The purpose of this Standard Operating Procedure (SOP) is to define the process for assessing taste-masking formulations in pharmaceutical products. Taste masking is an essential technique used in the development of oral dosage forms, especially for pediatric, geriatric, and certain adult populations. It involves modifying the taste profile of a formulation, particularly for bitter APIs, to improve patient compliance and ensure ease of administration. This SOP provides guidelines for evaluating the effectiveness of taste-masking methods and ensuring the formulation meets the desired taste masking and stability requirements.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for selecting and testing buffers in pharmaceutical formulations. Buffers are essential components in many formulations, particularly in oral, parenteral, and topical products, as they help maintain the desired pH and stability of the formulation. This SOP provides guidelines for selecting the appropriate buffers based on the formulation’s requirements and for testing their performance to ensure the stability and efficacy of the final product.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for optimizing pharmaceutical formulations in preparation for stability studies. Stability studies are essential to assess the shelf-life, safety, and efficacy of drug formulations under different environmental conditions. This SOP outlines the steps for optimizing the formulations to ensure they are stable, effective, and suitable for long-term storage, thereby supporting product development and regulatory submission processes.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for microencapsulation in pharmaceutical formulation screening. Microencapsulation is a critical technique for encapsulating active pharmaceutical ingredients (APIs) in a protective coating to control their release, improve stability, and mask taste or odor. This SOP provides guidelines for conducting microencapsulation studies, ensuring the proper selection of materials, methods, and conditions to achieve the desired formulation characteristics and performance.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedure for conducting particle size analysis during the screening of pharmaceutical formulations. Particle size is a critical factor influencing the bioavailability, stability, and release characteristics of pharmaceutical formulations, especially in solid dosage forms, suspensions, and emulsions. This SOP provides guidelines for the accurate and reproducible measurement of particle size to ensure formulation consistency and quality during development.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing formulations intended for preclinical testing. Preclinical testing is a critical step in the drug development process, where formulations are evaluated for safety, efficacy, and pharmacokinetic properties in animal models. This SOP provides guidelines for preparing formulations that are suitable for preclinical studies, ensuring consistency, accuracy, and quality in all stages of formulation preparation.
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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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