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povidone against drug amount gave good results in terms of process feasibility, process
efficiency, assay, fines and agglomeration. For process parameters, statistical
optimization study indicated that atomisation air pressure 0.78 to 1.0 bar, product bed
temperature 30 to 33°C and 10.2 to 11.9 gm/min yield good quality of drug pellets in
terms of required pellets quality attributes. Extended release coating formulation
optimisation study results dictate that 16.9 to 18.5 %w/w sustained release coating level
with 9.0-14.6%w/w talc concentration and 8.1 to 16.5%w/w tri-ethyl citrate concentration
gives desired drug release, efficiency and agglomerates which was verified by taking
confirmatory batches. Dose dumping study, multimedia dissolution and stability study
results were satisfactory for optimized formulation.

MUPs tablet formulation of optimized extended release coated pellets was developed and
found that 50.3 to 86.00 mg/tab microcrystalline cellulose (Ceolus KG 1000) as
cushioning agent, 15.7-30.0 mg/tab povidone as dry binder and 20.0-50.0 mg/tab cros-
povidone (Polyplasdone XL 10) as disintegrant level yields desired drug product quality
attributes and same was verified by confirmatory batches execution. MUPs tablet
compression process parameters optimization study revealed that 5-20 rpm speed is
optimum without any segregation or content uniformity issue for selected compression
machine and formulation. Even hopper fill level study at optimum compression machine
speed had no impact on content uniformity. Tablet hardness in the range of 5-10 kp
shows comparable drug release against extended release pellets while for 15 kp
hardness drug release was slower in initial time points then faster later on due to pellets
breakage at high compression force. Dose dumping study, multimedia dissolution and
stability study results of optimized MUPs tablets were satisfactory. Dexketoprofen
trometamol MUPs Tablet of Extended release coated pellets manufactured by both
techniques were satisfactory considering their own advantage with respect to pellets
manufacturing cost, quality and production output. Comparative evaluation of both
tablets shows that tablets manufactured by Extrusion spheronization pellets exhibited
more content uniformity issues due to its wide particle size distribution during
manufacturing process compared to wurster technique.
In vitro nasogastric and admixture study results displayed that proposed optimized
formulation was remain stable in purified water and apple juice for its studied quality
attributes like assay, physical appearance, drug release and impurities. Even nasogastric
administration study revealed that pellets were flushed through selected nasogastric
tube without any aggregation and blockage. Recovery in collection beaker is nearly 100%
of input material since pellets surface not become sticky after contact with water or
apple juice medium and tubing surface which supports this dosage can be administer
with some fluid liquid through nasogastric tubing to patients having swallowing or oral

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