|Title:|| Dosage forms of risedronate|
|Abstract:||The present invention is directed to a novel enteric-coated oral dosage form of a risedronate active ingredient comprised of a safe and effective amount of a pharmaceutical compostion which is comprised of a risedronate active ingredient and pharmaceutically-acceptable excipients. Said dosage forms prohibit the exposure of the risedronate active ingredient to the epithelial and mucosal tissues of the buccal cavity, pharynx, esophagus, and stomach and thereby protects said tissues from erosion, ulceration or other like irritation. Accordingly, the said dosage forms effect the delivery to the lower intestinal tract of said human or other mammal of a safe and effective amount of the risedronate active ingredient, and substantially alleviate the esophagitis or esophageal irritation which sometimes accompanies the oral administration of risedronate active ingredients.|
|Inventor(s):|| Dansereau; Richard John (Sherburne, NY), Mosher; Russell Youker (Norwich, NY), Axelrod; Douglas Wayne (Norwich, NY), Sietsema; William Kendall (Norwich, NY) |
|Assignee:|| The Procter & Gamble Company (Mason, OH) |
1. A pharmaceutical composition comprising, from 0.15% to 40.00% by weight of a risedronate active ingredient and from 60.00% to 99.75% by weight of excipients comprising:
lactose monohydrate, microcrystalline cellulose, crospovidone, and magnesium stearate.
2. The pharmaceutical composition according to claim 1 wherein said composition comprises from 0.5% to 30.00% by weight of said risedronate active ingredient and from 70.00% to 99.5% by weight of said excipients.
3. The pharmaceutical composition according to claim 1 wherein said composition comprises 11.76% by weight of said risedronate active ingredient and 88.24% by weight of said excipients.