PL203574B1 - Method and device for producing thin flakes from foil with the active ingredient - Google Patents

Method and device for producing thin flakes from foil with the active ingredient

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Publication number
PL203574B1
PL203574B1 PL366917A PL36691702A PL203574B1 PL 203574 B1 PL203574 B1 PL 203574B1 PL 366917 A PL366917 A PL 366917A PL 36691702 A PL36691702 A PL 36691702A PL 203574 B1 PL203574 B1 PL 203574B1
Authority
PL
Poland
Prior art keywords
film
stack
active substance
feed
cutting
Prior art date
Application number
PL366917A
Other languages
Polish (pl)
Other versions
PL366917A1 (en
Inventor
Schäfer Wolfgang
Hackbarth Ronald
Neuland Detlev
Original Assignee
Lts Lohmann Therapiesysteme Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from DE10110494A external-priority patent/DE10110494C1/en
Application filed by Lts Lohmann Therapiesysteme Ag filed Critical Lts Lohmann Therapiesysteme Ag
Publication of PL366917A1 publication Critical patent/PL366917A1/en
Publication of PL203574B1 publication Critical patent/PL203574B1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65HHANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
    • B65H35/00Delivering articles from cutting or line-perforating machines; Article or web delivery apparatus incorporating cutting or line-perforating devices, e.g. adhesive tape dispensers
    • B65H35/02Delivering articles from cutting or line-perforating machines; Article or web delivery apparatus incorporating cutting or line-perforating devices, e.g. adhesive tape dispensers from or with longitudinal slitters or perforators
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65HHANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
    • B65H35/00Delivering articles from cutting or line-perforating machines; Article or web delivery apparatus incorporating cutting or line-perforating devices, e.g. adhesive tape dispensers
    • B65H35/04Delivering articles from cutting or line-perforating machines; Article or web delivery apparatus incorporating cutting or line-perforating devices, e.g. adhesive tape dispensers from or with transverse cutters or perforators
    • B65H35/06Delivering articles from cutting or line-perforating machines; Article or web delivery apparatus incorporating cutting or line-perforating devices, e.g. adhesive tape dispensers from or with transverse cutters or perforators from or with blade, e.g. shear-blade, cutters or perforators
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65HHANDLING THIN OR FILAMENTARY MATERIAL, e.g. SHEETS, WEBS, CABLES
    • B65H39/00Associating, collating, or gathering articles or webs
    • B65H39/16Associating two or more webs
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/24Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24479Structurally defined web or sheet [e.g., overall dimension, etc.] including variation in thickness
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/202With product handling means
    • Y10T83/2033Including means to form or hold pile of product pieces
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/202With product handling means
    • Y10T83/2033Including means to form or hold pile of product pieces
    • Y10T83/2037In stacked or packed relation
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/202With product handling means
    • Y10T83/2033Including means to form or hold pile of product pieces
    • Y10T83/2037In stacked or packed relation
    • Y10T83/2046Including means to move stack bodily
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/202With product handling means
    • Y10T83/2033Including means to form or hold pile of product pieces
    • Y10T83/2037In stacked or packed relation
    • Y10T83/2046Including means to move stack bodily
    • Y10T83/2048By movement of stack holder
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/202With product handling means
    • Y10T83/2092Means to move, guide, or permit free fall or flight of product
    • Y10T83/2183Product mover including gripper means
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/647With means to convey work relative to tool station
    • Y10T83/6476Including means to move work from one tool station to another
    • Y10T83/6489Slitter station
    • Y10T83/6491And transverse cutter station
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/647With means to convey work relative to tool station
    • Y10T83/6572With additional mans to engage work and orient it relative to tool station
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/647With means to convey work relative to tool station
    • Y10T83/664Roller
    • Y10T83/6644With work-supplying reel
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T83/00Cutting
    • Y10T83/889Tool with either work holder or means to hold work supply
    • Y10T83/896Rotatable wound package supply

Description

