Related Experiment Video
Updated: Mar 15, 2026
05:45
Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
Published on: April 7, 2023
4.5K
Development of rapidly dissolving pellets within the Quality by Design approach.
A A Karatzas1, S N Politis1, D M Rekkas1
1a Faculty of Pharmacy, Department of Pharmaceutical Technology , University of Athens , Athens , Greece.
Drug Development and Industrial Pharmacy
|September 15, 2016
Summary
This study developed novel, fast-dissolving effervescent pellets using direct pelletization and Quality by Design (QbD). Design of Experiments (DoE) optimized the process for a multifunctional formulation platform.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Formulation Science
Background:
- Developing novel multiparticulate platforms is crucial for advanced drug delivery.
- Existing platforms often lack multifunctionality or require complex manufacturing.
- Fast disintegrating and effervescent dosage forms offer improved patient compliance and therapeutic efficacy.
Purpose of the Study:
- To develop novel, fast disintegrating, effervescent pellets using a single-step direct pelletization technique.
- To apply Quality by Design (QbD) principles and statistical experimental design for process and formulation optimization.
- To create a multifunctional formulation platform utilizing only water-soluble excipients.
Main Methods:
- Employed direct pelletization as a single-step manufacturing process.
- Utilized screening fractional factorial and full factorial designs for parameter identification.
- Applied response surface methodology and desirability functions for process optimization.
- Characterized pellets for sphericity, size, and size distribution.
Main Results:
- Identified critical formulation and process variables impacting pellet quality attributes.
- Demonstrated the positive influence of the powder feeder on critical quality attributes (CQAs).
- Optimized formulation and process parameters to achieve pellets with narrow size distribution and a geometric mean diameter of approximately 800 μm.
Conclusions:
- Successfully developed a novel, multifunctional effervescent pellet formulation platform.
- Validated the effectiveness of Design of Experiments (DoE) within the Quality by Design (QbD) framework for lean pharmaceutical development.
- Established a robust and efficient single-step process for producing fast-dissolving, effervescent pellets.
Related Concept Videos
01:22Modified-Release Drug Delivery Systems: Rate-Programmed I
76
Rate-programmed drug delivery systems (DDS) are designed to release drugs at specific, controlled rates to maintain consistent therapeutic levels. These systems are categorized based on their release mechanisms, including dissolution-controlled DDS, diffusion-controlled DDS, and combined dissolution-diffusion-controlled DDS.In dissolution-controlled DDS, the release rate depends on the slow dissolution of the drug itself or the surrounding matrix. Drugs with inherently slow dissolution rates,...
76
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
211
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
211
01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
1.9K
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...
1.9K
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
396
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
396
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
706
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...
706
01:19Modified-Release Drug Delivery Systems: Rate-Programmed II
72
Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
72