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Formulation development and evaluation of controlled release dispersible tablets using Box-Behnken design

1 Department of Pharmaceutical Technology, Shree Krishna Institute of Pharmacy, Mehsana, India
2 Parul Institute of Pharmacy, Vadodara, Gujarat, India

Correspondence Address:
Ketan J Patel,
Department of Pharmaceutical Technology, Shree Krishna Institute of Pharmacy, Mehsana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0975-7406.179422

Objective: The purpose of the present study was to develop controlled release dispersible tablets (CRDT) of aceclofenac. Methods: The CRDT were prepared from aceclofenac loaded microspheres by direct compression method. Possible drug-excipients interaction was assessed by Fourier transform infrared spectroscopy (FTIR). The formulation of CRDT was optimized using Box-Behnken experimental design. The CRDT were evaluated for different physicochemical characteristics, in-vitro drug release study and stability characteristics. Results: The results from the experimental design showed that higher level of microcrystalline cellulose (MCC) gave satisfactory performance of the CRDT. The friability was less than 1% for all experimental batches and hardness was achieved up to 5.4 Kg. The in-vitro drug release profiles from the CRDT showed the desired biphasic release behavior where it showed more than 80% release in 16 h. The results from stability study showed there was no significant change observed in CRDT. Conclusion: It was concluded that development of the CRDT from controlled release microspheres, without affecting their release pattern, could make value addition of the dosage form in terms of patient compliance which is essential for success of any therapy.

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