Opis wynalazku Przedmiotem wynalazku jest sposób oraz urz adzenie do wytwarzania cienkich p latków z folii z substancj a czynn a, zawieraj acej jedn a lub wi eksz a liczb e substancji czynnych, w szczególno sci do stosowania jako posta c dawkowana i posta c do podawania leków. Obok znanych postaci dawkowanych leków, takich jak tabletki, kapsu lki, krople lub podobnych postaci dawkowane, istnieje te z „op latek” jako posta c dawkowana leku. Chodzi tu o cienki p latek z folii z substancj a czynn a albo p latek z foli a z substancj a czynn a, zawieraj acy okre slon a ilosc substancji czynnej, który swoj a grubo scia i rozmiarami jest dostosowany do dozowanej ilo sci substancji czynnej. Poniewa z powierzchnia kontaktowa takiego op latka wiaze si e bezpo srednio z wielko scia dawki sub- stancji czynnej, wi ec jego wymiary musz a zgadza c si e mo zliwie dok ladnie z wyliczonymi wymiarami i powinny mie sci c si e w zakresie tolerancji. Dlatego wytwarzanie takiego op latka jest kosztowne. Znane jest wytwarzanie folii z substancj a czynn a metod a odlewania albo metod a powlekania. Zwykle folia z substancj a czynn a z materia lem pod lo zowym lub bez niego, na który odlewa si e lub nanosi w inny sposób materia l foliowy, jest zwijana na rolki z utworzeniem zapasu. Gdy nawijana jest folia z substancj a czynn a majaca materia l pod lo zowy, to w dalszym procesie przetwarzania tej folii z substancj a czynn a w cienkie p latki materia l pod lo zowy oddziela si e i zwija oddzielnie. Nast epnie tnie sie cienk a i elastyczn a foli e z substancj a czynn a. Uzyskiwane przy tym rzeczywiste wymiary cz esto nie odpowiadaj a wymaganej tolerancji wymiarowej powierzchni odpowiadaj acej dawce leku, które poprzez wielkosc powierzchni odzwierciedlaj a tolerancje dotycz ace ilo sci substancji czynnej. Zadaniem wynalazku jest opracowanie sposobu wytwarzania cienkich p latków folii z substancj a czynn a, za pomoc a którego mo zna wytwarza c p latki o okre slonej wielko sci z daleko posuni et a do- k ladno sci a. Zgodny z wynalazkiem sposób wytwarzania cienkich p latków folii z substancj a czynn a, zgodnie z którym t e foli e wytwarza si e przez odlanie albo nanoszenie substancji czynnej na materia l pod lo zowi i nawija z materia lem pod lo zowym lub bez niego na rolk e, po czym odwija z niej i tnie, przy czym foli e z substancj a czynn a odwija si e automatycznie, oddziela od istniejacego materia lu pod lozowego i w stanie naprezonym doprowadza do stanowiska ci ecia, w którym tnie si e j a w kierunku posuwu na w askie pasma o okre slonej szeroko sci, charakteryzuje si e tym, ze te pasma skupia si e ze sob a w kierunku posuwu i razem doprowadza za pomoc a nast epnego urz adzenia posuwowego do urz a- dzenia do ci ecia poprzecznego, w którym tnie si e poprzecznie w okre slonych odst epach skupione ze sob a pasma. W wyniku oddzielonego przestrzennie i czasowo przecinania wzd lu znego i poprzeczne- go folii z substancj a czynn a powstaj a czworok atne, w szczególno sci prostok atne lub te z kwadratowe p latki, przy czym folia z substancj a czynn a jest zwymiarowana co najmniej na szerokosc tak, ze jest ona przecinana na p latki o okre slonej wielko sci bez resztek i odpadów. Przy tym wielkosc p latków wp lywa na wielko sc dawki leku. Doprowadzanie naprezonej filii z substancj a czynn a do stanowiska rozcinania na pasma u latwia proces ci ecia. Równie z skupianie rozci etych w kierunku wzd lu znym pasm folii w wi azk e pasm u latwia ci ecie poprzeczne oraz przyczynia si e do zwi ekszenia niezawodno- sci procesu wytwarzania i dok ladno sci wymiarowej p latków. Odwijanie folii z substancj a czynn a z rolki zasobnikowej i doprowadzanie do stanowiska rozci- nania prowadzi si e korzystnie w sposób ci ag ly za pomoc a nap edzanego walca, po którym prowadzi sie t e foli e z substancj a czynn a i na którym tnie si e j a wzd lu znie na pasma. Celem u latwienia ci ecia foli e z substancj a czynn a poddaje si e wst epnemu napr ezeniu, co po- woduje jej wyg ladzenie i przyczynia si e do zwi ekszenia dok ladno sci procesu ci ecia wzd lu znego. Foli e z substancj a czynn a mo zna w prosty sposób obci azy c poprzecznie do kierunku posuwu, w szczegól- no sci za pomoc a odpowiedniego obci aznika, który w powi azaniu z szeroko scia folii z substancj a czynn a okre sla jej wst epne napr ezenie. Poci ete pasma folii skupia si e ze sob a i uk lada jedno na drugim z utworzeniem stosu tak, ze przylegaj a one g ladko do siebie. Dalszy przesuw pasm odbywa si e ruchem przerywanym i mo ze on by c niezawodnie realizowany. Korzystnie stos ten wci aga si e za pomoc a kolejnego urz adzenia posuwowego na prowadnic e slizgow a i wyg ladza si e. Celem przesuni ecia i dosuni ecia do urz adzenia do ci ecia poprzecznego, stos jest chwytany i dociskany za pomoc a szcz ek zaciskowych dzia laj acych na stron e górn a i stron e doln a stosu, który to stos korzystnie dosuwa si e ruchem przerywanym do urz adzenia do ci ecia poprzecznego. Aby równie z ta faza procesu przebiega la niezawodnie i precyzyjnie, stos prowadzi si e przed urz adzeniem zaciskowymPL 203 574 B1 3 z zachowaniem dok ladnych wymiarów celem dok ladnego na lo zenia pasm na siebie, z powtórnym ich wyg ladzaniem i naprezaniem, przy tym urz adzenie posuwowe ci agnie stos i doprowadza do urz adze- nia do ci ecia poprzecznego, przy czym eliminuje sie wzajemne przemieszczenie