Development of Novel formulations for Effective Delivery of Selected Pharmaceutical Actives

Abstract

The novel drug delivery system (NDDS) is a new approach to the drug delivery science that refers to the technologies, formulations, mechanisms, and systems for transporting a pharmaceutical active in the body as required to safely achieve the desired therapeutic effects. By means of these modern methods, the drug can be directly transported to the affected area or the site of action in the system. Moreover, novel delivery systems can prove advantageous in eliminating all the drawbacks associated with classical drug delivery systems. Various novel drug delivery approaches can be implemented to achieve targeted, controlled, or modulated drug delivery. newlinePreparation and evaluation of alendronate microemulsion for transdermal delivery newlineAlendronate (ALD) is clinically indicated for the treatment of osteoporosis but its therapeutic use has been marred by severe GIT adverse effects affecting quality of life in patients. In this study, we selected novel transdermal microemulsion (TDME) as a suitable carrier for ALD as the way of avoiding intestinal toxicity and highlighted its anti-osteoporotic efficacy with extensive pharmacokinetic and pharmacodynamic analysis. TDME achieved two folds increase in bioavailability as compared to oral administration in pharmacokinetic studies. To investigate the capability of TDME in alleviating symptoms of osteoporosis, it was administered to ovariectomised rats two months post-surgery. The results obtained after two months of treatment with ALD by trans-epidermal route exhibited improved bone density in DEXA scan of rats. These observations were further supported by biochemical investigations including analysis of bone formation and resorption markers. Moreover, TDME effectively suppressed the decline in bone mass of osteoporotic rats as determined through the biometric analysis and histopathological examination of bones. Additionally, skin histopath results showed no significant skin damage at the end of treatment.