Dissolution and Disintegration Testing

The Importance of Dissolution and Disintegration Testing

Dissolution and disintegration testing are important methods for evaluating the rate and extent of drug release from pharmaceutical formulations in the body. Dissolution testing involves measuring the rate at which the active ingredient in a drug product dissolves in a specific medium, while disintegration testing evaluates how quickly a drug product breaks down into smaller particles when exposed to a specific medium. Specifically,

• Dissolution testing is a test method used to determine the release rate or amount of dissolvable material under given conditions. It is usually used to evaluate the release performance of pharmaceutical formulations to ensure that they meet prescribed dissolution standards. In addition, it can detect the release rate of drug ingredients in preparations and determine the release rate of the drug, thereby understanding the efficacy of the drug in the body and optimizing the formulation and bioavailability of the preparation.
• Disintegration testing refers to the time required for a certain number of tablets to break down into smaller particles. It is often used to evaluate and determine the time it takes for a solid dosage form to dissolve in the human body or digestive tract. It is characterized by the dosage form being dissolved, dispersed, or softened. In addition, disintegration testing can determine the physical properties of the formulation, including its robustness and durability, as well as its suitability for different biological systems.

Dissolution Testing Services

The CD Formulation dissolution testing team has many years of experience in dissolution method development and analysis to support the formulation development of innovative drug delivery systems, new drugs, and generic drugs, from conventional immediate-release tablets/capsules to a variety of modified tablets/capsules. Our dissolution testing services include:

• Conventional dissolution testing services.
• Dissolution testing services for sustained and controlled release drug delivery systems.

Our dissolution development team provides standard dissolution testing based on methods described in the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP):

• For typical solid dosage forms such as tablets or floating capsules, we offer standard USP Apparatus 1 (basket) and Apparatus 2 (paddle) instrument methods.
• For extended-release solid dosage forms, we use USP Apparatus 2.
• For other formulations such as powders, suspensions, microspheres, etc., we offer the standard USP Apparatus 4 (flow cell) method.

Disintegration Testing Services

In addition to dissolution testing services, for some oral immediate-release solid dosage forms, we also offer disintegration testing services as an alternative to dissolution testing, thereby providing critical safety data on the bioavailability of the drug in vivo without utilizing in vivo methods.

Our disintegration testing team provides standard disintegration testing services based on methods described in the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).

• For solid dosage forms, we use baskets that can hold 1 to 6 tablets/capsules. It was then placed in a beaker and then placed in water, which was used to simulate gastric conditions at 37°C. Tablet disintegration time is measured with no residue on the screen.
• Note that throughout the test, if the tablet or capsule floated, a perforated plastic disk was placed on top of the tablet to keep it below the water level.

Applicable Standards

Dissolution and disintegration testing must produce consistent results. A typical approach involves the preparation of the dissolution medium similar to simulated gastric fluids in an attempt to replicate in vivo conditions. Specific methods may vary depending on sample characteristics and equipment, CD Formulation is capable of performing dissolution and disintegration testing according to the following pharmacopeias:

• European Pharmacopoeia (EP)
• United States Pharmacopoeia (USP)
• Japanese Pharmacopoeia (JP)
• Chinese Pharmacopoeia (ChP)

What Problem do Our Dissolution and Disintegration Testing Services Solve?

• Help customers evaluate the physical and chemical properties of candidate drugs to further screen the best solid form for preformulation studies.
• Elucidate the release mechanisms of drug candidates.
• As an indicator of robustness in expanding production.
• Ensure the safe release of drugs before market launch.

Why Choose CD Formulation for Dissolution and Disintegration Testing?

• Flexible, tailor-made solutions that meet dissolution and disintegration testing guidelines.
• Comprehensively understand the efficacy characteristics of finished drugs and preparations to ensure that they meet specified standards and requirements.
• Extensive experience and expertise in dissolution and disintegration analysis to handle complex analytical challenges.
• Various analytical technologies and equipment can meet a variety of dosage forms, including conventional solid preparations, sustained-release solid preparations, and other preparations such as powders, suspensions, and microspheres.

CD Formulation has extensive experience and expertise in performing dissolution and disintegration analysis services. Our team of experienced scientists will work with you to develop a customized testing plan that meets your specific needs. Please contact us to learn more about how we can help you conduct dissolution and disintegration testing and verify the safety of your products to regulatory requirements.