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SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

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SOPs for Liposome and Emulsion Formulations

SOP for Preparation of Oil-in-Water (O/W) Emulsions

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The purpose of this SOP is to outline the procedure for preparing oil-in-water (O/W) emulsions. In O/W emulsions, oil droplets are dispersed in an aqueous continuous phase, stabilized by emulsifying agents. These emulsions are widely used in pharmaceutical, cosmetic, and food products. This SOP ensures the consistency, stability, and homogeneity of O/W emulsions.
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Liposome and Emulsion Formulations

SOP for Use of Surfactants in Emulsion Formulations

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The purpose of this SOP is to outline the procedure for the selection and use of surfactants in emulsion formulations. Surfactants play a critical role in stabilizing emulsions by reducing the surface tension between two immiscible phases, such as oil and water. This SOP describes the criteria for selecting surfactants, the correct method for incorporating them into emulsions, and quality control procedures to ensure the stability and homogeneity of the emulsion.
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Liposome and Emulsion Formulations

SOP for Formulation of Cationic Liposomes for DNA Delivery

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The purpose of this SOP is to describe the procedure for the formulation of cationic liposomes for DNA delivery. Cationic liposomes are used for delivering genetic material such as plasmid DNA or siRNA into cells due to their positive charge, which facilitates interaction with negatively charged DNA and cell membranes. This SOP outlines the process for preparing cationic liposomes, ensuring efficient encapsulation and delivery of DNA.
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Liposome and Emulsion Formulations

SOP for Preparation of Immunoliposomes for Targeted Drug Delivery

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The purpose of this SOP is to describe the procedure for the preparation of immunoliposomes. Immunoliposomes are liposomes that are surface-modified with antibodies or antibody fragments for targeted drug delivery. These liposomes bind specifically to target cells, such as cancer cells, enhancing the efficacy of the delivered therapeutic agents while minimizing off-target effects. This SOP outlines the steps for antibody conjugation to liposomes, ensuring correct antibody attachment and functionality.
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Liposome and Emulsion Formulations

SOP for Incorporation of Targeting Ligands in Liposome Formulations

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The purpose of this SOP is to describe the procedure for incorporating targeting ligands into liposome formulations. Targeting ligands, such as antibodies, peptides, or small molecules, are added to the surface of liposomes to enable active targeting of specific cells or tissues, enhancing the efficacy of drug delivery. This procedure outlines the steps for ligand conjugation to liposomes, ensuring correct attachment and functionality of the targeting molecules.
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Liposome and Emulsion Formulations

SOP for Preparation of Sterically Stabilized Liposomes

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The purpose of this SOP is to describe the procedure for preparing sterically stabilized liposomes (also known as stealth liposomes). Sterically stabilized liposomes are coated with polymers such as polyethylene glycol (PEG) to extend their circulation time in the bloodstream, reduce recognition by the immune system, and enhance drug delivery to target tissues. This SOP outlines the formulation process, ensuring liposome stability and surface modification with PEG.
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Liposome and Emulsion Formulations

SOP for Formulating pH-Sensitive Liposomes

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The purpose of this SOP is to describe the procedure for preparing pH-sensitive liposomes. These liposomes are designed to release their encapsulated contents in response to specific pH changes, making them ideal for targeted drug delivery, particularly in acidic environments such as tumor sites or within cellular endosomes. This SOP outlines the formulation and preparation process to ensure stability and responsiveness to pH changes.
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Liposome and Emulsion Formulations

SOP for Preparation of Liposomes for Gene Delivery

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The purpose of this SOP is to outline the procedure for preparing liposomes specifically designed for gene delivery applications. Liposomes are effective vehicles for delivering genetic material, such as DNA or RNA, into cells. This SOP will ensure proper encapsulation of nucleic acids and liposome size uniformity, which are crucial for gene transfection efficiency and stability.
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Liposome and Emulsion Formulations

SOP for Preparation of Unilamellar Vesicles (ULVs)

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The purpose of this SOP is to describe the step-by-step procedure for the preparation of unilamellar vesicles (ULVs). ULVs are liposomes with a single lipid bilayer that encapsulate aqueous and lipid-soluble compounds for drug delivery. This SOP outlines the procedure for creating ULVs using common techniques such as extrusion, sonication, or high-pressure homogenization, ensuring uniformity and encapsulation efficiency.
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Liposome and Emulsion Formulations

SOP for Preparation of Multilamellar Vesicles (MLVs)

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This SOP outlines the procedure for the preparation of multilamellar vesicles (MLVs) in liposome formulations. MLVs consist of multiple lipid bilayers and are commonly used in drug delivery systems, as they can encapsulate both hydrophilic and lipophilic drugs. This method is suitable for creating larger vesicles that provide controlled release of encapsulated materials.
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Liposome and Emulsion Formulations

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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