Granule formation
The present invention relates to oral granules of montelukast sodium.
1. A flowable and dispersible pharmaceutical composition which comprises (i) granules comprising a pharmaceutically acceptable substrate which is spray-dried mannitol agglomerated with a pharmaceutically acceptable binder, and coated with montelukast sodium, and (ii) a pharmaceutically acceptable lubricant; wherein said binder is selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, methylcellulose, ethylcellulose and polyvinylpyrrolidone; and said granules are formed by coating said substrate with an aqueous solution consisting of montelukast sodium followed by drying.
2. A composition of claim 1 wherein said binder is hydroxypropyl cellulose.
3. A composition of claim 1 wherein said lubricant is magnesium stearate or talc.
4. A composition of claim 1 wherein said lubricant is magnesium stearate.
5. A flowable and dispersible pharmaceutical composition which comprises (i) granules comprising a pharmaceutically acceptable substrate which is spray-dried mannitol agglomerated with hydroxypropyl cellulose, said substrate being coated with montelukast sodium, and (ii) magnesium stearate, and said granules are formed by coating said substrate with an aqueous solution consisting of montelukast sodium followed by drying.