i zró znicowane wy- d luzenie poszczególnych pasm. Zgodne z wynalazkiem urz adzenie do realizacji tego sposobu zawiera wspornik dla rolki zasob- nikowej z foli a z substancja czynn a, nap edzany silnikiem elektrycznym walek posuwowy do odwijania tej folii z substancj a czynna z rolki zasobnikowej, maj acy szeroko sc co najmniej tak a jak folia, urz a- dzenie do ci ecia wzd lu znego na pasma, utworzone z wa lka posuwowego i wspó lpracuj acego z nim no zowego urz adzenia tn acego, urz adzenie do skupiania i uk ladania w stos (urz adzenie do uk ladania w stos) przesuwanych, poci etych pasm oraz nast epne urz adzenie posuwowe do pasm, a tak ze urz a- dzenie do ci ecia poprzecznego poci etych pasm. Mi edzy urz adzeniem do ci ecia wzd luznego i urz a- dzeniem do ci ecia poprzecznego jest usytuowane urz adzenie do uk ladania w stos zawieraj ace uk lad kana lów prowadz acych oraz srodki wyg ladzaj ace poci ete pasma i doprowadzaj ace je do urz adzenia do ci ecia poprzecznego. Korzystnie mi edzy rolk a zasobnikow a i urz adzeniem do ci ecia wzd lu znego s a umieszczone równolegle do tej rolki zasobnikowej dwie rolki zwrotne dla folii z substancj a czynn a, mi edzy którymi jest ona napr ezana za pomoc a rolki naci agowej. No zowe urz adzenie tn ace jest utworzone z przytrzymywacza, dociskanego do folii z substancj a czynn a za pomoc a wa lka posuwowego, i z umocowanych na nim obok siebie w regulowanych odst e- pach, ustawionych równolegle do kierunku posuwu folii z substancj a czynn a, obracaj acych si e i umieszczonych w odst epach no zy krazkowych. Wzajemny odst ep no zy krazkowych jest nastawny. Cz escia sk ladow a urz adzenia jest uk lad skupiania i uk ladania w stos poci etych, przesuwanych pasm. Tego rodzaju uk lad opisano w DE 19925 339 A1. Korzystnie, srodki do uk ladania w stos stanowi a uk lad podci snieniowych kana lów prowadz a- cych, których wej scia s a usytuowane obok siebie, a ich wyj scia s a umieszczone jedno nad drugim, przy czym do ka zdego pasma jest przyporz adkowany jeden podci snieniowy kana l prowadz acy. Skupione ze sob a i uformowane w stos pasma s a przesuwane ruchem przerywanym przez po- dajnik kleszczowy, który chwyta stos w sposób przerywany i powoduje jego naci agni ecie, i który tak ze dosuwa stos do urz adzenia do ci ecia poprzecznego. Za urz adzeniem do uk ladania w stos korzystnie jest umieszczona U-kszta ltna trójstronna pro- wadnica slizgowa dla utworzonego stosu, na której jest ustalony miejscowo w pionowych prowadni- cach co najmniej jeden obciaznik, który slizga si e po stosie przemieszczaj acym si e w prowadnicy sli- zgowej i wyg ladza pasma. Trójstronna prowadnica slizgowa jest wysklepiona w dó l wokó l osi po- przecznej do kierunku posuwu, patrz ac z góry na stos, tak ze w stosie powstaje okre slone napr ezenie wst epne, które musi by c pokonane jako dok ladnie okre slony opór przez podajnik kleszczowy. Skok posuwowy podajnika kleszczowego wyznacza d lugo sc p latków. Korzystnie, w kierunku posuwu za trójstronn a prowadnic a slizgow a jest usytuowany podajnik kleszczowy, który chwyta stos w sposób przerywany i doprowadza do urz adzenia do ci ecia po- przecznego. Podajnik kleszczowy korzystnie ma dwie szcz eki zaciskowe dla stosu, które s a sprz ezone z na- p edem, przez wymienn a, mimo srodow a krzywk e transportow a, która porusza te szcz eki zaciskowe w przód i w ty l wzgl edem kierunku posuwu, przy czym te szcz eki zaciskowe dociskaj a stos podczas jego ruchu do przodu. Szcz eki zaciskowe celem przesuni ecia stosu w przód zaciskaj a si e ze sob a w odst epie od ko nca stosu po stronie urz adzenia do ci ecia poprzecznego i sciagaj a go z prowadnicy slizgowej, pokonuj ac opór wytworzony na tej prowadnicy, i jednocze snie dosuwaj a do urz adzenia do ciecia poprzecznego znajduj acy si e w kierunku posuwu przed podajnikiem kleszczowym odcinek sto- su o okre slonej d lugo sci. Krzywka transportowa jest u lozyskowana mimo srodowo i stykaj a si e z ni a stale szcz eki zaciskowe tak, ze ci ag ly obrót krzywki transportowej jest przekszta lcany na okre slony ruch post epowy szcz ek zaciskowych w przód i wstecz. Zmiana wymiarów lub kszta ltu krzywki trans- portowej powoduje zmian e wielko sci ruchu post epowego, a wi ec i posuwu, co pozwala wyznacza c d lugo sc p latków. Korzystnie, mi edzy podajnikiem kleszczowym i urz adzeniem do ci ecia poprzecznego s a usytu- owane elementy prowadz ace. Przedmiot wynalazku jest uwidoczniony w przyk ladzie wykonania na rysunku, na którym jedyna figura przedstawia schematycznie urz adzenie do wytwarzania cienkich p latków z folii z substancj a czynn a.PL 203 574 B1 4 Urz adzenie to ma zamocowan a na niewidocznym na rysunku wsporniku rolk e zasobnikow a 1. z zapasem folii 2 z substancj a czynn a i o grubo sci oko lo 0,05 mm, nap edzany silnikiem M wa lek pod- cisnieniowy 3 jako wa lek posuwowy do odwijania folii 2 z substancj a czynn a z rolki zasobnikowej 1, urz adzenie 5 do ci ecia wzd luznego utworzone z wa lka podci snieniowego 3 i wspó lpracuj acego z nim urz adzenia tn acego 4, urz adzenie 6 do uk ladania w stos dla poci etych pasm 7, maj ace w przekroju U-kszta ltn a trójstronn