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product. Scale up batch of the optimized formula was also executed at higher scale of
around 50x. All results of drug layered pellets and extended release pellets were similar to
that of lab batch. No any critical observations were found during scale up process.
Optimized formulation was stable at different stability condition and all parameters were
found well within acceptance criteria.

Third extended release dosage form prepared was MUPS tablet. MUPS tablets contain
pellets compressed into tablets using tableting excipients. Major problem associated with
MUPS tablets is segregation of pellets during compression which leads to uniformity of
dosage unit problem in finished dosage form. For preparation of MUPS tablets, extended
release pellets prepared by extrusion and spheronization and by fluid bed system were
evaluated. Different diluent were evaluated and upon investigation, silicified
microcrystalline cellulose (Prosolv SMCC HD 90) was found best suitable diluents. Low
substituted hydroxyl propyl cellulose (L-HPC LH-11) used as an anti-capping agent and
copovidone (Kollidone VA 64) used as dry binder. Prepared tablets were evaluated for
different physical tests like hardness, thickness and friability. Finished product was
evaluated for multimedia dissolution profile and alcohol dose dumping study. Results of
drug release showed that there was no any potential crushing of pellets during
compression, which showed that selected excipients shows the good cushioning effect.
Out of both extended release pellets prepared by two different technologies, pellets
prepared by a fluid bed process gave good results for uniformity of dosage unit for MUPS
tablets. This might be due to narrow particle size distribution of pellets compared to
pellets prepared by extrusion and spheronization. Therefore, for final MUPS tablets
preparation pellets prepared by fluid bed technology were selected. Optimized
formulation showed a comparable dissolution profile to that of the innovator product in
different dissolution media and alcohol dose dumping compared to the innovator
product. Scale up batch of MUPS tablets was taken to evaluate the effects of
compression force, compression machine speed and compression cycle on segregation
of pellets during the whole process. Results of various compression studies at scale up
level suggested that there was no potential segregation of pellets were observed during
the entire process. Optimized formulation was stable at different stability condition and
all parameters were found well within acceptance criteria.
The conventional drug delivery system cannot control the drug release from dosage form
which ultimately do not maintain the effective concentration at the target site. In terms of
patient compliance, oral drug delivery is the most accepted dosage form. Due to the
gastric pH variation, conventional and reservoir type controlled release formulation
exhibit bioavaibility problem which can be overcome by Osmotic Release Oral Systems
(OROS). Osmotic Release Oral Systems (OROS) release the drug by utilizing the principle

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