4. Only solid binders are practically useful for granulation applications.
Additionally, it was noticeable that the 3-axis mixer and the Y-mixer presented more similar results than the ones obtained from the plastic bag, showing that automation increases the reliability of the mixing process. The results showed that the use of the 3-axis mixer was superior, or at least comparable, to the alternative methods (Figure 3) through the evaluation of the content uniformity among the capsules. In this scenario, in a general manner, all conditions tested (mixing time: from 2 to 8 min; speed range: from 10 to 100 rpm) were able to produce homogeneous powder mixtures, as can be evidenced by the CU of the capsules produced with such mixtures.
As the majority of the United States Pharmacopeia [8] and European Pharmacopoeia [9] monographs consider the acceptance range for finished products to be not less than 90% and not more than 110% of the labeled amount of the API, this was also considered to be indicative of the efficiency of the mixing process. Contact our engineers today to discuss how high shear mixers from Lancaster Products can solve your problem. In this paper, we evaluated the mixing efficacy of a new 3-axis mixer device and determined its optimal working conditions. Asachi M., Nourafkan E., Hassanpour A. Web page addresses and e-mail addresses turn into links automatically. As each granule contains the original formulation, we can consider that the homogeneity of the final product stays consistent, even if the separation of the coarse and the fine granules occur in a two-way or three-way collection system spray dryer (chamber, cyclone, and dust-house). It is often desirable to mix a powder and its frozen binder liquid particles at a below granulation speed to obtain a homogeneous powder mix and then increase mixing speed to achieve homogeneous granulation. The standard method to characterize flow properties of solid materials is the shear testing that provides the information for the yield locus of the solid in question. It can be used in a shaker to sprinkle in foods while cooking without dusting and forming lumps. It is critical that all specifications for homogeneity are met during the initial blending stage to avoid compounded issues in subsequent processes such as curing and extruding.
Going beyond just a mix of powders, wet mixing accepts different forms of raw materials, such as powders, liquids, suspensions, and/or colloids, giving more flexibility to the formulation. They can be dissolved in water or water-alcohol mixtures to form binder liquids. 08/103,704 filed on Aug. 9, 1993. Registered in England and Wales. Although there was a general positive result for all the tested ranges of conditions, it is possible to observe that some formulations were more homogeneous than others, for example, comparing the finasteride results and the multimineral results. 5. The invention relates to a method to achieve high homogeneity of mixing of liquids with powders in a mechanical mixer. Received 2021 Mar 30; Accepted 2021 Apr 15. Three different formulations were compounded with the device and a total of 540 individual assays were performed by HPLC or ICP-MS to validate its use, in addition to a direct comparison among it and two alternative mixing methods. On the basis of the outcomes of this study, we can conclude that the 3-axis mixer device was able to provide homogeneous mixtures and finished capsules with adequate content uniformity with a broad range of conditions of use (mixing times from 2 to 8 min, and speed of rotation from 10 to 100 rpm) regarding the tested formulations. Such applications often require only homogeneous mixing of a powder with a very small quantity of liquid, without changing its powder's form. Conceptualization, B.M. One method is dry mixing and the other is wet mixing followed by spray drying of the mixed slurry. 6. Besides, this invention can utilize very thick, such as cream-like and paste-like, binder liquids, such as food gum solutions, since they can be frozen and ground into easy to handle frozen particles, to granulate powder compositions. ; Validation, B.M., H.P. The powder and the liquid are mixed and/or granulated continuously in its intense mixing chamber, which contains fast rotating bars or pins, such as the Turbulizer of Bepex. A teaspoonful corn starch is dispersed in about 150 ml water and cooked in a microwave oven to form a soft paste. Even minor imperfections in the mix can compromise the overall performance requirements of demanding end products such as technical ceramics or precision flat panel glass. The mechanical mixing method of claim 1 wherein said frozen liquid is selected from the group consisting of ice, frozen water solution and frozen water alcohol solution of an intense sweetener, a high potency drug, a flavoring agent, a fertilizer, or a pesticide. However, alternative methods are also available, such as the use of small-volume V-shaped or Y-shaped mixers, or even the rudimentary use of manually agitated plastic bags [5,6]. Water and water solutions of solids, liquids, and gases are, however, the most useful and practical frozen liquids of this invention.
