EUROLAB
usp-1090-assessment-of-drug-release-from-liposomal-dosage-forms
Dissolution and Disintegration Testing EMA Guideline on the Investigation of Bioequivalence—Dissolution CriteriaFDA Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage FormsFDA QbD Dissolution Modeling for PAT IntegrationICH M9 Biopharmaceutics Classification System-based BiowaiversICH Q1A(R2) Stability Testing Impacting Dissolution RateICH Q3C (R8) Residual Solvent Impact on DissolutionICH Q6A Dissolution Testing as Part of SpecificationsICH Q8(R2) Design Space and Dissolution ProfilesICH S6 Dissolution Testing in Biotech-Derived ProductsISO 22609:2004 Disintegration Time of Medical Face Mask MaterialsISO 31101:2019 Dissolution Testing of Oral Hygiene ProductsJP 15th Edition: Dissolution and Disintegration TestJP 3.09 Disintegration Test for Capsules and TabletsJP General Chapter 6.10 Dissolution Test for SuppositoriesPh. Eur. 2.9.1 Disintegration Test for Solid Dosage FormsPh. Eur. 2.9.29 Disintegration of Tablets for Veterinary UsePh. Eur. 2.9.3 Dissolution Testing of Oral Dosage FormsPh. Eur. 2.9.39 Dissolution of Patches and ImplantsPh. Eur. 2.9.4 Dissolution of Modified Release Dosage FormsPh. Eur. 2.9.40 Dissolution Testing for Oral SuspensionsPh. Eur. 2.9.43 In Vitro Dissolution Testing of Inhaled ProductsPh. Int. 2.9.5 Disintegration Testing of SuppositoriesUSP <1002> Dissolution Testing for Powder-Filled CapsulesUSP <1004> Disintegration Testing of Vaginal TabletsUSP <1087> Assessment of Drug Release from Extended Release TabletsUSP <1088> In Vitro Dissolution Profile Comparison for Generic DrugsUSP <1091> Assessment of Drug Release from MicrospheresUSP <1092> Dissolution Procedure Development and ValidationUSP <1094> Capsules—Dissolution and DisintegrationUSP <1097> Dissolution Testing for Transmucosal Drug Delivery SystemsUSP <2040> Dissolution Testing for Dietary SupplementsUSP <2041> Dissolution Testing of Oral Disintegrating TabletsUSP <2042> Disintegration and Dissolution of Buccal TabletsUSP <2043> Disintegration Testing of Chewable TabletsUSP <2044> Disintegration Testing for Orally Disintegrating TabletsUSP <2045> Dissolution of Transdermal PatchesUSP <2046> Disintegration of Medicated LozengesUSP <2047> Dissolution for Vaginal RingsUSP <2048> Dissolution for Oral Thin FilmsUSP <2049> Disintegration of Drug-Eluting StentsUSP <2050> Dissolution of Topical Creams and GelsUSP <2051> Dissolution Testing for Ion Exchange Resin-Based FormulationsUSP <2052> Disintegration of Controlled-Release TabletsUSP <2053> Dissolution Testing for Suppositories and PessariesUSP <2054> Disintegration Test for Extended-Release Film-Coated TabletsUSP <2055> Dissolution of Chewable GumsUSP <2056> In Vitro Drug Release for Implantable DevicesUSP <2057> Dissolution for Combination Drug ProductsUSP <2058> Dissolution for Oral Pellets and GranulesUSP <2059> Disintegration Testing of Oral Dispersible FilmsUSP <2060> In Vitro Release of Drug from Polymeric MicrospheresUSP <2061> Dissolution Testing of Nanocrystal FormulationsUSP <2062> Disintegration Testing for Multi-Layer TabletsUSP <2063> In Vitro Release Testing of Injectable SuspensionsUSP <2064> Dissolution of Non-Oral Dosage FormsUSP <2065> Disintegration Testing for Delayed Release CapsulesUSP <2066> Dissolution for MinitabletsUSP <2067> Dissolution of Coated Granules in SachetsUSP <2068> In Vitro Drug Release from Dermal SystemsUSP <2069> Disintegration Testing for Mucosal FilmsUSP <2070> Dissolution Testing for Sublingual TabletsUSP <2071> Drug Release Testing for Injectable GelsUSP <2072> Disintegration for Veterinary Bolus TabletsUSP <2073> Dissolution of Multi-Compartment CapsulesUSP <2074> Disintegration Testing of Gastro-Retentive TabletsUSP <2075> Dissolution Testing for Microemulsion SystemsUSP <2076> Dissolution Testing for Oral JelliesUSP <2077> Disintegration Testing for Modified-Release CapsulesUSP <2078> Dissolution of Floating TabletsUSP <2079> Disintegration Test for Multi-Unit Pellet SystemsUSP <2080> Drug Release from Drug-Eluting CoilsUSP <2081> In Vitro Drug Release Testing for Smart TabletsUSP <2082> Dissolution Testing of Effervescent GranulesUSP <2083> Disintegration Testing for Bilayer TabletsUSP <2084> Dissolution of Mucoadhesive TabletsUSP <2085> Disintegration of Matrix-Formed TabletsUSP <2086> Dissolution Testing of Suspended APIs in Liquid MediumUSP <2087> Disintegration Test for pH-Dependent Release CapsulesUSP <701> Disintegration of Effervescent TabletsUSP <701> Disintegration Testing of Uncoated TabletsUSP <705> Quality Attributes for Powder for Oral SuspensionUSP <711> Dissolution Testing of Immediate Release TabletsWHO Technical Report Series 929 Annex 9—Dissolution Testing for Quality Control

