ZA200209649B - Method for preparing a composition. - Google Patents
Method for preparing a composition. Download PDFInfo
- Publication number
- ZA200209649B ZA200209649B ZA200209649A ZA200209649A ZA200209649B ZA 200209649 B ZA200209649 B ZA 200209649B ZA 200209649 A ZA200209649 A ZA 200209649A ZA 200209649 A ZA200209649 A ZA 200209649A ZA 200209649 B ZA200209649 B ZA 200209649B
- Authority
- ZA
- South Africa
- Prior art keywords
- solution
- dispersion
- composition
- gum
- fatty acid
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims description 91
- 239000000203 mixture Substances 0.000 title claims description 69
- 150000001875 compounds Chemical class 0.000 claims description 50
- -1 gentobiose Substances 0.000 claims description 40
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 39
- 239000006185 dispersion Substances 0.000 claims description 37
- 239000007788 liquid Substances 0.000 claims description 33
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 30
- 239000000463 material Substances 0.000 claims description 27
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 24
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 23
- 239000000194 fatty acid Substances 0.000 claims description 23
- 229930195729 fatty acid Natural products 0.000 claims description 23
- 239000007970 homogeneous dispersion Substances 0.000 claims description 23
- AHLBNYSZXLDEJQ-FWEHEUNISA-N orlistat Chemical group CCCCCCCCCCC[C@H](OC(=O)[C@H](CC(C)C)NC=O)C[C@@H]1OC(=O)[C@H]1CCCCCC AHLBNYSZXLDEJQ-FWEHEUNISA-N 0.000 claims description 20
- 229960001243 orlistat Drugs 0.000 claims description 19
- 238000001035 drying Methods 0.000 claims description 18
- 239000005913 Maltodextrin Substances 0.000 claims description 17
- 229920002774 Maltodextrin Polymers 0.000 claims description 17
- 229940035034 maltodextrin Drugs 0.000 claims description 17
- 239000008194 pharmaceutical composition Substances 0.000 claims description 17
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 15
- 238000009835 boiling Methods 0.000 claims description 12
- 229940086609 Lipase inhibitor Drugs 0.000 claims description 11
- 150000001720 carbohydrates Chemical class 0.000 claims description 11
- 235000014633 carbohydrates Nutrition 0.000 claims description 11
- 239000011521 glass Substances 0.000 claims description 11
- 239000002245 particle Substances 0.000 claims description 11
- 238000002360 preparation method Methods 0.000 claims description 11
- 239000004094 surface-active agent Substances 0.000 claims description 11
- 238000001816 cooling Methods 0.000 claims description 10
- 150000003839 salts Chemical class 0.000 claims description 10
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 9
- 229920005862 polyol Polymers 0.000 claims description 9
- 150000003077 polyols Chemical class 0.000 claims description 9
- 239000002552 dosage form Substances 0.000 claims description 8
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 7
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 7
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims description 7
- 229920000193 polymethacrylate Polymers 0.000 claims description 7
- 239000013557 residual solvent Substances 0.000 claims description 7
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims description 6
- 229920000591 gum Polymers 0.000 claims description 6
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 6
- 235000010449 maltitol Nutrition 0.000 claims description 6
- 239000000845 maltitol Substances 0.000 claims description 6
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- VSZGPKBBMSAYNT-RRFJBIMHSA-N oseltamivir Chemical compound CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1 VSZGPKBBMSAYNT-RRFJBIMHSA-N 0.000 claims description 6
- 229920000642 polymer Polymers 0.000 claims description 6
- DUXYWXYOBMKGIN-UHFFFAOYSA-N trimyristin Chemical compound CCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCC DUXYWXYOBMKGIN-UHFFFAOYSA-N 0.000 claims description 6
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 5
- 229930006000 Sucrose Natural products 0.000 claims description 5
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 5
- 238000009826 distribution Methods 0.000 claims description 5
- 238000004806 packaging method and process Methods 0.000 claims description 5
- 150000003904 phospholipids Chemical class 0.000 claims description 5
- 239000011734 sodium Substances 0.000 claims description 5
- 229910052708 sodium Inorganic materials 0.000 claims description 5
- 239000005720 sucrose Substances 0.000 claims description 5
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 claims description 4
