Addressing the Biggest Challenges in Polymorphism

Today, we take a different approach on the Pharma Lab show. There are a lot of challenges when it comes to making mixture standards for solid state analytical methods. Simon conducts a live episode where he discusses the different approaches and how to evaluate them.
Join us as we discuss:
Requirements for the ideal solid state mixture standards
Laboratory mixed standards are usually the largest source of error in a method
How to evaluate sources of error from measurement apparatus and sample
Standardless methods and component analysis.


Follow along with the video here: https://pharma.rigaku.com/insights/pharma-lab-show-mixtures-and-standards
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How far is the Pharmaceutical 3D Printing Revolution? In this episode, Simon speaks with Professor Mo Maniruzzaman, Assistant Professor in Pharmaceutics and Drug Delivery Assistant Professor in Pharmaceutics and Drug Delivery, The University of Texas at Austin.
They speak about:
How he became passionate about 3D printing
How far are we from personalized medicine through 3D printing?
How will Personalized “Pill Printing” evolve as the industry grows

Crystal structure prediction (CSP) has been a vital part of the mission of XtalPi, an artificial intelligence and quantum physics based pharmaceutical technology company aiming to improve the speed, scale, novelty, and success rate of drug discovery and development.
Chandler Greenwell, an applications scientist at XtaPi, shares how CSP is revolutionizing the field.
We discuss:
How polymorphism relates to CSP
Insights that CSP can provide for de-risking the polymorph landscape
Future applications for CSP
Resources mentioned during the podcast:
Facts and fictions about polymorphism
Why don’t we find more polymorphs?
Report on the sixth blind test of organic crystal structure prediction methods
Harnessing Cloud Architecture for Crystal Structure Prediction Calculations
Prediction of the Relative Free Energies of Drug Polymorphs above Zero Kelvin
Selecting a stable solid form of remdesivir using microcrystal electron diffraction and crystal structure prediction
Virtual Coformer Screening by Crystal Structure Predictions: Crucial Role of Crystallinity in Pharmaceutical Cocrystallization
Guiding Lead Optimization for Solubility Improvement with Physics-Based Modeling
Email Chandler: chandler.greenwell@xtalpi.com
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Spray drying has become one of the go-to techniques for the manufacture of amorphous dispersions and inhalable formulations due to the ability to control solvent content, morphology, size, and density of the resulting particulates in the dried powder.
X-ray computed tomography is a new technique for this spray dried dispersion application.
Peter Oberta, Managing Director at Rigaku, co-authored the study on this new approach and he joins the show to explain everything you need to know.
We discuss:
- The advantages of using this technique
- How to control particle size, morphology, and density using x-ray CT
- How much sample preparation is necessary for x-ray CT
- The qualitative results of the study
- The resolution that can be achieved with x-ray CT
- The data treatment required to complete the analysis
Mentioned during the podcast:
- Characterization of the Morphological Nature of Hollow Spray Dried Dispersion Particles Using X-ray Submicron-Computed Tomography
- X-Ray CT Imaging
- DigiM
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For successful rational indexing, you can’t just make a guess and refine. Each unit cell is defined by six parameters, meaning there could be billions of potential solutions. Your probability of being correct is abysmal.

Your best approach is to use advanced indexing tools. Machine learning can transform rational indexing from an intellectual challenge into the click of a button.

In this episode, Simon Bates , VP of Science and Technology at Rigaku, speaks with us about the problem that rational indexing solves, its uses in pharma since the 1940s, and near-future breakthroughs that will make it more efficient.

We discuss:

- Using diffraction data to identify crystal unit cells

- How rational indexing reduces the search space

- Why pharma should focus on identifying crystal unit cells

- The evolution of advanced indexing tools

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Pairwise distribution function (PDF) can be a very useful tool for pharmaceutical professionals, especially when characterizing active pharmaceutical ingredients.

Using PDF approaches you can confirm — and even solve — the molecular structure itself of new materials that we haven’t been able to properly analyze up until now.

In this episode, Simon Bates, VP of Science and Technology at Rigaku, shares why PDF and total diffraction combined together are so powerful in confirming molecular structures and why they are opening the door to new materials in pharmaceutics.

We discuss:


- The uses for PDF


- The challenges of total diffraction and PDF


- Keeping track of advances in PDF approaches

Check out these resources we mentioned during the podcast:


- The Collected Papers of Peter J.W. Debye


- Underneath the Bragg Peaks: Structural Analysis of Complex Materials by Takeshi Egami


- International Tables for Crystallography: Volume H, Powder Diffraction


- Pharmalytical Summit 2021

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Listening on a desktop & can’t see the links? Just search for The Pharma Lab Show in your favorite podcast player.

