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Dr. Vandana B.

Patravale
(Professor of Pharmaceutics)
Institute of Chemical Technology Mumbai, India

Zetasizer Nano ZS

Non-invasive back scatter (NIBS) technology takes particle sizing to new levels of sensitivity in the 0.6nm to 6 micron range. The new Zetasizer Nano ZS is the choice for the accurate, reliable and repeatable size analysis of particles and molecules in solution. Advantage includes determination of Colloid size and size distribution of Pharmaceuticals, Nanoparticles, Emulsions etc with little or no dilution of the sample. The new Zetasizer Nano ZS offers the highest ever sensitivity, accuracy and resolution for the measurement of zeta potential. This is achieved by a combination of laser Doppler velocimetry and phase analysis light scattering (PALS) in Malverns patented M3-PALS technique. Even samples of very low mobility can be analyzed and their mobility distributions calculated. Measurement of zeta potential can be used to determine Emulsion stability, Formulation stability, Pigment performance, Impurity determination

etc Using static light scattering (SLS) and the classical Debye plot, the molecular weight of random coiled polymers up to 5 x 105 Da as well as globular polymers and proteins up to 2 x 107 Da can be determined without the necessity for multi-angle measurements. The instrument can be used to advantage in Protein crystal screening, 2nd virial coefficient determination, Oligomer identification, Protein-melting point determination etc Applications The Zetasizer can measure three of the most important parameters for the colloid and polymer chemist: Particle size Light Zeta of particles and molecules from 0.6nm to 6 microns using NIBS technology and Dynamic Scattering in aqueous and non-aqueous dispersions using M3-PALS technology

potential -

Molecular weight - An absolute measurement using Static Light Scattering and the sensitivity from an avalanche-photodiode detector and fibre detection optics The Zetasizer Nano ZS is the pinnacle of the Malvern Zetasizer Nano series and can measure all three parameters with no performance compromises. The new technology incorporated in these systems provides unequalled sensitivity and versatility. The patented NIBS optics incorporated into the Nano Z. The unique disposable zeta potential cell ensures no cross contamination of samples. Freeze Dryer

Pharmaceutical and biotechnology Pharmaceutical companies often use freeze-drying to increase the shelf life of products, such as vaccines and other injectables. By removing the water from the material and sealing the material in a vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. Pharmaceutical Industry

Nanotechnology Freeze-drying has been considered as a good technique to improve the long-term stability of colloidal

nanoparticles. The poor stability in an aqueous medium of these systems forms a real barrier against the clinical use of nanoparticles. the major obstacle that limits the use of these nanoparticles is due to the physical instability (aggregation/particle fusion) and/or to the chemical instability (hydrolysis of polymer materials forming the nanoparticles, drug leakage of nanoparticles and chemical reactivity of medicine during the storage) which are frequently noticed when these nanoparticle aqueous suspensions are stored for an extended periods Food Industry Freeze-drying is used to preserve food and make it very lightweight. The process has been popularized in the forms of freeze-dried ice cream, an example of astronaut food. It is also popular and convenient for hikers because the reduced weight allows them to carry more food and reconstitute it with available water. Instant coffee is sometimes freeze-dried, despite high costs of freeze-dryers. The coffee is often dried by vaporization in a hot air flow, or by projection on hot metallic plates. Freeze-dried fruit is used in some breakfast cereal. However, the freeze-drying process is used more commonly in the pharmaceutical industry. Technological Industry In chemical synthesis, products are often lyophilized to make them more stable, or easier to dissolve in water for subsequent use. In bioseparations, freeze-drying can be used also as a late-stage purification procedure, because it can effectively remove solvents. Furthermore, it is capable of concentrating substances with low molecular weights that are too small to be removed by a filtration membrane. Freeze-drying is a relatively expensive process. The equipment is about three times as expensive as the equipment used for other separation processes, and the high energy demands lead to high energy costs. Furthermore, freeze-drying also has a long process time, because the addition of too much heat to the material can cause melting or structural deformations. Therefore, freeze-drying is often reserved for materials that are heat-sensitive, such as proteins, enzymes,microorganisms, and blood plasma. The low operating temperature of the process leads to minimal damage of these heat-sensitive products. High-Pressure Homogenizer

Pharmaceutical Homogenizer Applications Homogenization (known in the pharmaceutical industry as micronization) is the process of reducing the particle sizes of pharmaceutical products, under very high pressures, sheer, turbulence, acceleration and impact, to make them more stable and clinically effective. The bioavailability of the product increases and the tolerance of some otherwise borderline drugs can improve. The emulsion, suspension or solution is pumped into the high-pressure homogenizer after which it is forced through a special homogenization valve at extremely high pressures (up to 1,500 bar / 21,750 PSI). The particles enter the homogenizer with 500 m maximum sizes, after the treatment the large particles are dispersed

