Dias nummer 1 AWS
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
Aspiration anyone?
Feeding, swallowing, and respiration are activities that occur in the upper aerodigestive tract and are orchestrated by specific areas in the brain and cranial nerves. Successful oral feeding requires that children have functional oral sensorimotor and swallowing skills, overall adequate health (including pulmonary and gastrointestinal function), central nervous system integration, and musculoskeletal tone. A breakdown in coordination of swallowing and breathing can result in aspiration, which, over time, can progress to bronchiectasis. Aspiration may present with coughing and choking, usually during feeding, and is indicative of compromised airway protective reflexes. If laryngotracheal sensation is also affected, aspiration may be silent without any overt manifestations.
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 40
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
Aspiration anyone?
Feeding, swallowing, and respiration are activities that occur in the upper aerodigestive tract and are orchestrated by specific areas in the brain and cranial nerves. Successful oral feeding requires that children have functional oral sensorimotor and swallowing skills, overall adequate health (including pulmonary and gastrointestinal function), central nervous system integration, and musculoskeletal tone. A breakdown in coordination of swallowing and breathing can result in aspiration, which, over time, can progress to bronchiectasis. Aspiration may present with coughing and choking, usually during feeding, and is indicative of compromised airway protective reflexes. If laryngotracheal sensation is also affected, aspiration may be silent without any overt manifestations.
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
Aspiration anyone?
Feeding, swallowing, and respiration are activities that occur in the upper aerodigestive tract and are orchestrated by specific areas in the brain and cranial nerves. Successful oral feeding requires that children have functional oral sensorimotor and swallowing skills, overall adequate health (including pulmonary and gastrointestinal function), central nervous system integration, and musculoskeletal tone. A breakdown in coordination of swallowing and breathing can result in aspiration, which, over time, can progress to bronchiectasis. Aspiration may present with coughing and choking, usually during feeding, and is indicative of compromised airway protective reflexes. If laryngotracheal sensation is also affected, aspiration may be silent without any overt manifestations.
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 40
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
Aspiration anyone?
Feeding, swallowing, and respiration are activities that occur in the upper aerodigestive tract and are orchestrated by specific areas in the brain and cranial nerves. Successful oral feeding requires that children have functional oral sensorimotor and swallowing skills, overall adequate health (including pulmonary and gastrointestinal function), central nervous system integration, and musculoskeletal tone. A breakdown in coordination of swallowing and breathing can result in aspiration, which, over time, can progress to bronchiectasis. Aspiration may present with coughing and choking, usually during feeding, and is indicative of compromised airway protective reflexes. If laryngotracheal sensation is also affected, aspiration may be silent without any overt manifestations.
