JP2022521245A - 旨味製剤 - Google Patents
旨味製剤 Download PDFInfo
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- JP2022521245A JP2022521245A JP2021549085A JP2021549085A JP2022521245A JP 2022521245 A JP2022521245 A JP 2022521245A JP 2021549085 A JP2021549085 A JP 2021549085A JP 2021549085 A JP2021549085 A JP 2021549085A JP 2022521245 A JP2022521245 A JP 2022521245A
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Abstract
Description
本出願において記載およびクレームされるような本発明の目的のために、以下の用語および語句は以下のように定義される。
- 喘息および他の閉塞性気道疾患、例えば、慢性または難治性喘息、遅発性喘息、気道過敏症、気管支炎、気管支喘息、アレルギー性喘息、内因性喘息、外因性喘息、塵埃喘息、回帰性気道閉塞、および慢性閉塞性肺疾患;
- 自己免疫疾患または障害、例えば、単一臓器または単一細胞種自己免疫障害として指摘されるもの、例えば、自己免疫性溶血性貧血、悪性貧血の自己免疫性萎縮性胃炎、自己免疫性脳脊髄炎、自己免疫性睾丸炎、自己免疫性血小板減少症、交感性眼炎、潰瘍性大腸炎および膜性糸球体症、全身性自己免疫障害を伴うとして指摘されるもの、例えば、全身性ループスエリトマトーデス(systemic lupus erythematosis)、全身性硬化症、および水疱性類天疱瘡、変形性関節症(すなわち、関節変性疾患)、非びらん性免疫媒介性多発性関節炎、外傷性関節炎、ならびにO細胞(液性)ベースまたはT細胞ベースであり得る追加の自己免疫疾患、例えば、自己免疫性脱毛症および甲状腺炎;
- がんまたは腫瘍、例えば、消化管/胃腸管がん、結腸がん、肝臓がん、皮膚がん、例えば、肥満細胞腫瘍および扁平細胞癌、乳がん(breast cancerおよびmammary cancer)、卵巣がん、前立腺がん、リンパ腫、白血病、例えば、急性骨髄性白血病および慢性骨髄性白血病、腎臓がん、肺がん、筋肉がん、骨がん、膀胱がん、脳がん、黒色腫、例えば、口腔および転移性黒色腫、カポジ肉腫、骨髄腫、例えば、多発性骨髄腫、骨髄増殖性障害、増殖性糖尿病網膜症、ならびに血管新生関連障害、例えば、固形腫瘍;
- 目の疾患、障害または状態、例えば、目の自己免疫疾患、角結膜炎および乾性角結膜炎(ドライアイ);
- 腸の炎症、アレルギーまたは状態、例えば、潰瘍性大腸炎、炎症性腸疾患、セリアック病、直腸炎、好酸球性胃腸炎、および肥胖細胞症;
- 皮膚の疾患、状態または障害、例えば、アトピー性皮膚炎、湿疹、乾癬、強皮症、掻痒および他の掻痒性状態;
- アレルギー性反応、例えば、ウマアレルギー性疾患を含む動物におけるアレルギー性皮膚炎、例えば、咬傷過敏症、夏季湿疹および皮膚掻痒。
オクラシチニブマレイン酸塩を含有する旨味ソフト咀嚼用組成物を調製し、旨味性および安定性について評価した。
旨味性を評価するために、成熟した3~9歳齢のビーグル犬(N=48)を2シークエンス2期間クロスオーバーデザイン研究に無作為に割り当てた。動物にプラセボ(T01)ソフト咀嚼錠または5.4mgのApoquel(登録商標)を含有する試験ソフト咀嚼錠(T02-組成物1)を与えた。1つの錠剤を各群のイヌ(N=24/群)に連続する3日間1日毎に自由な経口消費のために与えた。プラセボ(T01)およびApoquel(登録商標)(T02)ソフト咀嚼錠の忍容性はそれぞれ79.9%および78.5%であった。
ソフト咀嚼錠は、3.6mg、5.4mg、および16mgのソフト咀嚼錠についてHDPEボトル中40℃/75%の相対湿度において1および2か月時に安定であることが示され、アッセイ(ラベルクレームの%)結果は98.3~101.5%に及んだ。
Claims (15)
- 旨味ソフトチュアブル錠剤獣医学的組成物であって、
a.治療有効量の獣医学的活性剤、
b.前記錠剤の総重量の約45w/w%~約55w/w%の量の少なくとも1つの動物ベースのパラタント、
c.前記錠剤の総重量の約10w/w%~約15w/w%の量の少なくとも1つの非動物ベースのパラタント、
d.少なくとも1つの獣医学的に許容される賦形剤
を含み、かつ
前記ソフトチュアブル錠剤が回転式錠剤プレスを用いて圧縮されている、
