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Claims for Patent: 6,165,513

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Claims for Patent: 6,165,513

Title: Film-coated tablet for improved upper gastrointestinal tract safety
Abstract:A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.
Inventor(s): Dansereau; Richard John (Mason, OH), Bekker; Petrus Jakobus (Cincinnati, OH)
Assignee: The Procter & Gamble Co. (Cincinnati, OH)
Application Number:09/095,322
Patent Claims: 1. An oral dosage form comprising a safe and effective amount of a bisphosphonate wherein said oral dosage form is oval shaped, about 0.23 to about 0.85 inches in length, about 0.11 to about 0.4 inches in width, and about 0.075 to about 0.3 inches in thickness and said oral dosage form is film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus wherein said film coating allows for delivery of said bisphosphonate to the stomach.

2. A dosage form according to claim 1 wherein the film coating is a polymer that is soluble at pH from about 1.2 to about 5.

3. A dosage form according to claim 2 wherein said film coating is selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, methylcellulose, ethylcellulose, acrylic resins, polyvinylpyrrolidone, gelatin, and mixtures thereof.

4. A dosage form according to claim 2 wherein said film coating is selected from the group consisting of hydroxypropylmethylcellulose and hydroxypropylcellulose.

5. A dosage form according to claim 4 wherein said active ingredient is selected from the group consisting of risedronate, alendronate, and pamidronate.

6. A dosage form according to claim 5 wherein said active ingredient is risedronate.

7. A dosage form according to claim 6 wherein said risedronate is from about 0.25% to about 40% of the composition.

8. A dosage form according to claim 1 wherein said dosage form is a compressed tablet comprising particles of the active ingredient and pharmaceutically-acceptable excipients.

9. A dosage form according to claim 1 wherein said active ingredient is selected from the group consisting of risedronate, alendronate and pamidronate.

10. A dosage form according to claim 9 wherein said dosage form is a compressed tablet comprising particles of the active ingredient and pharmaceutically-acceptable excipients.
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