Regulatory Perspective on the Development of Polymer Nanomaterials
Combination of nanomaterials with pharmaceutical sciences to produce lifesaving drug products is a rapidly growing field. Intense interest and evergrowing financial support in this area have propelled the research and development to become increasingly ma
- PDF / 330,416 Bytes
- 19 Pages / 439.37 x 666.142 pts Page_size
- 102 Downloads / 213 Views
Regulatory Perspective on the Development of Polymer Nanomaterials Xiaoming Xu and Mansoor A. Khan
Abstract Combination of nanomaterials with pharmaceutical sciences to produce lifesaving drug products is a rapidly growing field. Intense interest and evergrowing financial support in this area have propelled the research and development to become increasingly mature. In the current chapter, recent advances in the field of polymer nanomaterial are presented, including various definitions and considerations. Regulatory challenges and some of the recent policy developments associated with nanomaterial drug product are also discussed. Keywords Nanomaterial
Regulatory ANDA NDA
1 Introduction Nanomaterial refers to a class of material that has been deliberately manipulated to be within the nanometer size range to render new or altered physical, chemical, and/or biological properties. Nanomaterials have been around for over a millennium. As early as medieval time gold nanoparticles were used in stained glass, while nanotubes were found in blades of swords made in Damascus (Reibold et al. 2006). However, it is until the invention of high-powered microscopes that truly allow us to see things at the nanoscale and begin taking advantage of phenomenon occurring naturally at this scale.
X. Xu Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA M.A. Khan (&) Formulations Design and Development Core Laboratory, Texas A&M Health Science Center, Irma Lerma Rangel College of Pharmacy, Reynolds Medical Building, Suite 159, College Station, TX 77843-1114, USA e-mail: [email protected] © Springer International Publishing Switzerland 2016 C. Vauthier and G. Ponchel (eds.), Polymer Nanoparticles for Nanomedicines, DOI 10.1007/978-3-319-41421-8_19
615
616
X. Xu and M.A. Khan
Use of nanomaterial enables the development of new drug products, helps improving, and even saves people’s life. In recent decades, uses of nanomaterials in pharmaceutical drug products have seen great success. The unique physicochemical properties of nanomaterial, such as small size, large surface area to mass ratio, high reactivity can be useful to overcome some of the limitations found in traditional therapeutic and diagnostic agents. For example, reducing the size of a crystalline drug into nanometer range can significantly improve the dissolution rate of poorly water-soluble drugs (Kipp 2004; Verma et al. 2009). Delivery of drug using nanocarriers also helps in prolonging release of a drug or in a responsive manner thus decreasing the frequency of administration. Sometimes this system is used to target the drug to its site of action and thereby decreasing exposure of the drug to other tissues and thus minimizing its side effects (Allen 1994; Papahadjopoulos et al. 1991). Drug product using nanotechnology can also be used in combination therapy, in which, two or more biomolec
Data Loading...
