CN101595046B - Packaging containing soft capsules - Google Patents

Packaging containing soft capsules Download PDF

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Publication number
CN101595046B
CN101595046B CN2007800501183A CN200780050118A CN101595046B CN 101595046 B CN101595046 B CN 101595046B CN 2007800501183 A CN2007800501183 A CN 2007800501183A CN 200780050118 A CN200780050118 A CN 200780050118A CN 101595046 B CN101595046 B CN 101595046B
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China
Prior art keywords
container
soft capsule
packing
absorbent
passage
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Expired - Fee Related
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CN2007800501183A
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Chinese (zh)
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CN101595046A (en
Inventor
S·亨克
H·拜茨
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Merck Patent GmbH
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Merck Patent GmbH
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D81/00Containers, 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
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26Adaptations 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D81/00Containers, 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
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26Adaptations 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
    • B65D81/266Adaptations 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D81/00Containers, 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
    • B65D81/24Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D2585/00Containers, packaging elements or packages specially adapted for particular articles or materials
    • B65D2585/56Containers, packaging elements or packages specially adapted for particular articles or materials for medicinal tablets or pills

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  • 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

The invention relates to a packaging containing a packing means and soft capsules, a method for stabilising soft capsules and a method for producing the packaging.

Description

The packing of soft capsule is housed
The present invention relates to a kind of packing of packing and soft capsule, a kind of method and a kind of method that is used to make said packing that is used for stabilising soft capsules of comprising.
Soft capsule is such capsule; It has certain elasticity and flexibility owing to the hand modifier that contains adding in capsule shells such as glycerine, sorbierite, maltitol and carbowax, and is used for the administration of different material such as medicine, food additives and/or functional components.Soft capsule can for example be made based on gelatin or starch.Soft capsule such as Perle based on gelatin are known very early, and are provided by different suppliers.Soft capsule based on starch is a kind of new relatively development, is the soft capsule of being sold with
Figure G2007800501183D00011
trade mark by Switzerland Swiss Caps to this instance.
If the mode of passing through soft capsule is to liquid or semi-solid material administration; This material is encapsulate directly; Solid matter at first is dissolved or suspended in liquid or semisolid matrix as in fat, oil, wax mixture or the carbowax, combines with emulsifying agent if possible.According to medication such as oral, rectally or vagina administration, soft capsule can have different shapes, and they for example can be circular, oval, oblong or torpedo shape.Soft capsule can pass through the methods known in the art manufacturing, as according to Scherer method, Accogel method or micro drop method or blowing method (Blasverfahren).
The bating effect that is contained in the hand modifier composition in the soft capsule shell wraps into based on the association of water in its hygroscopic property and the capsule shells basically.Under room temperature (22 ℃/45% to 65%RH (RH=relative humidity)), soft capsule has the liquid water content of about 7-8 weight %.If liquid water content is starkly lower than this, for example owing to too dried storage or drying, this causes the embrittlement of capsule shells, follows the fragility of capsule wall to increase and structure crack.If liquid water content is apparently higher than this, for example because the storage of too wet, swelling and soft capsule inter-adhesive of capsule shells can appear.The material that too dried and too wet storage all can be treated administration produces unpredictable effect with any other assistant agent that is equipped with, and therefore can not guarantee to want to supply with the material that it wrapped into through taking soft capsule.The change of environment is incalculable fully to the influence of soft capsule stability, so their pot-life, and just soft capsule must satisfy with the time limit in the respective description of taking as required at them, can not be with desired deterministic forecast.Particularly owing to security reason, this is unacceptable.
The objective of the invention is to find a kind of simple and cheap mode; Avoid descending owing to quality appears in the embrittlement of capsule shells and swelling and bonding; And soft capsule is at high drying, high atmospheric moisture, follow under the possible high temperature simultaneously; Like high temperature in vogue in climatic zone III and IV, and under the atmospheric moisture that significantly changes, the pot-life obviously increases.
Surprising is, this purpose solves through packing that soft capsule is packed into, and in one/a plurality of inwalls of these packing, part surface wraps into a kind of absorbent and at least a passage forms agent (Kanalbildner) at least.Therefore; The present invention relates to a kind of packing that comprises reclosable container and at least a soft capsule; In one/a plurality of inwalls of this container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least, and wherein this soft capsule is contained in this container.
