JPH053312B2 - - Google Patents
Info
- Publication number
- JPH053312B2 JPH053312B2 JP26658985A JP26658985A JPH053312B2 JP H053312 B2 JPH053312 B2 JP H053312B2 JP 26658985 A JP26658985 A JP 26658985A JP 26658985 A JP26658985 A JP 26658985A JP H053312 B2 JPH053312 B2 JP H053312B2
- Authority
- JP
- Japan
- Prior art keywords
- capsule
- side wall
- cylindrical side
- standard
- head
- 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.)
- Expired - Lifetime
Links
- 239000002775 capsule Substances 0.000 claims description 55
- 239000007902 hard capsule Substances 0.000 claims description 7
- 238000000576 coating method Methods 0.000 description 8
- 239000011248 coating agent Substances 0.000 description 7
- 239000003814 drug Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000002702 enteric coating Substances 0.000 description 3
- 238000009505 enteric coating Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 238000001035 drying Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Description
本発明の背景
本発明は医薬用硬カプセルの改良に関する。特
に、薬物を充填した後腸溶性コーテイング等のコ
ーテイングを施すにの適した形状を有する硬カプ
セルに関する。
硬質ゼラチンカプセルは胃溶性であり、胃液中
で速やかに崩壊し、薬物を胃の中へ放出するよう
になつている。ところが薬物によつては胃中で放
出されずに腸で放出されることが望まれる場合が
ある。そのために腸溶性コーテイングを施した薬
物を充填するか、または薬物を充填後硬カプセル
へ腸溶性コーテイングが施される。本発明者は、
先に硬カプセルへ腸溶性コーテイング等のコーテ
イングを施す際に真空下で実施する方法を特許出
願した。特願昭60−169395号参照。カプセルのコ
ーテイング技術は基本的には錠剤の場合と同じで
あり、多数のカプセルを回転しているコーテイン
グパンへ収容し、回転下コーテイング液をスプレ
ーし、引き続き乾燥する操作によつて行われる。
その際個々のカプセルの表面がむらなくコーテイ
ングされるためには、コーテイングパンの回転に
つれてカプセルがそのすべての表面をスプレー液
の方向に向けてできるだけ均等に露出し得るよう
な形状であることが望ましい。しかしながら現在
市販されている標準型カプセルは、長さ／外径の
比が３近くもあり、そのための縦軸を中心とする
回転運動は容易であるが、縦軸に直交する横軸を
中心とする回転運動は困難である。従つて標準型
カプセルの形状は表面へむらなくコーテイングを
施すのに適した形状になつておらず、改良が望ま
れる。
最近、いたずらよけ等の目的で標準型カプセル
より長さ／外径比が著しく小さい新型カプセルが
開発され、市販されている。このカプセルは胴部
の円筒形側壁の殆ど全部が頭部側壁内に収容さ
れ、胴部は半球形端面のみが露出するようになつ
ている。特開昭59−80249号公報参照。この新型
カプセルは標準型に比べて長さ／外径比が小さい
ので横軸を中心とする回転運動が容易であり、表
面へ比較的むらなくコーテイングし易くなつてい
る。しかしながらこの新型カプセルは胴部と頭部
との合わせ目が胴部の円筒形側壁と半球形端壁と
の境界に位置するため、バンドシールすることが
困難である。また、この新型カプセルは標準型カ
プセルの各サイズと同じ容積とするため胴部の長
さを短くし、外形を太くしてあるので標準型カプ
セルの充填機を使用することができず、専用の特
別の充填機を使用しなければならない。
本発明の開示
本発明は、
(1) カプセルの縦軸を中心とする回転運動のみな
らず、横軸を中心とする回転運動も比較的容易
であり、そのため充填後のカプセルへむらなく
コーテイングを施すことができ、
(2) カプセル胴部の円筒形側壁の露出部分は比較
