Aragen’s Approach:
The team comprehensively gripped the influence of surfactant types. Equipped with this understanding, they chose suitable non-ionic and anionic surfactants to tackle concerns regarding crystal growth and pH
fluctuations. In the revised formulation, a co-solvent was additionally incorporated to address other physicochemical parameters.
Different steps for developing the optimal 40% emulsifiable concentrate formulation:
Identification of appropriate surfactants: Different blends of surfactants, encompassing non-ionic and anionic types, were formulated along with the active pharmaceutical ingredient (API) at varying concentrations to create an optimal emulsion.
Identification of appropriate co-solvents: Various environmentally friendly solvents were evaluated for their compatibility with the aqueous phase and for formulating the ideal emulsion with the required droplet size.
Lab scale stable formulation development: A laboratory-scale formulation was created using identified excipients. Parameters such as solvent volume, API concentration, RPM, temperature, and pH were optimised during the process.
Scale-up, parameter and physiochemical optimization: The laboratory-scale formulation was upscaled, and the parameters were fine-tuned to attain the optimal formulation. Comprehensive physiochemical
characterization was conducted, covering aspects such as precipitation behavior, crystal growth at low temperatures, emulsion stability, pH variations during extended storage, and the uniformity of emulsion
upon dilution.