a prowadnic e slizgow a 8 stosu 9 utworzonego z pasm 7, podajnik kleszczowy 10 i urz adzenie 11 do ci ecia poprzecznego stosu 9. Mi edzy rolk a zasobnikow a 1 i urz adzeniem 5 do ci e- cia wzd lu znego s a umieszczone równolegle do rolki zasobnikowej 1 dwie rolki zwrotne 12 do prowa- dzenia folii 2 z substancj a czynn a, a mi edzy tymi rolkami zwrotnymi 12 jest umieszczona rolka naci a- gowa 13 napr ezaj aca t e foli e 2 z substancj a czynn a. No zowe urz adzenie tn ace 4 sk lada si e z nieomawianego bli zej przytrzymywacza 14 i z utrzy- mywanych na nim w regulowanym odst epie, ustawionych równolegle do kierunku posuwu folii 2 z substancj a czynn a, obracaj acych si e no zy krazkowych 15, które s a dociskane do folii 2 z substancj a czynn a i przecinaj a j a wzd lu znie stosownie do ich rozmieszczenia podczas jej przesuwania za pomo- c a wa lka podci snieniowego 3. W tym przyk ladzie wykonania odst ep pomi edzy no zami krazkowymi 15 wynosi 20 mm. Urz adzenie 6 do uk ladania w stos ma dla ka zdego pasma 7 w bloku formuj acym 16 stos podci- snieniowy kana l prowadz acy 17, który na wspólnym wej sciu 18 jest po laczony w uk ladzie równoleg lym z pozosta lymi podci snieniowymi kana lami prowadz acymi 17. Kana ly prowadz ace 17 s a prowadzone w bloku formuj acym 16 stos tak, ze na wspólnym wyj sciu 19 s a rozmieszczone jeden nad drugim. Do urz adzenia 6 do uk ladania w stos jest dolaczona trójstronna prowadnica slizgowa 8. Jest ona wygi eta wokó l osi A poprzecznej do kierunku posuwu lub te z równoleg lej do osi wa lka podci snie- niowego 3, rolki zasobnikowej 1, rolek zwrotnych 12 i rolki naci agowej 13 i przejmuje stos 9 prowa- dz ac go z boku, przy czym boczne scianki prowadnicy slizgowej 8 maj a rozstaw odpowiadaj acy za- sadniczo szeroko sci stosu 9. Na stosie 9 jest umieszczony w niepokazanej na rysunku prowadnicy pionowej obci aznik 20 o masie 120 g, który przylega do stosu i sciskajac powoduje jego wyg ladzenie. W kierunku posuwu za trójstronn a prowadnic a slizgow a 8 jest umieszczony podajnik kleszczo- wy 10, który ma dwie umieszczone nad sob a szcz eki zaciskowe 21 i 22, chwytaj ace stos 9 w sposób przerywany, które s a sprz ezone z nap edem 24 za po srednictwem wymiennej mimo srodowej krzywki transportowej 23. Krzywka transportowa 23 i nap ed 24 poruszaj a szcz eki zaciskowe 21 i 22 w przód i w ty l wzgl edem kierunku posuwu, przy czym szcz eki zaciskowe 21 i 22 chwytaj a stos 9 w ich tylnym po lo zeniu martwym I i zwalniaj a ten stos w ich przednim po lozeniu martwym II. Za podajnikiem kleszczowym 10 s a umieszczone elementy prowadz ace 25 w postaci p lytek, mi edzy którymi stos 9 slizga si e ku urz adzeniu 11 do ci ecia poprzecznego, w którym nast epuje ci ecie poprzeczne mi edzy dwoma no zami gilotynowymi 26. Wst epnie wyznaczona d lugo sc odcinków stosu wynosi 25 mm tak, ze uzyskuje si e p latek o wielko sci 20 x 25 mm. Wytworzone p latki s a nast epnie umieszczane w pakowarce do dozowników, opakowa n p eche- rzykowych lub torebek. PLDescription of the invention The subject of the invention is a method and a device for the production of thin flakes from a film with an active ingredient, containing one or more active substances, in particular for use as a dosage form and form for the administration of drugs. . In addition to the known drug dosage forms, such as tablets, capsules, drops or similar dosage forms, there are those with "opaque" as the drug dosage form. It is a thin foil foil with the active substance or a foil foil with the active substance, containing a certain amount of active substance, whose thickness and dimensions are adapted to the dosed amount of the active substance. Since the contact surface of such a lathe is directly related to the dose of the active substance, its dimensions must agree as precisely as possible with the calculated dimensions and should be within the tolerance range. Therefore, the production of such an ophthalmic lamp is expensive. It is known to produce a film with an active ingredient by the casting method or by the coating method. Typically, the film with the active ingredient, with or without a base material, onto which the film material is cast or otherwise applied, is rolled onto rolls to form a reserve. When an active film having a base material is wound, in the further process of converting the active film into thin flakes, the base material separates and is rolled up separately. Then a thin and flexible film with the active substance is cut. The actual dimensions obtained in this process often do not correspond to the required dimensional tolerance of the surface corresponding to the drug dose, which through the size of the surface reflect the tolerances regarding the amount of the active substance. The object of the invention is to develop a method for the production of thin film flakes with an active ingredient, by means of which it is possible to produce cp laths of a specific size with a long advance and precision. The method of producing thin flakes according to the invention film with the active ingredient, according to which the film is produced by pouring or applying the active