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FORMULATION AND IN-VITRO EVALUATION OF CLOPIDOGREL BISULFATE IN PARENTERAL DOSAGE FORM USING LYOPHILIZATION TECHNIQUE

Journal Name:

  • The International Journal of Pharmaceutical Research and Bio-Science

Publication Year:

  • 2012

Key Words:

Author NameUniversity of Author
Abstract (2. Language): 
The aim of this work was to develop & evaluate in-vitro; a stable clopidogrel bisulfate formulation, in parenteral dosage form using lyophilization technique. Faxon DP et al. have reported use of antiplatelet therapy generally with clopidogrel bisulfate before percutaneous coronary interventions (PCI).1 Solubility of the drug in different solvents were determined. Solubility study suggested pH dependent solubility. Clopidogrel bisulfate hydrolyzes in aqueous phase into free base. In-order to get a stable parenteral dosage form, lyophilization technique was used. Optimized lyophilized cycle process along with graphical representation is presented. Compatibility study for rubber closures, tubing, and filter membrane were done and absences of any loss of drug due to the adsorption of any of the component were checked. Osmolarity of the lyophilized product was checked. Dilution studies with normal saline, 5% dextrose injection up to 150 mg/ml for 12 Hrs without any degradation and precipitation was observed. Stress studies for thermal cycling, effect in presence of nitrogen and oxygen and photo stability were carried out. Accelerated stability study indicated that the lyophilized product is stable at 40 °C/75% RH up to 3 months. Polymorphic change during the process was evaluated. Parenteral formulation of clopidogrel bisulfate is of considerable interest in the area of Novel drug dosage form for treating critical cardiovascular diseases.
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  • English