Surprising is, have a kind of reagent that causes desiccation owing to contain in the container of absorbent, so increases the shelf life of soft capsule.This is because all can be avoided through the present invention through removing embrittlement that moisture comes the capsule shells that drying soft capsule produces and fragility even cracking and similar state.
According to preferred embodiment, packing of the present invention comprises the Perle as soft capsule.Therefore, the present invention relates to a kind of packing, it is characterized in that the soft capsule of wherein packing into is a Perle.
According to another preferred embodiment, packing of the present invention comprises the soft capsule based on starch.Therefore, the present invention relates to a kind of packing, it is characterized in that the soft capsule of wherein packing into is based on the soft capsule of starch.
Container is a reclosable, and can be three-dimensional shape arbitrarily, for example, cylindrical or cuboid, condition is that it is enough greatly can hold soft capsule.
Reclosable refer to container can repeat to open with closure more for example at least once, preferably repeatedly, more preferably at least corresponding to the soft capsule number that in container, is equipped with.This container is tight closure after each open and close operation, gets in the container effectively to have prevented moisture and gas.
Carry out the open and close of container through the tight closure mode that matches with container.All types of closures can be used, as long as can guarantee after repeating the open and close container, gas and/or moisture can not or can only get in the container under the closure state with few amount.
According to embodiment of the present invention, use lid when closed.The instance of lid is a threaded cap, covers on the lid of container top edge or is screwed into the lid in the container.Have in profile under the situation at angle, like cube, the angle of opening and the lid of cooperation also can be round slightly, to improve the compactness of container for gas and moisture.
According to preferred embodiment, container has the three-dimensional shape of cuboid, the angle of circle, and pile up easily.Such embodiment has been carried out illustration in Fig. 1.This container comprises wall (2), fillet (7), and have and be used for closed lid (1), and the inside side of this wall part surface at least contains at least a passage and forms agent and at least a absorbent.
The absorbent and the passage formation agent that are contained in the container can be united in the inwall that directly is included in the container that is formed by poly-mer, perhaps are coated in the inwall of polymer container as coating.Equally, absorbent and passage form agent and can wrap in the inlay, and this inlay is packed into as embolus in the container, so that the inwall of at least a portion container covers thus.
Inwall is interpreted as the inside surface of one/a plurality of walls of container, promptly one of container/a plurality of with its in the surface that contacts of the soft capsule that is equipped with.
Can consider that the material as container is a poly-mer.The poly-mer that can mix use with absorbent and passage formation agent is especially thermoplastic; Polyolefin for example is like poly-vinyl and/or polypropylene, polyisoprene, poly-butadiene, polybutene, polysiloxane, polyamide, ethylene-vinyl acetate copolymer, ethylene-methyl acrylate copolymer, polystyrene, polyester, polyanhydride, polyacrylonitriles, polysulfonates, polyesteramide, polyacrylates, propylene-maleic anhydride copolymers, poly-vinyl-maleic anhydride, poly-vinyl-polyurethane, poly-vinyl-ethyl-vinyl alcohol, poly-vinyl-nylon and/or polyurethane.The surperficial within it wall with absorbent and passage formation agent has the polymer content of 10-90 weight % based on the total weight of the compound of poly-mer, passage formation agent and absorbent.
The absorbent that can exist is various types of desiccant in principle, promptly combines the cementitious agent of moisture.Can consider three groups of desiccant:
First group comprises chemical substance, and itself and water form hydrate.The instance of such chemical substance is an anhydrous salt, and it tends to absorb water or moisture, and in this process, forms stable hydrate.Moisture is absorbed, and prevents its release through chemical reaction.
Second group of desiccant comprises active substance.This material and water or reaction of moisture, thus new material formed.The new material that forms generally is stable at low temperatures, and it is reversible under the situation of high energy consumption only.Such desiccant is mainly used in dry solvent and as the water absorbing material of poly-mer, itself must maintains the state that moisture reduces.
The 3rd group of desiccant combines moisture through physical adsorption.This desiccant comprises having small particle capillaceous, and moisture can suck this capillary tub.The characteristic that absorbs has been confirmed with its density in aperture capillaceous in the desiccant.The instance of such desiccant is molecular sieve, silica gel, some synthetic polymers as being used for those of baby diaper, and starch.Because obviously be inertia and water insoluble, the 3rd group desiccant preferably is contained in the container.Here particularly preferably be that to have molecular sieve and/or the aperture that the aperture is the 3-15 dust be the silica gel of 24 dusts.
