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To develop an attractive formulation platform for the continuous production of directly compressible powders. This could have improved compressibility and compatibility, containing poorly compressible drug substance. Powder mixtures containing mannitol, MCC, Kyron T-314, maltodextrin, aerosil® 200 and neotame were Co-processed. A 10.0%w/v feed suspension was selected for process optimization. Preliminary optimization determined the optimal spray drying process (inlet temperature: 150°C, outlet temperature: 140°C, feed flow rate: 3 ml/min, aspiration rate: 50 Nm 3 /hr, atomization pressure: 1.5 bar). Adequate regression models developed after constructing D-optimal mixture design. The optimized formulation (mannitol: 49.5%w/w, MCC: 20%w/w, Kyron T-314: 10%w/w) found to be having a disintegration time of 13.2±0.08 sec and dilution potential up to 50%. Spray drying offers precise control over particle size and forms porous agglomerates suitable for direct compression, an advantage over melt granulation. The use of maltodextrin, MCC and mannitol in mixtures resulted in high process yields. Spray dried mixtures containing mannitol were non-hygroscopic with good flowability. MCC provides a free-flowing highly compressible powder. Kyron T-314 found to be excellent disintegrant. Maltodextrin provides appropriate tablet tensile strength. By incorporating systematic formulation approach, a novel excipient can be developed having improved compressibility, compatibility, flowability and reduced disintegration time.

Development of Multifunctional Directly Compressible Co-processed Orodispersible Excipient Using Spray Drying Technique.