CA2247877A1 - Systemes d'administration par solubilisation et methode de fabrication - Google Patents
Systemes d'administration par solubilisation et methode de fabrication Download PDFInfo
- Publication number
- CA2247877A1 CA2247877A1 CA002247877A CA2247877A CA2247877A1 CA 2247877 A1 CA2247877 A1 CA 2247877A1 CA 002247877 A CA002247877 A CA 002247877A CA 2247877 A CA2247877 A CA 2247877A CA 2247877 A1 CA2247877 A1 CA 2247877A1
- Authority
- CA
- Canada
- Prior art keywords
- active
- solubilizer
- parts
- eutectic
- particles
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
- 238000000034 method Methods 0.000 title claims abstract description 28
- 230000003381 solubilizing effect Effects 0.000 title claims description 16
- 238000004519 manufacturing process Methods 0.000 title claims description 8
- 230000005496 eutectics Effects 0.000 claims abstract description 57
- 239000002245 particle Substances 0.000 claims abstract description 37
- 239000004094 surface-active agent Substances 0.000 claims abstract description 17
- 239000013543 active substance Substances 0.000 claims abstract description 15
- 238000002156 mixing Methods 0.000 claims abstract description 4
- 239000002904 solvent Substances 0.000 claims description 64
- 229940079593 drug Drugs 0.000 claims description 41
- 239000003814 drug Substances 0.000 claims description 41
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 claims description 33
- 229960001680 ibuprofen Drugs 0.000 claims description 33
- 239000000203 mixture Substances 0.000 claims description 15
- 230000015572 biosynthetic process Effects 0.000 claims description 11
- 239000007787 solid Substances 0.000 claims description 9
- -1 H2 antagonists Substances 0.000 claims description 5
- 229940035676 analgesics Drugs 0.000 claims description 5
- 239000000730 antalgic agent Substances 0.000 claims description 5
- CMWTZPSULFXXJA-UHFFFAOYSA-N Naproxen Natural products C1=C(C(C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-UHFFFAOYSA-N 0.000 claims description 4
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 claims description 4
- 229960000991 ketoprofen Drugs 0.000 claims description 4
- 229960002009 naproxen Drugs 0.000 claims description 4
- CMWTZPSULFXXJA-VIFPVBQESA-N naproxen Chemical compound C1=C([C@H](C)C(O)=O)C=CC2=CC(OC)=CC=C21 CMWTZPSULFXXJA-VIFPVBQESA-N 0.000 claims description 4
- 229940122957 Histamine H2 receptor antagonist Drugs 0.000 claims description 3
- 230000002484 anti-cholesterolemic effect Effects 0.000 claims description 3
- 239000000043 antiallergic agent Substances 0.000 claims description 3
- 229940125684 antimigraine agent Drugs 0.000 claims description 3
- 239000002282 antimigraine agent Substances 0.000 claims description 3
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims description 3
- 229940021182 non-steroidal anti-inflammatory drug Drugs 0.000 claims description 3
- 230000000202 analgesic effect Effects 0.000 claims 2
- 230000008569 process Effects 0.000 abstract description 6
- 238000004090 dissolution Methods 0.000 description 21
- 239000000463 material Substances 0.000 description 19
- 229920001983 poloxamer Polymers 0.000 description 18
- 239000000047 product Substances 0.000 description 18
- 239000004615 ingredient Substances 0.000 description 17
- 239000013078 crystal Substances 0.000 description 11
- 238000002844 melting Methods 0.000 description 8
- 230000008018 melting Effects 0.000 description 8
- 239000011248 coating agent Substances 0.000 description 7
- 238000000576 coating method Methods 0.000 description 7
- 239000000126 substance Substances 0.000 description 7
- 238000003801 milling Methods 0.000 description 6
- 239000002552 dosage form Substances 0.000 description 5
- 239000000523 sample Substances 0.000 description 5
- 238000009987 spinning Methods 0.000 description 5
- 239000004480 active ingredient Substances 0.000 description 4
- 238000001816 cooling Methods 0.000 description 4
