SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the process for assessing storage conditions that ensure the stability of pharmaceutical formulations. Stability is a critical quality attribute of a drug product, and improper storage conditions can lead to changes in the physical, chemical, and microbiological properties of the formulation, potentially affecting its efficacy, safety, and shelf life. This SOP provides guidelines for evaluating storage conditions, conducting stability studies, and ensuring that the formulation maintains its desired quality attributes over time.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for screening hydrogels for drug delivery applications. Hydrogels are three-dimensional, cross-linked networks of hydrophilic polymers that can hold large amounts of water, making them suitable carriers for controlled drug release. This SOP provides guidelines for evaluating the properties of hydrogels, including their swelling behavior, drug release profiles, biocompatibility, and stability, to determine their suitability for various drug delivery systems.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for incorporating active pharmaceutical ingredients (APIs) into nanoemulsion formulations. Nanoemulsions are colloidal systems consisting of fine droplets (typically less than 100 nm) of oil dispersed in water, or vice versa. They are widely used in drug delivery systems to enhance the solubility, stability, and bioavailability of poorly soluble APIs. This SOP provides guidelines for the preparation of nanoemulsion formulations, selection of suitable excipients, and effective incorporation of APIs to ensure optimal therapeutic outcomes.
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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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