**8. Preformulation studies for nano-based therapeutics**

Nano-based therapeutics are suitable formulation strategies for the delivery of active drug ingredients because of their harmonious morphological design and features. The novel drug delivery systems are [76]. The objectives of the preformulation study for nano-based formulations are to design and demonstrate kinetic profile, acceptability with the other substances, physicochemical parameters, and

#### *Preformulation Studies: A Versatile Tool in Formulation Design DOI: http://dx.doi.org/10.5772/intechopen.110346*

polymorphism of the new drug entity to design an elegant dosage form [77]. At the preformulation stage, the shape, size, amorphous or crystal structure, and size variability are some of the important features which are evaluated for nano-based delivery systems hence the synthesis of nano-based therapeutics systems is truly based on the physiochemical characteristics [78]. The diluents and solvents also play a significant role in inhomogeneity, size and shape in the nanoprecipitation methods. The profiling of active moieties is crucial in terms of their solubility studies, melting point, thermal properties, and pKa behaviour. In the preformulation phase, physiochemical properties and the compatibility of the drug with excipients of the formulation are regulating the nano-system behavioural selected for the final formulation design. Preformulation studies are conducted to create an appropriate dosage form by establishing the pharmacokinetics and pharmacodynamic profile parameters [79, 80]. Moreover, the dissolution profile, polymorphic forms, the pharmacokinetics of the drug, and its bioavailability, details on the drug's deterioration process, undesirable drug-related conditions, and pharmacodynamic effects are also an important part of preformulation studies which are provided by physicochemical properties of the drug. The nano-based formulations can be used for topical, transdermal, injectable and oral deliveries for compound development, screening, therapeutic, imaging and diagnostic purposes therefore they are novel systems for targeting cancer, inflammatory diseases and autoimmune disorders [81, 82]. For example, these considerations are helpful for justification for the preparation of nanoparticles, lipid-based nanoparticles, polymeric nanoparticles, concerning polymer, adjuvant selection, crucial formulation profiling, preparatory techniques, process-related variables optimization for favourable formulation parameters, nanoparticle characterisation, stability profiling and entrapment efficiency enhancement [28].