and reduced, the particle size typically range from 0.4 to 1 micron depending on the specific application. High-pressure homogenization in the pharmaceutical industry has proven its ability to make more stable product, with better active ingredient dispersion, than has been achieved with conventional stirrers, rotorstator devices or colloid mills. This is achieved by reducing the particle size and uniformity under conditions of extreme pressure and stress. The result is a more clinically effective product with greater stability and shelf life. Typical Cosmetic, Biotech and Pharma Applications: Antibiotics Ointments Beauty creams Perfumes Cosmetics Proteins Liposome suspensions Soaps (liquid/bar) Lotion Syrups Enzymes Bacteria API (Active Pharmaceutical Ingredients) Medicinal syrups Toothpaste Moisture creams Vitamins Nail varnishes Shampoo Cream New-age health products Viruses Food and Dairy Applications High-pressure homogenization is an important sanitary process stage in the treatment of food, dairy, food ingredients, and nutraceutical (nutritional) products. It provides improved product stability, shelf life, digestion, and taste. Homogenizing effects can also significantly reduce the amount of additives required. It is often essential in preparing feeds so that subsequent spray drying produces the best quality of powders. This is especially the case with baby foods and many dairy / food products. Homogenization is the process of reducing the particle size of fluid products such as milk, fruit juice and sauces, under conditions of extreme pressure, sheer, turbulence, acceleration and impact, to make them more stable and have a better texture. The effect is achieved by forcing the product through a special homogenizing valve at a very high pressure. Particles enter the homogenizer with sizes ranging typically from 0.2 - 20 microns. Large particles are dispersed to produce a product with particles ranging typically from 0.4 to 1 micron depending on the application. High Speed Ultra-Turrax

Dispersion is simply the transport of one phase or ingredient (liquid, solid, gas) into a main continuous

phase (typically liquid), with which it would normally be immiscible. The fluid is said to be homogenized when sufficient energy input results in a final product that resembles a mono-dispersion fluid, with no differentiation between separate components. The system is considered colloidal when one or more of the components has at least one dimension that is less than a micrometer (10-6 m). In liquid mixing, we can classify the various systems as Suspensions (Solid/Liquid), Emulsions (Liquid/Liquid) and Foams (Gas/Liquid). High shear mixers create an intense, concentrated energy input that can produce a superior dispersion in significantly less time than traditional mixing methods. Cosmetic Applications Creams, Ointments, and Lotions Creams, ointments, and lotions include a wide variety of products, which are manufactured in a similar manner. The process generally involves dispersion and hydration of thickening agents, colors, perfumes, and active ingredients into either an oil or water phase. The two phases are then emulsified, cooled, and packaged. The challenges to the manufacturer are to effectively hydrate all the powders (which are often difficult to disperse), emulsify the phases, and maintain a consistent product. Creams, Ointments, Lotions Tooth Paste, Lacquers Flavors and Preservatives Suspending -Wet Milling (Solid-Liquid) Suspending is dispersing of solid particles in a liquid. It is often desirable to reduce the particle size of the solids in conjunction with dispersing, and this is often referred to as wet milling. With the use of high shear mixers and sufficient energy input, the final product will become homogenized. Emulsifying (Liquid-Liquid Systems) Emulsifying is the process of dispersing one liquid in a second immiscible liquid, such as oil dispersed in water. A colloidal suspension is a system comprising particles dispersed in a liquid that do not settle out of solution due to their extremely small size of less than one micrometer. In order to achieve the stable emulsion, a suitable amount of energy input is required to produce the droplet size that is necessary. A few examples of some common emulsions are: Ice cream Proteins Creams and Lotions Salad dressings and sauces Micro-encapsulations Paraffin Cosmetics Mineral oils Pesticides and herbicides Micro/Nanocolloids Dissolving Molecular/Colloidal Below is a list of some typical dissolving applications: Dyes Crystal powders Salts Sugar Detergents Binding agents Hydrocolloids Elastomers Resins Thixotropic agents Powder-Liquid Incorporation Incorporating powders into liquids offers many challenges to processors. The powders may be difficult to wet out, and may produce fish-eyes if not effectively dispersed into the liquid. The powders are often added to a vessel by dumping bags into the top, creating a plume of dust and creating a possible health hazard. Blenders, and other powder addition equipment will often clog, or not perform as well as desired, or the system is too complex to clean and maintain. Starches Milk solids Sugar Cellulose Carbopol Spray Driers

