Resumen

SIERRA PEREZ, Roxana de la Caridad; GONZALEZ CANAVACIOLO, Víctor Luis; VICENTE MURILLO, Roxana  y  TAMAME TIRADO, Dayana. STABILITY STUDIES OF D005, NEW ACTIVE PHARMACEUTICAL INGREDIENT OBTAINED FROM THE FRUITS OF ACROCOMIA CRISPA. Rev. CENIC Cienc. Quím. [online]. 2022, vol.53, n.2, pp. 252-259.  Epub 15-Jul-2022. ISSN 2221-2442.

Phytopharmaceuticals not only require reproducible production processes and efficient quality controls, but also stability studies that guarantee their efficacy and safety throughout their shelf life. D005 is a new antioxidant and anti-inflammatory active ingredient with benefits on acute lung damage and kidney damage, which is mainly composed of free fatty acids, extracted and purified from the oil of the fruits of the corojo palm (Acrocomia crispa), an endemic Cuban species of the Arecaceae family. Taking into account the potential use of this active ingredient, it was necessary to determine its stability. For this, samples of D005 packaged in amber glass and transparent glass bottles were subjected to stress conditions (oxidation, photolysis and thermolysis), and samples of D005 packaged in amber glass bottles were stored under accelerated conditions (40°C and 75 % RH) for 12 months and under refrigeration conditions (6ºC and 60% RH) and climate zone IV conditions (30°C and 70% RH) for 36 months. The quality parameters of D005: loss on drying, relative density, refractive index, and acid index, fulfilled the requirements of the pharmaceutical industry and the concentration of fatty acids was within the established range. Its main degradation pathways were photolysis and thermolysis, and its remains stable for 12 months under accelerated stability conditions and for 36 months under refrigeration and climatic zone IV conditions, being the glass bottle the one that offered the greatest protection.

Palabras clave : D005; stability; stress; accelerated; long term.