EUROLAB
ph-eur-294-dissolution-of-modified-release-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. 2.9.40 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 <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

Comprehensive Guide to Eurolabs Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms Laboratory Testing Service

Pharmaceutical laboratories around the world are required to adhere to specific standards and regulations when conducting dissolution testing on modified release dosage forms. The European Pharmacopoeia (Ph. Eur.) 2.9.4 is a harmonized standard that outlines the requirements for dissolution testing of oral modified-release products.

Legal and Regulatory Framework

The legal and regulatory framework surrounding Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing is governed by various international and national standards. These include:

  • ISO (International Organization for Standardization) 13813:2017

  • ASTM (American Society for Testing and Materials) E2261-12

  • EN (European Committee for Standardization) 13786:2003

  • TSE (Turkish Standards Institution) TS EN 13786

    • These standards outline the requirements for dissolution testing, including apparatus, sampling, analysis, and reporting.

    International and National Standards

    The international standard ISO 13813:2017 specifies the requirements for dissolution testing of oral modified-release products. This standard is harmonized with Ph. Eur. 2.9.4 and provides a framework for laboratories to conduct dissolution testing in accordance with regulatory requirements.

    National standards, such as EN 13786:2003, provide additional guidance on specific aspects of dissolution testing, including sampling and analysis methods.

    Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining standards related to Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing. These organizations include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EN (European Committee for Standardization)

    • These organizations collaborate with regulatory agencies, industry experts, and other stakeholders to develop and update standards that reflect changing technologies and regulatory requirements.

    Why This Test is Needed

    Dissolution testing of modified release dosage forms is critical to ensure the quality, safety, and efficacy of pharmaceutical products. The test provides information on the rate and extent of drug release from the formulation, which can impact patient outcomes.

    Failure to conduct dissolution testing can result in:

  • Inadequate product performance

  • Reduced patient safety and efficacy

  • Regulatory non-compliance

    • Industries and Sectors Requiring This Testing

    Pharmaceutical manufacturers, contract research organizations (CROs), and regulatory agencies require Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing for various products, including:

  • Modified-release tablets

  • Capsules

  • Granules

    • Regulatory agencies, such as the US FDA and EMA, also require dissolution testing data to support product approvals.

    Risk Factors and Safety Implications

    Conducting dissolution testing helps mitigate risks associated with modified release dosage forms, including:

  • Inconsistent drug release

  • Insufficient or excessive drug absorption

  • Patient safety concerns

    • By conducting Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing, laboratories can ensure that products meet regulatory requirements and minimize risks associated with product performance.

    Quality Assurance and Quality Control Aspects

    Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing involves various quality assurance and control aspects, including:

  • Equipment calibration

  • Method validation

  • Sampling and analysis methods

  • Reporting and documentation

    • By adhering to Ph. Eur. 2.9.4 requirements, laboratories can ensure the accuracy and reliability of test results.

    Competitive Advantages of Having This Testing Performed

    Conducting Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing offers several competitive advantages, including:

  • Improved product performance

  • Enhanced patient safety and efficacy

  • Regulatory compliance

  • Competitive market positioning

    • By conducting this testing, laboratories can demonstrate their commitment to quality and regulatory compliance.

    Cost-Benefit Analysis

    The cost-benefit analysis of performing Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing is a critical consideration for pharmaceutical manufacturers and contract research organizations. The benefits of testing include:

  • Improved product performance

  • Enhanced patient safety and efficacy

  • Regulatory compliance

    • However, the costs associated with conducting this testing can be substantial.

    Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing involves specific apparatus, sampling, analysis, and reporting requirements.

    Apparatus

    The dissolution test is conducted using a USP Apparatus 1 or 2, which consists of:

  • A glass flask

  • A stirrer bar

  • A thermometer

    • Sampling

    Sampling for dissolution testing involves collecting a portion of the dosage form from the dissolution medium at specified intervals.

    Analysis

    The analysis of dissolution data involves calculating the percentage release of the drug substance at specific time points. The method of analysis may involve:

  • High-performance liquid chromatography (HPLC)

  • Spectrophotometry

    • Reporting and Documentation

    The reporting and documentation requirements for Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing involve providing detailed information on the test apparatus, sampling, analysis, and results.

    Interpretation of Results

    The interpretation of dissolution data involves analyzing the percentage release of the drug substance at specific time points to determine whether the product meets regulatory requirements.

    Conclusion

    Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing is a critical component of pharmaceutical development and quality control. By conducting this testing, laboratories can ensure that products meet regulatory requirements and minimize risks associated with product performance.

    Eurolabs Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms Testing Services

    At Eurolab, we offer comprehensive Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing services to meet the regulatory requirements for pharmaceutical products. Our experienced team and state-of-the-art facilities ensure accurate and reliable results.

    Contact Us

    For more information on our Ph. Eur. 2.9.4 Dissolution of Modified Release Dosage Forms testing services, please contact us at insert contact information.

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