Oral film-form base and preparation
AssigneeNitto Denko Corporation
InventorsDaisuke Asari, Mitsuhiko Hori, Takuya Shishido
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Abstract
The present invention provides an oral film-form base which has a rapid dissolution profile in the mouth and sufficient film strength, and gives an improved taking property by foaming in the mouth. The oral film-form base includes an edible polymer soluble both in water and in an organic solvent having a solubility parameter of 9.7 or higher, a foaming agent, and an auxiliary foaming agent, wherein the foaming agent is foamable in the presence of water, and the foaming agent and the auxiliary foaming agent each are insoluble in the organic solvent, have an average particle size of 0.1 to 60 μm, and are included in particle states.
Claims7
An oral film-form preparation comprising an oral film-form base and a drug in the oral film-form base, wherein the oral film-form base comprises
- an edible polymer soluble both in water and in an organic solvent having a solubility parameter of 9.7 or higher, wherein the edible polymer is at least one of polyvinylpyrrolidone or hydroxypropyl cellulose,
- a foaming agent particle, and
- an auxiliary foaming agent particle,
- wherein the foaming agent particle is foamable in the presence of water,
- the foaming agent particle and the auxiliary foaming agent particle each are insoluble in the organic solvent, have an average particle size of 0.1 to 60 μm, and are included in particle states,
- the foaming agent particle and the auxiliary foaming agent particle are dispersed uniformly in a film containing the edible polymer and the drug,
- the foaming agent particle is at least one selected from the group consisting of sodium hydrogen carbonate, sodium carbonate, magnesium carbonate, ammonium hydrogen carbonate, ammonium carbonate, potassium carbonate, and calcium carbonate, and
- the auxiliary foaming agent particle is at least one selected from the group consisting of L-ascorbic acid, potassium L-bitartrate, calcium dihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, galacturonic acid, glucuronic acid, monosodium fumarate, potassium aluminum sulfate, sodium DL-malate, potassium dihydrogen phosphate, and dipotassium hydrogen phosphate.
An oral film-form preparation comprising an oral film-form base and a drug in the oral film-form base, wherein the oral film-form base comprises
- an edible polymer soluble both in water and in an organic solvent having a solubility parameter of 9.7 or higher,
- a foaming agent particle, and
- an auxiliary foaming agent particle,
- wherein the foaming agent particle is foamable in the presence of water,
- the foaming agent particle and the auxiliary foaming agent particle each are insoluble in the organic solvent, have an average particle size of 0.1 to 60 μm, and are included in particle states,
- the foaming agent particle and the auxiliary foaming agent particle are uniformly dispersed in a film containing the edible polymer and the drug, wherein the film is a dried film,
- the foaming agent particle is at least one selected from the group consisting of sodium hydrogen carbonate, sodium carbonate, magnesium carbonate, ammonium hydrogen carbonate, ammonium carbonate, potassium carbonate, and calcium carbonate, and
- the auxiliary foaming agent particle is at least one selected from the group consisting of L-ascorbic acid, potassium L-bitartrate, calcium dihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, galacturonic acid, glucuronic acid, monosodium fumarate, potassium aluminum sulfate, sodium DL-malate, potassium dihydrogen phosphate, and dipotassium hydrogen phosphate.
Dependencies are inferred from the claim text.