Lamotrigine suspension dosage form
AssigneeJubilant Generics Limited
InventorsKamal Surendra Mehta, Dinesh Kumar, Saurabh Srivastava, Amit Jha, Rakesh K. Singh
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AssigneeJubilant Generics Limited
InventorsKamal Surendra Mehta, Dinesh Kumar, Saurabh Srivastava, Amit Jha, Rakesh K. Singh
Estimating the term…
The present invention relates to a stable ready to use and powder for oral suspension dosage forms of Lamotrigine and its pharmaceutically acceptable salts and process of preparing such compositions. The liquid and powder for oral suspension dosage forms of Lamotrigine have been previously known only as extemporaneous preparations. Present invention relates to manufacture of liquid and powder for oral suspension dosage forms of Lamotrigine having improved physico-chemical properties with desired technical attributes. The prepared dosage forms are useful in patients having difficulties in swallowing tablets and provide physician with more options for dose titration.
An immediate release oral pharmaceutical powder for suspension of lamotrigine or its pharmaceutically acceptable salt, hydrate or polymorph thereof with one or more pharmaceutically acceptable excipients comprising lamotrigine present at from about 0.1% w/w to 40% w/w of the power for suspension, wherein the pH of the reconstituted composition is from 4-8 when reconstituted with water.
An immediate release oral pharmaceutical powder for suspension of lamotrigine or its pharmaceutically acceptable salt, hydrate or polymorph thereof with one or more pharmaceutically acceptable excipients comprising lamotrigine from about 0.01% w/w to 10% w/w by weight on the basis of the total weight of the composition wherein the composition exhibits in-vitro dissolution rate of more than 85% of drug release within 20 minutes when placed in a dissolution vessel filled with 900 ml of 0.1N HCL, pH 1.2 maintained at 37±0.5° C. and stirred at a paddle speed of 50 rpm using a USP Type II (paddle) apparatus.)
(canceled)
An immediate release oral pharmaceutical suspension of lamotrigine or its pharmaceutically acceptable salt, hydrate or polymorph thereof with one or more pharmaceutically acceptable excipients prepared by a process comprising the following steps:
Dependencies are inferred from the claim text.