Controlled- release dosage forms of azithromycin
First Claim
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1. A controlled release dosage form comprising azithromycin and a pharmaceutically acceptable carrier which, following Ingestion by a mammal in need thereof, releases azithromycin to said mammal'"'"'s gastrointestinal tract at a rate such that the total amount of azithromycin released therein is:
- not more than about 4 mg of azithromycin per kg of mammal weight in the first 15 minutes after ingestion, not more than about 10 mg of azithromycin per kg of mammal weight in the first hour after ingestion, not more than about 20 mg of azithromycin per kg of mammal weight in the first 2 hours after ingestion, not more than about 30 mg of azithromycin per kg of mammal weight in the first 4 hours after ingestion, and not more than about 40 mg of azithromycin per kg of mammal weight in the first 6 hours after ingestion
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Abstract
A controlled-release dosage form of azithromycin having an improved side effect profile; a process for preparing the dosage form; and a method of treating a microbial infection, comprising administering azithromycin in such a controlled-release dosage form to a mammal, including a human patient, in need of such treatment.
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Citations
71 Claims
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1. A controlled release dosage form comprising azithromycin and a pharmaceutically acceptable carrier which, following Ingestion by a mammal in need thereof, releases azithromycin to said mammal'"'"'s gastrointestinal tract at a rate such that the total amount of azithromycin released therein is:
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not more than about 4 mg of azithromycin per kg of mammal weight in the first 15 minutes after ingestion, not more than about 10 mg of azithromycin per kg of mammal weight in the first hour after ingestion, not more than about 20 mg of azithromycin per kg of mammal weight in the first 2 hours after ingestion, not more than about 30 mg of azithromycin per kg of mammal weight in the first 4 hours after ingestion, and not more than about 40 mg of azithromycin per kg of mammal weight in the first 6 hours after ingestion - View Dependent Claims (23, 57, 58, 63, 64, 65, 66, 68, 69, 70, 71)
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2. A controlled release dosage form comprising azithromycin and a pharmaceutically acceptable carrier which, following ingestion by a mammal in need thereof, releases azithromycin to said mammal'"'"'s gastrointestinal tract at a rate such that the total amount of azithromycin released therein is:
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not more than about 200 mg of azithromycin in the first 15 minutes after ingestion, not more than about 500 mg of azithromycin in the first hour after ingestion, not more than about 1000 mg in the first 2 hours after ingestion, not more than about 1500 mg in the first 4 hours after ingestion, and not more than about 2000 mg in the first 6 hours after ingestion. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 56, 59, 60, 61, 62)
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22. A method for administering azithromycin to a human in need of such treatment, comprising orally administering said azithromycin to said human in a dosage form which effects release of said azithromycin into the GI tract at a rate such that the total amount of azithromycin released therein is;
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less than about 200 mg in the first 15 minutes following ingestion, less than about 500 mg in the first hour following ingestion, less than about 1000 mg in the first 2 hours following ingestion, less than about 1500 mg in the first 4 hours following ingestion, and less than about 2000 mg in the first 6 hours after ingestion. - View Dependent Claims (24, 25, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 67)
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26. A dosage form for oral administration comprising azithromycin and a pharmaceutically acceptable carrier, which releases not more than 10% of its incorporated azithromycin into a mammal'"'"'stomach, and which releases not more than an additional 10% during the first 15 minutes after entering said mammal'"'"'s duodenum.
Specification