Related Experiment Video
Updated: Dec 5, 2025
06:34
Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
Published on: November 29, 2024
478
Multiple use applicator for vaginal tablets/vaginal inserts: compliance verification and suitability studies
Heiko Brunner1, Rudolf A Theodor2
1HELM AG, Nordkanalstrasse 28, 20097, Hamburg, Germany. dr.h.brunner@helmag.com.
BMC Women'S Health
|October 16, 2020
Summary
A new reusable vaginal applicator demonstrated excellent patient acceptability and functionality. Developed cleaning procedures minimize contamination risk, qualifying the device for multiple uses.
Area of Science:
- Medical Device Development
- Gynecological Health
- Product Suitability Testing
Background:
- Lack of standardized testing procedures for reusable vaginal applicators.
- Need for evaluation of general suitability for vaginal tablets/inserts.
Purpose of the Study:
- To evaluate the general suitability of a newly developed multiple-use vaginal applicator.
- To establish and validate testing procedures for such medical devices.
Main Methods:
- Phase III clinical trial for patient acceptability (EudraCT: 2017-000142-22).
- Development and verification of a cleaning procedure using simulated vaginal fluid.
- Mechanical stability and functionality testing after simulated multiple uses.
Main Results:
- High patient compliance and acceptability demonstrated after two weeks of daily use.
- Effective cleaning procedure verified, meeting European Pharmacopeia microbiological criteria.
- Mechanical stability and functionality confirmed after 50 simulated uses for all tested batches.
Conclusions:
- The developed tests confirm the suitability of the multiple-use vaginal applicator.
- The applicator meets predefined acceptance criteria for patient compliance, safety, and functionality.
- The outlined procedures can serve as a guideline for testing similar medical devices.
Related Concept Videos
01:13In Vitro Drug Dissolution: Compendial Testing Models I
128
Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
128
01:09In Vitro Drug Dissolution: Compendial Testing Models II
111
Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
111
01:13Bioequivalence studies: Biowaivers
107
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
107
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
99
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
99
01:10In Vitro Drug Release Testing: Overview, Development and Validation
149
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
149
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
100
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
100