Risperidone Pellets, Pycnogenol^®, and Glucomannan Gummy Formulation for Managing Weight Gain and ADHD in Autistic...

Area of Science:

• Pharmaceutical Technology
• Pediatric Formulations
• Drug Delivery Systems

Background:

• Risperidone is an atypical antipsychotic used for schizophrenia and autism-related irritability.
• Pediatric patients often face challenges with traditional oral medications.
• Medicated gummies offer a potentially more acceptable and effective dosage form for children.

Purpose of the Study:

• To develop and characterize novel Risperidone-loaded medicated gummies for pediatric use.
• To evaluate the controlled-release properties of Risperidone from gummy formulations.
• To assess the suitability of gummy formulations for improving pediatric medication adherence.

Main Methods:

• Development of two gummy bases using Glucomannan and Gelatin.
• Loading gummy bases with coated Risperidone pellets featuring a controlled-release layer.
• Evaluation of physical properties (pH, viscosity) and chemical properties (content uniformity, drug content, dissolution profile).

Main Results:

• Both gummy formulations (F1 and F2) exhibited appropriate rheology and met uniformity standards.
• Acidic media showed limited Risperidone release (25% for F1, 11% for F2 after 2 hours).
• Complete drug release over 24 hours was observed at pH 6.8 for both formulations.

Conclusions:

• Chewable semi-solid gummy formulations containing coated Risperidone pellets are suitable for pediatric patients.
• High gastro-resistance coated pellets ensure proper drug release and can help overcome pediatric medication challenges.
• These novel gummies represent a promising alternative for pediatric Risperidone administration.