SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the process for incorporating active pharmaceutical ingredients (APIs) into liposomal formulations. Liposomes are widely used for drug delivery due to their ability to encapsulate both hydrophobic and hydrophilic drugs, offering controlled release and improving the stability and bioavailability of APIs. This SOP provides guidelines for selecting suitable methods to incorporate APIs into liposomes, ensuring that the final formulation meets the required quality standards and therapeutic objectives.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for screening pharmaceutical formulations designed for transdermal drug delivery. Transdermal delivery offers a non-invasive route of administration for drugs, enabling sustained release over time while avoiding first-pass metabolism. This SOP provides guidelines for evaluating the suitability of different formulations for transdermal delivery, assessing their ability to enhance drug penetration through the skin and maintaining the stability of the drug within the formulation.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for selecting appropriate solubilizers for poorly soluble drugs in pharmaceutical formulations. Poor solubility is a common challenge in drug development, particularly for oral dosage forms. This SOP provides guidelines for selecting solubilizers that improve the bioavailability of poorly soluble APIs, enhance their dissolution rate, and ensure the stability of the final formulation.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for comparing dissolution profiles of different pharmaceutical formulations during screening. Dissolution testing is an essential tool in the development of oral drug dosage forms, as it helps determine the rate and extent of drug release from the formulation. This SOP provides guidelines for conducting dissolution profile comparisons to ensure formulation optimization and to support regulatory submissions by demonstrating the equivalence of formulations.
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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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