 2007-01-20 2007-12-10 Emballage comprenant des capsules souples

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP07001257 2007-01-20
EP07856517A EP2109570A1 (fr) 2007-01-20 2007-12-10 Emballage comprenant des capsules souples
PCT/EP2007/010743 WO2008086852A1 (fr) 2007-01-20 2007-12-10 Emballage comprenant des capsules souples

Publications (1)

Publication Number Publication Date
EP2109570A1 true EP2109570A1 (fr) 2009-10-21

Family

ID=39259524

Family Applications (1)

Application Number Title Priority Date Filing Date
EP07856517A Withdrawn EP2109570A1 (fr) 2007-01-20 2007-12-10 Emballage comprenant des capsules souples

Country Status (13)

Country Link
US (1) US20100065444A1 (fr)
EP (1) EP2109570A1 (fr)
JP (1) JP2010516308A (fr)
KR (1) KR20090103950A (fr)
CN (1) CN101595046B (fr)
AU (1) AU2007344507B2 (fr)
BR (1) BRPI0720951A2 (fr)
CA (1) CA2675892A1 (fr)
CL (1) CL2008000141A1 (fr)
MX (1) MX2009007511A (fr)
RU (1) RU2470846C2 (fr)
WO (1) WO2008086852A1 (fr)
ZA (1) ZA200905771B (fr)

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CN102369147A (zh) * 2009-04-08 2012-03-07 日立化成工业株式会社 粘接膜包装体及其制造方法
JP5798735B2 (ja) * 2009-10-30 2015-10-21 興和株式会社 ロキソプロフェン含有医薬組成物
JP2011116750A (ja) * 2009-10-30 2011-06-16 Kowa Co ロキソプロフェン含有医薬組成物
JP5798734B2 (ja) * 2009-10-30 2015-10-21 興和株式会社 ロキソプロフェン含有医薬の組成物
JP2011132226A (ja) * 2009-11-27 2011-07-07 Kowa Co ロキソプロフェン含有医薬組成物及び該組成物を含む医薬製剤
US20120107395A1 (en) * 2010-11-01 2012-05-03 Viva Pharmaceutical Inc. Probiotic Soft Gel Compositions
GB201415862D0 (en) * 2014-09-08 2014-10-22 Ayanda Group As Process
CN111513331A (zh) * 2020-04-16 2020-08-11 仙乐健康科技股份有限公司 一种包含益生菌的产品
AU2023303004A1 (en) * 2022-07-06 2024-09-12 Csp Technologies, Inc. Secondary packaging configured to hold and/or prevent inadvertent actuation of a device for administering a drug

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Also Published As

Publication number Publication date
CA2675892A1 (fr) 2008-07-24
MX2009007511A (es) 2009-07-21
WO2008086852A1 (fr) 2008-07-24
US20100065444A1 (en) 2010-03-18
AU2007344507A1 (en) 2008-07-24
KR20090103950A (ko) 2009-10-01
ZA200905771B (en) 2010-05-26
JP2010516308A (ja) 2010-05-20
CN101595046B (zh) 2012-01-25
CL2008000141A1 (es) 2008-06-13
CN101595046A (zh) 2009-12-02
RU2470846C2 (ru) 2012-12-27
BRPI0720951A2 (pt) 2014-03-18
AU2007344507B2 (en) 2013-07-04
RU2009131447A (ru) 2011-02-27

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