SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting the formulation screening activities in the development of pharmaceutical products. Formulation screening is a critical step in identifying the optimal formulation that meets the therapeutic and stability requirements. This SOP provides a systematic approach to ensure that all formulation screening activities are properly documented to facilitate reproducibility, regulatory compliance, and transparency in the development process.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing drug-excipient interaction reports. Drug-excipient interactions are crucial factors to consider during the development of pharmaceutical formulations, as they can significantly influence the stability, efficacy, and safety of the final product. This SOP provides guidelines for conducting compatibility studies between active pharmaceutical ingredients (APIs) and excipients and documenting the results to ensure that no adverse interactions occur during formulation development.
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The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the use of High-Performance Liquid Chromatography (HPLC) in the testing of pharmaceutical formulations. HPLC is a critical analytical technique used for the qualitative and quantitative analysis of active pharmaceutical ingredients (APIs), excipients, and degradation products in formulations. This SOP defines the process for using HPLC to assess the purity, potency, and stability of drug products, ensuring that the formulations meet required specifications for therapeutic use.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting in-vitro testing of pharmaceutical formulations to assess their efficacy. In-vitro testing is a critical step in the development of new drug formulations, as it allows for the evaluation of key therapeutic properties such as drug release, bioavailability, and biological activity without the need for animal or human testing at initial stages. This SOP outlines the necessary steps for performing in-vitro testing, including the testing methods, required equipment, and documentation procedures to ensure the formulation meets therapeutic objectives.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for scaling up prototype formulations from laboratory or pilot scale to larger commercial batch sizes. The scale-up process is critical to ensuring that the formulation maintains its quality, safety, and efficacy when produced on a larger scale. This SOP provides a systematic approach for scaling up prototype formulations, including adjustments to formulation components, manufacturing processes, and quality control parameters.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing formulation development reports for pharmaceutical formulations. The formulation development report is a critical document that summarizes the formulation design, process development, testing results, and optimization procedures followed during the development of a pharmaceutical product. This SOP ensures that all necessary information is captured accurately and comprehensively, providing a foundation for further stages of the product lifecycle, including regulatory submission, clinical studies, and commercial manufacturing.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting pilot stability studies of pharmaceutical formulations. Pilot stability studies are essential to assess the impact of storage conditions on the stability of a formulation and to predict its shelf life. These studies help in determining the appropriate storage conditions, packaging requirements, and formulation adjustments needed to ensure the stability and efficacy of the drug product throughout its intended shelf life. This SOP outlines the necessary steps for conducting pilot stability studies in compliance with regulatory guidelines.
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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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