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US 12,636,255 B2Granted
Nongranulated compressed tablets of mesalamine, and process of preparation thereof
AssigneeAtoz Pharmaceuticals Pvt Ltd
InventorsOlaganathan Arumugam, Natarajan Venkatachalam
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Abstract
The present disclosure discloses a composition suitable for direct compression into tablets without prior granulation procedures comprising: a) mesalamine or its prodrug or derivatives thereof and b) at least one pharmaceutically acceptable excipient, wherein the composition is directly compressed into a minitablet such that largest dimension in the minitablet is range of 1.00 mm to 2.8 mm. Further disclosed is a process of preparation of composition of the present disclosure.
Claims5
A minitablet composition comprising:
- a. mesalamine or its prodrug or derivatives thereof;
- and
- b. pharmaceutically acceptable excipients,
- wherein:
- said pharmaceutically acceptable excipients comprises:
- (a) 75-200 mg microcrystalline cellulose having 90% of particles having a diameter of from about 100 μm to 500 μm as measured by laser diffraction technique;
- (b) 5-10 mg of talc or 20-30 mg of glyceryl dibehenate or 5-10 mg of pregelatinized starch;
- (c) 5-15 mg of silicon dioxide;
- and (d) 5-15 mg of magnesium stearate;
- said minitablet composition is a non-granulated composition and directly compressed into a minitablet;
- and largest dimension of said minitablet is in the range of from 1.00 mm to 2.8 mm;
- and
- said mesalamine or its prodrug or derivatives thereof are present in an amount of 62%-78% w/w with respect to the composition and having d90 of from 100 μm to 900 μm as measured by laser diffraction technique.
10 more elements
Dependencies are inferred from the claim text.