SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening solid dispersion methods in the formulation of drug candidates. Solid dispersions are a promising strategy to enhance the solubility and bioavailability of poorly soluble drugs. This SOP provides guidelines for selecting excipients, preparing solid dispersions, evaluating their physical and chemical properties, and selecting the most suitable method for formulation development.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening polymorphs of Active Pharmaceutical Ingredients (APIs) during the drug development process. Polymorphism can significantly influence the solubility, bioavailability, stability, and processing characteristics of drug substances. This SOP provides guidelines for the identification, characterization, and selection of the most suitable polymorph for formulation development based on the drug’s physicochemical properties.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening lipid-based formulations for the delivery of poorly water-soluble drugs. Lipid-based formulations, such as liposomes, solid lipid nanoparticles (SLNs), and self-emulsifying drug delivery systems (SEDDS), are widely used to improve the solubility, bioavailability, and therapeutic efficacy of hydrophobic drugs. This SOP outlines the necessary steps for preparing lipid-based formulations, testing for solubility enhancement, and evaluating the physicochemical properties of the formulations.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for screening drug nanoparticles aimed at enhancing the solubility of poorly water-soluble drugs. Nanoparticles can significantly improve the solubility and bioavailability of drugs that are hydrophobic or poorly soluble in aqueous media. This SOP outlines the preparation, characterization, solubility testing, and selection of the most effective nanoparticle formulation for solubility enhancement.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening emulsion formulations in pharmaceutical development. Emulsions are widely used for the delivery of hydrophobic drugs in a stable, bioavailable form. This SOP provides guidelines for preparing, testing, and optimizing emulsions for solubility enhancement, stability, and drug release properties.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the process for selecting surfactants during formulation development. Surfactants are essential in the preparation of emulsions, suspensions, solid dispersions, and other drug delivery systems. The selection of an appropriate surfactant is critical to the stability, bioavailability, and overall performance of the final formulation. This SOP provides guidelines for choosing the right surfactant based on its properties, compatibility with the drug, and the desired formulation characteristics.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to establish the process for screening formulations intended for injectable delivery. Injectable formulations must meet stringent criteria for safety, stability, solubility, and sterility, among other factors. This SOP provides guidelines for evaluating different formulation types, such as solutions, suspensions, and emulsions, for their suitability as injectable drug delivery systems.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening tablet formulations during pharmaceutical development. Tablet formulations must meet specific criteria to ensure their stability, bioavailability, and manufacturing suitability. This SOP provides guidelines for the preparation, characterization, and optimization of tablet formulations, with a focus on excipient selection, drug release, and tablet quality attributes.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening film-coating formulations used in pharmaceutical tablet manufacturing. Film-coating is an essential process for improving tablet stability, appearance, and controlled drug release. This SOP provides guidelines for selecting and evaluating film-coating formulations, including excipient selection, preparation, testing, and optimization to ensure the best performance of the coated tablets.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for testing the compatibility of pharmaceutical formulations with packaging materials. The choice of packaging material is critical to the stability, safety, and quality of the drug product. This SOP provides guidelines for assessing the interaction between the drug product and packaging materials to ensure that the packaging does not affect the product’s stability, efficacy, or safety over its shelf life.
Click to read the full article.