Rapidly dissolving film for delivery of an active agent
First Claim
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1. A film for administration of an active agent to a body surface, the film comprising:
- a blend comprised of a hydrophilic polymer and a plasticizer miscible with the hydrophilic polymer, the hydrophilic polymer and the plasticizer blended to form non-covalent bonds between the hydrophilic polymer and the plasticizer, wherein the hydrophilic polymer has an average molecular weight of approximately 100,000 to 2,000,000 Daltons and wherein the plasticizer is present in the film at a weight percent (wt%) of 10 to 40wherein the wt% of the plasticizer is based on the film composition exclusive of the active agent,a rapidly dissolving polymeric material; and
an effective amount of an active agent,wherein the blend and the rapidly dissolving material are effective to facilitate dissolution of the film within 10 minutes following application of the film to a moist body surface.
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Abstract
A rapidly dissolving film is provided for delivery of an active agent to a moist body surface, e.g., mucosal tissue. The film comprises a film-forming binder, a rapidly dissolving polymeric material, and an active agent.
338 Citations
47 Claims
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1. A film for administration of an active agent to a body surface, the film comprising:
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a blend comprised of a hydrophilic polymer and a plasticizer miscible with the hydrophilic polymer, the hydrophilic polymer and the plasticizer blended to form non-covalent bonds between the hydrophilic polymer and the plasticizer, wherein the hydrophilic polymer has an average molecular weight of approximately 100,000 to 2,000,000 Daltons and wherein the plasticizer is present in the film at a weight percent (wt%) of 10 to 40wherein the wt% of the plasticizer is based on the film composition exclusive of the active agent, a rapidly dissolving polymeric material; and an effective amount of an active agent, wherein the blend and the rapidly dissolving material are effective to facilitate dissolution of the film within 10 minutes following application of the film to a moist body surface. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. A film for administration of an active agent to a body surface, the film comprising:
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(a) a blend consisting of (i) a hydrophilic polymer having an average molecular weight of approximately 100,000 to 2,000,000 Daltons, and (ii) about 10 to 40 wt% of a plasticizer having a molecular weight of between 45 to 800 Daltons, and (b) rapidly dissolving polymeric material, the hydrophilic polymer and the plasticizer blended to form non-covalent bonds between the hydrophilic polymer and the plasticizer, wherein the wt% of the plasticizer and of the rapidly dissolving polymeric material is each based on the film composition exclusive of the active agent; and an effective amount of an active agent, wherein the blend and the rapidly dissolving material are effective to facilitate dissolution of the film within 10 minutes following application of the film to a moist body surface. - View Dependent Claims (42, 43, 44, 45, 46, 47)
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Specification