Functional Category
Coating agent; disintegrant; film-forming agent; mucoadhesive; tablet binder; viscosity increasing agent.
Applications in Pharmaceutical Formulation
Chitosan is used in cosmetics and is under investigation for use in a number of pharmaceutical formulations. The suitability and performance of chitosan as a component of pharmaceutical formulations for drug delivery applications has been investigated in numerous studies.(3,5–8) These include controlled drug delivery applications,(9–14) use as a component of mucoadhesive dosage forms,(15,16) rapid release dosage forms,(17,18) improved peptide delivery,(19,20) colonic drug delivery systems,(21,22) and use for gene delivery.(23) Chitosan has been processed into several pharmaceutical forms including gels,(24,25) films,(11,12,26,27) beads,(28,29) microspheres,(30,31) tablets,(32,33) and coatings for liposomes.(34) Furthermore, chitosan may be processed into drug delivery systems using several techniques including spray-drying,(15,16) coacervation,(35) direct compression,(32) and conventional granulation processes.(36)
Description
Chitosan occurs as odorless, white or creamy-white powder or flakes. Fiber formation is quite common during precipitation and the chitosan may look ‘cottonlike
Stability and Storage Conditions
Chitosan powder is a stable material at room temperature, although it is hygroscopic after drying. Chitosan should be stored in a tightly closed container in a cool, dry place. The PhEur 6.5 specifies that chitosan should be stored at a temperature of 2–8C
Incompatibilities
Chitosan is incompatible with strong oxidizing agents.
Safety
Chitosan is being investigated widely for use as an excipient in oral and other pharmaceutical formulations. It is also used in cosmetics. Chitosan is generally regarded as a nontoxic and nonirritant material. It is biocompatible(41) with both healthy and infected skin.(42) Chitosan has been shown to be biodegradable.(3,41) LD50 (mouse, oral): >16 g/kg(43)