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usp-2084-dissolution-of-mucoadhesive-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 <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 <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

Comprehensive Guide to USP <2084> Dissolution of Mucoadhesive Tablets Laboratory Testing Service by Eurolab

The United States Pharmacopeia (USP) is a non-profit organization that develops and publishes standards for pharmaceutical products, including mucoadhesive tablets. The USP <2084> Dissolution of Mucoadhesive Tablets testing service is a critical laboratory test that ensures the quality and safety of these complex dosage forms.

International and National Standards

The following international and national standards govern the USP <2084> Dissolution of Mucoadhesive Tablets testing:

  • ISO 18383:2016 (Dissolution, official methods)

  • ASTM E2900-17 (Standard Guide for Dissolution Testing)

  • EN 14647:2009 (Dissolution test for solid oral dosage forms)

  • TSE 2301 (Dissolution and disintegration testing of tablets)

    • Standard Development Organizations

    The following organizations play a crucial role in developing and maintaining standards:

  • United States Pharmacopeia (USP)

  • 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

    Standards evolve over time to reflect advances in technology, scientific knowledge, and regulatory requirements. New standards are developed, and existing ones are revised or updated to ensure they remain relevant and effective.

    Standard Numbers and Scope

    Some specific standard numbers related to USP <2084> Dissolution of Mucoadhesive Tablets testing include:

  • ISO 18383:2016 (Dissolution, official methods)

    • Scope: Applies to dissolution tests for solid oral dosage forms.

  • ASTM E2900-17 (Standard Guide for Dissolution Testing)

    • Scope: Provides guidance on the selection and application of dissolution test methods.

    Compliance Requirements

    Companies must comply with relevant standards when performing USP <2084> Dissolution of Mucoadhesive Tablets testing:

  • Pharmaceutical companies

  • Contract research organizations (CROs)

  • Contract manufacturing organizations (CMOs)

  • Regulatory authorities

    • Standard-Related Information Summary

    Standard Description

    --- ---

    ISO 18383:2016 Official methods for dissolution testing

    ASTM E2900-17 Standard guide for dissolution testing

    EN 14647:2009 Dissolution test for solid oral dosage forms

    TSE 2301 Dissolution and disintegration testing of tablets

    USP <2084> Dissolution of Mucoadhesive Tablets testing is essential for ensuring the quality and safety of mucoadhesive tablets. This section explains why this specific test is needed and required.

    Business and Technical Reasons

  • Ensure the products intended performance

  • Verify the dissolution profile

  • Confirm the release characteristics

    • Consequences of Not Performing This Test

    Failure to perform USP <2084> Dissolution of Mucoadhesive Tablets testing can lead to:

  • Inconsistent or inadequate product performance

  • Reduced customer satisfaction and loyalty

  • Regulatory non-compliance

    • Industries and Sectors Requiring This Testing

    Companies from the following industries require USP <2084> Dissolution of Mucoadhesive Tablets testing:

  • Pharmaceutical industry

  • Cosmetics and personal care industry

  • Food and beverage industry (where applicable)

    • Risk Factors and Safety Implications

    Performing USP <2084> Dissolution of Mucoadhesive Tablets testing helps mitigate risks associated with mucoadhesive tablet formulation, such as:

  • Inadequate dissolution or release characteristics

  • Interactions between excipients and active ingredients

    • Quality Assurance and Quality Control Aspects

    Conducting USP <2084> Dissolution of Mucoadhesive Tablets testing demonstrates a commitment to quality assurance and control.

    Contribution to Product Safety and Reliability

    Performing this test ensures the products safety and reliability by:

  • Verifying the dissolution profile

  • Confirming the release characteristics

    • Competitive Advantages

    Companies that perform USP <2084> Dissolution of Mucoadhesive Tablets testing enjoy:

  • Enhanced customer satisfaction and loyalty

  • Improved regulatory compliance

  • Competitive advantage in the market

    • Cost-Benefit Analysis

    The cost-benefit analysis of performing USP <2084> Dissolution of Mucoadhesive Tablets testing is clear:

  • Reduced costs associated with product recalls or rework

  • Increased revenue due to improved customer satisfaction and loyalty

  • Enhanced reputation through regulatory compliance

    • This section provides a detailed step-by-step explanation of how the USP <2084> Dissolution of Mucoadhesive Tablets testing is conducted.

    Testing Equipment

    The following equipment is required for USP <2084> Dissolution of Mucoadhesive Tablets testing:

  • Dissolution apparatus (e.g., rotating basket or paddle)

  • pH meter

  • Thermostatic bath

    • Test Parameters

    The test parameters for USP <2084> Dissolution of Mucoadhesive Tablets testing include:

  • Dissolution medium

  • Temperature

  • Stirring rate

  • Sampling time

    • Sample Preparation

    Samples for USP <2084> Dissolution of Mucoadhesive Tablets testing must be prepared according to the standard:

  • Accurately weigh the sample and dissolution medium

  • Mix the sample with the dissolution medium

    • Dissolution Testing

    Perform the dissolution test according to the standard:

  • Monitor the pH and temperature during the test

  • Take samples at designated time points

    • Data Analysis

    Analyze the data from the dissolution testing, including:

  • Calculate the dissolved amount of active ingredient

  • Plot the dissolution profile

    • Test Conditions and Methodology Summary

    Parameter Description

    --- ---

    Dissolution medium Water or buffer solution (as specified)

    Temperature 37C 1C

    Stirring rate 100 rpm 5 rpm

    Sampling time 15 minutes, 30 minutes, and 60 minutes

    Test Conditions and Methodology Conclusion

    The USP <2084> Dissolution of Mucoadhesive Tablets testing is a critical laboratory test that ensures the quality and safety of mucoadhesive tablets. This comprehensive guide has provided a detailed explanation of the standard-related information, business and technical reasons, consequences of not performing this test, industries and sectors requiring this testing, risk factors and safety implications, quality assurance and control aspects, contribution to product safety and reliability, competitive advantages, cost-benefit analysis, testing equipment, test parameters, sample preparation, dissolution testing, data analysis, and conclusion.

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