CA3021071A1 - Oral pharmaceutical compositions of mesalazine - Google Patents
Oral pharmaceutical compositions of mesalazine Download PDFInfo
- Publication number
- CA3021071A1 CA3021071A1 CA3021071A CA3021071A CA3021071A1 CA 3021071 A1 CA3021071 A1 CA 3021071A1 CA 3021071 A CA3021071 A CA 3021071A CA 3021071 A CA3021071 A CA 3021071A CA 3021071 A1 CA3021071 A1 CA 3021071A1
- Authority
- CA
- Canada
- Prior art keywords
- mesalazine
- unit dose
- pharmaceutical product
- minitablets
- dose pharmaceutical
- 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.)
- Pending
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- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical group NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 title claims abstract description 254
- 229960004963 mesalazine Drugs 0.000 title claims abstract description 252
- 239000008203 oral pharmaceutical composition Substances 0.000 title description 2
- 238000013265 extended release Methods 0.000 claims abstract description 126
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims abstract description 56
- 238000000034 method Methods 0.000 claims abstract description 21
- 239000008185 minitablet Substances 0.000 claims description 234
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 91
- 229940127557 pharmaceutical product Drugs 0.000 claims description 91
- 238000000576 coating method Methods 0.000 claims description 83
- 239000011248 coating agent Substances 0.000 claims description 75
- 239000000872 buffer Substances 0.000 claims description 59
- 239000011159 matrix material Substances 0.000 claims description 52
- 230000001419 dependent effect Effects 0.000 claims description 33
- 239000002702 enteric coating Substances 0.000 claims description 33
- 238000009505 enteric coating Methods 0.000 claims description 33
- 210000003405 ileum Anatomy 0.000 claims description 29
- 210000001072 colon Anatomy 0.000 claims description 27
- 229920001577 copolymer Polymers 0.000 claims description 22
- 229920000642 polymer Polymers 0.000 claims description 22
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 22
- 238000009506 drug dissolution testing Methods 0.000 claims description 21
- 238000000338 in vitro Methods 0.000 claims description 21
- 239000012738 dissolution medium Substances 0.000 claims description 20
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 19
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- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 18
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 18
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- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 claims description 8
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- A61K9/2072—Pills, 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
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- Nutrition Science (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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| US201662324416P | 2016-04-19 | 2016-04-19 | |
| US62/324,416 | 2016-04-19 | ||
| PCT/US2017/028067 WO2017184566A1 (en) | 2016-04-19 | 2017-04-18 | Oral pharmaceutical compositions of mesalazine |
Publications (1)
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| CA3021071A1 true CA3021071A1 (en) | 2017-10-26 |
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| ITUA20162293A1 (it) * | 2016-04-05 | 2017-10-05 | Sofar Spa | Processo per formulazioni solide di mesalazina |
| CA3021066C (en) | 2016-04-19 | 2024-04-09 | Ferring B.V. | Oral pharmaceutical compositions of nicotinamide |
| TR201722039A2 (tr) * | 2017-12-27 | 2019-07-22 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Mesalazi̇ni̇n kati oral farmasöti̇k kompozi̇syonlari |
| IT201800011120A1 (it) | 2018-12-14 | 2020-06-14 | Dpl Pharma S P A | Composizioni farmaceutiche orali solide per la somministrazione di mesalazina o suoi derivati |
| CA3136081A1 (en) * | 2019-05-03 | 2020-11-12 | Azora Therapeutics, Inc. | Compositions comprising indigo and/or an indigo derivative and methods of use thereof |
| US20210236519A1 (en) * | 2020-01-30 | 2021-08-05 | Atoz Pharmaceuticals Pvt Ltd | Controlled release dosage forms of 5-aminosalicylic acid and process thereof |
| US20220125733A1 (en) * | 2020-10-23 | 2022-04-28 | Atoz Pharmaceuticals Pvt Ltd | Nongranulated compressed tablets of mesalamine, and process of preparation thereof |