ingredient to the substrate material and winding it with or without the substrate material on a roll, then unwrapping it and cutting it , whereby the foil with the active substance unwinds automatically, separates it from the existing bedding material and, under tension, leads to the cutting position, where it is cut in the direction of the feed into narrow bands of a specific width, characterized by the fact that these strands are focused together in the direction of the feed and lead together by the next feed device to the transverse cutting device, in which it is cut transversely at specific intervals chained bands together. As a result of spatially and temporally separated lengthwise and transverse cutting of the film with the active substance, quadrilateral, in particular rectangular or square flaps are formed, the film with the active substance being dimensioned at least on width so that it is cut into flakes of a certain size without leftovers and waste. The size of the age group influences the dose of the drug. Supplying the taut branch with the active substance to the strand cutting station facilitates the cutting process. Also, the concentration of the sloped loosely strands of the foil into a bundle of strands facilitates cross-cuts and contributes to increasing the reliability of the production process and the dimensional accuracy of flakes. Unwinding the film with the active substance from the bunker roll and feeding it to the cutting station is preferably carried out continuously by means of a powered roller, on which the film is guided with the active substance and on which it is cut along the length. on strands. In order to facilitate the cutting, the foil with the active substance is subjected to initial stress, which causes its smoothing and contributes to increasing the accuracy of the longitudinal cutting process. The film with the active substance can be easily loaded transversely to the feed direction, in particular with the use of a suitable weight, which in combination with the width of the film with the active substance determines its initial stress ezenie. The cut strips of foil are grouped together and stacked on top of each other to form a stack so that they adhere smoothly to each other. The further strand advance takes place in an intermittent movement and can therefore be reliably realized. Advantageously, the stack is pulled onto the slide guide by means of a further feeding device and smoothed out. In order to move and approach the device to the cross-cut, the stack is gripped and pressed by means of the clamping jaws of the gun. on the top side and bottom side of the stack, which stack preferably advances intermittently against the cross-cut device. In order for this process phase to run reliably and precisely, the stack is led in front of the clamping device PL 203 574 B1 3 with exact dimensions for precise alignment of the strands with one another, smoothing and re-tensioning them. The feeder pull pulls the stack and leads the device to the transverse cut, eliminating mutual displacement and different loosening of individual strands. The device according to the invention for implementing this method comprises a support for a feed roll made of active substance foil, a feed roller driven by an electric motor for unwinding the active substance foil from the feed roll, having a width of at least as much as foil, device for slitting along the strand, consisting of a feed roller and a cooperating knife cutting device, device for focusing and stacking (stacking device ) of sliding, half-length strands and another device for the feeding of the strands, as well as the device for the transverse cutting of the partially-finished strands. A stacking device is arranged between the slack-cutting device and the cross-cutting device, which comprises a guide channel system and means for smoothing the fins of the band and feeding them to the device for the cross cut. Preferably, two deflection rollers for the active substance film between which the film is tensioned by means of a pull roller are arranged parallel to this feed roller, between the feed roller and the slitting device. The knife cutting device consists of a holding device pressed against the active substance foil by means of a feed roller, and fixed to it side by side at adjustable intervals, parallel to the direction of the feed of the active substance foil. , rotating and spaced disc knives. The mutual distance between the disc knives is adjustable. The component part of the device is the grouping and stacking of the cut, shifted bands. Such a system is described in DE 19925 339 A1. Preferably, the stacking means is a system of vacuum guide channels, the entrances of which are located next to each other, and their exits are arranged one above the other, with one sub-choke assigned to each strand. vascular guide canal. The clustered and stacked strands are displaced intermittently by the forceps feeder, which grips the stack intermittently and presses it, and which also pushes the stack to the device to the cross section. Downstream of the stacking device there