Particle Engineering

Sterling boasts a long and robust experience in the production of API with targeted properties.

Sterling defines the best storage conditions and provide to the customer a deep characterization on the behavior of the particles over the time.

The particle technology involves several approaches from the conventional size reduction processes to the newer, novel particle technologies that modify the solubility properties of the drugs and produce solid, powdered form of the drugs that are readily soluble in water and can be easily formulated into various dosage forms.
The development of an API done by Sterling takes care of all the critical attributes related to the quality of the product not only in terms of purity (content of organic and inorganic impurities, residual solvents and water content), but also Sterling pays particular attention to the physical CQA of the final powder. (PSD, SSA, morphology, rugosity of the surface, PSD fluctuation, amorphous behavior , Surface Energy, Tapped Density Powder Flow, Flowability, APSD, … ).

The particle technology involves several approaches from the conventional size reduction processes to the newer, novel particle technologies that modify the solubility properties of the drugs and produce solid, powdered form of the drugs that are readily soluble in water and can be easily formulated into various dosage forms.
The development of an API done by Sterling takes care of all the critical attributes related to the quality of the product not only in terms of purity (content of organic and inorganic impurities, residual solvents and water content), but also Sterling pays particular attention to the physical CQA of the final powder. (PSD, SSA, morphology, rugosity of the surface, PSD fluctuation, amorphous behavior , Surface Energy, Tapped Density Powder Flow, Flowability, APSD, … ).

It is well know that the polymorphic form of an API affects the behavior (solubility etc..) of the API in the formulation, for that reason deeply studies of the polymorphism of the API is done during the R&D development of the product, followed by amorphous content evaluation and quantification.

Another key physical property is the dimension of the particles (PSD): several processes (crystallization with anti-solvent, sonocrystallization or milling) allows to produce particles with different morphology and well characterized dimensions, customized depending on the final formulation required.  Sterling boasts a long and robust experience in the production of API with targeted properties. 
Even if the PSD is the one of the most important CQA, other characterizations of the particles have to be done as Surface Area (B.E.T.) and the Morphology measurement. PSD, morphology, SSA and amorphous content together provide a well characterization of a particle, that is not static, but dynamic picture. All the properties may change over the time, for that reason stability studies (at different climatic conditions) are usually done in order to monitoring the above mentioned properties:  the outcomes of these studies allow Sterling to defined the best storage conditions and to provide to the customer a deep characterization on the behavior of the particles over the time.

Another key physical property is the dimension of the particles (PSD): several processes (crystallization with anti-solvent, sonocrystallization or milling) allows to produce particles with different morphology and well characterized dimensions, customized depending on the final formulation required.  Sterling boasts a long and robust experience in the production of API with targeted properties. 
Even if the PSD is the one of the most important CQA, other characterizations of the particles have to be done as Surface Area (B.E.T.) and the Morphology measurement. PSD, morphology, SSA and amorphous content together provide a well characterization of a particle, that is not static, but dynamic picture. All the properties may change over the time, for that reason stability studies (at different climatic conditions) are usually done in order to monitoring the above mentioned properties:  the outcomes of these studies allow Sterling to defined the best storage conditions and to provide to the customer a deep characterization on the behavior of the particles over the time.