JP3572871B2

JP3572871B2 - Divided tablets

Info

Publication number: JP3572871B2
Application number: JP15257497A
Authority: JP
Inventors: 智晴菅; 等工藤; 孝一中道
Original assignee: Nippon Shinyaku Co Ltd
Current assignee: Nippon Shinyaku Co Ltd
Priority date: 1997-06-10
Filing date: 1997-06-10
Publication date: 2004-10-06
Anticipated expiration: 2017-06-10
Also published as: JPH111425A

Description

【０００１】
【発明の属する技術分野】
本発明は、医療用分割錠に関するものである。詳しくは、本発明は、硬面に錠剤を置き、上から押圧することによって、少なくとも２分割することができる医療用分割錠に関するものである。
ここで「分割錠」とは、錠剤を均等に少なくとも２分割して服用することが想定されている錠剤をいう。
【０００２】
【従来の技術】
分割錠は、個々の患者に応じて投与量を調節すべく、また処方の幅を広げるために開発されてきた。
【０００３】
当該分割錠は、通常指で摘んで両手指でもって内側に力を加え分割するタイプ（例、特開平８−２７７２１８号公報、実開平５−３７９２４号公報、実開平７−１９３３９号公報）と、錠剤を硬面に置き、指（主に親指）の腹を使って上から押圧することによって分割するタイプ（例、実公昭４０−３６８０号公報、特開昭６１−２８９０２７号公報（実開平８−１０１２号公報）、特開平７−１７９３３３号公報、特開平８−５３３４５号公報）とに大きく分類することができる。
【０００４】
前者のタイプは、錠剤が通常の包装形態であるＰＴＰ包装されている場合、ＰＴＰ包装から錠剤を取り出して分割しなければならないので、錠剤を摘み取るのが困難な患者にとっては不便である。また、分割するのに比較的強い力が必要である。一方、後者のタイプは、ＰＴＰ包装された状態のまま分割することができるので、上記患者にとっても対応可能であるが、力の掛かり方が不均一になって、均等な分割が十分に行えないおそれがある。また、ＰＴＰ包装された状態で分割する場合に、割線のある面が上を向いていると、ＰＴＰ包装の裏から押圧することになるが、かかる場合ＰＴＰ包装のカバーシートが障害となって、分割するに際してより強い押圧力が必要となる。フィルムコーティングされた錠剤の場合には、さらに強い押圧力が必要となる。
【０００５】
特開平７−１７９３３３号公報に記載されている分割錠は、上下両表面のいずれにも割線を有し得るため、上記ＰＴＰ包装に係る分割の問題を回避することができる。しかし、全周にわたって一定幅の側帯部を有する分割錠であるため、製造上、厚みのある錠剤を製造することが極めて困難であり、どうしても薄く錠径の大きな錠剤となってしまうなど、種々の制限を受ける。錠径が大きいと、包装するにおいても服用する使用者にとっても不便である。また硬度が劣ることも懸念される。
【０００６】
【発明が解決しようとする課題】
本発明の目的は、ＰＴＰ包装に係る前記問題がなく、より均等な分割ができ、かつ厚みのある比較的錠径の小さい医療用分割錠を提供することにある。
【０００７】
【課題を解決するための手段】
本発明者らは、鋭意研究を重ねた結果、錠剤の上下両表面に、割線を有する適当な幅を持った比較的大きな溝を施すなどによって、上記目的を達成しうることを見出し、本発明を完成するに到った。
【０００８】
本発明は、上下両表面のそれぞれに大きな溝を有する錠剤であって、当該溝の幅がいずれも４ｍｍ〜１０ｍｍの範囲内にあり、当該溝の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する少なくとも１対の互いに平行な割線があり、かかる１対の割線を含む断面に対して左右が対称であり、上下両表面の割線間距離が２ｍｍ〜８ｍｍの範囲内であり、かつ錠厚（上下両表面間の最長距離）が４ｍｍ〜１０ｍｍの範囲内であることを特徴とする医療用分割錠（以下「本発明分割錠」という）である。
【０００９】
本発明に係る溝の幅は、後述する分割方法から、上記のように上下とも４ｍｍ〜１０ｍｍの範囲内が適当であるが、５ｍｍ〜８ｍｍの範囲内が好ましい。また、当該溝の垂直直交断面の形状は、上下同型であっても上下異型であってもよいので、当該溝の幅も上下で異なっていてもよい。但し、上下同型が適当である。
当該溝の深さは、後述するような、割線部に施しうる僅かな凹みを考慮しなければ、１．５ｍｍ〜８ｍｍの範囲内が適当であり、２ｍｍ〜５ｍｍの範囲内が好ましい。
【００１０】
当該溝の垂直直交断面の形状としては、図１〜図８の各正面図（２）に例示するように、上下両表面とも種々のものが考えられる。図１〜図４では上下同型のＶ字型、図５及び図６では上下同型の２段Ｖ字型、図７では上下同型の凸円弧型、図８では上下異型のＶ字型のものを示している。この中、上下同型の、Ｖ字型や２段Ｖ字型が好ましい。２段Ｖ字型、円弧Ｖ字型のように単一斜面から構成されていない溝の場合には、途中に平坦部を有することができる。また、２段Ｖ字型等において、底部を鋭角なＶ字型にすることによって、最深部の割線の認識をより良好にすることができる。
【００１１】
本発明に係る割線は、上下両表面それぞれに少なくとも１本づつの１対有することができるが、上下両表面それぞれに１本づつの１対が適当である。当該１対の割線を有する本発明分割錠は、錠剤を２等分に分割することができ、本発明２分割錠ということができる。上下両表面それぞれに互いに直交する２本づつの２対の割線を有する本発明分割錠の場合には、均等に４等分に分割することができ、本発明４分割錠ということができる。
当該割線は、中央部が正確に認識しうるよう一直線と認識しうるものが適当であるが、中央部が認識でき、かつ均等に分割するのに実質的に支障がなければ、僅かな幅（例えば、０．１ｍｍ〜０．５ｍｍ）をもった平面又は曲面であってもよい。割線に相当するかかる平面及び曲面は、僅かに凹んでいてもよい。
本発明において、上下両表面の割線間距離は２ｍｍ〜８ｍｍの範囲内が適当であるが、３ｍｍ〜５ｍｍの範囲内が好ましい。錠厚（上下両表面間の最長距離）は３ｍｍ〜１０ｍｍの範囲内が適当であるが、４ｍｍ〜６ｍｍの範囲内が好ましい。このように本発明錠剤は、比較的厚みのある錠剤とすることができる。
【００１２】
本発明分割錠の最長径は、特に制限されないが、６ｍｍ〜１２ｍｍの範囲内が適当であり、７ｍｍ〜１０ｍｍの範囲内が好ましい。本発明分割錠の最短径は、特に制限されないが、４ｍｍ〜１２ｍｍの範囲内が適当であり、６ｍｍ〜１０ｍｍの範囲内が好ましい。
【００１３】
本発明分割錠は、上下両表面上又はいずれか一方において、割線に向かう溝の切り込み口と縁部との間に平坦部を有することができる。上下両表面上の溝の切り込み口と縁部との間のいずれにも平坦部を有するものが好ましい。このように平坦部を有することにより、押圧による支点の崩れを少なくすることができる。当該平坦部の最大幅は、錠剤の平面形状、溝の幅等によって異なり、また特に制限されないが、例えば、０．５ｍｍ〜１．５ｍｍもあれば十分である。なお、溝の各切り込み口は、丸くする方が好ましい。このような丸みを与えるこれにより押圧による各切り込み口の崩れを少なくすることができる。
【００１４】
本発明分割錠は、また、上下両表面上又はいずれか一方において、周縁部が面取りされていてもよい。上下両表面上のいずれの周縁部も面取りされているものが好ましい。このように面取りされていることにより、運搬時等において周縁部の欠けを防止することができる。当該面取り角は、周側面に対して１５〜６０°の範囲内、好ましくは２５〜４５°の範囲内が適当である。
本発明分割錠の上下両表面の平面形状としては、例えば、円形、楕円形、不完全円形、不完全楕円形、矩形、多角形を挙げることができる。不完全円形、不完全楕円形としては、例えば、割線と直交又は平行するように縁部の一部が欠けている円形又は楕円形を挙げることができる（図２〜図８参照）。