- 150000004665 fatty acids Chemical class 0.000 claims description 4
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 4
- 229920002307 Dextran Polymers 0.000 claims description 3
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 3
- 229920002472 Starch Polymers 0.000 claims description 3
- ZAKOWWREFLAJOT-ADUHFSDSSA-N [2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate Chemical group CC(=O)OC1=C(C)C(C)=C2OC(CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-ADUHFSDSSA-N 0.000 claims description 3
- 150000001412 amines Chemical group 0.000 claims description 3
- 229940071162 caseinate Drugs 0.000 claims description 3
- 229920002678 cellulose Polymers 0.000 claims description 3
- 239000001913 cellulose Substances 0.000 claims description 3
- 229940082500 cetostearyl alcohol Drugs 0.000 claims description 3
- 229960000541 cetyl alcohol Drugs 0.000 claims description 3
- 235000012000 cholesterol Nutrition 0.000 claims description 3
- 230000003247 decreasing effect Effects 0.000 claims description 3
- 235000019329 dioctyl sodium sulphosuccinate Nutrition 0.000 claims description 3
- 229960000878 docusate sodium Drugs 0.000 claims description 3
- 229920001983 poloxamer Polymers 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- APSBXTVYXVQYAB-UHFFFAOYSA-M sodium docusate Chemical compound [Na+].CCCCC(CC)COC(=O)CC(S([O-])(=O)=O)C(=O)OCC(CC)CCCC APSBXTVYXVQYAB-UHFFFAOYSA-M 0.000 claims description 3
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 3
- 239000008107 starch Substances 0.000 claims description 3
- 235000019698 starch Nutrition 0.000 claims description 3
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims description 3
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 claims description 3
- 229940113164 trimyristin Drugs 0.000 claims description 3
- 229920001285 xanthan gum Polymers 0.000 claims description 3
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical group CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- LUEWUZLMQUOBSB-FSKGGBMCSA-N (2s,3s,4s,5s,6r)-2-[(2r,3s,4r,5r,6s)-6-[(2r,3s,4r,5s,6s)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2r,4r,5s,6r)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-4,5-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol 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]2[C@H](O[C@@H](OC3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-FSKGGBMCSA-N 0.000 claims description 2
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims description 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 2
- PVXPPJIGRGXGCY-TZLCEDOOSA-N 6-O-alpha-D-glucopyranosyl-D-fructofuranose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)C(O)(CO)O1 PVXPPJIGRGXGCY-TZLCEDOOSA-N 0.000 claims description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
- 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 claims description 2
- 241000416162 Astragalus gummifer Species 0.000 claims description 2
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims description 2
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- 229920000858 Cyclodextrin Polymers 0.000 claims description 2
- GUBGYTABKSRVRQ-CUHNMECISA-N D-Cellobiose 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)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-CUHNMECISA-N 0.000 claims description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
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- QWIZNVHXZXRPDR-UHFFFAOYSA-N D-melezitose Natural products O1C(CO)C(O)C(O)C(O)C1OC1C(O)C(CO)OC1(CO)OC1OC(CO)C(O)C(O)C1O QWIZNVHXZXRPDR-UHFFFAOYSA-N 0.000 claims description 2
- 239000004386 Erythritol Substances 0.000 claims description 2
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims description 2
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
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- 229930091371 Fructose Natural products 0.000 claims description 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 2
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Classifications
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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- A—HUMAN NECESSITIES
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- A61P3/04—Anorexiants; Antiobesity agents
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- A61P3/06—Antihyperlipidemics
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- A—HUMAN NECESSITIES
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| GB9827423D0 (en) * | 1998-12-11 | 1999-02-03 | Relax Limited | Method of drying a solution |
