MICROPARTICLES CONTAINING BUPROPION
This disclosure relates to microparticles containing bupropion, e.g., microparticles having a particle diameter of about 50 μm to about 100 μm. These microparticles may be included in pharmaceutical compositions and/or dosage forms for treatment of various disease, such as depression.
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4 . A dosage form comprising microparticles containing about 105 mg bupropion hydrochloride and about 40 mg to about 70 mg of a cysteine, wherein at least about 80% of the microparticles have a particle diameter of about 1 μm to about 300 μm.
5 . The dosage form of claim 4 , wherein the particle diameter is determined by laser diffraction.
6 . The dosage form of claim 4 , wherein the median microparticle diameter is about μm to about 100 μm as determined by laser diffraction.
7 . A dosage form comprising microparticles containing bupropion hydrochloride, wherein at least about 80% of the microparticles have a particle diameter of about 1 μm to about 300 μm, and wherein the 10 th percentile of microparticle diameter is about 1 μm to about 30 μm as determined by laser diffraction.
8 . The dosage form of claim 7 , wherein the 90 th percentile of microparticle diameter is about 200 μm to about 300 μm as determined by laser diffraction.
9 . The dosage form of claim 7 , wherein the 90 th percentile of microparticle diameter is about 2 times to about 10 times the median microparticle diameter as determined by laser diffraction.
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12 . The dosage form of claim 7 , further comprising microcrystalline cellulose.
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15 . The dosage form of claim 7 , wherein the microparticles containing bupropion have a median particle diameter of about 50 μm to about 100 μm as determined by laser diffraction.
16 . A pharmaceutical composition comprising microparticles containing bupropion, wherein at least 80% of the microparticles have a particle diameter of about 1 μm to about 300 μm, and wherein microparticles in the 10 th percentile based upon particle diameter have a diameter of about 1 μm to about 30 μm as determined by laser diffraction.
17 . The pharmaceutical composition of claim 16 , wherein microparticles in the 90 th percentile based upon particle diameter have a diameter of about 200 μm to about 300 μm as determined by laser diffraction.
18 . The pharmaceutical composition of claim 16 , wherein the 90 th percentile of microparticle diameter is about 2 times to about 10 times the median microparticle diameter as determined by laser diffraction.
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21 . The pharmaceutical composition of claim 16 , further comprising a sustained release or controlled release polymer.
22 . The pharmaceutical composition of claim 16 , further comprising magnesium stearate.