Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children-A Multi-Institutional...

Area of Science:

• Pharmaceutical Sciences
• Pediatric Pharmacy
• Drug Formulation

Background:

• Ensuring the quality and stability of extemporaneously prepared pediatric medications is a significant challenge in clinical practice.
• Crushed and diluted drug preparations require rigorous validation to guarantee patient safety and therapeutic efficacy.

Purpose of the Study:

• To validate a previously established method for the quality-assured preparation of crushed baclofen, clonidine, and hydrocortisone powders from tablets.
• To assess the stability, drug elution, and content uniformity of these preparations under various storage conditions.

Main Methods:

• A multicenter study involving five medical facilities evaluated the preparation method.
• In-hospital preparations were subjected to different crushing and mixing conditions.
• Stability, drug elution, and content uniformity were assessed after 120 days of storage in closed bottles, in-use bottles, and laminated paper.

Main Results:

• All three active pharmaceutical ingredients (baclofen, clonidine, hydrocortisone) remained within 90%-110% of their initial content for 120 days at 25 ± 2 °C and 60 ± 5% relative humidity.
• No changes in dissolution were observed across all formulations prepared at the five facilities.
• Content uniformity was consistently found to be acceptable.

Conclusions:

• The validated preparation method ensures the quality and stability of crushed and diluted pediatric formulations.
• This method can contribute to the reliable preparation of pediatric dosage forms, enhancing medication safety and adherence.