Lyophilization

ABOUT AUTHORS: *Naveen Kamboj 1, Sadanand Maurya 2, Sonia Kamboj 3, Gaurav kumar Singh 2 1Chandigarh College of Pharmacy, Landran, Mohali, Panjab 2Transalam Institute of Pharmaceutical Education and Reaserch, Meerut, Uttar Pradesh 3ISF college of pharmacy moga, Punjab * ABSTRACT The most important method for developing the very stable and suitable formulation for thermolabile as well as thermostable drug is lyophilization which works on the principle of sublimation of ice crystal from frozen material. Principle of the process through the basis of formulation, freezing, primary drying and secondary drying . In order to design optimum lyophilization process, process development scientific need to the critical properties of the formulation and how to apply to this information to process design. Lyophilized formulation not only has the advantage of better stability, but also provide easy handling i.e. shipping and storage. This article present an overview of lyophilization process, its advantage and pharmaceutical application. REFERENCE ID: PHARMATUTOR-ART-1844 FREEZE DRYING TECHNOLOGY Historical Overview Drying from the frozen state is not uncommon in nature. In the winter, snow vanishes along the roads in dry cold air without melting. In Central Siberia, scientists have found the large bodies of mammoths that have been progressively freeze-dried during the past 15,000 years. In the Peruvian high plateau, the Incas reportedly stored, in their tambos, meat that had been dried ...

Canning, pickling, freezing, drying, and fermenting are well-known methods of preserving fruits and vegetables for future use. These processes have been used for generations and made simpler and safer over time with the help of science and innovation. Freeze drying (lyophilization) is a more recent option for home food preservation due to the advent of home freeze dry units. HarvestRight, a company in Salt Lake City, Utah, introduced a freeze drying unit for home use in 2018 that has opened new opportunities for home food preservation.Early in 2023, a second company, Prep4Life, introduced a slightly different freeze drying unit for home use known as THE CUBE; Prep4Life is also a Utah based company. Home Freeze Drier unit on display at retail outlet. Freeze drying is not a new process. The process may date back to the 13 th century with the Incas using a simple process to preserve potatoes in the Andes. The first patent was issued in 1934. During World War II it was used to safely transport blood serum and penicillin to the battle field.In the 1950s–1960s, freeze drying began to be viewed as a multi-purpose tool for both pharmaceuticals and food processing and became a major component of space and military rations. Freeze drying has been widely used in the food industry for some time to extend the shelf-life of food while maintaining quality (think berries in commercial cereals that feature real berries) and offer consumers fast meal prep, emergency preparedness, and portab...

The Basics of Lyophilization One of the best ways to store a bacterial, fungal, yeast or other microorganism culture for long periods of time is to use the process of freeze-drying. This short laboratory procedure can be undertaken with any commercially available freeze-dryer that will preserve your culture collection. The Step-by-Step Process of Lyophilization • Grow your overnight culture, or lawn, of the microorganism on Luria broth or other appropriate nutrient agar plates. • Prepare sterile crimp-cap vials by autoclaving (method of sterilizing using steam, pressure and heat) ahead of time, with the caps (rubber stoppers) placed loosely on top. Place paper labels printed with the culture's identification inside the tubes prior to autoclaving. Alternatively, use tubes with caps designed for sterility. • Add 4 milliliters of lyophilization buffer to the plate. If necessary, the cells can be suspended using a sterile glass rod. • Quickly transfer the culture suspension to the sterilized vials. Add approximately 1.5 milliliters per vial. Seal with the rubber cap. • Freeze the culture suspension inside the vials by placing the vials in a freezer set at minus 20 degrees Celsius. • Once the cultures are frozen, prepare the freeze-dryer by turning it on and allowing time for the appropriate temperature and vacuum conditions to stabilize. Do this according to the manufacturer's instructions for the particular brand of freeze-dryer you're using. • Carefully, and aseptically, pla...