的狭いが、なお合わせ目をバンドシールするこ
とが可能であり、
(3) しかも、標準型カプセルの充填機を共用し得
る新型硬カプセルを提供することを目的とす
る。
本発明のカプセルは、それぞれ相互にぴつたり
嵌合し得る寸法の円筒形側壁と、円筒形側壁の一
端に半球形の閉鎖端および他端に開放端を有する
胴部および頭部とよりなる。
本発明の特徴は、対応する号数の標準型カプセ
ルに比較して頭部の形状および寸法は同じであ
り、胴部の外径は等しいが長さは65〜80％に短か
くなつており、そのため胴部と頭部とを嵌合した
状態において長さ／外径の比が1.9ないし2.5であ
り、かつ胴部の円筒形側壁が該円筒形側壁の全長
の30％未満で少なくとも１mmの幅の環状露出部を
残して頭部の円筒形側壁内に嵌入するようになつ
ていることである。
好ましい具体例の説明
第１図および第２図に、嵌合した後の本発明の
硬カプセルおよび標準型カプセルの正面図を示
す。
図面から明らかなように、本発明のカプセルの
頭部１は標準型カプセルの頭部１と形状、寸法
（長さL2および外径D1）において同じである。胴
部２は標準型カプセルに比較して外径D2は等し
いが、長さL3が約70％ほどに短くなつており、
従つて全長L1も標準型カプセルに比較して短く
なつている。そのため標準型カプセルの全長
L1／外径D1の比は約３であるのに対し、本発明
のカプセルのL1／D1の比は1.9〜2.5、好ましくは
約２になつている。また、標準型カプセルにおい
てはロツクした状態において胴部２と頭部１の合
わせ目３はカプセルのほぼ中央に位置するが、本
発明のカプセルの合わせ目３は胴部２の半球形閉
鎖端に片寄つている。しかしながら該合わせ目３
は半球形閉鎖端と円筒形側壁との境界まで達せ
ず、胴部円筒形側壁の全長の30％未満で少なくと
も１mmの幅Ｗをもつて胴部２の円筒形側壁が露出
するようになつている。
本発明のカプセルの内容積（充填容積）は、同
じ外径を有する標準型カプセルより１クラス小さ
い標準サイズのカプセルの内容積にほぼ匹敵する
ように構成できる。例えば標準サイズの00号と同
じ頭部を使用する本発明のカプセルの内容積は標
準サイズの０号に、同様に０号は１号に、１号は
２号に対応させることができる。
下表に、カプセル充填時の胴部円筒形側壁の環
状露出部の幅Ｗを1.1mmに設定したときの本発明
のカプセルの諸元の一例を標準型カプセルの諸元
と対比して示す。ただしカプセルの号数は標準型
のものであり、例えば本発明の４号カプセルはそ
の内容積に置いて１クラス小さい標準型カプセル
の５号に匹敵する。
BACKGROUND OF THE INVENTION The present invention relates to improvements in pharmaceutical hard capsules. In particular, the present invention relates to hard capsules having a shape suitable for applying a coating such as an enteric coating after being filled with a drug. Hard gelatin capsules are gastrosoluble and are designed to disintegrate rapidly in gastric fluids, releasing the drug into the stomach. However, some drugs may be desired to be released in the intestines rather than in the stomach. For this purpose, the enteric coated drug is filled, or the enteric coating is applied to the hard capsule after filling the drug. The inventor is
The company previously filed a patent application for a method of applying coatings such as enteric coating to hard capsules under vacuum. See patent application No. 169395/1983. The capsule coating technique is basically the same as that for tablets, and is carried out by placing a large number of capsules in a rotating coating pan, spraying a coating liquid while rotating, and then drying.
