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公开(公告)号：US20160243036A1
公开(公告)日：2016-08-25
申请号：US14630699
申请日：2015-02-25
Applicant: IntelGenx Corp.
Inventor： Nadine Paiement , Rodolphe Obeid , Billal Tir
IPC: A61K9/00 , A61K31/4985 , A61K47/38 , A61K47/36 , A61K47/10 , A61K31/5513 , A61K9/70
CPC classification number: A61K47/10 , A61K9/006 , A61K9/7007 , A61K31/196 , A61K31/216 , A61K31/40 , A61K31/415 , A61K31/4985 , A61K31/5513 , A61K31/5517 , A61K31/573 , A61K31/58 , A61K31/60 , A61K31/704 , A61K31/7076 , A61K38/00
Abstract: Oral thin film dosage form of a stable dispersion of non-solubilized amorphous or partially amorphous active agent(s), having a mean particle size diameter D50 equal or lower than 250 μm, that remains uniformly distributed within a film matrix and contains at least one film former polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s). The oral thin film dosage exhibits increased solubility or rate of dissolution and enhanced bioavailability compared to a crystalline form of the active agent(s). The oral dosage form also exhibits long term stability confirmed by no changes in the dissolution profile over time.
Abstract translation: 平均粒度直径D50等于或低于250μm的非溶解无定形或部分无定形活性剂的稳定分散体的口服薄膜剂型，其保持均匀分布在膜基质内并含有至少一种 成膜剂聚合物和任选的药学上可接受的赋形剂，例如稀释剂，增塑剂，表面活性剂，甜味剂和掩味剂。 与活性剂的结晶形式相比，口服薄膜剂量显示增加的溶解度或溶解速率和增强的生物利用度。 口服剂型还显示长期稳定性，通过随时间的溶出曲线没有变化而证实。
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公开(公告)号：US11957785B2
公开(公告)日：2024-04-16
申请号：US17346874
申请日：2021-06-14
Applicant: Intelgenx Corp.
Inventor： Rodolphe Obeid , Nadine Paiement , Erick Gonzalez-Labrada
IPC: A61K9/00 , A61K31/05 , A61K31/352 , A61K36/185 , A61K45/06 , A61K47/10 , A61K47/12 , A61K47/20 , A61K47/26 , A61K47/32 , A61K47/34 , A61K47/36 , A61K47/42 , A61K47/44 , A61K47/46
CPC classification number: A61K9/006 , A61K31/05 , A61K31/352 , A61K36/185 , A61K45/06 , A61K47/10 , A61K47/12 , A61K47/20 , A61K47/26 , A61K47/32 , A61K47/34 , A61K47/36 , A61K47/42 , A61K47/44 , A61K47/46 , A61K9/0065 , A61K31/352 , A61K2300/00 , A61K31/05 , A61K2300/00
Abstract: An orally administered dosage form that facilitates delivery of an agent locally in the buccal cavity for a sustained period of time includes mucoadhesive particles that are made of at least a mucoadhesive material combined with the agent, and which are dispersed in a disintegrating film. The dosage form is capable of delivering an agent to a patient at the desired oral mucosa site over an extended period of time while reducing patient discomfort or annoyance associated with conventional sustained release mucoadhesive films that must reside on the oral mucosa during the period of sustained release.
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公开(公告)号：US11648212B2
公开(公告)日：2023-05-16
申请号：US16053383
申请日：2018-08-02
Applicant: Intelgenx Corp.
Inventor： Mobarik Bilal , Rodolphe Obeid , Nadine Paiement
IPC: A61K31/553 , A61K47/10 , A61K47/28 , A61K9/70 , A61K9/00 , A61K47/36 , A61K47/32 , A61K47/26 , A61K47/18 , A61K47/38
CPC classification number: A61K9/7015 , A61K9/006 , A61K9/7007 , A61K31/553 , A61K47/10 , A61K47/186 , A61K47/26 , A61K47/28 , A61K47/32 , A61K47/36 , A61K47/38
Abstract: A loxapine film oral dosage form includes loxapine salt, free base, or prodrug in an amount effective to provide relief from acute agitation associated with schizophrenia or bipolar 1 disorder via oral transmucosal delivery, dispersed in a polymeric film forming system. Advantageously, the film oral dosage form further includes a sweetener, a refreshing agent, an antioxidant, a pH stabilizer, a penetration enhancer, a mucoadhesive agent and a plasticizer. The loxapine film oral dosage form provides rapid onset of relief from acute agitation associated with schizophrenia or bipolar 1 disorder without presenting pulmonary health risks, thereby reducing risks to patients and others.
