Glyburide composition
OwnerGillian Cave, Sarah J. Nicholsoninventors
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Abstract
The present invention relates to a physical form of the known drug substance glyburide, also known as glibenclamide, and chemically defined as 5-chloro-N-[2-[4-[[[(cyclohexylamino)-carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide (Merck Index, Tenth Edition, p. 642), as well as to dosage forms, e.g., tablets and capsules, incorporating said physical form of glyburide.
Claims10
The substance 5-chloro-N-[2-[4-[[[(cyclohexylamino)-carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide having the following particle size distribution characteristics:
- 25% undersize value between 3 and 11 μm,
- 50% undersize value between 6 and 23 μm, and
- 75% undersize value between 15 and 46 μm.
The substance 5-chloro-N-[2-[4-[[[(cyclohexylamino)-carbonyl]amino]sulfonyl]phenyl]ethyl]-2-methoxybenzamide having the following particle size distribution characteristics:
- 25% undersize value not more than 6 microns,
- 50% undersize value not more than 7 to 10 microns, and
- 75% undersize value not more than 21 microns.
Dependencies are inferred from the claim text.