Encapsulation of Vitamin A palmitate for animal supplementation: Formulation, manufacturing and stability implications.
Two manufacturing methods and numerous formulative approaches have been evaluated to obtain a stable oral pharmaceutical form of Vitamin A palmitate (VAP), a substance very sensitive to light, temperature, humidity and metal ions. The best results were obtained by formulating VAP, stabilized with butylated hydroxytoluene (BHT), in double layer microcapsules constituted by a core of chitosan, Tween 20, CaCl(2) and EDTA surrounded by a first chitosan-alginate membrane and an outer membrane of calcium-alginate. This formulation design enabled the production of beads with high drug loading (42% w/w) and high encapsulation efficiency (94%). The stability of VAP-loaded microcapsules was assessed according to EMEA guidelines. This formulation design showed the best performance in terms of VAP recovery (t(50%) > 360 days) after 1 year of storage at room conditions. This is a very important result considering the poor shelf-life (45 days) of pure VAP stabilized with BHT stored at the same conditions.
Albertini
Beatrice
B
Department of Pharmaceutical Sciences, University of Bologna, Bologna, Italy. beatrice.albertini@unibo.it
Di Sabatino
Marcello
M
Calogerà
Giacomo
G
Passerini
Nadia
N
Rodriguez
Lorenzo
L
D002214:Capsules / Q000737:chemistry; D004224:Diterpenes; D004339:Drug Compounding / Q000191:economics / Q000379:methods*; D004355:Drug Stability; D008027:Light; D000084562:Retinyl Esters; D013696:Temperature; D014801:Vitamin A / Q000008:administration & dosage / Q000031:analogs & derivatives*
D002214:Capsules; D004224:Diterpenes; D000084562:Retinyl Esters; D014801:Vitamin A; C014794:retinol palmitate