【００１５】
本発明分割錠には、フィルムコーティングされているものも含むことができる。フィルムコーティングされている本発明分割錠の分割性も優れている。
【００１６】
【発明の実施の形態】
本発明分割錠は、例えば、所望の形態になるように加工された杵を打錠機にセットし、適当に処方された打錠用の顆粒を当該打錠機に送り、常法により打錠機を操作することによって製造することができる。
本発明分割錠を製造するための打錠成形用杵は、特別に加工する必要があるので、本発明にとって特別なものであるということができる。
【００１７】
本発明分割錠は、上下両表面のそれぞれに割線を有する溝があり、その溝の幅が４ｍｍ〜１０ｍｍの範囲内にあるので、従来の分割錠と異なって、割線に沿って爪を立て、又は爪に相当する適当な器具で割線に沿って押圧力を加えるか、中心部を押圧することによって分割することができる。また、上下両表面に割線を有するから、ＰＴＰ包装されたまま、ＰＴＰ包装面を裏返さずに常に表の面（錠剤が見える面）から前記のように分割することができる。このように本発明では、押圧力を割線に集中させる形態を採っていることから、より優れた均等な分割が可能である。なお、溝の幅が４ｍｍより小さいと爪を立てるなどして分割することが困難となり、１０ｍｍより大きいと爪を立てるなどして分割しようという動機付けが薄れ、従来と同様に指の腹で分割されるおそれがあり、その結果十分に均等な分割が行われないおそれがある。
【００１８】
【実施例】
以下、図面に示す実施例を参照して、本発明を更に詳述する。
【００１９】
図１に示す本発明分割錠Ａ−１は、幅ａが７ｍｍ、深さｂが１．５ｍｍの上下同型のＶ字型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２ｍｍ、錠厚ｄが５ｍｍ、錠径ｅが９ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、平面形状が円形である。
【００２０】
図２に示す本発明分割錠Ａ−２は、幅ａが７ｍｍ、深さｂが１．５ｍｍの上下同型のＶ字型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２ｍｍ、錠厚ｄが５ｍｍ、錠剤の最長径ｅ１が９ｍｍ、錠剤の最短径ｅ２が８．５ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、平面形状が、平面図（１）からわかるように、割線２と直交するように縁部が一部水平に欠けている不完全円形である。当該本発明分割錠Ａ−２は、平面形状が円形の本発明分割錠Ａ−１と比べて割線が短い（支点間距離が長い）ので、より分割性に優れる。
【００２１】
図３に示す本発明分割錠Ａ−３は、幅ａが７ｍｍ、深さｂが１．５ｍｍの上下同型のＶ字型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２ｍｍ、錠厚ｄが５ｍｍ、錠剤の最長径ｅ１が９ｍｍ、錠剤の最短径ｅ２が８ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、当該４つの切り込み口はいわゆるＲ面で丸く削られており、平面形状が、平面図（１）からわかるように、割線２と直交するように縁部が一部水平に欠けている不完全円形である。当該本発明分割錠Ａ−３は、平面形状が円形の本発明分割錠Ａ−１と比べて割線が短い（支点間距離が長い）ので、より分割性に優れる。
【００２２】
図４に示す本発明分割錠Ａ−４は、幅ａが６ｍｍ、深さｂが１ｍｍの上下同型のＶ字型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが３ｍｍ、錠厚ｄが５ｍｍ、錠剤の最長径ｅ１が８ｍｍ、錠剤の最短径ｅ２が９ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、平面形状が、平面図（１）からわかるように、割線２と平行するように縁部が一部水平に欠けている不完全円形である。当該本発明分割錠Ａ−４は、最長径が割線に平行であるので、最長径の方向に沿って切断する錠剤半切器に掛けても割線に沿って分割させることができる。
【００２３】
図５に示す本発明分割錠Ｂ−１は、幅ａが７ｍｍ（ａ１が３．０ｍｍ、ａ２が１ｍｍ）、深さｂが１．５ｍｍ（ｂ１が１ｍｍ、ｂ２が０．５ｍｍ）の上下同型の２段Ｖ字型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２ｍｍ、錠厚ｄが５ｍｍ、錠剤の最長径ｅ１が９ｍｍ、錠剤の最短径ｅ２が８ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、平面形状が、平面図（１）からわかるように、割線２と直交するように縁部が一部水平に欠けている不完全円形である。
【００２４】
図６に示す本発明分割錠Ｂ−２は、幅ａが７ｍｍ（ａ１が１ｍｍ、ａ２が２ｍｍ、ａ３が１ｍｍ）、深さｂが１ｍｍ（ｂ１が０．５ｍｍ、ｂ２が０．５ｍｍ）の途中に平坦部５を有する上下同型の２段Ｖ字型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２．５ｍｍ、錠厚ｄが４．５ｍｍ、錠剤の最長径ｅ１が９ｍｍ、錠剤の最短径ｅ２が８ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平面部４を有し、平面形状が、平面図（１）からわかるように、割線２と直交するように縁部が一部水平に欠けている不完全円形である。
【００２５】
図７に示す本発明分割錠Ｃ−１は、幅ａが７ｍｍ、深さｂが１．５ｍｍの上下同型の凸円弧型溝１を有し、当該溝１の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２があり、かかる１対の割線２を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２ｍｍ、錠厚ｄが５ｍｍ、錠剤の最長径ｅ１が９ｍｍ、錠剤の最短径ｅ２が８ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、平面形状が、平面図（１）からわかるように、割線２と直交するように縁部が一部水平に欠けている不完全円形である。
【００２６】
図８に示す本発明分割錠Ｄ−１は、幅ａ１が７ｍｍ、深さｂ１が１．５ｍｍの上表面にある溝１と、幅ａ２が７ｍｍ、深さｂ２が１．５ｍｍの下表面にある溝１’からなる上下異型のＶ字型溝１及び１’を有し、当該溝１及び１’の各底部には見掛け上形成され、かつ当該錠剤の上下両表面それぞれの中央部に沿って錠剤を２等分する１対の互いに平行する割線２及び２’があり、かかる１対の割線２及び２’を含むＸ−Ｘ線断面に対して左右が対称であり、上下両表面の割線間距離ｃが２ｍｍ、錠厚ｄが５ｍｍ、錠剤の最長径ｅ１が９ｍｍ、錠剤の最短径ｅ２が８ｍｍであり、上下両表面上の周縁部が周側面に対して角度３０°（α）で面取りされており、上下両表面上の溝１及び１’の、割線２に向かう４つの切り込み口と面取り縁部３との間に平坦部４を有し、平面形状が、平面図（１）からわかるように、割線２及び２’と直交するように縁部が一部水平に欠けている不完全円形である。
【００２７】
試験例１分割錠の性状
常法により製造された打錠用顆粒を応用試験装置オートグラフＡＧ−５０００Ａ（島津製作所製、以下同じ）を用いて、１錠重量２８０ｍｇ、打錠圧７００ｋｇの条件下で表１形状の欄に示す４種のサンプル（いずれも裸錠）を製造した。また、得られた４種の裸錠をコーティング装置ドリアコーター５００型（パウレック社製）でヒドロキシプロピルメチルセルロースを主体に被覆してコーティング錠とした。なお、サンプルＮｏ．１〜３錠の溝角度は全て約１５０度であり、Ｎｏ．４の溝角度は約９０度で深さは約０．５ｍｍである。
【００２８】
得られた４種の裸錠とコーティング錠の径方向に、オートグラフＡＧ−５０００Ａで力を加え、錠剤が破壊するまでの最大押圧力を硬度として表１に示す。測定値は錠剤の割線を垂直に位置させたもの（５錠）、割線を水平に位置させたもの（５錠）についての平均値である。
【００２９】
【表１】

