SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the process for using predictive tools in formulation development. Predictive tools are computational methods and models that are used to forecast the behavior of drug formulations under various conditions. These tools can help optimize formulation strategies, reduce the need for extensive experimental work, and accelerate the development of new drug products. This SOP provides guidelines for the selection, implementation, and validation of predictive tools in the formulation development process.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the process for screening oral drug delivery formulations. Oral delivery systems are among the most commonly used pharmaceutical dosage forms, and formulation screening is critical to ensure the drug’s solubility, stability, and bioavailability. This SOP provides guidelines for evaluating different formulation types (e.g., tablets, capsules, solutions) to determine the most effective delivery system for oral administration.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to establish the procedure for using dissolution testing in the screening of pharmaceutical formulations. Dissolution testing is a critical method used to evaluate the release rate of a drug from its dosage form under simulated physiological conditions. This SOP provides guidelines for conducting dissolution tests on various formulations, such as tablets, capsules, and oral dosage forms, to assess their performance, quality, and consistency in drug release.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting moisture sensitivity testing of pharmaceutical formulations. Moisture sensitivity is an important factor in determining the stability of drug products, particularly solid dosage forms such as tablets, capsules, and powders. This SOP provides guidelines for evaluating the impact of moisture on the physical and chemical stability of formulations during development and storage.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for selecting suitable polymers for controlled release drug formulations. The selection of the right polymer is critical to achieving the desired drug release profile, stability, and performance of controlled release formulations. This SOP provides guidelines for evaluating and selecting polymers based on their properties, compatibility with the active pharmaceutical ingredient (API), and ability to achieve the desired drug release characteristics.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing prototype formulations for testing. Prototype formulations are initial versions of drug products that are developed to assess the feasibility, stability, and performance of the formulation under various conditions. This SOP provides guidelines for preparing these formulations, ensuring they are suitable for initial testing to evaluate drug release, stability, and compatibility with excipients.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to establish the process for assessing the mechanical properties of pharmaceutical formulations, particularly solid dosage forms such as tablets, capsules, and granules. Mechanical properties, including hardness, friability, and tensile strength, are critical to the formulation’s integrity, stability, and performance. This SOP outlines the methods for testing and evaluating these properties to ensure that the formulations meet the required quality standards and perform as intended during handling, storage, and administration.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting rheological studies during the screening of pharmaceutical formulations. Rheological studies are critical for understanding the flow, viscosity, and shear stress characteristics of formulations, particularly for semi-solid dosage forms such as creams, gels, and suspensions. This SOP outlines the methods and techniques for performing rheological testing to evaluate the physical properties of formulations and optimize their performance for various applications.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to outline the process for conducting spray drying in the screening of pharmaceutical formulations. Spray drying is a critical technique used in the preparation of dry powders from liquid formulations, particularly for improving the solubility, stability, and bioavailability of poorly soluble drugs. This SOP provides guidelines for performing spray drying to optimize the formulation, ensuring the successful production of powders with the desired properties for further development and testing.
Click to read the full article.

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting freeze-drying (lyophilization) screening studies for pharmaceutical formulations. Freeze-drying is a critical process used to stabilize and preserve sensitive biological materials, proteins, and pharmaceuticals by removing water while maintaining the product’s structure and activity. This SOP provides guidelines for conducting freeze-drying screening studies to optimize formulation conditions and ensure the stability, solubility, and performance of the drug product.
Click to read the full article.