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
testing and analysis and how
laboratory services perform these
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
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
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
Created on Apr 17th 2019 03:28. Viewed 208 times.