(cid:38)(cid:68)(cid:83)(cid:86)(cid:88)(cid:74)(cid:72)(cid:79)(cid:3)(cid:40)(cid:91)(cid:75)(cid:76)(cid:69)(cid:76)(cid:87)(cid:3)(cid:20)(cid:19)(cid:20)(cid:22)
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`Page 1 of 26
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`Page 1 of 26
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`1" 0151631-1-----
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`llO
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`ui-I“
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`‘
`
`10 BACK GROUND OF THE INVENTION
`
`Various softencapsulated medicines, foods, table
`
`luxuries and the like are widely on the market, and as those
`
`containing solid fillers therein, there are known oily soft
`
`15 capsules in which solid and oil agents are encapsulated with
`
`a capsule film-forming substance consisting mainly of
`
`gelatin (refer to Japanese Patent Publication No.
`
`20 42044/1982). However, a multiple soft capsule in which one
`
`or more inner soft capsules are contained together with a
`
`liquid materials in an outer soft capsule.
`
`25 SUMMARY OF THE INVENTION
`
`The present invention provides multiple soft
`
`capsules containing one or more inner soft capsules in an
`
`outer soft capsule, which are especially useful in combining
`
`30 two or more components which cannot be enclosed together in
`
`35
`
`Page 2 of 26
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`fl..—
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`Page 2 of 26
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`I
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`I
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`N
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`.....s
`0a I!
`
`011631 1
`
`a single capsule or in the regulation of the rate of
`
`dissolution in vivo of the medicines by properly selecting
`
`the kind of the film—forming substance for the outer and
`
`inner soft capsules.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`The present invention relates to novel multiple
`
`soft capsules in which a soft capsule is contained in
`
`another soft capsule.
`
`10
`
`15
`
`Hitherto, various softencapsulated medicines,
`
`foods, table luxuries, etc. are widely on the market, and as
`
`those containing solid fillers therein,
`
`there are known oily
`
`soft capsules in which solid and oil agents are enclosed
`
`with a capsule film—forming substance consisting mainly of
`
`gelatin (refer to Japanese Patent Publication No.
`
`42044/1982].
`
`The present inventors found that the use of
`
`softencapsulated products is markedly extended by causing a
`
`soft capsule to contain_another soft capsule therein, and
`
`2D
`
`thus attained to the present invention.
`
`The gist of the present invention is to provide
`
`multiple soft capsules in which one or more inner soft
`
`capsules are contained in an outer soft capsule.
`
`The film-forming substance of the soft capsules,
`
`25
`
`either inner soft capsule or outer one, used in the present
`
`invention is not particularly limited, but as preferred
`
`substances, there are given, for example, those containing
`
`Page 3 of 26
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`Page 3 of 26
`
`
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`E
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`0116311
`
`gelatin alone as an essential component;
`
`those containing
`
`(a) gelatin,
`
`(b) a water-soluble polyhydric alcohol or its
`
`water-soluble derivative as an essential component; or those
`
`which are obtained by treating a composition containing (a)
`
`‘5
`
`gelatin,
`
`(b) a water-soluble polyhydric alcohol or its
`
`water-soluble derivative and (c) a lower methoxylpectin or
`
`sodium alginate with a compound capable of geletinizing an
`
`aqueous solution of lower methoxylpectin or sodium alginate,
`
`and the like.
`
`10
`
`Of the film—forming substances for the soft
`
`capsules, as to gelatin and the water~soluble polyhydric
`
`alcohol or its water-soluble derivative,
`
`those of a-grade so
`
`far used for producing soft capsules may be used as such.
`
`As the water-soluble polyhydric alcohol or its
`
`15
`
`water-soluble derivative,
`
`there are given, for example,
`
`glycerin, polyglycerin, sorbite, ethylene glycol,
`
`polyethylene glycol, propylene glycol, polypropylene glycol,
`
`ethylene oxide/propylene oxide copolymer, oligosaccharide,
`
`sugar ester, glyceride, sorbitan ester and the like, which
`
`20
`
`are not however to be regarded as limitative.
`When gelatin and the water-soluble polyhydric
`
`‘
`
`alcohol or its water-soluble derivative are used as a
`
`'film—forming substance for soft capsule, it is preferred
`
`that the amount of gelatin used and that of the
`
`25
`
`water-soluble polyhydric alcohol or its water-soluble
`
`derivative used are 60 to 90 weight % and 10 to 40 weight a,
`
`respectively, based on the total weight of the Capsule film.
