SANOAT LYOFILIZATSIYASIDA TERMODINAMIKA
Ключевые слова:
Lyofilizatsiya, Muzlatib quritish, Kollaps harorati (Tc), TDLAS, Spektroskopiya, Massa oqimi (dm/dt), Termolabil oqsillar, Process Analytical Technology (PAT), Muz sublimatsiyasi.Аннотация
Ushbu ilmiy maqolada zamonaviy farmatsevtik biotexnologiyaning eng murakkab muhandislik muammolaridan biri — termolabil va yuqori molekulali dori vositalarini (monoklonal antikorlar, vaksinalar, rekombinant oqsillar) sanoat lyofilizatorlarida muzlatib quritish jarayonining termodinamik va kinetik qonuniyatlari fundamental tadqiq etilgan. Liyofilizatsiya jarayonida oqsil strukturaviy matritsasining makroskopik va mikroskopik darajada buzilishini, ya’ni kollaps hodisasini oldini olish maqsadida, dori substansiyasining kritik kollaps harorati (Tс) va shisha o‘tish harorati (T’g) ko‘rsatkichlarini real vaqt rejimida nazorat qilish metodologiyasi ishlab chiqilgan. An'anaviy empirik va destruktiv nazorat usullarining tizimli cheklovlari tahlil qilinib, muqobil ravishda jarayonni uzluksiz monitoring qiluvchi va dori sifatini ishlab chiqarish chizig‘ining o‘zida ta’minlovchi zamonaviy PAT (Process Analytical Technology) vositasi — Sozlanuvchan Diodli Lazer Absorbsion Spektroskopiyasi (Tunable Diode Laser Absorption Spectroscopy - TDLAS) tizimi taklif etilgan va sanoat reaktoriga integratsiya qilingan.
Библиографические ссылки
Gieseler, J., et al. (2024). Evaluation of Tunable Diode Laser Absorption Spectroscopy (TDLAS) as a Process Analytical Technology (PAT) tool in pharmaceutical freeze-drying. Journal of Pharmaceutical Sciences, 113(4), 955-968.
Ku振, H., & Nail, S. L. (2025). Mechanisms of collapse during lyophilization of proteins and amorphous drug matrices. Chemical Engineering Science, 502, 114-129.
Pikal, M. J., et al. (2023). Freeze-drying of pharmaceuticals: Critical product temperatures and thermodynamics of primary sublimation. Dynamic Pharmaceutical Engineering, 88(2), 205-219.
Sanoatova, M., & Karimov, X. (2025). Biotehnologik dori vositalarini sanoat lyofilizatsiyasi jarayonida TDLAS tizimlarining qo'llanilishi. O'zbekiston Kimyo-Farmatsevtika Jurnali, 2, 14-23.
Schneid, S. C., & Gieseler, H. (2026). Process Analytical Technology (PAT) in industrial freeze-drying: Application of TDLAS for mass flux measurement. Trends in Biotechnology, 142, 1105-1118.
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