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applications of ball milling in pharmaceutical industry

overview of milling techniques for improving the solubility of poorly water-soluble drugs - sciencedirect

overview of milling techniques for improving the solubility of poorly water-soluble drugs - sciencedirect

Milling involves the application of mechanical energy to physically break down coarse particles to finer ones and is regarded as a topdown approach in the production of fine particles. Fine drug particulates are especially desired in formulations designed for parenteral, respiratory and transdermal use. Most drugs after crystallization may have to be comminuted and this physical transformation is required to various extents, often to enhance processability or solubility especially for drugs with limited aqueous solubility. The mechanisms by which milling enhances drug dissolution and solubility include alterations in the size, specific surface area and shape of the drug particles as well as milling-induced amorphization and/or structural disordering of the drug crystal (mechanochemical activation). Technology advancements in milling now enable the production of drug micro- and nano-particles on a commercial scale with relative ease. This review will provide a background on milling followed by the introduction of common milling techniques employed for the micronization and nanonization of drugs. Salient information contained in the cited examples are further extracted and summarized for ease of reference by researchers keen on employing these techniques for drug solubility and bioavailability enhancement.

milling equipment for api (active pharmaceutical ingredient)

milling equipment for api (active pharmaceutical ingredient)

In new drug development, particle size is crucial in affecting the properties of bio-availability and stability. The more potent molecules in development need to achieve the narrowest of Particle Size Distribution (PSDs).

We have enabled clients to achievesmaller particle sizes&tighter particle size distributions than are possible using standard conical mills, hammer mills or pin mills. Which has reduced waste for a better bottom line.

Our recognized leadership in specialized process equipment means we have helped a wide variety of customers around the globe. When you invest in Quadro Pharma Milling Equipment, you get more than just superior engineering and quality, you get access to our team of experts who will ensure you achieve your objectives.

Quadro Engineering, a division of IDEX MPT, Inc has earned the respect & trust of customers worldwide through our commitment to improving the performance of their powder processing operations. We set the standards by which others are measured.

ball milling - an overview | sciencedirect topics

ball milling - an overview | sciencedirect topics

Ball milling is often used not only for grinding powders but also for oxides or nanocomposite synthesis and/or structure/phase composition optimization [14,41]. Mechanical activation by ball milling is known to increase the material reactivity and uniformity of spatial distribution of elements [63]. Thus, postsynthesis processing of the materials by ball milling can help with the problem of minor admixture forming during cooling under air after high-temperature sintering due to phase instability.

Ball milling technique, using mechanical alloying and mechanical milling approaches were proposed to the word wide in the 8th decade of the last century for preparing a wide spectrum of powder materials and their alloys. In fact, ball milling process is not new and dates back to more than 150 years. It has been used in size comminutions of ore, mineral dressing, preparing talc powders and many other applications. It might be interesting for us to have a look at the history and development of ball milling and the corresponding products. The photo shows the STEM-BF image of a Cu-based alloy nanoparticle prepared by mechanical alloying (After El-Eskandarany, unpublished work, 2014).

Ball milling, a shear-force dominant process where the particle size goes on reducing by impact and attrition mainly consists of metallic balls (generally Zirconia (ZrO2) or steel balls), acting as grinding media and rotating shell to create centrifugal force. In this process, graphite (precursor) was breakdown by randomly striking with grinding media in the rotating shell to create shear and compression force which helps to overcome the weak Vander Waal's interaction between the graphite layers and results in their splintering. Fig. 4A schematic illustrates ball milling process for graphene preparation. Initially, because of large size of graphite, compressive force dominates and as the graphite gets fragmented, shear force cleaves graphite to produce graphene. However, excessive compression force may damage the crystalline properties of graphene and hence needs to be minimized by controlling the milling parameters e.g. milling duration, milling revolution per minute (rpm), ball-to-graphite/powder ratio (B/P), initial graphite weight, ball diameter. High quality graphene can be achieved under low milling speed; though it will increase the processing time which is highly undesirable for large scale production.

Fig. 4. (A) Schematic illustration of graphene preparation via ball milling. SEM images of bulk graphite (B), GSs/E-H (C) GSs/K (D); (E) and (F) are the respective TEM images; (G) Raman spectra of bulk graphite versus GSs exfoliated via wet milling in E-H and K.