【００３０】
サンプルＮｏ．１の本発明分割錠は、裸錠及びフィルムコーティング錠とも、他の従来の分割錠に比べて優るとも劣らない硬度を有した。
【００３１】
試験例２分割に要する押圧力と分割の均等性
試験例１に係る４種の裸錠とコーティング錠の厚み方向に、オートグラフＡＧ−５０００Ａで力を加え、錠剤が分割された時の最大押圧力を測定した。また、分割された錠剤片の重量からＣＶ値（％）を求めた。ここでＣＶ値とは、分割された錠剤片間での重量偏差値を平均重量で割り、これを％で表したものであり、分割の均等性を表す指標となるものである。ＣＶ値が小さいほど均等に分割されたことになる。
分割した時の最大押圧力の測定は、試料台Ａに間隔が６ｍｍの２つの棒状部材Ｂの上に、割線が下向きに、かつ棒状部材Ｂと平行になるようにサンプル錠剤を置き、先端の角度を約６０度に削ぎ落とした刃物状の加圧治具Ｃの先端を各錠剤の割線と平行になるように位置させ、これを下方へ移動し錠剤を加圧することによって行った。
【００３２】
この時の分割方法の模式図を図１０に、押圧力の測定結果を図１１に、分割の均等性の結果を図１２に、それぞれ示す。
当該押圧力の測定の結果、本発明分割錠に相当するＮｏ．１錠は、裸錠及びコーティング錠とも、硬度が高いにも拘わらず最も小さな押圧力で分割された。分割の均等性については、Ｎｏ．１〜３錠が優れていたが、中でも本発明分割錠に相当するＮｏ．１錠が最も優れていた。
【００３３】
試験例３包材（ＰＴＰ）内での分割に要する押圧力（上面）
試験例１に係る４種の裸錠とコーティング錠を割線が下面となるようにＰＴＰ包装し、指で厚み方向に力を加え、錠剤が分割した時の最大押圧力をオートグラフＡＧ−５０００Ａで測定した。
ＰＴＰ包装は、塩化ビニルＤをポケット状に成形し、これに各サンプル錠剤を投入した後アルミ箔Ｅを圧着して行った。ここでＮｏ．１錠については、形態上その方向性を問わないが、Ｎｏ．２，３錠については、割線をアルミ箔側に位置させた。
分割した時の最大押圧力の測定は、ＰＴＰ包装した各錠剤を試料台Ａに置き、最も分割しやすい方法、即ち、親指で塩化ビニル側から垂直方向に加圧することによって行った。なお、押圧方法は、最も割りやすい方法、即ち、Ｎｏ．１錠の場合は爪を割線にあてがい垂直方向に押圧する方法１で、Ｎｏ．２，３錠の場合は錠剤の頂点を親指の腹で垂直方向に押圧する方法２で行った。
【００３４】
この時の分割方法の模式図を図１３に、押圧力の測定結果を図１４に、それぞれ示す。
当該押圧力の測定の結果、本発明分割錠に相当するＮｏ．１錠は、裸錠及びコーティング錠とも、硬度が高いにも拘わらず最も小さな押圧力で分割された。分割の均等性については、試験例２と同様の結果となった。
【００３５】
試験例４包材（ＰＴＰ）内での分割に要する押圧力（下面）
試験例１に係る４種の裸錠とコーティング錠を割線が上面となるようにＰＴＰ包装し、指で厚み方向に力を加え、錠剤が分割した時の最大押圧力をオートグラフＡＧ−５０００Ａで測定した。
ＰＴＰ包装は、塩化ビニルＤをポケット状に成形し、これに各サンプル錠剤を投入した後アルミ箔Ｅを圧着して行った。ここでＮｏ．１錠については、形態上その方向性を問わないが、Ｎｏ．２，３錠については、割線を塩化ビニル側に位置させた。
分割した時の最大押圧力の測定は、ＰＴＰ包装した各錠剤を試料台Ａに置き、最も分割しやすい方法、即ち、Ｎｏ．１錠については塩化ビニル側から、Ｎｏ．２，３錠についてはアルミ箔側から親指で垂直方向に加圧することによって行った。なお、押圧方法は、最も割りやすい方法、即ち、Ｎｏ．１錠の場合は爪を割線にあてがい垂直方向に押圧する方法１で、Ｎｏ．２，３錠の場合は錠剤の頂点を親指の腹で垂直方向に押圧する方法３で行った。
【００３６】
この時の分割方法の模式図を図１５に、押圧力の測定結果を図１６に、それぞれ示す。
当該押圧力の測定の結果、本発明分割錠に相当するＮｏ．１錠は、裸錠及びコーティング錠とも、硬度が高いにも拘わらず最も小さな押圧力で分割された。Ｎｏ．２，３錠が分割に大きな押圧力を必要としたのは、包材である塩化ビニルシートが押圧力によって錠剤の割線が開こうとする力を阻害するためではないかと思われる。
分割の均等性については、試験例２と同様の結果となった。
なお、Ｎｏ．２錠及びＮｏ．３錠について、上記とは逆に塩化ビニル側（上面）から親指の腹で垂直方向に加圧したところ、押圧力が２０ｋｇを越えても分割されず、現実的に分割は不可能であった。
【００３７】
【発明の効果】
本発明の効果として、これまでに掲げた効果の他に、例えば下記の効果を挙げることができる。
▲１▼短径に割線を有する、上下両表面の平面形状が楕円形の本発明分割錠、及び割線と直交するように縁部の一部が欠けている、上下両表面の平面形状が不完全円形の本発明分割錠は、割線を短く又は支点間距離を長くすることができるので、分割性（均等な分割、押圧力の低下等）を上げることができる。また、逆に長径に割線を有する、上下両表面の平面形状が楕円形の本発明分割錠、及び割線と平行するように縁部の一部が欠けている、上下両表面の平面形状が不完全円形の本発明分割錠は、通常病院内等で使用される、いわゆる錠剤半切器に掛けても割線に沿って分割させることができる。
【００３８】
▲２▼上下両表面の平面形状が円形の分割錠を一般の打錠機で製造する場合、下杵も臼も円柱状であるため、下杵が臼の中で自由に回転することになり、その結果上下割線を平行に位置させることが困難となる。しかし、上下両表面の平面形状が円形でない本発明分割錠の場合には、下杵及び臼の構造は下杵が臼の中で自由回転できない構造となるため、無理なく上下割線を平行に位置させることができる。
▲３▼本発明分割錠は、分割時の押圧点が錠剤周辺部より下方に位置することから、輸送中等の外圧による不必要な分割の発生を少なくすることができる。
▲４▼本発明分割錠は、錠剤周辺部が肉厚な構造であることから、両手で保持する分割方法においても保持しやすく分割性に優れる。
【図面の簡単な説明】
【図１】本発明分割錠の一態様を３面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図である。
【図２】本発明分割錠の一態様を４面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図、（４）はその背面図である。
【図３】本発明分割錠の一態様を３面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図である。
【図４】本発明分割錠の一態様を３面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図である。
【図５】本発明分割錠の一態様を３面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図である。
【図６】本発明分割錠の一態様を３面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図である。
【図７】本発明分割錠の一態様を３面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図である。
【図８】本発明分割錠の一態様を４面図で表し、（１）はその平面図、（２）はその正面図、（３）はその側面図、（４）はその底面図である。
【図９】本発明分割錠Ａ−１に係る斜視図を示す。
【図１０】試験例２における分割方法の模式図を示す。太矢印は、力の方向を表す。
【図１１】分割に要した最大押圧力を示す。横軸はサンプル錠剤番号を、縦軸は最大押圧力（ｋｇ）を、それぞれ表す。また、左白抜きカラムは各裸錠のデータを、右黒塗りカラムは各フィルムコーティング錠のデータを、それぞれ表す。
【図１２】分割後の各錠剤片の重量偏差を示す。横軸はサンプル錠剤番号を、縦軸はＣＶ値（％）を、それぞれ表す。また、左白抜きカラムは各裸錠のデータを、右黒塗りカラムは各フィルムコーティング錠のデータを、それぞれ表す。
【図１３】試験例３における分割方法の模式図を示す。太矢印は、力の方向を表す。
【図１４】包材上面からの分割に要した最大押圧力を示す。横軸はサンプル錠剤番号を、縦軸は最大押圧力（ｋｇ）を、それぞれ表す。また、左白抜きカラムは各裸錠のデータを、右黒塗りカラムは各フィルムコーティング錠のデータを、それぞれ表す。
【図１５】試験例４における分割方法の模式図を示す。太矢印は、力の方向を表す。
【図１６】包材下面からの分割に要した最大押圧力を示す。横軸はサンプル錠剤番号を、縦軸は最大押圧力（ｋｇ）を、それぞれ表す。また、左白抜きカラムは各裸錠のデータを、右黒塗りカラムは各フィルムコーティング錠のデータを、それぞれ表す。
【符号の説明】
１，１’・・・溝
２，２’・・・割線
３・・・面取り縁部
４・・・平坦部
５・・・溝内平坦部
６・・・周側面[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a medical divided tablet. More specifically, the present invention relates to a divided medical tablet that can be divided into at least two parts by placing a tablet on a hard surface and pressing the tablet from above.
Here, the term "divided tablet" refers to a tablet that is assumed to be divided into at least two divided tablets and taken.
[0002]
[Prior art]
Divided tablets have been developed to adjust the dosage for individual patients and to broaden the range of formulations.
[0003]
The divided tablet is usually of a type that is picked with a finger and divided by applying force to the inside with both fingers (eg, JP-A-8-277218, JP-A-5-37924, and JP-A-7-19339). A tablet is placed on a hard surface and divided by pressing from above using the belly of a finger (mainly a thumb) (eg, Japanese Utility Model Publication No. 40-3680, Japanese Patent Application Laid-Open No. 61-289027 (Japanese Utility Model Application No. 8-1012), JP-A-7-179333, and JP-A-8-53345).
[0004]
The former type is inconvenient for a patient who has difficulty in picking up tablets because the tablets must be taken out of the PTP package and divided when the tablets are packaged in PTP, which is a normal packaging form. Also, a relatively strong force is required to divide. On the other hand, the latter type can be divided even in the PTP-packaged state, so that the above-mentioned patient can be dealt with. However, the method of applying the force becomes uneven and the uniform division cannot be sufficiently performed. There is a risk. Also, in the case of dividing in the state of PTP wrapping, if the side with the dividing line faces upward, it will be pressed from the back of the PTP wrapping, but in such a case, the cover sheet of the PTP wrapping will be an obstacle, A stronger pressing force is required for dividing. In the case of a film-coated tablet, a stronger pressing force is required.
[0005]
