Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important in ensuring a product meets its target performance profile. Within this, the polymorphism and crystallinity of the Active Pharmaceutical Ingredients (APIs) and excipients present within a product formulation are crucial. Presence of an undesired polymorph could lead to a reduction in therapeutic benefit, due to changes in API solubility, and may even cause an adverse effect to the patient. Polymorph selection, and conformation of polymorphic stability over time, is therefore vital. This becomes even more important when an amorphous for of the API is selected to improve solubility, as unexpected crystallization of an insoluble form can be fatal.
During this webinar, we will focus on the advanced analysis methods available using an XRPD system, namely the Empyrean. These methods can help with understanding the following aspects of pharmaceutical products:
- Stability of a formulation over time and as a function of temperature and/or relative humidity;
- Distribution of components within pharmaceutical solid dosage forms;
- Influence of different manufacturing methods on the internal and surface structure for solid dosage forms;
- Amorphous content and the structure of amorphous materials, in support of stability studies and detailed product specification.
Find more about our solutions for pharmaceutical oral solid dose drugs over here
Join our series of Pharma oral and inhaled solid dose drugs analysis
- Webinar 1: Advanced your analysis with X-ray diffraction. More info
- Webinar 2: Expanding your analysis using XRD with advanced screening including for amorphous content
- Webinar 3: Introduction to powder XRD. More info
- Webinar 4: Introduction to analysing the dissolution and stability of your APIs and excipients with particle size analysis using laser diffraction More info
- Webinar 5: Particle size data analysis and interpretation from laser diffraction results collected from the Mastersizer 3000 More info
- Webinar 6: Assessing the bioequivalence of nasal sprays with careful particle size analysis More info
Speakers
Dr Natalia Dadivanyan, XRD Application Specialist, Malvern Panalytical's Supply Center in the Netherlands
Dr Natalia studied chemistry at Moscow State University (Russia). After completing her master thesis on synthesis and characterization of polymer liquid crystalline films Natalia moved to University of Freiburg (Germany) to obtain her PhD degree working on liquid crystalline elastomers. This was followed by a post-doc position at the Eindhoven University of Technology (The Netherlands), where Natalia focused on organic semi-conductors. In 2012 Natalia joined Malvern Panalytical as an Application Specialist XRD, in Almelo (The Netherlands).
Dr Mangesh Mahajan, XRD Application Specialist at Malvern Panalytical
Dr Mahajan has a Ph.D. and postdoctoral experience in material science from National Chemical Laboratory, Pune, India. For more than 12 years, Dr Mahajan has used multiple characterization techniques for various materials. In 2016, he joined Malvern Panalytical as an application specialist for X-ray diffraction. In his line of work, he has been instrumental in supporting various customers in pharmaceuticals, cements, mining and metal industries, universities, national institutions and more. This spans from advising on applications, experimental set up, samples analysis, proof of concept through to helping clients optimise the use of their XRD instrumentation.
Dr Sandeep Nagar, XRD Application Specialist at Malvern Panalytical
Dr Nagar has 16 years of R and D experience. He completed his PhD in Materials Science from KTH Sweden in 2012. He thereafter taught at various Indian universities as an Assistant Professor for 6 years. In 2018, he joined Malvern Panalytical as an application specialist for X-ray diffraction. In his work, he has provided application and technical support to customers from various industries including academic research, to mining, steel, cement, pharmaceuticals and more. His area of specialty is in mineralogical and structural research using X-ray diffraction.
Amol Pandit, Manager for Pharmaceutical Solutions involving X-ray diffraction at Malvern Panalytical
More information
Join our series of Pharma oral solid dose drugs analysis
- Webinar 1: Advanced your analysis with X-ray diffraction. More info
- Webinar 2: Expanding your analysis using XRD with advanced screening including for amorphous content
- Webinar 3: Introduction to powder XRD. More info
- Webinar 4: Introduction to analysing the dissolution and stability of your APIs and excipients with particle size analysis using laser diffraction More info
- Webinar 5: Particle size data analysis and interpretation from laser diffraction results collected from the Mastersizer 3000 More info