There are mechanical mixers whose container also rotates to enhance mixing and granulation actions, such as the Mix Pelletizer of Eirich Machine. Mixing frozen liquid particles with powder instead of spraying liquid on powder in a mechanical mixer results in improving mixing homogeneity, reducing processing time, and simplifying mixing equipment and method. Flowability can never be expressed as a single value or index. The frozen liquid mixing method of this invention eliminates the need of a liquid delivery system, such as spraying nozzle with pressurized air atomizing system and its associated problems, such as dust, expenses, and time consuming. There is, therefore, a need of improvement of the mixing homogeneity of mechanical mixing and granulation methods which add liquids to powders and a need of a method to mix viscous liquids with powders. This article provides some illustrations of the characteristics of two different mixing methods for powders. The funder (Fagron B.V.) had no influence on the design of the study and in the collection and analyses of data. All authors have read and agreed to the published version of the manuscript. This can be explained because the powders can have different particle size and size distribution, density, surface morphology, and particle shape, which are some of the factors that influence powder flow [11]. It is difficult to add viscous liquid to and disperse it in powders. The mechanical mixing method of claim 1 wherein said frozen liquid particles have a spherical shape made by freezing fine liquid droplets dropping out of fine needle holes. and H.P. For adding a solvent to slow dissolving powders, there is a time delay for binding effect to fully develop. Products of this type are made either with very expensive mixing methods, such as multiple step mixing and fluid-bed granulation, or having poor content uniformity. It is necessary, therefore, to add binder liquid slowly, for obtaining up more uniform granular particle sizes. For that, the capsules were compounded again using the optimal condition previously defined for the device, and two alternative methods were used to verify which one provided the best homogeneity (in terms of the AV) for the formulations. Thus, dusting segregation occurs due to the difference in particle size between coarser and fine particles and their ability to suspend in the air as the blend material is discharged from the mixer or charged and discharged from the storage bin.
of solids are also determined from the yield loci. Pharmaceutical industries need to provide evidence of the validation of the production process, and this includes objective parameters that attest to the homogeneity of the mixtures and the consequent uniformity of the final dosage forms. The reason being is that the droplets formed through the atomizer wheel or spray nozzle will lead into granules containing the exact formulation made in the slurry. Careers. After determining the spread of composition, the results are reported as the variance. The efficacy of the 3-axis mixer device was evaluated through its capacity to produce homogeneous powder mixtures for hard-shell capsules filling.
Instead of adding liquid, which dissolves and aggromerates some powder particles instantaneously upon contact, the inventive method adds frozen powder or granular particles of liquids. The mechanical mixing method of claim 1 comprising the steps of: a. adding dry powder to a mechanical mixer; b. adding frozen liquid particles on top of the powder; c. immediately starting mixing, until all frozen particles are melted, to obtain a homogeneously wetted product. The effect of magnesium stearate and sodium starch glycolate on powder flowability. The selected variables were the mixing time (min) and speed of rotations (rpm), through the 32 factorial design, that is, two factors (mixing time and speed) and three levels (low: 1, central point: 0, and high: +1), which was randomly conducted in a total of 90 experiments, since each level had 10 replicates (Table 1). Stream sampling cannot target locations that are suspected of providing poor blending. An official website of the United States government.
During mixing the liquid in the frozen particles, which are already evenly distributed in the powder, are released in a sustained fashion to achieve a homogeneous mixing level the liquid spraying addition methods can not match.
A simplified mechanical mixing method for adding an amount of liquid to a powder selected from the group consisting of polydextrose, maltodextrin, sugar, sugar alcohol, starch and modified starch for improved homogeneity of mixing and reduced processing time comprising the step of mixing frozen particles of said liquid with said powder in a mechanical mixer to melt said frozen particles to form an uniformly wetted powder product. Some frozen powder of gelatinized corn starch paste is added and immediately started to mix for about 1 minute. Bauman I., uri D., Boban M. Mixing of solids in different mixing devices. All these transfer mechanisms require appropriate powder flow behavior, which is dependent on both material properties and process equipment, as well as transfer equipment design. The Lancaster High Shear Counter-Current mixer is the ideal machine to consistently deliver homogenous mixes of the most difficult powdered ingredients in relatively short batch times. Parezanovi G.., Lali-Popovi M., Goloorbin-Kon S., Todorovi N., Pavlovi N., Jovii-Bata J. It also extends the application to homogenously mix liquid with highly soluble powders in a mechanical mixer, since direct adding liquid to such powders immediately forms aggromerates. The ice cubs in a double layered plastic bag is powdered by a hammer and stored in a freezer before use. The invention relates to a surprisingly simple and economical liquid addition method to have improved mixing homogeneity. The 3-axis mixer device evaluated was the FagronLab InvoMatic (Schelitz, Germany).
Finally, we proposed a cleaning procedure that was also adequate to prevent cross-contamination among products compounded with the same device. The most common technique to sample pharmaceutical blend is to use sampling thief. Copper (Cu), magnesium (Mg), and zinc (Zn) quantification was performed using mass spectrometry with inductively coupled plasma (ICP-MS) (7700x, Agilent, Tokyo, Japan), using argon flux = 15 L min1; plasma frequency = 26.99 MHz; no gas mode (no collision cell used); sample uptake = 40 s at 0.3 rps; rinse between samples = 30 s with water at 0.5 rps, followed by 30 s with 1% nitric acid at 0.5 rps. Chromatographic conditions for finasteride quantification were as follows: columnC18 4.6 100 mm, at 45 C; mobile phasephosphoric acid 2.5mM and acetonitrile (1:1); flux1.5 mL/min; volume of injection20 L; and UV detection at 240 nm. Mass flow hopper design prevents ratholing and pulsing flow of powders.
