Related Experiment Video
Updated: Aug 17, 2025
11:27
A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
2.1K
Dose dumping of modified-release solid oral dosage forms.
Summary
This review discusses dose dumping in modified-release drugs, focusing on alcohol and food triggers. It highlights formulation strategies and regulatory guidelines to mitigate this critical issue in solid dosage forms.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Pharmacokinetics
Background:
- Dose dumping, the rapid release of a drug from a modified-release dosage form, is a significant concern.
- This phenomenon can lead to unpredictable pharmacokinetics and potential toxicity.
- Understanding dose dumping is crucial for ensuring the safety and efficacy of modified-release medications.
Approach:
- This review synthesizes findings from international research, experimental studies, and regulatory guidelines.
- It specifically addresses alcohol-induced and food-induced dose dumping.
- The compilation aims to inform a broader audience about this often-overlooked issue.
Key Points:
- Identifies key factors contributing to dose dumping in solid dosage forms.
- Explores various formulation approaches to prevent or minimize dose dumping.
- Discusses the two primary types: alcohol-induced and food-induced dose dumping.
Conclusions:
- Dose dumping is a critical consideration in the development of modified-release drug products.
- Formulation design and understanding influencing factors are essential for mitigation.
- Adherence to current regulatory requirements for testing is paramount for product safety.
Related Concept Videos
01:18Drug Delivery: Enteral Route
589
The enteral drug administration involves three primary routes: oral, sublingual, and buccal. Oral ingestion is the most prevalent, safe, economical, and convenient method for drug administration. However, it has certain drawbacks, including limited absorption due to the drug's low water solubility or poor membrane permeability, possible emesis from GI mucosa irritation, destruction of drugs by digestive enzymes or low gastric pH, and irregular absorption along with food or other drugs.
589
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
177
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...
177
01:18Routes of Drug Administration: Enteral
4.0K
Medications can be administered through the enteral route using liquids, capsules, or tablets.
Enteral administration involves drug administration via the mouth in two ways: orally or sublingually.
Unlike sublingually drugs, drugs that are taken orally pass through the gastrointestinal (GI) tract and get metabolized by the liver. Once metabolized, the drug is absorbed into the systemic circulation, reaching different body parts via the bloodstream. However, while passing through the stomach,...
Enteral administration involves drug administration via the mouth in two ways: orally or sublingually.
Unlike sublingually drugs, drugs that are taken orally pass through the gastrointestinal (GI) tract and get metabolized by the liver. Once metabolized, the drug is absorbed into the systemic circulation, reaching different body parts via the bloodstream. However, while passing through the stomach,...
4.0K
01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
933
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...
933
01:22Drug Delivery: Miscellaneous Routes
432
Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection, and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
432
00:56One-Compartment Open Model for IV Bolus Administration: Estimation of Clearance
121
Clearance is a key pharmacokinetic parameter that quantifies the volume of body fluid from which a drug is entirely removed within a specific time frame. It is crucial in assessing how a drug is eliminated from the body and has critical clinical applications.
In the one-compartment open model for intravenous (IV) bolus administration, clearance is estimated by dividing the elimination rate by the plasma drug concentration. This equation leverages the elimination rate constant and the apparent...
In the one-compartment open model for intravenous (IV) bolus administration, clearance is estimated by dividing the elimination rate by the plasma drug concentration. This equation leverages the elimination rate constant and the apparent...
121