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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 Reserve University Chief, Pediatric Pharmacology and Critical Care Rainbow Babies and Children’s Hospital Cleveland, Ohio.

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drug formulation in pediatrics if it tastes bad it must be good for you

Drug Formulationin Pediatrics:If it tastes bad it must be good for you

Jeffrey Blumer, Ph.D., M.D.Professor of Pediatrics and PharmacologyCase Western Reserve University

Chief, Pediatric Pharmacology and Critical CareRainbow Babies and Children’s HospitalCleveland, Ohio

drug treatment for infants and children the challenge
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 treatment for infants and children the challenge1
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 issues in pediatric drug dosing
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 issues in pediatric drug dosing1
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 available for treating infants and children
Intravenous

Solutions

Emulsions

Oral

Solutions

Suspensions

Elixirs

Syrups

Granules

Tablets

Effervescent tablets

Chewable tablets

Drops

Rectal

Solutions

Foams

Cutaneous

Creams

Ointments

Percutaneous

Patches

Formulations Availablefor Treating Infants and Children
pediatric formulation methods
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 type of formulation for children
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
Recommended Drug Formulations for Infantsand Children
  • Oral solutions
  • Oral suspensions
  • Rapidly dissolving tablets
  • Sprinkles/sachets
  • Transcutaneous delivery systems
  • Implantable reservoirs
the pediatric holy grail

The Pediatric Holy Grail

AnOralLiquidPreparation

statement of the pediatric pharmacy advocacy group http www ppag org
Statement of thePediatric Pharmacy Advocacy Grouphttp://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.

pediatric formulation approaches
Pediatric Formulation Approaches
  • Proprietary – Liquids, suspensions, chewable tablets
  • Extemporaneous preparations
    • Compounded with known vehicles
    • Crushed solid dosage forms
oral formulations for children the down side
Oral Formulations for Children– The Down Side –
  • Solutions often contain potentially toxic excipients
  • Suspensions often result in unequal drug delivery over time due to nonuniform dispersal
  • Suspensions often have palatability problems due to both taste and texture
  • Sprinkles/sachets often have erratic absorption
  • Transcutaneous delivery systems depend on uniform nature of integument
issues affecting extemporaneous preparations
Issues Affecting Extemporaneous Preparations
  • Stability
  • Bioavailability
  • Nonuniform composition
  • Variable effect of food
the food myth
The Food Myth
  • Generally accepted that food may affect bioavailability
  • “Not all applesauce is created equal”S. Hirschfeld M.D., Ph.D.
  • Generally little impact
  • No studies dealing with foods children actually eat
results to date
Results to Date

Bona fide

  • Many antivirals
  • Atovaquone/proguanil
  • Ibuprofen/ pseudoephedrine
  • Gabapentin
  • Midazolam

Extemporaneous “standardized”

  • Enalapril
  • Sotalol

Sprinkles

  • Topiramate
  • Montelukast
bona fide applications pediatric antivirals
“Bona Fide” Applications – Pediatric Antivirals

Zidovudine Oral Solution

Didanosine Powder (reconstitute with antacid)

Lamivudine Oral Solution

Abacavir Oral Solution

Nevirapine Suspension

Efavirenz Capsules (50 mg for 7 kg patient)

Ritonavir Solution

Nelfinavir mesylate Oral Powder (mix with foods)

Amprenavir Oral Solution (propylene glycol)

Lopinavir/Ritonavir Oral Solution

Acyclovir Oral Suspension

Ribavirin Powder for Inhalation Solution

Oseltamavir phosphate Suspension