STABILITY STUDIES OF CONJUGATED NANOCONSTRUCTS OF DACARBAZINE IN VARIOUS CONDITIONS AS PER ICH GUIDELINES
Abstract
Background
The design of the stability studies for the finished pharmaceutical product (FPP) should be based on knowledge of the behaviour and properties of the API, information from stability studies on the active pharmaceutical ingredients (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.
Objective
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.
Methods:
Stability studies were carried out for DPGN-3. The prepared Dacarbazine loaded PLGA formulations 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). Every three months the drug content, in vitro release studies were determined for the nano-formulation subjected for long term stability studies.
Results
The prepared Dacarbazine PLGA loaded formulations were stored at the various conditions as per ICH guideline, in every three months the drug content, in vitro release studies were carried out for the nanoformulation and the results were recorded.
Conclusion
The stability studies it was witnessed that the prepared the loaded PLGA nanoformulation DPGN-3 will be stable at 5±3 °C, 30 ± 2 °C, 65 ± 5% RH for a period of 12 months.
Key Words: Dacarbazine, PLGA, Nanoformulation, melanoma, ICH
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