Milling of graphite layers can be instigated in two states: (i) dry ball milling (DBM) and (ii) wet ball milling (WBM). WBM process requires surfactant/solvent such as N,N Dimethylformamide (DMF) [22], N-methylpyrrolidone (NMP) [26], deionized (DI) water [27], potassium acetate [28], 2-ethylhexanol (E-H) [29] and kerosene (K) [29] etc. and is comparatively simpler as compared with DBM. Fig. 4BD show the scanning electron microscopy (SEM) images of bulk graphite, graphene sheets (GSs) prepared in E-H (GSs/E-H) and K (GSs/K), respectively; the corresponding transmission electron microscopy (TEM) images and the Raman spectra are shown in Fig. 4EG, respectively [29].

Compared to this, DBM requires several milling agents e.g. sodium chloride (NaCl) [30], Melamine (Na2SO4) [31,32] etc., along with the metal balls to reduce the stress induced in graphite microstructures, and hence require additional purification for exfoliant's removal. Na2SO4 can be easily washed away by hot water [19] while ammonia-borane (NH3BH3), another exfoliant used to weaken the Vander Waal's bonding between graphite layers can be using ethanol [33]. Table 1 list few ball milling processes carried out using various milling agent (in case of DBM) and solvents (WBM) under different milling conditions.

Ball milling of graphite with appropriate stabilizers is another mode of exfoliation in liquid phase.21 Graphite is ground under high sheer rates with millimeter-sized metal balls causing exfoliation to graphene (Fig. 2.5), under wet or dry conditions. For instance, this method can be employed to produce nearly 50g of graphene in the absence of any oxidant.22 Graphite (50g) was ground in the ball mill with oxalic acid (20g) in this method for 20 hours, but, the separation of unexfoliated fraction was not discussed.22 Similarly, solvent-free graphite exfoliations were carried out under dry milling conditions using KOH,23 ammonia borane,24 and so on. The list of graphite exfoliations performed using ball milling is given in Table 2.2. However, the metallic impurities from the machinery used for ball milling are a major disadvantage of this method for certain applications.25

Reactive ball-milling (RBM) technique has been considered as a powerful tool for fabrication of metallic nitrides and hydrides via room temperature ball milling. The flowchart shows the mechanism of gas-solid reaction through RBM that was proposed by El-Eskandarany. In his model, the starting metallic powders are subjected to dramatic shear and impact forces that are generated by the ball-milling media. The powders are, therefore, disintegrated into smaller particles, and very clean or fresh oxygen-free active surfaces of the powders are created. The reactive milling atmosphere (nitrogen or hydrogen gases) was gettered and absorbed completely by the first atomically clean surfaces of the metallic ball-milled powders to react in a same manner as a gas-solid reaction owing to the mechanically induced reactive milling.

Ball milling is a grinding method that grinds nanotubes into extremely fine powders. During the ball milling process, the collision between the tiny rigid balls in a concealed container will generate localized high pressure. Usually, ceramic, flint pebbles and stainless steel are used.25 In order to further improve the quality of dispersion and introduce functional groups onto the nanotube surface, selected chemicals can be included in the container during the process. The factors that affect the quality of dispersion include the milling time, rotational speed, size of balls and balls/ nanotube amount ratio. Under certain processing conditions, the particles can be ground to as small as 100nm. This process has been employed to transform carbon nanotubes into smaller nanoparticles, to generate highly curved or closed shell carbon nanostructures from graphite, to enhance the saturation of lithium composition in SWCNTs, to modify the morphologies of cup-stacked carbon nanotubes and to generate different carbon nanoparticles from graphitic carbon for hydrogen storage application.25 Even though ball milling is easy to operate and suitable for powder polymers or monomers, process-induced damage on the nanotubes can occur.

Ball milling is a way to exfoliate graphite using lateral force, as opposed to the Scotch Tape or sonication that mainly use normal force. Ball mills, like the three roll machine, are a common occurrence in industry, for the production of fine particles. During the ball milling process, there are two factors that contribute to the exfoliation. The main factor contributing is the shear force applied by the balls. Using only shear force, one can produce large graphene flakes. The secondary factor is the collisions that occur during milling. Harsh collisions can break these large flakes and can potentially disrupt the crystal structure resulting in a more amorphous mass. So in order to create good-quality, high-area graphene, the collisions have to be minimized.

The ball-milling process is common in grinding machines as well as in reactors where various functional materials can be created by mechanochemical synthesis. A simple milling process reduces both CO2 generation and energy consumption during materials production. Herein a novel mechanochemical approach 1-3) to produce sophisticated carbon nanomaterials is reported. It is demonstrated that unique carbon nanostructures including carbon nanotubes and carbon onions are synthesized by high-speed ball-milling of steel balls. It is considered that the gas-phase reaction takes place around the surface of steel balls under local high temperatures induced by the collision-friction energy in ball-milling process, which results in phase separated unique carbon nanomaterials.

