JPWO2020246120A5 - - Google Patents
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- Publication number
- JPWO2020246120A5 JPWO2020246120A5 JP2021524680A JP2021524680A JPWO2020246120A5 JP WO2020246120 A5 JPWO2020246120 A5 JP WO2020246120A5 JP 2021524680 A JP2021524680 A JP 2021524680A JP 2021524680 A JP2021524680 A JP 2021524680A JP WO2020246120 A5 JPWO2020246120 A5 JP WO2020246120A5
- Authority
- JP
- Japan
- Prior art keywords
- orally disintegrating
- disintegrating tablet
- powder
- tablet
- acetaminophen
- 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.)
- Granted
Links
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 88
- 239000006191 orally-disintegrating tablet Substances 0.000 claims description 59
- 229960005489 paracetamol Drugs 0.000 claims description 44
- 239000003826 tablet Substances 0.000 claims description 39
- 239000000843 powder Substances 0.000 claims description 36
- 239000002245 particle Substances 0.000 claims description 33
- 238000002156 mixing Methods 0.000 claims description 26
- 238000004519 manufacturing process Methods 0.000 claims description 17
- 229920002678 cellulose Polymers 0.000 claims description 14
- 239000007884 disintegrant Substances 0.000 claims description 14
- 239000001913 cellulose Substances 0.000 claims description 13
- 239000000203 mixture Substances 0.000 claims description 12
- 239000000796 flavoring agent Substances 0.000 claims description 10
- 210000000214 mouth Anatomy 0.000 claims description 9
- 235000003599 food sweetener Nutrition 0.000 claims description 7
- 239000003765 sweetening agent Substances 0.000 claims description 7
- 235000013355 food flavoring agent Nutrition 0.000 claims description 6
- 239000003205 fragrance Substances 0.000 claims description 5
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims description 4
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 4
- 235000019634 flavors Nutrition 0.000 claims description 4
- 229940041616 menthol Drugs 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims description 2
- 239000000120 Artificial Saliva Substances 0.000 claims description 2
- 108010011485 Aspartame Proteins 0.000 claims description 2
- 235000005979 Citrus limon Nutrition 0.000 claims description 2
- 244000131522 Citrus pyriformis Species 0.000 claims description 2
- 240000000560 Citrus x paradisi Species 0.000 claims description 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 2
- 235000016623 Fragaria vesca Nutrition 0.000 claims description 2
- 240000009088 Fragaria x ananassa Species 0.000 claims description 2
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims description 2
- 244000246386 Mentha pulegium Species 0.000 claims description 2
- 235000016257 Mentha pulegium Nutrition 0.000 claims description 2
- 235000004357 Mentha x piperita Nutrition 0.000 claims description 2
- 229920000881 Modified starch Polymers 0.000 claims description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 2
- 244000228451 Stevia rebaudiana Species 0.000 claims description 2
- 239000004376 Sucralose Substances 0.000 claims description 2
- 235000010358 acesulfame potassium Nutrition 0.000 claims description 2
- 229960004998 acesulfame potassium Drugs 0.000 claims description 2
- 239000000619 acesulfame-K Substances 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 239000000605 aspartame Substances 0.000 claims description 2
- 235000010357 aspartame Nutrition 0.000 claims description 2
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 2
- 229960003438 aspartame Drugs 0.000 claims description 2
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 2
- 229960000913 crospovidone Drugs 0.000 claims description 2
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 2
- 229940065115 grapefruit extract Drugs 0.000 claims description 2
- 235000001050 hortel pimenta Nutrition 0.000 claims description 2
- 239000007788 liquid Substances 0.000 claims description 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 2
- HELXLJCILKEWJH-NCGAPWICSA-N rebaudioside A Chemical compound O([C@H]1[C@H](O)[C@@H](CO)O[C@H]([C@@H]1O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HELXLJCILKEWJH-NCGAPWICSA-N 0.000 claims description 2
- 235000019204 saccharin Nutrition 0.000 claims description 2
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims description 2
- 229940081974 saccharin Drugs 0.000 claims description 2
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 claims description 2