It is hydroaropic substance that the passage that is fit to forms agent, like poly-glycol, ethyl vinyl alcohol, glycerine, polyvinyl alcohol, polyvinylpyrrolidone, vinyl pyrrolidone, N-methyl pyrrolidone, polysaccharide, sugar and/or sugar alcohol.Preferred poly-glycol is carbowax and/or polypropylene glycol.Operable sugar for example is glucose, mannose, galactose and/or fructose.The sugar alcohol that is fit to for example is sweet mellow wine, sorbierite, hexitol, melampyrin, xylitol, ribitol and/or erythrite.Polysaccharide for example refers to dextrin and/or hydrolyzed starch.
Be furnished with the inwall that absorbent and passage form agent, this passage forms agent and accounts for 10-40 weight % based on the mixture total weight amount that poly-mer, passage form agent and absorbent.
Absorbent and passage form in the part surface or whole surface of one/a plurality of inwalls that agent wraps into container.Part surface refer to container all form that at least a portion contains absorbent and passage formation agent in the area of inwalls.
The area that all surfaces refers to all formation inwalls of container contains absorbent and passage formation agent.According to preferred embodiment, based on all internal surface areas of container, at least 10%, preferably at least 50%, contain absorbent and passage formation agent especially at least in preferred 90% the inwall.
Contain absorbent and passage and form agent and be applicable to that the polymer container of the container that the present invention packs is known in the prior art, and for example be described among WO 97/32663A1, EP 1000873A2 and WO 03/086900A1, the EP 1421991A1.The container that can in the present invention's packing, use is commercial purchasing; For example the Capitol Specialty Plastics Inc. from No. 2039, U.S. Alabama McMillan StreetAuburn buys with trade mark Activ-Vial, and Ostenrieder Sta.15 number the Sued Chemie that perhaps admires Regensburg 85368 from Germany buys with trade mark 2AP Multipolymer.
In the container of the present invention's packing through reclosable that soft capsule is packed into, closed container is made subsequently, in one/a plurality of inwalls of this container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least.Therefore; The present invention also relates to a kind of method of making packing, it is characterized in that pack into the container of reclosable of soft capsule, with this container of rear enclosed; In one/a plurality of inwalls of this container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least.
Packing of the present invention has prolonged the pot-life of the soft capsule that is equipped with in it.Therefore the present invention also relates to a kind of method that prolongs the soft capsule pot-life; It is characterized in that this capsule packs in the reclosable container; With this container of rear enclosed, in one/a plurality of inwalls of this container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least.
Therefore the stablizing effect of the present invention's packing, can make this capsule obtain the long pot-life based on the influence of container for the soft capsule in it.Therefore, the realization of effect of the present invention requires soft capsule is packed in the container, and soft capsule and container are together as packing.
Except stablizing effect for soft capsule shell, in packing of the present invention, reactive compound that is equipped with in it and/or assistant agent, just whole prescription has also produced stability.Particularly, if reactive compound that is equipped with and/or adjuvant to moisture-sensitive, then this is particularly useful.Instance to the reactive compound of moisture-sensitive (so it preferably is contained in the soft capsule in the packing) is multiple pharmaceutical active compounds, like hormone or protein, vitamin, cell, like probio.
Embodiment explains the present invention, but is not limited thereto.
Embodiment 1
The soft capsule in the present invention's packing and the stability test of the soft capsule in the ordinary packing material
Multivitamin soft capsule (reactive compound is formed and capsule shells is described below) is introduced by PVC 250 μ m+40g/m separately 2PVDC processes and with (model: M-3006-16 Activ-Vial) in the Heat forming chamber film of aluminium film (20 μ m) heat-sealing and in the container of the reclosable of packing into; In one/a plurality of inwalls of this container/on; At least part surface wraps at least a passage and forms agent and at least a absorbent, is the molecular sieve of 1.92g at the container inner wall capacity of being embedded with.
Bubble-cap (Blister) and the container that this multivitamin soft capsule is housed stores under 40 ℃ and 75% relative humidity, after the predetermined time, takes out, and the visual assessment outward appearance is also analyzed the reactive compound amount of packing into.The result is placed in the table 1 and 2 together.
Table 1
Figure G2007800501183D00051
Figure G2007800501183D00061
* soft capsule shell is formed: gelatin 209.76mg, glycerine 85%, 65.83mg, sorbitol solution 70%, 44.21mg, black indian red 1.22mg, red iron oxide 3.89mg
Table 2
Figure G2007800501183D00062
* soft capsule shell is formed: gelatin 209.76mg, glycerine 85%, 65.83mg, sorbitol solution 70%, 44.21mg, black indian red 1.22mg, red iron oxide 3.89mg
Embodiment 2
The check of the soft capsule stability in the present invention's packing
Multivitamin soft capsule (reactive compound is formed and the capsule shells is described below) reclosable container of packing into (model: M-3006-16 Activ-Vial); In one/a plurality of inwalls of this container/on; At least part surface wraps at least a passage and forms agent and at least a absorbent, and the wall capacity of being embedded with is the molecular sieve of 1.92g within it.
This multivitamin soft capsule stores down 30 ℃ and 65% relative humidity (RH), the predetermined time after, takes out the reactive compound amount that its outward appearance of visual assessment and analysis are packed into.The result lists in table 3.
Table 3
Figure G2007800501183D00071
* soft capsule shell is formed: gelatin, glycerine 98-100%, sorbitol solution 70%, water

