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 loratadine, pectin, sugar, hydrolyzed starch hydrolysate, glycerin, water, and a pH adjusting agent.
2 . The semi-solid dosage form of claim 1 , wherein pectin is present in an amount from about 0.5% by weight to about 7% by weight, hydrolyzed starch hydrolysate is present in an amount from about 40% by weight to about 90% by weight, and glycerin is present in an amount from about 0.1% by weight to about 10% by weight.
3 . The semi-solid dosage form of claim 2 , wherein the water content of the semi-solid dosage form is from about 8% by weight to about 15% by weight.
4 . The semi-solid dosage form of claim 2 , wherein loratadine is present in an amount of from about 0.1% to about 1.0% by weight.
5 . The semi-solid dosage form of claim 2 , wherein loratadine is present in an amount of about 10 mg.
6 . The semi-solid dosage form of claim 2 , wherein pectin is present in an amount from about 1% by weight to about 5% by weight.
7 . The semi-solid dosage form of claim 2 , wherein hydrolyzed starch hydrolysate is present in an amount from about 40% by weight to about 60% by weight.
8 . The semi-solid dosage form of claim 2 , wherein glycerin is present in an amount from about 0.5% by weight to about 5% by weight.
9 . A semi-solid chewable dosage form comprising:
loratadine;
pectin in an amount from about 0.5% by weight to about 7% by weight;
hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 90% by weight;
glycerin in an amount from about 0.1% by weight to about 10% by weight;
sodium citrate in an amount from about 0.1% by weight to about 1% by weight;
citric acid in an amount from about 0.5% by weight to about 3% by weight; and
water,
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 dosage form of claim 9 , wherein loratadine is present in an amount of from about 0.1% to about 1.0% by weight.
11 . The semi-solid dosage form of claim 9 , wherein loratadine is present in an amount of about 10 mg.
12 . 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.
13 . The semi-solid dosage form of claim 9 , wherein hydrolyzed starch hydrolysate is present in an amount from about 40% by weight to about 60% by weight.
14 . The semi-solid dosage form of claim 9 , wherein glycerin is present in an amount from about 0.5% by weight to about 5% by weight.
15 . A semi-solid chewable dosage form comprising:
about 10 mg loratadine;
pectin in an amount from about 1% by weight to about 5% by weight;
hydrolyzed starch hydrolysate in an amount from about 40% by weight to about 60% by weight;
glycerin in an amount from about 0.5% by weight to about 5% by weight; and
water,
wherein the water content of the semi-solid dosage form is from about 8% by weight to about 15% by weight.