What are Analytical Laboratory Services for Drug Testing and Analysis?

by Maria B. Medical Expert

Before a drug is released, pharmaceutical testing of the product is the key to quality control and drug development. Typically, drug testing measures how active pharmaceutical ingredient (API) from the product matrix is released when it is in a controlled laboratory environment. In the testing, the dosage of the drug is subjected to a set of conditions which leads to drug release. During this time, it is predicted how in vitro conditions will turn out in vivo conditions. The in vivo condition here means humans.

Talking in terms of quality control, drug testing is utilized to assess whether a batch complies with pre-set criteria. This also includes the long-term stability of the active pharmaceutical ingredient.

In this article, we are discussing drug testing and analysis and how analytical laboratory services perform these tests.

Understanding Dissolution

To know how dissolution is used to find out the changes in the performance of drugs, understanding the process is important. Read on to know how dissolution works:

For most of the oral drugs that we consume, the absorption of API is necessary for systemic circulation as it helps in taking the API to the site of action. This whole process is divided into two parts, dissolution and permeability or absorption. During the dissolution phase, the solid form of the drug is extracted in solution form in the GI tract. Then, during absorption, the drug substance is taken to the systemic circulation.

In vitro studies analyze how API converts from solid dosage, which is the crux of evaluating the efficiency of drug substance in in vivo form.

Drug Testing by Analytical Testing Services

To assess the manufacturing stability and quality of drug product, in vitro drug dissolution studies are carried out by the analytical services laboratory. Some of these methods used for drug testing are explained below:

  • Oral Dosage Testing: This In vitro testing assesses how an oral drug product goes into solution form per unit time when it is subjected to standardized conditions. The major goal of this type of dissolution is to check the bioavailability of the drug. Apart from this, the oral dosage dissolution also tests how safe the drug product is and what is the influence of manufacturing process variance on the drug.

  • Transdermal and Topical In Vitro Release Testing: A vertical diffusion cell is utilized to understand the API release in case of transdermal and topical products. The product is placed such that it is in contact with the membrane, which, in turn, is in contact with the receiving medium. The receiving medium is basically a time function. The membrane is made of animal skin, cadaver, synthetic polymer, and tissue constructs. This technique is useful for topical formulations that are externally applied along with products used for rectal, vaginal, and nasal routes.

  • Elution Testing: Elution testing is carried out for a drug-device combination, in which, how the drug leaves the device is evaluated. This is achieved by placing the device containing a drug into a suitable medium. In the elution test, the medium choice, exchange frequency, and test volumes depend on the device's nature.

It is necessary for dissolution or drug testing to choose the right testing condition in accordance with the drug medium for a desirable outcome. The correct execution of in vitro is essential for simulating the nearly similar impact of the drug in the in vivo conditions.

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About Maria B. Freshman   Medical Expert

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Joined APSense since, April 1st, 2019, From Hamden, United States.

Created on Apr 17th 2019 02:28. Viewed 1,325 times.


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