is preferably a U-shaped trilateral slide guide for the stack to be formed, on which at least one weight is locally fixed in the vertical guides, which slides on the stack moving in the guide smooth and smoothes the strands. The three-sided sliding track is arched downwards around the axis transverse to the feed direction when viewed from above at the stack, so that a certain preload is generated in the stack which must be overcome as an exactly defined salty resistance by the feeder tickly. The feed stroke of the forceps feeder determines the length of the flies. Preferably, in the feed direction behind the three-sided slide guide, there is a gripper feeder which grips the stack intermittently and feeds the device to the crosscut. The clamp feeder preferably has two clamping jaws for the stack which are engaged with the drive by an interchangeable central transport cam which moves the clamping jaws forwards and backwards with respect to the feed direction. which the clamping jaws press against the stack as it moves forward. Clamping jaws to move the stack forward, clamp together and at a distance from the end of the stack on the side of the device to the cross-cut and pull it from the slide, overcoming the resistance created on this slide, and at the same time up to the cross-cutting device, the section of the stack of a specific length in the direction of feed in front of the gripper feeder. The transport cam is positioned against the center and is in constant contact with it by the clamping jaws so that the continuous rotation of the transport cam is converted into a defined progressive forward and backward movement of the clamping jaws. A change in the dimensions or shape of the transport cam causes a change in the amount of the postal movement, and hence in the feed, which allows the length of the flash to be determined. Preferably, guide elements are positioned between the gripper and the cross-cutting device. The subject of the invention is illustrated in an exemplary embodiment in the drawing, in which the only figure shows schematically a device for producing thin flakes from a film with an active substance. The device has a roller mounted on a support not visible in the drawing. bunker 1.with a reserve of film 2 with the active substance and a thickness of about 0.05 mm, driven by a Mwa motor, vacuum medication 3 as a feed roller for unwinding the film 2 with the active substance from the batch roller 1, Line 5 for slack cutting formed by a vacuum roller 3 and a cutting device 4 cooperating with it, a stacking device 6 for half-length strands 7, having a trilateral U-section and the slide guide 8 of the stack 9 formed by the strips 7, the clamp feeder 10 and the cross-cutting device 11 for the stack 9. Between the roll and the feeder 1 and the longitudinal cutting device 5 are placed parallel to feed roller 1 two deflection rollers 12 for guiding the active substance film 2, and between these deflecting rollers 12 there is a feed roller 13, which stretches the film 2 with the active substance. New cutting device 4 It consists of an undisclosed holder 14 and held at an adjustable distance on it, positioned parallel to the feed direction of the film 2 with the active substance, rotating disc knives 15, which are pressed against the film 2 with the substance the active and intersect them along or intersectly according to their arrangement during its displacement by means of a vacuum roller 3. In this embodiment, the distance ep between the disc knives 15 is 20 mm. The stacking device 6 has, for each strand 7 in the stacking block 16, a vacuum guide channel 17, which on a common input 18 is connected in parallel with the other vacuum channels guide 17. The guide channels 17 are guided in a stack forming block 16 such that on a common output 19 they are arranged one above the other. Attached to the stacking device 6 is a three-sided sliding guide 8. It is bent around the axis A transverse to the feed direction or parallel to the axis of the vacuum roller 3, storage roller 1, deflection rollers 12 and tension roller 13 and takes over the stack 9 guiding it from the side, the side walls of the slide guide 8 having a spacing essentially corresponding to the width of the stack 9. On the stack 9 a weight is placed in a vertical guide not shown in the drawing 20 with a mass of 120 g, which adheres to the stack and squeezes it smooths it. In the direction of the feed behind the three-sided slide guide 8 there is a gripper 10, which has two clamping jaws 21 and 22 arranged above each other, gripping the stack 9 intermittently, and which are coupled to the drive 24 by via an interchangeable central transport cam 23. The transport cam 23 and drive 24 move the clamping jaws 21 and 22 forwards and backwards with respect to the feed direction, the clamping jaws 21 and 22 gripping the stack 9 in their rearward direction. lay dead I and release this pile in their front after dead II. Behind the grapple feeder 10 there are guide elements 25 in the form of plates, between which the stack 9 slides towards the cross-cutting device 11, in which the cross-cuts between two guillotine knives 26 occur. the length of the sections of the stack is 25 mm, so that an ep lathe with a size of 20 x 25 mm is obtained. The flasks produced are then placed in a packing machine for dispensers, bubble packs or bags. PL