- 229920001993 poloxamer 188 Polymers 0.000 description 4
- 229920000642 polymer Polymers 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 239000002775 capsule Substances 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 239000000155 melt Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000009736 wetting Methods 0.000 description 3
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 229960000514 ethenzamide Drugs 0.000 description 2
- SBNKFTQSBPKMBZ-UHFFFAOYSA-N ethenzamide Chemical compound CCOC1=CC=CC=C1C(N)=O SBNKFTQSBPKMBZ-UHFFFAOYSA-N 0.000 description 2
- 239000000374 eutectic mixture Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000011068 loading method Methods 0.000 description 2
- 239000006186 oral dosage form Substances 0.000 description 2
- 239000000811 xylitol Substances 0.000 description 2
- 229960002675 xylitol Drugs 0.000 description 2
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 description 1
- MKXZASYAUGDDCJ-SZMVWBNQSA-N LSM-2525 Chemical compound C1CCC[C@H]2[C@@]3([H])N(C)CC[C@]21C1=CC(OC)=CC=C1C3 MKXZASYAUGDDCJ-SZMVWBNQSA-N 0.000 description 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 238000002441 X-ray diffraction Methods 0.000 description 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 208000029618 autoimmune pulmonary alveolar proteinosis Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 229940046978 chlorpheniramine maleate Drugs 0.000 description 1
- 229960001380 cimetidine Drugs 0.000 description 1
- CCGSUNCLSOWKJO-UHFFFAOYSA-N cimetidine Chemical compound N#CNC(=N/C)\NCCSCC1=NC=N[C]1C CCGSUNCLSOWKJO-UHFFFAOYSA-N 0.000 description 1
- 239000013066 combination product Substances 0.000 description 1
- 229940127555 combination product Drugs 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000013270 controlled release Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 229960001985 dextromethorphan Drugs 0.000 description 1
- HSUGRBWQSSZJOP-RTWAWAEBSA-N diltiazem Chemical compound C1=CC(OC)=CC=C1[C@H]1[C@@H](OC(C)=O)C(=O)N(CCN(C)C)C2=CC=CC=C2S1 HSUGRBWQSSZJOP-RTWAWAEBSA-N 0.000 description 1
- 229960000520 diphenhydramine Drugs 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 229940126534 drug product Drugs 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- HQPMKSGTIOYHJT-UHFFFAOYSA-N ethane-1,2-diol;propane-1,2-diol Chemical compound OCCO.CC(O)CO HQPMKSGTIOYHJT-UHFFFAOYSA-N 0.000 description 1
- 239000006023 eutectic alloy Substances 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- RWTNPBWLLIMQHL-UHFFFAOYSA-N fexofenadine Chemical compound C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RWTNPBWLLIMQHL-UHFFFAOYSA-N 0.000 description 1
- 229960003592 fexofenadine Drugs 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
- 239000011859 microparticle Substances 0.000 description 1
- 239000012768 molten material Substances 0.000 description 1
- CDBRNDSHEYLDJV-FVGYRXGTSA-M naproxen sodium Chemical compound [Na+].C1=C([C@H](C)C([O-])=O)C=CC2=CC(OC)=CC=C21 CDBRNDSHEYLDJV-FVGYRXGTSA-M 0.000 description 1
- 229910052757 nitrogen Inorganic materials 0.000 description 1
- 238000010951 particle size reduction Methods 0.000 description 1
- 239000002304 perfume Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229960000502 poloxamer Drugs 0.000 description 1
- 229940044519 poloxamer 188 Drugs 0.000 description 1
- 229920002523 polyethylene Glycol 1000 Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 238000011045 prefiltration Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000012047 saturated solution Substances 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 238000005549 size reduction Methods 0.000 description 1
- 239000007962 solid dispersion Substances 0.000 description 1
- 239000006104 solid solution Substances 0.000 description 1
- 239000002195 soluble material Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N urea group Chemical group NC(=O)N XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000010447 xylitol Nutrition 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IE980115 | 1998-02-16 | ||