The divided tablet described in Japanese Patent Application Laid-Open No. 7-179333 can have a dividing line on both the upper and lower surfaces, thereby avoiding the problem of division related to the PTP packaging. However, since it is a divided tablet having a side band of a constant width over the entire circumference, it is extremely difficult to produce a tablet having a large thickness in production, and it is inevitably a thin tablet having a large tablet diameter. Be restricted. When the tablet diameter is large, it is inconvenient for the user who takes the package when packaging. It is also feared that the hardness is inferior.
[0006]
[Problems to be solved by the invention]
It is an object of the present invention to provide a medical divided tablet having a relatively small tablet diameter that can be divided more evenly without the above-mentioned problems relating to PTP packaging.
[0007]
[Means for Solving the Problems]
The present inventors have conducted intensive studies and found that the above object can be achieved by forming relatively large grooves having an appropriate width with a score line on both upper and lower surfaces of the tablet. Was completed.
[0008]
The present invention relates to a tablet having a large groove on each of the upper and lower surfaces, wherein the width of each groove is in the range of 4 mm to 10 mm, and each tablet is apparently formed at the bottom of the groove, and There is at least one pair of parallel secant lines bisecting the tablet along the center of each of the upper and lower surfaces, and the left and right sides are symmetrical with respect to a cross section including such a pair of secant lines. Wherein the distance between the tablets is in the range of 2 mm to 8 mm, and the tablet thickness (the longest distance between the upper and lower surfaces) is in the range of 4 mm to 10 mm (hereinafter referred to as the "divided tablet of the present invention"). It is).
[0009]
The width of the groove according to the present invention is suitably in the range of 4 mm to 10 mm at the top and bottom as described above, but is preferably in the range of 5 mm to 8 mm from the dividing method described later. Further, since the shape of the vertical orthogonal cross section of the groove may be the same shape in the vertical direction or the vertical shape, the width of the groove may be different in the vertical direction. However, an upper and lower same type is appropriate.
The depth of the groove is appropriately in the range of 1.5 mm to 8 mm, and preferably in the range of 2 mm to 5 mm, without considering a slight dent that can be formed in the score line portion as described later.
[0010]
As the shape of the vertical orthogonal cross section of the groove, as shown in each front view (2) of FIGS. FIGS. 1 to 4 show a vertical V-shape, FIGS. 5 and 6 show a vertical two-stage V-shape, FIGS. 7 and 8 show a vertical arc-shaped convex arc, and FIG. Is shown. Among them, a V-shape or a two-stage V-shape having the same upper and lower shapes is preferable. In the case of a groove that is not formed by a single slope, such as a two-stage V-shape or an arc V-shape, it may have a flat portion in the middle. Further, in a two-stage V-shape or the like, by making the bottom portion an acute V-shape, it is possible to improve the recognition of the deepest part of the secant.
[0011]
The score line according to the present invention may have at least one pair on each of the upper and lower surfaces, but one pair on each of the upper and lower surfaces is appropriate. The dividable tablet of the present invention having the pair of score lines can divide the tablet into two equal parts, and can be referred to as a dividable tablet of the present invention. In the case of the dividable tablet of the present invention having two pairs of two secant lines orthogonal to each other on both the upper and lower surfaces, the dividable tablet of the present invention can be equally divided into four equal parts, and can be referred to as the quadruple tablet of the present invention.
It is appropriate that the dividing line can be recognized as a straight line so that the central part can be accurately recognized. However, if the central part is recognizable and there is substantially no problem in dividing equally, a small width ( For example, it may be a flat or curved surface having a thickness of 0.1 mm to 0.5 mm). Such planes and curved surfaces corresponding to secant lines may be slightly concave.
In the present invention, the distance between the secant lines on the upper and lower surfaces is suitably in the range of 2 mm to 8 mm, but is preferably in the range of 3 mm to 5 mm. The thickness of the tablet (the longest distance between the upper and lower surfaces) is suitably in the range of 3 mm to 10 mm, but is preferably in the range of 4 mm to 6 mm. As described above, the tablet of the present invention can be a relatively thick tablet.
[0012]
The longest diameter of the divided tablet of the present invention is not particularly limited, but is suitably in the range of 6 mm to 12 mm, and preferably in the range of 7 mm to 10 mm. The shortest diameter of the divided tablet of the present invention is not particularly limited, but is suitably in the range of 4 mm to 12 mm, and preferably in the range of 6 mm to 10 mm.
[0013]
The divided tablet of the present invention can have a flat portion between the cutout of the groove toward the score line and the edge on either or both of the upper and lower surfaces. It is preferable to have a flat portion at any position between the notch and the edge of the groove on both the upper and lower surfaces. By having such a flat portion, collapse of the fulcrum due to pressing can be reduced. The maximum width of the flat portion varies depending on the planar shape of the tablet, the width of the groove, and the like, and is not particularly limited. For example, 0.5 mm to 1.5 mm is sufficient. In addition, it is preferable that each cut-out of the groove is rounded. By providing such roundness, it is possible to reduce collapse of each cutout due to pressing.
