JP2022521319A - インライン混合中の懸濁液の通気の最小化 - Google Patents
インライン混合中の懸濁液の通気の最小化 Download PDFInfo
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Abstract
Description
本出願は、2019年2月22日に出願された米国仮出願第62/809,293号の利益を主張し、この全内容は、参照により本明細書に組み込まれる。
Claims (47)
- 薬学的組成物を作製する方法であって、
マトリックス形成剤、構造形成剤、抗通気剤、及び溶媒を含むマトリックス溶液/懸濁液を提供することと、
複数の疎水性粒子を前記マトリックス溶液/懸濁液中に混合して、薬学的懸濁液を形成することと、
前記薬学的懸濁液を予め形成されたブリスターパックに投与することと、を含み、前記投与された薬学的懸濁液の投与重量が、目標投与重量の10%以内である、
前記方法。 - 前記投与された薬学的懸濁液の前記投与重量が、目標投与重量の5%以内である、請求項1に記載の方法。
- 前記投与された薬学的懸濁液の前記投与重量が、目標投与重量の2.5%以内である、請求項1に記載の方法。
- 前記複数の疎水性粒子が、コーティングされた活性薬学的成分(API)を含む、請求項1~3のいずれかに記載の方法。
- 前記コーティングされたAPIが、抗炎症剤、鎮痛剤、抗精神薬、制吐薬、緩下剤、抗下痢剤、抗ヒスタミン剤、または抗うつ剤のうちの1つ以上を含む、請求項4に記載の方法。
- 前記機能的にコーティングされたAPIの組成物が、30~90%w/wのAPIを含む、請求項4または5に記載の方法。
- 前記マトリックス溶液/懸濁液が、粘度調整剤を含む、請求項1~6のいずれかに記載の方法。
- 前記粘度調整剤が、キサンタンガムを含む、請求項7に記載の方法。
- 前記マトリックス溶液/懸濁液中に複数の疎水性粒子を混合することが、摂氏15~20℃でのインライン混合を含む、請求項1~8のいずれかに記載の方法。
- 前記抗通気剤が、テルペンまたはテルピノールのうちの1つ以上を含む、請求項1~9のいずれかに記載の方法。
- 前記抗通気剤が、液体フレーバーを含む、請求項1~10のいずれかに記載の方法。
- 前記抗通気剤が、リモネンを含む液体フレーバーを含む、請求項1~11のいずれかに記載の方法。
- 前記抗通気剤が、オレンジフレーバー、レモンフレーバー、グレープフルーツフレーバー、ライムフレーバー、ストロベリーフレーバー、またはペパーミントフレーバーのうちの1つ以上を含む、請求項1~12のいずれかに記載の方法。
- 前記マトリックス溶液/懸濁液または薬学的懸濁液が、0.1~1.5%w/wの抗通気剤を含む、請求項1~13のいずれかに記載の方法。
- 前記マトリックス溶液/懸濁液または薬学的懸濁液が、2.0~5.0%w/wのマトリックス形成剤を含む、請求項1~14のいずれかに記載の方法。
- 前記マトリックス溶液/懸濁液または薬学的懸濁液が、1.0~5.0%w/wの構造形成剤を含む、請求項1~15のいずれかに記載の方法。
- マトリックス形成剤、構造形成剤、抗通気剤、及び溶媒を含むマトリックス溶液/懸濁液を提供するステップと、
複数の疎水性粒子を前記マトリックス溶液/懸濁液中に混合して、薬学的懸濁液を形成するステップと、
前記薬学的懸濁液を予め形成されたブリスターパックに投与するステップと、を含むプロセスによって調製された薬学的組成物であって、前記投与された薬学的懸濁液の投与重量が、目標投与重量の10%以内である、前記薬学的組成物。 - 前記投与された薬学的懸濁液の前記投与重量が、目標投与重量の5%以内である、請求項17に記載の薬学的組成物。
- 前記投与された薬学的懸濁液の前記投与重量が、目標投与重量の2.5%以内である、請求項17に記載の薬学的組成物。
- 前記複数の疎水性粒子が、コーティングされた活性薬学的成分(API)を含む、請求項17~19のいずれかに記載の薬学的組成物。
- 前記コーティングされたAPIが、抗炎症剤、鎮痛剤、抗精神薬、制吐薬、緩下剤、抗下痢剤、抗ヒスタミン剤、または抗うつ剤のうちの1つ以上のうちの1つ以上を含む、請求項20に記載の薬学的組成物。
- 前記薬学的組成物が、65~85%w/wのAPIを含む、請求項20または21に記載の薬学的組成物。
- 前記マトリックス溶液/懸濁液が、粘度調整剤を含む、請求項17~22のいずれかに記載の薬学的組成物。
- 前記粘度調整剤が、キサンタンガムを含む、請求項23に記載の薬学的組成物。
