Last Updated: June 9, 2026

Claims for Patent: 5,314,697

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Summary for Patent: 5,314,697

Title:	Stable extended release oral dosage composition comprising loratadine and pseudoephedrine
Abstract:	A film-coated extended release oral dosage composition containing the nasal decongestant pseudoephedrine sulfate in a unique polymer matrix core and a film-coating on such core containing the non-sedating antihistamine, loratadine, and use of the said composition for treating patients showing the signs and symptoms associated with upper respiratory diseases and nasal congestion are disclosed.
Inventor(s):	Henry K. Kwan, Stephen M. Liebowitz
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US07/965,470
Patent Claims:	1. A film-coated extended release oral dosage composition comprising:a. a matrix core comprising: ______________________________________ mg/core ______________________________________ Pseudoephedrine Sulfate 120-360 Hydroxypropyl Methylcellulose 2208 160-480 100,000 cps Ethylcellulose 40-120 Dibasic Calcium Phosphate Dihydrate 56-164 Povidone 20-60 Silicon Dioxide 6-12 and Magnesium Stearate 2-6 Matrix Core Weight Range: 400-1200 mg ______________________________________ and b. a coating on said core comprising: ______________________________________ mg/tablet ______________________________________ Loratadine 5-15 Hydroxypropyl Methylcellulose 2910 6 cps 17-50 Polyethylene Glycol 400 0.25-5.0 Polyethylene Glycol 3350 3.4-10.15 Approximate Coating Weight Range: 26-80.0 mg Approximate Composition Weight Range: 427-1280 mg ______________________________________ 2. A method of treating patients showing the signs and symptoms associated with upper respiratory diseases which comprises administering to such a patient the oral dosage composition of claim 1. 3. The oral dosage composition of claim 1 wherein 240 mg. of pseudoephedrine sulfate is in the core and 10 mg. of loratadine is in the coating. 4. A film-coated extended release oral dosage composition comprising:a. a matrix core comprising: ______________________________________ mg/core ______________________________________ Pseudoephedrine Sulfate 240 Hydroxypropyl Methylcellulose 2208 100,000 cps. 160-480 Ethylcellulose 40-120 Dibasic Calcium Phosphate Dihydrate 56-164 Povidone 20-60 Silicon Dioxide 6-12 and Magnesium Stearate 2-6 Approximate Core Weight Range: 520-1080 mg ______________________________________ and b. a coating on said core comprising: ______________________________________ mg/tablet ______________________________________ Loratadine 10 Hydroxypropyl Methylcellulose 2910 6 cps. 17-50 Polyethylene Glycol 400 0.25-5.0 Polyethylene Glycol 3350 3.4-10.15 Approximate Coating Weight Range: 31-75 mg Approximate Composition Weight Range: 552-1155 mg ______________________________________ 5. A method of treating a patient showing the signs and/or symptoms associated with upper respiratory diseases which comprises administering to such a patient the oral dosage form of claim 4. 6. A film-coated extended release oral dosage composition comprising:a. a matrix core comprising: ______________________________________ mg/core ______________________________________ Pseudoephedrine Sulfate USP 240 Hydroxypropyl Methylcellulose 2208 USP 100,000 cps 320 Ethylcellulose NF Type 7 80 Dibasic Calcium Phosphate USP Dihydrate 108 Povidone USP 40 Silicon Dioxide NF 8 and Magnesium Stearate NF 4 Approximate Core weight 800 mg ______________________________________ and b. a coating upon said core comprising: ______________________________________ mg/tablet ______________________________________ Loratadine, Micronized 10 Hydroxypropyl Methylcellulose 2910 USP 6 cps 33 Polyethylene Glycol 400 NF 0.67 Polyethylene Glycol 3350 NF 6.75 Color Dispersion (Solids) 6.25 Approximate Coating Weight 57 mg Approximate Composition Weight 857 mg ______________________________________ 7. A method of treating a patient suffering from the signs and symptoms associated with upper respiratory disease and nasal congestion which comprises administering to such a patient the oral dosage composition of claim 6. 1. A film-coated extended release oral dosage composition comprising: a. a matrix core comprising: and b. a coating on said core comprising: 2. A method of treating patients showing the signs and symptoms associated with upper respiratory diseases which comprises administering to such a patient the oral dosage composition of claim 1. 3. The oral dosage composition of claim 1 wherein 240 mg. of pseudoephedrine sulfate is in the core and 10 mg. of loratadine is in the coating. 4. A film-coated extended release oral dosage composition comprising: a. a matrix core comprising: and b. a coating on said core comprising: 5. A method of treating a patient showing the signs and/or symptoms associated with upper respiratory diseases which comprises administering to such a patient the oral dosage form of claim 4. 6. A film-coated extended release oral dosage composition comprising: a. a matrix core comprising: and b. a coating upon said core comprising: 7. A method of treating a patient suffering from the signs and symptoms associated with upper respiratory disease and nasal congestion which comprises administering to such a patient the oral dosage composition of claim 6.

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