[0014]
The divided tablet of the present invention may have a chamfered peripheral portion on both upper and lower surfaces or one of the surfaces. It is preferable that both peripheral edges on both upper and lower surfaces are chamfered. By being chamfered in this way, it is possible to prevent chipping of the peripheral portion during transportation or the like. The chamfer angle is suitably in the range of 15 to 60 ° with respect to the peripheral side surface, preferably in the range of 25 to 45 °.
Examples of the planar shape of the upper and lower surfaces of the divided tablet of the present invention include a circle, an ellipse, an incomplete circle, an incomplete ellipse, a rectangle, and a polygon. Examples of the incomplete circular shape and the incomplete elliptical shape include a circular shape and an elliptical shape in which a part of an edge is missing so as to be orthogonal or parallel to the dividing line (see FIGS. 2 to 8).
[0015]
The dividable tablet of the present invention may include a tablet coated with a film. The splittable tablet of the present invention coated with a film is also excellent in dividability.
[0016]
BEST MODE FOR CARRYING OUT THE INVENTION
The divided tablet of the present invention is prepared by, for example, setting a punch processed into a desired form in a tableting machine, sending appropriately formulated tableting granules to the tableting machine, and performing tableting by a conventional method. It can be manufactured by operating the machine.
Since the tableting punch for producing the split tablet of the present invention requires special processing, it can be said that the punch is special to the present invention.
[0017]
The divided tablet of the present invention has a groove having a dividing line on each of the upper and lower surfaces, and the width of the groove is in the range of 4 mm to 10 mm, so unlike the conventional divided tablet, the nail is set up along the dividing line, Alternatively, the sheet can be divided by applying a pressing force along a dividing line with an appropriate device corresponding to a nail or pressing the central portion. In addition, since the upper and lower surfaces have the dividing lines, the PTP package can be divided as described above from the front surface (the surface where the tablet is visible) without turning over the PTP packaging surface. As described above, in the present invention, the pressing force is concentrated on the dividing line, so that more excellent and even division can be performed. If the width of the groove is smaller than 4 mm, it is difficult to divide by erecting a nail, and if it is larger than 10 mm, motivation to divide by erecting a claw is weakened. And there is a possibility that a sufficiently uniform division is not performed.
[0018]
【Example】
Hereinafter, the present invention will be described in more detail with reference to embodiments shown in the drawings.
[0019]
The split tablet A-1 of the present invention shown in FIG. 1 has a vertically-shaped V-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm, and is apparently formed at each bottom of the groove 1. There is a pair of parallel secant lines 2 bisecting the tablet along the center of each of the upper and lower surfaces of the tablet, and the right and left sides of the XX line cross section including the pair of secant lines 2 It is symmetrical, the distance c between the dividing lines on the upper and lower surfaces is 2 mm, the tablet thickness d is 5 mm, the tablet diameter e is 9 mm, and the peripheral edge on both the upper and lower surfaces is chamfered at an angle of 30 ° (α) to the peripheral side surface. The groove 1 on both upper and lower surfaces has a flat portion 4 between the four cutouts toward the dividing line 2 and the chamfered edge portion 3 and has a circular planar shape.
[0020]
The divided tablet A-2 of the present invention shown in FIG. 2 has a vertically-shaped V-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm, and is apparently formed at each bottom of the groove 1. There is a pair of parallel secant lines 2 bisecting the tablet along the center of each of the upper and lower surfaces of the tablet, and the right and left sides of the XX line cross section including the pair of secant lines 2 The distance c between the dividing lines on the upper and lower surfaces is 2 mm, the tablet thickness d is 5 mm, the longest diameter e1 of the tablet is 9 mm, and the shortest diameter e2 of the tablet is 8.5 mm. A chamfered edge at an angle of 30 ° (α) with respect to the side surface, a flat portion 4 between the four cuts of the groove 1 on the upper and lower surfaces toward the dividing line 2 and the chamfered edge portion 3, As can be seen from the plan view (1), the shape is an incomplete circle in which an edge part is partially horizontal so as to be orthogonal to the dividing line 2. is there. The dividable tablet A-2 of the present invention has a shorter dividing line (longer distance between fulcrums) than the dividable tablet A-1 of the present invention having a circular planar shape, and thus is more excellent in dividability.
[0021]
