FI88674B - Foerfarande foer framstaellning av en farmaceutisk produkt - Google Patents
Foerfarande foer framstaellning av en farmaceutisk produkt Download PDFInfo
- Publication number
- FI88674B FI88674B FI862967A FI862967A FI88674B FI 88674 B FI88674 B FI 88674B FI 862967 A FI862967 A FI 862967A FI 862967 A FI862967 A FI 862967A FI 88674 B FI88674 B FI 88674B
- Authority
- FI
- Finland
- Prior art keywords
- emulsion
- glass transition
- transition temperature
- active ingredient
- polymer
- Prior art date
Links
- 239000000825 pharmaceutical preparation Substances 0.000 title claims description 14
- 229940127557 pharmaceutical product Drugs 0.000 title description 2
- 230000009477 glass transition Effects 0.000 claims abstract description 26
- 239000002245 particle Substances 0.000 claims abstract description 26
- 230000003111 delayed effect Effects 0.000 claims abstract description 5
- 239000004480 active ingredient Substances 0.000 claims description 30
- 229920000642 polymer Polymers 0.000 claims description 18
- 229920000058 polyacrylate Polymers 0.000 claims description 14
- 239000002904 solvent Substances 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 12
- 239000003814 drug Substances 0.000 claims description 11
- 229940079593 drug Drugs 0.000 claims description 11
- 239000004908 Emulsion polymer Substances 0.000 claims description 10
- 239000000839 emulsion Substances 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 9
- 239000002775 capsule Substances 0.000 claims description 5
- 229920001577 copolymer Polymers 0.000 claims description 5
- 230000007423 decrease Effects 0.000 claims description 5
- 125000004494 ethyl ester group Chemical group 0.000 claims description 4
- 239000007787 solid Substances 0.000 claims description 4
- 239000013543 active substance Substances 0.000 claims description 3
- 238000001704 evaporation Methods 0.000 claims description 3
- 230000008020 evaporation Effects 0.000 claims description 3
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 2
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims description 2
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 239000012876 carrier material Substances 0.000 abstract description 3
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 239000008177 pharmaceutical agent Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000010408 film Substances 0.000 description 25
- 239000003826 tablet Substances 0.000 description 16
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 12
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 9
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 8
- 239000004816 latex Substances 0.000 description 8
- 229920000126 latex Polymers 0.000 description 8
- 239000000546 pharmaceutical excipient Substances 0.000 description 7
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 6
- 239000010410 layer Substances 0.000 description 6
- GJSURZIOUXUGAL-UHFFFAOYSA-N Clonidine Chemical compound ClC1=CC=CC(Cl)=C1NC1=NCCN1 GJSURZIOUXUGAL-UHFFFAOYSA-N 0.000 description 5
- 229960002896 clonidine Drugs 0.000 description 5
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- HBLPYIOKPJVFQW-UHFFFAOYSA-N 6-ethyl-4,5,7,8-tetrahydro-[1,3]oxazolo[4,5-d]azepin-2-amine;hydron;dichloride Chemical compound Cl.Cl.C1CN(CC)CCC2=C1OC(N)=N2 HBLPYIOKPJVFQW-UHFFFAOYSA-N 0.000 description 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 3
- 150000001298 alcohols Chemical class 0.000 description 3
- 239000000969 carrier Substances 0.000 description 3
- 238000009792 diffusion process Methods 0.000 description 3
- 239000006185 dispersion Substances 0.000 description 3
- 238000004128 high performance liquid chromatography Methods 0.000 description 3
- 239000008101 lactose Substances 0.000 description 3
- 239000000314 lubricant Substances 0.000 description 3
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 239000004793 Polystyrene Substances 0.000 description 2
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 2
- 150000001412 amines Chemical class 0.000 description 2
