Compositions and methods of manufacture for oral dissolvable...

A - Human Necessities – 61 – K

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A61K 9/20 (2006.01) A61K 9/00 (2006.01)

Patent

CA 2439376

Compositions and methods of manufacture for dissolvable and nondissolvable drug-containing dosage-forms for noninvasive administration of medicaments through mucosal tissues of the mouth, pharynx, and esophagus of a patient. The dosage-forms are particularly useful in the transmucosal delivery of central nervous system affecting drugs in a dose-to-effect manner such that a sufficient dose is administered to produce a desired effect. A dissolvable drug-containing dosage-form includes a binding agent that is formed into a solid matrix dissolvable in the mouth of the patient, and a pharmacologically effective dose of a central nervous system affecting drug dispersed throughout the matrix. A nondissolvable drug-containing dosage-form includes a drug containment matrix that is nondissolvable in the mouth of the patient, and a central nervous system affecting drug incorporated into the nondissolvable matrix. The dissolvable and nondissolvable drug-containing dosage-forms may include permeation enhancers capable of modifying the permeability of the mucosal tissues of the mouth, pharynx, and esophagus in order to facilitate transmucosal absorption of the drug.

Compositions et méthodes de fabrication de formes galéniques solubles et non solubles contenant un principe actif pour l'administration non effractive de médicaments à travers les muqueuses de la bouche, du pharynx et de l'oesophage d'un patient. Lesdites formes galéniques sont particulièrement utiles pour l'administration à travers les muqueuses de médicaments ayant un effet sur le système nerveux central selon une relation dose-effet, si bien qu'une dose suffisante est administrée pour produire un effet désiré. Une forme galénique soluble contenant un principe actif comporte un liant se présentant sous forme de matrice solide soluble dans la bouche du patient, et une dose efficace sur le plan pharmaceutique d'un médicament ayant un effet sur le système nerveux central, dispersée dans la matrice. Une forme galénique non soluble contenant un principe actif comporte une matrice destinée à contenir le principe actif, qui n'est pas soluble dans la bouche du patient, et un médicament ayant un effet sur le système nerveux central incorporé dans la matrice non soluble. Les formes galéniques solubles et non solubles contenant un principe actif peuvent contenir des activateurs de pénétration capables de modifier la perméabilité des muqueuses de la bouche, du pharynx et de l'oesophage afin de faciliter l'absorption du médicament à travers les muqueuses.

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