Oral metronidazole pharmaceutical compositions
AssigneeDr. Reddy's Laboratories, Inc.
InventorsBijay Kumar Padhi, Muzammil Tariq, Sagar Dilip Mandawgade, Rajesh Gandhi, Rajeev Singh Raghuvanshi, Dushyanth Surakanti, Kent Allenby
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Abstract
The present invention relates to an oral pharmaceutical composition comprising metronidazole, wherein metronidazole is released from the composition generally at the pH 5.0 and above.
Claims29
A metronidazole composition comprising:
- (i) a core containing metronidazole, and
- (ii) a release layer comprising at least one release material which dissolves/erodes in the aqueous environment at a pH of more than about 5.0.
An oral pharmaceutical composition of metronidazole, wherein said composition releases not more than 10% of metronidazole at a period of 120 minute in 900 ml of 0.1N HCl solution and not less than 60% of metronidazole at a period of 240 minutes in 900 ml of aqueous buffer having pH of 6.5, when tested in a USP Type 2 apparatus at 75 rpm and 37° C.
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An oral pharmaceutical composition comprising
- (i) a core comprising metronidazole,
- (ii) a separating layer, and
- (iii) a release layer comprising of:
- a. at least one release material which dissolves at a pH more than or equal to about 5.0, and/or
- b. at least one release material which dissolves at a pH more than or equal to about 6.5;
- wherein said composition has
- Tmax of not less than 4.0 hours, and
- Tlag of more than 1.0 hour,
- when administered to a human subject under fasting condition.
-39. (canceled)
-43. (canceled)
Dependencies are inferred from the claim text.