SI8710853A

SI8710853A - IMPROVED CAPSULE

Info

Publication number: SI8710853A
Application number: SI8710853A
Authority: SI
Inventors: Bernard Schweiger; Alfred Wagner
Original assignee: Shionogi Europ
Priority date: 1986-05-15
Filing date: 1987-05-13
Publication date: 1997-02-28
Also published as: HRP940191B1; HRP940191A2; SI8710853B

Abstract

Pokrov želatinaste kapsule ima prstenast žleb v delu odprtega konca zaradi zmanjšanja ovalnosti.The gelatin capsule cap has an annular groove in the open end portion to reduce ovality.

Description

Pronalazak ee odnosi na onu vrstu kapsula koja se sestoji od uglavnom cilindrično# dola tela i poklopca koji se teleskop» skl postavlja na telo, a posebno se odnosi na vratu tvrdih žela» tinskih kapsula koje se šesto koriste aa punjenje faraaoeutskia preparatima·The invention relates to a type of capsule that consists of a mostly cylindrical body and a lid that is telescoped onto the body, but it particularly relates to the neck of hard gelatin capsules that are used for filling pharmaceutical preparations.

Tvrde Želatinske kapsule prave se Is dva dela saronjavanjem Seličnih stubiča u istopijeni rastvor želatina, formiranjem 1 su» Senjem želatina i skidanjem formiranih školjki sa stublča·Hard Gelatin capsules are made in two parts by soaking the Selic stalks in a melted gelatin solution, forming 1 layer of gelatin and removing the formed shells from the stalk.

OpŠte je posnato da se film želatina pri sušenju skuplja· Kontrola vlažnosti u toku i posle operacije sušenja kritična je sa dlmensionalnu stabilnost formiranih kapsula· Skupljanjo sevi» si od broja faktora, kao količine vode koju trba ukloniti, vrste upotrebljenog želatina, režima sušenja i broja 1 vrste dodataka, kao Sto au boje 1 površinski aktivna jedinjenja· Kapsule gube još do $$ vlage posle skldanja sa stubiča, na kojima su se for» mlrale·It is generally known that the gelatin film shrinks during drying. Humidity control during the drying process and after the drying operation is critical to the dimensional stability of the formed capsules.

Efekat promena uslova sušenja i sestava želatina vodi do promena prečnika formiranih i suvih Školjki· Zatim efekat toka želatina u sudu sa uronjavanje, zajedno aa konusnlm stublČisa i sogučia prieuetvora profila koji obesbedjuju spajanje polovina kapsula, komblnovano aa sistemom sušenja koji usrokuje da presek suve kapsule ne bude okrugao, pravi ovalni otvor«The effect of changing the drying conditions and the composition of the gelatin leads to a change in the diameter of the formed and dry shells. Then the effect of the flow of the gelatin in the vessel is immersion, together with the conical stems and the congruence of the profile profile that ensure the joining of half the capsule, combined with the drying system that ensures that the cross section of the dry capsule is not round, a true oval opening.

Jedan od efekata te ovalnosti je da pravi teškoče pri epa» jenju dveju polovina kapsule· Kesto teleskopsko# uvlačenja jed» ne u drogu, dve polovine mogu se uvučl do neke granice, us so * gučnost proeipanja jedne 111 obe polovine kapsule, sa trenutnim ili kasnijlm gubljenja« sadržaja kapsule·One of the effects of this ovality is that it makes it difficult to separate the two halves of the capsule. When the two halves are retracted with a rod, the two halves can be retracted to a certain limit, resulting in the ability to penetrate one and both halves of the capsule, with immediate or delayed loss of the contents of the capsule.

Vrženi su napori da ae problemi ovalnosti prevasldju, napr. prosenem oblika· Ipak, do sada nije bilo moguče da se nadje sa» dovoljavajuče rešenj e problema i merenj» vržena na veličini 1 poklopca kapsule prečnika 6*9 mm pokesala su da ovalno st, odredjena merenje« razlike izmedju največlh i najmanjih prečnika, Is» nosi do 0*5 mm, bes obzira na proizvodjača kapsula*Efforts have been made to overcome problems of ovality, e.g. However, until now it has not been possible to find a satisfactory solution to the problem and the measurements taken on the size 1 of the capsule lid with a diameter of 6*9 mm have turned out to be oval.

