Formulation Development of Oral Mucoadhesive Coated Terbutaline Sulphate Tablets Using Some Natural Materials Extracted from Edible Fruits Available in India

Abstract

Mucoadhesive polymers that bind to the gastric mucin or epithelial cell surface are useful in drug delivery for the purpose of increasing the intimacy and duration of contact of drug with the absorbing membrane. Several synthetic polymers are in use for this purpose. Since the biodegradability of the synthetic polymers are questionable, in this investigation, an oral mucoadhesive controlled delivery system has been developed for terbutaline sulphate using natural mucoadhesive materials extracted from edible fruits like <em>Zizyphus mauritiana</em> and <em>Aegle marmelos</em> that have better mucoadhesive property than synthetic polymer hydroxypropylmethyl-cellulose K4M (HPMCK4M). The <em>in vitro</em> adhesive and mucoadhesive strength and swelling property of mucoadhesive materials extracted from edible fruits of <em>Z.</em> <em>mauritiana </em>and<em> A. marmelos </em>were evaluated and compared with HPMCK4M by Share<em> </em>stress and Wilhelmy plate method. Different formulations of oral mucoadhesive coated terbutaline sulphate tablets were prepared using these natural materials and HPMCK4M and hardness, thickness, friability, weight variation and assay of tablets were tested. The <em>in vitro</em> release of terbutaline sulphate was studied in buffer pH 7.2 at 37±0.5 C. The blood plasma concentration of terbutaline sulphate in rabbits was determined using HPLC. It was found that mucoadhesive materials extracted from edible fruits of <em>Z. mauritiana</em> and <em>A. marmelos</em> exhibited better adhesiveness and mucoadhesiveness as compared with the synthetic mucoadhesive agent HPMCK4M by different methods. The <em>in vitro</em> and <em>in vivo</em> drug release study of terbutaline sulphate exhibited extended drug release profile for tablets prepared with natural materials than synthetic polymers. After <em>in vitro</em> and <em>in vivo</em> correlation study, it was seen that both <em>in vitro</em> and <em>in vivo</em> drug release study showed the same release profile. The present study shows that natural mucoadhesive materials extracted from edible fruits of <em>Z. mauritiana</em> and <em>A. marmelos</em> have greater mucoadhesive property than HPMCK4M where both are used in the same amount.