`
`Page 4 of 26
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`Page 4 of 26
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`(‘
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`01.16311 1__
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`When gelatin, a lower methoxylpectin and the
`
`water-soluble polyhydric alcohol or its water-soluble
`
`derivative are used as a film-forming substance for soft
`
`capsule, it is preferred that the amounts of the first,
`
`5
`
`second and the latter used are 65 to 75 weight %, 5 to 20
`
`weight %, preferably 10 to 15 weight %, and 10 to 30 weight
`%, respectively, based on the total weight of the capsule
`
`film.
`
`When gelatin, sodium alginate and the
`
`10
`
`waterusoluhle polyhydric alcohol or its water-soluble
`
`derivative are used as a film-forming substance for soft
`
`capsule, it is preferred that the amounts of the first,
`second and the latter used are 65 to 85 weight %,
`1 to 10'
`
`weight %, preferably 30 to 5 weight % and 10 to 30 weight 8,
`
`15
`
`respectively, based on the total weight of the capsule film.
`
`A preferred lower methyoxylpectin is those in
`
`which the molecular weight is not less than 200,000 and the
`
`degree of methoxylation is 1 to 6 %, particularly 3.5 to 5
`
`%.
`
`20
`
`As the compound capable of gelatinizing aqueous
`
`solutions of a lower methoxylpectin or sodium alginate,
`
`there may properly be used the salt of polyvalent metals
`
`having two or more valences, particularly the water-soluble
`
`salts of calcium, magnesium, etc. for a lower
`
`25
`
`methoxylpectin, and water—soluble calcium salts such as
`
`calcium chloride, calcium phosphate, etc. for sodium
`
`_alginate.
`
`Page 5 of 26
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`Page 5 of 26
`
`
`
`The multiple soft capsule according to the present
`
`invention may be used,
`
`in addition to those which are taken,
`
`orally such as medicines, foods, table luxuries, etc., for
`
`those which are applied to industrial uses such as various
`
`5
`
`industrial products (e.g.
`
`two-component type adhesives,
`
`etc.), feeds, agricultural and horticultural chemicals,
`
`cosmetics, medical supplies and the like. Consequently,
`
`the
`
`film-forming substance for the inner and outer soft
`
`capsules, kind of liquors to be encapsulated in the inner
`
`10
`
`soft capsule (the liquor is shorten as an inner capsule
`
`liquor hereinafter), size of the capsules, number of the
`inner soft capsules contained and the like may properly be
`
`selected according to the object of use and usages.
`
`The multiple soft capsule according to the present
`
`15
`
`invention is suitable in the fields of medicines,
`
`foods and
`
`table luxuries, particularly in the field of medicines.
`
`When the multiple soft capsule is medicines,
`
`the
`
`rate of dissolution in vivo of the medicines can be
`
`.
`
`regulated by properly selecting the kind of the film-forming
`substance for the outer and inner soft capsules.
`‘
`
`20
`
`I
`
`For example, by making the film of the outer soft
`
`capsule soluble at stomach by preparing the film from the
`
`foregoing film-forming components (a) and (b), and by making
`
`the film of the inner soft capsule soluble at intestine by
`
`25
`
`preparing the film from the foregoing film-forming
`components (a),
`(b) and (c), various excellent effects can
`
`be obtained, for example,
`
`the effiCacy of medicines can be
`
`Page 6 of 26
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`f
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`Page 6 of 26
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`_6_
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`0116311
`
`maintained in vivo, or medicines can be protected from
`
`decompoaition by gastric juice.
`
`Next, production of the multiple soft capsule
`
`according to the present invention will be illustrated with
`
`reference to the accompanying drawings.
`
`BRIEF DESCRIPTION OF DRAWING
`
`Figs.
`
`1 and 2 are schematic vertical sectional
`
`views illustrating the embodiments of nozzle part for
`
`producing a multiple soft capsule.
`
`Figs.
`
`3 and 4 are schematic flow sheets
`
`illustrating the production of a multiple soft capsule.
`
`Fig.
`
`l is a schematic vertical sectional view
`
`illustrating one embodiment of the nozzle part of a suitable
`
`equipment for producing the multiple soft capsule according
`
`to the present invention.
