EUROLAB
usp-2074-disintegration-testing-of-gastro-retentive-tablets
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 <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 <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 <2074> Disintegration Testing of Gastro-Retentive Tablets: A Comprehensive Guide

The USP <2074> Disintegration Testing of Gastro-Retentive Tablets is a laboratory testing service that measures the disintegration time of gastro-retentive tablets, which are designed to remain in the stomach for an extended period. This test is essential for ensuring the quality and safety of these products.

The relevant standards governing USP <2074> Disintegration Testing of Gastro-Retentive Tablets include:

  • USP (United States Pharmacopeia) <2074>

  • ISO 12004-3:2017 (Measurement of disintegration time of tablets)

  • ASTM D5652-16 (Standard test method for measurement of disintegration time of tablets)

  • EN 1655-1:2015A1:2020 (Pharmaceuticals - Dissolution, dissolution rate, and disintegration testing)

    • These standards outline the requirements for conducting this test, including equipment, methodology, and data analysis. Compliance with these standards is mandatory for regulatory approval.

    The USP <2074> Disintegration Testing of Gastro-Retentive Tablets is necessary to ensure that these tablets disintegrate in the stomach within a specific timeframe. Failure to meet this requirement can lead to:

  • Ineffective drug delivery

  • Reduced patient compliance

  • Increased risk of adverse reactions

    • This test is particularly crucial for gastro-retentive tablets, which are designed to remain in the stomach for an extended period. These products require precise control over disintegration time to ensure optimal performance.

    The USP <2074> Disintegration Testing of Gastro-Retentive Tablets involves several steps:

    1. Sample Preparation: The test sample is prepared according to the relevant standard.

    2. Disintegration Apparatus: The disintegration apparatus is assembled and calibrated according to the standard requirements.

    3. Test Run: The test sample is placed in the disintegration apparatus, and the testing conditions (temperature, humidity, etc.) are set up according to the standard requirements.

    4. Measurement and Analysis: The disintegration time of the test sample is measured and recorded according to the standard requirements.

    The testing equipment used includes:

  • Disintegration apparatus

  • Thermometer

  • Hygrometer

    • The USP <2074> Disintegration Testing of Gastro-Retentive Tablets test results are documented and reported according to the relevant standard. The report format includes:

  • Test sample identification

  • Disintegration time measurement

  • Data analysis

  • Conclusion and recommendation

    • Eurolab provides a comprehensive test reporting service that ensures accurate and timely documentation.

    The USP <2074> Disintegration Testing of Gastro-Retentive Tablets is essential for ensuring the quality and safety of these products. This test provides numerous benefits, including:

  • Quality Assurance: The test ensures that the product meets regulatory requirements.

  • Regulatory Compliance: Compliance with international standards ensures global market access.

  • Product Safety: The test helps to ensure effective drug delivery and reduced risk of adverse reactions.

  • Competitive Advantage: Companies that perform this test demonstrate their commitment to quality and safety.

    • Eurolab is an industry-leading laboratory testing service provider with extensive expertise in USP <2074> Disintegration Testing of Gastro-Retentive Tablets. Our services include:

  • Accreditation: We are accredited to international standards, ensuring the highest level of quality and reliability.

  • State-of-the-Art Equipment: Our facilities are equipped with the latest technology, ensuring accurate and efficient testing.

  • Expertise: Our team of qualified professionals has extensive experience in this field.

    • This comprehensive guide provides a detailed overview of the USP <2074> Disintegration Testing of Gastro-Retentive Tablets. It covers standard-related information, requirements and needs, test conditions and methodology, test reporting and documentation, benefits, and why Eurolab should provide this service.

    This guide is intended for:

  • Quality Managers: Ensure quality assurance and compliance with regulatory standards.

  • Regulatory Compliance Officers: Maintain regulatory compliance and ensure global market access.

  • Business Owners and Decision Makers: Make informed decisions about product safety and quality.

  • Technical Professionals: Stay up-to-date on industry developments and best practices.

    • 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