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US 10,500,282 B2Granted
Supersaturated stabilized nanoparticles for poorly soluble drugs
AssigneeKashiv Biosciences, LLC
InventorsDipen Desai, Wantanee Phuapradit, Anekant Jain, Atsawin Thongsukmak, Navnit H. Shah
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Abstract
A pharmaceutical composition and method of producing supersaturated stabilized nanoparticles of poorly soluble drugs having average sizes less than 1 μm, or less than 800 nm, or less than 500 nm, comprising at least one pharmaceutically active ingredient, a hydrophilic polymer, a water-soluble surfactant, and subsequently stabilized by ionic polymers.
Claims9
A stabilized suspension suitable for oral administration and downstream processing of solid dosage forms, consisting of:
- a) an aqueous solution consisting of an aqueous solvent, a water-soluble surfactant, a de-agglomeration agent and a water-soluble polymer;
- and
- b) particles of a poorly soluble pharmaceutically active ingredient suspended in the aqueous solution,
- wherein the water-soluble surfactant is an anionic surfactant selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, docusate salt, sodium stearate, and a combination thereof, the de-agglomeration agent is an anionic polymer that is a copolymer of methacrylic acid and ethyl acrylate, and the water-soluble polymer is hydroxypropyl methylcellulose,
- wherein the poorly soluble pharmaceutically active ingredient has an average particle size of about 800 nm or less,
- wherein, apart from the water-soluble surfactant and the water-soluble polymer, no other polymer is added to the aqueous solution containing the particles of the poorly soluble pharmaceutically active ingredient before particle size reduction, and
- wherein the stabilized suspension provides a supersaturated concentration of the poorly soluble pharmaceutically active ingredient.
4 more elements
A dry powder consisting of:
- a) a water-soluble surfactant, a de-agglomeration agent, and a water-soluble polymer;
- and
- b) particles of a poorly soluble pharmaceutically active ingredient, wherein the water-soluble surfactant is an anionic surfactant selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, docusate salt, sodium stearate, and a combination thereof, the de-agglomeration agent is an anionic polymer that is a copolymer of methacrylic acid and ethyl acrylate, and the water-soluble polymer is hydroxypropyl methylcellulose,
- wherein the poorly soluble pharmaceutically active ingredient has an average particle size of about 800 nm or less, and
- wherein, apart from the water-soluble surfactant and the water-soluble polymer, no other polymer is present before particle size reduction.
2 more elements
Dependencies are inferred from the claim text.