KR101863133B1 - Soft capsule containing solid formulation as core ingredient - Google Patents
Soft capsule containing solid formulation as core ingredient Download PDFInfo
- Publication number
- KR101863133B1 KR101863133B1 KR1020150117684A KR20150117684A KR101863133B1 KR 101863133 B1 KR101863133 B1 KR 101863133B1 KR 1020150117684 A KR1020150117684 A KR 1020150117684A KR 20150117684 A KR20150117684 A KR 20150117684A KR 101863133 B1 KR101863133 B1 KR 101863133B1
- Authority
- KR
- South Korea
- Prior art keywords
- tablet
- die roll
- solid
- gelatin
- soft capsule
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
Abstract
The present invention relates to a soft capsule comprising a solid formulation and a content solution on a solution or suspension in the form of a gelatin, wherein the solid formulation is a solid formulation of a square shape, a solid formulation of a triangle shape, The present invention provides a soft capsule containing the solid formulation as the contents.
Description
The present invention relates to a soft capsule containing a solid dosage form as its contents. More particularly, the present invention relates to a solid dosage form such as a tablet and a soft capsule containing the liquid content liquid as a content.
Generally, a gelatin soft capsule is prepared by dissolving a drug in a liquid form as a core component, sealing it and shaping it with gelatin. In addition, the core component of the gelatin soft capsule can be prepared in the form of a paste, a tablet, as well as a dissolved liquid phase.
In the case of a hydrophilic drug, polyethylene glycol (PEG) 200, 300, 400 or 600, propylene glycol or the like is used as a liquid-phase dissolving agent for dissolving pharmaceuticals, and in the case of a hydrophobic drug, lecithin is usually added to soybean oil as a surfactant have.
However, conventional gelatin soft capsules are difficult to use as sustained-release preparations because liquid core drug, which is easily absorbed in the gastrointestinal tract, rapidly increases the blood concentration.
On the other hand, in the case of sustained-release preparations, they have been developed into tablets or hard capsule formulations by adding sustained-release controlled-release polymers to medicines.
However, in the case of tablets or hard capsule preparations containing sustained-release release-controlling polymers, storage stability and / or pH stability are deteriorated when exposed to various external environments, so that when sustained-release tablets or hard capsules are taken two to three months after preparation It was difficult to show the effect of the slow release.
Recently, PCT International Publication WO-A-2012/17326 'Capsules Containing Solid Formulations in Capsules and Apparatus for Manufacturing the Same' discloses a capsule containing a pellet, a small capsule, a small tablet, a sustained- Soft gel capsules containing shaped formulations.
Also, in the patent document, (a) two spreader boxes; (b) two casting drums; (c) a pair of rotary die having suction means; (d) a liquid filler system; (e) a wedge for heating the gelatin ribbon and feeding the filler; And (f) a two-sided dispenser, said two side dispensers comprising: a hopper having a solid dosage form; a channel guide for transferring the solid dosage form; And a grip protrusion for insertion into the formed soft gel pocket.
In the above-described soft gel capsule manufacturing apparatus, a solid formulation is put on a pair of left and right die rolls, and rotated together with the die roll to insert and seal the solid formulation on both sides of the left and right gelatin sheets .
However, in order to prepare the soft gel capsules by injecting the solid dosage form on both sides of the left and right gelatin sheets and sealing the gelatin sheet as disclosed in the above patent document, in order to transfer the solid dosage form along the outer peripheral surface of the left and right die rolls, In order to prevent the gelatin sheet and the solid dosage form from being diverted to the outside of the die roll.
The decompression of the outer peripheral surface of the die roll using the vacuum state causes the gelatin sheet transferred along the outer peripheral surface to stick to the outer peripheral surface of the die roll so that the gelatin sheet is not sewn to the right and left, Resulting in defective production of the resulting soft gel article.
In addition, a large amount of electric power is required for decompression using the vacuum state of the pair of left and right die rolls, which is problematic in cost.
Therefore, the present inventors have developed a soft capsule containing a solid formulation, which minimizes the phenomenon that the gelatin sheet is adhered to the outer circumferential surface of the die roll by the pressure reduction of the die roll, and minimizes the defects of the soft gel article.
Conventionally, a solid formulation injected from both the right and left die rolls is injected only into the right die roll, so that only the right die roll, in which the solid formulation is injected, The present inventors have developed a soft capsule containing the solid formulation in which the deficiency of the soft capsule product is minimized even when the solid formulation is contained as the contents, by which the soft capsule can be performed continuously and quantitatively.