-2Pronalazak predvidja r®Sonje problema ovalnosti no menja juči nalove formiranja i gašenja kapsulo·-2 The discovery predicts r®Sonje's problem of ovality but changes the ways of forming and extinguishing the capsule.

Ovaj pronalasak predvidja da školjka kapsulo ima prstenast žleb u delu otvorenog kraja« Poželjno je da je Žleb na poklopou.This invention provides that the capsule shell has an annular groove in the part of the open place" It is preferable that the groove is on the lid.

»boo otvorenog kraja” enači da ae nalazi blizu otvorenog kraja, tj« ne dalje od 2 ma, poželjno izmedju 0.5 mm i 1*5 sta od sečenog kraja, u zavisnosti od veličine kapsule·"boo of an open place" means that ae is located near the open place, i.e. not further than 2 ma, preferably between 0.5 mm and 1*5 from the cut place, depending on the size of the capsule.

Prisustvo prestenastog žleba dozvoljava da ee film kapsule suši pri normalnim ueloviaa, uz mnogo smanjenu mogučnost etva* ranja ovala« Sod kapsule veličine 1 napr. najbolje je postaviti žleb na rastojanju od oko 0.5 ®m do oko 1*6 sm od otvorenog kraja školjke« Žleb treba da bude neprekidan. Ipak, moguče je postiči smanjenje ovalnosti upotrebom eegmentnog žleba, napr* od oko 2 do oko 12 segmenata. Segmenti bi trebalo da okruže najtanje oko 90$ obima školjke« Tipično je da je Širino Žleba od okoThe presence of a ring-shaped groove allows the capsule film to dry at normal ueloviaa, with a much reduced possibility of forming an oval" Sod capsule size 1 e.g. it is best to place the gutter at a distance of about 0.5 ®m to about 1*6 cm from the open part of the shell" The gutter must be continuous. However, it is possible to achieve a reduction in ovality by using an eegment groove, eg* from about 2 to about 12 segments. The segments should surround the thinnest eye 90$ of the circumference of the shell" It is typical that the Width of the Groove from the eye

0*3 mm do oko 1*9 na, e dubina od oko O«ol ms do oko O.o5 aa« Dimenzije, profil poprečnog pržseka i položaj Žleba nisu 0*3 mm to eye 1*9 na, e depth from eye O«ol ms to eye O.o5 aa« Dimensions, cross-section profile and position of the Groove are not kritični, critical, a poželjne dimenzijo zavlse od veličine kapsule* Ovi and the desired dimension depends on the size of the capsule* These parametri parameters za obične veličine kapsula mogu ze izabrati for regular sizes, the capsule can be chosen is tabele. from the table. Voličina kapsule Volicina capsules Žleb dubina (mm) Groove depth (mm) Rastojanje od sečenog kraja(om)^x Distance from cut place(s) ^x žleb 3irina(®m) groove 3width(®m) 00 00 Ο*ο25-Ο·ο35 Ο*ο25-Ο·ο35 1-1.6 1-1.6 0*51-0.55 0*51-0.55 0 0 O.o25-O.o35 O.o25-O.o35 1-1*6 1-1*6 0*91-0.55 0*91-0.55 1 1 O.o2o-O«e3o O.o2o-O«e3o 1-1*6 1-1*6 0.46-0.50 0.46-0.50 2 2 O*el5~©«o25 O*el5~©«o25 0.8-1.4 0.8-1.4 0.37-0.41 0.37-0.41 5 5 0*olo-0«o2o 0*olo-0«o2o 0*7-1.3 0*7-1.3 0.32-0.36 0.32-0.36 4 4 G.Gle-O.©2o Mr.Gle-O.©2o 0.7-1.3 0.7-1.3 0.32-0.36 0.32-0.36 ^xHereno do orediSta žleba* ^x Hereno to the Oreda gutter* e e

Poprečni presek Žleba može biti kriv ili ugaoni i može ee menjati prema obliku, napr« od jednostruke do višestruke veličine prečnika, Ui da bude u obliku V, do višeugaonih oblika, kao kvadratnog, pravougaonog ili trapeznog.The cross-section of the gutter can be curved or angular and can change according to the shape, for example, from single to multiple sizes of the cross-section, Ui to be V-shaped, to polygonal shapes, such as square, rectangular or trapezoidal.

