Stability studies of Pharmaceutical products


A presentation on  stability studies at accelerated conditions is presented for formulated drug products briefly.


Comments

Post a Comment

Popular posts from this blog

Stress studies in Drugs

Chemical stability of pharmaceutical molecules is most important as it has impact on the safety and efficacy of the drug products. Stress testing or forced degradation is an analytical tool to study  the behaviour of the products as well as to understand the resolving power of  the analytical method used. Stress testing reveals the quality of  pharmaceutical products exposed over the time period as well as different environmental conditions viz.,  heat, hydrolysis, oxidation, photolytic etc. ICH guideline defines stress testing as: Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing. Stress studies provides more valuable information about the degradation impurities, called as degradants, which are likely to form during the shelf life of the product lifecycle in a very short period compared to...
Read more

Polymorph in Drugs

Image
Molecules exist in nature in any of the three states viz., solid. liquid and vapour. But most of the molecules, organic and inorganic , exist in solid states. It is very interesting that if these solid state molecules  have therapeutic benefits, they’re used as a drug substance.   In a solid state, the  molecules or the elements   exist as crystals  which are  oriented in a organised or disorganised ways. Hence multiple orientations are possible for a molecule. In a pharmaceutical drug, these different crystalline orientations are named as Polymorphs.  Polymorphism may be defined as the ability of a compound to crystallize in two or more crystalline phases with different arrangements and/or conformations of the molecules in the crystal lattice. Hence, polymorphs are different crystalline forms of the same pure chemical compound.  Since these crystalline forms are oriented differently, their free energies are also different which makes them as uniq...
Read more

Analytical Quality by Design (AQbD)

The concept of quality by design (QbD) in pharmaceutical industry has been introduced to enhance robust manufacturing process and to facilitate product quality. Quality is built in the product and process by design and scientific approach. As the number of  out-of-trend (OOT) results, out-of-specification (OOS) results are increasing in pharmaceutical industry and the current quality system is unable to address the growing concern,  a strategy to make a robust manufacturing process is felt and a cocept if QbD has emerged. FDA has implemented the QbD concept first in drug formulation manufacturing processes as the finished drug products are directly consumed by the patients and any variation in the quality will adversaly affect the safety of the patients. Similar to robust product development, an equally important analytical methods employed to test the quality of product must be robust and capable of producing accurate results.  The benefits of implementing AQbD are 1.con...
Read more