`
`10
`
`15
`
`20
`
`The multiple soft capsule (7] according to the
`
`present invention is obtained as follows:
`
`25
`
`An inner soft capsule {3}
`
`(containing a proper
`
`inner capsule liquor] sent to the nozzle part, and an outer
`
`capsule liquor {4)
`
`to be filled in an outer soft capsule, as
`
`sent from A and passed through a slit (6)Ir are pushed
`
`together out of the ring-form tip of an inner nozzle (1),
`
`and at the same time therewith, an outer film-forming liquor
`
`(5) for the outer soft capsule, as sent from B,
`
`is pushed
`
`out of the ring-form tip of an outer nozzle (2} arranged
`
`outside said ring-form tip and in the form.o£ concentric
`
`80
`
`85
`
`Page 7 of 26
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`Page 7 of 26
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`
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`l-
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`l
`v. u.
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`0 Ioo
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`-7-
`
`':
`
`.EJII' 01.16311-
`
`1 circle,
`
`thereby to form a double jet which is then
`
`discharged into a cooling liquor (8).
`
`In this case, when the inner soft capsule (3)
`
`is a
`
`5 double soft capsule, a triple soft capsule is obtained, and
`
`when it is a triple soft capsule, a quadruple soft capsule
`
`is obtained.
`
`In the same manner as above, any of desired
`
`multiple soft capsusles may be produced.
`
`10
`
`In the prior art method wherein the filler is a
`
`”liquid only, the encapsulation is made easy and the particle
`
`diameter is made uniform by giving moderate perturbation to
`
`the multiple jet flow using a perturbation means to cause
`
`15
`
`the flow to be out well.
`
`In the method of the present
`
`invention described above, however,
`
`the inner soft capsule
`
`(3), on being pushed out of the tip of the nozzle, acts to
`
`pull the outer capsule liquor (4) and outer film-forming
`
`20
`
`liquor (5)
`
`into the flow, so that the same effect as with
`
`the perturbation means can be given to the multiple jet
`
`flow.
`
`25
`
`of course,
`
`in the method of the present invention,
`
`a proper perturbation means may be employed if desired
`
`a»
`
`according-to the kind and property of the inner soft capsule
`
`and the number thereof contained.
`
`30
`
`I
`
`With the multiple soft capsule produced as above
`
`using the foregoing gelatin or (a) and (b) as essential
`
`components for the film of the outer soft capsule, it
`
`suffices to use a vegetable oil, mineral oil, animal oil or
`
`35
`
`Page 8 of 26
`
`#
`
`Page 8 of 26
`
`
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`-5-
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`0116311
`
`1
`
`the like as a cooling liquor and after solidifying the
`
`capsule by cooling,
`
`to dry and wash the capsule as such.
`
`While, with the multiple soft capsule produced as
`
`above using the foregoing (a),
`
`[bl and (c) as essential
`
`components for the film of the outer soft capsule,
`
`the
`
`capsule, after solidified by cooling, is brought into
`
`contact with a solution, preferably an aqueous solution of
`
`the compound capable of gelatinizing aqueous solutions of a
`
`lower methoxylpectin or sodium alginate.
`
`In this case, it
`
`is a common practice to dip the capsule to be treated in an
`
`aqueous solution containing 1 to 10 weight %, preferably 3
`
`to 5 weight % of said.tompound at 5°C to 30°C, preferably
`
`10°C to 15°C for 1 to 5 minutes, preferably 1 to 3 minutes.
`
`The contact between the multiple soft capsule and the
`
`treating liquor may be carried out,
`
`in addition to the
`
`dipping method, by other methods such as the spraying
`
`method. But the dipping method is most simple as well as
`
`applicable uniformly.
`
`The multiple soft capsule treated as
`
`above is then dried and washed.
`
`Another method suitable to produce the multiple
`
`soft capsule according to the present invention is a method
`
`characterized in that an inner capsule liquor, a
`
`film-forming liquor for the inner soft capsule (shorten as
`
`an inner film—forming liquor hereinafter), an outer capsule
`
`liquor and an outer film~forming liquor therefor are at the
`
`same time pushed out of the first nozzle, second one, third
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`Page 9 of 26
`
`Page 9 of 26
`
`
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`. 21:}..ofifial‘i __
`
`1 one and forth one respectively, as arranged in the form of
`
`concentric circle, having increasing radii in this order,
`
`thereby to form a multiple jet which is then discharged into
`
`5 a cooling liquor. Fig.
