EUROLAB
usp-2068-in-vitro-drug-release-from-dermal-systems
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 <1090> Assessment of Drug Release from Liposomal Dosage FormsUSP <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 <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 <2068> In Vitro Drug Release from Dermal Systems: Eurolabs Laboratory Testing Service

Standard-Related Information

The US Pharmacopeia (USP) <2068> standard is a comprehensive framework for evaluating the in vitro drug release from dermal systems. This standard is designed to provide a uniform and scientifically sound approach to assessing the performance of transdermal patches, creams, gels, and other topical dermatological products.

International and National Standards

The USP <2068> standard is based on the following international and national standards:

  • ISO 10993-5: Biological evaluation of medical devicesPart 5: Tests for in vitro cytotoxicity

  • ASTM E2229: Standard Practice for In Vitro Release Testing (IVRT) of Dermally Applied Transdermal Patches

  • EN 14428: Medical devicesBiocompatibility testing of active implantable medical devices and diagnostic medical devicesPart 1: General requirements

    • Standard Development Organizations

    The development of standards such as USP <2068> is a collaborative effort between standard development organizations (SDOs) worldwide. These SDOs include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standard Evolution and Updates

    Specific Standard Numbers and Scope

    The following are specific standard numbers and their scope related to the USP <2068> standard:

  • ISO 10993-5:2014 - Biological evaluation of medical devicesPart 5: Tests for in vitro cytotoxicity (applicable to dermal systems)

  • ASTM E2229-09 - Standard Practice for In Vitro Release Testing (IVRT) of Dermally Applied Transdermal Patches (applicable to transdermal patches)

    • Industry Compliance Requirements

    Compliance with the USP <2068> standard is mandatory for companies marketing dermatological products that claim to deliver active ingredients through the skin.

    Regulatory authorities worldwide require manufacturers of dermal systems to demonstrate compliance with the USP <2068> standard. Failure to comply may result in product recalls, market withdrawals, and reputational damage.

    Business and Technical Reasons for Conducting USP <2068> Testing

    Conducting USP <2068> testing is essential for companies that wish to:

  • Ensure product safety and efficacy

  • Comply with regulatory requirements

  • Enhance customer confidence and trust

  • Differentiate products from competitors

    • The consequences of not performing this test include:

  • Product recalls and market withdrawals

  • Reputational damage and loss of customer confidence

  • Non-compliance with regulatory requirements

  • Potential harm to consumers due to ineffective or unsafe products

    • Test Conditions and Methodology

    To conduct USP <2068> testing, the following conditions and methodology are employed:

  • Sample preparation: The test sample is prepared according to the manufacturers instructions.

  • Testing equipment: Equipment used for testing includes a dissolution apparatus, a spectrophotometer, and a chromatograph.

  • Testing environment: Temperature (25C 2C), humidity (60 5), and pressure are controlled.

  • Sample preparation procedures: The test sample is carefully prepared to ensure accuracy and precision.

  • Testing parameters and conditions: The testing parameters and conditions include pH, temperature, agitation rate, and dissolution medium.

  • Measurement and analysis methods: Spectrophotometry and chromatography are employed for measuring the amount of active ingredient released from the dermal system.

    • Test Reporting and Documentation

    The test report includes:

  • A summary of the test results

  • The actual test data (raw data)

  • Calculations performed on the raw data

  • Interpretation of the test results

    • The certification and accreditation aspects include:

  • Certification by a recognized third-party accrediting body

  • Accreditation to ISO/IEC 17025 or similar standards

    • Why This Test Should Be Performed

    Performing USP <2068> testing provides numerous benefits, including:

  • Enhanced product safety and efficacy

  • Compliance with regulatory requirements

  • Improved customer confidence and trust

  • Competitive advantages in the market

    • The risk assessment and mitigation through testing include:

  • Reducing the risk of product recalls and market withdrawals

  • Mitigating reputational damage and loss of customer confidence

    • Why Eurolab Should Provide This Service

    Eurolabs expertise and experience in conducting USP <2068> testing make it an ideal choice for companies requiring this service. Our state-of-the-art equipment, qualified personnel, and accreditation to ISO/IEC 17025 ensure the accuracy and reliability of our test results.

    Conclusion

    In conclusion, the USP <2068> standard provides a comprehensive framework for evaluating the in vitro drug release from dermal systems. Conducting USP <2068> testing is essential for companies that wish to ensure product safety and efficacy, comply with regulatory requirements, and enhance customer confidence and trust. Eurolabs laboratory testing service ensures the accuracy and reliability of our test results, providing customers with a high level of confidence in their products.

    ---

    Appendix

  • References:

    • USP <2068> - In Vitro Release Testing (IVRT) of Dermally Applied Transdermal Patches

    ISO 10993-5:2014 - Biological evaluation of medical devicesPart 5: Tests for in vitro cytotoxicity

    ASTM E2229-09 - Standard Practice for In Vitro Release Testing (IVRT) of Dermally Applied Transdermal Patches

  • Glossary:

    • Dermal system: A product designed to deliver active ingredients through the skin, such as transdermal patches, creams, gels, and lotions.

    USP <2068> standard: A comprehensive framework for evaluating the in vitro drug release from dermal systems.

    ---

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers