Formulation Development and Stability Studies of Norfloxacin Extended-Release Matrix Tablets

Abstract

The aim of this research was to develop a new hydrophilic matrix system containing norfloxacin (NFX). Extended-release tablets are usually intended for once-a-day administration with benefits to the patient and lower discontinuation of the therapy. Formulations were developed with hydroxypropylmethylcellulose or poly(ethylene oxide) as hydrophilic polymers, with different molecular weights (MWs) and concentrations (20 and 30%). The tablets were found to be stable (6 months at 40 ± 2°C and 75 ± 5% relative humidity), and the film-coating process is recommended to avoid NFX photodegradation. The dissolution profiles demonstrated an extended-release of NFX for all developed formulations. Dissolution curves analyzed using the Korsmeyer exponential equation showed that drug release was controlled by both drug diffusion and polymer relaxation or erosion mechanisms. A more erosion controlled system was obtained for the formulations containing lower MW and amount of polymer. With the increase in both MW and amount of polymer in the formulation, the gel layer became stronger, and the dissolution was more drug-diffusion dependent. Formulations containing intermediate MW polymers or high concentration (30%) of low MW polymers demonstrated a combination of extended and complete in vitro drug release. This way, these formulations could provide an increased bioavailability in vivo.

Preparation and Evaluation of Novel Extended Release Trihexyphenidyl Hydrochloride Tablets

“…The aim of stability test is to ensure how the quality of a proprietary medicinal product varies as functions of environmental factors. Stability testing was done to establish the storage conditions and shelf life for the manufactured products [29,30]. For further study of stability testing of the prepared THP extended release tablets via the effect of different conditions as well as different packaging materials, we select F8 containing 2 % Carbopol 971P® which gave the optimum dissolution profile and complying official requirements according to USP 38 [1].…”

Untitled

“…Stability Study: 8,9 In the present study, stability studies were carried out at 40 ºC and 75% RH for a specific time period up to 90 days for optimized formulation. For stability study, the tablets were sealed in aluminum packing coated inside with polyethylene.…”

Design and Comparative Evaluation of Clarithromycin Gastric Bioadhesive Tablets by Ex Vivo and in Vivo Methods

“…The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light and to establiSsh a retesting for the drug substance or a shelf-life for the drug product and recommended storage conditions [11].…”