Claims (10)

1. packing that comprises reclosable container and at least a soft capsule, in one/a plurality of inwalls of said container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least, and wherein said soft capsule is contained in the said container.
2. packing according to claim 1 is characterized in that said soft capsule is a Perle.
3. packing according to claim 1 is characterized in that said soft capsule is based on the soft capsule of starch.
4. packing according to claim 1 is characterized in that said container has the basic configuration of cuboid.
5. packing according to claim 2 is characterized in that said container has the basic configuration of cuboid.
6. packing according to claim 3 is characterized in that said container has the basic configuration of cuboid.
7. according to each described packing in the claim 1 to 6, it is characterized in that said container contains the desiccant as absorbent, said desiccant combines moisture through physical adsorption.
8. packing according to claim 7 is characterized in that said desiccant is molecular sieve or silica gel.
9. one kind is used for making the method according to each said packing of claim 1 to 8; It is characterized in that said soft capsule packs in the reclosable container; Closed subsequently said container; In one/a plurality of inwalls of said container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least.
10. method that is used to prolong the soft capsule pot-life; It is characterized in that said soft capsule packs in the reclosable container; Closed subsequently said container, in one/a plurality of inwalls of said container/on, part surface wraps at least a passage and forms agent and at least a absorbent at least.
CN2007800501183A 2007-01-20 2007-12-10 Packaging containing soft capsules Expired - Fee Related CN101595046B (en)

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EP07001257 2007-01-20
EP07001257.0 2007-01-20
PCT/EP2007/010743 WO2008086852A1 (en) 2007-01-20 2007-12-10 Packaging containing soft capsules

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CN101595046B true CN101595046B (en) 2012-01-25

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BRPI0720951A2 (en) 2014-03-18
ZA200905771B (en) 2010-05-26
RU2470846C2 (en) 2012-12-27
CL2008000141A1 (en) 2008-06-13
KR20090103950A (en) 2009-10-01
JP2010516308A (en) 2010-05-20
US20100065444A1 (en) 2010-03-18
EP2109570A1 (en) 2009-10-21
AU2007344507B2 (en) 2013-07-04
RU2009131447A (en) 2011-02-27
MX2009007511A (en) 2009-07-21
CN101595046A (en) 2009-12-02
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