Dissolution Testing and Drug Release Profiling for Live Biotherapeutic Products

Creative Biolabs is a global leader dedicated to the development and optimization of LBP drugs. We have invincible knowledge in drug formulation development and provide professional and comprehensive services for live biotherapeutic products (LBPs) development.

Drug dissolution testing is an analytical technique used to evaluate the release of drugs in pharmaceutical products, usually solid oral products. To reflect drug absorption or more accurately drug release in vivo, drug dissolution tests are performed in vitro to simulate the physiological environment of the gastrointestinal (GI) tract.

Dissolution Profile

The GI tract environment is characterized by slight agitation of drug products in an aqueous solution, such as 0.1 N HCl or buffers with a pH of 4.0-7.5. The cumulative dissolution percentage of a drug at several time points can be determined and reported as a graph of the percentage of drug dissolution versus sampling times. The resulting curve is usually called the "dissolution profile", which provides a way to compare the drug release in vivo.

Significance of Dissolution Testing

If a drug is to produce its effect, it must be released from the product and should usually be dissolved in the GI tract. Therefore, the drug dissolution test can be considered as an indicator of the potential release and absorption characteristics of drugs in humans as well as in animals. Thus, the dissolution test is usually considered as an alternative method to evaluate the availability of drugs in vivo, which is usually called bioavailability.

Dissolution testing for immediate release solid oral dosage forms in vitro plays an important role in assessing the batch-to-batch quality of a drug product, guiding the development of new formulations, and ensuring product quality and performance after certain changes. Thus, the dissolution test is not only a procedure for product development but is also extensively used as a quality control technique.

Dissolution in LBP Development

In order to assist with dosage form optimization, dissolution testing is a standardized method for measuring the rate of drug release from a given dosage form. Now, LBPs are mainly developed into an oral dosage form.

The oral dosage form is still one of the most flexible and effective treatments available to patients. Dissolution testing is required for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a key analytical test used to detect physical changes in an active pharmaceutical ingredient and formulated product. At the early stages of drug development, dissolution testing in vitro supports the optimization of drug release from a given formulation. The effectiveness of an oral dosage form depends on the intrinsic ability of the drug to dissolve in the gastrointestinal fluid before it is absorbed into circulation. Therefore, the dissolution rate of tablets or capsules is the key to this process.

Fig.1 Schematic diagram of the proposed system for automatic dissolution testing. (Chi, 2019)

Dissolution testing is a common test in the pharmaceutical and biopharmaceutical industries. The test method must be reliable and repeatable and can detect any key changes in product performance. Many parameters must be taken into consideration for the design of a suitable dissolution procedure, including the API, formulation, and analytical method.

During the whole process, it is important to ensure that the dissolution in vitro is similar to that in vivo, if the dissolution procedure is designed effectively, it will speed up drug development, and ideally reduce the need for human research. Creative Biolabs has extensive experience in this field, offering the best chance of product success. Contact us for more detailed information.

Reference

1. Chi, Z.M.; et al. Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug Tablets. Sci Rep. 2019, 9: 17114.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.