JP2018058910A - 口腔内崩壊錠及びその製造方法 - Google Patents
口腔内崩壊錠及びその製造方法 Download PDFInfo
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- JP2018058910A JP2018058910A JP2018008108A JP2018008108A JP2018058910A JP 2018058910 A JP2018058910 A JP 2018058910A JP 2018008108 A JP2018008108 A JP 2018008108A JP 2018008108 A JP2018008108 A JP 2018008108A JP 2018058910 A JP2018058910 A JP 2018058910A
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- Prior art keywords
- orally disintegrating
- disintegrating tablet
- drug
- tablet according
- crystalline cellulose
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- FIQOFIRCTOWDOW-BJLQDIEVSA-N temocapril Chemical compound C([C@@H](C(=O)OCC)N[C@@H]1C(N(CC(O)=O)C[C@H](SC1)C=1SC=CC=1)=O)CC1=CC=CC=C1 FIQOFIRCTOWDOW-BJLQDIEVSA-N 0.000 description 1
- 229960004084 temocapril Drugs 0.000 description 1
- 229950000034 teneligliptin Drugs 0.000 description 1
- WUBVEMGCQRSBBT-UHFFFAOYSA-N tert-butyl 4-(trifluoromethylsulfonyloxy)-3,6-dihydro-2h-pyridine-1-carboxylate Chemical compound CC(C)(C)OC(=O)N1CCC(OS(=O)(=O)C(F)(F)F)=CC1 WUBVEMGCQRSBBT-UHFFFAOYSA-N 0.000 description 1
- 239000000892 thaumatin Substances 0.000 description 1
- 235000010436 thaumatin Nutrition 0.000 description 1
- 229960000278 theophylline Drugs 0.000 description 1
- 229960002961 ticlopidine hydrochloride Drugs 0.000 description 1
- MTKNGOHFNXIVOS-UHFFFAOYSA-N ticlopidine hydrochloride Chemical compound [H+].[Cl-].ClC1=CC=CC=C1CN1CC(C=CS2)=C2CC1 MTKNGOHFNXIVOS-UHFFFAOYSA-N 0.000 description 1
- YDLQKLWVKKFPII-UHFFFAOYSA-N timiperone Chemical compound C1=CC(F)=CC=C1C(=O)CCCN1CCC(N2C(NC3=CC=CC=C32)=S)CC1 YDLQKLWVKKFPII-UHFFFAOYSA-N 0.000 description 1
- 229950000809 timiperone Drugs 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- 229960004479 trihexyphenidyl hydrochloride Drugs 0.000 description 1
- QDWJJTJNXAKQKD-UHFFFAOYSA-N trihexyphenidyl hydrochloride Chemical compound Cl.C1CCCCC1C(C=1C=CC=CC=1)(O)CCN1CCCCC1 QDWJJTJNXAKQKD-UHFFFAOYSA-N 0.000 description 1
- UJMBCXLDXJUMFB-UHFFFAOYSA-K trisodium;5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4h-pyrazole-3-carboxylate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)C1=NN(C=2C=CC(=CC=2)S([O-])(=O)=O)C(=O)C1N=NC1=CC=C(S([O-])(=O)=O)C=C1 UJMBCXLDXJUMFB-UHFFFAOYSA-K 0.000 description 1
- RUDATBOHQWOJDD-UZVSRGJWSA-N ursodeoxycholic acid Chemical compound C([C@H]1C[C@@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)CC1 RUDATBOHQWOJDD-UZVSRGJWSA-N 0.000 description 1
- 229960001661 ursodiol Drugs 0.000 description 1
- 229960004699 valsartan Drugs 0.000 description 1
