Stock material or miscellaneous articles – Coated or structually defined flake – particle – cell – strand,... – Particulate matter
Reexamination Certificate
2000-09-14
2002-08-13
Le, Hoa T. (Department: 1773)
Stock material or miscellaneous articles
Coated or structually defined flake, particle, cell, strand,...
Particulate matter
C264S109000, C264S299000, C264S309000, C264S319000, C424S465000, C424S474000
Reexamination Certificate
active
06432534
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a tablet production method and a tablet, specifically to a tablet production method wherein molding material is hardly adhered on a punch and a die of a tabletting machine so that material can be continuously tabletted for a long time and disintegration time and hardness of produced tablet is the same as that of a tablet produced by an internal lubricant method and to a newly constructed tablet which can be produced by such a method.
BACKGROUND ART
A tablet is a very useful pharmaceuticals for carrying and dosing and is easy to be taken for an elder person or a patient because it doesn't float on the water when dosing with water. Further, it has many advantages such that production cost of a tablet can be held down. Therefore, it is a most multipurpose dosage form for internal application and oral application.
Such a tablet is generally produced by a compression method.
However, when a tablet is produced by a compression method, there have been problems such that molding material is adhered on the punch and the dies of the tabletting machine to cause gride between the punch and the dies and sticking, capping, and laminating are apt to be caused.
In order to solve such problems, lubricant such as magnesium stearate, lauryl sodium sulphate, talc and so on are mixed in the molding material to be tabletted other than active component and diluting agent and the mixture is compressed to obtain a tablet so as to prevent that molding material to be tabletted is apt to attach on the punches and dies and gride between the punch and die is apt to be caused, to execute smooth tabletting, and to prevent defective goods (hereinafter, this tablet production method is called as “an internal lubricant method”).
On the other hand, it is advisable that adequate amount of lubricant is attached on the surfaces of the punches, the dies, and a tablet in order to prevent adhering of the molding material to be tabletted on the punches and the dies of the tabletting machine. Lubricant isn't required to be contained in the tablet.
Based on these idea, there is a so called external tablet spraying method disclosed in for example JP-B-41-11273, JP-A-56-14098, and JP-A-7-124231 as a technique wherein the molding material to be tabletted is prevented from adhering on the punches and the dies of the tabletting machine while tabletting and the produced tablet is prevented from causing sticking and so on.
FIG. 7
schematically shows the procedures of the prior tablet production method disclosed in JP-B-41-11273.
According to this method, lubricant L is sprayed by air pressure from a spray nozzle
55
to a surface (lower surface)
53
s
of an upper punch
53
and a surface (upper surface)
54
s
of a lower punch
54
as shown in FIG.
7
(
a
). Then, molding material m is charged in a die
51
provided for a rotary table
52
in the procedure shown in FIG.
7
(
b
). Further, the molding material m is compressed to produce a tablet by means of the upper punch
53
of which surface (lower surface)
53
s
is applied with lubricant and the lower punch
4
of which surface (upper surface)
54
s
is applied with lubricant as shown in FIG.
7
(
c
).
FIG. 8
schematically shows the procedures of the prior tablet production method disclosed in JP-A-56-14098.
According to this method, lubricant L is sprayed in a spray
56
provided above a die
51
of a rotary table 52 as shown in FIG.
8
(
a
).
Then, lubricant L is placed on a surface (upper surface)
54
s
of a lower punch
54
as shown in FIG.
8
(
b
). Compressed air is sprayed against the lower punch
54
from a nozzle
58
provided in a spraying chamber
57
which is provided separately from the spray
56
. The lubricant L on the lower punch
54
is blown to be dispersed and the dispersed lubricant L is attached on a surface (inner wall)
51
s
of the die
51
and the surface (lower surface)
53
s
of the upper punch
53
as shown in FIG.
8
(
c
). Accordingly, molding material (not shown) is compressed to produce a tablet by means of the die
51
, the upper punch
53
, and the lower punch
54
of which surface (inner wall)
51
s,
the surface (lower surface)
53
s,
and the surface (upper surface)
54
s
are lubricated.
However, according to the production methods described in JP-B-41-11273 and JP-A-56-14098, it has been impossible to apply lubricant L uniformly and stably on the surface (inner wall)
51
s
of the die
51
, the surface (lower surface)
53
s
of the upper punch
53
, and the surface (upper surface)
54
s
of the lower punch for a long time of tabletting. Therefore, they has problem such that they can't be executed as an industrial production method.
The tablet production method disclosed in Jp-A-7-124231 has been proposed by the present inventors in order to solve the above-mentioned problems.
FIG. 9
schematically shows the procedures of the tablet production method disclosed in JP-A-7-124231.
According to this method, a tabletting machine in which a pulsating vibration air generation means
67
is connected above the die
51
before a step for charging molding material in the die
51
and a spraying chamber
58
having a spray nozzle
59
for spraying lubricant L is provided is prepared.
Then when the die
51
, the upper punch
53
, and the lower punch
54
come to a place where the spraying chamber
58
is provided by rotating the rotary table
52
, pulsating vibration air is generated in the spraying chamber
58
by driving the pulsating vibration air generation means
67
and the lubricant L is sprayed from the spray nozzle
59
so as to attach on the surface (inner wall)
51
s
of the die
51
, the surface (lower surface)
53
s
of the upper punch
53
, and the surface (upper surface)
54
s
of the lower punch
54
, as shown in FIG.
9
(
a
).
As shown in FIG.
9
(
b
), molding material is charged in the die
51
.
Thereafter, molding material m is compressed to produce a tablet by means of the upper punch
53
and the lower punch
54
of which surfaces (lower surface
53
s
and upper surface
54
s
) are lubricated.
According to the production method disclosed in JP-A-7-124231, lubricant L can be uniformly and stably applied on the dies
51
and the punches
53
,
54
by pulsating vibration air in a step of applying lubricant L so that material m is prevented from sticking on the punches
53
,
54
and the die
51
and material can be continuously tabletted smoothly and stably for a long time, comparing to the production methods disclosed in JP-B-41-11273 and JP-A-56-14098.
However, according to the methods in JP-B-41-11273, JP-A-56-14098, and JP-A-7-124231, as lubricant L isn't included in a tablet, there has been problems wherein property is differed such that disintegration time becomes fast and hardness becomes high, or absorption speed of active component into body is changed.
The present invention is proposed to solve the above-mentioned problems. The object of the invention is to provide a method for producing tablet wherein molding material doesn't cause sticking and so on for the punches and the dies of the tabletting machine, tabletting can be continuously executed stably for a long time, it can be executed as an industrial tabletting method, and properties of the produced tablet such as disintegration time and hardness and absorption speed of active component into body don't differ from a tablet produced by a normal internal lubricant method. And another object of the present invention is to provide a newly constructed tablet produced according to this tablet production method.
DISCLOSURE OF THE INVENTION
According to the method for producing tablet described in claim
1
, a tablet including active component, diluting agent, and lubricant is produced by means of a tabletting machine provided with punches and dies, comprising steps of; preparing molding material including active component, diluting anent, and a part of lubricant; applying most of remaining amount of the lubricant on a surface of the punch and a surface of the die; and tabletting the molding
Hayakawa Eiji
Ito Kunio
Morimoto Hiroyuki
Morimoto Kiyoshi
Ohta Motohiro
Fitzpatrick ,Cella, Harper & Scinto
Kyowa Hakko Kogyo Co. Ltd.
Le Hoa T.
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