Abstract

DEVELOPMENT OF CHEMICALLY MODIFIED PECTIN BASED EXTENDED RELEASE TABLETS OF NIFEDIPINE

Murali Krishna Reddy. P¹, S. Bharath*¹, R. Deveswaran¹ , B.V.Basavaraj¹, V.Madhavan²

¹Department of Pharmaceutics, M. S. Ramaiah College of Pharmacy, M.S.R.Nagar, M.S.R.I.T. Post, Bangalore-54, India.
²Department of Pharmacognosy, M. S. Ramaiah College of Pharmacy, M.S.R.Nagar, M.S.R.I.T. Post, Bangalore-54, India.

ABSTRACT

The main aim of the present research was to work on established natural polymer and further improvement of its efficacy by overcoming its limitations. Pectin, a naturally occurring polysaccharide is a potential polymeric material used in the extended drug delivery systems. But its aqueous solubility leads to undesirable and abrupt drug release over a period of time. Hence, pectin was chemically modified by acetylation process using 20%, 40% and 60% w/v phenyl acetyl chloride to reduce its polarity, the obtained modified pectins were examined for various physico-chemical properties and FTIR studies to prove the hydrophobicity of the semisynthetic modified polymer and the results revealed that the chemical modification of the polymer has occurred. The drug-excipient compatibility studies were carried out and the results showed that there was no interaction between the drug and excipients and found to be compatible. The extended release tablets of nifedipine were developed by wet granulation technique using various fractions of chemically modified pectins and compared with pure pectin in varied polymer ratios and evaluated for official and unofficial quality control tests. All the tablet formulations complied with the pharmacopieal specifications. In-vitro dissolution studies were carried out for all the formulated tablets in pH 1.2 buffer and the release profile compared with the pharmacopoeial standard limits . Based on the experimental results , 4PAP3 was selected as the optimized formulation and compared with the marketed product showed similarity factor (f2) value above 50, the stability studies showed that the optimized formulation was physically and chemically stable when studied carried out at the accelerated conditions according to ICH guidelines assuring modified pectin as an effective drug release retardant polymer. Thus modified pectin served as an effective polymer when compared to pure pectin in extending the drug release from the formulated dosage form.

Keywords: modified pectin, nifedipine, extended release tablets, in-vitro release.