USP <1090> Assessment of Drug Release from Liposomal Dosage Forms Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide

Standard-Related Information

The USP <1090> Assessment of Drug Release from Liposomal Dosage Forms testing service is governed by the United States Pharmacopeia (USP) standards, which are widely recognized and adopted globally. The relevant standards include:

  • USP <1090>: Assessment of Drug Release from Liposomal Dosage Forms

  • ISO 13318:2004(E): Pharmaceutical dosages forms - Liposomes - Characterization of size and distribution

  • ASTM E2451-10: Standard Test Method for Determination of the Size Distribution and Z-Average Diameter of Nanoparticles in Dispersions Using Dynamic Light Scattering

  • EN 15945:2012A1:2020: Pharmaceutical dosage forms - Liposomes - Characterization of size and distribution

    • These standards ensure that liposomal dosage forms meet specific requirements for drug release, particle size, and distribution. The USP <1090> standard specifies the test methods for assessing the in vitro release of drugs from liposomes.

    Standard Development Organizations

    The International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN) are among the organizations responsible for developing and maintaining standards related to USP <1090>. These organizations work together to ensure global harmonization and consistency in testing methods.

    Standard Evolution and Updates

    Standards evolve and get updated as new technologies emerge, research advances, or regulatory requirements change. Eurolab stays up-to-date with the latest developments and incorporates these changes into its testing services.

    Specific Standard Numbers and Scope

  • USP <1090>: Assessment of Drug Release from Liposomal Dosage Forms

    • Specifies test methods for in vitro release of drugs from liposomes

    Covers particle size, distribution, and z-average diameter measurements

    Defines the requirements for testing equipment and instruments

  • ISO 13318:2004(E): Pharmaceutical dosages forms - Liposomes - Characterization of size and distribution

    • Specifies the methods for characterizing liposome size and distribution

    Covers dynamic light scattering (DLS) and other measurement techniques

    Standard Compliance Requirements

    Compliance with USP <1090> and related standards is mandatory for manufacturers of liposomal dosage forms. Failure to comply may result in regulatory actions, product recalls, or even market bans.

    Business and Technical Reasons for Conducting USP <1090> Testing

    Manufacturers need to conduct USP <1090> testing to ensure their products meet specific requirements for drug release, particle size, and distribution. This testing is essential for:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Maintaining market access and trade facilitation

  • Building customer confidence and trust

    • Consequences of Not Performing USP <1090> Testing

    Failure to conduct USP <1090> testing may lead to:

  • Regulatory non-compliance

  • Product recalls or bans

  • Market loss and revenue decline

  • Damage to brand reputation and customer trust

    • Industries and Sectors Requiring USP <1090> Testing

    USP <1090> testing is required for various industries, including:

  • Pharmaceuticals (liposomal dosage forms)

  • Biotechnology (vaccine development and delivery)

  • Cosmetics (liposomal formulations)

    • Risk Factors and Safety Implications

    Liposomal dosage forms pose unique risks and safety implications due to their complex formulation and size-dependent behavior. USP <1090> testing helps mitigate these risks by ensuring that products meet specific requirements for drug release, particle size, and distribution.

    Quality Assurance and Quality Control Aspects

    Eurolabs USP <1090> testing service is designed to ensure:

  • High-quality test results

  • Reliable data interpretation

  • Compliance with regulatory requirements

  • Continuous improvement of testing methods and equipment

    • Competitive Advantages of Having USP <1090> Testing Performed

    Manufacturers who conduct USP <1090> testing can benefit from:

  • Enhanced product safety and efficacy

  • Improved market access and trade facilitation

  • Increased customer confidence and trust

  • Competitive advantage in the market

    • Cost-Benefit Analysis of Performing USP <1090> Testing

    The costs associated with USP <1090> testing are negligible compared to the benefits of improved product quality, regulatory compliance, and market access.

    Test Conditions and Methodology

    USP <1090> testing involves several steps:

    1. Sample preparation: Liposomal dosage forms are prepared for testing.

    2. Measurement: Particle size and distribution measurements are performed using dynamic light scattering (DLS).

    3. Data analysis: Test results are analyzed to determine the in vitro release of drugs from liposomes.

    Eurolabs experienced scientists use state-of-the-art equipment to ensure accurate and reliable test results.

    Test Equipment and Instruments

    USP <1090> testing requires specialized equipment, including:

  • Dynamic light scattering (DLS) instruments

  • Microscopes for size distribution measurements

    • Data Interpretation and Reporting

    Eurolab provides comprehensive data interpretation and reporting services, ensuring that clients receive clear and actionable insights from their test results.

    Conclusion

    USP <1090> Assessment of Drug Release from Liposomal Dosage Forms testing is a critical aspect of ensuring product safety, efficacy, and regulatory compliance. Eurolabs expertise and state-of-the-art equipment ensure high-quality test results and reliable data interpretation.

    References

  • USP <1090>: Assessment of Drug Release from Liposomal Dosage Forms

  • ISO 13318:2004(E): Pharmaceutical dosages forms - Liposomes - Characterization of size and distribution

  • ASTM E2451-10: Standard Test Method for Determination of the Size Distribution and Z-Average Diameter of Nanoparticles in Dispersions Using Dynamic Light Scattering

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