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14.发明申请公开(公告)号：US20190133925A1
公开(公告)日：2019-05-09
申请号：US16131995
申请日：2018-09-14
Applicant: Intelgenx Corp.
Inventor： Nadine Paiement , Horst G. Zerbe , Justin W. Conway , Rodolphe Obeid , Ludwig Aigner , Johanna Michael
Abstract: Disclosed is a method of administration and device for the improved bioavailability of leukotriene receptor antagonists. This method and device involve an alkaline surface pH oral film dosage form designed to deliver leukotriene receptor antagonists, such as Montelukast, to the stomach in an amorphous precipitate suspended in aqueous medium. Also disclosed is a device and method for treating a disease, such as a neurodegenerative disease or condition associated with neuroinflammation induced by a leukotriene. The device is a film unit dosage form having an alkaline surface pH film layer and a safe and effective amount of Montelukast. The device is configured and formulated to predominantly achieve enteral delivery of the Montelukast. The method includes enterally delivering to a human or an animal in need of treatment, a safe and effective amount of Montelukast capable of crossing the blood-brain barrier.
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公开(公告)号：US20190000770A1
公开(公告)日：2019-01-03
申请号：US16053383
申请日：2018-08-02
Applicant: Intelgenx Corp.
Inventor： Mobarik Bilal , Rodolphe Obeid , Nadine Paiement
Abstract: A loxapine film oral dosage form includes loxapine salt, free base, or prodrug in an amount effective to provide relief from acute agitation associated with schizophrenia or bipolar 1 disorder via oral transmucosal delivery, dispersed in a polymeric film forming system. Advantageously, the film oral dosage form further includes a sweetener, a refreshing agent, an antioxidant, a pH stabilizer, a penetration enhancer, a mucoadhesive agent and a plasticizer. The loxapine film oral dosage form provides rapid onset of relief from acute agitation associated with schizophrenia or bipolar 1 disorder without presenting pulmonary health risks, thereby reducing risks to patients and others.
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Patent Agency Ranking
公开(公告)号：US20180110724A1
公开(公告)日：2018-04-26
申请号：US15848819
申请日：2017-12-20
Applicant: Intelgenx Corp.
Inventor： Horst G. Zerbe , Nadine Paiement , Cormac Long , Rodolphe Obeid
IPC: A61K9/00 , A61K9/14 , A61K9/70 , A61K31/4985 , A61K31/4709 , A61K31/58 , A61K31/19 , A61K31/40 , A61K31/34 , A61K31/496 , A61K31/439 , A61K31/553 , A61K31/353 , A61K47/14
CPC classification number: A61K9/006 , A61K9/14 , A61K9/145 , A61K9/1635 , A61K9/7007 , A61K31/19 , A61K31/34 , A61K31/353 , A61K31/40 , A61K31/439 , A61K31/4709 , A61K31/496 , A61K31/4985 , A61K31/553 , A61K31/58 , A61K47/14
Abstract: Oral film dosage forms that provide improved solubilization and stabilization of an active ingredient in particle form include at least one primary crystallization inhibitor in an amount that inhibits growth and/or agglomeration of the active ingredient, a polyoxyethylated fatty acid glycerides in an amount that further enhances inhibition of crystallization, growth and agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form.
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公开(公告)号：US20170157119A1
公开(公告)日：2017-06-08
申请号：US15426149
申请日：2017-02-07
Applicant: Intelgenx Corp.
Inventor： Horst G. Zerbe , Nadine Paiement , Angela Angusti , Cormac Long , Rodolphe Obeid
CPC classification number: A61K31/4985 , A61K9/006 , A61K9/7007
Abstract: Oral film dosage forms that provide improved solubilization and stabilization of an active ingredient in particle form include at least one primary crystallization inhibitor in an amount that inhibits growth and/or agglomeration of the active ingredient, a polyoxyethylated fatty acid glycerides in an amount that further enhances inhibition of crystallization, growth and agglomeration of the particles of the pharmaceutically active ingredient; and at least one plasticizer present in an amount that is effective to increase flexibility and elasticity of the film dosage form.