- 239000011324 bead Substances 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000007720 emulsion polymerization reaction Methods 0.000 description 2
- 239000003925 fat Substances 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000000227 grinding Methods 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- -1 methyl ethyl Chemical group 0.000 description 2
- 239000000178 monomer Substances 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- 229920003148 Eudragit® E polymer Polymers 0.000 description 1
- 229920003159 Eudragit® RS 100 Polymers 0.000 description 1
- 239000005909 Kieselgur Substances 0.000 description 1
- 239000005062 Polybutadiene Substances 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 description 1
- 125000005396 acrylic acid ester group Chemical group 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- NEDGUIRITORSKL-UHFFFAOYSA-N butyl 2-methylprop-2-enoate;2-(dimethylamino)ethyl 2-methylprop-2-enoate;methyl 2-methylprop-2-enoate Chemical compound COC(=O)C(C)=C.CCCCOC(=O)C(C)=C.CN(C)CCOC(=O)C(C)=C NEDGUIRITORSKL-UHFFFAOYSA-N 0.000 description 1
- 235000011089 carbon dioxide Nutrition 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000008120 corn starch Substances 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 230000009969 flowable effect Effects 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 150000008282 halocarbons Chemical class 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 229920000747 poly(lactic acid) Polymers 0.000 description 1
- 229920002239 polyacrylonitrile Polymers 0.000 description 1
- 229920002857 polybutadiene Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 229920001290 polyvinyl ester Polymers 0.000 description 1
- 229920001289 polyvinyl ether Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000004017 vitrification Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Macromonomer-Based Addition Polymer (AREA)
- Polyesters Or Polycarbonates (AREA)
- Macromolecular Compounds Obtained By Forming Nitrogen-Containing Linkages In General (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Saccharide Compounds (AREA)
Claims (7)
1. Förfarande för framställning av farmaceutiskt preparat, vilket preparat uppvisar en reglerat kontrollerad och retarde-rad frigöring av det aktiva ämnet och som innehäller en pä ett emulsionspolymerisat baserat bärare med undantag för preparat som bestär av emulsionspolyakrylater med en partikelstor1ek pä ca 140 nm och vars glasningstemperatur är ca 30oc, k ä n -netecknat därav, att en tili en partikelstorlek av 50 - 500 nm polymeriserad emulsionspolymerisat med en glasningstemperatur av mellan -20oC och +8O0C suspenderas med det aktiva ämnet i ett 1ösningsmedel, (a) det aktiva ämnet innehällande polymerlösningen utbreds tili en film och efter dunstningen av lösningsmedlet förses det aktiva ämnet innehällande fiImen eventuellt med ett änga ogenomträngligt underskikt och bearbetas tili önskad form, el 1 er (b) lösningsmedlet dunstas, det fasta läkemedlet innehällande emulsionspolymerisatet malas tili en partikelstorlek av mellan 10 - 500 pm vid en temperatur under glasningstemperaturen, bearbetas med sedvanliga tabletteringshjälpmedel och presses till tabletter eller används i kapslar, varvid avtagande partikelstorlek ökar frigöringen av det aktiva ämnet, och en höjning av glasningstemperaturen minskar frigöringshastigheten.
2. Förfarande enligt patentkravet 1, kännetecknat därav, att emulsionspolymerisatets glasningstemperatur är mellan -10 och +30oC.
3. Förfarande enligt patentkraven 1 eller 2, kännetecknat därav, att bärarens med det aktiva läkemedlet partikelstorlek är 10 - 500 pm. 13 88674
4. Förfarande enligt patentkraven 1 eller 2, kanne- t e c k n a t därav, att filmens skikttjocklek är mellan 40 och 200 μπν, företrädesvis mellan 60 - 140 μιη.
5. Förfarande enligt patentkravet 1, 2, 3 eller 4, kanne-t e c k n a t därav, att bäraren bestSr av ett emulsionspoly-meriserat kopolymerisat.
6. Förfarande enligt patentkravet 5, kännetecknat därav, att polymeren bestär av akryl- och metakrylsyrans metyl- och/eller etylestrars emulsionspolymeriserade kopoly-merat.