The divided tablet A-3 of the present invention shown in FIG. 3 has an upper and lower identical V-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm, and is apparently formed at each bottom of the groove 1. There is a pair of parallel secant lines 2 bisecting the tablet along the center of each of the upper and lower surfaces of the tablet, and the right and left sides of the XX line cross section including the pair of secant lines 2 The distance c between the dividing lines on the upper and lower surfaces is 2 mm, the tablet thickness d is 5 mm, the longest diameter e1 of the tablet is 9 mm, and the shortest diameter e2 of the tablet is 8 mm. The groove 1 is chamfered at an angle of 30 ° (α), and has a flat portion 4 between the four cutouts of the groove 1 on the upper and lower surfaces toward the secant line 2 and the chamfered edge portion 3. The cut is rounded at the so-called R-plane, and the plane shape is directly aligned with the score line 2 as can be seen from the plan view (1). It is an incomplete circle with some edges missing horizontally so as to intersect. The dividable tablet A-3 of the present invention has a shorter dividing line (longer distance between fulcrums) than the dividable tablet A-1 of the present invention having a circular planar shape, and thus is more excellent in dividability.
[0022]
The divided tablet A-4 of the present invention shown in FIG. 4 has an upper and lower identical V-shaped groove 1 having a width a of 6 mm and a depth b of 1 mm, and is apparently formed at each bottom of the groove 1, and There is a pair of parallel secant lines 2 that bisect the tablet along the center of each of the upper and lower surfaces of the tablet, and the left and right sides are symmetrical with respect to the XX line cross section including the pair of secant lines 2. The distance c between the secant lines on the upper and lower surfaces is 3 mm, the tablet thickness d is 5 mm, the longest diameter e1 of the tablet is 8 mm, and the shortest diameter e2 of the tablet is 9 mm. The groove 1 is chamfered at an angle of 30 ° (α), and has a flat portion 4 between the four cuts of the groove 1 on the upper and lower surfaces toward the secant line 2 and the chamfered edge portion 3. As can be seen from FIG. 1A, the edge is partially imperfectly circular in parallel with the dividing line 2. Since the longest diameter of the divided tablet A-4 of the present invention is parallel to the dividing line, it can be divided along the dividing line even when it is hung on a tablet half-cutting device that cuts along the direction of the longest diameter.
[0023]
The divided tablet B-1 of the present invention shown in FIG. 5 has a width a of 7 mm (a1 is 3.0 mm, a2 is 1 mm) and a depth b of 1.5 mm (b1 is 1 mm, b2 is 0.5 mm). A two-stage V-shaped groove 1 which is apparently formed at each bottom of the groove 1 and halves the tablet along the center of each of the upper and lower surfaces of the tablet. The left and right sides are symmetrical with respect to the cross section taken along the line XX including the pair of split lines 2, the distance c between the upper and lower surfaces is 2 mm, the tablet thickness d is 5 mm, and the longest diameter e1 of the tablet Is 9 mm, the shortest diameter e2 of the tablet is 8 mm, and the peripheral edge on both upper and lower surfaces is chamfered at an angle of 30 ° (α) with respect to the peripheral side surface. It has a flat part 4 between the four notches and the chamfered edge 3, and the plan shape can be seen from the plan view (1). Thus, an incomplete circle in which the edge is partially horizontally cut off so as to be orthogonal to the dividing line 2.
[0024]
The divided tablet B-2 of the present invention shown in FIG. 6 has a width a of 7 mm (a1 is 1 mm, a2 is 2 mm, a3 is 1 mm), and a depth b is 1 mm (b1 is 0.5 mm, b2 is 0.5 mm). A two-stage V-shaped groove 1 having the same shape as the upper and lower portions having a flat portion 5 in the middle is formed apparently at the bottom of each groove 1, and the tablet is formed along the center of each of the upper and lower surfaces of the tablet. There is a pair of parallel secant lines 2 bisecting each other. The left and right sides are symmetrical with respect to the XX line cross section including the pair of secant lines 2, and the distance c between the upper and lower surfaces is 2.5 mm. The tablet thickness d is 4.5 mm, the longest diameter e1 of the tablet is 9 mm, the shortest diameter e2 of the tablet is 8 mm, and the peripheral edges on both upper and lower surfaces are chamfered at an angle of 30 ° (α) with respect to the peripheral side surface. A flat portion 4 is formed between the four notches of the groove 1 on the upper and lower surfaces toward the dividing line 2 and the chamfered edge portion 3. As can be seen from the plan view (1), the planar shape is an incomplete circle in which an edge part is partially horizontal so as to be orthogonal to the dividing line 2.
[0025]
The divided tablet C-1 of the present invention shown in FIG. 7 has a vertically arcuate convex arc-shaped groove 1 having a width a of 7 mm and a depth b of 1.5 mm, and is apparently formed at each bottom of the groove 1. There is a pair of parallel secant lines 2 bisecting the tablet along the center of each of the upper and lower surfaces of the tablet, and the right and left sides of the XX line cross section including the pair of secant lines 2 The distance c between the dividing lines on the upper and lower surfaces is 2 mm, the tablet thickness d is 5 mm, the longest diameter e1 of the tablet is 9 mm, and the shortest diameter e2 of the tablet is 8 mm. On the other hand, the groove 1 is chamfered at an angle of 30 ° (α), and has a flat portion 4 between the four notches of the groove 1 on the upper and lower surfaces toward the secant line 2 and the chamfered edge portion 3. As can be seen from the plan view (1), the edge is partially imperfectly circular so as to be orthogonal to the secant line 2. You.
[0026]
The divided tablet D-1 of the present invention shown in FIG. 8 has a groove 1 having a width a1 of 7 mm and a depth b1 of 1.5 mm on the upper surface, and a groove a2 having a width a2 of 7 mm and a depth b2 of 1.5 mm on the lower surface. It has V-shaped