`
`2 is a schematic vertical sectional
`
`view illustrating one embodiment of the nozzle part of an
`
`equipment for practicing this method.
`
`In the equipment shown in Fig. 2,
`
`the multiple
`
`10 soft capsule (7) according to the present invention is
`
`.obtained as follows:
`
`An inner capsule liquor (11') sent from C, an
`
`inner film-forming liquor (12') sent from D, an outer
`capsule liquor_(l3'L sent from A and outer film-forming
`
`15
`
`liquor (14') sent from B are at the same time pushed out of
`
`the ring-form tips of the first nozzle (11), second one
`
`20
`
`(12), third one (l3) and fourth one (14), respectively, as
`
`arranged in the form of concentric circle, having increasing
`
`radii in this order,
`
`thereby to form a multiple jet flow
`
`which is then discharged into a cooling liquor (8).
`
`35
`
`Also in this case, with the multiple soft capsule
`
`produced using the foregoing (a) and (b) as essential
`
`components for.the film of the outer soft capsule, it
`
`suffices to dry and wash the capsule as such. But, with the
`
`30 multiple soft capsule produced using the foregoing (a),
`(b)
`and (c) as said components,
`the capsule, after treated as
`
`above, is dried and washed.
`
`35
`
`The present invention extends the use of
`
`softencapsulated products in all the industrial fields, and
`
`Page 10 of 26
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`w
`
`Page 10 of 26
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`
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`-10-
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`?-
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`0116311
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`particularly it is effective in combining two or more
`
`components which cannot be enclosed together in a single
`
`capsule because of inocmpatibility and the like. Further, a
`
`5 synergistic effect, sustained effect, etc. can also be
`
`obtained depending upon the components contained.
`
`The aesthetic appearance of the multiple soft
`
`capsule according to the present invention is expected to
`
`10 contribute to extending demands for said encapsulated
`
`product.
`
`Next,
`
`the present invention will be illustrated
`
`15 with reference to the following examples.'
`
`Example 1
`
`According to the conventional method, a garlic
`
`20
`
`oilwcontaining inner soft capsule (particle diameter, 2mm)
`.
`.
`.
`.
`was prepared using an inner film-forming liquor of the
`
`following recipe.
`
`Recipe for the inner film—forming liquor:
`
`25
`
`Parts by weight
`
`Gelatin
`
`D—sorbite
`
`Purified water
`
`16
`
`4
`
`80
`
`30
`
`According to the flow sheet shown in Fig. 3,
`
`the
`
`inner soft capsule obtained above and a vitamin E-containing
`
`oil were encapsulated together using an outer film-forming
`
`liquor for outer soft capsule of the following recipe to
`
`35 obtain a double capsule having an outside diameter of 6mm.‘
`
`L
`
`Page11 of26
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`Page 11 of 26
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`
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`_n_
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`.
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`:3301163112
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`Recipe of the outer film-forming liquor:
`
`Parts by weight
`
`Gelatin
`
`d-sorbite
`
`Purified water
`
`16
`
`4
`
`80
`
`10
`
`15
`
`The flow sheet in Fig.
`
`3 will be illustrated
`
`later.
`
`A vitamin E-containing oil
`
`(4)
`
`(an outer capsule
`
`liquor) is sent from an outer capsule liquor storage tank
`
`(19)
`
`to an inner capsule storage tank (18)
`
`through a pump
`
`(20)
`
`to mix with inner soft capsules.
`
`The temperature of
`
`said outer capsule liquor (4)
`
`is kept constant (in this
`
`example, 20 t 1°C), and the viscosity of the liquor is
`
`preferably 400cps.
`
`The inner soft capsule (3) and the
`
`liquor (4) are sent together, at a flow rate of 0.3 ml/min.,
`
`20
`
`from the tank (18)
`
`through a pipe (29)
`
`(inside diameter,
`
`2.5mm), an extruder (16) and the pipe (29)
`
`to a double
`
`nozzle (17)
`
`(inner nozzle diameter, 3.0mm; outer nozzle
`
`diameter, 6.0mm).
`
`An aligning machine (15) is set between
`
`25
`
`30
`
`35
`
`the extruder (16) and double nozzle (17)
`
`to make a distance
`
`between the inner soft capsules constant (in this example,
`
`pitch number, 2.5mm).
