Harish Kumar Chandrawanshi, Dr Neelesh Chaubey


The design of the stability studies for the finished pharmaceutical product (FPP) should be based on knowledge of the behavior and properties of the active pharmaceutical ingredients (API), information from stability studies on the API and on experience gained from preformulation studies, similar marketed formulations and investigational FPPs. The likely changes during storage and the rationale for the selection of attributes to be tested in the stability studies should be stated. The aim of present study is to determine stability studies of conjugated nanoconstructs of dacarbazine in various conditions as per ICH guidelines. Stability studies should include testing of stability-indicating attributes of the FPP, i.e. those that are susceptible to change during storage and are likely to influence quality, safety and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes, preservative content. The prepared dacarbazine loaded PLGA and PLA nanoformulations were stored at the following conditions i.e., 5 ± 3 °C, 30 ± 2 °C, 65% ± 5% RH (long term stability), 40 ± 2 °C, 75% ± 5% (accelerated stability), as per ICH guideline. Every three months the drug content, in vitro release studies were determined for the nano-formulation subjected for long term stability studies. The drug content of both kind of nanoparticles stored at 5 ± 3 °C for a period of 12 months showed a slight decrease in the drug content when compared to the initial drug content of the nanoformulation after storing the sample for 12 months. From the stability studies it was witnessed that the prepared loaded nanoformulations will be stable at 5 ± 3 °C, 30 ± 2 °C, 65 ± 5% RH for a period of 12 months.

Key Words: Dacarbazine, PLGA, PLA, Nanoformulation, melanoma, ICH


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