| HU229550B1 (en) * | 2000-06-27 | 2014-01-28 | Hoffmann La Roche | Method for preparing compositions |
| US20030027786A1 (en) | 2001-06-06 | 2003-02-06 | Karsten Maeder | Lipase inhibiting composition |
| MY135783A (en) * | 2001-09-07 | 2008-06-30 | Meiji Dairies Corp | Nutritional composition for controlling blood sugar level |
| ATE453390T1 (de) * | 2002-04-26 | 2010-01-15 | Hoffmann La Roche | Pharmazeutische zusammensetzung enthaltend einen lipase - inhibitor und glucomannan |
| KR100517072B1 (ko) * | 2002-11-25 | 2005-09-26 | 주식회사 태평양 | 폴리올/고분자 마이크로캡슐 및 이를 이용한 효소 안정화방법 |
| US9174176B2 (en) | 2003-01-09 | 2015-11-03 | Disperse Systems, Inc. | Ultrasonic dispersion apparatus, system, and method |
| US20050089502A1 (en) * | 2003-08-21 | 2005-04-28 | Todd Schansberg | Effervescent delivery system |
| US8940321B2 (en) | 2003-12-12 | 2015-01-27 | Otic Pharma Ltd. | Compositions for treatment of ear disorders and methods of use thereof |
| WO2005055921A2 (en) | 2003-12-12 | 2005-06-23 | Eran Eilat | Compositions for treatment of ear disorders and methods of use thereof |
| CA2562213A1 (en) * | 2004-04-06 | 2005-11-24 | Rpg Life Sciences Limited | Mouth dissolvable and meltable, and water dispersable delivery formulation |
| JP4329816B2 (ja) * | 2004-09-15 | 2009-09-09 | 萬有製薬株式会社 | サンプリング方法、サンプリング装置、ｌｏｇＤ測定方法及びｌｏｇＤ測定システム |
| EP1837032A4 (en) * | 2004-12-31 | 2009-06-10 | Mikhail Yurievich Gotovsky | MAGNETIC RESONANCE PREPARATIONS AND DEVICE FOR INDIVIDUALLY SELECTING SUCH PREPARATIONS TO INCREASE THE ACTIVITY OF AN ORGANISM UNDER CURRENT ENVIRONMENTAL CONDITIONS |
| US20060198856A1 (en) * | 2005-03-01 | 2006-09-07 | Keith Whitehead | Ibuprofen suspension stabilized with docusate sodium |
| US20060246141A1 (en) * | 2005-04-12 | 2006-11-02 | Elan Pharma International, Limited | Nanoparticulate lipase inhibitor formulations |
| US7984717B2 (en) * | 2005-04-29 | 2011-07-26 | Medtronic, Inc. | Devices for augmentation of lumen walls |
| US20070060610A1 (en) * | 2005-06-16 | 2007-03-15 | Wempe Michael F | Methods and pharmaceutical formulations for increasing bioavailability |
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| US20070048364A1 (en) * | 2005-08-04 | 2007-03-01 | Yingxu Peng | Free flowing granules containing carbomer |
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| US10010494B2 (en) | 2005-10-19 | 2018-07-03 | Menni Menashe Zinger | Methods for the treatment of hyperhidrosis |
| JP5214464B2 (ja) | 2005-12-28 | 2013-06-19 | アドバンスド バイオニュートリション コーポレーション | 多糖類、糖類およびポリオール類の乾燥マトリックスを含む、ガラス形態の、プロバイオティクス細菌用送達媒体およびその製造方法 |
| US8968721B2 (en) | 2005-12-28 | 2015-03-03 | Advanced Bionutrition Corporation | Delivery vehicle for probiotic bacteria comprising a dry matrix of polysaccharides, saccharides and polyols in a glass form and methods of making same |
| FR2895908B1 (fr) * | 2006-01-12 | 2008-03-28 | France Etat | Procede de fabrication d'une forme pharmaceutique de phosphate d'oseltamivir |
| CN101389323B (zh) | 2006-02-20 | 2013-08-21 | 中外制药株式会社 | 含有磷酸奥塞米韦的药物组合物 |
| US7903256B2 (en) | 2006-03-16 | 2011-03-08 | Duke University | Methods, systems, and computer program products for performing real-time quadrature projection based Fourier domain optical coherence tomography |
| CN1820744B (zh) * | 2006-04-04 | 2011-01-26 | 中国人民解放军军事医学科学院毒物药物研究所 | 磷酸奥司他韦颗粒剂及其制备方法 |
| EP1872777A1 (en) * | 2006-06-27 | 2008-01-02 | LEK Pharmaceuticals D.D. | Pharmaceutical composition comprising tetrahydrolipstatin |
| KR100812824B1 (ko) | 2006-09-27 | 2008-03-12 | 주식회사 제닉 | 키토산과 폴리에틸렌글리콜을 이용한 생체친화성 저독성필름 |
| CA2673120C (en) | 2006-12-18 | 2012-08-07 | Advanced Bionutrition Corporation | A dry food product containing live probiotic |
| RU2482841C2 (ru) * | 2007-05-18 | 2013-05-27 | ТиТиАй Эллебо, Инк. | Устройства для трансдермальной доставки, обеспечивающие улучшенное высвобождение действующего начала через биологическую поверхность |
| KR101439470B1 (ko) * | 2007-05-22 | 2014-09-16 | 한미사이언스 주식회사 | 오를리스타트 및 대변 연화제를 포함하는 비만의 예방 또는치료용 조성물 |
| US20100317642A1 (en) * | 2007-10-15 | 2010-12-16 | Inventis Dds Pvt Limited | Pharmaceutical composition of orlistat |
| PL216542B1 (pl) | 2008-03-20 | 2014-04-30 | Zakłady Farmaceutyczne POLPHARMA Spółka Akcyjna | Sposób wytwarzania stabilnej kompozycji orlistatu w postaci kapsułkowanego proszku |
| GB0900551D0 (en) * | 2009-01-14 | 2009-02-11 | Horton Richard | Ingestible compositions and processes of preparation |
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| WO2011040956A1 (en) * | 2009-09-29 | 2011-04-07 | Michael Burnet | Novel pesticide formulations |
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