Study of the stability of tablets containing 10 mg of policosanol as active principle.
The stability studies of tablets containing 10 mg of policosanol, a new cholesterol lowering drug, were conducted to predict an expiration date and to search the appearance of putative degradation products. All quality specification parameters such as colour, moisture content, hardness, disintegration, policosanol content and microbiological limits of the tablets were done. The effect of drastic treatments such as acid and basic hydrolysis, oxidative and photolytic degradation as well as thermolysis on such parameters was studied. In addition; studies under drastic conditions of storage (40 degrees C and 75% R.H.) and under ambient conditions of storage for climatic zones II and IV were performed. These studies demonstrate that these tablets are a stable pharmaceutical formulation, without significant changes on their quality criteria at the stressed conditions studied. The chromatographic profile of the samples after 9 months of thermal degradation shows chromatographic peaks that corresponds to the octacosanoyl, triacontanoyl and hexacosanoyl esters of palmitate and stearate, being the only degradation products observed on these studies.
C.N.I.C., Playa, Havana, Cuba.
L
L
Cabrera
V
V
González
E
E
Uribarri
R
R
Sierra
A
A
Laguna
J
J
Magraner
D
D
Mederos
C
C
Velázquez
D004355:Drug Stability; D005079:Excipients; D005233:Fatty Alcohols / Q000008:administration & dosage* / Q000032:analysis*; D006244:Hardness; D006358:Hot Temperature; D006868:Hydrolysis; D013058:Mass Spectrometry; D010084:Oxidation-Reduction; D010782:Photolysis; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000032:analysis*; D013607:Tablets
D005079:Excipients; D005233:Fatty Alcohols; D010975:Platelet Aggregation Inhibitors; D013607:Tablets; C080710:policosanol