Related Experiment Video
Updated: Apr 12, 2026
08:42
Challenges in Rheological Characterization of Highly Concentrated Suspensions — A Case Study for Screen-printing Silver Pastes
Published on: April 10, 2017
19.9K
Using in-line measurement and statistical analyses to predict tablet properties compressed using a Styl'One
Issa Munu1, Andrei L Nicusan2, Jason Crooks3
1School of Chemical Engineering, The University of Birmingham, Edgbaston, Birmingham B15 2TT, UK; GSK Global Supply Chain, Priory St, Ware SG12 0DJ, UK.
International Journal of Pharmaceutics
|December 18, 2024
Summary
This study links in-line measurements during high shear wet granulation (HSWG) to granule and tablet properties. A predictive model for tablet tensile strength proved effective across different compaction simulators, indicating scalability for industrial tablet manufacturing.
Area of Science:
- Pharmaceutical Manufacturing
- Process Analytical Technology (PAT)
- Granulation Science
Background:
- High shear wet granulation (HSWG) is crucial for tablet manufacturing, enhancing powder properties and preventing segregation.
- In-line process analytical technology (PAT) is vital for real-time monitoring and control of complex granulation processes.
Purpose of the Study:
- To establish relationships between Lenterra in-line measurements and resultant granule and tablet properties.
- To investigate granule growth mechanisms during HSWG.
- To develop a predictive model for tablet tensile strength using PAT data.
Main Methods:
- Utilized the Styl'One Evolution compaction simulator to produce tablets, mimicking industrial rotary tablet presses.
- Employed Lenterra in-line measurements to capture particle dynamics.
- Developed a predictive model based on data from a Gamlen tabletting press.
Main Results:
- Identified an induction granule growth mechanism specific to the studied conditions.
- The predictive model achieved high accuracy (R²=0.9535, RMSE=0.4040 MPa) when applied to data from a different compaction simulator (Styl'One Evolution).
- Demonstrated the model's ability to predict tablet tensile strength irrespective of the compaction machine used.
Conclusions:
- The developed model shows high predictability for tablet tensile strength across different compaction equipment.
- Findings suggest significant potential for the model's application in industrial-scale tablet manufacturing.
- This research advances the understanding and monitoring of granulation processes for scalable pharmaceutical production.
Related Concept Videos
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
777
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...
777
01:13In Vitro Drug Dissolution: Compendial Testing Models I
515
Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
515
01:09In Vitro Drug Dissolution: Compendial Testing Models II
597
Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
597
01:14Drug Dissolution: Requirements and Profile Comparison
434
The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
434
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
221
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,...
221
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
405
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...
405