SEMI-SOLID CHEWABLE DOSAGE FORM FOR OVER-THE-COUNTER MEDICATIONS AND METHOD FOR PRODUCING SAME
The invention provides a semi-solid chewable dosage form that contains one or more active pharmaceutical ingredients that are generally available as over-the-counter medications including, for example, chlorpheniramine maleate, phenylephrine hydrochloride, guaifenesin, dextromethorphan hydrobromide, loratadine, or a combination thereof. The invention further provides a semi-solid chewable dosage form that contains chlorpheniramine maleate, phenylephrine hydrochloride or a combination thereof, a gelling agent, gelatin, sugar, a polyol, and a pH adjusting agent. The invention further provides a semi-solid chewable dosage form that contains the active pharmaceutical ingredient chlorpheniramine maleate, phenylephrine hydrochloride or a combination thereof, a gelling agent, gelatin, sugar, corn syrup, and a pH adjusting agent. The semi-solid chewable dosage form is useful for administration to individuals to treat symptoms from allergies, colds, congestion, and the like.
1 . A semi-solid chewable dosage form comprising an active pharmaceutical ingredient selected from the group consisting of chlorpheniramine maleate, phenylephrine hydrochloride, and a combination thereof, a gelling agent, gelatin, sugar, a polyol, and a pH adjusting agent.
2 . The semi-solid chewable dosage form of claim 1 , wherein the active pharmaceutical ingredient is a combination of chlorpheniramine maleate and phenylephrine hydrochloride.
3 . The semi-solid chewable dosage form of claim 2 , wherein the gelling agent is pectin.
4 . The semi-solid chewable dosage form of claim 2 , wherein the gelatin is hydrolyzed gelatin.
5 . The semi-solid chewable dosage form of claim 2 , wherein the polyol is hydrolyzed starch hydrolysate.
6 . The semi-solid chewable dosage form of claim 2 , wherein the pH adjusting agent is sodium citrate and citric acid.
7 . The semi-solid chewable dosage of claim 1 , wherein the gelling agent is pectin in an amount from about 0.5% by weight to about 7% by weight, the gelatin is hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight, and the polyol is hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight.
8 . A semi-solid chewable dosage form comprising an active pharmaceutical ingredient selected from the group consisting of chlorpheniramine maleate, phenylephrine hydrochloride, and a combination thereof, a gelling agent, gelatin, sugar, corn syrup, and a pH adjusting agent.
9 . The semi-solid chewable dosage form of claim 8 , wherein the active pharmaceutical ingredient is a combination of chlorpheniramine maleate and phenylephrine hydrochloride.
10 . The semi-solid chewable dosage form of claim 9 , wherein the gelling agent is pectin.
11 . The semi-solid chewable dosage form of claim 9 , wherein the gelatin is hydrolyzed gelatin.
12 . The semi-solid chewable dosage form of claim 9 , wherein the pH adjusting agent is sodium citrate and citric acid.
13 . The semi-solid chewable dosage of claim 8 , wherein the gelling agent is pectin in an amount from about 0.5% by weight to about 7% by weight, and the gelatin is hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight.
14 . A semi-solid chewable dosage form comprising:
chlorpheniramine maleate;
phenylephrine hydrochloride;
pectin in an amount from about 0.5% by weight to about 7% by weight;
sugar in an amount from about 40% by weight to about 95% by weight;
hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight;
hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight;
sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and
citric acid in an amount from about 0.5% by weight to about 3% by weight.
15 . The semi-solid chewable dosage form of claim 14 , further comprising glycerin in amount from about 0.5% by weight to about 5% by weight.
16 . The semi-solid chewable dosage form of claim 15 , further comprising dodecalactone.
17 . The semi-solid chewable dosage form of claim 15 , wherein the water content of the semi-solid dosage form is from about 8% by weight to about 15% by weight.
18 . A semi-solid chewable dosage form comprising:
chlorpheniramine maleate;
phenylephrine hydrochloride;
pectin in an amount from about 0.5% by weight to about 7% by weight;
sugar in an amount from about 40% by weight to about 95% by weight;
corn syrup in an amount from about 40% by weight to about 90% by weight;
hydrolyzed gelatin in an amount from about 0.5% by weight to about 8% by weight;
sodium citrate in an amount from about 0.1% by weight to about 1% by weight; and
citric acid in an amount from about 0.5% by weight to about 3% by weight.
19 . The semi-solid chewable dosage form of claim 18 , further comprising glycerin in amount from about 0.5% by weight to about 5% by weight.
20 . The semi-solid chewable dosage form of claim 19 , wherein the water content of the semi-solid dosage form is from about 8% by weight to about 15% by weight.