Lipophilic active oral film formulation and method of making the same

    公开(公告)号:US11602504B2

    公开(公告)日:2023-03-14

    申请号:US16383813

    申请日:2019-04-15

    Abstract: Disclosed is a description and methods for formulating oral films containing lipophilic active ingredient(s), more particularly lipophilic active having a positive log P. The method involves dispersing the lipophilic active(s) in a carrier oil and uniformly distributing them as emulsified oil droplets into a polymer matrix. The methods reported here produce oral films containing a stable emulsion with up to 40% oil phase. The oil phase consists of the carrier oil and lipophilic active(s). This offers the possibility to enhance the amount of lipophilic actives to be included in the film formulation while preserving the film characteristics. The resulting oral films offer a standardized dosage form for lipophilic actives as well as easier and more convenient administration, transportation, handling, and storage.

    LOXAPINE FILM ORAL DOSAGE FORM
    45.
    发明申请

    公开(公告)号:US20190314293A1

    公开(公告)日:2019-10-17

    申请号:US16455916

    申请日:2019-06-28

    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.

    FILM DOSAGE FORM WITH EXTENDED RELEASE MUCOADHESIVE PARTICLES

    公开(公告)号:US20190209459A1

    公开(公告)日:2019-07-11

    申请号:US16353628

    申请日:2019-03-14

    CPC classification number: A61K9/006 A61K45/06 A61K47/32 A61K47/34

    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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