A problem to be solved by the present invention is that a solid dosage form to be injected in both the right and left die rolls is injected only into the right die roll and thus only the right die roll into which the solid dosage form is injected, The present invention has been made to develop a soft capsule containing a solid formulation in which the content of a soft capsule product is minimized even when a solid formulation is contained as a content by allowing a more sophisticated sealing to be performed continuously and stituously when the sheet is sealed.
An object of the present invention is to provide a soft capsule containing a solid formulation and a content solution on a solution or suspension as a content and being molded with gelatin, wherein the solid formulation is a solid formulation of a square shape, a solid formulation of a triangle shape or a pair of ellipse shapes And the solid dosage form is characterized in that it is a solid dosage form of a soft capsule.
Here, the soft capsule containing the solid formulation as the contents comprises the steps of: i) supplying the first gelatin sheet cooled in the first
In addition, the solid dosage form is characterized by being a solid formulation of at least one medicament to be medicated selected from tablets, coated tablets, pellets, microcapsules, sustained release tablets, immediate-release tablets or core-shell tablets.
On the other hand, the content liquid is characterized by being omega oil,
In addition, the above-mentioned contents liquid further includes a non-ionic surfactant in order to improve the blending compatibility between the oil and the solid dosage form.
The effect of the present invention is that a gelatin sheet on both sides can be sutured to perform a more sophisticated suture continuously and quantitatively so that a soft capsule containing the solid formulation in which the deficiency of the soft capsule is minimized even if the solid formulation is contained therein, .
BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an overall configuration diagram of a manufacturing apparatus used for manufacturing a soft capsule containing the solid dosage form of the present invention as its contents. Fig.
Fig. 2 is a detailed view showing a configuration of a manufacturing apparatus of a soft capsule forming part used for manufacturing a soft capsule containing the solid dosage form of the present invention as contents.
3 is a plan view showing the shape of a tablet supply shooter for dispensing a solid dosage form used in the manufacture of a soft capsule containing the solid dosage form of the present invention.
4A is a side view showing the shape of a tablet supply shooter for dispensing a solid dosage form used in the manufacture of a soft capsule containing the solid dosage form of the present invention as a content.
Figure 4b is a partial detail view showing the shape of a tablet supply shooter for dispensing a solid dosage form for use in the manufacture of a soft capsule containing the solid dosage form of the present invention.
5 is a schematic view showing a shape after a soft capsule containing the solid dosage form of the present invention as a content is molded.
6A is a schematic view showing one shape of a soft capsule containing the solid dosage form of the present invention as its contents.
FIG. 6B is a schematic view showing another shape of the soft capsule containing the solid dosage form of the present invention as contents. FIG.
Fig. 6C is a schematic view showing still another shape of a soft capsule containing the solid dosage form of the present invention as its contents. Fig.
The present invention relates to a soft capsule comprising a solid formulation and a content solution on a solution or suspension in the form of a gelatin, wherein the solid formulation is a solid formulation of a square shape, a solid formulation of a triangle shape, Wherein the solid dosage form is a soft capsule containing the solid dosage form as a content.
Hereinafter, the present invention will be described in more detail.
The soft capsule containing the solid dosage form of the present invention as the contents comprises: i) feeding the first gelatin sheet cooled in the first
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An apparatus and a method for producing a soft capsule containing a solid dosage form of the present invention as a content will be described in detail with reference to the accompanying drawings.
The solid dosage form of the present invention is a solid dosage form of one or more medications to be dosed selected from tablets, coated tablets, pellets, microcapsules, sustained release solid, immediate release solid or core-shell solid dosage forms.
Typically, the solid pharmaceutical formulations used in the present invention include general medicines such as non-steroidal anti-inflammatory analgesics and antihistamines, and medicines for treating chronic metabolic diseases such as antihypertensive agents, anti-cholesterol agents, anti-hypertensive agents and anti-diabetic agents.
Also, the solid pharmaceutical formulation used in the present invention may be a sustained release formulation. In the case of sustained-release pharmaceuticals, the polymer for release control may be included in the solid dosage form.
Also, the soft capsule containing liquid of the present invention is preferably omega oil,
Also, in the content solution of the present invention, a solvent such as polyvinyl pyrrolidone and the like may be contained.
Also, in the content of the present invention, a nonionic surfactant may be further included to enhance the blending compatibility between the oil and the solid formulation, and may include a surfactant such as tween or lecithin.
