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, CaCl2 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 (t50% >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 stabilised with BHT stored at the same conditions.
B. Albertini, M. Di Sabatino, G. Calogerà, N. Passerini, L. Rodriguez (2010). Encapsulation of vitamin A palmitate for animal supplementation: formulation, manufacturing and stability implications. JOURNAL OF MICROENCAPSULATION, 27(2), 150-161 [10.3109/02652040903052036].
Encapsulation of vitamin A palmitate for animal supplementation: formulation, manufacturing and stability implications
ALBERTINI, BEATRICE;DI SABATINO, MARCELLO;CALOGERA', GIACOMO;PASSERINI, NADIA;RODRIGUEZ, LORENZO
2010
Abstract
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, CaCl2 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 (t50% >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 stabilised with BHT stored at the same conditions.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
