Novel disintegration oral film formulation with a controlled or sustained active release
AssigneeIntelgenx Corp.
InventorsBillal TIR, Carolin MADWAR, Nadine PAIEMENT
Life of this patent
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Abstract
Oral film formulations comprising at least one hydrophobic active agent; and a polymeric matrix at least partly composed of hydrophobic or insoluble excipients, or a combination thereof, to facilitate a controlled or sustained dissolution. Wherein when the oral film formulation has an unfavorable environment for fast dissolution, it exhibits partial disintegration within 1 to 10 minutes and a sustained rate of dissolution as confirmed by a disintegration test conducted in a limited volume petri dish, and wherein the film undergoes disintegration into smaller and smaller pieces.
Claims20
An oral film formulation comprising:
- a) at least one hydrophobic active agent;
- b) a polymeric matrix at least partly composed of hydrophobic or insoluble excipients, or a combination thereof, to facilitate a controlled or sustained dissolution;
- wherein the oral film formulation has an unfavorable environment for fast dissolution, exhibits partial disintegration within 1 to 10 minutes and a sustained rate of dissolution as confirmed by a disintegration test conducted in a limited volume petri dish, and wherein the film undergoes disintegration into smaller and smaller pieces.
An oral film formulation comprising:
- a) Maropitant as the active agent;
- b) a polymeric matrix composed of about 50% soluble polymers selected from the group consisting of Hydroxypropyl Methylcellulose, Polyethylene Oxide, Hydroxypropyl Cellulose, or a combination thereof;
- c) a surfactant;
- and/or an emulsifier
- d) a plasticizer, and
- e) a pH rage from 6 to 9 promoting an unfavorable environment for dissolution
- wherein the oral film formulation has an unfavorable environment for fast dissolution, exhibits slow disintegration and gradual erosion, enabling a controlled and sustained release of the drug into the aqueous media.
An oral film formulation comprising:
- a) a cannabinoid active agent
- b) a water-soluble polymer mixture;
- c) an oil phase rendering the environment unfavorable for fast dissolution;
- thereby slowing the release of the cannabinoid active agent from the polymer mixture;
- d) and
- e) a surfactant;
- and/or an emulsifier;
- wherein, upon encountering an aqueous medium, the polymer mixture deagglomerates into subunits, and wherein the cannabinoid active agent remains entrapped within the polymer mixture subunits until further eroded, released and solubilized in saliva.
Dependencies are inferred from the claim text.