USP Dissolution with Surfactant Addition Testing
The United States Pharmacopeia (USP) dissolution testing method is a critical quality control procedure used in pharmaceutical development and manufacturing. This method evaluates the rate and extent to which drugs dissolve from solid dosage forms, such as tablets or capsules, under specified conditions. Dissolution testing ensures that formulated products meet established therapeutic requirements by providing consistent drug release profiles.
In certain scenarios, where active ingredients are poorly soluble or require solubilization, surfactants play a crucial role in facilitating the dissolution process. Surfactant addition can enhance the solubility and bioavailability of drugs, thereby improving their efficacy. This service focuses on the USP Chapter 716 dissolution test with surfactant addition, which is particularly useful for assessing the solubility and bioavailability of poorly soluble drugs.
The testing process involves preparing a solution containing the drug substance and the desired surfactant concentration. The mixture is then subjected to agitation in a medium that simulates physiological conditions (e.g., pH 6.8 phosphate buffer). Samples are withdrawn at predetermined time intervals for analysis, typically using high-performance liquid chromatography (HPLC) or UV spectrophotometry.
The primary objective of USP dissolution with surfactant addition testing is to assess the effectiveness of various excipients and formulations in enhancing drug solubility. This service provides valuable insights into the dissolution behavior of poorly soluble compounds, enabling researchers and quality assurance teams to optimize formulation parameters for improved product performance.
Our laboratory adheres strictly to USP guidelines, ensuring accurate and reliable results that are compliant with international standards. By leveraging advanced analytical techniques and experienced personnel, we deliver precise data on drug release rates and solubility enhancements achieved through surfactant addition.
| Time Points | Dissolution Percentage | Surfactant Concentration |
|---|---|---|
| 0 minutes | 5% | 1% Sodium Lauryl Sulfate |
| 30 minutes | 40% | - |
| 60 minutes | 75% | 2% Cholic Acid |
| 120 minutes | 90% | 3% Polysorbate 80 |
Our comprehensive approach ensures that clients receive detailed reports highlighting the impact of surfactant addition on drug dissolution. These reports are essential for regulatory submissions and internal quality assurance processes.
Eurolab Advantages
- Experienced personnel with extensive knowledge in pharmaceutical testing
- State-of-the-art analytical instrumentation for precise measurements
- Comprehensive USP compliance ensuring accurate results
- Dedicated teams focused on delivering timely and reliable reports
- Access to specialized techniques like HPLC, UV-Vis spectroscopy, and pH monitoring
- ISO 17025 accreditation for laboratory management and technical competence
- Supporting regulatory compliance with multiple international standards
We pride ourselves on providing a seamless service from sample receipt to final report generation. Our commitment to quality is reflected in our ISO 17025 accreditation, which guarantees that all processes are rigorously controlled and validated.
Customer Impact and Satisfaction
- Enhanced drug solubility leading to improved bioavailability
- Precise assessment of formulation performance in different dissolution media
- Support for regulatory submissions with compliant data
- Optimized product development through enhanced understanding of dissolution behavior
- Increased confidence in product quality and consistency
- Avoidance of potential issues related to poor drug solubility
- Detailed reports aiding internal decision-making processes
- Simplified compliance with international standards
Our clients have reported significant improvements in drug development timelines and cost-effectiveness. By leveraging our expertise, they gain a competitive edge by ensuring their products meet the highest quality standards.
Use Cases and Application Examples
- Evaluation of new formulations for poorly soluble drugs
- Determination of optimal surfactant concentration for enhanced dissolution
- Investigation of excipient effects on drug release kinetics
- Development of pediatric formulations requiring improved solubility
- Assessment of API solubility in different pH conditions
- Prediction of in vivo bioavailability through ex vivo dissolution studies
- Optimization of sustained-release dosage forms
- Investigation of drug-drug interaction potential
The USP dissolution with surfactant addition testing is widely used across various sectors, including pharmaceutical research and development, contract manufacturing organizations (CMOs), and regulatory authorities. This versatile method allows for a deeper understanding of the dissolution behavior of poorly soluble compounds, facilitating informed decisions in product development.
