SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the process for evaluating the bioavailability of screening formulations. Bioavailability is a critical factor in determining the efficacy of a drug, as it quantifies the extent and rate at which the active pharmaceutical ingredient (API) becomes available at the site of action. This SOP provides guidelines for evaluating the bioavailability of new formulations to ensure their suitability for further development and clinical testing.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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