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公开(公告)号：US20160324773A1
公开(公告)日：2016-11-10
申请号：US15216903
申请日：2016-07-22
Applicant: IntelGenx Corp.
Inventor： Nadine Paiement , Rodolphe Obeid , Billal Tir
IPC: A61K9/00 , A61K31/4985 , A61K47/38 , A61K31/5513
CPC classification number: A61K47/10 , A61K9/006 , A61K9/7007 , A61K31/196 , A61K31/216 , A61K31/40 , A61K31/415 , A61K31/4985 , A61K31/5513 , A61K31/5517 , A61K31/573 , A61K31/58 , A61K31/60 , A61K31/704 , A61K31/7076 , A61K38/00
Abstract: Oral thin film dosage form of a stable dispersion of non-solubilized amorphous or partially amorphous active agent(s), having a mean particle size diameter D50 equal or less than 250 μm, that remains uniformly distributed within a film matrix and contains at least one film forming polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s), are prepared by a process including first providing the active agent in an amorphous particle form having a mean particle size diameter D50 equal or less than 250 μm. Next, the active agent is suspended in a liquid film-forming formulation without dissolving the active agent. Therefore, the solvent is removed to form a film.
Abstract translation: 具有平均粒度直径D50等于或小于250μm的未溶解的无定形或部分无定形活性剂的稳定分散体的口服薄膜剂型保持均匀分布在膜基质内并含有至少一种 成膜聚合物和任选的药学上可接受的赋形剂，例如稀释剂，增塑剂，表面活性剂，甜味剂和掩味剂，通过包括首先提供具有平均颗粒的无定形颗粒形式的活性剂的方法制备 尺寸直径D50等于或小于250μm。 接下来，将活性剂悬浮在液体成膜剂中而不溶解活性剂。 因此，除去溶剂以形成膜。
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公开(公告)号：US20210315802A1
公开(公告)日：2021-10-14
申请号：US17346874
申请日：2021-06-14
Applicant: Intelgenx Corp.
Inventor： Rodolphe Obeid , Nadine Paiement , Erick Gonzalez-Labrada
IPC: A61K9/00 , A61K47/34 , A61K47/32 , A61K47/26 , A61K47/36 , A61K47/42 , A61K47/20 , A61K47/10 , A61K47/12 , A61K31/352 , A61K36/185 , A61K47/44 , A61K45/06 , A61K47/46 , A61K31/05
Abstract: An orally administered dosage form that facilitates delivery of an agent locally in the buccal cavity for a sustained period of time includes mucoadhesive particles that are made of at least a mucoadhesive material combined with the agent, and which are dispersed in a disintegrating film. The dosage form is capable of delivering an agent to a patient at the desired oral mucosa site over an extended period of time while reducing patient discomfort or annoyance associated with conventional sustained release mucoadhesive films that must reside on the oral mucosa during the period of sustained release.
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公开(公告)号：US11033493B2
公开(公告)日：2021-06-15
申请号：US16110737
申请日：2018-08-23
Applicant: Intelgenx Corp.
Inventor： Rodolphe Obeid , Nadine Paiement , Erick Gonzalez-Labrada
IPC: A61K9/00 , A61K47/34 , A61K47/32 , A61K47/26 , A61K47/36 , A61K47/42 , A61K47/20 , A61K47/10 , A61K47/12 , A61K31/352 , A61K36/185 , A61K47/44 , A61K45/06 , A61K47/46 , A61K31/05
Abstract: An orally administered dosage form that facilitates delivery of an agent locally in the buccal cavity for a sustained period of time includes mucoadhesive particles that are made of at least a mucoadhesive material combined with the agent, and which are dispersed in a disintegrating film. The dosage form is capable of delivering an agent to a patient at the desired oral mucosa site over an extended period of time while reducing patient discomfort or annoyance associated with conventional sustained release mucoadhesive films that must reside on the oral mucosa during the period of sustained release.
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