Harvinder PopliDelhi Pharmaceutical Science and Research University , India
Title: Novel pharmaceutical approaches for management of severe pain
Injury or physical trauma results in substantial damage to the tissue and cells of body and evoke a painful condition. The pain management has always been a concern and a challenge to the medical fraternity when it comes to pre-hospitalization level during war or battlefield scenario or any other surgical or orthopedic trauma. In order to provide fast relief from severe pain, parenteral opioids are administered during the hospitalization under the supervision of medical staff. It is therefore very imperative to have a non-injectable technique that can deliver the drug into the systemic circulation for rapid onset of action. The thesis work primarily focusing on preparation, evaluation and optimization of various nano formulations of nalbuphine and to explore their prospective role in mimicking pain (unpleasant sensation). Formulations such as pulmonary Nanoparticle (NPs), nasal Solid Lipid Nanoparticle (SLN), submental, chitosan NPs are mainstay treatment approaches undertaken in this notion to attenuate painful conditions. Rationale behind selection of non-invasive routes is that they are competent enough to cross the BBB barrier and deliver the drug at kappa receptors in brain and spinal cord. This leads to generation of central as well as peripheral analgesic action. As Nalbuphine drug is kappa agonist and mu antagonist, effective in producing analgesic action with no respiratory depression or any other kind of adverse effect (those generally encountered in morphine and its analogues). The work focuses on several routes i.e. (nasal, submental, pulmonary delivery) to deliver the drug effectively for pain management with negligible side effects. The major approach throughout the development of formulation was to fabricate and optimise nanoparticle of drug using either lipids or mucoadhesive agents. Further, the characterization of the developed nanoparticles for their size, morphology, release profiles from the formulation, was performed then in vivo studies including toxicity, efficacy and Pk studies in animals along with establishing a proof of concept (POC) in human volunteers using gamma scintigraphy.
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