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School of Pharmaceutical Sciences

Swallowability in Children Where to find inspiration for Age-Appropriate Formulations Daniel Bar-Shalom School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

The message:

Licensed from Mark Anderson at www.andertoons.com

School of Pharmaceutical Sciences

To make the long story short (A.K.A. “Bottom-line”);

Thou shall not find the answer in a pharmaceutical development laboratory Note: Apparently it is de rigueur to use a childish font in pediatric presentations..

School of Pharmaceutical Sciences

Is the Pediatric Problem a “Problem”? Daniel Bar-Shalom School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

Yes, it is a problem! (as long as we live in the past)

(Cartoon has been licensed)

School of Pharmaceutical Sciences

“If Your Only Tool Is a Hammer Then Every Problem Looks Like a Nail”

Enhedens navn

GOOD NEWS! We have TWO hammers! (and syrups)

School of Pharmaceutical Sciences

Quiz: What was developed/ invented/ compounded in this pharmacy?

School of Pharmaceutical Sciences

Yes, I know, got the message! Do not repeat!

https://image.slidesharecdn.com/alterationsingenitourinaryfunctioninchildrenfall2017-170515232953/95/alterations-in-genitourinaryfunction-in-children-fall-2017-10-1024.jpg?cb=1494891037

School of Pharmaceutical Sciences

Flash: Neonates are not small children!!!!

School of Pharmaceutical Sciences

The way we were (and still are)

Wening K, Breitkreuz J. Oral drug delivery in personalized medicine: unmet needs and novel approaches. Int J Pharm 2011;404:1–9

School of Pharmaceutical Sciences

Liquid formulations Some actually work but…

School of Pharmaceutical Sciences

This tastes like shit!

School of Pharmaceutical Sciences

(A)dressing taste

SEMANTICS: Taste Masking: the situation where chemicals are added to modify the taste, including addition of other flavors, sweeteners, pH modifiers (mostly to render the offending molecule insoluble/unavailable) etc.

Taste Concealing: situations where the molecule is made unavailable to the taste receptors by “physical” means, such as entrapping the bad tasting substance by coating/encapsulation or in a matrix designed to retain the bad tasting substance, at least until it is swallowed.

School of Pharmaceutical Sciences

Chewable whatevers

School of Pharmaceutical Sciences

Mini-tablets

https://www.senopsys.com/case-studies/

School of Pharmaceutical Sciences

Age appropriate my foot…

http://www.huffingtonpost.co.uk/2012/07/10/megafamilies-christi-dave-cason-parents-child-pictures_n_1661550.html

School of Pharmaceutical Sciences

Yes, but

More than 60 chewable tablet formulations are approved for use in the United States, encompassing a wide breadth of therapeutic areas. This literature review suggests that the chewable tablet formulation is well tolerated in children of 2 years of age and older, providing a safe dosage form that is easily administered.

School of Pharmaceutical Sciences

The known knowns, the known unknowns and the unknown unknowns

• Knowns: very few; (children are not small adults, taste is an issue, deglutition is a moving target) • Known unknowns: lots: pH, motility, residence time, and pretty much anything else (but work is being done) • Unknown unknowns: I wish I knew…

School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

What works for whom?

Enhedens navn

Hammer cannot solve the problem?

Try a pneumatic hammer!

School of Pharmaceutical Sciences

…you could get a different tool…

…or (inspired by nature?) you may invent a new tool

School of Pharmaceutical Sciences

http://lumberjocks.com/topics/27991

Porridge

Tapioca

Banana

Rice Puding

Mashed Potato

Pumpkin

Applesauce

Quinoa

Batata – Sweet potato Grits - Mazzamorra

Polenta

Parvulet®

But this is for fixed doses! www.egalet.com

The vision… All drugs, at the indvidualized dose in the same dosage unit, b.i.d.

Mixtures of Acetylsalicylic acid, Ranitidine HCL and Amlodipine besilate, uncoated and coated, stored at open, light, open dark, closed dark and closed, light conditions, respectively.

The Robot exists

Department of Pharmacy

School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

The population

Pediatrics

Geriatrics

Can swallow Tablets & Capsules (any number of any (reasonable size)

School of Pharmaceutical Sciences

0-½

½-2

2-6

6-150

• No Deglutition • Only Suckling

• Developing deglutition • Some ability?

• Partial Deglutition • May Swallow Tablets

• Can Swallow Tablets • Disphagia?

School of Pharmaceutical Sciences

Can it be done?

"If you think something cannot be done, do not interrupt person the who is doing it.” Chinese proverb? “Never interrupt someone doing what you said could not be done.” Amelia Earhart

School of Pharmaceutical Sciences

To make the long story short (A.K.A. “Bottom-line”);

Thou shall not find the answer in a pharmaceutical development laboratory Note: Apparently it is de rigueur to use a childish font in pediatric presentations..

School of Pharmaceutical Sciences

To make the long story short:

• Aim for an universal solution • Find inspiration in food • Try and try again

Enhedens navn

Thank you for trying, grandpa!

Sted og dato Slide 39

School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

Chewed Banana

Plum seed

1st Pill

School of Pharmaceutical Sciences

Oysters anyone?

https://disanddes.wordpress.com/tag/belon-oysters/

School of Pharmaceutical Sciences

Cachets

School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

School of Pharmaceutical Sciences

School of Pharmaceutical Sciences