| IE19980115A IE980115A1 (en) | 1998-02-16 | 1998-02-16 | Solubilizing delivery systems and method of manufacture |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2247877A1 true CA2247877A1 (fr) | 1999-08-16 |
Family
ID=11041714
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002247877A Abandoned CA2247877A1 (fr) | 1998-02-16 | 1998-09-23 | Systemes d'administration par solubilisation et methode de fabrication |
| CA002247994A Abandoned CA2247994A1 (fr) | 1998-02-16 | 1998-09-23 | Systemes d'administration par solubilisation et methode de fabrication |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002247994A Abandoned CA2247994A1 (fr) | 1998-02-16 | 1998-09-23 | Systemes d'administration par solubilisation et methode de fabrication |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP1058561A1 (fr) |
| JP (1) | JP2003522097A (fr) |
| AU (1) | AU9498998A (fr) |
| CA (2) | CA2247877A1 (fr) |
| IE (1) | IE980115A1 (fr) |
| WO (1) | WO1999040943A1 (fr) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE60027761T2 (de) * | 1999-12-09 | 2007-01-25 | Reckitt Benckiser Healthcare (Uk) Ltd., Slough | Komprimierte zubereitung enthaltend nichtsteroidale entzündungshemmer |
| US20050232995A1 (en) | 2002-07-29 | 2005-10-20 | Yam Nyomi V | Methods and dosage forms for controlled delivery of paliperidone and risperidone |
| TW200533374A (en) * | 2003-11-13 | 2005-10-16 | Alza Corp | Melt blend dispersions |
| CA2548281C (fr) | 2003-12-09 | 2013-11-12 | Medcrystalforms, Llc | Procede de preparation de cocristaux a phase mixte avec des agents actifs |
| WO2005065653A1 (fr) * | 2003-12-19 | 2005-07-21 | E.I. Du Pont De Nemours And Company | Enrobage intime d'ibuprofene avec des poloxameres afin d'ameliorer la dissolution aqueuse |
| WO2011032916A1 (fr) | 2009-09-17 | 2011-03-24 | Basf Se | Granules recouvertes d'enrobages renfermant des substances actives |
| WO2013143688A1 (fr) | 2012-03-26 | 2013-10-03 | Glatt Ag | Granulés d'ibuprofène de saveur masquée |
| PL2987484T3 (pl) * | 2013-04-18 | 2019-07-31 | Shandong Luye Pharmaceutical Co., Ltd. | Kompozycja farmaceutyczna mikrosfery o przedłużonym uwalnianiu gosereliny |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| LU87233A1 (fr) * | 1988-06-07 | 1990-02-28 | Pharlyse Sa | Composition pharmaceutique a base d'un anti-inflammatoire non steroidien,son procede de preparation et son utilisation |
| EP0580860B2 (fr) * | 1991-04-16 | 2004-12-15 | Nippon Shinyaku Company, Limited | Procede de production d'une dispersion solide |
| US5340591A (en) * | 1992-01-24 | 1994-08-23 | Fujisawa Pharmaceutical Co., Ltd. | Method of producing a solid dispersion of the sparingly water-soluble drug, nilvadipine |
| CA2118517C (fr) * | 1992-06-10 | 2003-10-14 | Gary G. Liversidge | Nanoparticules d'ains a surface modifiee |
| IE80467B1 (en) * | 1995-07-03 | 1998-07-29 | Elan Corp Plc | Controlled release formulations for poorly soluble drugs |
| TW487582B (en) * | 1995-08-11 | 2002-05-21 | Nissan Chemical Ind Ltd | Method for converting sparingly water-soluble medical substance to amorphous state |
-
1998
- 1998-02-16 IE IE19980115A patent/IE980115A1/en unknown
- 1998-09-22 AU AU94989/98A patent/AU9498998A/en not_active Abandoned
- 1998-09-22 WO PCT/US1998/019750 patent/WO1999040943A1/fr not_active Ceased
- 1998-09-22 EP EP98948412A patent/EP1058561A1/fr not_active Withdrawn
- 1998-09-22 JP JP2000531194A patent/JP2003522097A/ja active Pending
- 1998-09-23 CA CA002247877A patent/CA2247877A1/fr not_active Abandoned
- 1998-09-23 CA CA002247994A patent/CA2247994A1/fr not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| AU9498998A (en) | 1999-08-30 |
| IE980115A1 (en) | 2000-02-09 |
| WO1999040943A1 (fr) | 1999-08-19 |
| CA2247994A1 (fr) | 1999-08-16 |
| EP1058561A1 (fr) | 2000-12-13 |
| JP2003522097A (ja) | 2003-07-22 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Dead |