Carrier for oromucosal administration of physiologically active substances
Inventors
Stranska, Denisa • Klabanova, Adela • Dolezal, Pavel • Vrbata, Petr • Berka, Pavel • Musilova, Marie
Assignees
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Publication Number
US-9789060-B2
Publication Date
2017-10-17
Expiration Date
Abstract
The present disclosure relates to a carrier for oromucosal, especially sublingual administration of physiologically active substances, especially of medicinal drugs, which consists of at least one elastic layer (1) of polymer nanofibers workable according to the shape of the selected wall of mouth cavity to which it should be applied and in this elastic layer (1) of polymer nanofibers a drug and/or other physiologically active substance are deposited in a releasable manner.
Core Innovation
The invention provides a carrier for oromucosal administration of physiologically active substances, in particular for sublingual administration. The carrier comprises at least one flexible layer of polymer nanofibres having a first side and a second side, where the polymer nanofibres comprise a releasable drug and/or other physiologically active substance, and the polymer nanofibres include an adhesive adapted for contact and adhesion with a sublingual surface at an adhesion location in a mouth cavity.
The carrier further comprises a covering layer that overlaps a first side of the at least one flexible layer of polymer nanofibres. The covering layer is adapted to prohibit leaching of the releasable drug and/or other physiologically active substance from the at least one flexible layer of polymer nanofibres to outside of the adhesion location and into the mouth cavity, and the releasable drug and/or other physiologically active substance is released at the adhesion location.
The described multi-layer structures include elastic, shapeable polymer nanofiber layers and configurations with adhesive means for fixation to sublingual mucosa and non-adhesive covering layer(s) to prevent or control drug leaching into the saliva/mouth cavity. Protective layers can form enclosed structures with a fixation rim.
Claims Coverage
The independent claim defines a multi-component carrier for oromucosal administration with an adhesive nanofiber layer and an overlapping covering layer that inhibits leaching, with needleless electrostatic spinning and release at an adhesion location. Dependent claims refine the carrier structure and add an administration method tied to where release occurs.
Adhesive nanofiber layer with releasable drug
A carrier with at least one flexible layer of polymer nanofibres comprising a releasable drug and/or other physiologically active substance, where the polymer nanofibres comprise an adhesive adapted for contact and adhesion with a sublingual surface of a mouth cavity of a subject on an adhesion location.
Overlapping covering layer inhibiting leaching to the mouth cavity
A covering layer that overlaps a first side of the at least one flexible layer of polymer nanofibres, adapted to prohibit leaching of the releasable drug and/or other physiologically active substance from the at least one flexible layer to outside of the adhesion location and into the mouth cavity.
Needleless electrostatic spinning of the nanofiber layer
The at least one flexible layer of polymer nanofibres is produced by needleless electrostatic spinning.
Release at the adhesion location
The releasable drug and/or other physiologically active substance is released at the adhesion location.
Adhesion-based administration with release at the adhesion location
A method for sublingual administration comprising adhering the carrier to the adhesion surface, wherein the releasable drug and/or other physiologically active substance is released from the carrier at the adhesion location and not within the mouth cavity of the subject.
Overall, the claim coverage centers on an adhesive-capable flexible polymer nanofiber layer carrying a releasable physiologically active substance, an overlapping covering layer that inhibits leaching into the mouth cavity, needleless electrostatic spinning, and release specifically at an adhesion location. An additional claim covers adhering the carrier to achieve release at the adhesion location rather than within the mouth cavity.
Stated Advantages
Reduced dose and reduced toxicity compared to oral administration.
Painless and reproducible administration compared to injection or inhalation.
Documented Applications
Oromucosal/sublingual administration of physiologically active substances using the described carrier, including embodiments exemplified for caffeine, paracetamol, nabumetone, sumatriptane, and insulin.
Use of the carrier to control or inhibit drug leaching into the saliva/mouth cavity at an adhesion location, with in vitro sublingual penetration and microscopy liberation profiles reported for at least one example.
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