Application of Dominance-Based Rough Set Approach for Optimization of Pellets Tableting Process
Maciej Karolak1, Łukasz Pałkowski1, Bartłomiej Kubiak2
1Department of Pharmaceutical Technology, Collegium Medicum, Nicolaus Copernicus University, 85-089 Bydgoszcz, Poland.
Pharmaceutics
|October 29, 2020
Summary
Multiple-unit pellet systems (MUPS) maintain drug release profiles after tableting. Optimal formulation involves specific polymer coatings, compression forces above 6 kN, and excipients like microcrystalline cellulose for consistent API delivery.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Multiple-unit pellet systems (MUPS) offer advantages over conventional solid dosage forms.
- MUPS enable controlled release of active pharmaceutical ingredients (APIs) and patient convenience.
- Maintaining API release profiles during MUPS compression is a significant challenge.
Purpose of the Study:
- To explore relationships between formulation/process parameters and MUPS quality.
- To apply data mining (dominance-based rough set approach - DRSA) to identify critical factors for API release.
- To discover cause-effect relationships for optimal MUPS development.
Main Methods:
- Application of dominance-based rough set approach (DRSA) for data mining.
- Analysis of MUPS composition, properties, and process parameters.
- Evaluation of API release profile using similarity factor (f2).
Main Results:
- DRSA generated decision rules linking formulation and process attributes to API release.
- Optimal conditions include specific polymer coatings (Eudragit NE, no ethyl cellulose), compression force >6 kN, Avicel 102 excipient, and tablet hardness ≥42.4 N.
- These conditions ensure similar API release profiles before and after tableting.
Conclusions:
- DRSA is effective for analyzing complex pharmaceutical technological data.
- Identified decision rules aid technologists in optimizing MUPS formulation development.
- Proper selection of polymers, compression force, excipients, and hardness ensures consistent drug release from MUPS.
Keywords:
DRSAdata miningknowledge discoverymachine learningmultiple-unit pellet systempharmaceutical technologytabletsMore Related Videos
05:45Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
Published on: April 7, 2023
4.0K
06:00Optimization of the Epimedii Folium Mutton-Oil Processing Technology and Testing Its Effect on Zebrafish Embryonic Development
Published on: March 17, 2023
720
Related Concept Videos
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
98
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...
98
01:24Factors Affecting Workability
209
The workability of concrete is a critical characteristic that influences the ease of mixing, handling, and finishing the concrete. It is affected by several factors including water content, aggregate properties, and admixtures like air entrainment. Water plays a fundamental role as it lubricates the concrete mix, facilitating easier movement and placement. However, the water requirement varies depending on the texture and shape of aggregates. Finer particles and angular, rough-textured...
209
01:24Design Example: Aggregate Gradation
238
The right type and quality of aggregates are crucial for concrete as they significantly influence its properties, mix proportions, and cost-effectiveness. If different sources are available for sand, the commonly used fine aggregate in concrete, the selection of sand is primarily based on its gradation.
The grading, or particle-size distribution, of sand is determined using sieve analysis, with standard sizes ranging from 150 μm to 10 mm (ASTM No. 100 sieve to 3⁄8 in. sieve). Sand is...
The grading, or particle-size distribution, of sand is determined using sieve analysis, with standard sizes ranging from 150 μm to 10 mm (ASTM No. 100 sieve to 3⁄8 in. sieve). Sand is...
238
01:16Response Surface Methodology
461
Response Surface Methodology (RSM) is a collection of statistical and mathematical techniques used to develop, improve, and optimize processes. It is particularly valuable when many input variables or factors potentially influence a response variable.
The process of RSM involves several key steps:
The process of RSM involves several key steps:
461
01:16Precipitate Formation and Particle Size Control
3.7K
In precipitation gravimetry, the precipitating agent should react specifically or selectively with the analyte. While a specific reagent reacts with the analyte alone, a selective reagent can react with a limited number of chemical species.
The obtained precipitate should be either a pure substance of known composition or easily converted to one by a simple process, such as ignition or drying. In addition, the precipitate should be insoluble and easily filterable. In general, filterability...
The obtained precipitate should be either a pure substance of known composition or easily converted to one by a simple process, such as ignition or drying. In addition, the precipitate should be insoluble and easily filterable. In general, filterability...
3.7K
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
294
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...
294