Related Experiment Video

Updated: Jul 10, 2025

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
09:28

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation

Published on: May 18, 2020

8.5K

Optimisation of the Manufacturing Process of Organic-Solvent-Free Omeprazole Enteric Pellets for the Paediatric

Khadija Rouaz-El-Hajoui1, Encarnación García-Montoya1,2, Andrea López-Urbano1

  • 1Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, 08028 Barcelona, Spain.

Pharmaceutics
|November 25, 2023
PubMed

Insights

Developing stable enteric-coated omeprazole pellets using aqueous dispersions offers a promising alternative for pediatric patients. This approach addresses the challenge of gastro-resistance, improving therapeutic efficacy for this vulnerable population.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Pediatric Formulations

Background:

  • Liquid formulations are common for pediatric patients but pose stability challenges for certain active pharmaceutical ingredients (APIs).
  • Omeprazole lacks a suitable pediatric formulation that meets gastro-resistance requirements, impacting therapeutic efficacy.
  • Current compounded omeprazole formulas for children do not meet necessary gastro-resistance specifications.

Purpose of the Study:

  • To develop stable enteric polymer-coated pellets for omeprazole.
  • To create a pediatric formulation alternative that ensures gastro-resistance.
  • To utilize aqueous coating dispersions, avoiding organic solvents in the coating process.

Main Methods:

  • Experimental study focused on developing enteric polymer-coated pellets.
  • Utilized the Design of Experiments (DoE) method for statistical analysis.
  • Employed a randomized full factorial design (2^2 + 1 central point) with mean weight increases of protective and enteric coating as factors.

Main Results:

  • Successfully developed enteric polymer-coated pellets using aqueous dispersions.
  • The Design of Experiments method facilitated efficient experiment design and analysis.
  • The developed pellets demonstrated potential as an alternative to existing pediatric omeprazole formulations.

Conclusions:

  • The developed enteric-coated omeprazole pellets offer a viable alternative for pediatric use.
  • This formulation approach overcomes the gastro-resistance challenge for omeprazole in children.
  • The use of aqueous dispersions presents a safer and potentially more stable manufacturing process.

Keywords:
design of experiments and paediatric populationenteric coatingomeprazolepellets

More Related Videos

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality05:45

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality

Published on: April 7, 2023

3.4K
A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM13:54

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

Published on: August 18, 2023

4.6K

Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
134
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
208
Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
855
Factors Influencing Drug Absorption: Physicochemical Parameters01:22

Factors Influencing Drug Absorption: Physicochemical Parameters

The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
Enhanced drug absorption can be achieved by reducing particle sizes and increasing surface areas, thereby facilitating...
297