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US 2019/0167592 A1Published application
Process for directly compressible co-processed excipient for modified release application
OwnerAnil K. Jain, Rajan KALEinventors
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Abstract
The present invention provides a process for manufacturing a co-processed directly compressible excipient for sustained/extended release formulation based on pharmaceutically acceptable inert diluent, hydrophilic swellable polymer and a binder.
Claims11
A process of producing a co-processed directly compressible excipient comprising an inert diluent, a hydrophilic swellable polymer and a binder, wherein the said compressible excipient controls the rate of drug release.
A process for producing a co-processed directly compressible excipient comprising the steps of:
- a) mixing water insoluble diluent and water to form wet mass of diluent;
- b) unloading wet mass of step (a) and collect in a collector;
- c) performing dry blending by loading pre-sifted hydrophilic swellable polymer in high shear mixer granulator having impeller-chopper combination and dry mix;
- d) slow addition of wet mass of diluent of step (a) to the dry powder blend of step (c) to granulate dry blend and addition of binder during granulation;
- e) discharging wet granulated mass and drying it in fluidized bed dryer;
- and
- f) addition of glidant and/or lubricants to the dried and sized granules.
4 more elements
Dependencies are inferred from the claim text.