SOPs for Drug Discovery

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.
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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.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for utilizing high-throughput formulation screening (HTFS) techniques in pharmaceutical formulation development. HTFS techniques are designed to rapidly evaluate and optimize multiple formulation parameters simultaneously, significantly improving the efficiency of the drug development process. This SOP outlines the steps for implementing high-throughput screening in formulation development, from experimental setup to data analysis, with a focus on minimizing resource consumption and time while maximizing information gain.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for applying the Design of Experiments (DoE) methodology in formulation screening. DoE is a structured and systematic approach used to determine the relationship between formulation variables and their impact on the desired product characteristics. This SOP provides guidelines for utilizing DoE techniques to optimize formulation parameters, enhance product quality, and reduce development time and costs during the formulation screening process.
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The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting compatibility studies between Active Pharmaceutical Ingredients (APIs) and excipients used in drug formulations. Compatibility studies are crucial in ensuring that excipients do not interact negatively with the API, which could affect the stability, efficacy, and safety of the final drug product. This SOP provides guidelines for performing compatibility testing and interpreting the results to support formulation development.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting preformulation studies of drug candidates. Preformulation studies are essential in the early stages of drug development to assess the physicochemical properties of a drug substance and its suitability for formulation. This SOP outlines the necessary steps for evaluating the physical, chemical, and biological characteristics of drug candidates, which is critical for selecting appropriate formulation strategies, improving solubility, and ensuring stability.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for screening excipients for formulation development. The selection of excipients is a critical step in the formulation of pharmaceutical products, influencing the stability, bioavailability, and safety of the final drug product. This SOP outlines the steps for selecting, evaluating, and testing excipients to ensure that they meet the required specifications and are suitable for use in the formulation of drug products.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting pH-solubility profiling of drug candidates. pH-solubility profiling is an essential step in preformulation studies, providing crucial information on the solubility of drug candidates under varying pH conditions. This SOP outlines the process for preparing drug solutions, selecting pH ranges, conducting the profiling experiments, and analyzing the solubility behavior of drug candidates, which is critical for predicting their absorption and bioavailability.
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The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for stability testing of screening formulations in pharmaceutical development. Stability testing is crucial for evaluating the shelf life, degradation profiles, and storage conditions of drug formulations. This SOP provides standardized procedures for conducting stability studies on screening formulations to ensure that they maintain their efficacy, safety, and quality over time under different conditions.
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The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for solubility testing of drug candidates. Solubility is a critical physicochemical property of pharmaceutical compounds, influencing their absorption, bioavailability, and overall effectiveness. This SOP provides standardized procedures for determining the solubility of drug candidates in various solvents and under different conditions, ensuring consistency and reproducibility in solubility testing during the drug development process.
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