Pronalazak če ee bolje razumeti uz priložen ortež, gde sl.1 prikazuje neobavezno poklopac kapsule urad j en prema pronalasku, a sl« 2 prikazuje uvedene oblike detalja označenog se A ne sl.1«The invention can be better understood with the attached diagram, where fig. 1 shows an optional capsule cover made according to the invention, but fig. 2 shows the introduced forms of the detail marked A not fig. 1.

Sl« 1 prikazuje deo poklopca kapsule veličine X« Ukupna du5žina poklopca kapsule veličine 1 iznosi 10 mm« Žleb dubine O.o2 aa i Širine 0«5o as formiran je ea sredižtem na raetojanju 1*3 ss od scčenog kraja« Poklopac je formiran na atubiču odgovara * jučeg profila»Fig. 1 shows a part of the cap of the capsule of size X. The total length of the cap of the capsule of size 1 is 10 mm.

Oblik poprečnog preseka žleba seže biti aa koji« več usvojeni, a sl. 2 prikasuje niz odgovarajučih oblika poprečnog pre« seka žleba, koji ee aogu koristit, a koji nije konačan.The shape of the cross-section of the gutter reaches to be aa koji" more adopted, but fig. 2 shows a series of suitable shapes of the cross-section of the gutter, which will be useful, but which are not final.

Školjke kapsule preša pronalasku mogu imati druge oblike, kao napr. oblik satvaranja, prema britanskim patentiaa 970761, 1040859 i 1442121.The capsule shells of the press of the invention can have other shapes, such as e.g. forms of production, according to British patents 970761, 1040859 and 1442121.

8a druge strane poam&trano, pronalazak se odnosi i na stubič koji ima prstenast žleb pogodan ea pravljenje Školjke kapsule prema pronalasku.On the other hand, it is understood that the invention also relates to a stem having an annular groove suitable for making a capsule shell according to the invention.

Vržena je serija proba da se naprave lelatinski poklopci razUčltib oblika, koji eadrže ili 2 »PRE-IOK» (saStitai trgo« vački znak) foraacije, ili 4 PRS-IOK formacije (videti brit« anski patent 1442121). Poklopci se prave sa žlebom O.o2 ma, prikazano na sl. 9.A series of tests was conducted to determine the shape of the plastic lids, which holds either 2 "PRE-IOK" (saStitai trago" sign) formations, or 4 PRS-IOK formations (see British patent 1442121). The covers are made with a groove O.o2 ma, shown in fig. 9.

ESSSžJ.ESSSŽJ.

Poklopci kapsula veličine 1 napravljeni su aa 2 PRE—LOK^Mformscijom i pratenastla žlebom, kao Sto je ranije opisano* Bi« multano su napravljeni i poklopci kapsula veličine 1 sa 4 PRELOK formacijo«, ali bez prstenastog žleba« Uzorak od po $0 po« klopaca od obe vrste uzet je pri reletivnoj vlažnosti od 15%· Ovelnost svakog poklopca odredjena je merenjea največeg i naj« manjeg prečnika i odredjivanjem razlike« Za standardne poklopca srednja ovalnoet bila je 0«127 mm, dok je za kapsule sa krožnim Žlebom srednja ovalnoet smanjena na C«o89 mm.Size 1 capsule lids are made with a 2 PRELOK ^M formation and an annular groove, as described earlier* Size 1 capsule lids are also made with a 4 PRELOK formation, or without an annular groove. A sample of $0 per" lid from both types is taken at a relative humidity of 15%. The thickness of each lid is determined by measuring the largest and smallest diameter and determining the difference" For standard caps, the average ovality was 0"127 mm, while for capsules with a circular groove, the average ovality was reduced to C"o89 mm.