X-ray technology has come a long way in the past 20 years. Using x-ray imaging, we can now characterize drug products and solid dosage forms — taking a closer look without the destruction of the drug.

In this episode, I talk with Aya Takase, Director of X-ray Imaging at Rigaku Americas Corporation, about how x-ray technology has progressed during her time in the industry and what the future holds.

In this episode we discuss:

- An overview of x-ray imaging


- The multiple use cases of x-ray


- Why x-ray imaging isn’t in use in every drug making facility


- Resolution expectations from x-ray imaging


- The future of x-ray imaging

Check out this resource mentioned during the podcast:

- https://rigaku.com/

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Listening on a desktop & can’t see the links? Just search for The Pharma Lab Show in your favorite podcast player.

Research into the benefits of polymorphs is proceeding at a revolutionary rate.

What does the future hold for these exciting prospects and the companies who are investing these innovations?

Join Simon Bates, our host for this episode and Business Development Manager at Rigaku Americas Corporation, as he engages in a lively roundtable discussion with six industry experts on the future of polymorphs and current challenges.

What we talked about:


- Stunning evolutionary advances in the field of pharmaceutical polymorphs.


- Bringing in computational and big data solutions.


- Challenges in patentability for smaller companies.


- A bright future in polymorphism.

Today’s amazing guests:


- Steve Byrn, Professor and Dept. Head at Purdue University


- Raj Suryanarayanan, Professor at University of Minnesota


- Ann Newman, Solid-State and Pharmaceutical Consultant at Seventh Street Development Group


- Ken Morris, University Professor, Director Lachman Institute for Pharmaceutical Analysis, Long Island University


- Eyal Barash, Life Sciences Patent Attorney


- Mansoor Khan, Professor and Vice Dean, Presidential Impact Fellow, Texas A&M University, Rangel College of Pharmacy

For more insights into the pharmaceutical industry, subscribe to the show on Apple Podcasts, Spotify, or wherever podcasts are found.

Listening on a desktop & can’t see the links? Just search for The Pharma Lab Show in your favorite podcast player.

In this episode, a roundtable of distinguished guests discuss the impact and challenges of polymorphism. You’ll hear from these life science and pharmaceutical experts:

- Eyal Barash, Life Sciences Patent Attorney and Founder at Barash Law


- Steve Byrn, Professor and Dept. Head at Purdue University


- Mansoor Khan, Professor and Vice Dean, Presidential Impact Fellow, Rangel College of Pharmacy, Texas A&M University


- Ken Morris, University Professor, Director Lachman Institute for Pharmaceutical Analysis, Long Island University


- Ann Newman, Solid-State and Pharmaceutical Consultant at Seventh Street Development Group


- Raj Suryanarayanan, Professor and WIlliam and Mildred Peters Endowed Chair at University of Minnesota

We talked about:


- The guests’ backgrounds and origin stories in life science


- The biggest challenges with respect to polymorphism


- Thinking in terms of practical benefit vs. the clinical benefit


- Distinguishing the formulation effect from the form effect

This episode is Part 1 of 2 on our polymorph roundtable discussion. Don’t miss the conclusion!

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For this inaugural episode of The Pharma Lab, we wanted to have a detailed discussion around amorphous APIs, why they’re so important, the misconceptions around amorphous materials, and the future of amorphous material development.

So we sat down with Dr. Ann Newman, a Pharmaceutical Consultant at Seventh Street Development Group, and Dr. Kenneth Morris, University Professor Emeritus at Long Island University, for a discussion all about:

- The differences between amorphous and a polymorph

- Why amorphous forms are important for drug product development, and in particular, patient outcomes

- The biggest challenges in dealing with amorphous materials for pharmaceuticals

- What we really need to focus on for the future development of amorphous materials

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It’s hard to imagine how new drugs could be developed without appropriate analytical support. This podcast aims to provide it.

Rita Richa, Producer at Sweet Fish Media, talks with Simon Bates, the host of the show and Business Development Manager at Rigaku Americas Corporation, and Chris Carolan, Director of Marketing at Rigaku Americas Holding, about what to expect on The Pharma Lab Show.

What we talked about:

- Understanding the analytical needs of customers

- Providing a platform for scientists and business leaders to discuss pharmaceutical development

- Other topics that will be touched upon during the show

Have an idea for an episode topic or guest? Contact Simon Bates or Chris Carolan on LinkedIn.

For more insights into the pharmaceutical industry, subscribe to the show on Apple Podcasts, Spotify, or wherever podcasts are found.

Listening on a desktop & can’t see the links? Just search for The Pharma Lab Show in your favorite podcast player.