Related Experiment Video
Updated: Jun 28, 2026
05:59
Green Synthesis of Quinoline-Based Ionic Liquid
Published on: September 27, 2024
Biowaiver monographs for immediate release solid oral dosage forms: quinidine sulfate
S Grube1, P Langguth, H E Junginger
1Institute of Pharmacy, Department of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg-University, Mainz, Germany.
Journal of Pharmaceutical Sciences
|November 4, 2008
Summary
A biowaiver for quinidine sulfate immediate-release dosage forms is not recommended due to inconclusive data and the drug
Area of Science:
- Pharmacokinetics and Drug Development
- Pharmaceutical Sciences
- Regulatory Science
Background:
- Review of literature on quinidine sulfate immediate-release (IR) solid oral dosage forms.
- Assessment of factors relevant to in vivo bioequivalence (BE) testing waivers.
Purpose of the Study:
- To evaluate the suitability of a biowaiver for quinidine sulfate IR dosage forms.
- To determine if quinidine sulfate meets criteria for waiving in vivo BE testing for new or reformulated products.
Main Methods:
- Literature review of quinidine sulfate's solubility, permeability, pharmacokinetics, and therapeutic index.
- Analysis of excipient interactions and reported bioequivalence (BE)/bioavailability (BA) issues.
- Assessment against Biopharmaceutics Classification System (BCS) criteria.
Main Results:
- Quinidine sulfate appears highly soluble and moderately to highly permeable, suggesting potential BCS Class I or III classification.
- Available data are not fully conclusive regarding its biopharmaceutical properties.
- Quinidine sulfate has a narrow therapeutic window and critical indications.
Conclusions:
- A biowaiver for quinidine sulfate containing dosage forms is not recommended.
- This applies to both new multisource products and postapproval changes to existing formulations.
- The drug's critical nature and data inconclusiveness outweigh potential biowaiver benefits.
Related Concept Videos
01:13Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
01:22Antiarrhythmic Drugs: Class I Agents as Sodium Channel Blockers
Class I antiarrhythmic drugs are used to treat various types of arrhythmias or irregular heart rhythms. These drugs block the sodium (Na+) channels in the cardiac cells, thereby affecting the movement of electrical impulses across the heart. Class I antiarrhythmic drugs are divided into three subgroups: Class IA, Class IB, and Class IC, each with distinct mechanisms of action and effects on the heart.
Class 1A Antiarrhythmic Drugs: These drugs work by moderately blocking sodium channels,...
Class 1A Antiarrhythmic Drugs: These drugs work by moderately blocking sodium channels,...
01:20Antiarrhythmic Drugs: Class IV Agents as Calcium Channel Blockers
Class IV antiarrhythmic drugs, such as verapamil and diltiazem, block calcium channels. They primarily affect the heart, slowing the conduction in calcium-dependent tissues like the SA and AV nodes. These drugs manage reentrant supraventricular tachycardia (SVT) and reduce ventricular rate in atrial flutter/fibrillation.
Verapamil, a calcium channel blocker, inhibits calcium movement across myocardial cell membranes and vascular smooth muscle. This results in the dilation of coronary and...
Verapamil, a calcium channel blocker, inhibits calcium movement across myocardial cell membranes and vascular smooth muscle. This results in the dilation of coronary and...
01:12Antiarrhythmic Drugs: Class III Agents as Potassium Channel Blockers
Class III antiarrhythmic drugs are a group of medications that can prolong action potentials in the heart. They achieve this by blocking potassium channels or enhancing inward currents from sodium channels. However, these drugs have a unique property of "reverse use-dependence," which is most pronounced at slower heart rates and can lead to torsades de pointes—a specific type of arrhythmia. However, it is essential to note that excessive QT interval prolongation—a measure of the heart's...
01:24Antiarrhythmic Drugs: Class II Agents as β-Adrenergic Blockers
Adrenergic stimulation generally impacts cardiac rate and rhythm. Specifically, stimulation of the β-adrenoceptors triggers an increase in intracellular calcium ion influx and pacemaker currents, which may cause arrhythmias. Catecholamines like adrenaline also demonstrate β2-adrenoceptor-mediated hypokalemia, impacting cardiac action potential and disrupting the normal cardiac rhythm. Class II antiarrhythmic drugs are β-adrenoceptor antagonists or β-blockers, which indirectly block calcium...
01:28IV Infusion to Oral Dosing: Conversion Methods
The development of extended-release formulations has facilitated the transition from intravenous to oral medication, offering a more convenient and patient-friendly approach to drug administration. This transition, however, requires careful management to ensure that therapeutic drug levels are maintained, preserving efficacy and avoiding adverse effects. Understanding pharmacokinetic principles and dosage calculations is critical during this process.Pharmacokinetics of the...