Synergistic quantification of mixed insulin preparations using time domain NMR techniques

Alam H., Ozesme Taylan G., Yamalı C., Öztop H. M.

Journal of Pharmaceutical and Biomedical Analysis, cilt.247, 2024 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 247
  • Basım Tarihi: 2024
  • Doi Numarası: 10.1016/j.jpba.2024.116260
  • Dergi Adı: Journal of Pharmaceutical and Biomedical Analysis
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Analytical Abstracts, Aquatic Science & Fisheries Abstracts (ASFA), BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Chimica, International Pharmaceutical Abstracts, Veterinary Science Database
  • Anahtar Kelimeler: Biotechnological drugs, Humulin, Insulin, Quality control, T1T2 maps, T2 relaxation
  • Orta Doğu Teknik Üniversitesi Adresli: Evet

Özet

Diabetes patients often rely on tailored insulin therapies, necessitating precise blends of various insulin types to achieve optimal pharmacokinetic profiles, including the quantity and action duration of insulin absorption into the bloodstream. This study aimed to develop an accurate quantification method for mixed insulin preparations, consisting of Insulin-NPH and Insulin Regular in ratios varying between 0:100–100:0. Time Domain NMR (TD-NMR) techniques, T2 relaxation times, and T1T2 maps were used to analyze the mixtures. Individually, neither technique provided a reliable determination of insulin ratios. However, the integration of both methods through chemometrics has been proven to be a synergistic approach, yielding a robust quantification technique suitable for quality control in the assessment of mixed insulin drugs. This innovative combined TD-NMR method is non-invasive, cost-effective, and user-friendly, offering at the same time a significant potential for preventing health complications associated with improper insulin dosing. Furthermore, our work elucidates the broader applicability of converging multiple TD-NMR techniques for analyzing intricate mixtures.