• العربية • Български • Català • Čeština • Dansk • Deutsch • Eesti • Español • Esperanto • Euskara • فارسی • Français • Gaeilge • 한국어 • Bahasa Indonesia • Italiano • עברית • Jawa • Қазақша • Latviešu • Lietuvių • Magyar • Nederlands • 日本語 • Norsk bokmål • Polski • Português • Română • Русский • Slovenčina • Slovenščina • Српски / srpski • Suomi • Svenska • Türkçe • Українська • Winaray • 中文 Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature Because of the low temperature used in processing, History [ ] The [ citation needed] Modern freeze drying began as early as 1890 by A significant turning point for freeze drying occurred during Early uses in food [ ] Freeze-dried foods became a major component of Stages of freeze drying [ ] There are four stages in the complete freeze drying process: pretreatment, freezing, primary drying, and secondary drying. Pretreatment [ ] Pretreatment includes any method of treating the product prior to freezing. This may include concentrating the product, In many instances the decision to pretreat a product is based on theoretical knowledge of freeze-drying and its requirements, or is demanded by cycle time or product quality considerations. Freezing and annealing [ ] During the freezing stage, the material is cooled below its [ further explanation needed] or collapse during primary and secondary drying. Structurally sensitive goods [ ] In the case of goods where preservation of structure is required, like food ...

Freeze drying, lyophilization, and cryodesiccation are all terms used to describe the process of removing water from a sample at low temperature. This low-temperature dehydration process maximizes product or sample stability and shelf life, maintains chemical or biological function, and enables easier transportation and storage compared to a cold chain. The process has applications in assay kit development, where it enables room-temperature shipping and storage of reagents and complete assays. Sample stabilization by lyophilization enables the production of pre-dispensed, single-dose reagents, which help: • simplify assay setup, • increase assay robustness and reliability, • reduce the risk of sample contamination What is lyophilization? the triple point of water—the combination of temperature and pressure where the three phases of water (solid, liquid and gas) can co-exist and are equally stable. The lyophilization process typically involves three stages (Fig 1): • Freezing • Primary drying • Secondary drying A product or sample is first frozen with cryoprotective excipients, either in a dedicated freeze dryer or in a freezer at temperatures of approximately -40°C (below the triple point of water). Excipients provide a layer of protection during the freeze-drying process and help maintain stability of the intended function over time. The optimum combination and concentration of excipients are unique to each product or sample. Gradual freezing would usually provide maximum...

• • STELLAR ® Laboratory Freeze Dryer 3.75 to 6.25 sq ft (0.348 to 0.581 sqM) • REVO® Research & Development Freeze Dryer 2 to 12 sq ft (0.186 to 1.115 sqM) • MAGNUM® Pilot Freeze Dryer 10 to 20 sq ft (0.929 to 1.858 sqM) • MAGNUM® XL Pilot Freeze Dryer 20 to 30 sq ft (1.858 to 2.787 sqM) • EPIC™ Small Production Freeze Dryer 15 to 30 sq ft (1.394 to 2.787 sqM) • • Commercialization What is lyophilization? How does it work? Lyophilization and freeze drying are synonymous. Lyophilization is a water removal process typically used to preserve perishable materials, to extend shelf life or make the material more convenient for transport. Lyophilization works by freezing the material, then reducing the pressure and adding heat to allow the frozen water in the material to sublimate. Lyophilization occurs in three phases, with the first and most critical being the freezing phase. Proper lyophilization can reduce drying times by 30%. Freezing Phase There are various methods to freezing the product. Freezing can be done in a freezer, a chilled bath (shell freezer) or on a shelf in the freeze dryer. Cooling the material below its triple point ensures that sublimation, rather than melting, will occur. This preserves its physical form. Lyophilization is easiest to accomplish using large ice crystals, which can be produced by slow freezing or annealing. However, with biological materials, when crystals are too large they may break the cell walls, and that leads to less-than-ideal freeze...

Biosimilars and parenteral generally require drying at the stage of final bulk packaging. But traditional drying techniques can’t be used since they require high heat which can denature such products. So, to overcome this; freeze-drying or Lyophilization method is employed which dry such products using low heat to remove the unnecessary solvents. Page Contents • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Lyophilization Definition Lyophilization is a simple dehydration technique where; • The product mixture is frozen first and • Vacuum is applied to dry the product. Equipment used to conduct the lyophilization process is called Lyophilizer. The ice under the vacuum directly changes to vapor without attaining the liquid phase. This condition helps the product to stabilize. It also minimizes the impact of oxidation that may degrade the product quality. Lyophilization Process The lyophilization process involves three main sub-steps: • Freezing – Ice formation • Primary Drying– Sublimation • Secondary Drying– Desorption One of the major advantages of using Lyophilization is that it consumes less heat for drying the product. Also, the harvested powder has enhanced integrity and stability. However, the major downfall of this process is increased cycle time. Often, pretreatment operations are conducted before starting the lyophilization process to improve final product quality and yield. Let us see the most common pretreatment options. Pre-Treatment Options Preservi...