`
`The number of the inner soft capsules
`
`extruded is fixed to 8/sec. While an outer film-forming
`
`liquor (5), while being maintained at a constant temperature
`
`(in this example, 60 : 2°C), is sent, at a flow rate of 0.2
`
`ml/sec,
`
`from a film—forming liquor storage tank (21)
`
`through
`
`a pump (22)
`
`to the double nozzle (17)
`
`to form a double jet
`
`which is then discharged into a cooling liquor (vegetable
`
`Page120f26
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`Page 12 of 26
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`-12—
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`:'
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`0116311-"“
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`1 oil in this example}. The cooling liquor
`
`{B}
`
`is kept at a
`
`low and constant temperature (9 1 U.S°C in this example) by
`
`a cooler
`
`(24) and circulated by means of a pump (27), at a
`
`5
`
`flow rate of 240 ml/sec,
`
`through a cooling pipe (28)
`
`(inside
`
`diameter, 120mm;
`
`length, 1000mm),
`
`forming pipe [23)
`
`(inside
`
`diameter, 30mm;
`
`length, 600mm} set in the cooling pipe (28},
`
`tank (26). pump (27) and cooler (24)
`
`in this order.
`
`The
`
`10 capsules formed in the forming pipe (23) are sent,
`
`together
`
`with the circulating flow of the cooling liquor (8),
`
`to a
`
`15
`
`25
`
`25
`
`separator (25)
`
`(sieve! wherein the capsules are separated
`
`from the cooling liquor [8), and then dried and washed.
`
`The
`
`outside diameter of the outer soft capsule of the double
`
`capsule thus obtained is 6 i 0.2mm.
`
`Example 2
`
`In the same manner as in Example 1, a double
`
`capsule of the following recipe was prepared.
`
`Diameter of the inner Soft capsule:
`
`4 mm
`
`‘
`
`Inner capsule liquor:
`
`,
`
`parts by weight
`
`ethylcysteine hydrogene
`
`chloride
`
`safflower oil
`
`30
`
`70
`
`30
`
`Recipe for an inner film—forming liquor:
`
`parts by weight
`
`Gelatin
`
`D-sorbite
`
`Sodium alginate
`
`Water
`
`75
`
`20
`
`5
`
`300
`
`35
`
`Page 13 of 26
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`Page 13 of 26
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`
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`1
`
`5
`
`10
`
`15
`
`20
`
`-13-_
`
`2:3.- 0116311'
`
`Diameter of the outer soft capsule:
`
`8mm
`
`Outer capsule liquor:
`
`parts by weight
`
`cytric acid carbeta-
`
`pentane
`
`safflower oil
`
`10
`
`90
`
`Recipe for an outer film-forming liquor:
`
`Gelatin
`
`D~sorbite
`
`Water
`
`parts by weight
`
`80
`
`20
`
`350
`
`Manufacturing condition:
`
`Pitch of aligning machine (15):
`
`4.5mm
`
`Forming pipe (23):
`
`inside diameter, 30mm;
`
`length, 600mm;
`
`Cooling pipe (28):
`
`inside diameter, 120mm
`
`length, 1000mm
`
`Pipe (29):
`
`inside diameter, 4.5mm
`
`25
`
`Temperature of the outer film—forming liquor: 60°C
`
`Temperature of the outer capsule liquor: 20°C
`
`Temperature of the cooling liquor: 9°C
`
`Flow rate of the outer film-forming liquor:
`0.4 ml/sec
`
`Flow rate of the outer capsule liquor:
`
`0.3 mllsec
`
`240 ml/sec
`Flow rate of the cooling liquor:
`- Number of inner capsules extruded: 8/sec
`
`30
`
`35
`
`Page 14 of 26
`
`Page 14 of 26
`
`
`
`1
`
`'
`
`The outer soft capsule of the double capsule thus
`
`'14-
`
`0116311
`
`obtained is soluble at stomach and the inner soft capsule
`
`thereof is soluble at intestine, so that the efficacy of the
`
`5
`
`reapective medicines is displayed effectively.
`
`Example 3
`
`According to the flow sheet shown in Fig. 4 double
`
`10
`
`1 5
`
`20
`
`25
`
`30
`
`capsule having an outside diameter of 8mm is obtained.
`
`The recipes of the capsule are as follows:
`
`Inner capsule liquor:
`
`parts by weight
`
`Vitamin B2
`
`Safflower oil
`
`20
`
`80
`
`Inner film-forming liquor:
`
`parts by weight
`
`Gelatin
`
`Purified water
`
`30
`
`70
`
`Outer capsule liquor:
`
`Vitamin E
`
`parts by weight
`50
`
`Wheat germ oil
`
`.