組成物。 - 前記獣医学的に許容される活性剤がオクラシチニブであり、かつ前記動物ベースのパラタントが粉末化ブタ肝臓である、請求項1に記載の組成物。
- 前記少なくとも1つの獣医学的に許容される賦形剤が、崩壊剤、結合剤、湿潤剤、滑沢剤、滑剤、および香味修飾剤の少なくとも1つずつから選択され、かつ前記非動物ベースのパラタントが酵母である、請求項2に記載の組成物。
- 前記獣医学的に許容される崩壊剤が、クロスポビドン、デンプングリコール酸ナトリウム、またはこれらの混合物である、請求項3に記載の組成物。
- 前記崩壊剤が、クロスポビドンおよびデンプングリコール酸ナトリウムの混合物であり、かつ前記錠剤の総重量の約10w/w%~約15w/w%の量で組み合わせられている、請求項4に記載の組成物。
- 前記獣医学的に許容される結合剤が、ポリエチレングリコール、ガム、またはこれらの混合物を含む、請求項3に記載の組成物。
- 前記ポリエチレングリコールがポリエチレングリコール3350であり、かつ前記ガムがキサンタンガムであり、かつポリエチレングリコールおよび前記ガムの前記混合物が前記錠剤の総重量の約5w/w%~約7w/w%を構成する、請求項6に記載の組成物。
- 前記獣医学的に許容される湿潤剤が、前記錠剤の総重量の約10w/w%~約15w/w%の量のグリセロールである、請求項3に記載の組成物。
- 前記獣医学的に許容される滑沢剤がステアリン酸マグネシウムおよびモノステアリン酸グリセロールの混合物であり、かつ前記組成物が約1w/w%~約3w/w%の滑剤および約0.4w/w%~約0.6w/w%の香味修飾剤を含む、請求項3に記載の組成物。
- 旨味ソフトチュアブル錠剤獣医学的組成物であって、
a.前記錠剤の総重量の約4w/w%~約5w/w%の量である治療有効量のオクラシチニブマレイン酸塩、
b.ブタ肝臓に由来する少なくとも1つの動物ベースのパラタント、
c.ビール酵母である少なくとも1つの非動物ベースのパラタント、
d.崩壊剤、結合剤、湿潤剤、滑沢剤、滑剤、および香味修飾剤の1つずつである少なくとも1つの獣医学的に許容される賦形剤
を含み、
かつ前記ソフトチュアブル錠剤が回転式錠剤プレスを用いて圧縮されている、
組成物。 - 前記ブタ肝臓が粉末化されており、かつ前記錠剤の総重量の約46w/w%~約52w/w%の量であり、かつ前記ビール酵母が前記錠剤の総重量の約11w/w%~約14w/w%の量である、請求項10に記載の組成物。
- 前記少なくとも1つの崩壊剤が、クロスポビドン、デンプングリコール酸ナトリウム、またはこれらの混合物からなる群から選択され、かつ前記錠剤の総重量の約10w/w%~約15w/w%の量であり、前記少なくとも1つの結合剤が、ポリエチレングリコール3350、キサンタンガム、またはこれらの混合物からなる群から選択され、かつ前記錠剤の総重量の約5w/w%~約7w/w%の量であり、前記少なくとも1つの湿潤剤がグリセロールであり、かつ前記錠剤の総重量の約11w/w%~約14w/w%の量であり、前記滑沢剤が、ステアリン酸マグネシウム、モノステアリン酸グリセロール、またはこれらの混合物からなる群から選択され、かつ前記錠剤の総重量の約1w/w%~約2w/w%の量であり、前記少なくとも1つの滑剤が前記錠剤の総重量の約1w/w%~約3w/w%の量のコロイド状二酸化ケイ素であり、かつ前記香味修飾剤が前記錠剤の総重量の約0.4w/w%~0.6w/w%の量の塩化ナトリウムである、請求項11に記載の組成物。
- 旨味ソフトチュアブル錠剤獣医学的組成物であって、
a.前記錠剤の総重量の約4w/w%の量の治療有効量のオクラシチニブマレイン酸塩、
b.動物ベースのパラタントおよび非動物ベースのパラタントを含む前記錠剤の総重量の約55w/w%~約70w/w%の量のパラタントの混合物、
c.ポリエチレングリコール3350およびキサンタンガムから選択される前記錠剤の総重量の約5w/w%~約7w/w%の量の結合剤の混合物、
d.クロスポビドンおよびデンプングリコール酸ナトリウムを含む前記錠剤の総重量の約8w/w%~約18w/w%の量の崩壊剤の混合物、
e.前記錠剤の総重量の約11w/w%~約14w/w%の量の湿潤剤グリセロール、
f.前記錠剤の総重量の約0.4w/w%~約0.6w/w%の量の香味修飾剤、
g.前記錠剤(the table)の総重量の約1w/w%~約3w/w%の量の滑剤コロイド状二酸化ケイ素
を含み、
かつ前記ソフトチュアブル錠剤が回転式錠剤プレスで圧縮されている、
組成物。 - 伴侶動物におけるがん、喘息、アトピー性皮膚炎、自己免疫障害、アレルギー性皮膚炎と関連付けられる掻痒、アレルギー、および慢性呼吸器疾患の治療または予防のための旨味ソフトチュアブル錠剤獣医学的組成物の使用であって、前記組成物が、
