Drug Formulation in Pediatrics: If it tastes bad it must be good for you Jeffrey Blumer, Ph.D., M.D. Professor of Pediatrics and Pharmacology Case Western Reserve University Chief, Pediatric Pharmacology and Critical Care Rainbow Babies and Children’s Hospital
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Drug Formulation in Pediatrics: If it tastes bad it must be good for you Jeffrey Blumer, Ph.D., M.D. Professor of Pediatrics and Pharmacology Case Western.
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Drug Formulationin Pediatrics:
If it tastes bad it must be good for you
Jeffrey Blumer, Ph.D., M.D.Professor of Pediatrics and Pharmacology
Case Western Reserve University
Chief, Pediatric Pharmacology and Critical CareRainbow Babies and Children’s Hospital
Cleveland, Ohio
Determinants of Effective TherapyDeterminants of Effective TherapyPharmacokineticsPharmacokinetics
• Absorption • Distribution • Metabolism • Excretion
• Absorption • Distribution • Metabolism • Excretion
• Mechanism of action • Safety profile• Mechanism of action • Safety profile
• Formulation • Inert ingredients • Taste
• Formulation • Inert ingredients • Taste
CHILDREN ARE
DIFFERENT
CHILDREN ARE
DIFFERENT
BUT — THEY'RE NOT MARTIANSBUT — THEY'RE NOT MARTIANS
Drug Treatmentfor Infants and Children
– The Challenge – Pediatric Patients are dynamic with respect to
drug disposition– Developmental changes in body
composition– Developmental changes in drug metabolism– Developmental changes in organ function
Drug Treatmentfor Infants and Children
– The Challenge – Pediatric patients are different with respect to drug
action– Ontogeny of receptor expression and function– Greater regenerative and recuperative potential– Unique disease processes– Patients with chronic diseases will undergo
growth and developmental changes during therapy
Practical Issuesin Pediatric Drug Dosing
Traditionally pediatric dosing is weight based (mg/kg)
Drug dose will often require change as the child grows
Parenteral dosage forms often require significant dilution prior to administration
Children are often unable to swallow pills or capsules until they are 6 (or 7 or 12 or never) years of age
Practical Issuesin Pediatric Drug Dosing
Complex solid dosage forms (e.g. sustained release preparations) are not engineered with consideration of pediatric GI physiology
Palatability is the major determinant of compliance with treatment with oral liquids and chewable/dissolving dosage forms
Dosing of young children generally depends on parent/guardian
Formulations Availablefor Treating Infants and Children Intravenous
Pediatric Formulation Methods Bona fide pediatric formulations (e.g.,
drops, suspensions, chewable tablets or syrups)
Extemporaneous pediatric formulations made with “standardized” extemporaneous vehicles (e.g., NF, USP, or marketed vehicles)
Extemporaneous pediatric formulations made with food (e.g., sprinkles on applesauce or yogurt)
Determinants of the Typeof Formulation for Children Age Ability to handle solid dosage forms Disease / Disorder being treated
Recommended Drug Formulations for Infants
and Children Oral solutions Oral suspensions Rapidly dissolving tablets Sprinkles/sachets Transcutaneous delivery systems Implantable reservoirs
The Pediatric Holy GrailAn
OralLiquid
Preparation
Statement of thePediatric Pharmacy Advocacy Group
http://www.ppag.org/
For every new chemical entity and currently marketed drug still under patent, with or without safety and effectiveness data in children, where no oral liquid dosage form is available, the manufacturer should be required to provide a formulation that effectively converts an oral solid or intravenous dosage form to an oral solution or suspension dosage form.