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coating material, hypromellose 3cps as pore former, acetyl tri butyl citrate as plasticizer
and talc as anti-adherent material to provide extended release pellets of S-Metoprolol
Succinate. Extended release coated pellets were evaluated for bulk density, particle size
distribution, process efficiency, assay and drug release profile in different dissolution
media. To obtain an extended release dosage form having a similar dissolution profile to
that of the innovator product, extended release coating was optimized using central
composite design (CCD). After getting design space, confirmatory batches in design
space were also taken to evaluate the design space. Predicted and actual results were
compared and results showed that there was no difference between actual and predicted
results. Optimized formulation showed a comparable dissolution profile to that of the
innovator product in different dissolution media and lower alcohol dose dumping
compared to the innovator product. Optimized formulation was stable at different
stability condition and all parameters were found well within acceptance criteria.

A second technique used to prepare extended release pellets of S-Metoprolol Succinate,
was a fluid bed process. In fluid bed process, first drug pellets were made by spraying a
drug binder solution over inner core. Microcrystalline cellulose pellets having size of 150-
300 micro meter were selected. Microcrystalline cellulose sphere gives more advantage
over sugar sphere as during process sugar sphere tends to melt when drug solution is
applied and are more friable compared to microcrystalline cellulose. Literature review of
innovator product shows that the initial size of inner pellets was around 150-300 micro
meter and microcrystalline cellulose sphere (CelphereTM CP 203) is also available in this
size range. The first step of preparation of extended release pellets was preparation of
drug pellets which was manufactured by applying a drug binder solution on
microcrystalline cellulose spheres. After completion of the drug layering process, drug
pellets were sifted to remove any agglomeration and fine generated during the process.
Drug pellets were coated using ethyl cellulose as extended release coating material,
hypromellose 3cps as pore former, acetyl tri butyl citrate as plasticizer and talc as anti-
adherent material to provide extended release pellets of S-Metoprolol Succinate.
Extended release coated pellets were evaluated for bulk density, particle size distribution,
process efficiency, assay and drug release profile in different dissolution media. To obtain
an extended release dosage form having a similar dissolution profile to that of innovator
product, extended release coating was optimized using central composite design (CCD).
After getting design space, confirmatory batches in design space were also taken to
evaluate the design space. Predicted and actual results were compared and results
showed that there was no difference between actual and predicted results. Optimized
formulation showed a comparable dissolution profile to that of the innovator product in
different dissolution media and lower alcohol dose dumping compared to the innovator

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