Abstract

FORMULATION & EVALUATION OF CHOLESTEROL LOWERING SUSTAINED RELEASE TABLET ATORVASTATIN CALCIUM: IN-VITRO ANALYSIS

Sushil Kumar, Ankur Kumar* and Sachin Kumar

ABSTRACT

Both the saturation solubility and dissolving rate of atorvastatin calcium were increased utilising solid dispersions by dropping method, and it was observed that this method significantly increased these properties compared to pure drug. Atorvastatin calcium tablets were examined for appearance, disintegration speed, drug release, average weight, weight variability, thickness, diameter, and hardness. The tablets' formulation complied with all Pharmacopoeia requirements. When the drug release profiles of all batches were compared to those of the innovator tablet, it was discovered that the F6 batch's drug release profile was nearly identical to that of the innovator tablet. The formulation F6, which contained Atorvastatin Calcium IP 21.86mg, CaCO3 IP 15mg, sodium starch glycolate IP 25mg, microcrystalline cellulose IP 45mg, lactose IP 61.64mg, starch IP 7mg, talcum IP 2.75mg and magnesium stearate IP 1.75mg was optimized formulation. Film coating with Hydroxypropyl methylcellulose E5 (HPMC E5) was done on optimized batch F6 by taking polyethylene glycol as a plasticizer, Quinoline yellow lake as a colouring agent, talcum as a glidant, titanium dioxide as a opacifier, isopropyl alcohol and methylene chloride as a solvent. After film coated tablets were examined for their physical characteristics, including diameter, thickness, hardness, disintegration time, and drug release profile, and then compared to innovator tablets, it was determined that the formed tablets had not undergone any appreciable change. Tablets of optimized F6 batch were kept for stability study at 300C ± 20C/65%RH ± 5% RH and 400C ± 20C/75%RH ± 5% RH and it was found that the drug degradation rate constant at 400C ± 20C/75% RH ± 5% RH was greater than those stored at 300C ± 20C/65% RH ± 5% RH.

Keywords: Atorvastatin calcium, Dissolution rate, Hyperlipidaemia, Innovator, Quinoline, Sustained release.