SI8811698A8 - Process for obtaining bipartited solid gelatine capsules - Google Patents

Process for obtaining bipartited solid gelatine capsules Download PDF

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Publication number
SI8811698A8
SI8811698A8 SI8811698A SI8811698A SI8811698A8 SI 8811698 A8 SI8811698 A8 SI 8811698A8 SI 8811698 A SI8811698 A SI 8811698A SI 8811698 A SI8811698 A SI 8811698A SI 8811698 A8 SI8811698 A8 SI 8811698A8
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SI
Slovenia
Prior art keywords
capsules
hard
shellatin
fibrous material
gelatin
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SI8811698A
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Slovenian (sl)
Inventor
Brian Ellwood Jones
Original Assignee
Shionogi Europ
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Priority claimed from GB8721455A external-priority patent/GB8721455D0/en
Application filed by Shionogi Europ filed Critical Shionogi Europ
Publication of SI8811698A8 publication Critical patent/SI8811698A8/en

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Description

Tehnički problemTechnical problem

Ove kapsule prave se uranjan jera oblikovanih stubica u vruč rastvor želatina i uklanjanjem stubica is rastvora kako bi se želatin sušenjem forairao u školjke, koje se satir uklone sa stubica· U procesu sušenja gubi se voda, što daje tvrdu želatinaka školjka, sa sadržajera vode koji se održava na oko 13 - 16·$·These capsules are made by immersing the molded column in hot gelatin solution and removing the column from solution to make gelatin by drying into shells, which remove the satire from the columns · During the drying process, water is lost, which gives the shell gelatin hard from the water contents which is held at around 13 - 16 · $ ·

Uklanjam jem dalje količine vode iz školjke zidovi ka psula postaju krti i tada, posle punjenja i zatvaranja ka psula može doči do gubitka sadržaja kapsula, zbog oštečenja koje se dešsvaju u toku mehanickog rukovanja pri pako vanju, ili zbog pritiska ne zid kapsula pri uklanjanju iz pakovanja·I remove further amounts of water from the shell from the walls to the psyllium and then, after filling and closing to the psyche, the contents of the capsules may be lost due to damage that occurs during mechanical handling during packaging, or due to the pressure of the wall of the capsules when removing from the shell. packaging ·

Gubitak vode i krtost mogu biti prouzrokcvane nizom usroka. Tako, kapsule mogu biti skladišten© ili transportovane pre ili posle punjenje i spajanja u usloviraa koji dovode do gubitka vode iz zidova kapsula u atmosfera· A vrlo često u farmaceutskoj industriji dešava se da treba kapsalirati higroskspno ili topljive satorije, da se sproži absorpcija vlage is atmosfere, koja nože isasvati razlaganj©. Ako se aa ovo upotrebe tvrde kapsule tada higroskopae ili topljive saterije mogu da oduzictaju vodu ia želatinske kapsule, Sto prouzrokuje krtoat i seže dovest© do oštečsnja kap« sole i do gubitka ili kvarenja sadržaja* Kisik patedanja posebno je veliki pri uklanjanju kapsula ia blistir pakovanja, sbog priaene nauobiaajenog napresanja na školjka» Dako, dvodelno želatinske kapsulo, koje sadrže higroskepne ili topljivo aatorijs i koje se nalase u blister pskovanjis» moggu postati krte u vroaensko® perioda od proisvsdnje do upotrsfee, Sto je uaiOk sogadib pukotina i prelom kapsula i gabit« ka sadržaja, pri nspreeanjim koja kapsula trpi pri uklanjanju ia blister pakovanja»Water loss and brittleness can be caused by a number of causes. Thus, capsules can be stored © or transported before or after filling and coupling in conditions that lead to the loss of water from the capsule walls into the atmosphere · And very often in the pharmaceutical industry it is necessary to encapsulate hygroscopically or soluble satoriums to initiate moisture absorption and atmosphere, which at night does not dissipate decomposition ©. If this capsule is used, then hygroscopes or soluble sateria can deprive water of gelatin capsules, which causes chrtoate and can lead to damage of the sole and to the loss or spoilage of contents. * The oxygen of the pate is particularly high when removing capsules and blisters. , because of the usual stress on the shell, "Of course, two-part gelatin capsules containing hygroscopic or soluble aatorium and found in blister blisters" may become brittle during the period from the dawn to the end of use, which may break even after use. «To contents, at nspreeing, which capsule suffers while removing blister pack»

c) Stanje tehnikec) State of the art

Vrženi su pokušnji da se problem krtosti tvrdih želatin« skih kapsule reži« ?ako je pokuSano da se dodaju ploetifika« tori, kao glicerin, sorbitol ili dragi poHoli, u aelatinzki raetvor ia koga se formiraju kapsule« Ovi plastifikatori su inače u atalno, j upotrebi u proizvodnji jednodolnih šokih Že« latinskih kapsula« Sragi pokušaj bio Je umožavanje nakih aa« torija, kao dietilftalata ili triacetins, koji so upotrebijava ju kao plastifikatori u prevlečenju tableta filmom.Attempts have been made to reduce the brittleness of hard gelatin capsules - if an attempt was made to add plaetifics, such as glycerin, sorbitol, or expensive pills, to the gelatin solution and to which the capsules were formed. used in the manufacture of mono-shocks Already "Latin capsules" A succinct attempt was to soak up any aa thorium, such as diethyl phthalate or triacetins, which used salt as plasticizers in film-coated tablets.