grooves

1 and 1 ′ of an irregular shape consisting of a certain groove 1 ′, which are apparently formed at the bottom of each of the

grooves

1 and 1 ′, and along the center of each of the upper and lower surfaces of the tablet. There are a pair of

parallel secant lines

2 and 2 ′ that divide the tablet into two equal parts. The left and right sides are symmetric with respect to the XX line cross section including the pair of

secant lines

2 and 2 ′. The distance c between the secant lines is 2 mm, the tablet thickness d is 5 mm, the longest diameter e1 of the tablet is 9 mm, the shortest diameter e2 of the tablet is 8 mm, and the peripheral edge on both upper and lower surfaces is at an angle of 30 ° (α) to the peripheral side surface. Between the four notches of the

grooves

1 and 1 ′ on the upper and lower surfaces facing the score line 2 and the chamfered edge 3. As shown in the plan view (1), the planar shape is an incomplete circular shape having a part of the edge partly horizontal so as to be orthogonal to the

dividing lines

2 and 2 ′.
[0027]
Test Example 1 Properties of Divided Tablets
The granules for tableting manufactured by a conventional method were applied to the column of the shape of Table 1 under the conditions of a tablet weight of 280 mg and a tableting pressure of 700 kg using an applied test device Autograph AG-5000A (manufactured by Shimadzu Corporation, same hereafter). The four types of samples shown (all were plain tablets) were produced. Further, the obtained four types of naked tablets were coated mainly with hydroxypropylmethylcellulose using a coating apparatus Doria Coater Model 500 (manufactured by Powrex) to obtain coated tablets. The sample No. No. 1 to 3 tablets have a groove angle of about 150 degrees. The groove angle of No. 4 is about 90 degrees and the depth is about 0.5 mm.
[0028]
A force was applied in the radial direction of the obtained four types of uncoated tablets and coated tablets using an Autograph AG-5000A, and the maximum pressing force until the tablets were broken is shown in Table 1 as hardness. The measured values are the average values of the tablet with the dividing line positioned vertically (5 tablets) and the tablet with the dividing line positioned horizontally (5 tablets).
[0029]
[Table 1]

