Non-systemic topical compositions comprising corticosteroids
AssigneeBanner Life Sciences LLC
InventorsYinyan Zhao, Justin Hughey, Jason Vaughn, Qi Fang
Life of this patent
Estimating the term…
Abstract
Described herein are topical, non-systemic, slow releasing oral pharmaceutical compositions, methods for making the same, and methods for treating subjects in need thereof with such compositions. In particular, the oral composition provides topical, non-systemic administration of one or more active pharmaceutical ingredients to the oral cavity and upper gastrointestinal track, including the esophagus. In one embodiment, the pharmaceutical composition provides topical corticosteroids to the esophagus and oral cavity.
Claims30
A topical, non-systemic, oral, slow releasing, solid, soft lozenge pharmaceutical composition comprising:
- (a) about 1% to about 5% by mass of one or more release modifiers comprising polyethylene oxide polymers comprising a molecular weight of about 900,000 to about 8,000,000;
- (b) about 10% to about 60% by mass of one or more film-forming polymers comprising gelatins;
- (c) about 5% to about 20% by mass of one or more plasticizers comprising glycerol, sorbitol, or combinations thereof;
- and
- (d) less than 1% by mass of one or more corticosteroids.
A topical, non-systemic, oral, slow releasing, solid, soft lozenge pharmaceutical composition comprising:
- (a) about 10% to about 60% by mass of one or more gelatins;
- (b) about 5% to about 20% by mass of one or more of glycerol, sorbitol, or combinations thereof;
- (c) about 0.1% to about 5% by mass of one or more of citric acid, acetic acid, lactic acid, malic acid, tartaric acid, fumaric acid, or combinations thereof;
- (d) about 10% to about 80% by mass of one or more of maltitol, xylitol, mannitol, sucralose, aspartame, stevia, or combinations thereof;
- (e) about 5% to about 30% by mass of water;
- (g) about 1% to about 5% by mass of one or more polyethylene oxide polymers comprising a molecular weight of about 900,000 to about 8,000,000;
- (h) about 0.1% to about 5% by mass of one or more polysorbates;
- and
- (i) about 0.001% to about 1% by mass of fluticasone propionate.
A topical, non-systemic, oral slow releasing, solid, soft lozenge pharmaceutical dosage form comprising a shell encapsulating a semisolid matrix fill, the shell comprising:
- (a) about 10% to about 60% by mass of one or more gelatins;
- (b) about 5% to about 20% by mass of glycerol;
- (c) about 0.1% to about 5% by mass of citric acid, acetic acid, lactic acid, malic acid, tartaric acid, fumaric acid, or combinations thereof;
- (d) about 10% to about 80% by mass of one or more of maltitol, xylitol, sucralose or combinations thereof;
- and
- (e) about 5% to about 30% by mass of water;
- and
- the matrix comprising:
- (f) about 5% to about 30% by mass of one or more gelatins;
- (g) about 1% to about 5% by mass of one or more polyethylene oxides comprising a molecular weight of about 900,000 to about 8,000,000;
- (h) about 5% to about 20% by mass of glycerol;
- (i) about 0.5% to about 5% by mass of one or more of citric acid, acetic acid, lactic acid, malic acid, tartaric acid, fumaric acid, or combinations thereof;
- (j) about 10% to about 80% by mass of one of maltitol, xylitol, sucralose, or combinations thereof;
- (k) about 0.1% to about 1% by mass of polysorbate 20, polysorbate 40, polysorbate 60, or polysorbate 80;
- (l) about 5% to about 30% by mass of water;
- and
- (m) about 0.001% to about 1% by mass of fluticasone or a salt thereof.
Dependencies are inferred from the claim text.