SEMI-SOLID CHEWABLE DOSAGE FORM FOR OVER-THE-COUNTER MEDICATIONS AND METHOD FOR PRODUCING SAME
The invention provides a semi-solid chewable dosage form for use as an over-the-counter medication that contains an active pharmaceutical ingredient to treat symptoms associated with allergies, colds, coughs, fever, pain, gastrointestinal disorders, sleep, and other common conditions. The invention further provides a semi-solid chewable dosage form that contains an active pharmaceutical ingredient, a gelling agent, gelatin, sugar, a polyol, and a pH adjusting agent. The invention also provides a semi-solid chewable dosage form that contains a gelling agent, sugar, a polyol, glycerin, and a pH adjusting agent.
1 . A semi-solid chewable dosage form comprising an active pharmaceutical ingredient, a gelling agent, gelatin, sugar, a polyol, and a pH adjusting agent.
2 . The semi-solid chewable dosage form of claim 1 , wherein the gelling agent is pectin, the gelatin is hydrolyzed gelatin, and the polyol is hydrolyzed starch hydrolysate.
3 . The semi-solid dosage form of claim 2 , wherein pectin is present in an amount from about 0.5% by weight to about 7% by weight, hydrolyzed gelatin is present in an amount from about 0.5% by weight to about 8% by weight, and hydrolyzed starch hydrolysate is present in an amount from about 40% by weight to about 90% by weight.
4 . The semi-solid chewable dosage form of claim 1 , wherein the active pharmaceutical ingredient is diphenhydramine hydrochloride.
5 . The semi-solid chewable dosage form of claim 4 , wherein the gelling agent is pectin.
6 . The semi-solid chewable dosage form of claim 4 , wherein the gelatin is hydrolyzed gelatin.
7 . The semi-solid chewable dosage form of claim 4 , wherein the polyol is hydrolyzed starch hydrolysate.
8 . The semi-solid dosage form of claim 4 , wherein the gelling agent is pectin present in an amount from about 0.5% by weight to about 7% by weight, the gelatin is hydrolyzed gelatin present in an amount from about 0.5% by weight to about 8% by weight, and the polyol is hydrolyzed starch hydrolysate present in an amount from about 40% by weight to about 90% by weight.
9 . A semi-solid chewable dosage form comprising:
an active pharmaceutical ingredient;
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;
wherein the water content of the semi-solid dosage form is from about 8% by weight to about 15% by weight.
10 . The semi-solid chewable dosage form of claim 9 , wherein the active pharmaceutical ingredient is diphenhydramine hydrochloride.
11 . The semi-solid dosage form of claim 9 , wherein pectin is present in an amount from about 1% by weight to about 5% by weight, hydrolyzed gelatin is present in an amount from about 1% by weight to about 5% by weight, and the hydrolyzed starch hydrolysate present in an amount from about 40% by weight to about 60% by weight.
12 . A semi-solid chewable dosage form comprising an active pharmaceutical ingredient, a gelling agent, sugar, a polyol, glycerin, and a pH adjusting agent.
13 . The semi-solid chewable dosage form of claim 12 , wherein the gelling agent is pectin and the polyol is hydrolyzed starch hydrolysate.
14 . The semi-solid dosage form of claim 13 , wherein pectin is present in an amount from about 0.5% by weight to about 7% by weight, hydrolyzed starch hydrolysate present in an amount from about 40% by weight to about 90% by weight, and glycerin is present in an amount from about 0.5% by weight to about 5% by weight.
15 . The semi-solid chewable dosage form of claim 12 , wherein the active pharmaceutical ingredient is loratadine.
16 . The semi-solid chewable dosage form of claim 15 , wherein the gelling agent is pectin.
17 . The semi-solid chewable dosage form of claim 15 , wherein the gelatin is hydrolyzed gelatin.
18 . The semi-solid chewable dosage form of claim 15 , wherein the polyol is hydrolyzed starch hydrolysate.
19 . The semi-solid dosage form of claim 15 , wherein the gelling agent is pectin present in an amount from about 0.5% by weight to about 7% by weight, the polyol is hydrolyzed starch hydrolysate present in an amount from about 40% by weight to about 90% by weight, and glycerin is present in an amount from about 0.5% by weight to about 5% by weight.
20 . A semi-solid chewable dosage form comprising:
an active pharmaceutical ingredient;
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;
glycerin in an amount from about 0.5% by weight to about 5% 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;
wherein the water content of the semi-solid dosage form is from about 8% by weight to about 15% by weight.
21 . The semi-solid chewable dosage form of claim 20 , wherein the active pharmaceutical ingredient is loratadine.