Related Experiment Video
Updated: May 13, 2026
05:44
Formation of Dispersible Taohong Siwu Tablets
Published on: February 3, 2023
Process analytical technology to understand the disintegration behavior of alendronate sodium tablets
Xiaoming Xu1, Abhay Gupta, Vilayat A Sayeed
1Division of Product Quality Research, OTR/OPS, Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Journal of Pharmaceutical Sciences
|March 2, 2013
Summary
This study investigated alendronate tablet disintegration, finding rapid disintegration likely causes esophageal irritation. A new in-line sensor method revealed near-instantaneous disintegration and pH changes, aiding understanding of fast-dissolving drug products.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Analytical Chemistry
Background:
- Alendronate tablets are associated with esophageal irritation, potentially due to rapid disintegration.
- Understanding the disintegration process is crucial for patient safety and drug efficacy.
Purpose of the Study:
- To evaluate the disintegration characteristics of alendronate tablets.
- To assess the utility of a novel in-line sensor testing device for disintegration analysis.
Main Methods:
- Six alendronate tablet drug products were tested using a compendial disintegration method.
- A newly developed testing device with in-line sensors monitored particle count and pH change during disintegration.
- In-house prepared alendronate tablets were also analyzed.
Main Results:
- Significant variation in disintegration times was observed with the compendial method.
- In-line sensors indicated near-instantaneous disintegration (under 2 seconds) for all tested products.
- A rapid drop in solution pH correlated with disintegration, with slower pH changes for slower disintegrating tablets.
- Rapid drug solubilization appears to contribute to fast tablet disintegration.
Conclusions:
- The novel in-line sensor method provides enhanced insights into tablet disintegration and drug solubilization.
- This method, combined with compendial procedures, improves the understanding of fast-dissolving drug products like alendronate tablets.
- Findings suggest rapid disintegration and solubilization are key factors in alendronate tablet behavior.
More Related Videos
Related Concept Videos
01:28Factors 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...
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
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...
01:13In Vitro Drug Dissolution: Compendial Testing Models I
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...
01:14Drug Dissolution: Requirements and Profile Comparison
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...
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
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,...
01:17In Vitro Drug Dissolution: Alternative Methods
Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...