Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems

2012 ◽  
Vol 3 (12) ◽  
pp. 1383-1394 ◽  
Author(s):  
Kim E Sapsford ◽  
Kristina Lauritsen ◽  
Katherine M Tyner
2020 ◽  
Vol 21 ◽  
Author(s):  
Dickson Pius Wande ◽  
Qin Cui ◽  
Shijie Chen ◽  
Cheng Xu ◽  
Hui Xiong ◽  
...  

: As a unique and pleiotropic polymer, d-alpha-tocopheryl polyethylene glycol succinate (Tocophersolan) is a polymeric synthetic version of vitamin E. Tocophersolan has attracted enormous attention as a versatile excipient in different biomedical applications including drug delivery systems and nutraceuticals. The multiple inherent properties of Tocophersolan make it play flexible roles in drug delivery system design, including excipients with outstanding biocompatibility, solubilizer with the ability of promoting drug dissolution, drug permeation enhancer, P-glycoprotein inhibitor and anticancer compound. For these reasons, Tocophersolan has been widely used for improving the bioavailability of numerous pharmaceutical active ingredients. Tocophersolan has been approved by stringent regulatory authorities (such as US FDA, EMA, and PMDA) as a safe pharmaceutical excipient. In this review, we systematically curated current advances in nano-based delivery systems consisting of Tocophersolan with possibilities for futuristic applications in drug delivery, gene therapy, and nanotheranostic.


Author(s):  
Sabyasachi Maiti

Natural polysaccharides are getting increasing attention in the development of pharmaceutical dosage forms due to their encouraging reports on nontoxicity and biodegradability. Natural gums can also be engineered to have better materials for drug delivery system design. Gellan gum originates from microbial fermentation and has been declared as safe by US FDA for human consumption. It possesses gelling ability in presence of multivalent earth metal cations and thus enabled the design of mutiparticulate drug delivery systems in completely aqueous environment avoiding the use of organic solvents. Due to faster drug release profiles of divalent cation-induced gellan gum particles, nowadays chemically modified forms of gellan polysaccharide are currently being investigated for the controlled release of drugs. This chapter discusses the factors contributing to the varying gelling characteristics of gellan gum and the recent developments in its chemical modification towards the fabrication of novel controlled drug delivery devices.


Author(s):  
Sabyasachi Maiti

Natural polysaccharides are getting increasing attention in the development of pharmaceutical dosage forms due to their encouraging reports on nontoxicity and biodegradability. Natural gums can also be engineered to have better materials for drug delivery system design. Gellan gum originates from microbial fermentation and has been declared as safe by US FDA for human consumption. It possesses gelling ability in presence of multivalent earth metal cations and thus enabled the design of mutiparticulate drug delivery systems in completely aqueous environment avoiding the use of organic solvents. Due to faster drug release profiles of divalent cation-induced gellan gum particles, nowadays chemically modified forms of gellan polysaccharide are currently being investigated for the controlled release of drugs. This chapter discusses the factors contributing to the varying gelling characteristics of gellan gum and the recent developments in its chemical modification towards the fabrication of novel controlled drug delivery devices.


2017 ◽  
pp. 246-273
Author(s):  
Sabyasachi Maiti

Natural polysaccharides are getting increasing attention in the development of pharmaceutical dosage forms due to their encouraging reports on nontoxicity and biodegradability. Natural gums can also be engineered to have better materials for drug delivery system design. Gellan gum originates from microbial fermentation and has been declared as safe by US FDA for human consumption. It possesses gelling ability in presence of multivalent earth metal cations and thus enabled the design of mutiparticulate drug delivery systems in completely aqueous environment avoiding the use of organic solvents. Due to faster drug release profiles of divalent cation-induced gellan gum particles, nowadays chemically modified forms of gellan polysaccharide are currently being investigated for the controlled release of drugs. This chapter discusses the factors contributing to the varying gelling characteristics of gellan gum and the recent developments in its chemical modification towards the fabrication of novel controlled drug delivery devices.


Author(s):  
G.E. Visscher ◽  
R. L. Robison ◽  
G. J. Argentieri

The use of various bioerodable polymers as drug delivery systems has gained considerable interest in recent years. Among some of the shapes used as delivery systems are films, rods and microcapsules. The work presented here will deal with the techniques we have utilized for the analysis of the tissue reaction to and actual biodegradation of injectable microcapsules. This work has utilized light microscopic (LM), transmission (TEM) and scanning (SEM) electron microscopic techniques. The design of our studies has utilized methodology that would; 1. best characterize the actual degradation process without artifacts introduced by fixation procedures and 2. allow for reproducible results.In our studies, the gastrocnemius muscle of the rat was chosen as the injection site. Prior to the injection of microcapsules the skin above the sites was shaved and tattooed for later recognition and recovery. 1.0 cc syringes were loaded with the desired quantity of microcapsules and the vehicle (0.5% hydroxypropylmethycellulose) drawn up. The syringes were agitated to suspend the microcapsules in the injection vehicle.


Sign in / Sign up

Export Citation Format

Share Document