Room stable hydroxyurea oral suspension
AssigneeAkums Drugs & Pharmaceuticals Limited
InventorsSanjeev JAIN, Sunil JAISWAL, Arun CHAUDHARY, Krishna PAL
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Abstract
The present invention provides a liquid composition comprising effective amount of Hydroxyurea for oral administration. The invention further discloses liquid formulation in form of ready to use oral suspension which remains stable at room temperature at the time of dispensing, storage and even after reopening of the container comprising the suspension. Also provided is a method of preparing the formulation and treating sickle cell anemia in pediatric patients.
Claims8
A stable liquid formulation comprising hydroxyurea or pharmaceutically acceptable salts thereof and at least one pharmaceutically acceptable excipient wherein liquid pharmaceutical formulation is stable when stored at room temperature for longer than 3 months.
A process of preparing a stable liquid formulation of Hydroxyurea wherein the process comprises the steps of:
- a) preparing the bulk suspension phase by mixing vegetable oil (medium chain triglyceride) with polysorbate, colloidal silicon dioxide, sucralose and vitamin E acetate with continuous stirring for 1 hour to obtain lumpsfree suspension;
- b) adding micronized Hydroxyurea with continuous stirring into bulk suspension obtain from step (a) to form a lumpsfree dispersion and allow the mixing for 01-02 hours;
- c) adding flavouring agent to above solution obtained in step (b) with continuous stirring until lumpsfree dispersion obtained;
- and
- d) filtering the suspension through a suitable filter followed by filling and sealing in a suitable packaging.
Dependencies are inferred from the claim text.