Formulation and evaluation of an oral timed pulsatile drug delivery for alleviating pain in rheumatoid arthritis
Abstract
Objective: The present study was aimed to formulate and evaluate an oral timed-release pulsatile drug delivery of AcecloFenac (AF) for rheumatoid arthritis pain by the Chronopharmaceutical approach with early morning breakthrough of AF as analgesic and anti-inflammatory agent for the treatment of rheumatoid arthritis. Methods: A solubility was enhanced by formulating it as a self-emulsified system with a suitable oil and surfactant mixture. The interaction between the drug and the excipient was examined using Fourier Transform Infra-Red (FTIR) spectroscopy. The prepared formulation consists of 2 different parts: The basic design consists of burst-release core tablets with solid self-emulsified AF by using different super disintegrants, and the press-coating of optimised tablets by using different compositions of Ethylcellulose (hydrophobic) and Hydroxy Propyl Methyl Cellulose (HPMC K100) (hydrophilic) polymers. Results: FTIR studies revealed no interaction between drug and excipients. From the solubility data, suitable oil and surfactants were selected. Pseudo-ternary plots help in finding of suitable surfactant mixtures for solid self-emulsified AF. Core tablets were evaluated for pre-compression characteristics, disintegration time, drug content, weight variation, hardness, friability, thickness, and % drug release. Among all solid self-emulsified formulations, S1C6 is successful, with 98.88% drug release in 20 min. The compression coat formulations were also evaluated for…
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