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 description 1
- 229960001254 vildagliptin Drugs 0.000 description 1
- SYOKIDBDQMKNDQ-XWTIBIIYSA-N vildagliptin Chemical compound C1C(O)(C2)CC(C3)CC1CC32NCC(=O)N1CCC[C@H]1C#N SYOKIDBDQMKNDQ-XWTIBIIYSA-N 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
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- A61K9/2022—Organic macromolecular compounds
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Abstract
【解決手段】薬物、かさ密度が0.23g/cm3以下(好ましくは0.10g/cm3以上、0.23g/cm3以下)の結晶セルロース、糖アルコール及びアルファー化デンプンを含有する口腔内崩壊錠であって、かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール及びアルファー化デンプンが薬物不含有顆粒に含まれている口腔内崩壊錠。
【選択図】なし
Description
以下の1)または2)の方法を用いて、薬物不含有顆粒を製造することができる。
1)かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール(例えばD−マンニトール)とアルファー化デンプンを含む混合物を水により湿式造粒する方法。
2)かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール(例えばD−マンニトール)を含む混合物を、アルファー化デンプンを水などに溶解または分散させた液により造粒する方法。
薬物は、粉末上のまま、あるいは所望により顆粒状にしてから、薬物不含有顆粒と混合することができる。薬物含有顆粒は、例えば、慣用の押し出し造粒法、混合攪拌造粒法、高速攪拌造粒法、流動層造粒法、転動造粒法で製造できる。
薬物不含有顆粒と、薬物または薬物含有顆粒および所望により崩壊剤、滑沢剤、その他の添加剤を混合し圧縮成形して口腔内崩壊錠とする。混合は、例えば、タンブルミキサー、対流式ミキサーを用いることで行われる。
態様C:薬物、かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール及びアルファー化デンプンを含有する薬物含有顆粒を圧縮成形して得られる口腔内崩壊錠。
D-マンニトール(メルク製)910gを流動層造粒機(フロイント製、FLO-2型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)35gを精製水600gに分散した液を噴霧後、乾燥することで造粒物を得た。得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧8kN及び10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール3600g(メルク製)、結晶セルロース(旭化成ケミカルズ製、セオラスPH302、かさ密度0.35-0.46g/cm3)1600gを流動層造粒機(フロイント製、FLO-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)200gを精製水1800gに分散した液を噴霧後、乾燥することで造粒物を得た。得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)4360g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)520gを流動層造粒機(フロイント製、FLO-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)200gを精製水2300gに分散した液を噴霧後、乾燥することで造粒物を得た。
得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧12kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール3880g(メルク製)、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)1000gを流動層造粒機(フロイント製、FLO-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)200gを精製水2300gに分散した液を噴霧後、乾燥することで造粒物を得た。
得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧12kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)9240g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)4180gを流動層造粒機(パウレック製、GPCG-15)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)550gを精製水6325gに分散した液を噴霧後、乾燥することで造粒物を得た。