7. Förfarande enligt nägot av patentkraven 1-6, kännetecknat därav, att det innehäller aktivt ämne mellan 0,1 och 30 %, företrädesvis 1 - 10 %.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19853525767 DE3525767A1 (de) | 1985-07-19 | 1985-07-19 | Pharmazeutische zubereitung mit kontrollierter und verzoegerter wirkstofffreigabe und verfahren zu deren herstellung |
| DE3525767 | 1985-07-19 |
Publications (4)
| Publication Number | Publication Date |
|---|---|
| FI862967A0 FI862967A0 (fi) | 1986-07-17 |
| FI862967L FI862967L (fi) | 1987-01-20 |
| FI88674B true FI88674B (fi) | 1993-03-15 |
| FI88674C FI88674C (sv) | 1993-06-28 |
Family
ID=6276155
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FI862967A FI88674C (sv) | 1985-07-19 | 1986-07-17 | Förfarande för framställning av en farmaceutisk produkt |
Country Status (22)
| Country | Link |
|---|---|
| EP (1) | EP0209121B1 (sv) |
| JP (1) | JPH0816068B2 (sv) |
| KR (1) | KR930007246B1 (sv) |
| AT (1) | ATE72110T1 (sv) |
| AU (1) | AU589983B2 (sv) |
| CA (1) | CA1289076C (sv) |
| CS (1) | CS264133B2 (sv) |
| DD (2) | DD265327A5 (sv) |
| DE (2) | DE3525767A1 (sv) |
| DK (1) | DK343586A (sv) |
| ES (1) | ES2001858A6 (sv) |
| FI (1) | FI88674C (sv) |
| GR (1) | GR861872B (sv) |
| HU (1) | HU196314B (sv) |
| IE (1) | IE59024B1 (sv) |
| IL (1) | IL79439A (sv) |
| NO (1) | NO174086C (sv) |
| NZ (1) | NZ216897A (sv) |
| PH (1) | PH22993A (sv) |
| PL (1) | PL260689A1 (sv) |
| PT (1) | PT83009B (sv) |
| ZA (1) | ZA865363B (sv) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9021674D0 (en) * | 1990-10-05 | 1990-11-21 | Ethical Pharma Ltd | Transdermal device |
| DE19603402A1 (de) * | 1995-02-24 | 1996-08-29 | Basf Ag | Weichgelatinekapseln |
| DE19940238A1 (de) | 1999-08-25 | 2001-03-01 | Lohmann Therapie Syst Lts | Wirkstoffhaltiges therapeutisches System zur Applikation auf der Haut mit mindestens zwei polymerhaltigen Schichten |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| USRE28316E (en) * | 1968-09-03 | 1975-01-21 | Entrapment compositions and processes | |
| JPS57116011A (en) * | 1981-01-08 | 1982-07-19 | Nitto Electric Ind Co Ltd | Pharmaceutical preparation |
| DE3204551A1 (de) * | 1982-02-10 | 1983-08-18 | Boehringer Ingelheim KG, 6507 Ingelheim | Verfahren zur herstellung einer pharmazeutischen zubereitung in form eines polyacrylat-films |
| DE3314003A1 (de) * | 1983-04-18 | 1984-10-18 | Boehringer Ingelheim KG, 6507 Ingelheim | Teilbare tablette mit verzoegerter wirkstofffreigabe und verfahren zu deren herstellung |
-
1985
- 1985-07-19 DE DE19853525767 patent/DE3525767A1/de not_active Withdrawn
-
1986
- 1986-07-16 DD DD86292545A patent/DD265327A5/de not_active IP Right Cessation
- 1986-07-16 DE DE8686109726T patent/DE3683700D1/de not_active Expired - Lifetime
- 1986-07-16 AT AT86109726T patent/ATE72110T1/de not_active IP Right Cessation
- 1986-07-16 EP EP86109726A patent/EP0209121B1/de not_active Expired - Lifetime
- 1986-07-17 IL IL79439A patent/IL79439A/xx not_active IP Right Cessation
- 1986-07-17 PL PL1986260689A patent/PL260689A1/xx unknown
- 1986-07-17 CS CS865452A patent/CS264133B2/cs unknown
- 1986-07-17 FI FI862967A patent/FI88674C/sv not_active IP Right Cessation
- 1986-07-17 GR GR861872A patent/GR861872B/el unknown
- 1986-07-18 HU HU862967A patent/HU196314B/hu not_active IP Right Cessation
- 1986-07-18 ZA ZA865363A patent/ZA865363B/xx unknown
- 1986-07-18 NO NO862907A patent/NO174086C/no unknown
- 1986-07-18 DK DK343586A patent/DK343586A/da not_active Application Discontinuation
- 1986-07-18 CA CA000514139A patent/CA1289076C/en not_active Expired - Fee Related
- 1986-07-18 JP JP61169644A patent/JPH0816068B2/ja not_active Expired - Lifetime
- 1986-07-18 AU AU60304/86A patent/AU589983B2/en not_active Ceased
- 1986-07-18 PT PT83009A patent/PT83009B/pt not_active IP Right Cessation
- 1986-07-18 ES ES8600406A patent/ES2001858A6/es not_active Expired
- 1986-07-18 NZ NZ216897A patent/NZ216897A/xx unknown
- 1986-07-18 IE IE191486A patent/IE59024B1/en not_active IP Right Cessation
- 1986-07-19 KR KR1019860005857A patent/KR930007246B1/ko not_active Expired - Fee Related
- 1986-07-21 PH PH34040A patent/PH22993A/en unknown
-
1988
- 1988-04-15 DD DD88314795A patent/DD272604A5/de not_active IP Right Cessation
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| BB | Publication of examined application | ||
| MM | Patent lapsed |
Owner name: BOEHRINGER INGELHEIM KG |