Gornja proba napravljena je pod posebnim uslovima i uzorci au uzeti pri relativno j vlažnosti 14,5%. standardne kapsule po« kazale su srednju ovalnoet od 0.132 mo, dok su kapsule sa prst« enastim žlebovima imele srednju ovalnoet samo 0«©79 mm.The above test was made under special conditions and samples were taken at a relative humidity of 14.5%. The standard capsules showed a mean ovality of 0.132 mm, while the capsules with finger grooves had a mean ovality of only 0.79 mm.

iaisJiaisJ

Poklopci kapstla veličine 1 napravljeni su sa 2 “FRS-LOK forma©ijom i sa prstenasti® žlebovima keo prema probi 1. Siaul« tene su napravljeni poklopci kapsula standardne veličine 1 sa pab-LOK* formacijama i ea P06ILCK (zaStitni trgovački znak) formacijo®» prema britanskem patentu 1442121» ali boa prstana« stog »loba« Pedeset usoraka pcsmatrano ja od evekih» pri naleti vnoj vlažnosti 14.63 i morena je ovalnoot kao u probi 1· Stan* dardni POSILOK poklopci imali su srednju ovalnost 0»lo2 mm» dok su poklopci kapsule prema pronalasku imali srednju ovanlnost samo O.e62 mm*Size 1 capsule caps are made with 2" FRS-LOK formations and annular grooves according to test 1. Siaul" tene are made standard size 1 capsule caps with PAB-LOK* formations and ea P06ILCK (Protected Trade Mark) formation®" according to British patent 1442121" or "lobe" stack "Fifty Usorak pcsmatrano yes from the ages" in case of incoming humidity 14.63 and morena is oval like in sample 1· Stan* dard POSILOK lids had an average ovality of 0»lo2 mm» while capsule lids according to the invention had an average ovality of only O.e62 mm*

Bmanjenje ovalnosti kapsula» prosa pronalasku» olakžava rad sa saSinom» kao sortiranja» punjenja 1 spajanje» a poboljšava i apa^panje. 2bog poboljŠanog spajanja omenjena je toleran olja ogrsničernja u proizvodnji» Sto rezeultuje boljim spajanjem tela i poklopca i smanjenim slučajnim odvajanjem polovina kap aule poale punjenja.Reducing the ovality of the capsule, millet invention, facilitates rad saSin, such as sorting, filling and splicing, and also improves absorption. 2, the reason for the improved connection is the tolerance of rapeseed oil in production, which results in a better connection between the body and the cap and reduced accidental discharge of half of the filling cap.

