Film dosage form with extended release mucoadhesive particles
AssigneeIntelgenx Corp.
InventorsRodolphe Obeid, Nadine Paiement, Erick Gonzalez-Labrada
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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.
Claims20
An oral film dosage form providing transport of an active agent in a buccal cavity of a subject, comprising:
- (a) a disintegrable film;
- and
- (b) solid polymer particles dispersed in the disintegrable film, the particles comprising a mucoadhesive material exhibiting adhesivity to mucosa in the buccal cavity,
- i. wherein the active agent is encapsulated in the solid polymer particles, and the active agent is a cannabis extract, cannabis oil, synthetic tetrahydrocannabinol (THC), THC purified from cannabis extract, THC complexated with cyclodextrin (CD), cannabidiol (CBD), or a THC/CBD combination;
- and
- ii. wherein the disintegrable film exhibits lower mucoadhesivity than the mucoadhesive particles.
An oral film dosage form providing transport of an agent for local delivery in a buccal cavity of a subject for at least two different agents for a sustained period of time, comprising:
- (a) a disintegrable film;
- (b) first solid polymer particles dispersed in the disintegrable film, the first solid polymer particles comprising a first mucoadhesive material exhibiting adhesivity to mucosa in the buccal cavity and a first active agent in the first solid polymer particles for release over a sustained period from the first mucoadhesive material;
- and
- (c) second solid polymer particles dispersed in the disintegrable film, the second solid polymer particles comprising a second mucoadhesive material exhibiting adhesivity to mucosa in the buccal cavity that is different from the first mucoadhesive material and a second active agent contained in the second solid polymer particles that is the same as or different from the first active agent and is released over a sustained period from the second mucoadhesive material, wherein at least one of the first and second active agents is a cannabis extract, cannabis oil, tetrahydrocannabinol (THC), THC complexed with cyclodextrin (CD), cannabidiol (CBD), or a THC/CBD combination, wherein the disintegrable film exhibits lower mucoadhesivity than the mucoadhesive particles.
An oral dosage form providing transport of an agent for transmucosal delivery in a buccal cavity of a subject, comprising:
- (a) a disintegrable film matrix;
- and
- (b) solid polymer particles dispersed in the disintegrable film matrix, the particles comprising a mucoadhesive material exhibiting adhesivity to mucosa in the buccal cavity and at least a first active agent contained in the mucoadhesive particles,
- (c) wherein the first active agent is capable of being absorbed transmucosally through the buccal mucosa, and wherein the disintegrable film matrix exhibits lower mucoadhesivity than the mucoadhesive particles.
Dependencies are inferred from the claim text.