JP6336078B2 - 医薬組成物 - Google Patents
医薬組成物 Download PDFInfo
- Publication number
- JP6336078B2 JP6336078B2 JP2016536190A JP2016536190A JP6336078B2 JP 6336078 B2 JP6336078 B2 JP 6336078B2 JP 2016536190 A JP2016536190 A JP 2016536190A JP 2016536190 A JP2016536190 A JP 2016536190A JP 6336078 B2 JP6336078 B2 JP 6336078B2
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- pharmaceutical composition
- viperpertin
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Classifications
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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Description
i. ビトペルチンをラクトース一水和物、トウモロコシデンプン、クロスカルメロース(crosarmellose)ナトリウム及びポビドンと混合すること、
ii. 段階iからの混合された粉末を、精製水を使用して造粒すること、
iii. 段階iiからの顆粒(granulate)を乾燥及び篩過すること、
iv. 段階iiiからの顆粒にタルク、ステアリン酸マグネシウム及び結晶セルロースを添加し、混合すること、
v. 顆粒を錠剤に圧縮すること、
vi. ポリビニルアルコール、二酸化チタン、マクロゴール3350、タルク、任意で黄酸化鉄及び精製水を含有する事前混合物を使用してフィルムコーティング懸濁物を調製すること、並びに
vii. 段階viからの懸濁物で錠剤をフィルムコーティングすること
によって入手可能な医薬組成物に関する。
表1:ビトペルチン30mg錠についての種々の増量剤/希釈剤組合せの評価
実施例1:錠剤重量150mg(及びコート重量5mg)についてビトペルチン5mg
i. ビトペルチンを希釈剤、増量剤、崩壊剤及び結合剤と混合すること、
ii. 段階iからの混合された粉末を、精製水を使用して造粒すること、
iii. 段階iiからの顆粒を乾燥及び篩過すること、
iv 段階iiiからの顆粒に滑沢剤及び圧縮助剤を添加し、混合すること、
v. 顆粒を錠剤に圧縮すること、
vi. コーティング剤、着色剤、可塑剤、滑沢剤及び精製水を含有する事前混合物を使用してフィルムコーティング懸濁物を調製すること、並びに
vii. 段階viからの懸濁物で錠剤をフィルムコーティングすること
によって入手可能な医薬組成物に関する。
i. ビトペルチンをラクトース一水和物、トウモロコシデンプン、クロスカルメロースナトリウム及びポビドンと混合すること、
ii. 段階iからの混合された粉末を、精製水を使用して造粒すること、
iii. 段階iiからの顆粒を乾燥及び篩過すること、
iv. 段階iiiからの顆粒にタルク、ステアリン酸マグネシウム及び結晶セルロースを添加し、混合すること、
v. 顆粒を錠剤に圧縮すること、
vi. ポリビニルアルコール、二酸化チタン、マクロゴール3350、タルク、黄酸化鉄及び精製水を含有する事前混合物を使用してフィルムコーティング懸濁物を調製すること、並びに
vii. 段階viからの懸濁物で錠剤をフィルムコーティングすること
によって入手可能な医薬組成物に関する。
錠剤は、湿式高剪断造粒、流動層乾燥、調合、圧縮及びフィルムコーティングという従来の薬学的操作を用いて製造される。
1. 粉砕されたビトペルチン原薬、ラクトース一水和物、トウモロコシデンプン、クロスカルメロースナトリウム及びポビドン30を高剪断ミキサー中に装入する。
2. 適切なrpmで5〜10分間調合する。
3. 10分経過中に水を添加し、適切なrpmでさらに5〜10分間練合する。
4. 5mm篩を通して湿式顆粒を流動層乾燥機内に移し、以下の条件で乾燥する:給気温度:50〜70℃、風量:300〜600m3/h。LODによって決定された乾燥終点4%(範囲:2.5〜5.5%)、運転時間:45分。
5. 1.5mm Frewittコーン型篩により適切なロータ速度で顆粒を篩過する。
6. 結晶セルロースをそのままで添加し、タルク及びステアリン酸マグネシウムを、0.5mmの手篩を通して顆粒に添加し、ビンブレンダー(bin blender)を用いて6rpmで20分間調合する。
7. [段階6]からの最終調合物を適切な圧縮力及びロータ速度で錠剤核に圧縮して、硬さ50〜90Nの錠剤を得る。
