Lyophilization of liposomal drug forms (Review)

Arshinova, O. Yu.; Санарова, Е. В.; Ланцова, А. В.; Оборотова, Н. А.

doi:10.1007/s11094-012-0768-2

Cited by 23 publications

(7 citation statements)

References 53 publications

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“…In the third stage-secondary drying-the bound water is removed until the residual moisture content reaches its target level, ensuring the integrity of the obtained lyophilisate tablet. [11][12][13].…”

Section: -3mentioning

confidence: 99%

Features of the Development of a Lyophilized Injectable Dosage Form of the Original Anticancer Drug LCS-1208

Gulyakin

Ланцова²,

Nikolaeva

et al. 2021

Int J App Pharm

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Objective: Development of a lyophilized injectable dosage form LCS-1208, an original antitumor drug based on an indolocarbazole derivative. Methods: The prepared solution of the injectable dosage form LCS-1208 is transferred to sterilizing filtration, which is carried out under vacuum on a «Stericup» filter unit with a filter pore size of 0.22 μm. The sterile solution of the injectable dosage form LCS-1208 is poured into sterile vials using a dispenser and lyophilized in a freeze-drying chamber. At the end of drying, the preparation is corked in the chamber of a sublimation unit using a hydraulic device and transferred to crimping with aluminum caps using a seaming machine. Quantitative determination of the drug content was determined by spectrophotometry using a standard sample at λ = 320±2 nm. The pH was determined by potentiometry. Results: A freeze-drying regimen for the injectable dosage form LCS-1208 has been developed. The required solution freezing temperature was established taking into account the presence of 2 eutectic zones: a solution of LCS-1208 in DMSO (-35 ÷-32) °С, an aqueous solution of Kollidon 17PF (-10 ÷-8) °С. As a result of a series of experiments, the optimal lyophilization regime was chosen that does not require preliminary freezing in a low-temperature chamber, with freezing on the shelves of freeze-drying at a temperature of-47 °C without their preliminary cooling. The most acceptable vial filling volume was determined, amounting to 3 ml, and the rate of temperature rise during secondary drying of the preparation was justified. When using the developed regime of lyophilization of the LCS-1208 solution, it was shown that it can be sublimated while preserving the initial qualitative and quantitative characteristics. Conclusion: In this article, using the example of creating a lyophilized injectable dosage form LCS-1208 (the original antitumor drug from the indolocarbazole group), the main problems that arose during the lyophilization of the selected composition of the model solution, as well as ways to improve the process.

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Section: -3mentioning

confidence: 99%

Features of the Development of a Lyophilized Injectable Dosage Form of the Original Anticancer Drug LCS-1208

Gulyakin

Ланцова²,

Nikolaeva

et al. 2021

Int J App Pharm

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“…Liyofilizasyon ile oluşabilecek mutasyonların önüne geçmek için, kurutma vasatının içerisine sülfhidril'den zengin bileşiklerin katılmasına ihtiyaç duyulabilmektedir. Ayrıca bazı hassas biyolojik materyaller ise aşırı kurutulduğunda inaktif olabilmektedirler [5,11,26].…”

Section: Mikroorganizmaların Liyofilizasyona Yanıtıunclassified

Biyolojik Maddelerin Kurutularak Saklanması: Liyofilizasyon

Ergün¹

2015

Etlik Veteriner Mikrobiyoloji Dergisi

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Organik maddelerden suyun uzaklaştırılması sürecini tanımlayan liyofilizasyon, günümüzde tüm dünyada gerek sağlık endüstrisinde ve gerekse gıda endüstrisinde çok fazla kullanım alanı bulan bir tekniktir. Bu teknikte azaltılmış basınç (vakum) altında, dondurulmuş haldeki solüsyonlardan suyun uzaklaştırılması ile biyolojik maddeler ve gıdalar, bozulma meydana gelmeden uzun süre saklanabilmektedir. Liyofilizasyonun, uzun bir süreç olması, sıcaklık ve basıncın içinde bulunduğu hassas dengeler üzerine kurulmuş olması gibi dezavantajları bulunmasına rağmen halen dünyada sıklıkla kullanılan bir yöntemdir. Bu teknik, aslen eski bir yöntem olmasına karşın biyolojik ve organik maddelerin saklanmasına ilişkin daha etkin bir teknik geliştirilemediğinden günümüzde tüm dünyada halen etkinliğini ve önemini korumaktadır. Bununla birlikte prensipte aynı olmakla birlikte liyofilizasyon teknolojisi sürekli geliştirilmektedir.Anahtar kelimeler: Liyofilizasyon, liyofilizasyon basamakları, liyofilizasyon dezavantaj/avantajı, liyofilizasyon mekanizması, liyofilizasyon metotları (dondurma, birincil kurutma, ikincil kurutma) Protection of biological materials by drying: LyophilizationSummary: Lyophilization which defines the process of evaporating the water from organic materials is a widely used technique over the world including health and food industries. This technique provides long term storing of biological materials and food by removing the water from frozen solutions under low pressure (vacuum). Although lyophilization has some disadvantages such as being a time taking process and built delicate balances involving temperature and pressure, it is still commonly used over the world. Even though it is originally an old technique, there has not been developed a more effective technique for long term storing of biological and organic materials yet. For this reason, lyophilization still protect its importance and effectiveness. Though their basic principles are the same, novel lyophilization techniques are continuously developing.

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“…Of course, in natural cells, lipids are closely associated with water and the role of hydration in lipid structures is beginning to be understood . Lyophilizing, or freeze drying, is well‐known method to preserve a hydrated molecular structure after water removal; such preserved moieties can later be reconstituted for use, including drug delivery, protein‐based drugs, and vaccines . To investigate the role of water in molecular structure and stabilization, the interactions between lipids and water have been measured by conventional differential scanning calorimetry (DSC), small‐angle X‐ray scattering (SAXS), fourier transform infrared spectroscopy (FTIR), and neutron diffraction .…”

Section: Introductionmentioning

confidence: 99%