In order to coat the surface of each individual capsule evenly, it is desirable that the capsule be shaped so that as the coating pan rotates, all its surfaces can be exposed as evenly as possible toward the spray liquid. . However, the standard capsules currently on the market have a length/outer diameter ratio of nearly 3, which makes rotational movement around the vertical axis easy, but rotational movement around the horizontal axis perpendicular to the vertical axis is easy. Rotational motion is difficult. Therefore, the shape of the standard capsule is not suitable for evenly coating the surface, and improvements are desired. Recently, a new type of capsule with a significantly smaller length/outer diameter ratio than the standard type capsule has been developed and commercially available for the purpose of preventing tampering. In this capsule, almost all of the cylindrical side wall of the body is contained within the head side wall, leaving only the hemispherical end surface of the body exposed. See Japanese Patent Application Laid-Open No. 59-80249. This new capsule has a smaller length/outer diameter ratio than the standard type, making it easier to rotate around the horizontal axis, making it easier to coat the surface relatively evenly. However, in this new capsule, the seam between the body and the head is located at the boundary between the cylindrical side wall and the hemispherical end wall of the body, making it difficult to band seal. In addition, this new type of capsule has a shorter body length and a thicker outer shape in order to have the same volume as each standard capsule size, so it is not possible to use a standard capsule filling machine, so a dedicated capsule filling machine is required. Special filling machines must be used. DISCLOSURE OF THE INVENTION The present invention provides the following features: (1) Not only rotational movement around the vertical axis of the capsule but also rotational movement around the horizontal axis is relatively easy, and therefore coating can be applied evenly to the capsule after filling. (2) Although the exposed portion of the cylindrical side wall of the capsule body is relatively narrow, it is still possible to band-seal the seam; (3) Moreover, it can share the same filling machine as standard capsules. The purpose is to provide a new type of hard capsule that can The capsule of the present invention comprises a cylindrical side wall each dimensioned to fit snugly into each other, a body and a head having a hemispherical closed end at one end of the cylindrical side wall and an open end at the other end. The features of the present invention are that the head has the same shape and dimensions as the standard capsule of the corresponding number, the outer diameter of the body is the same, but the length is 65-80% shorter. , so that when the body and head are fitted, the length/outer diameter ratio is between 1.9 and 2.5, and the cylindrical side wall of the body is less than 30% of the total length of the cylindrical side wall and has a length of at least 1 mm. It is adapted to fit into the cylindrical side wall of the head leaving an annular portion of the width exposed. DESCRIPTION OF PREFERRED EMBODIMENTS FIGS. 1 and 2 show front views of the hard capsule of the present invention and the standard capsule after mating. As is clear from the drawings, the head 1 of the capsule of the invention is the same in shape and dimensions (length L 2 and outer diameter D 1 ) as the head 1 of the standard capsule. The body 2 has the same outer diameter D 2 as the standard capsule, but the length L 3 is about 70% shorter.
Therefore, the total length L 1 is also shorter than that of the standard capsule. Therefore, the total length of the standard capsule is
The ratio L 1 /outer diameter D 1 is about 3, whereas the ratio L 1 /D 1 of the capsules of the invention is between 1.9 and 2.5, preferably about 2. In addition, in the standard capsule, the seam 3 between the body 2 and the head 1 is located approximately at the center of the capsule in the locked state, but the seam 3 of the capsule of the present invention is located at the hemispherical closed end of the body 2. It's off to one side. However, the seam 3
does not reach the boundary between the hemispherical closed end and the cylindrical side wall, and the cylindrical side wall of the body 2 is exposed with a width W of at least 1 mm at less than 30% of the total length of the cylindrical side wall of the body. There is. The internal volume (filling volume) of the capsule of the present invention can be configured to be approximately comparable to the internal volume of a standard size capsule that is one class smaller than a standard capsule having the same outer diameter. For example, the internal volume of the capsule of the present invention using the same head as the standard size No. 00 can be made to correspond to the standard size No. 0, similarly, the No. 0 can be made to correspond to the No. 1, and the No. 1 can be made to correspond to the No. 2. The table below shows an example of the specifications of the capsule of the present invention in comparison with the specifications of a standard capsule when the width W of the annular exposed portion of the cylindrical side wall of the body is set to 1.1 mm when the capsule is filled. However, the size of the capsule is of a standard type; for example, the No. 4 capsule of the present invention is comparable to the standard No. 5 capsule, which is one class smaller in terms of internal volume.
