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Product Volume & API Process ...

API manufacturing processes can be complex and ...

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FDA Crackdown on Compounders: Too ...

The FDA now admits that it could have done more to ...

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ICH Q11 & Stealth QbD for Drug ...

Last May, ICH Q11 came on the scene without much hoopla, ...

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Quality & Risk Management: Beware ...

Never underestimate the complexity of pharmaceutical ...

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Understanding Pharma Patents

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Question-Based Review, APIs & the ...

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Pharma Evolution Blogs

In-Silico Drug Development: A Must-Read Paper

Agnes Shanley, Editor-in-Chief, 20/05/13 Comment now

And now for the second article in the brief "technology of tomorrow" series...

Latest comment I felt like a contemporary of Jules Verne's must have felt when reading one of his novels when I read this paper. But why couldn't...

Can Simulation Take Drug Development Into the Future?

Agnes Shanley, Editor-in-Chief, 20/05/13 Comment now

At a time when some drug manufacturers still stumble on relatively simple concepts such as loading the correct amount of active ingredient in their formulations (something that may result in criminal charges for J&J executives in South ...

Latest comment Aah Drying, I came from the Paper Industry to Pharmaceuticals. In the Paper Industry- the most significant, energy intensive and...

A Spoonful of Sugar

Adele Graham-King, Blogger, 17/05/13 Comment now

When I was young, we were given our polio vaccine on a sugar cube. We were given medicines full of sugar, we held our noses to take nasty suspensions, and we were regularly pinned down by our parents to ensure that we took the horrid ...

Latest comment Incredible though when the likes of the diabetes and asthma markets attract multi-million dollar investment to advance and improve...

Improving APIs & Formulation: Are You Harnessing the Power of Liquids?

Girish Malhotra, President & Founder, Epcot International, 14/05/13 Comment now

Liquids are an essential part of our planet. Imagine our landscape and lives without them. We may take them for granted, but liquids play an important role in the reactive processes that produce small molecule active pharmaceutical ...

Latest comment This is a good review of basic solvent chemistry. I wonder how many industry professsionals are, in fact. "harnessing the power of...

Who Has Won Our Cartoon Caption Writing Contests So Far?

Agnes Shanley, Editor-in-Chief, 09/05/13 Comment now

You may have noticed the unmistakeable style of our cartoons, sketched by the brilliant and prolific Jerry King. But some of you may have been wondering whether this contest was a work of fiction.

Latest comment I would like to see the cartoons! Yeah!

Reformulating to a More Convenient Tablet for Patients With Dementia

Agnes Shanley, Editor-in-Chief, 07/05/13 Comment now

Orally disintegrating tablets (ODT) are becoming more important in physicians' efforts to ensure that patients take their prescribed dose of medication.

Latest comment @ALM Seems promising but also uncertain. With more evaluation and cases having well-tolerated treatment in patient population is important...

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Message Boards

jasmine 5/21/2013 1:29:18 AM
Can Simulation Take Drug Development Into the Future?
Re: Drying:
Aah Drying, I came from the Paper Industry to Pharmaceuticals. In the Paper Industry- the most significant, energy intensive and the literally 'make or break' unit operation is Drying. It was very well understood, controlled and monitored. Fast forward to the Pharma Industry where...

Agnes Shanley 5/20/2013 12:57:47 PM
In-Silico Drug Development: A Must-Read Paper
Why can't In Silico modeling/prototyping be done? :
I felt like a contemporary of Jules Verne's must have felt when reading one of his novels when I read this paper. But why couldn't drug development work this way? The tools do exist today, even if everyone doesn't have access to them. (Another question: how might...

Emil W. Ciurczak 5/20/2013 12:17:49 PM
Can Simulation Take Drug Development Into the Future?
Drying:
The trouble with drying is that we have always treated the granulation as if it was homogeneous. The various components of a pharmaceutical mixture each "wets" differently. That is, when the chemical-water complex (in a crystal, we say salt.4H2O, for example to show a crystal lattice)...

Emil W. Ciurczak 5/20/2013 11:15:47 AM
Can Simulation Take Drug Development Into the Future?
Simulation:
Wow! You hit on about 20 problems in one posting. To answer "why do we have trouble understanding," I would answer, "we have the wrong people." The traditional mix of process engineers and pharamacists is based on a 1950's model. The FDA (at that time) was looking at an industrial...

Agnes Shanley 5/20/2013 9:52:58 AM
Can Simulation Take Drug Development Into the Future?
Deceptive simplicity?:
Why is it that the "simplest" processes (seemingly) are often the most difficult to understand and control? Drying is another good example.

Adele Graham-King 5/19/2013 10:15:43 AM
A Spoonful of Sugar
Re: spoonful of sugar:
Incredible though when the likes of the diabetes and asthma markets attract multi-million dollar investment to advance and improve usability and adherance, and yet the numbers of people who dose with the likes of paracetamol daily is way higher. Admittedly the long term prognosis...

Emil W. Ciurczak 5/19/2013 9:58:47 AM
A Spoonful of Sugar
spoonful of sugar:
unfortunately, going all the way back to the original Pure Food and Drug Act, the industry seldom does anything for "the right reasons." Unfortunately, the FDA had to adopt Al Capone's slogan (in a plaque on his desk), "You get more with a gun and a kind word than with a kind word...

Adele Graham-King 5/19/2013 9:53:47 AM
A Spoonful of Sugar
Re: spoonful of sugar:
Emil you're probably right - but I can't understand why there has been no obvious technical advance in almost 20 years. Even taking the aesthetic and usability issues out for the target audience it would create a huge commercial advantage!

Emil W. Ciurczak 5/19/2013 9:38:24 AM
A Spoonful of Sugar
spoonful of sugar:
Indeed, it would be nice. However, as you well know, the industry will make a series of "fits and starts" to save money. That means, we "may and should" get to the proper dosage form...but, it won't be all that soon. (And may not be that pretty...)

Adele Graham-King 5/19/2013 9:33:38 AM
A Spoonful of Sugar
Re: spoonful of sugar:
Emil, I think it's a valid point about not masking the taste and certainly making medication too sweet. And the 'Child resistant closure' (CRC) is a different issue. If we could create a user friendly, anti-spill, accurate child suspension delivery device this would aid in optimum...

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