[ influence of coating film composition on Hts stability of simvastatin tablets]

ABSTRACT

The involvement of low- density lipoprotein cholesterol [LDL-C] in atherogenesis has been well-documented in clinical and pathological studies. Epidemiological studies have established that high LDL- C, low high density lipoprotein cholesterol [HDL- C], and high plasma triglycerides [TG] are risk factors for coronary heart disease [CHD]. Cholesterol- enriched TG- rich lipoproteins, including very-low-density lipoproteins [VLDL], intermediate- density lipoproteins [IDL], and remnants, cans also promote atherosclerosis. As such, it is important to study the efficacy and the stability of the drugs uses in the treatment in its pharmaceutical dosage form to achieve the therapeutically goal. In this research we studied the stability of simvastasin in its tablets [5; 20 and 40 mg] by using coating film and we concentrated on the effect of titanium dioxide and iron oxides witch added to the coating film as obscure agents which can aid in the stability of light sensitive active material [simvastatine]. Physical properties of the coated tablets were defined and simvastatine degradation was followed using the method proposed by USP24. The tablets with coated film contains 65 gram of titanium dioxide [for 2000 tablets] and 15 gram of iron oxides [red and yellow] have been showed to be more stable but not sufficiently witch lead us to beginning with 110% o0f label quantity witch gave after 3 years of study sufficient results: