Gato del Monte A, Padrón YAS

Language: Spanish
References: 10
Page: 173-182
PDF size: 70.02 Kb.

ABSTRACT

Objective: to develop a cisplatin formulation at 1mg/mL concentration by setting the solution preparation procedure for parenteral administration, with good physical, chemical, biological and microbiological stability.
Methods: two formulation variants of cisplatin: one solution with and the other without acetate buffer. Both were followed in terms of physical and chemical stability for 3 months. The formulations used raw material from IMPEX SA company, which has 99.74 % power as certified by the manufacturer analysis. Three batches of 10mg cistoplatin at pilot scale in amber 10 R vials, 3 batches of 50 mg cisplatin in amber 50 H vials and the dose was 1mg/ml. Excipients were used to give isotony and stability to the formulation with 0.1 N chlorhydric acid and injection water for vehicle. The high performance liquid chromatography allowed evaluating the stability to determine the expiry date of the drug. The biological and microbiological methods determined lack of pyrogens and sterility respectively.
Results: both formulations showed no differences in physical and chemical results, so the second formulation was used at industrial scale. During 12 months, 10 and 50 mg cisplatin solutions exhibited good physical and chemical stability, ranging its concentrations from 90.0 to 105.0 % whereas pH was 3.5 to 6.5 at room temperature.
Conclusions: 10 and 50mg cisplatin formulations have the physical-chemical, microbiological and biological specifications reported in 12 months at room temperature. Since this drug meets all the quality parameters, the Cuban regulatory agency registers it as a safe drug for patients.

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