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21.
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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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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25.
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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26.
公开(公告)号:US20220362164A1
公开(公告)日:2022-11-17
申请号:US17729442
申请日:2022-04-26
Applicant: INTELGENX CORP.
Inventor: Nadine PAIEMENT , Horst G. ZERBE , Justin W. CONWAY , Rodolphe OBEID
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: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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公开(公告)号:US20210022991A1
公开(公告)日:2021-01-28
申请号:US17063644
申请日:2020-10-05
Applicant: INTELGENX CORP.
Inventor: Nadine PAIEMENT , Rodolphe OBEID , Justin CONWAY , Billal TIR
IPC: A61K9/00 , A61K47/38 , A61K31/4985
Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no. 2 at 60 rpm
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公开(公告)号:US10828254B2
公开(公告)日:2020-11-10
申请号:US16146516
申请日:2018-09-28
Applicant: Intelgenx Corp.
Inventor: Nadine Paiement , Rodolphe Obeid , Justin W. Conway , Billal Tir
IPC: A61K9/00 , A61K47/38 , A61K31/4985
Abstract: An oral film dosage form includes a high viscosity polymer in an amount of from 1% to 5% by dry weight to reduce, modulate and/or control Cmax of an active agent. The high viscosity polymer has a viscosity of from 100 cps to 500 cps as determined at 2% concentration in water by weight at 25° C. using a Brookfield LVF viscometer with spindle no. 2 at 60 rpm.
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