Stable tocotrienol with immunomodulating action
AssigneesFondazione Irccs Istituto Nazionale Dei Tumori (50%), Famafarm S.R.L. (50%)
InventorsCristina Ferraris, Francesca Ferri, Maria Teresa Armano
Life of this patent
Estimating the term…
Abstract
The present patent application relates to a lyophilisation process of Annatto Bixa Orellana L. powder having a tocotrienol content >35% (w/w), comprising a pre-freezing step and a freeze-drying step, in which the Annatto powder resulting from the freeze-drying step (c) has a tocotrienol content >39% (w/w). The invention also relates to pharmaceutical compositions comprising lyophilised Annatto powder obtained with the process of the invention and therapeutic uses of such compositions, in particular to support cancer therapy.
Claims18
Lyophilisation process of Annatto Bixa Orellana L. powder comprising the steps of:
- a) providing Annatto seed powder with a tocotrienol content >35% (w/w);
- b) freezing Annatto powder at a temperature of <-15° C.;
- c) submitting the frozen powder according to phase (b) to a freeze-drying process characterized in that the freeze-drying step (c) comprises the sub-steps of
- i) performing a first drying step at a pressure of <2.5 mbar and a temperature between
- −45° C. and 0° C.;
- ii) performing a second drying step, following the first drying step (i), at a constant pressure greater than the pressure of the first drying, at a temperature between 0° C. and 20° C.,
- wherein the Annatto powder resulting from the freeze-drying phase (c) has a tocotrienol content ≥39% (w/w).
10-14. (canceled)
A method for treating non-metastatic breast cancer during the pre-operative stage of an oncological treatment, said method comprising
- orally administering a therapeutically effective amount of a composition comprising lyophilised powder of Annatto Bixa Orellana L. in combination with suitable excipients and/or diluents, wherein the Annatto powder has a tocotrienol content ≥39% (w/w), a residual water content ≤4,00% (w/w), and an apparent volume ≥0,68 g/cm3.
Dependencies are inferred from the claim text.