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|Title:||Compositions and methods for improved efficacy of penicillin-type antibiotics|
|Abstract:||Disclosed are once-a-day penicillin-type antibiotic products comprising at least one modified release dosage form comprising penicillin-type antibiotics and pharmaceutically acceptable carriers, which compositions provide T>MIC.sub.90 in the serum for at least 5 hours (preferably for at least five consecutive hours), within a 24-hour dosing interval, for a given bacterial pathogen's MIC.sub.90, while providing a total dosage of the penicillin-type antibiotic for a 24-hour dosing interval.|
|Inventor(s):||Flanner; Henry H. (Montgomery Village, MD), Guttendorf; Robert J. (Gaitherburg, MD), Clausen; Susan P. (Ijamsville, MD), Treacy; Donald (Woodbine, MD), Burnside; Beth A. (Bethesda, MD)|
|Assignee:||Shionogi Inc. (Florham Park, NJ)|
1. A once-a-day amoxicillin antibiotic product comprising; first, second, and third amoxicillin antibiotic dosage forms, each of said amoxicillin antibiotic dosage forms
comprising at least one amoxicillin antibiotic and a pharmaceutically acceptable carrier, said first amoxicillin antibiotic dosage form being, an immediate release dosage form, said second and third amoxicillin antibiotic dosage forms being delayed
release: dosage forms, wherein said second amoxicillin antibiotic dosage form comprises amoxicillin coated with a methacrylic acid copolymer dispersion and said third amoxicillin antibiotic dosage form comprises amoxicillin coated with a first layer of a
methacrylic acid copolymer dispersion and a second layer of hypromellose acetate succinate, and wherein each of said first, second, and third amoxicillin antibiotic dosage forms initiates release at different times, Cmax of the total amoxicillin
antibiotic released from said amoxicillin antibiotic product is achieved in less that about 12 hours from administration; wherein said product contains the total dosage of amoxicillin, for a 24-hour dosing interval.
2. The product of claim 1, wherein said total dosage of amoxicillin is from about 775 mg to about 1550 mg.
3. The product of claim 1, wherein said first amoxicillin antibiotic dosage form comprises 10-90% of the product, wherein said second amoxicillin antibiotic dosage form comprises 10-90% of the product, and wherein said third amoxicillin antibiotic dosage form comprises 10-90% of the product.
4. The product of claim 3, wherein said first amoxicillin antibiotic dosage form comprises 45% of the product, wherein said, second amoxicillin antibiotic dosage form comprises 30% of the, product, and wherein said third amoxicillin antibiotic dosage form comprises 25% of the product.
5. The product of claim 1, wherein when the product is administered to a patient or subject in need thereof, the product provides a concentration of amoxicillin in the serum at or above the MIC.sub.90 for an infecting bacterial pathogen for at least 5 hours within a 24-hour dosing interval.
6. The product of claim 1, wherein said second and third amoxicillin antibiotic dosage forms further comprise microcrystalline cellulose, povidone, and polyoxyl 35 castor oil.
7. The product of claim 1, wherein amoxicillin is the only antibiotic present in the first, second, and third amoxicillin antibiotic dosage forms.
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