Fast dissolving pharmaceutical composition comprising lornoxicam
AssigneeAbbott Healthcare Private Limited
InventorsSanjay Boldhane, Kuldeep Bhokare, Shripad Jathar, Geraldine Ann Elliott
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Abstract
The present invention discloses a fast dissolving pharmaceutical composition comprising lornoxicam or pharmaceutically acceptable salts thereof as an active ingredient along with at least one alkalinizer, at least one organic acid and at least one pharmaceutically acceptable excipient. The present invention also discloses processes of preparing fast dissolving pharmaceutical composition.
Claims17
A fast dissolving pharmaceutical composition comprising:
- a. lornoxicam or pharmaceutically acceptable salts thereof;
- b. at least one alkalinizer;
- c. at least one organic acid;
- and
- d. pharmaceutically acceptable excipients,
- wherein the weight ratio of lornoxicam to alkalinizer(s) is in the range of from about 1:43 to about 1:85 and the weight ratio of alkalinizer(s) to organic acid(s) is in the range of from about 3:1 to about 100:1,
- wherein at least 30% of lornoxicam is released from said composition within 3 minutes and at least 40% of lornoxicam is released from said composition within 10 minutes.
A fast dissolving pharmaceutical composition comprising:
- a) lornoxicam or pharmaceutically acceptable salts thereof in an amount of about 0.5% to about 2.5% of the mass of the composition;
- b) at least one alkalinizer;
- c) at least one organic acid;
- and
- d) pharmaceutically acceptable excipients
- wherein the weight ratio of lornoxicam to alkalinizer(s) is in the range of from about 1:43 to about 1:85 and the weight ratio of alkalinizer(s) to organic acid(s) is in the range of from about 3:1 to about 100:1;
- wherein said composition exhibits a dissolution profile within the following ranges:
- Time
- lornoxicam
- 3 minutes
- at least 30%
- 10 minutes
- at least 40%
- in a USP type II apparatus at 30 rpm using 0.0033 M HCl as a dissolution medium at 37±0.5° C.
A process for the preparation of a fast dissolving pharmaceutical composition;
- said process comprising the following steps:
- (a) mixing lornoxicam or pharmaceutically acceptable salts thereof with at least one alkalinizer and other pharmaceutically acceptable excipients to obtain a mixture;
- (b) optionally granulating the mixture;
- (c) adding at least one organic acid to the mixture to obtain a blend,
- (c) compressing the blend to form a tablet;
- and
- (d) optionally coating the tablet to convert it into pharmaceutically acceptable film coated tablet;
- wherein the weight ratio of lornoxicam:alkalinizer(s) is in the range of from about 1:43 to about 1:85 and the weight ratio of alkalinizer(s):organic acid(s) is in the range of from about 3:1 to about 100:1.
Dependencies are inferred from the claim text.