EUROLAB
usp-2059-disintegration-testing-of-oral-dispersible-films
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 <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 <2059> Disintegration Testing of Oral Dispersible Films Laboratory Testing Service

Provided by Eurolab: Understanding the Importance and Benefits of This Essential Testing Service

The United States Pharmacopeia (USP) <2059> standard, also known as Disintegration Testing of Oral Dispersible Films, is a laboratory testing service that evaluates the disintegration properties of oral dispersible films. These films are designed to dissolve quickly in water, making them ideal for patients who have difficulty swallowing traditional tablets or capsules.

The USP <2059> standard is one of several international and national standards that govern the testing of oral dispersible films. Other relevant standards include:

  • ISO 16587:2017, which provides a general guideline for disintegration testing of orally disintegrating tablets

  • ASTM E2874-17, which outlines the testing requirements for disintegration testing of orally disintegrating tablets

  • EN 13795:2002, which specifies the testing requirements for disintegration testing of orally disintegrating tablets in Europe

    • The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) also have specific guidelines for the testing of oral dispersible films.

    In addition to these international and national standards, there are several standard development organizations that contribute to the development and maintenance of these standards. These organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standards evolve over time as new technologies and testing methods become available. Standard development organizations continually review and update existing standards to reflect the latest scientific knowledge and advances in testing technology.

    Oral dispersible films require specific testing to ensure their disintegration properties meet regulatory requirements. This testing is necessary for several reasons:

    1. Safety: Oral dispersible films must break down quickly in water to prevent any potential harm to the patient.

    2. Effectiveness: The tablets must release their active ingredients rapidly, ensuring that they are absorbed by the body and take effect as intended.

    3. Regulatory compliance: Manufacturers of oral dispersible films must comply with regulatory requirements set forth by government agencies such as the FDA.

    Failure to conduct this testing can result in:

  • Product recalls due to non-compliance

  • Regulatory actions against manufacturers

  • Loss of business and revenue

    • Oral dispersible films are required in various industries, including pharmaceuticals, food, and cosmetics. The risk factors associated with oral dispersible films include:

  • Incorrect disintegration times can lead to reduced efficacy or toxicity.

  • Failure to meet regulatory requirements can result in product recalls and loss of business.

    • To conduct USP <2059> Disintegration Testing of Oral Dispersible Films, the following steps are taken:

    1. Sample preparation: The oral dispersible films are carefully prepared for testing by cutting them into uniform sizes.

    2. Equipment setup: A suitable apparatus, such as a disintegration tester, is set up to test the oral dispersible films under controlled conditions (temperature, humidity, pressure).

    3. Testing parameters and conditions: The testing parameters and conditions are set according to the USP <2059> standard.

    4. Measurement and analysis methods: The disintegration time of the oral dispersible films is measured using a suitable method, such as a timer or a spectrophotometer.

    Quality control measures during testing include:

  • Calibration of equipment

  • Validation of testing procedures

  • Statistical analysis of test results

    • After completing the USP <2059> Disintegration Testing of Oral Dispersible Films, a comprehensive report is provided to the client. This report includes:

  • A detailed description of the testing procedure

  • The disintegration time of the oral dispersible films

  • Any deviations from the standard

  • Recommendations for improvement

    • The reporting standards and formats used include:

  • USP <2059> compliant reports

  • Electronic reporting systems

  • Confidentiality and data protection measures are in place to ensure that client information is safeguarded.

    • The benefits of conducting USP <2059> Disintegration Testing of Oral Dispersible Films include:

    1. Product safety: Ensures the oral dispersible films break down quickly and safely in water.

    2. Regulatory compliance: Meets regulatory requirements set forth by government agencies.

    3. Competitive advantage: Demonstrates a commitment to quality and safety, which can be used as a marketing tool.

    Failure to conduct this testing can result in:

  • Regulatory actions against manufacturers

  • Loss of business and revenue

    • Conclusion

    The USP <2059> Disintegration Testing of Oral Dispersible Films is an essential laboratory testing service that evaluates the disintegration properties of oral dispersible films. This testing ensures product safety, regulatory compliance, and competitive advantage.

    By understanding the importance and benefits of this testing service, manufacturers can ensure their products meet regulatory requirements and maintain a commitment to quality and safety.

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