得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)2880g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)2000gを流動層造粒機(フロイント製、FLO-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)200gを精製水2300gに分散した液を噴霧後、乾燥することで造粒物を得た。
得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧6kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)3360g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-802、かさ密度0.13-0.23g/cm3)1520gを流動層造粒機(フロイント製、FLO-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)200gを精製水2300gに分散した液を噴霧後、乾燥することで造粒物を得た。
得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)672g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)304g、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)40gを混合し、混合物を得た。
得られた混合物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)840g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)380g、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)50gを流動層造粒機(フロイント製、FLO-2型)に投入し、精製水575gを噴霧後、乾燥することで造粒物を得た。
得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧12kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)252g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)114gを高速撹拌造粒機(パウレック製、VG-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)15gを精製水135gに分散した液を滴下しながら錬合した。錬合物を流動層造粒機(フロイント製、FLO-2型)に投入し、乾燥することで造粒物を得た。
得られた造粒物198gにステアリン酸マグネシウム(マリンクロッド製)2gを混合後、ロータリー打錠機にて、打錠圧6kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
実施例3の前段と同じ方法で得られた造粒物480g、クロスポビドン(BASF製、コリドンCL-F)15gを混合し、混合物を得た。得られた混合物495gにステアリン酸マグネシウム5g(マリンクロッド製)を混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
実施例3の前段と同じ方法で得られた造粒物465g、クロスポビドン(BASF製、コリドンCL-F)30gを混合し、混合物を得た。得られた混合物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
実施例3の前段と同じ方法で得られた造粒物455g、カルメロースカルシウム(五徳薬品製、ECG-505)40gを混合し、混合物を得た。得られた混合物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧8kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)2590g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)1610g、カルメロースカルシウム(五徳薬品製、ECG-505)385gを流動層造粒機(フロイント製、FLO-5型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)175gを精製水3000gに分散した液を噴霧後、乾燥することで造粒物を得た。得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧6kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
D-マンニトール(メルク製)266g、D-マンニトール(メルク製、パーテックM100)266g、結晶セルロース(旭化成ケミカルズ製、セオラスKG-1000、かさ密度0.10-0.15g/cm3)329g、クロスポビドン(BASF製、コリドンCL-F)56gを流動層造粒機(フロイント製、FLO-2型)に投入し、アルファー化デンプン(旭化成ケミカルズ製、swelstar PD-1)35gを精製水600gに分散した液を噴霧後、乾燥することで造粒物を得た。得られた造粒物495gにステアリン酸マグネシウム(マリンクロッド製)5gを混合後、ロータリー打錠機にて、打錠圧8kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
