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Related Concept Videos

Steady State Concentration01:05

Steady State Concentration

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A steady state refers to the level of a drug in the body once it has reached an equilibrium between administration and elimination. It represents the point at which the drug administration rate equals the drug elimination rate, resulting in a relatively constant concentration in the body over time. The dynamic equilibrium is crucial to ensure the drug's effectiveness with minimal risk of toxicity.
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Dosage Regimen: Fixed Dose01:01

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Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
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Heart Failure Drugs: Inotropic Agents01:26

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Positive inotropic agents are commonly used as the first line of treatment for heart failure. One such agent is digoxin, derived from the genus Digitalis, which has been known for centuries but effectively utilized since 1785. However, these cardiac glycosides can have potentially toxic effects due to their mechanism of action, which involves inhibiting Na+/K+-ATPase and increasing contractility. Digoxin is absorbed orally and distributed in various tissues, including the CNS. It has a long...
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Rational Dosage Regimen: Maintenance Dose and Loading Dose01:24

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A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
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Nonlinear Pharmacokinetics: Drug Elimination for IV Bolus Injection00:59

Nonlinear Pharmacokinetics: Drug Elimination for IV Bolus Injection

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In pharmacokinetics, the elimination rate of a drug following a capacity-limited model is primarily controlled by two parameters: Vmax and KM. These parameters are crucial in how the drug behaves inside the body after administration.
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We can also...
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One-Compartment Model: IV Infusion01:09

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Intravenous (IV) infusion is often utilized when continuous and controlled drug delivery is necessary, such as during surgery or in the treatment of chronic diseases. This method offers numerous advantages, including immediate drug action, precise control over dosage, and bypassing the first-pass metabolism.
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Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
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Stability of Compounded Digoxin Solution 0.05 mg/mL for Injection.

Mihaela Friciu1, Ruth Bernine Marcelin1, Pascal Bédard2

  • 1Université de Montréal, Montréal, QC, Canada.

Hospital Pharmacy
|May 23, 2022
PubMed
Summary
This summary is machine-generated.

Compounded pediatric digoxin injection (0.05 mg/mL) remained chemically stable for 180 days. This study assessed digoxin stability in diluted formulations, offering a viable alternative after commercial product discontinuation.

Keywords:
digoxininjectionpediatricstability

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Area of Science:

  • Pharmaceutical Science
  • Drug Stability
  • Pediatric Formulations

Background:

  • Commercial pediatric digoxin injection (0.05 mg/mL) was discontinued in 2015.
  • Only adult concentration (0.25 mg/mL) is available, necessitating stable diluted formulations.
  • No prior studies documented long-term chemical stability of diluted digoxin injection.

Purpose of the Study:

  • To assess the chemical stability of a compounded digoxin injection (0.05 mg/mL).
  • To evaluate stability in two different vehicles (normal saline and a commercial vehicle copy).
  • To determine stability at two storage temperatures (5°C and 25°C) over 180 days.

Main Methods:

  • Compounded digoxin 0.05 mg/mL by diluting the 0.25 mg/mL concentration.
  • Stored solutions in normal saline and a commercial vehicle copy.
  • Analyzed chemical stability via HPLC-UV at multiple time points up to 180 days.
  • Assessed organoleptic changes, particulate matter, and sterility.

Main Results:

  • Digoxin concentration remained above 90% of the initial concentration for all preparations throughout 180 days.
  • No observed organoleptic changes or particulate matter issues.
  • All samples met sterility specifications.

Conclusions:

  • Compounded digoxin 0.05 mg/mL is chemically stable for at least 180 days.
  • Stability was confirmed in both normal saline and a commercial vehicle copy.
  • This provides a stable, accessible option for pediatric digoxin injection.