ži jedan od pokusaja, umd.jenife do rada, sije dnu sadovoijnvejuče tvrde šolatinske kapsulo, kojo ae sogu skladišči ti sa higros&epnim i topljivim sadržajina, a da ne postanu krte« fredložona rešenja ili vode ka slabljenju kapsula, ili dekasuju da jo to soBOguco isvosti, zbog inkopatibilnosti polimera.one of the attempts, umd.jenfe to work, sows the bottom of a fruit-hard hard capsule capsule, which can store it with hygroscopic and soluble contents without becoming brittle solutions or lead to a weakening of the capsule, or decoupling it further. , due to the incompatibility of the polymer.

d) Onia rešenja tehniško^ problemd) Onia solutions technically ^ problem

Pronašli smo postupak dobijanje tvrdih Selatinskih kap« sala iz dva dola, oiji zidovi ne postaja krti niti se cepaj u pri akladiStenju, a sadrže higroskepne ili topljive materijeWe have found a procedure for obtaining hard Selatine caps from two valleys, the walls of which do not become brittle or cleave upon accretion, and which contain hygroscopic or soluble substances

Pronalasak predvidja dvodelna fcvrdu Školjka kapsulo koja se sastoji od sraaže želatina i vlaknastih aaterija« larss dvodelna školjka kapsule snači da so kapsula sastoji od cilindrično oblikovano® tela i poklapan i oba isaju jodan etvew ijodan setvena kraj, a telo je aanjeg prečnika ed poklopoa tako da ao poklopac seže ratvoriti uvlačsnje» otvore * nog kaaja tela u poklopac« Vlaknasti materijal poželjno je hidrefila» i bubri pri absorbovanju vode« Vlaknasti autori * jal prisutan je α želatina kao doda tak noraalaia ekscipljen* tisa i aditivisa, kao na priaer sredetvisa se hejanjo* sr<?d~ stvina sa kvačenje, preservsnsiaa i drugia dodanima.The invention provides for a two-part hard shell capsule consisting of a gelatin and fibrous aater «larss two-part capsule shell that the capsule consists of cylindrically shaped® body and is coincident and both have an iodine etvew and iodine sowing end, and the body is too narrow as the lid can dissolve the "open kayaking" of the body into the lid "Fibrous material is preferably hydrophilic" and swell when absorbing water "Fiber authors * alpha gelatin is present as added to such crazy and additive, as in the center of gravity hejjo * sr <? d ~ things with crochet, preservsnsiaa and others added.

Količina vlaknaste aatorije koja se dodaja α Želatin nije kritična, saože biti prisutna α količini do oko 10$. Ροζ oljno je da bude prisotna a količini do oko a boljo da ja isaedju oko 0,5$ do oko 2,oM« Optimalna količina savisi salo 1 od osobina isabrano vlaknaste Baterije i obučeai tednik aože je lako odrediti«The amount of fibrous aatorium added to α Gelatin is not critical, it is present in an α amount of up to about $ 10. It is advisable that it be present in quantities up to about 2 and better than about $ 0.5 to about 2, oM «The optimum amount depends on the fat 1 of the properties of the selected Fiber Batteries and Training and it is easy to determine«

Vlaknasta materija upotrebljava se u oblika praha, dulina vlakana treba da je ispod 1000 mikrona, poželjno oko 300 alkrona, na primer od oko 50 do oko mikrona.The fiber material is used in powder form, the fiber length should be below 1000 microns, preferably about 300 alkrons, for example from about 50 to about microns.