メマンチン塩酸塩40g、実施例3の前段と同じ方法で得られた造粒物460g、クロスポビドン(BASF製、コリドンCL-F)33.84g、アスパルテーム(味の素製)20g、香料(高砂香料工業製)0.56gを混合し、混合物を得た。得られた混合物554.4gにステアリン酸マグネシウム(マリンクロッド製)5.6gを混合後、ロータリー打錠機にて、打錠圧12kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
メマンチン塩酸塩3000g、D-マンニトール(メルク製)6000g、結晶セルロース(旭化成ケミカルズ製、セオラスPH101)1200g、カルメロースカルシウム(五徳薬品製、ECG-505)675gを流動層造粒機(パウレック製、GPCG-15)に投入し、ヒドロキシプロピルセルロース(日本曹達製、HPC-L)375gを精製水5875gに溶解した液を噴霧し、乾燥することで薬物含有造粒物を得た。
薬物含有造粒物150g、実施例3の前段と同じ方法で得られた造粒物350g、クロスポビドン(BASF製、コリドンCL-F)33.84g、アスパルテーム(味の素製)20g、香料(高砂香料工業製)0.56gを混合し、混合物を得た。得られた混合物554.4gにステアリン酸マグネシウム(マリンクロッド製)5.6gを混合後、ロータリー打錠機にて、打錠圧12kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
実施例15の前段と同じ方法で得られた薬物含有造粒物10500gを流動層造粒機(パウレック製、GPCG-15)に投入し、コーティング液27020g(組成:メタクリル酸コポリマーLD(エボニック製、オイドラギットL30D-55)51.8%、クエン酸トリエチル(森村商事製、シトロフレックス)1.6%、タルク(松村産業製)7.8%、精製水38.8%)を噴霧し、乾燥することで薬物含有コーティング物を得た。
薬物含有コーティング物3690g、実施例3の前段と同じ方法で得られた造粒物3810g、クロスポビドン(BASF製、コリドンCL-F)507.6g、アスパルテーム(味の素製)300g、香料(高砂香料工業製)8.4gを混合し、混合物を得た。得られた混合物8316gにステアリン酸マグネシウム(マリンクロッド製)84gを混合後、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9mmφ、質量280mg)を得た。
実施例16の前段と同じ方法で得られた薬物含有コーティング物4.89g、実施例3の前段と同じ方法で得られた造粒物2.91g、クロスポビドン(BASF製、コリドンCL-F)0.52gを混合し、混合物を得た。得られた混合物8.32gにステアリン酸マグネシウム(マリンクロッド製)0.084gを混合後、単発打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(9mmφ、280mg)を得た。
ヒドロモルフォン塩酸塩42.38g、実施例3の前段と同じ方法で得られた造粒物2677.5g、低置換度ヒドロキシプロピルセルロース(信越化学工業製、L-HPC(LH-11))250.1gを混合し、混合物を得た。得られた混合物2970gにステアリン酸マグネシウム(マリンクロッド製)30gを混合し、打錠用混合物を得た。打錠用混合物について、ロータリー打錠機にて、打錠圧6kNで打錠を行い、口腔内崩壊錠(錠剤径6mmφ、質量80mg)を得た。
実施例18で得られた打錠用混合物について、ロータリー打錠機にて、打錠圧10kNで打錠を行い、口腔内崩壊錠(錠剤径9.5mmφ、質量320mg)を得た。
実施例及び比較例で得た錠剤について、以下の方法で評価を行った。
硬度は、錠剤連続計測装置(WHT:Pharm Test製)により測定した(10錠の平均値を記載)。
口腔内崩壊時間は、健康な成人男子の口腔内に試験錠剤を含ませ、噛まない状態で完全に崩壊するまでの時間を測定した(6例の平均値を記載)。実施例18および19で得た錠剤は、口腔内崩壊時間に代えて、第十六改正日本薬局方の『崩壊試験法』に準じて、崩壊時間を測定した(3錠の平均値を記載)。
摩損度試験は、第十六改正日本薬局方の『錠剤の摩損度試験法』に準じて、測定した(10錠)。
Claims (28)
- 薬物、かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール及びアルファー化デンプンを含有する口腔内崩壊錠であって、かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール及びアルファー化デンプンが薬物不含有顆粒に含まれている、口腔内崩壊錠。
- 結晶セルロースのかさ密度が、0.10g/cm3以上、0.23g/cm3以下である請求項1に記載の口腔内崩壊錠。
- 結晶セルロースのかさ密度が、0.15g/cm3以下である請求項1または2記載の口腔内崩壊錠。
- 結晶セルロースの該崩壊錠中の配合率が、5〜50重量%である請求項1〜3のいずれか1項に記載の口腔内崩壊錠。
- アルファー化デンプンの平均アルファー化度が90%以下である請求項1〜4のいずれか1項に記載の口腔内崩壊錠。
- 糖アルコールが、エリスリトール、キシリトール、マルチトールまたはソルビトールである請求項1〜5のいずれか1項に記載の口腔内崩壊錠。
- さらに崩壊剤を含有する請求項1〜6のいずれか1項に記載の口腔内崩壊錠。
- 崩壊剤が、クロスポビドン、カルメロースカルシウム、カルメロース、クロスカルメロースナトリウム、低置換度ヒドロキシプロピルセルロース、トウモロコシデンプン及びデンプングリコール酸ナトリウムからなる群から選ばれる1種または2種以上である請求項7記載の口腔内崩壊錠。
- さらに滑沢剤を含有する請求項1〜8のいずれか1項に記載の口腔内崩壊錠。
- 滑沢剤が、ステアリン酸マグネシウム、ステアリン酸カルシウム、フマル酸ステアリルナトリウム及びタルクからなる群から選ばれる1種または2種以上である請求項9記載の口腔内崩壊錠。
