Immune response modifier formulations and methods
OwnerTerri Busch, Leo Kueperinventors
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Abstract
Pharmaceutical formulations including an immune response modifier (IRM) compound having a 2-aminopyridine moiety fused to a five-membered nitrogen-containing heterocyclic ring; a preservative system including a sorbic acid preservative selected from the group consisting of sorbic acid, esters thereof, salts thereof, and combinations thereof; an antioxidant; and an optional chelating agent.
Claims53
A pharmaceutical formulation comprising:
- an immune response modifier (IRM) compound comprising a 2-aminopyridine moiety fused to a five-membered nitrogen-containing heterocyclic ring;
- a preservative system comprising a sorbic acid preservative selected from the group consisting of sorbic acid, esters thereof, salts thereof, and combinations thereof;
- and
- an antioxidant.
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A pharmaceutical formulation comprising:
- 0.001% by weight to 5.0% by weight of an immune response modifier (IRM) compound comprising a 2-aminopyridine moiety fused to a five-membered nitrogen-containing heterocyclic ring;
- a preservative system comprising:
- 0.02% by weight to 0.2% by weight of a sorbic acid preservative selected from the group consisting of sorbic acid, esters thereof, salts thereof, and combinations thereof,
- 0 to 10.0% by weight of a preservative enhancing solubilizer;
- and
- 0.05% by weight to 0.2% by weight of a secondary preservative compound;
- 0.001% by weight to 0.2% by weight of an antioxidant comprising hydrogen atom donating functionality;
- 0 to 0.1% by weight of a chelating agent;
- 1% by weight to 30% by weight of a fatty acid;
- 1% by weight to 15% by weight of a medium-chain triglyceride;
- 0.2% by weight to 2.0% by weight of a viscosity enhancing agent;
- 0.1% by weight to 6.0% by weight of an emulsifier;
- and
- water;
- wherein the formulation has a pH of 4.0 to 6.0 and the weight percentages are based on the total weight of the formulation.
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A pharmaceutical formulation comprising:
- 0.001% by weight to 5.0% by weight of an imidazonaphthyridine amine;
- 0.02% by weight to 0.2% by weight of a sorbic acid preservative selected from the group consisting of sorbic acid, esters thereof, salts thereof, and combinations thereof;
- 0 to 10.0% by weight of propylene glycol;
- 0.05% by weight to 0.2% by weight of methylparaben;
- 0.001% by weight to 0.2% by weight of butylated hydroxyanisole, butylated hydroxytoluene, or combinations thereof;
- 0 to 0.1% by weight of ethylenediaminetetraacetic acid, a hydrate thereof, a salt thereof, a hydrate of a the salt thereof, or combinations thereof;
- 1% by weight to 30% by weight of isostearic acid;
- 1% by weight to 15% by weight of a medium-chain triglyceride;
- 0.2% by weight to 2.0% by weight of a carbomer;
- 0.1% by weight to 6.0% by weight of a poloxamer;
- and
- water;
- wherein the formulation has a pH of 4.0 to 6.0 and the weight percentages are based on the total weight of the formulation.
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Dependencies are inferred from the claim text.