`
`50
`
`Outer film-forming liquor:
`
`Gelatin
`
`D-sorbite
`
`Purified water
`
`parts bx weight
`_
`25
`
`5
`
`70
`
`35
`
`The above inner capsule liquor,
`
`inner film—forming
`
`Page15of26
`
`Page 15 of 26
`
`
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`,_15_
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`0116311'-
`
`1
`
`liquor, outer capsule liquor and outer film-forming liquor
`
`are charged in an inner capsule liquor storage tank (30), an
`
`inner film-forming liquor storage tank (31), an outer
`
`5
`
`capsule liquor storage tank (32) and an outer film-forming
`
`liquor storage tank (33), respectively, which are kept at
`
`following temperatures:
`
`10
`
`15
`
`20
`
`Inner capsule liquor
`
`_
`
`10 i 1°C
`
`Inner film-forming liquor
`
`60 t 2°C
`
`Outer capsule liquor
`
`20 t 1°C
`
`Outer film~forming liquor
`
`60 t 1°C
`
`Every storage tank is connected with the first
`
`nozzle (¢ 1.5 mm)
`
`(11),
`
`the second nozzle (¢ 2.5 mm)
`
`(12),
`
`the third nozzle (d 3 mm)
`
`(13), and the fourth nozzle (d 5
`
`to which the inner capsule liquor,
`(14), respectively,
`mm)
`inner film-forming liquor, outer capsule liquor and outer
`
`film-forming liquor are sent by pumps at flow rates of 0.5
`
`ml/sec, 0.1 mllsec, 1.0 ml/sec and 0.3 ml/sec, respectively,
`
`25
`
`to be pushed into a cooling liquor (vegetable oil in this
`
`example)
`
`(8) stocked in a forming pipe (inside diameter: ¢
`
`30 mm,
`
`length: 600 mm)
`
`(23).
`
`The cooling liquor is
`
`circulated through cooling pipe (28) at a constant flow rate
`
`30
`
`(240 ml/sec in this example), as maintained at a given
`
`uniform temperature (9 i 0.5°C) by cooler (24). An obtained
`
`double capsule is sent to a separator (60 meshes) by the
`
`cooling liquor, dried and washed.
`
`The obtained soft capsule
`
`35
`
`Page 16 of 26
`
`W
`
`Page 16 of 26
`
`
`
`I
`It
`
`e
`It
`
`O
`II
`
`(I
`
`9
`
`-15-
`
`'
`
`‘
`
`oi £6311 ;.-
`
`has an average outside diameter of 8 mm and inner capsule
`
`diameter of 5 mm.
`
`The content of the every soft capsule is
`
`as follows:
`
`Inner capsule liquor
`
`60 mg
`
`(average)
`
`Inner film-forming liquor
`
`10 mg
`
`[average]
`
`Outer capsule liquor
`
`120 mg
`
`(average)
`
`Outer film-forming liquor
`
`46 mg
`
`{average}
`
`1
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`Page17of26
`
`Page 17 of 26
`
`
`
`-17-
`
`’i
`
`.’ "
`0116311..
`
`.
`
`:
`
`;
`
`What is claimed is:
`
`1.
`
`A multiple soft capsule wherein one or more
`
`inner soft capsules are contained with outer capsule liquor
`
`in an outer soft capsule.
`
`5
`
`2.
`
`A multiple soft capsule according to Claim 1
`
`which is medicines,
`
`foods or table luxuries.
`
`3.
`
`A multiple soft capsule according to Claim 1,
`
`wherein film-forming substance for the inner and/or the
`
`outer soft capsule essentially comprises gelatin.
`
`10
`
`4.
`
`A multiple soft capsule according to Claim 1,
`
`wherein a film-forming substance for the inner and/or the
`
`outer soft capsule essentially comprises (a) gelatin-and (b)
`
`a water-soluble polyhydric alcohol or its water-soluble
`
`derivative.
`
`15
`
`5.
`
`A multiple soft capsule according to Claim 1,
`
`wherein a film-forming substance for the inner and/or outer
`
`soft capsule is those which are obtained by treating a
`
`composition containing essentially (a) gelatin,
`
`(b) a
`
`water—soluble polyhydric alcohol or its waternsoluble
`
`20
`
`derivative and (c) a lower methoxylpectin or sodium alginate
`
`with a compound capable of gelatinizing an aqueous solution
`
`of said lower methoxylpectin or sodium alginate.