Primer ovog aaterijnls jo kroskaraelosa, poprečno umre* ženi oblik natrijem karboksiaetilcolulose, koje delani od kao +Ac2iScl* ί upotrebljava ao kod tableta sa rasdvvajsnje na sastojke i sa rastvaranje· To je vlaknasti materi* jal koji sadrži vlakna dušiae 50*300 mikrona, sledečih oso* binat a) bubrenje pri dodiru sa vodo« i b) sedržsvasjo ab * sortovane vode·An example of this aateric croscaraellos crosslinked * sodium carboxyethylcolulose form, used as + Ac2iScl * ί by ao for tablets with separation to dissolve and dissolve · It is a fibrous material * containing fiber 50 * 300 microns in size, as follows oso * binate a) swelling when in contact with water «and b) containing ab * sorted water ·

Isaedju različitih vlaknastih materijala koji ista ju prednosti u upotrebi aože se poaenuti aikrokristalna oelu* losa 1 polietilenska vlakna visoke gustina« Ipak, poželjno je da vlaknasti »aterijal bude bidrofilan, sa israženom o« soblnoa aadržavaaja vode*Isaacs of various fibrous materials, which have the same advantages in use, may be enhanced by aichrocrystalline ole * bad 1 high-density polyethylene fibers "However, it is desirable that the fibrous" atherium is bidrophilic, with a pronounced "water content" *

Poaenuti aaterijali samo eu primeri, svaki ebučen rednik aože isabrati i druge «aterijale, na osnovu navedenih Žaljenih osobina« Pri oralno j primeni vlaknasti materijal mora biti i faraaoeutski odnosno veterinarski prihvatljiv·The aforementioned aaterials are only examples, each ecclesiastical monk may choose other "aterials, on the basis of the aforementioned Mourners" When used orally, the fibrous material must also be pharaoic or veterinary acceptable.

Kapsule preša pronalasku nogu se proizvoditi tehnoloskia postupke» koji se aoraalnc priaenjaje» Potrebna količina vl&knaetog snterijala doda »e u «slatin pre, u toku« 111 posle rastvarenja, sa priaer u obliku vodeus suspenzije, is koje «» prave školjke kapsula ae aebidejeni nadia»Pressing capsules of the invention for the manufacture of technological processes "which are adhered aorally" The required amount of fibrous material is added to the "slurry before, during" 111 after dissolution, with the form of a water suspension, from which the "real shells of the capsule are filled"

Dobri efekti pronalaska jasno su obja£njeui slsdečisi priaeroa.The good effects of the invention are clearly explained by the following examples.

a^sasa ^ sas

Kapsule šarše br* δ proizvedene au od Želatina u koji je dodano 1» i 2-8 kroskarseloze, kao suspenzija, računate kao težina/s&preoina« Odredjea broj standardnih kapsula i kapsula koje sadrže vlakna punjen je, svaka oa po 150 ag karal tisa, koji je vrlo higroskopna kristalna čvrsta supsteuoa. Uzorci svake earle kapsula ispitivani su visuolao u iatorvalisa od 5 «ia, tražeei naprsliae ili šepanje kapsula» iksperiosnbalne kapeule pokesale su veliko poboljšanje otpomooti preme. krtoati» Kapsule proizvedene od «©letina koji sadrži 1$ kroekaraeloae nisu pokušale šepanje, a one proizvedene od želatina koji sadrži 2.8 kroekaroelaze poka«ele su vrlo oalu tendenciju šepanje u ekstreanisj ualoviza u poredjenju sa standardni» kapeulaaa, koje sa postale krte i pacale u vremenu izmedju 10 sin i 2 Sasa.Cartridge capsules br * δ produced au gelatin to which 1 "and 2-8 croscellose were added as suspension, count as weight / s & preoin" Determines the number of standard capsules and capsules containing fibers filled, each oa 150 ag caral yew. which is a very hygroscopic crystalline solid of supsteuoa. Specimens of each earle capsule were examined visuolao in iatorvalis of 5 "ia, seeking naps or capsule whispering" of theperiospinal capsule revealed a great improvement in the pre-emptive capsule. the "Capsules made of" © letin containing $ 1 croekaraeloae did not attempt to limp, and those made of gelatin containing 2.8 kroekaroelases showed a very salient tendency to limp into extraanalysis compared to the standard "capsules," which became mole and tart. between 10 sons and 2 Sas.

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Adv/SLOBODAN VUČKOVIČAdv / FREE VUKOVIC

