Ensuring quality control in HME, a quantitative analysis of hydrocortisone filament using a portable Raman...

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Materials Science

Background:

• 3D printing enables personalized medication and complex drug formulations.
• Quality control is crucial for the safety and efficacy of 3D-printed drugs.
• Raman spectroscopy offers a powerful tool for analyzing pharmaceutical materials.

Purpose of the Study:

• To develop a quantitative analytical method for hydrocortisone (HCT) concentration in pharmaceutical filaments.
• To adapt a validated HCT quantification method for direct analysis within 3D printing filaments.
• To assess the accuracy and applicability of a portable Raman spectrometer for filament quality control.

Main Methods:

• Established and validated a quantitative method for HCT in solution following ICH guidelines.
• Adapted the method for direct HCT quantification in a filament (20% HCT and excipients).
• Optimized spectral region selection and preprocessing techniques (smoothing, baseline correction, derivatives, EMCSC).

Main Results:

• Successfully adapted a Raman spectroscopy method for HCT quantification directly within the filament.
• Achieved high accuracy for the target HCT concentration across three filament batches.
• Demonstrated a mean absolute error of 2.96% for HCT quantification in the filament.

Conclusions:

• A portable Raman probe is valuable for real-time quality control of pharmaceutical filaments.
• This method ensures the quality of filament used in 3D-printed personalized medicines.
• The developed technique supports the safe and effective production of individualized solid oral dosage forms.