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Raman spectroscopy is an established spectroscopic technique for measuring the chemical identity and structure of materials across many industries, including pharmaceuticals, fine chemicals, minerals and foods.
Raman spectroscopy has a very high chemical specificity and is routinely used to differentiate between different polymorphs of the same compound for example. When used in conjunction with static image analysis it provides a powerful means of measuring the chemical identity of individually dispersed particles within a sample.
Applications of this technique include:
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Oral Solid Dosage (OSD) forms still represent a significant share of the pharmaceutical market. As a result, they remain an important target for generic product developers. In this white paper we introduce a workflow for OSD product deformulation and...
Deformulation of oral solid dose (OSD) products requires generic companies to determine the physical and chemical properties of the excipients and active pharmaceutical ingredients (APIs) present within the reference listed drug product (...
The development of generic dry powder inhaler products represents a significant challenge to product developers due to the complex interactions which occur between the formulation, device and patient during drug delivery. Regulatory guidance ...
The aim of formulation development is to design a product and its manufacturing process to consistently deliver the intended Quality Target Product Profile (QTPP). This involves determining the Critical Quality Attributes (CQAs) for the Activ...
Successful development of generic nasal drug products requires sponsors to understand how the dose is atomized by the chosen pump device in order to achieve bioequivalence. In addition, the impact of atomization of the particle size of the dr...
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