FORMULATION AND EVALUATION OF STABLE LYOPHILIZED INJECTABLE DOSAGE FORM CONTAINING ANTIBIOTIC DRUG

Abstract

The aim of present study is to formulate an intravenous injection of VCIL01 using lyophilization technique. VCIL01 belongs to the category of antibiotics and it has been widely used in staphylococcal endocarditis. It is available in tablet, and capsule dosage form but sometimes associated with an issue of the stability in the final product. To overcome this problem, lyophilization technique is widely used which keeps the moisture content at very low level in the product and also vial is aseptically sealed. Lyophilization was carried out with varying concentrations of different solvents by keeping same lyophilization cycle in the SMART Lyophilizer as well as in the ADVANTAGE Lyophilizer. After optimizing the solvent and its concentration, the lyophilization cycle was also optimized. The lyophilized batches were further characterized for in vitro parameters such as cake appearance, reconstitution time, clarity of reconstituted solution, pH, assay, osmolality and water content. Based on results of characterization studies of all lyophilized batches, batch 6 was considered as an optimized formulation. All the in-vitro evaluation parameters complied with the limits as per the specifications of USP. The compatibility study confirmed that batch 6 was compatible with the SS vessel, filter and rubber stoppers. The result of dilution study of optimized batch was matched with the marketed formulation and found satisfactory. The accelerated stability study was carried out for 6 months and the optimized batch was found stable. From the results it was concluded that lyophilization technique is an advantageous tool for the development of stable injectable dosage form for the drug VCIL01.