INVESTIGADORES
BUCALA Veronica
congresos y reuniones científicas
Título:
Long term stability of Ivermectin nanosuspensions
Autor/es:
STARKLOFF, WALTER; TROVATO, G.; PALMA, SANTIAGO; VERONICA BUCALA; GONZALEZ VIDAL, NOELIA
Lugar:
CORDOBA
Reunión:
Congreso; 4° Reunión Internacional de Ciencias Farmacéuticas (RICiFa); 2016
Institución organizadora:
UNC
Resumen:
In recent years, the development of new formulation strategies for poorlywater-soluble active pharmaceutical ingredients (API) has focused on the study of nanometric systems. It has been proved thatthe reduction of API particle size, increase the dissolution rate and thus could improve oral bioavailability.High-pressure homogenization (HPH) is a milling technique frequently used to process hydrophobic APIs in aqueous media. Ivermectin (IVM) is an antiparasitic agent that exhibits a broad-spectrum activity, in veterinary and human therapy. It is a good candidate to formulate as nanosuspension (NS) due to its low aqueous solubility.NSs are thermodynamically unstable and the addition of adequate stabilizers are required.The aim of this work was to assess the long-termstability of IVM NSs obtained by HPH. The composition of the developed NS was IVM:Tween80:Polyvinylpirrolidone (1:0.5:0.5 % w/v). NSs were characterized in terms of particle size distribution, dissolution rate, chemical stability(high performance liquid chromatography-HPLC) and crystalline state (differential scanning calorimetry-DSC, powder X-ray diffraction-PXRD), along two yearsof storage under natural aging conditions (25 °C and 60% of relative humidity).Median particle size (D50) results were 236±5, 330±1 and 301±7 nm for fresh NS, and after one and two years of storage, respectively. Even though this slight increase in D50, no statisticallydifferences have been detected between dissolution profiles, compared via f2 similarity factor (with fresh IVM NS as reference). Furthermore, no statistically significant differences were observed in dissolution rate or kinetics constants. DSC and PXRD results indicate that IVM remained in amorphous state after storage. HPLC results indicatechemical stability of the NSs, sinceno significant differences were detected in IVM content, and no degradation peaks were observed.In conclusion, IVM NSs obtained by HPH are physicochemically stable for a period of two years, an attractive shelf life time for this formulation.