Development, Characterization & Statistical Optimization of Matrix Type Transdermal Patches of Almotriptan Malate for The Treatment of Migraine
ABSTRACTThe present work is focused on the development, evaluation and statistical optimization of almotriptan malate transdermal patches. Almotriptan malate is used as anti-migraine drug and reported to have the best-sustained pain free rate and the lowest adverse events rate of all the triptans and thus making interest in the development of new route for the therapeutic administration of the drug, So, the present research work was aimed to develop matrix type transdermal patches using polymers HPMC K15M, ERS100 and EC and plasticizers DBP and PEG400 by solvent casting method. This formulation would help to avoid non-compliance of the tablet dosage form The IR spectra of the drug and physical mixtures of drug-polymer confirmed the absence of incompatibility between drug and polymers. The in-vitro drug release studies revealed that patches made of HPMC K15M-ERS 100 with DBP as plasticizer was considered as the best formulation and incorporated in 22 factorial design and evaluated for further studies. The concentration of HPMC K 15M and ERS 100 are chosen as the independent variables. Drug content, %moisture absorption %, moisture loss, and cumulative % drug released at 12h are chosen as dependent variables. The drug release from transdermal patches followed zero order kinetics. Various physicochemical parameters of the patches were investigated. The current research work of transdermal patches of almotriptan malate may provide sustained delivery for prolonged periods in the management of migraine, which can be a good way to bypass the extensive hepatic first-pass metabolism. Keywords: migraine, almotriptan malate, transdermal patches, solvent casting, 22 factorial design