`
`6.
`
`A multiple soft capsule according to Claim 4
`
`or 5, wherein the water-soluble polyhydric alcohol is
`
`25
`
`selected from the group consisting of glycerin, sorbite,
`
`sugar ester and sorbitan ester.
`
`Page 18 of 26
`
`;
`
`Page 18 of 26
`
`
`
`‘13'
`
`M16311.
`
`7.
`
`A multiple soft capsule according to Claim 5,
`
`wherein the lower methoxylpectin has a molecular weight of
`
`not less than 200,000 and a degree of methoxylation of 1 to
`
`6 %.
`
`B.
`
`A multiple soft capsule according to Claim 4,
`
`wherein the contents of gelatin and the water-soluble
`
`polyhydric alcohol or its water—soluble derivative are 60 to
`
`90 weight % and 40 to 10 weight %, reSpectively, based on
`
`the total weight of the film.
`
`10
`
`9.
`
`A multiple soft capsule according to Claim 5,
`
`wherein the contents of gelatin. the lower methoxylpectin
`
`and the water-soluble polyhydric alcohol or its
`
`water—soluble derivative are 65 to 75 weight %,
`
`5 to 20
`
`weight % and 10 to 30 weight %, respectively, based on the
`
`15
`
`total weight of the film.
`
`10.
`
`A multiple soft capsule according to Claim 5,
`
`wherein the contents of gelatin, sodium alginate and the
`
`water—soluble polyhydric alcohol or its water—soluble
`
`derivative are 65 to 85 weight %,
`
`1 to 10 weight % and 10 to
`
`20
`
`30 weight %, respectively, based on the total weight of the
`film.
`-
`
`11.
`
`A multiple soft capsule according to Claim 1
`
`having a double capsule structure that the outer soft
`
`capsule is soluble at stomach and the inner soft capsule is
`
`25
`
`soluble at intestine.
`
`12.
`
`A method for producing a multiple soft
`
`capsule characterized in that an inner soft capsule and an
`
`Page 19 of 26
`
`Page 19 of 26
`
`
`
`_ 19 _
`
`-t
`
`0116311
`
`outer capsule liquor to be encapsulated in an outer soft
`
`capsule are pushed together out of the ring-form tip of an
`
`inner nozzle, and at the same time therewith, an outer
`
`film—forming liquor for the outer soft capsule is pushed out
`
`5
`
`of the ring-form tip-of an outer nozzle arranged outside
`
`said ring-form tip and in the form of concentric circle,
`
`thereby to form a multiple jet which is then discharged into
`
`a cooling liquor.
`
`13.
`
`A method for producing a multiple soft
`
`10
`
`capsule according to Claim 12, wherein the outer
`
`filmvforming liquor-essentially comprises gelatin.
`
`14.
`
`A method for producing a multiple soft
`
`capsule according to Claim 12, wherein the outer
`
`film-forming liquor essentially comprises (a) gelatin and
`
`15
`
`(b) a waterwsoluble polyhydric alcohol or its wateresoluble
`
`derivative.
`
`15.
`
`A method for producing a multiple soft
`
`capsule according to Claim 12r wherein the outer
`
`film-forming liquor essentially comprises (a) gelatin,
`
`(b) a
`
`20
`
`water-soluble polyhydric alcohol or its water—soluble
`
`derivative and (c) a lower methoxylpectin or Sodium
`
`alginate, and the obtained multiple soft capsule is further
`
`treated with a compound capable of gelatinizing an aqueous
`
`solution of said lower methoxylpecting or sodium alginate.
`
`25
`
`16. A method for producing a multiple soft
`
`capsule characterized in that an inner capsule liquor for an
`
`inner soft capsule, an inner film-forming liquor therefor,
`
`Page 20 of 26
`
`fir;—
`
`Page 20 of 26
`
`
`
`-2(1-
`
`1
`
`av {3'011631i n
`
`an outer capsule liquor for an outer soft capsule and an
`
`outer film-forming liquor therefor are at the same time
`
`pushed out of the first nozzle, second one, third one and
`
`fourth‘one respectively, as arranged in the form of
`
`concentric circle, having increasing radii in this order,
`
`thereby to form a multiple jet which is then discharged into
`
`a cooling liquor.
