What are Analytical Laboratory Services for Drug Testing and Analysis

What are Analytical Laboratory Services for Drug
Testing and Analysis
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.