a.治療有効量のオクラシチニブ、
b.動物ベースのパラタント、非動物ベースのパラタント、および香味修飾剤、
c.ならびに崩壊剤、結合剤、湿潤剤、滑沢剤、および滑剤の少なくとも1つずつ
を含み、
かつ前記ソフトチュアブル錠剤が回転式錠剤プレスで圧縮されている、
使用。 - イヌである伴侶動物におけるアレルギー性皮膚炎と関連付けられる掻痒およびアトピー性皮膚炎の治療または予防のための、請求項14に記載の使用。
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AU2020341552A1 (en) * | 2019-09-06 | 2022-04-21 | Elanco Us Inc. | Palatable granular veterinary compositions |
WO2023198476A1 (en) * | 2022-04-15 | 2023-10-19 | Krka, D.D., Novo Mesto | Soft chewable veterinary dosage form |
JP7355175B1 (ja) | 2022-07-25 | 2023-10-03 | フジテック株式会社 | エレベータのブレーキ制動能力検査方法及びブレーキ制動能力検査装置 |
FR3138315A1 (fr) | 2022-07-27 | 2024-02-02 | Virbac | Produit à usage vétérinaire et procédé pour sa fabrication |
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- 2020-02-19 JP JP2021549085A patent/JP7442540B2/ja active Active
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- 2020-02-19 US US17/421,533 patent/US20220062287A1/en active Pending
- 2020-02-19 KR KR1020217025387A patent/KR20210114978A/ko not_active Application Discontinuation
- 2020-02-19 BR BR112021016480-4A patent/BR112021016480A2/pt unknown
- 2020-02-19 CN CN202080015345.8A patent/CN113438941A/zh active Pending
- 2020-02-19 WO PCT/US2020/018762 patent/WO2020172232A1/en active Application Filing
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CA3127621A1 (en) | 2020-08-27 |
US20220062287A1 (en) | 2022-03-03 |
CO2021010698A2 (es) | 2021-08-30 |
IL285078A (en) | 2021-09-30 |
AU2020224102B2 (en) | 2022-09-08 |
MX2021010066A (es) | 2021-09-21 |
EP3927315A1 (en) | 2021-12-29 |
AU2020224102C1 (en) | 2023-03-16 |
KR20210114978A (ko) | 2021-09-24 |
MA55027A (fr) | 2021-12-29 |
BR112021016480A2 (pt) | 2021-10-13 |
CN113438941A (zh) | 2021-09-24 |
NZ779157A (en) | 2023-10-27 |
JP7442540B2 (ja) | 2024-03-04 |
AU2020224102A1 (en) | 2021-08-19 |
ECSP21059181A (es) | 2021-11-30 |
UA126843C2 (uk) | 2023-02-08 |
WO2020172232A1 (en) | 2020-08-27 |
CL2021002192A1 (es) | 2022-04-01 |
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