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AssigneeConceptra Biosciences, LLC
InventorsThomas W. Leonard, Gary Gamerman, Colleen Johns
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A dispersible solid pharmaceutical composition non-oral dosage form is provided that results in a better pharmacokinetic profile in conjunction with a reduced incidence of adverse side effects and may be administered under fasting conditions. The non-oral dosage form may also have reduced oral irritation as compared to oral forms. The non-oral dosage form may include misoprostol or a pharmaceutically acceptable salt thereof, one or more disintegrants, lubricants, diluents, and optionally one or more other excipients (including but not limited or antioxidant, color, or flavor). The non-oral dosage form may have a hardness of about 6 to about 10 kp, allows administration non-orally, namely sublingually, vaginally or rectally; disintegration or dispersion in less than about 60 seconds; and has a greater than about 80 percent dissolution at 15 minutes.
A dispersible solid pharmaceutical composition non-oral dosage form comprising:
A method of administering a non-oral dosage form for treatment of a condition wherein misoprostol is indicated, the non-oral dosage form comprising solid pharmaceutical composition non-oral dosage form comprising misoprostol or a pharmaceutically acceptable salt thereof;
In a method of treating various obstetric or gynecological conditions of a patient in need thereof with a pharmaceutically acceptable solid misoprostol composition or pharmaceutically acceptable salt thereof in non-oral dosage form, the non-oral dosage form having a hardness from about 6 to about 10 kp and when administered non-orally disintegrates or disperses in less than about 60 second and has a greater than about 80 percent dissolution at 15 minutes, the improvement comprising the elevation of Cmax, Tmax and AUC remaining the same and less adverse events as compared to misoprostol or salts thereof given non-orally under fed conditions.
Dependencies are inferred from the claim text.