TŽAČIB 2A PSIVKSBKD gPOTKSBU PRONALASKAAPPLICATION 2A PSIVKSBKD gPOTKSBU FINDING

Farsaceutska industrija veš duž© vreme traži rešenje problema icrtoati tvrdih dvodelnih Selatiaskih kapsula. Svaki proizvodjač pokuŠao je da reši ovaj problem na svoj nadln, tako da su u želatinski rastvor dod&vani plastifikatori, koji se veš upotrebljavaju u proizvodnji jednočalnih nekih žslatinskih kapsula, ili se upotrebljavaju u proizvodnji filnova za prevladenje tableta. Cva rešenja nisu dala zadovoljavajuče rezultate. Postupak dobijanja tvrdih dvodelnih želatinskih kapsula, čiji zidovi ne postaju krti, sastoji se u dodatku do najviše 10M vlatoastog materijala, a to je prena pronalasku natriju» karboksimetiloeluloza, u rastvor želatina iz koga se formiraju tvrde kapsule» Postoje i drugi vlaknasti naterijali, koji se mogu koristiti preaa pronalasku, važno je da budu hidrofilni i da iaaju izražena osobina zadrsavanja vode.The pharmaceutical industry of linen is looking for a solution to the problem of icrtoates of hard two-part Selatias capsules. Each manufacturer has tried to solve this problem on its own, so that plasticizers have been added to the gelatin solution, which is used in the manufacture of single-layer some gelatin capsules, or used in the production of tablets to overcome tablets. Cva solutions did not produce satisfactory results. The process of obtaining hard two-part gelatin capsules, the walls of which do not become brittle, consists in the addition of up to a maximum of 10M of fibrous material, which is before the invention of sodium "carboxymethylcellulose, into a solution of gelatin from which hard capsules are formed" There are other fibrous materials which can use the invention, it is important that they be hydrophilic and have a pronounced water retention property.

Tako napravljeno tvrde dvodelne želatinske kapsule neaaju krte zidove i ns cepaju se priliko» sklndištenja, transportovanja, ili uklanjanja iz pakovanja, te na taj način ne dolazi do gubitka ili do kvarenja sadržaja kapsula.Hard two-part gelatin capsules made in this way have no solid walls and are not cleaved when stored, transported, or removed from the package, thus no loss or deterioration of the contents of the capsules.

Claims (7)

1· Postupak aa dobijanje dvodelnih tvrdih želatinskih kapsula, naznačen time što je kapsula od smeše želatina i vlaknastog materijala»1 · Procedure aa obtain two-part hard gelatin capsules, characterized in that the capsule is made up of a mixture of gelatin and fibrous material » 2. Postupak za dobijanje dvodelnih tvrdih šelatinskih kapsula prema zahtevu 1, naznačen time što se u školjki nalasi do 1C; vlaknastog materijala·2. A process for the preparation of two-part hard shellatin capsules according to claim 1, wherein the shell is up to 1C; fibrous material · 3. Postupak za dobijanje dvodelnih tvrdih Šelatinskih kapsula prema zahtevu 1 ili zahtevu 2, naznačen tise što ja vlaknasti materijal hidrofilan.3. A process for the preparation of two-part hard shellatin capsules according to claim 1 or claim 2, characterized in that the fibrous material is hydrophilic. 4· Postupak za dobijanje dvodelnih tvrdih Šelatinskih kapsula prema zahtevu 3» naznačen tise što je vlaknasti mafcerijal poprečno uarežena natrijum karboksimetilceluloza·The method of producing two-part hard shellatin capsules according to claim 3, characterized in that the fiber mafzerial is cross-sectioned sodium carboxymethylcellulose. 5. Postupak za dobijanje dvodelnih tvrdih šelatinskih kapsula prema zahtevu 4, naznačen time što vlakna u vlaknastem materijalu imaju dužinu do 1CCC mikrona.A method for producing two-part hard shellatin capsules according to claim 4, wherein the fibers in the fibrous material have a length of up to 1CCC microns. 5. Postupak za dobijanje dvodelnih tvrdih šelatinskih kapsula prema zahtevu 5, naznačen time što 3Θ dužina vlakana naiazi u opsegu od 50 do 300 mikrona·5. A process for producing two-part hard shellatin capsules according to claim 5, characterized in that the 3Θ length of the fibers is in the range of 50 to 300 microns. 7, Postupak za dobijanje dvodelnih tvrdih šolatinskih kapsula prema ma kom od zahteva 1 do 6, naznačen tise što je vlaknasti materijal prisutan u količini od 0.5 '· do 2·ο*.7, A process for producing two-piece hard scholatine capsules according to any one of claims 1 to 6, characterized in that the fibrous material is present in an amount of 0.5 '· to 2 · ο *. 8. /ostupak za dobijanje dvodelnih tvrdih šelatinskih kapsula koje sadrže higroskopno ili topivo punjenje, naznačen time Sto je Školjka kapsule prema ma kom od zahteva 1 do 7·8. A process for the preparation of two-piece hard shellatin capsules containing hygroscopic or soluble filling, wherein the shell is a capsule according to any one of claims 1 to 7.
SI8811698A 1987-09-11 1988-09-07 Process for obtaining bipartited solid gelatine capsules SI8811698A8 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8721455A GB8721455D0 (en) 1987-09-11 1987-09-11 Capsules
YU169888A YU46641B (en) 1987-09-11 1988-09-07 PROCEDURE FOR OBTAINING TWO - PART HARD GELATINE CAPSULES

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SI8811698A8 true SI8811698A8 (en) 1996-02-29

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SI8811698A SI8811698A8 (en) 1987-09-11 1988-09-07 Process for obtaining bipartited solid gelatine capsules

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SI (1) SI8811698A8 (en)

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