Abstract: Methods and formulations for making extended release bupropion hydrochloride tablets using direct compression, and tablets formed thereby, are provided which combine bupropion hydrochloride, binders such as polyethylene oxide or hydroxypropyl cellulose, a filler such as lactose, glidants and lubricants under low shear conditions to form hard, chip-resistant tablets which exhibit improved cohesiveness and are easily and reproducibly formed without adhering to the compression punches and dies.

Abstract: Metformin Hydrochloride (herein referred to as metformin HCl) that may be 98.5%-100% pure is a high dose drug capable of being directly compressed with specific excipients into tablets having desired, hardness, disintegrating ability, and acceptable dissolution characteristics. Metformin HCl is not inherently compressible and thus presents formulation problems. Excipients used in the formulation enhance the flow and compaction properties of the drug and tableting mix. Optimal flow contributes to uniform die fill and weight control. The binder used ensures sufficient cohesive properties that allow metformin HCl to be compressed using the direct compression method. The tablets produced provide an acceptable in-vitro dissolution profile.