|00:00:00||Focus on PharmaSolid Form Analysis: Advance Your Analysis|
|00:03:59||Why Solid Form Analysis?|
|00:04:49||Why Solid Form Analysis?|
|00:07:01||Why Solid Form Analysis?|
|00:09:09||How does Quality by Design (QbD) help?|
|00:09:55||Applying QbD to drug product development|
|00:12:11||What parameters can be considered CMAs?|
|00:12:45||What parameters can be considered CMAs?|
|00:13:11||What can be considered a CMA?|
|00:13:39||What can be considered a CMA?|
|00:13:54||When is solid form considered a CMA?|
|00:15:29||When is solid form considered a CMA?|
|00:17:32||Solutions for solid form analysis|
|00:19:51||Solutions for solid form analysis|
|00:22:28||Industry need for on-line monitoring|
|00:22:59||Applications for in situ studies|
|00:23:49||DL-Alanine crystallization at pH = 6.1|
|00:25:41||Crystallinity change after tablet stress (T)|
|00:26:41||Why study polymorphs?|
|00:28:31||Case study: oral solid dose products|
|00:30:30||1. Comparison with multiple reference patterns|
|00:31:03||1. Automatic identification using HighScore|
|00:32:20||2. Polymorph identification – indexing method|
|00:32:45||2. Unit cell search & indexing – Example|
|00:33:21||2. Fitting with known unit cell parameters|
|00:33:48||3. Comparison to Calculated pattern|
|00:34:58||3. Rietveld refinement|
|00:36:06||What are the benefits of asking ‘why?’|
|00:37:50||Questions & Answers|
|00:47:11||Thank you for your attention!|
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.
This webinar series will consider the guidance available regarding polymorph and crystallinity analysis for pharmaceutical products and how appropriate methods can be developed using the technique of X-Ray Powder Diffraction (XRPD).
In this first presentation we will discuss why a polymorph specification may be required. We’ll review the guidance provided in ICH Q6A, which recommends that formulation developers consider how product bioavailability, uniformity, stability and processability may be impacted by structural changes. We will then consider how XRPD can aid formulation developers in material selection and in understanding the impact of formulation processing operations on product performance.
The second webinar in the series will consider how an appropriate method for XRPD analysis can be developed and how various sample preparation techniques can influence it.
The final webinar will focus on the advanced analysis methods available using an XRPD system which can help with understanding the distribution of components within pharmaceutical dosage forms and can also provide a means of describing amorphous materials.
Natalia Dadivanyan Ph.D. has 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 PANalytical as an Application Specialist XRD, in Almelo (The Netherlands).
- Who should attend?
- Anyone engaged in developing methods for XRPD
- Anyone who is developing pharmaceutical formulations
- Researchers engaged in chemical development or support of scale up activities
- Anyone engaged in polymorph screening activities as part of lead optimization activities
- Anyone engaged in producing or setting specifications for pharmaceutical raw materials or intermediate
- Why attend?
- To learn about why polymorphism is important for pharmaceutical products.
- To understand the regulatory guidance relating to XRPD.
- Understand how XRPD can be applied within pharmaceutical development.