Spray drying is a commonly used method of drying a liquid feed through a hot gas. Typically, this hot gas is air, but sensitive materials such as pharmaceuticals, and solvents like ethanol require oxygen-free drying and nitrogen gas is used instead. The liquid feed varies depending on the material being dried and is not limited to food or pharmaceutical products, and may be a solution, colloid or suspension. This process of drying is a one step rapid process and eliminates additional processing. The liquid feed is pumped through an atomiser device that produces fine droplets into the main drying chamber. Atomisers vary with rotary, single fluid, two-fluid, and Ultrasonic Nozzle designs. These different styles have different advantages and disadvantages depending on the application of the spray drying required. In some instances a Spray Nozzle is used in place of an atomiser for a different dispersion rate. The hot drying gas can be passed as a co-current or counter-current flow to the atomiser direction. The cocurrent flow enables the particles to have a lower residence time within the system and the particle separator (typically a cyclone device) operates more efficiently. The counter-current flow method enables a greater residence time of the particles in the chamber and usually is paired with a fluidised bed system. Spray-drying is a common technique used in pharmaceuticals to produce a dry powder from a liquid phase [1]. This technique has also been employed as a microencapsulation method because it can be adapted to the development of different systems, microspheres or microcapsules, depending on the initial aqueous formulation, a solution, a suspension or an emulsion [2]. Another application is its use as a preservation method, increasing the storage stability due to the water elimination. In addition, drying polymeric nanoparticles using spray-drying technique is a promising platform to improve the physicochemical stability of formulations and/or to control the release of drugs. It is often used as an encapsulation technique by the food and pharmaceutical industries. The application of the spray drying encapsulation technique is to prepare "dehydrated" powders of substances which do not have any water to dehydrate. For example, instant drink mixes are spray dries of the various chemicals which make up the beverage. The technique was once used to remove water from food products; for instance, in the preparation of dehydrated milk. Recent research is now suggesting that the use of spraydrying techniques may be an alternative method for crystallisation of amorphous powders during the drying

process since the temperature effects on the amorphous powders may be significant depending on drying residence times. Application For R&D and Food Perfumes Broad range Spray drying Microencapsulation Recovery of Ultracentrifuge fields Pharmaceuticals Herbals Biochemicals Flavors Standardisation Products of and and synthetic and micronization coating extracted Applications Ayurvedics

products

Optima MAX-XP is the right choice for wide variety of applications. Capable of handling volumes from as little as 175 L to 108 mL, this versatile bench top ultracentrifuge excels at separation of: Sub-cellular particles (pelleting, rate-zonal gradient) Viruses (pelleting, rate-zonal gradient) Protein purification/isolation (pelleting, rate zonal gradient) DNA (pelleting, CsCI isopycnic) RNA (CsCI pelleting, density gradient) Lipoproteins (differential flotation or gradient) Supercritical Fluid Extractor cum Nanoparticles Generator

Supercritical fluid extraction processing shows numerous advantages when compared to traditional organic solvent extraction. In traditional extraction, for example, the residual solvent is unavoidable. In supercritical fluid extraction, however, there is no residual solvent in the final product. This translates into lower operating costs because of the reduction in postprocessing steps, cleanup and safety measurements. Additionally, because CO2 processing requires low temperatures, there is less deterioration of heat sensitive components in the extract. Furthermore, since there is no oxygen in the process, the potential for oxidation of the extract is significantly minimized. The laboratory supercritical fluid extraction (SFE) system scale models start from 100 mL up to 10 L. Models can include cosolvent pump, fractionation and recycling. Food and Pharmaceutical Industries Decaffeinating of coffee and tea Extraction of essential oils (vegetable and fish oils) Extraction of flavors from natural resources (nutraceuticals) Extraction of ingredients from spices and red peppers Extraction of fat from food products Fractionation of polymeric materials Extraction from natural products Photoresist cleaning Precision part cleaning Minimate TFF System

TFF stands for Tangential Flow Filtration, a rapid and efficient method for separation and purification of biomolecules/macromolecules. It is a pressure-driven, size-based, membrane separation process. With TFF, the sample mixture is not forced through the membrane in a single pass as in direct flow filtration (DFF). Instead, the flow is continuously recirculated for multiple, tangential passes across the membrane surface. This sweeping action, driven by applied pressure, reduces the build up of starting material on the surface of the membrane. Target molecules larger than the molecular weight cutoff (MWCO) of the membrane are retained, while small molecules and buffer pass through the membrane. TFF is an effective method to concentrate and diafilter (desalt) sample solutions ranging in volume from 10 mL to thousands of liters. It can be used to fractionate large from small biomolecules, harvest cell suspensions, and clarify fermentation broths and cell lysates. TFF can be applied to a wide range of applications in protein chemistry, molecular biology, immunology, biochemistry, and microbiology. It can be applied to a wide range of biological fields such as immunology, protein chemistry, molecular biology, biochemistry, and microbiology. Applications Concentrate and desalt proteins, peptides, or nucleic acids (DNA, RNA, oligonucleotides) Recover antibodies or recombinant proteins from clarified cell culture media Process metal sensitive enzymes and molecules Separate (fractionate) large from small biomolecules Recover or remove viruses from solutions Prepare samples prior to column chromatography Concentrate samples after gel filtration Replace dialysis applications Depyrogenate water, buffers, and media solutions Other Facilities/Instruments High Performance Liquid Chromatography (HPLC) with UV, PDA, Fluorescence Detectors Dissolution Testing Apparatus USP Controlled Orbital Shaker Centrifuge Central Pharmaceutical Departmental Facilities Single Station Tablet Presses Fluidized Bed Dryer Viscometer Dissolution Rate Apparatus Spheronizer Infra-Red Spectrophotometer Digital Polarimeter Skin Permeation System APV-Gaulin Homogeniser Particle Size Analyzer Mastersizer Mixer Mathis Lab Coater Spray Drier Atomic Absorption Spectroscopy Gel Permeation Chromatography

Stability Chambers DSC Gas Chromatography UV-Visible Double Beam Spectrophotometer

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