The aim of this study was to investigate the transdermal iontophoretic delivery of methotrexate, alone or in combination with microneedles, in-vitro and in-vivo using intracutaneous microdialysis in the hairless rat. The average depth of the microdialysis probe in the skin was found to be 0.54 mm. Methotrexate was stable in the presence of an applied electric field as determined by cyclic voltammetry. A current density of 0.4 mA cm(-2) applied for 60 min was used in combination with maltose microneedles to enhance delivery of methotrexate across the skin. Delivery was enhanced by iontophoresis and microneedles, both in-vitro and in-vivo. A synergistic 25-fold enhancement of delivery was observed in-vivo when a combination of microneedles and ionto- phoresis was used compared with either modality alone.

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Oral combination drug delivery systems have been proven to be highly beneficial and vital in the treatment of several dreadful diseases such as cancer, HIV (AIDS) and tuberculosis. Further, pharmaceutical companies have often explored the strategy of combination drug therapy for treating diseases such as diabetes (Type 2), cardiovascular diseases, central nervous system (CNS) disorders, and for treating several other microbial infections. Patenting combination drug delivery systems and formulations has been proven to be very beneficial for the sustainment and growth of pharmaceutical industry. Several pharmaceutical companies have explored this opportunity in extending the life cycle of their blockbuster molecules, and providing additional sources of revenues when the new chemical entity (NCE) discovery is scarce. The article reviews some recent combination formulation patents and patent publications, particularly the US patents and patent applications, relevant to oral delivery of pharmaceuticals. Examples of some oral combination products on the US and worldwide market are presented. Patents and patent applications on combination oral formulations relevant to analgesics (including anti-inflammatory and antipyretics), cardiovascular system (CVS) products, antibacterial and antiviral, and central nervous system (CNS) products are briefly discussed.

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