| EP4382099A1 (en) * | 2022-12-05 | 2024-06-12 | ADD Advanced Drug Delivery Technologies, Ltd. | Drug loaded modified release pellets |
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| IT1246382B (it) * | 1990-04-17 | 1994-11-18 | Eurand Int | Metodo per la cessione mirata e controllata di farmaci nell'intestino e particolarmente nel colon |
| US6458383B2 (en) | 1999-08-17 | 2002-10-01 | Lipocine, Inc. | Pharmaceutical dosage form for oral administration of hydrophilic drugs, particularly low molecular weight heparin |
| IT1318625B1 (it) | 2000-07-14 | 2003-08-27 | Roberto Valducci | Formulazioni farmaceutiche solide orali a rilascio multifasicoph-dipendente. |
| CA2359812C (en) * | 2000-11-20 | 2004-02-10 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures |
| ES2298236T3 (es) * | 2001-01-31 | 2008-05-16 | Evonik Rohm Gmbh | Forma medicamentosa de particulas multiples, que contiene por lo menos dos formas de granulos, revestidas de manera diferente. |
| US8048924B2 (en) | 2001-08-29 | 2011-11-01 | Biocon Limited | Methods and compositions employing 4-aminophenylacetic acid compounds |
| US20040185097A1 (en) | 2003-01-31 | 2004-09-23 | Glenmark Pharmaceuticals Ltd. | Controlled release modifying complex and pharmaceutical compositions thereof |
| US20080286344A1 (en) | 2007-05-16 | 2008-11-20 | Olivia Darmuzey | Solid form |
| CA2746767A1 (en) | 2008-12-17 | 2010-07-08 | Altheus Therapeutics, Inc. | Oral formulations |
| GB201003734D0 (en) | 2010-03-05 | 2010-04-21 | Univ Strathclyde | Delayed prolonged drug delivery |
| GB201003731D0 (en) | 2010-03-05 | 2010-04-21 | Univ Strathclyde | Immediate/delayed drug delivery |
| EP2468264A1 (en) * | 2010-12-27 | 2012-06-27 | Laboratorios Liconsa, S.A. | Oral pharmaceutical tablet for controled release of mesalazine and process for obtaining it |
| US10071058B2 (en) * | 2012-03-07 | 2018-09-11 | Santarus, Inc. | Controlled-release solid dosage forms of mesalamine |
| CN102579388A (zh) * | 2012-03-10 | 2012-07-18 | 吉林化工学院 | 美沙拉秦结肠定位给药缓释片的制备 |
| WO2013144176A1 (en) | 2012-03-30 | 2013-10-03 | Laboratorios Del Dr. Esteve, S.A. | Controlled release formulatin comprising mesalamine |
| CA2876540C (en) | 2012-06-15 | 2022-11-29 | Conaris Research Institute Ag | A pharmaceutical composition containing nicotinic acid and/or nicotinamide and/or tryptophan for positively influencing the intestinal microbiota |
| US20140178468A1 (en) | 2012-12-24 | 2014-06-26 | Ranbaxy Laboratories Limited | Multiparticulate extended-release composition of mesalamine |
| US9763887B2 (en) * | 2013-03-15 | 2017-09-19 | Allergan Pharmaceuticals International Limited | Mesalamine pharmaceutical composition with multiple dosage elements for reduced delivery variability |
| ES2788866T3 (es) | 2013-12-13 | 2020-10-23 | Conaris Res Institute Ag | Una composición farmacéutica que contiene ácido nicotínico y/o nicotinamida para su uso en influir beneficiosamente en los niveles de lípidos en sangre mediante la modificación de la microbiota intestinal |
| CA2932504A1 (en) | 2013-12-13 | 2015-06-18 | Conaris Research Institute Ag | A pharmaceutical composition containing combinations of nicotinamide and 5-aminosalicylic acid for beneficially influencing the intestinal microbiota and/or treating gastrointestinal inflammation |
| US20160045442A1 (en) * | 2014-08-13 | 2016-02-18 | Cadila Healthcare Limited | Stable pharmaceutical compositions of mesalamine |
| CN104257669A (zh) | 2014-09-25 | 2015-01-07 | 合肥平光制药有限公司 | 一种用于向肠道递送水杨酸类药物的口服给药组合物 |
| CN105687158B (zh) * | 2016-01-21 | 2019-06-07 | 贝沃特医药技术(上海)有限公司 | 一种时间依赖释放机制的美沙拉嗪微粒制剂及其制备方法 |
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| US20190105275A1 (en) | 2019-04-11 |
| CN109310642A (zh) | 2019-02-05 |
| BR112018071370A2 (pt) | 2019-02-05 |
| EP3445340A1 (en) | 2019-02-27 |
| RU2744576C2 (ru) | 2021-03-11 |
| KR20180133503A (ko) | 2018-12-14 |
| US20210220281A1 (en) | 2021-07-22 |
| RU2018137359A (ru) | 2020-05-19 |
| US10874617B2 (en) | 2020-12-29 |
| CN109310642B (zh) | 2021-07-20 |
| MX387731B (es) | 2025-03-18 |
| KR102381586B1 (ko) | 2022-04-04 |
| MX2018012618A (es) | 2019-06-24 |
| WO2017184566A1 (en) | 2017-10-26 |
| AU2017252410A1 (en) | 2018-11-01 |
| AR108231A1 (es) | 2018-08-01 |
| TW201740932A (zh) | 2017-12-01 |
| RU2018137359A3 (enExample) | 2020-07-03 |
| JP2019513800A (ja) | 2019-05-30 |
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