Therapeutic Use of Nanoproducts in Clinical Practice and Products in the Pipeline for Clinical Development

Abstract

Nanotechnology has been slowly and surely growing in the past few years and is showing remarkable progress in electrical engineering, mechanical engineering, communication industry, and even medicine. The application of nanotechnology within the medical field is called nanomedicine. Any pharmaceutical formulation incorporating nanomaterials, intended for internal or external medical use for diagnosis, therapy, or health enhancement, is classified as a "nano-pharmaceutical. A nanomaterial is a substance characterized by particle dimensions between 1-100 nm in one dimension at least. Additionally, a formulation is classified as a nanopharmaceutical if it exhibits physical, chemical, or biological activity due to its dimension in the range beyond the nanoscale up to 1000 nm. The Indian guidelines for the evaluation of nanopharmaceuticals further classify nanomaterials into subtypes based on their degradability, whether biodegradable or not, based on the nature of nanomaterial, whether organic, inorganic or multi-component and based on their forms, whether nanocarriers are loaded with the active pharmaceutical ingredient (API) or if APIs are converted to nanoforms. Also, while all nanopharmaceuticals are considered as ‘new drugs’ by the central licensing authority in India, depending on their approval status elsewhere they are subjected to differential scrutiny, with differing requirements of safety, quality and efficacy data.