RESUMO
The work investigates the development and optimization of fenugreek (Trigonella foenum-graecum L.) seed mucilage (FSM)-alginate mucoadhesive beads containing metformin HCl through ionotropic gelation using 3(2) factorial design. The effect of polymer-blend ratio (sodium alginate to FSM) and cross-linker (CaCl(2)) concentration on the drug encapsulation efficiency (DEE, %), and cumulative drug release after 10h (R(10h), %) was optimized. The DEE (%) of all these beads was within the range of 71.63 ± 2.32 to 95.08 ± 3.73% with sustained in vitro drug release of 69.78 ± 2.43% to 95.70 ± 4.26% over 10h. The in vitro drug release from these beads was followed controlled-release (zero-order) pattern (R(2)=0.9910 to 0.9953) with super case-II transport mechanism. The average size of these beads was within the range of 0.92 ± 0.05 to 1.30 ± 0.14 mm. The beads were also characterized by SEM, FTIR and (1)H NMR. The swelling and degradation of FSM-alginate beads containing metformin HCl were influenced by pH of the test medium. These beads also exhibited good mucoadhesivity in wash-off test. The optimized FSM-alginate mucoadhesive beads containing metformin HCl showed significant hypoglycemic effect in alloxan-induced diabetic rats over prolonged period after oral administration.