[0030]
Sample No. In one of the divided tablets of the present invention, both the uncoated tablet and the film-coated tablet had hardness equal to or lower than that of other conventional divided tablets.
[0031]
Test example 2 Pressing force required for division and uniformity of division
A force was applied to the four types of naked tablets and the coated tablets according to Test Example 1 in the thickness direction using an autograph AG-5000A, and the maximum pressing force when the tablets were split was measured. The CV value (%) was determined from the weight of the divided tablet pieces. Here, the CV value is a value obtained by dividing the weight deviation value between the divided tablet pieces by the average weight and expressing the result in%, and is an index indicating the uniformity of the division. The smaller the CV value, the more evenly the CV value is divided.
For the measurement of the maximum pressing force at the time of division, the sample tablet was placed on two bar-shaped members B with an interval of 6 mm on the sample table A so that the score line was downward and parallel to the bar-shaped member B. The cutting was performed by positioning the tip of a blade-shaped pressing jig C whose angle was cut off to about 60 degrees so as to be parallel to the dividing line of each tablet, and moving this downward to press the tablets.
[0032]
FIG. 10 shows a schematic diagram of the dividing method at this time, FIG. 11 shows a measurement result of the pressing force, and FIG. 12 shows a result of the uniformity of the division.
As a result of the measurement of the pressing force, No. 1 corresponding to the divided tablet of the present invention was obtained. One tablet was divided with the smallest pressing force despite the hardness being high for both the uncoated tablet and the coated tablet. Regarding the uniformity of the division, Nos. 1 to 3 tablets were excellent. One tablet was the best.
[0033]
Test Example 3 Pressing force (upper surface) required for division in packaging material (PTP)
The four types of naked tablets and coated tablets according to Test Example 1 were PTP-packed such that the score line was on the lower side, and a force was applied in the thickness direction with a finger, and the maximum pressing force when the tablets were divided was determined by Autograph AG-5000A. It was measured.
The PTP packaging was performed by molding vinyl chloride D into a pocket, charging each sample tablet into the pocket, and pressing the aluminum foil E by pressure. Here, No. Regarding one tablet, the shape may be determined in any direction. For a few tablets, the score line was located on the aluminum foil side.
The maximum pressing force at the time of division was measured by placing each PTP-packaged tablet on the sample table A and applying the method of easiest division, that is, pressing vertically from the vinyl chloride side with the thumb. The pressing method is the easiest to split, that is, the No. In the case of one tablet, the nail is applied to the score line and pressed in the vertical direction. In the case of a few tablets, Method 2 was used in which the top of the tablet was pressed vertically with the belly of the thumb.
[0034]
FIG. 13 shows a schematic diagram of the dividing method at this time, and FIG. 14 shows the measurement results of the pressing force.
As a result of the measurement of the pressing force, No. 1 corresponding to the divided tablet of the present invention was obtained. One tablet was divided with the smallest pressing force despite the hardness being high for both the uncoated tablet and the coated tablet. Regarding the uniformity of division, the same result as in Test Example 2 was obtained.
[0035]
Test Example 4 Pressing force (lower surface) required for division within packaging material (PTP)
The four types of naked tablets and coated tablets according to Test Example 1 were packaged in PTP so that the score line was on the upper side, and a force was applied in the thickness direction with a finger, and the maximum pressing force when the tablets were split was determined with an autograph AG-5000A. It was measured.
The PTP packaging was performed by molding vinyl chloride D into a pocket, charging each sample tablet into the pocket, and pressing the aluminum foil E by pressure. Here, No. Regarding one tablet, the shape may be determined in any direction. For a few tablets, the score line was located on the vinyl chloride side.
The maximum pressing force at the time of division is measured by placing each tablet packaged in the PTP on the sample table A, and dividing the tablet in the most easily divided manner. No. 1 tablet from the vinyl chloride side. For a few tablets, pressing was performed in the vertical direction with the thumb from the aluminum foil side. The pressing method is the easiest to split, that is, the No. In the case of one tablet, the nail is applied to the score line and pressed in the vertical direction. In the case of a few tablets, Method 3 was used in which the top of the tablet was pressed vertically with the belly of the thumb.
[0036]
FIG. 15 shows a schematic diagram of the dividing method at this time, and FIG. 16 shows the measurement results of the pressing force.
As a result of the measurement of the pressing force, No. 1 corresponding to the divided tablet of the present invention was obtained. One tablet was divided with the smallest pressing force despite the hardness being high for both the uncoated tablet and the coated tablet. No. It is considered that the reason why a few tablets required a large pressing force for the division was that the vinyl chloride sheet as the packaging material hindered the force of opening the score line of the tablet by the pressing force.
Regarding the uniformity of division, the same result as in Test Example 2 was obtained.
In addition, No. 2 tablets and no. Contrary to the above, when three tablets were pressed vertically from the vinyl chloride side (upper surface) with the abdomen of the thumb, even if the pressing force exceeded 20 kg, the tablets were not split, and splitting was practically impossible. .
[0037]
【The invention's effect】
The effects of the present invention include, for example, the following effects in addition to the effects listed above.
{Circle around (1)} The split tablet of the present invention having a dividing line in the minor axis, the upper and lower surfaces of the upper and lower surfaces being elliptical, and a part of the edge part missing so as to be orthogonal to the dividing line, the upper and lower surfaces not flat. The completely circular tablet of the present invention can shorten the score line or lengthen the distance between the fulcrums, so that the dividing property (equal division, reduction of pressing force, etc.) can be improved. Conversely, the present splittable tablet of the present invention having a dividing line in the major axis, the upper and lower surfaces of which are elliptical in plan view, and a part of the edge portion missing so as to be parallel to the dividing line, the upper and lower surfaces are not flat. The divided tablet of the present invention having a perfect circular shape can be divided along the dividing line even when it is hung on a so-called tablet half-cut device usually used in hospitals and the like.
[0038]
(2) When manufacturing a divided tablet having a circular top and bottom surface with a general tableting machine, both the lower punch and the die are cylindrical, so that the lower punch freely rotates in the die. As a result, it is difficult to position the upper and lower secant lines in parallel. However, in the case of the divided tablet of the present invention in which the upper and lower surfaces are not circular, the lower punch and the die have a structure in which the lower punch cannot rotate freely in the die, so that the upper and lower split lines are easily placed in parallel. Can be done.
(3) In the divided tablet of the present invention, since the pressing point at the time of division is located below the periphery of the tablet, unnecessary division due to external pressure during transportation or the like can be reduced.
{Circle around (4)} Since the tablet peripheral portion of the present divided tablet has a thick structure, it is easy to hold even in the dividing method in which the tablet is held with both hands, and is excellent in dividability.
[Brief description of the drawings]
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows one embodiment of the divided tablet of the present invention in three views, (1) is a plan view, (2) is a front view, and (3) is a side view.
FIG. 2 shows one embodiment of the divided tablet of the present invention in four views, wherein (1) is a plan view, (2) is a front view, (3) is a side view, and (4) is a rear view. is there.
FIG. 3 shows one embodiment of the split tablet of the present invention in three views, (1) is a plan view, (2) is a front view, and (3) is a side view.
FIG. 4 shows one embodiment of the divided tablet of the present invention in three views, wherein (1) is a plan view, (2) is a front view, and (3) is a side view.
FIG. 5 shows one embodiment of the divided tablet of the present invention in three views, wherein (1) is a plan view, (2) is a front view, and (3) is a side view.
FIG. 6 shows one embodiment of the split tablet of the present invention in three views, (1) is a plan view, (2) is a front view, and (3) is a side view.
FIG. 7 shows one embodiment of the divided tablet of the present invention in three views, wherein (1) is a plan view, (2) is a front view, and (3) is a side view.
FIG. 8 shows one embodiment of the divided tablet of the present invention in four views, (1) is a plan view, (2) is a front view, (3) is a side view, and (4) is a bottom view. is there.
FIG. 9 shows a perspective view of the divided tablet A-1 of the present invention.
FIG. 10 shows a schematic diagram of a division method in Test Example 2. Thick arrows indicate the direction of the force.
FIG. 11 shows the maximum pressing force required for division. The horizontal axis represents the sample tablet number, and the vertical axis represents the maximum pressing force (kg). The white columns on the left represent data for each uncoated tablet, and the black columns on the right represent data for each film-coated tablet.
FIG. 12 shows the weight deviation of each tablet piece after division. The horizontal axis represents the sample tablet number, and the vertical axis represents the CV value (%). Further, the left blank column represents data of each uncoated tablet, and the right black column represents data of each film-coated tablet.
FIG. 13 shows a schematic diagram of a division method in Test Example 3. Thick arrows indicate the direction of the force.
FIG. 14 shows the maximum pressing force required for division from the upper surface of the packaging material. The horizontal axis represents the sample tablet number, and the vertical axis represents the maximum pressing force (kg). The white columns on the left represent data for each uncoated tablet, and the black columns on the right represent data for each film-coated tablet.
FIG. 15 shows a schematic diagram of a division method in Test Example 4. Thick arrows indicate the direction of the force.
FIG. 16 shows the maximum pressing force required for division from the lower surface of the packaging material. The horizontal axis represents the sample tablet number, and the vertical axis represents the maximum pressing force (kg). The white columns on the left represent data for each uncoated tablet, and the black columns on the right represent data for each film-coated tablet.
[Explanation of symbols]
1, 1 '... groove
2,2 '・・・ Separation line
3 ... Chamfered edge
4 Flat part
5 ... flat part in the groove
6 ・・・ Surface side

Claims

A tablet having a large groove on each of the upper and lower surfaces, both the width of the groove is in the range of 4 mm to 10 mm, it is formed apparently in the bottom of the groove, upper and lower surfaces of those tablets There is at least one pair of parallel secant lines that bisect the tablet along each central portion, the left and right sides are symmetrical with respect to the cross section including the pair of secant lines, and the distance between the upper and lower surfaces is 2 mm. in the range of ～8Mm, tablet thickness (vertical maximum distance between the two surfaces) is in the range of 4 mm to 10 mm, and medical scored tablets, wherein the this no side band of constant width.

The divided tablet for medical use according to claim 1, wherein the longest diameter of the tablet is 6 mm to 12 mm, and the shortest diameter is 4 mm to 12 mm.

The medical divided tablet according to claim 1 or 2, wherein a flat portion is provided between the notch of the groove toward the score line and the edge on either or both of the upper and lower surfaces.

The medical divided tablet according to any one of claims 1 to 3, wherein a peripheral edge portion is chamfered on both or one of the upper and lower surfaces.

The medical divided tablet according to any one of claims 1 to 4, wherein the shape of the groove present on both upper and lower surfaces in a vertical orthogonal cross section is a V-shape or a two-stage V-shape of the same shape in the upper and lower sides.

The medical divided tablet according to any one of claims 1 to 5, wherein a planar shape of both upper and lower surfaces is a circle, an ellipse, an incomplete circle, an incomplete ellipse, a rectangle, or a polygon.

The divided medical tablet according to any one of claims 1 to 6, which is film-coated.

A tableting punch for producing the divided medical tablet according to any one of claims 1 to 6.