FORMULATION AND CHARACTERIZATION OF CONTROLLED RELEASE BUCCOADHESIVE BILAYERED TABLET OF

Abstract

Preformulation studies are the first step in the rational development of dosage form of a drug substance. The objective of pre formulation studies are to develop a portfolio of information about the drug substance, so that this information useful to develop formulation.API and excipients are to be thoroughly mixed in predetermined ratiofor compatibility studies,there is no color change and no lumps observed in sample charged at 40ºc/75%RH for 1 month and 60ºc for 15 days, A differential scanning calorimeter was used for thermal analysis of drug and mixture of drug and excipients, Five ml of sample was withdrawn from this solution and dilute up to 25 ml phosphate buffer pH 6.8 in 25 ml amber colored volumetric flask and absorbance of this solution was measured at 255 nm. in U.V. Buccoadhesive bilayered tablet of Prochlorperazine maleate were prepared by wet granulation technique using different concentration of Hydroxipropyl methylcellulose (HPMC K4M CR premium) and Carbomer (Carbopol 974 P NF) in equal ratio.Granular grad of Ethyl cellulose (Ethocel N10) was mixed with the lack of sunset yellow colour passed through the sieve no 100 and mixed well.The adhesive layer was compressed in 12 station rotary compression machine using 8mm (13/32 inches) flat surface punches at hardness of 2.5 to 3 Kp.All the Prepared bilayered tablets of the trial series were evaluated for following official and unofficial parameter like Physical characterization, Drug content, Swelling index, Bioadhesive strength, In-vitro drug release.

KEY WORDS: Tablet, Buccoadhesive, Prochlorperazine maleate, Carbopol 974 P NF