Meanwhile, the gelatin skin of the present invention contains gelatin as a main component and may include a plastic material such as glycerin sorbitol.
Hereinafter, a method of preparing a soft capsule containing the solid formulation of the present invention as a content will be described in detail with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an overall configuration diagram of a manufacturing apparatus used for manufacturing a soft capsule containing the solid dosage form of the present invention as its contents. Fig.
The soft capsule production apparatus containing the solid dosage form of the present invention as its contents is composed of four partial units. The configuration of each partial unit is as follows.
The first partial unit is a unit for feeding the first gelatin sheet cooled in the first
The third subunit is a unit for transferring the tablet supplied from the
Also, the tablet injected in this unit corresponds to the solid dosage form of the present invention, and means a tablet and all solid dosage forms equivalent thereto. For example, tablets, coated tablets, pellets, microcapsules, sustained release solid, immediate release solid, core-shell solid solid, and the like.
The fourth subunit includes a first gelatin sheet supplied to the left die roll
At this time, the inner liquid is injected from the inner
A feature of the present invention is that a conventional solid dosage form is inserted only in the right die roll in both the right and left die rolls, and thus only the right die roll in which the die roll outer peripheral surface reduced pressure and the solid dosage form are inserted, The more sophisticated suture can be performed continuously and quantitatively.
The present invention also provides a soft capsule containing a solid formulation having uniform shape and weight as its contents by controlling the content of the tablet and the content liquid in the soft capsule containing the solid formulation as the content.
Fig. 2 is a detailed view showing a configuration of a manufacturing apparatus of a soft capsule forming part used for manufacturing a soft capsule containing the solid dosage form of the present invention as contents.
2, the wedge segment 80 is adjacent to the left die roll
At this time, the tablet supplied from the
On the other hand, the right die roll
In order to reduce the pressure of the right die roll
The production of only the right die roll
3 is a plan view showing the shape of a tablet supply shooter for dispensing a solid dosage form used in the manufacture of a soft capsule containing the solid dosage form of the present invention.
As shown in FIG. 3, the
4A is a side view showing the shape of a tablet supply shooter for dispensing a solid dosage form used in the manufacture of a soft capsule containing the solid dosage form of the present invention as a content.
Fig. 4A shows a shape in which the
The tablet is supplied from the outer circumferential surface of the rotating conveying
Figure 4b is a partial detail view showing the shape of a tablet supply shooter for dispensing a solid dosage form for use in the manufacture of a soft capsule containing the solid dosage form of the present invention.
The
5 is a schematic view showing a shape after a soft capsule containing the solid dosage form of the present invention as a content is molded.
The soft capsule containing the solid formulation of the present invention, which is molded and molded in the
This is different from the case where a plurality of molded soft capsules are asymmetric in the case of a conventional soft capsule packaging apparatus. For example, in the case of the soft capsule formed in the Korean Patent Registration No. 10-1268491 'capsule packing apparatus', the asymmetrical shape of the upper, lower, left and right can be seen in a zigzag shape.
6A is a schematic view showing one shape of a soft capsule containing the solid dosage form of the present invention as its contents.
FIG. 6B is a schematic view showing another shape of the soft capsule containing the solid dosage form of the present invention as contents. FIG.
Fig. 6C is a schematic view showing still another shape of a soft capsule containing the solid dosage form of the present invention as its contents. Fig.
As shown in FIG. 6A, the soft capsule containing the solid dosage form of the present invention includes a
The content liquid is liquid and usually consists of a clear liquid or suspension.
FIG. 6B shows a case where the solid dosage form of the present invention is a triangular solid dosage form, and FIG. 6C shows a case where the solid dosage form of the present invention is a pair of elliptical solid dosage forms.
However, the shapes shown in FIGS. 6A, 6B and 6C are merely exemplary shapes and do not limit the shape of the soft capsule containing the solid formulation of the present invention as the contents. The shape of the solid dosage forms of the present invention may be modified as desired by those skilled in the art within the scope of protection described in the claims.
