Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2005-11-01
2005-11-01
Spear, James M. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S452000, C424S457000, C424S463000, C424S465000, C424S468000, C424S469000, C424S474000
Reexamination Certificate
active
06960356
ABSTRACT:
A pharmaceutical composition in the form of tablets or capsules provides a combination of temporal and spatial control of drug delivery to a patient for effective therapeutic results. The pharmaceutical composition comprises a drug, a gas generating component, a swelling agent, a viscolyzing agent, and optionally a gel forming polymer. The swelling agent belongs to a class of compounds known as superdisintegrants (e.g., cross-linked polyvinylpyrrolidone or sodium carboxymethylcellulose). The viscolyzing agent initially and the gel forming polymer thereafter form a hydrated gel matrix which entraps the gas, causing the tablet or capsule to be retained in the stomach or upper part of the small intestine (spatial control). At the same time, the hydrated gel matrix creates a tortuous diffusion path for the drug resulting in sustained release of the drug (temporal control). A preferred once daily ciprofloxacin formulation comprises 69.9% profloxacin base, 0.34% sodium alginate, 1.103% xanthan gum, 13.7% sodium bicarbonate, 12.1% cross-linked polyvinylpyrrolidone, and optionally other pharmaceutical xcipients, the formulation being in the form of a coated or uncoated tablet or capsule.
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Sen Himadri
Staniforth John N.
Talwar Naresh
Deshmukh Esq. Jayadeep R.
Heibel Esq. George E.
Ranbaxy Laboratories Limited
Spear James M.
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