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EnglishTwo 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.
| Titolo: | Encapsulation of vitamin A palmitate for animal supplementation: formulation, manufacturing and stability implications |
| Autore/i: | ALBERTINI, BEATRICE; DI SABATINO, MARCELLO; CALOGERA', GIACOMO; PASSERINI, NADIA; RODRIGUEZ, LORENZO |
| Autore/i Unibo: | |
| Anno: | 2010 |
| Rivista: | |
| Digital Object Identifier (DOI): | http://dx.doi.org/10.3109/02652040903052036 |
| 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. |
| Data prodotto definitivo in UGOV: | 2010-03-11 10:46:47 |
| Appare nelle tipologie: | 1.01 Articolo in rivista |
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