When making sure pharmaceuticals comply to quality standards, there are four areas where Thermal Analysis can help to determine potential problems. This article will explain those Terms.
Thermal stability is a concept that is easy to conceive. But how to measure and quantify it? A fast and safe method for this is to use a thermobalance.
The term polymorphism comes from the Greek, “poly” meaning “multiple” and “morph” meaning “form”. Used in different areas as programming or biology, it designates the ability of a variable, of an object, of a gene to take on multiple forms. In the pharmaceutical industry, polymorphism refers to the ability of a material to exist in … Read moreThe Phenomenon Polymorphism – A Major Impact on Drug Performance
Compatibility refers to harmony in a relationship, but is also an important term in science, be it in medicine where only a compatible organ can be transplanted to a recipient, or in computing to refer to software packages that can be used together. This concept is also well-known in the pharmaceutical field: Two components (e.g., … Read moreCompatibility of Drug and Excipient: Faster and Easier By Means of Thermal Analysis and SuperPosition
– In particular for users of differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) – Installation qualification (IQ) and operational qualification (OQ) are part of the so-called analytical instrument qualification (AIQ) process at the user´s lab to confirm that an instrument is properly installed, works correctly and yields the expected results. A key term in … Read moreIQ and OQ – What Does This Mean for Thermal Analysis Users?
Many pharmaceutical solids exhibit polymorphism, i.e., the ability of a substance to exist in different crystalline forms. The polymorphic form can have significant influence on pharmaceutical processing and can, for example, affect grinding, granulation and tabletability. A DSC measurement allows for the characterization of the present modification. Here, different modifications of paracetamol are distinguished by means of DSC.
Caffeine exists under 2 polymorphic forms (I and II). Compression of form I induces its transformation into form II, leading to changes in its properties. Heating with DSC ensures that caffeine is in the correct form.
Spray-dried a-lactose monohydrate is a matrix of amorphous lactose in which lactose monohydrate crystals are embedded. Humidity has no influence on the crystal but amorphous lactose is very hygroscopic: in presence of humidity, it will transform into the crystalline form. This has consequences on the tableting properties of the substance. Thermal Analysis gives you first Information about the water content of your lactose and the consequences for its compressing properties.
The glass transition of lactose is in direct relation with the stickiness and the flowability of powders containing it. This in turn influences the processing.
How to determine the shelf life of drugs without long time testing? First predictions about the shelf-life concerning thermal stability are achieved using thermogravimetric measurements with a kinetics Evaluation. This occurs within some hours or days.