Claims (14)

Zastrze zenia patentowe 1. Sposób wytwarzania cienkich p latków folii z substancj a czynn a, zgodnie z którym t e foli e wy- twarza si e przez odlanie albo nanoszenie substancji czynnej na materia l pod lo za i nawija z materia lem pod lo zowym lub bez niego na rolk e, po czym odwija z niej i tnie, przy czym foli e z substancj a czynn a odwija si e automatycznie, oddziela od istniej acego materia lu pod lo za i w stanie naprezonym dopro- wadza do stanowiska ci ecia, w którym tnie si e j a w kierunku posuwu na w askie pasma o okre slonej szeroko sci, znamienny tym, ze te pasma skupia si e ze sob a w kierunku posuwu i razem doprowadza za pomoc a nast epnego urz adzenia posuwowego do urz adzenia do ci ecia poprzecznego, w którym tnie si e poprzecznie w okre slonych odst epach skupione ze sob a pasma.Claims 1. Method for the production of thin film flakes with an active ingredient, according to which the film is produced by pouring or applying the active ingredient to a substrate material and winding it with or without the substrate material on a roll, then unwinds and cuts, while the foil with the active substance unwinds automatically, separates it from the existing material under the ground and, under tension, leads to the cutting position, where it is cut ee in the feed direction into narrow strands of a specific width, characterized by the fact that these strands are concentrated together and in the direction of the feed, and they are brought together by the next feed device to the cross-cut device in which it is cut that the bands are linked transversely at specific intervals. 2. Sposób wed lug zastrz. 1, znamienny tym, ze odwijanie folii z substancj a czynn a z rolki za- sobnikowej i doprowadzanie do stanowiska rozcinania prowadzi si e korzystnie w sposób ci ag ly za pomoc a nap edzanego walca, po którym prowadzi si e t e foli e z substancj a czynn a i na którym tnie si e ja wzd lu znie na pasma.2. The method according to claim The method of claim 1, characterized in that the unwinding of the film with the active substance from the feed roll and the feeding to the cutting station is preferably carried out continuously by means of a powered roller, on which the film with the active substance is guided on which cuts it along or into strands. 3. Sposób wed lug zastrz. 1, znamienny tym, ze te pasma skupia si e ze sob a i uk lada jedno na drugim z utworzeniem stosu.PL 203 574 B1 53. The method according to claim The method of claim 1, wherein the bands are concentrated together and stacked on top of each other to form a stack. 4. Sposób wed lug zastrz. 1 albo 3, znamienny tym, ze stos ten wci aga si e za pomoc a kolej- nego urz adzenia posuwowego na prowadnic e slizgow a i wyg ladza si e.4. The method according to claim The method as claimed in claim 1 or 3, characterized in that the stack is pulled by a further feed device onto the slide guide and smoothes out. 5. Sposób wed lug zastrz. 1, znamienny tym, ze stos dosuwa si e ruchem przerywanym do urz adzenia do ci ecia poprzecznego.5. The method according to claim The method of claim 1, characterized in that the stack advances intermittently against the cross-cutting device. 6. Urz adzenie do wytwarzania cienkich p latków folii z substancj a czynn a, zawieraj ace wspor- nik dla rolki zasobnikowej z foli a z substancj a czynn a, nap edzany wa lek posuwowy do odwijania folii z substancj a czynn a z rolki zasobnikowej, urz adzenie do ci ecia wzd luznego utworzone z wa lka posu- wowego i no zowego urz adzenia tn acego oraz urz adzenie do ci ecia poprzecznego poci etych pasm, znamienne tym, ze miedzy urz adzeniem (5) do ci ecia wzd lu znego i urz adzeniem (11) do ci ecia po- przecznego jest usytuowane urz adzenie (16) do uk ladania w stos zawieraj ace uk lad kana lów prowa- dz acych (17) oraz srodki wyg ladzaj ace poci ete pasma (7) i doprowadzaj ace je do urz adzenia (11) do ciecia poprzecznego.6. A device for the production of thin flakes of film with the active substance, including a support for the feed roller with the active substance film, a driven roller, feeder for unwinding the film with the active substance from the feed roller, the device for slack cutting, formed from the feed roller and knife of the cutting device, and a device for the transverse cutting of half-strands, characterized in that between the longitudinal cutting device (5) and the device ( 11) a stacking device (16) is arranged to the transverse cut, containing a guide channel system (17) and means for smoothing the cut-offs (7) and feeding them to the devices loading (11) for cross cutting. 7. Urz adzenie wed lug zastrz. 