`
`17.
`
`A method for producing a multiple soft
`
`capsule according to Claim 16, wherein the inner
`
`10
`
`film—forming liquor andfor the outer film—forming liquor
`
`essentially comprises gelatin.
`
`18.
`
`A method for producing a multiple soft
`
`capsule according to Claim 16, wherein the inner and/or
`
`outer film-forming liquor essentially comprises [a] gelatin
`
`15
`
`and (bi water-soluble polyhydric alcohol or its
`
`water-soluble derivative.
`
`19.
`
`A method for producing a multiple soft
`
`capsule according to Claim 16, wherein the outer
`
`film-forming liquor essentially-comprises (a) gelatin,
`
`(bl a
`
`20
`
`watervsoluble polyhydric alcohol or its water—soluble
`
`derivative and (c) a lower methoxylpectin or sodium
`
`alginate, and the obtained multiple soft capsule is further
`
`treated with a compound capable of gelatinizing an aqueous
`
`solution of said lower methoxylpectin or sodium alginate.
`
`Page 21 of 26
`
`Page 21 of 26
`
`
`
`
`
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`.
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`1/4
`
`ccccc
`
`011.6313
`
`FIG.
`
`1
`
`I’l/
`
`
`.....\./
`
`”EH:Wm,.
`
`
`
`Page 22 of 26
`
`Page 22 of 26
`
`
`
`
`
`
`2/4
`
`"biweati
`
`FIG.
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`,I
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`I C
`
`.3...‘.‘““I.‘I‘I u‘v
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`m_
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`r 'I- 1111110111,.
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`
`Page 23 of 26
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`Page 23 of 26
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`"0116311 "
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`3/!-
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`ngfiCgKv-a‘olo'o‘al-IOIO..o
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`27
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`"9
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`
`Page 24 of 26
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`
`
`Page 24 of 26
`
`
`
`0116311
`
`LII.
`
`
`
`Page 25 of 26
`
`
`Page 25 of 26
`
`
`
`0116311
`
`DE — A1 - 3 030 801 (MITSUBISHI
`PAPER MILLS, LTD.)
`
`A 61 K
`
`9/48
`
`
`DOCUMENTS CONSIDERED TO 35 RELEVANT
`BP 84 1 0039 8 - 1
`
`'
`i
`i
`'
`.u
`‘
`CLASS FICATION OF THE
`-——W
`
`
`
`
`
`1/00
`A 23 F
`
`
`
`
`* Claim 1; page 6,
`lines
`B 01 J 13/02
`
`
`6-12; fig. 1,2 *
`
`
`
`* Claims 1,3; page 4,
`line 3
`page 5,
`line 19 *
`
`
`DE - Al - 2 729 068 (LIEDTKE)
`
`
`
`GB - A - 715 879 (R.P. SCHERER
`CORPORATIONS
`
`GB — A — 1 538 510 (MORISHITA
`JINTAN COMPANY LIMITED)
`
`* Page 3,
`1-3 *
`
`lines 13—32; fig.
`
`
`* Claim 1; page 2,
`lines
`13-16 *
`
`
`
`
`TECHNICAL FIELDS
`SEARCHED (Int. CI. ’)
`
`
`
`
`
`
`
`
`
`
`B 01 J 13/00
`
`
`
` GB — A — l 564 452 (UNILEVER
`12,15, A 23 L
`LIMITED;
`A 23 G
`
`
`* Claims 1—5
`*
`
`A 23 P
`
`
`A 61 K
`
`9/00
`
`The preeent search report has beendmn up for all claim
`
`Pleceoheucn
`
`VIENNA
`
`Deteolcompietionoitneeeucn
`
`13-04—1984
`
`
`
`
`
`T. theoty ormixeptriyundeflying the invention
`' CATEGORY OF CITED DOCUMENTS
`:earlierp
`document. but publiahed on. or
`utter the mi
`x : paniculany reievant it taken alone
`0: document ct ed int'ti'Ie application
`Y : particularty relevent it combined with another
`
` L: document cited tor other reeeone
`document of the same category
`
`
`A : technological background
`1.......1 .1.1111.11.11....1111.
`11.
`
`
`O : non-written disciosure
`.
`a: member of the same patent family. corresponding
`
`
`P :
`intermediate document
`document
`
`
`
`
`8
`8
`.
`3
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`E
`g
`
`PageZBof26
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`Page 26 of 26
`
`
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