Changing the lives of infants suffering from GERD

Patient Need

Gastro-Esophageal Reflux Disease (GERD) in infants

Effective anti-reflux treatment is required for young infants suffering from GERD. Proton Pump Inhibitors (PPIs) are the most widely used effective medicines

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The Challenges:

  • Existing formulations of Omeprazole are limited to tablets and capsules, which are unsuitable for the treatment of paediatrics / young children, who require a low dose and are unable to swallow tablets/capsules
  • Needs of many infants who require a liquid PPI medicine generally met by extemporaneous formulations (e.g. crushing capsules) with uncertain stability, efficacy, dosing and poor acceptability

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Meeting the unmet need

The development of an oral liquid formulation of omeprazole suitable for pediatric use presents a formidable technical challenge. Omeprazole is unstable in aqueous solutions and also presents challenges with bioavailability (acid-sensitive) and taste-masking. Our proprietary, patented solutions addressed these challenges.

Pedippi®

A novel, patented, immediate release formulation of the gold standard treatment for GERD in age-appropriate, child-friendly form1

PPI approved

First multidose liquid
PPI approved

Children < 1 year

First Proton Pump Inhibitor approved in Europe for children < 1 year

mg/kg dosing

First PPI product approved for dosing on a mg/kg basis

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Reference:

  1. SmPC for Pedippi 2 mg/ml powder for oral suspension (IE). www.hpra.ie
    SmPC for Pedippi 4 mg/ml powder for oral suspension (IE). www.hpra.ie