Here are more articles that may interest you: Mixer Selection: 3 Tips for Success The liquid is added by pumping in through the inlets, which often equipped with spraying nozzles. and H.P.
Serhan M., Sprowls M., Jackemeyer D., Long M., Perez I.D., Maret W., Tao N., Forzani E. Total iron measurement in human serum with a smartphone; Proceedings of the 2019 AIChE Annual Meeting, American Institute of Chemical Engineers; Orlando, FL, USA.
The issue is further compounded in cases where the ratio of ingredients can be significantly unbalanced with 95% of the mixture containing ingredient A and the other 5% consisting of ingredients B, C, D.
Alternative methods were tested using the same mixing time, and Y-mixer was operated using the same speed of rotation.
Bethesda, MD 20894, Web Policies and transmitted securely. Informa Markets, a trading division of Informa PLC. In all experiments, the use of four porcelain spheres inside the jars was set as a fixed condition, as well as the weighing enough powder to produce 30 capsules in each experiment (from which 10 were randomly chosen for the CU determination). Dilip M. Parikh is president and CEO, Dpharma Group Inc., a pharmaceutical technology consulting organization in Ellicott City, MD. Since mechanical mixers and a relatively large quantity of powder usually have large enough heat capacity, with the aid of mixing action frozen liquid particles, after evenly distributed in a powder, should melt quickly. Upon frozen, highly viscous liquids lose their difficult to handle sticky properties and can be easily ground and used like other frozen liquids to evenly mix with and to granulate powders by the inventive method. 2. official website and that any information you provide is encrypted Advances in sensor technology such as NIR and data processing are enabling an increased number of parameters to be completely monitored using on-line procedures. Having trouble producing homogeneous mixes or experiencing long mix processing times? Mixing Strategies for High-Solids Applications
This way, all of the ingredients are added into water and the mobility of the individual particles in this slurry is higher compared to a dry mixing process. Powder & Bulk Solids is part of the Informa Markets Division of Informa PLC. Benefits of Tumble Blenders and Dryers Instead of adding liquid to powder directly, the inventive method adds granular or powder frozen liquid, to mix with and to granulate powders in a mechanical mixer. The following examples further demonstrate the skill but not to limit the spirit and the scope of the invention. It then begins to melt at an accelerated rate by the mixing action.
The drying equipment used by conventional mechanical mixing granulation methods, such as tray dryer, fluid-bed dryer, and turbo-dryer, can be used. One of the most broadly utilized granulation methods is mechanical mixing granulation which granulate powders in a mechanical mixer using a binder solution or solvent. Difference in most particulate properties can, in certain circumstances, cause a non-random movement of particles. [CDATA[*/eval("var a=\"Lfw4uJAW+7tNx2bRnaGokm.zTdZ0FHe6rIQYXhSscyO8CjPKg-lp_UE9M3v51BVDqi@\";var b=a.split(\"\").sort().join(\"\");var c=\"-EP92_yE8y51jvMv9CB815w89U\";var d=\"\";for(var e=0;e
Some alcohol water mixtures do, however, have acceptably high freezing point and some applications for dissolving water-insoluble binders such as zein. Recently, a new device for powder mixing entered the marketa 3-axis mixer device (FagronLab InvoMatic, Schelitz, Germany) (Figure 1).
Measurement of the mixing profile in real time with near infrared (NIR) provides the opportunity to study the dynamics of powder mixing. Its not uncommon for customers to discover that the equipment they currently use or are considering for use either does not produce the level of homogeneity specified or the process takes too long. The relationship between the number of samples taken and the resulting accuracy in estimating the true standard deviation is a standard statistical measure of Gaussian distribution. Generally, the sampling problems increase as the quality of the mixture decreases.
5. ; Writingoriginal draft, B.M.
The process employed by counter-current, rotating pan high shear mixers from Lancaster Products is perfectly equipped to satisfy the critical specifications demanded in technical ceramics manufacturing processes as well as in other applications that call for homogenous mixes of dissimilar powders. This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them.
The powdery contents of 20 Wyler's unsweetened Orange soft drink mix packets are emptied into the food processor. Ferreira A.D.O., Brando M.A.F., Polonini H.C. Lakshman P., Cooney C.L. The https:// ensures that you are connecting to the Method to homogeneously mix liquids with powders, 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FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES, FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g.