- 前記マトリックス溶液/懸濁液中に複数の疎水性粒子を混合することが、摂氏15~20℃でのインライン混合を含む、請求項17~24のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、テルペンまたはテルピノールのうちの1つ以上を含む、請求項17~25のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、液体フレーバーを含む、請求項17~26のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、リモネンを含む液体フレーバーを含む、請求項17~27のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、オレンジフレーバー、レモンフレーバー、グレープフルーツフレーバー、ライムフレーバー、ストロベリーフレーバー、またはペパーミントフレーバーのうちの1つ以上を含む、請求項17~28のいずれかに記載の薬学的組成物。
- 前記マトリックス溶液/懸濁液または薬学的懸濁液が、0.1~1.5%w/wの抗通気剤を含む、請求項17~29のいずれかに記載の薬学的組成物。
- 前記マトリックス溶液/懸濁液または薬学的懸濁液が、2.0~5.0%w/wのマトリックス形成剤を含む、請求項17~30のいずれかに記載の薬学的組成物。
- 前記マトリックス溶液/懸濁液または薬学的懸濁液が、1.0~5.0%w/wの構造形成剤を含む、請求項17~31のいずれかに記載の薬学的組成物。
- 請求項17~32のいずれかに記載の薬学的組成物を患者に投与することを含む、患者を治療する方法。
- 前記患者が、ヒトである、請求項33に記載の方法。
- 複数のAPI粒子と、
前記複数のAPI粒子の各API粒子をカプセル化するコーティング材料と、
マトリックス形成剤と、
構造形成剤と、
抗通気剤と、
を含む、薬学的組成物。 - 前記薬学的組成物が、前記マトリックス形成剤、前記構造形成剤、及び前記抗通気剤を含むマトリックス溶液/懸濁液を作製することによって形成される、請求項35に記載の薬学的組成物。
- 前記複数のAPI粒子が、抗炎症剤、鎮痛剤、抗精神薬、制吐薬、緩下剤、抗下痢剤、抗ヒスタミン剤、または抗うつ剤のうちの1つ以上のうちの1つ以上を含む、請求項35または36に記載の薬学的組成物。
- 前記マトリックス溶液/懸濁液が、粘度調整剤を含む、請求項35~37のいずれかに記載の薬学的組成物。
- 前記粘度調整剤が、キサンタンガムを含む、請求項38に記載の薬学的組成物。
- 前記抗通気剤が、テルペンまたはテルピノールのうちの1つ以上を含む、請求項35~39のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、液体フレーバーを含む、請求項35~40のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、リモネンを含む液体フレーバーを含む、請求項35~41のいずれかに記載の薬学的組成物。
- 前記抗通気剤が、オレンジフレーバー、レモンフレーバー、グレープフルーツフレーバー、ライムフレーバー、ストロベリーフレーバー、またはペパーミントフレーバーのうちの1つ以上を含む、請求項35~42のいずれかに記載の薬学的組成物。
- 前記薬学的組成物が、65~85%w/wのAPIを含む、請求項35~43のいずれかに記載の薬学的組成物。
- 前記薬学的組成物が、1~5%w/wの抗通気剤を含む、請求項35~44のいずれかに記載の薬学的組成物。
- 前記薬学的組成物が、3~10%w/wのマトリックス形成剤を含む、請求項35~45のいずれかに記載の薬学的組成物。
- 前記薬学的組成物が、3~10%w/wの構造形成剤を含む、請求項35~46のいずれかに記載の薬学的組成物。
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EP3927313A1 (en) | 2019-02-22 | 2021-12-29 | Catalent U.K. Swindon Zydis Limited | Preserving functionally-coated api particles produced by solventless mixing processes in aqueous suspension |
AR118419A1 (es) | 2019-02-22 | 2021-10-06 | Catalent Uk Swindon Zydis Ltd | Minimización de aglomeración de material de revestimiento de partícula de medicamento durante el almacenaje para estabilizar los tiempos de desintegración de productos farmacéuticos |
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