- 薬物不含有顆粒の平均粒子径が、第十六改正日本薬局方の『粒度測定法 第2法 ふるい分け法』に準じ測定し、篩上対数積分法により算出するとき、40〜150μmである、請求項1〜10のいずれか1項に記載の口腔内崩壊錠。
- 薬物がメマンチンまたはその薬学上許容される塩である請求項1〜11のいずれか1項に記載の口腔内崩壊錠。
- メマンチンの薬学上許容される塩がメマンチン塩酸塩である請求項12記載の口腔内崩壊錠。
- 口腔内崩壊錠の製造方法であって、かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール及びアルファー化デンプンを含有する薬物不含有顆粒を得る工程と、得られた薬物不含有顆粒と薬物または薬物含有顆粒を圧縮成形して得る工程を含む口腔内崩壊錠の製造方法。
- 薬物不含有顆粒が、かさ密度が0.23g/cm3以下の結晶セルロース及び糖アルコールを含む混合末を、アルファー化デンプンを溶解または分散させた液により造粒して得られるものである請求項14に記載の口腔内崩壊錠の製造方法。
- さらに崩壊剤が薬物含有顆粒、薬物不含有顆粒または顆粒外に配合されている請求項14または15に記載の口腔内崩壊錠の製造方法。
- 崩壊剤が、クロスポビドン、カルメロースカルシウム、カルメロース、クロスカルメロースナトリウム、低置換度ヒドロキシプロピルセルロース、トウモロコシデンプン及びデンプングリコール酸ナトリウムからなる群から選ばれる1種または2種以上である、請求項16に記載の口腔内崩壊錠の製造方法。
- 薬物含有顆粒が、薬物を含む粒状物の表面をコーティングしたものである請求項14〜17のいずれか1項に記載の口腔内崩壊錠の製造方法。
- 薬物がメマンチンまたはその薬学上許容される塩である請求項18に記載の口腔内崩壊錠の製造方法。
- かさ密度が0.23g/cm3以下の結晶セルロース及び糖アルコールを含む混合物をアルファー化デンプンを溶解または分散させた液により湿式造粒するか、または、かさ密度が0.23g/cm3以下の結晶セルロース、糖アルコール及びアルファー化デンプンを含む混合物を水により湿式造粒し、乾燥することで得られる薬物不含有顆粒、粉末状または造粒された薬物および所望により添加剤を混合して圧縮成形する工程を含む口腔内崩壊錠の製造方法。
- 湿式造粒が、流動層造粒である請求項20に記載の口腔内崩壊錠の製造方法。
- さらに崩壊剤が混合物または他の添加剤に含まれている請求項20または21に記載の口腔内崩壊錠の製造方法。
- 圧縮成形する前に滑沢剤を添加する工程を含む請求項20〜22のいずれか1項に記載の口腔内崩壊錠の製造方法。
- 粉末状または造粒された薬物が、当該薬物の表面にコーティングが施されたものである請求項20〜23のいずれか1項に記載の口腔内崩壊錠の製造方法。
- 薬物がメマンチンまたはその薬学上許容される塩である請求項20〜24のいずれか1項に記載の口腔内崩壊錠の製造方法。
- メマンチンまたは薬学上許容される塩がメマンチン塩酸塩である請求項25記載の口腔内崩壊錠の製造方法。
- 薬物不含有顆粒の平均粒子径が、第十六改正日本薬局方の『粒度測定法 第2法 ふるい分け法』に準じ測定し、篩上対数積分法により算出するとき、40〜150μmである、請求項14〜26のいずれか1項に記載の口腔内崩壊錠の製造方法。
- 糖アルコールが、エリスリトール、キシリトール、マルチトールまたはソルビトールである請求項14〜27のいずれか1項に記載の口腔内崩壊錠の製造方法。
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CN115701992A (zh) * | 2020-07-03 | 2023-02-14 | 步制药股份有限公司 | 片剂及其制造方法 |
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EP2842549A4 (en) | 2015-09-23 |
KR20150003740A (ko) | 2015-01-09 |
ES2694224T3 (es) | 2018-12-19 |
JP6545839B2 (ja) | 2019-07-17 |
BR112014026292B1 (pt) | 2022-09-27 |
JP2017008112A (ja) | 2017-01-12 |
EP2842549B1 (en) | 2018-08-08 |
EP2842549A1 (en) | 2015-03-04 |
KR101943686B1 (ko) | 2019-01-29 |
JP6325627B2 (ja) | 2018-05-16 |
BR112014026292A2 (pt) | 2017-06-27 |
JP7028829B2 (ja) | 2022-03-02 |
TW201347792A (zh) | 2013-12-01 |
CN106913553A (zh) | 2017-07-04 |
TWI572371B (zh) | 2017-03-01 |
US9827200B2 (en) | 2017-11-28 |
JP6066351B2 (ja) | 2017-01-25 |
HK1206983A1 (en) | 2016-01-22 |
CA2870868C (en) | 2018-02-20 |
JP2019151670A (ja) | 2019-09-12 |
WO2013161823A1 (ja) | 2013-10-31 |
IN2014MN02029A (ja) | 2015-08-14 |
JPWO2013161823A1 (ja) | 2015-12-24 |
CA2870868A1 (en) | 2013-10-31 |
CN104244930A (zh) | 2014-12-24 |
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