【表】【table】
【表】
効 果
本発明のカプセルは、全長L1／外径D1の比を
1.9〜2.5、好ましくは約２としたため標準型カプ
セルよりも回転し易く、従つて充填後カプセルの
表面にむらなくコーテイングし易い。頭部と胴部
の合わせ目は胴部の閉鎖端へ向かつて片寄つてい
るので標準型カプセルよりも頭部と胴部が分離し
難く、いたずらよけにも役立つが、充填した状態
においてもなお少なくとも１mm幅の胴部円筒形側
壁が露出するので、合わせ目をバンドシールをも
つてシールすることができる。
さらに頭部は標準型カプセルの形状、寸法と変
わらず、胴部の外径は標準型カプセルと同じであ
り、長さは標準型の約70％ほどに短くなつている
が、なお標準型カプセルの充填機をもつて充填す
ることが可能な長さである。むしろ胴部が短いた
め充填が容易であり、重量偏差を少なくすること
ができ、カプセルの小型化にも貢献する。[Table] Effects The capsule of the present invention has a ratio of total length L 1 /outer diameter D 1
Since the ratio is set to 1.9 to 2.5, preferably about 2, it is easier to rotate than a standard type capsule, and therefore it is easier to coat the surface of the capsule evenly after filling. The seam between the head and body is offset toward the closed end of the body, making it harder to separate the head and body than with standard capsules, which helps prevent mischief, but even when filled. Since the cylindrical side wall of the body, which is at least 1 mm wide, is exposed, the seam can be sealed with a band seal. Furthermore, the head is the same shape and dimensions as the standard capsule, the outer diameter of the body is the same as the standard capsule, and the length is about 70% shorter than the standard capsule, but it is still the same as the standard capsule. The length is such that it can be filled with a filling machine. Rather, the short body makes it easier to fill the capsule, reducing weight deviation and contributing to the miniaturization of the capsule.
第１図は本発明のカプセルの正面図、第２図は
標準型カプセルの正面図である。
１は頭部、２は胴部、３は合わせ目である。
FIG. 1 is a front view of a capsule of the present invention, and FIG. 2 is a front view of a standard capsule. 1 is the head, 2 is the body, and 3 is the seam.
Claims (1)
筒形側壁と、円筒形側壁の一端に半球形の閉鎖端
および他端に開放端を有する胴部および頭部とよ
りなる医薬用硬カプセルにおいて、対応する号数
の標準型カプセルに比較して頭部の形状および寸
法は同じであり、胴部の外径は等しいが長さは65
〜80％に短かくなつており、そのため嵌合した状
態において、長さ／外径の比が1.9ないし2.5であ
り、かつ胴部の円筒形側壁が該円筒形側壁の全長
の30％未満で少なくとも１mm幅の環状露出部を残
して頭部の円筒形側壁内に嵌入するようになつて
いる医薬用硬カプセル。1. A hard capsule for pharmaceutical use comprising a cylindrical side wall dimensioned to fit tightly into each other, and a body and a head having a hemispherical closed end at one end of the cylindrical side wall and an open end at the other end, Compared to the standard capsule of the corresponding number, the head shape and dimensions are the same, the body has the same outer diameter but a length of 65
~80%, so that in the mated state the length/outer diameter ratio is between 1.9 and 2.5, and the cylindrical side wall of the body is less than 30% of the total length of the cylindrical side wall. A hard pharmaceutical capsule adapted to fit into a cylindrical side wall of the head leaving an annular exposure at least 1 mm wide.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP26658985A JPS62127055A (en) | 1985-11-26 | 1985-11-26 | Medical hard capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP26658985A JPS62127055A (en) | 1985-11-26 | 1985-11-26 | Medical hard capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS62127055A JPS62127055A (en) | 1987-06-09 |
| JPH053312B2 true JPH053312B2 (en) | 1993-01-14 |
Family
ID=17432906
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP26658985A Granted JPS62127055A (en) | 1985-11-26 | 1985-11-26 | Medical hard capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS62127055A (en) |
-
1985
- 1985-11-26 JP JP26658985A patent/JPS62127055A/en active Granted
Also Published As
| Publication number | Publication date |
|---|---|
| JPS62127055A (en) | 1987-06-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| EXPY | Cancellation because of completion of term |