Protheragen-ING Lab provides comprehensive pharmaceutical physical and chemical analysis services to ensure the quality, safety, and efficacy of your drug products. One of our key areas of expertise is dissolution testing, a critical quality control procedure for solid oral dosage forms.
What is dissolution testing?
Dissolution testing is a pharmacopeial test used to evaluate the rate and extent of active pharmaceutical ingredient (API) release from a solid dosage form, such as tablets or capsules. It provides important information about the in vitro performance of the drug product, which can be used to:
- Assess batch-to-batch consistency.
- Support formulation development.
- Evaluate the impact of manufacturing changes.
- Provide surrogate measures of in vivo performance.
The dissolution profile of a drug product is influenced by various factors, including the physicochemical properties of the API, the formulation composition and manufacturing process, and the dissolution test conditions.
Protheragen-ING Lab's dissolution testing capabilities
Our state-of-the-art pharmaceutical analysis laboratory is equipped with the latest dissolution testing equipment and instrumentation, allowing us to perform a wide range of dissolution studies in accordance with pharmacopeia standards (e.g., USP, EP, JP) and regulatory guidelines. Our experienced team of analytical scientists and formulation experts work closely with you to design and execute dissolution testing protocols that address your specific product and regulatory requirements.
We employ several advanced methods for determining the dissolution profile of pharmaceutical dosage forms:
USP Apparatus 1 (Basket Method)
This method uses a rotating basket to hold the dosage form, which is immersed in a dissolution medium. The basket rotates at a specified speed, and the dissolution rate is measured by sampling the medium at predefined intervals.
USP Apparatus 2 (Paddle Method)
This method involves placing the dosage form in a dissolution vessel containing the medium, with a paddle rotating at a specified speed. Samples are taken at predetermined intervals to measure the amount of drug dissolved.
USP Apparatus 3 (Reciprocating Cylinder)
This method uses a reciprocating cylinder to move the dosage form between different media, simulating the transit through various parts of the gastrointestinal tract. It is particularly useful for modified-release formulations.
USP Apparatus 4 (Flow-Through Cell)
This method involves pumping the dissolution medium through a flow-through cell containing the dosage form. It is suitable for low-solubility drugs and dosage forms requiring specific flow conditions.
In Situ Fiber Optic Analysis
This advanced technique uses fiber optic probes to continuously monitor the concentration of the drug in the dissolution medium, providing real-time dissolution profiles.
Why choose our dissolution testing services?
By partnering with our company for your dissolution testing needs, you can expect:
- Reliable, high-quality data to support your product development and regulatory submissions.
- Tailored solutions to meet your unique testing requirements.
- Compliance with current good laboratory practices (GLP).
- Rapid turnaround times and responsive customer service.
- Extensive experience in dissolution testing for a wide range of pharmaceutical products.
For more information or to request our dissolution testing services, please contact us.