10: first gelatin freezing drum 11: first gelatin spreader box
12: first feed roller 20: second gelatin freezing drum
21: second gelatin spreader box 22: second conveying roller
30: Left die roll 40: Right die roll
45: Tablet feed roller 50: Tablet feeder shoe
51: Tablet supply hopper 60: Contents solution heating hopper
70: System controller 71: Display panel
80: Wedge segment
100: main motor 110: main speed reducer
200: molded solid tablet-containing capsule 201: square-shaped solid dosage form
202: Content solution 203: Gelatin shell
204: Solid formulation of triangular shape 205: Solid formulation of a pair of elliptical shapes
301: Left die roll peripheral part 310: Guide roller
401: Right die roll peripheral part 402: Die roll peripheral pressure reducing surface
403: sealed molding part 404: pocket
410: Guide roller 451: Transfer tablet
501: Tablet feed route 502: Tablet feed hopper connection
503: input tablet 504: tablet feed latch
505: Tablet supply shoe support 801: Central part liquid infusion tube
802: Wedge segment bonding surface 803: Wedge segment bonding surface
804: side portion liquid infusion tube 805: side portion liquid infusion tube
Claims (5)
Ii) feeding the second gelatin sheet cooled in the second gelatin freezing drum 20 to the upper end of the right die roll 40 through the second feed roller 22;
Iii) a tablet supply shooter (not shown) for feeding the tablet 503 to be fed along the slope of the hole-shaped tablet feeding route 501 and feeding the fed tablet to the tablet feed roller 45 one by one by the tablet feed latch 504 50 to the right die roll peripheral depression surface 402 through the tablet feed roller 45; And
Iv) The first gelatin sheet supplied to the left die roll peripheral portion 301 and the second gelatin sheet on the right die roll peripheral pressure reducing surface 402 whose outer peripheral surface is reduced through the generation of the vacuum state inside the right die roll 40 The second gelatin sheet having the pockets 404 formed in the right die roll peripheral portion 401 is adjusted and conveyed to embed the tablet so that the left and right die rolls contact each other in the sealed forming portion 403, Injecting the inner liquid from the inner liquid inlet tube 801, thermocompression-cutting the gelatin sheet surfaces of the two gelatin sheets to form a soft capsule;
The present invention relates to a soft capsule containing, as its contents, a solid formulation which minimizes defective soft capsules due to seams by continuously performing fine suturing when a gelatin sheet is squeezed by only applying a tablet to the right die roll only and decompressing the outer periphery of the right die roll,
The solid dosage form is a solid dosage form consisting of a combination of a polymer with at least one medicament selected from the group consisting of a coating tablet, a pellet, a microcapsule, a sustained-release solid, an immediate-release solid or a core-shell solid,
Wherein the content liquid is a liquid containing at least one of polyethylene glycol (PEG) 200, PEG 300, PEG 400 or PEG 600, propylene glycol, soybean oil or vegetable oil at room temperature and having compatibility with solid formulations,
Further comprising polyvinylpyrrolidone as a solvent in the content liquid,
The content liquid further includes a nonionic surfactant in order to improve the mixing compatibility between the oil and the solid dosage form,
Solid formulations in soft capsules and uniform contents and liquid content control uniform shape and weight
Characterized in that it comprises a solid formulation which is characterized by the contents.
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020150117684A KR101863133B1 (en) | 2015-08-21 | 2015-08-21 | Soft capsule containing solid formulation as core ingredient |
US14/865,194 US20170049707A1 (en) | 2015-08-21 | 2015-09-25 | Manufacturing method for softgel capsule containing solid and liquid formulations as core ingredient |
EP15188232.1A EP3141247A1 (en) | 2015-08-21 | 2015-10-02 | Manufacturing method for softgel capsule containing solid and liquid formulations as core ingredient |
JP2015197741A JP6280903B2 (en) | 2015-08-21 | 2015-10-05 | Method for producing soft gel capsule containing solid preparation and liquid preparation as core component |
CN201510648481.1A CN106466229A (en) | 2015-08-21 | 2015-10-09 | Containing solid preparation and liquid preparation as the soft capsule of nucleuses manufacture method |
US16/557,068 US20200022874A1 (en) | 2015-08-21 | 2019-08-30 | Manufacturing method for softgel capsule containing solid and liquid formulations as core ingredient |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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KR1020150117684A KR101863133B1 (en) | 2015-08-21 | 2015-08-21 | Soft capsule containing solid formulation as core ingredient |
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KR20170022553A KR20170022553A (en) | 2017-03-02 |
KR101863133B1 true KR101863133B1 (en) | 2018-05-31 |
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KR1020150117684A KR101863133B1 (en) | 2015-08-21 | 2015-08-21 | Soft capsule containing solid formulation as core ingredient |
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