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.

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.
2010
B. Albertini; M. Di Sabatino; G. Calogerà; N. Passerini; L. Rodriguez
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/88492
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