- 229920003109 sodium starch glycolate Polymers 0.000 claims description 2
- 229940079832 sodium starch glycolate Drugs 0.000 claims description 2
- 239000008109 sodium starch glycolate Substances 0.000 claims description 2
- 235000019408 sucralose Nutrition 0.000 claims description 2
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims description 2
- 239000008186 active pharmaceutical agent Substances 0.000 description 16
- 235000019658 bitter taste Nutrition 0.000 description 16
- 229940088679 drug related substance Drugs 0.000 description 16
- 235000010980 cellulose Nutrition 0.000 description 10
- 238000001000 micrograph Methods 0.000 description 6
- 238000009826 distribution Methods 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 238000004513 sizing Methods 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 4
- 238000002425 crystallisation Methods 0.000 description 4
- 230000008025 crystallization Effects 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 239000000314 lubricant Substances 0.000 description 4
- 239000008187 granular material Substances 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000002994 raw material Substances 0.000 description 3
- 238000010008 shearing Methods 0.000 description 3
- 235000019640 taste Nutrition 0.000 description 3
- 238000003332 Raman imaging Methods 0.000 description 2
- 239000000654 additive Substances 0.000 description 2
- 235000019606 astringent taste Nutrition 0.000 description 2
- 230000000975 bioactive effect Effects 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 230000001953 sensory effect Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000001629 suppression Effects 0.000 description 2
- 206010013911 Dysgeusia Diseases 0.000 description 1
- 206010019233 Headaches Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 239000003907 antipyretic analgesic agent Substances 0.000 description 1
- 239000007894 caplet Substances 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 231100000869 headache Toxicity 0.000 description 1
- 238000007561 laser diffraction method Methods 0.000 description 1
- 230000004807 localization Effects 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 210000003800 pharynx Anatomy 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 238000002636 symptomatic treatment Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2019106806 | 2019-06-07 | ||
| JP2019106806 | 2019-06-07 | ||
| PCT/JP2020/014429 WO2020246120A1 (ja) | 2019-06-07 | 2020-03-30 | 口腔内崩壊錠及びその製造方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JPWO2020246120A1 JPWO2020246120A1 (https=) | 2020-12-10 |
| JPWO2020246120A5 true JPWO2020246120A5 (https=) | 2022-05-19 |
| JP7360460B2 JP7360460B2 (ja) | 2023-10-12 |
Family
ID=73653120
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021524680A Active JP7360460B2 (ja) | 2019-06-07 | 2020-03-30 | 口腔内崩壊錠及びその製造方法 |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JP7360460B2 (https=) |
| WO (1) | WO2020246120A1 (https=) |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3680627B2 (ja) * | 1999-04-27 | 2005-08-10 | 富士電機機器制御株式会社 | ノイズフィルタ |
| JP3389205B2 (ja) * | 1999-06-29 | 2003-03-24 | 武田薬品工業株式会社 | 口腔内速崩壊錠 |
| JP4719899B2 (ja) * | 2000-01-07 | 2011-07-06 | 大正製薬株式会社 | 口腔内速崩壊性錠剤 |
| CN1271997C (zh) * | 2004-02-27 | 2006-08-30 | 石药集团中奇制药技术(石家庄)有限公司 | 对乙酰氨基酚口腔崩解片及其制备方法 |
| JP3996626B2 (ja) * | 2004-06-22 | 2007-10-24 | 塩野義製薬株式会社 | 口腔内速崩壊錠 |
| JP5499599B2 (ja) * | 2008-10-01 | 2014-05-21 | 大正製薬株式会社 | アセトアミノフェン含有錠剤 |
| JP5575119B2 (ja) * | 2009-05-20 | 2014-08-20 | 大日本住友製薬株式会社 | 口腔内崩壊錠 |
| JP2011157348A (ja) * | 2010-01-05 | 2011-08-18 | Fuji Chem Ind Co Ltd | 崩壊性高強度球状粒子組成物 |
| EP2745848B1 (en) * | 2011-09-26 | 2023-04-12 | Nippon Soda Co., Ltd. | Orally disintegrating tablet containing hydroxyalkyl cellulose fine particles |
| IN2014DN07797A (https=) * | 2012-03-29 | 2015-05-15 | Daicel Corp | |
| JP6926404B2 (ja) * | 2015-06-12 | 2021-08-25 | ゼリア新薬工業株式会社 | 口腔内崩壊錠 |
| CN109069455B (zh) * | 2016-05-10 | 2020-10-09 | 日本脏器制药株式会社 | 对乙酰氨基酚制剂的制造方法 |
| US20190328674A1 (en) * | 2016-06-16 | 2019-10-31 | Towa Pharmaceutical Co., Ltd. | Orally disintegrating tablet |
| JP6832753B2 (ja) * | 2017-03-09 | 2021-02-24 | 旭化成株式会社 | セルロース複合体 |
-
2020
- 2020-03-30 WO PCT/JP2020/014429 patent/WO2020246120A1/ja not_active Ceased
- 2020-03-30 JP JP2021524680A patent/JP7360460B2/ja active Active
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