6, znamienne tym, ze miedzy rolk a zasobnikow a (1) i urz adze- niem (5) do ci ecia wzd lu znego s a umieszczone równolegle do tej rolki zasobnikowej (1) dwie rolki zwrotne (12) dla folii z substancj a czynn a, mi edzy którymi jest ona napr ezana za pomoc a rolki naci a- gowej (13).7. A device according to claim 6, characterized in that between the roller and the feeder (1) and the device (5) for slitting along the slurry, two return rollers (12) for the film with the active substance are arranged parallel to the feed roller (1) a, between which it is tensioned by a pinch roller (13). 8. Urz adzenie wed lug zastrz. 7, znamienne tym, ze no zowe urz adzenie tn ace (4) jest utwo- rzone z przytrzymywacza (14) i z umocowanych na nim obok siebie w regulowanych odst epach, usta- wionych równolegle do kierunku posuwu folii (2) z substancj a czynn a, obracaj acych si e no zy krazko- wych (15).8. A device according to claim 7, characterized in that the knife cutting device (4) is formed by a retainer (14) and fixed thereon side by side at adjustable intervals arranged parallel to the direction of advance of the film (2) with the active substance a, the rotating disc knives (15). 9. Urz adzenie wed lug zastrz. 6, znamienne tym, ze srodki do uk ladania w stos stanowi a uk lad podci snieniowych kana lów prowadz acych (17), których wej scia (18) s a usytuowane obok siebie, a ich wyj scia (19) s a umieszczone jedno nad drugim, przy czym do ka zdego pasma (7) jest przypo- rz adkowany jeden podci snieniowy kana l prowadz acy (17).9. A device according to claim 6. The stacking means according to claim 6, characterized in that the stacking means is a system of vacuum guide channels (17), the inlets (18) of which are adjacent to one another and their outlets (19) are arranged one above the other, one vacuum guide channel (17) is assigned to each strip (7). 10. Urz adzenie wed lug zastrz. 9, znamienne tym, ze za urz adzeniem do uk ladania w stos jest umieszczona U-kszta ltna trójstronna prowadnica slizgowa (8) dla utworzonego stosu (9), na której jest ustalony miejscowo w pionowych prowadnicach co najmniej jeden obci aznik (20), który slizga si e po stosie (9) przemieszczaj acym si e w prowadnicy slizgowej (8) i wyg ladza pasma (7).10. A device according to claim A U-shaped tripartite sliding guide (8) for the stacked (9) is provided behind the stacking device, on which at least one weight (20) is locally fixed in the vertical guides, which slides over the stack (9) moving in the sliding guide (8) and smooths the strands (7). 11. Urz adzenie wed lug zastrz. 10, znamienne tym, ze trójstronna prowadnica slizgowa (8) jest wysklepiona w dó l wokó l osi poprzecznej do kierunku posuwu.11. A device according to claim 10. The apparatus of claim 10, characterized in that the three-sided sliding track (8) is arched downwards about an axis transverse to the feed direction. 12. Urz adzenie wed lug zastrz. 10 albo 11, znamienne tym, ze w kierunku posuwu za trójstron- n a prowadnic a slizgow a (8) jest usytuowany podajnik kleszczowy (10), który chwyta stos (9) w sposób przerywany i doprowadza do urz adzenia (11) do ci ecia poprzecznego.12. A device according to claim 10 or 11, characterized in that in the feed direction behind the three-sided slide guide (8) there is a grapple feeder (10), which grips the stack (9) intermittently and feeds the cutter to the machine (11). transverse. 13. Urz adzenie wed lug zastrz. 12, znamienne tym, ze podajnik kleszczowy (10) ma dwie szcz eki zaciskowe (21, 22) dla stosu (9), które s a sprz ezone z nap edem (24) przez wymienn a, mimo- srodow a krzywk e transportow a (23), która porusza te szcz eki zaciskowe (21, 22) w przód i w ty l wzgl edem kierunku posuwu, przy czym te szcz eki zaciskowe dociskaj a stos (9) podczas jego ruchu do przodu.13. A device according to claim Device according to claim 12, characterized in that the clamp feeder (10) has two clamping jaws (21, 22) for the stack (9) which are coupled to the drive (24) via an interchangeable eccentric transport cam ( 23), which moves the clamping jaws (21, 22) back and forth with respect to the feed direction, the clamping jaws pressing against the stack (9) as it moves forward. 14. Urz adzenie wed lug zastrz. 13, znamienne tym, ze miedzy podajnikiem kleszczowym (10) i urz adzeniem (11) do ci ecia poprzecznego s a usytuowane elementy prowadz ace (25).PL 203 574 B1 6 Rysunek Departament Wydawnictw UP RP Cena 2,46 z l (w tym 23% VAT) PL14. A device according to claim 13, characterized in that between the gripper feeder (10) and the cross-cutting device (11) there are guide elements (25). PL 203 574 B1 6 Drawing Department of Publications of the Polish Patent Office Price PLN 2.46 (including 23 % VAT) PL
PL366917A 2001-02-14 2002-02-04 Method and device for producing thin flakes from foil with the active ingredient PL203574B1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US26880501P 2001-02-14 2001-02-14
US60/268,805 2001-02-14
DE10110494A DE10110494C1 (en) 2001-02-14 2001-03-05 Thin wafer manufacture from an active film involves slitting film into long strips which are stacked and smoothed before cross-cutting to length
DE10110494.4 2001-03-05

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PL366917A1 PL366917A1 (en) 2005-02-07
PL203574B1 true PL203574B1 (en) 2009-10-30

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