cesto se želi da ee zalepi traka na epejenu kapoulu» kako bi se izbeglo curenje u slučaju tečnog sardžaja» ili da kapsula bude obeležena za nasilno otvaranje» ili otporne na isto» ili radi identifikacije. Cvo se može postiči upotrebom poznatih postupaka i opreme» kao Sto je Quali~Seal mašina (1’anufacturing Cheaist» dan« 193?» str. 27). U ovim uslovima poklopac kapsule ea žlebom ima iznenadjujuče prednosti pri povezivanju sa trakom za spajanje» a posebno je koristen kada kapsula sadrži tečno punjenje» Prvo» omenjen® ovalnost poklopca ne samo da ol&kšava postupak sa mašinoa» tj» ublažava obrtanja 1 emanjuje neste bilnoet pri obrtanju na načini za zatvaranje psi postavljanju trake sa spajanje» več Sto je ječ važnije» utiče da je razmak po obimu poklopca i tela kapsule ujednačenlji» nego što je kod kapsule konvencionalno^ oblika» Kada se traka za spajanje» kao što je že latinska» postavi izmedju kraja poklopca i tela kap sule razmak koji traka treba da premosti ujednačenlji je i dozvoljava tačnije spajanje» istovremeno dozvoljavajučl da se može upotrebiti tanja Selatinska traka za spajanje» Drugo» rav nemarnost razmaka po obimu» a prema gore Izleženo®» zajedno sa boljim dimenzionim ulclapenjem 1 dodatno» aadržavajudom grenlcom koji se poetižu postupkom prema pronalasku» obezbedjuju dodatne prednosti» kada kapsula treba da sadrži malo viskozna tečnost» •5kao ulj® jagerževine* 17 ovi» kapsulama koja sadrže tečnost pot· robno ja spražiti curecjo retkog ulja ili druge težnosti u oko· licu zatvaranje® trkaom» ili drugi® tehnikama* Ako so pogreši u sprečavanju ourenja u toku 5*10 min posla punjenja» u koa vre· senu aapunjeno kapsule mogu biti sortirane i »ažinoa postavljena u pravilen položaj za spajanja» graška spajanja kapsula čire se u oslu zenu kontakta» uz rizlk daljeg ourenja sadrŽcja is kap sula. iznenadjujuče ja naznanja da sa na tastu od pola siliona kapsula napunjenih uljem jagorževine videle ds ja satanjenje eu· ranja sadržaj a kapsula bilo rezultat upotrebe poklopca sa pr · stenastira žlebom» a prema pronalasku«the road would like to stick a tape on the sealed hood" in order to avoid leakage in the case of liquid sarjaj" or for the capsule to be marked for violent opening" or resistant to the same" or for the sake of identification. This can be achieved using known procedures and equipment such as the Quali~Seal machine (1'anufacturing Cheaist" day" 193? p. 27). In these conditions, the capsule cover with a groove has surprising advantages when connecting to the splicing tape, but it is especially useful when the capsule contains a liquid filling. The first mentioned ovality of the cap not only facilitates the process with the machine, i.e. it eases the rotations, it reduces the risk of damage when working on methods of closing and placing the splicing tape. More importantly, the distance around the circumference of the cap and the body of the capsule is more uniform than in the case of a capsule. conventional^ shape" When the splicing tape" as already Latin" is placed between the place of the cover and the body of the cap, the distance that the tape has to bridge is more uniform and allows for a more accurate splicing" at the same time allowing the use of thinner Selatin splicing tape" Other" even the carelessness of the distance along the circumference" a upwards Extruded®" together with a better dimensional ulstalping 1 additionally" aa to support the heaters that are subject to the procedures of the invention" provide additional advantages" when the capsule must contain a low-viscosity liquid" • 5 such as oil® jaggery* 17 envelopes" capsules that contain liquid, it is necessary to spray a trickle of thin oil or other gravity in the eye; closing with a "knock" or other® techniques* If there are mistakes in preventing evaporation during the 5*10 min filling job" in the case of heat, the filled capsules can be sorted and "just placed in the correct position for joining" pea When the capsule is joined, the ulcer is formed due to contact with the risk of further development of the contents of the capsule. surprising announcements that half a million capsules filled with jaggery oil were found on the table, and the contents of the capsule were stained and the contents of the capsule were the result of using the lid, which was lined with a groove" according to the invention"

Claims

PATENT APPLICATIONS

1. A capsule shell characterized in that it has a annular groove in the portion of the open end.

Capsule shell according to claim 1, characterized in that it is a capsule cover.

Capsule shell according to claims 1 and 2, characterized in that it has a continuous groove throughout the circumference.

Capsule shell according to claims 1, 2 and 3, characterized in that the groove is at a distance of 0.5 mm to 1.5 mm from the open portion.

The capsule shell according to claim 4, characterized by stem, provides a groove at a distance of about 1.3 mm.

6. Capsule shell according to claims 1, 2, 3, 4 and 5, characterized in that the groove width is from 0.3 mm to 1.5 mm.

7. Capsule shell according to claim 6, characterized in that the groove width is about 0.5 mm.

The capsule shell according to claims 1, 2, 3, 4, 5, 6 and 7, characterized in that the groove depth is from 0.01 mm to 0.05 mm.

A capsule shell according to claim 8, characterized in that the groove depth is about 0.02 mm.

The capsule shell according to claims 1, 2, 3, 4, 5, 6, 7, 8 and 9, characterized in that it is gelatin.

11. Filled gelatin capsule, characterized in that it consists of a capsule shell according to any one of claims 1 to 10.

12. The filled gelatin capsule according to claim 11, characterized in that it has a fastening strap which is mounted at the end of the cap and body of the capsule.

13. The filled capsule according to claim 12, characterized in that it is filled with liquid.

14. Ring groove pillar for the manufacture of capsules according to one of claims 1 to 10.