Impact of base type on diclofenac sodium release from semi-solid dosage forms
Journal Title: Annales Academiae Medicae Silesiensis - Year 2014, Vol 68, Issue 1
Abstract
BACKGROUND Semi-solid preparations for the skin are very popular. Bases affecting the release of active substances are the main component of this group of preparations. Among dermal formulations, a large percentage are those that contain non-steroidal anti-inflammatory drugs, including diclophenac sodium. Unfortunately, the permeation of diclofenac sodium through the skin is negligible, hence, nu-merous studies are conducted on its pharmaceutical availability. AIM OF THE STUDY The aim of the study was to assess the impact of the base on the release of diclo-phenac sodium from semi-solid dermal preparations. The following types of bases have been analyzed: gel-type, lipophilic, absorption and emulsion. MATERIAL AND METHODS The study compared two commercial preparations: Veral and Diclac Lipogel, and five formulations prepared with a prescription blender. The pharmaceutical availability of diclophenac sodium was examined using Kerckhoffs and Huizing apparatus. The release of diclophenac sodium was carried out at 37°C and 32°C. The absorbance of the samples was measured spectrophotometrically. RESULTS The ointment formulation based on glycerol possessed optimum pharmaceutical availability, which showed a high percentage of released diclofenac sodium, a high velocity release constant (k) and a low half-time release (t1/2). The least suitable bases for diclophenac sodium were the lipophilic vehicle – Vaseline and the absorption medium – eucerine. The pharmacokinetic parameters obtained from the glycerol ointment proved to be more advantageous than those from the gels based on carbopol. The kinetics of the other drugs turned out to be less favorable than for the commercial gels. Faster and greater release of diclophenac sodium occurred at 37°C. CONCLUSIONS The study showed that the best release of diclofenac sodium was observed in the case of the prescription formu-lation (glycerol ointment), even compared to the commercially available preparations. The temperature influenced the amount and rate of diclofenac sodium released from the two analyzed gels.
Authors and Affiliations
Anna Banyś, Beata Sarecka-Hujar, Andrzej Jankowski, Monika Zalewska
Keywords
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