8. 精製水並びにOpadry II Yellow 85F32645フィルムコーティング混合物(ポリビニルアルコール(部分けん化物)、二酸化チタン、マクロゴール/PEG3350、タルク及び黄酸化鉄)を使用してコーティング懸濁物を調製し、少なくとも1時間撹拌する。
9. [段階8]からのコーティング懸濁物を、[段階7]からの錠剤核上に噴霧する。
Claims (9)
- 統合失調症における陰性症状又は認知症状、自閉症スペクトラム障害(ASD)における社会的コミュニケーション及び社会的相互作用の欠陥、初期アルツハイマー病(AD)におけるアパシー、最近の大うつ病エピソード後の動機付けの残遺症状、又は外傷後ストレス障害(PTSD)の処置のための、統合失調症の高リスク患者のための予防のための、或いはパーキンソン病におけるアパシー又は認知欠陥の処置のための、フィルムコーティング錠の形態の錠剤用の医薬組成物であって、微粒子化ビトペルチン又はその塩と、微細な平均粒度を有する増量賦形剤とを含み、該増量賦形剤が、トウモロコシデンプンとラクトースとの組み合わせ又はトウモロコシデンプンと結晶セルロースとの組み合わせであり、該トウモロコシデンプンが10〜25μmの平均粒子径(d50)を有する、医薬組成物。
- 素錠重量150mg及びフィルムコート重量5mgを有する、請求項1記載の医薬組成物。
- 微粒子化ビトペルチン又はその塩3、5、10、20、30又は60mgを含む、請求項1又は2記載の医薬組成物。
-
(ここで、ビトペルチンは微粒子化ビトペルチンであり、増量賦形剤は微細な平均粒度を有する)
を含む、請求項1〜3のいずれか一項記載の医薬組成物。 -
(ここで、ビトペルチンは微粒子化ビトペルチンであり、増量賦形剤は微細な平均粒度を有する)
を含む、請求項1〜3のいずれか一項記載の医薬組成物。 -
(ここで、ビトペルチンは微粒子化ビトペルチンであり、増量賦形剤は微細な平均粒度を有する)
を含む、請求項1〜3のいずれか一項記載の医薬組成物。 - 1日1回投与される、請求項1〜6のいずれか一項記載の医薬組成物。
- 請求項1〜7のいずれか一項記載の医薬組成物を調製するための方法であって、
i. ビトペルチンを希釈剤、増量剤、崩壊剤及び結合剤と混合すること、
ii. 段階iからの混合された粉末を、精製水を使用して造粒すること、
iii. 段階iiからの造粒物を乾燥及び篩過すること、
iv. 段階iiiからの造粒物に滑沢剤及び圧縮助剤を添加し、混合すること、
v. 段階ivからの造粒物を錠剤に圧縮すること、
vi. コーティング剤、着色剤、可塑剤、滑沢剤及び精製水を含有する事前混合物を使用してフィルムコーティング懸濁物を調製すること、並びに
vii. 段階viからの懸濁物で錠剤をフィルムコーティングすること
を含み、
ここで、ビトペルチンは微粒子化ビトペルチンであり、増量賦形剤は微細な平均粒度を有する、
方法。 - i. ビトペルチンをラクトース一水和物、トウモロコシデンプン、クロスカルメロースナトリウム及びポビドンと混合すること、
ii. 段階iからの混合された粉末を、精製水を使用して造粒すること、
iii. 段階iiからの造粒物を乾燥及び篩過すること、
iv. 段階iiiからの造粒物にタルク、ステアリン酸マグネシウム及び結晶セルロースを添加し、混合すること、
v. 段階ivからの造粒物を錠剤に圧縮すること、
vi. ポリビニルアルコール、二酸化チタン、マクロゴール3350、タルク、黄酸化鉄及び精製水を含有する事前混合物を使用してフィルムコーティング懸濁物を調製すること、並びに
vii. 段階viからの懸濁物で錠剤をフィルムコーティングすること
を含み、
ここで、ビトペルチンは微粒子化ビトペルチンであり、増量賦形剤は微細な平均粒度を有する、
請求項8記載の方法。
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EP13195401.8 | 2013-12-03 | ||
PCT/EP2014/076035 WO2015082367A1 (en) | 2013-12-03 | 2014-12-01 | Pharmaceutical composition |
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AU2014359499A1 (en) | 2016-03-17 |
IL244365A0 (en) | 2016-04-21 |
KR20160068975A (ko) | 2016-06-15 |
HK1220143A1 (zh) | 2017-04-28 |
MX2016006742A (es) | 2016-08-12 |
EP3076953A1 (en) | 2016-10-12 |
CA2924016A1 (en) | 2015-06-11 |
US20160271126A1 (en) | 2016-09-22 |
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