Conventional ball milling is a traditional powder-processing technique, which is mainly used for reducing particle sizes and for the mixing of different materials. The technique is widely used in mineral, pharmaceutical, and ceramic industries, as well as scientific laboratories. The HEBM technique discussed in this chapter is a new technique developed initially for producing new metastable materials, which cannot be produced using thermal equilibrium processes, and thus is very different from conventional ball milling technique. HEBM was first reported by Benjamin [38] in the 1960s. So far, a large range of new materials has been synthesized using HEBM. For example, oxide-dispersion-strengthened alloys are synthesized using a powerful high-energy ball mill (attritor) because conventional ball mills could not provide sufficient grinding energy [38]. Intensive research in the synthesis of new metastable materials by HEBM was stimulated by the pioneering work in the amorphization of the Ni-Nb alloys conducted by Kock et al. in 1983 [39]. Since then, a wide spectrum of metastable materials has been produced, including nanocrystalline [40], nanocomposite [41], nanoporous phases [42], supersaturated solid solutions [43], and amorphous alloys [44]. These new phase transformations induced by HEBM are generally referred as mechanical alloying (MA). At the same time, it was found that at room temperature, HEBM can activate chemical reactions which are normally only possible at high temperatures [45]. This is called reactive milling or mechano-chemistry. Reactive ball milling has produced a large range of nanosized oxides [46], nitrides [47], hydrides [48], and carbide [49] particles.

The major differences between conventional ball milling and the HEBM are listed in the Table 1. The impact energy of HEBM is typically 1000 times higher than the conventional ball milling energy. The dominant events in the conventional ball milling are particle fracturing and size reductions, which correspond to, actually, only the first stage of the HEBM. A longer milling time is therefore generally required for HEBM. In addition to milling energy, the controls of milling atmosphere and temperature are crucial in order to create the desired structural changes or chemical reactions. This table shows that HEBM can cover most work normally performed by conventional ball milling, however, conventional ball milling equipment cannot be used to conduct any HEBM work.

Different types of high-energy ball mills have been developed, including the Spex vibrating mill, planetary ball mill, high-energy rotating mill, and attritors [50]. In the nanotube synthesis, two types of HEBM mills have been used: a vibrating ball mill and a rotating ball mill. The vibrating-frame grinder (Pulverisette O, Fritsch) is shown in Fig. 1a. This mill uses only one large ball (diameter of 50 mm) and the media of the ball and vial can be stainless steel or ceramic tungsten carbide (WC). The milling chamber, as illustrated in Fig. 1b, is sealed with an O-ring so that the atmosphere can be changed via a valve. The pressure is monitored with an attached gauge during milling.

where Mb is the mass of the milling ball, Vmax the maximum velocity of the vial,/the impact frequency, and Mp the mass of powder. The milling intensity is a very important parameter to MA and reactive ball milling. For example, a full amorphization of a crystalline NiZr alloy can only be achieved with a milling intensity above an intensity threshold of 510 ms2 [52]. The amorphization process during ball milling can be seen from the images of transmission electron microscopy (TEM) in Fig. 2a, which were taken from samples milled for different lengths of time. The TEM images show that the size and number of NiZr crystals decrease with increasing milling time, and a full amorphization is achieved after milling for 165 h. The corresponding diffraction patterns in Fig. 2b confirm this gradual amorphization process. However, when milling below the intensity threshold, a mixture of nanocrystalline and amorphous phases is produced. This intensity threshold depends on milling temperature and alloy composition [52].

Figure 2. (a) Dark-field TEM image of Ni10Zr7 alloy milled for 0.5, 23, 73, and 165 h in the vibrating ball mill with a milling intensity of 940 ms2. (b) Corresponding electron diffraction patterns [52].

Fig. 3 shows a rotating steel mill and a schematic representation of milling action inside the milling chamber. The mill has a rotating horizontal cell loaded with several hardened steel balls. As the cell rotates, the balls drop onto the powder that is being ground. An external magnet is placed close to the cell to increase milling energy [53]. Different milling actions and intensities can be realized by adjusting the cell rotation rate and magnet position.

The atmosphere inside the chamber can be controlled, and adequate gas has to be selected for different milling experiments. For example, during the ball milling of pure Zr powder in the atmosphere of ammonia (NH3), a series of chemical reactions occur between Zr and NH3 [54,55]. The X-ray diffraction (XRD) patterns in Fig. 4 show the following reaction sequence as a function of milling time:

The mechanism of a HEBM process is quite complicated. During the HEBM, material particles are repeatedly flattened, fractured, and welded. Every time two steel balls collide or one ball hits the chamber wall, they trap some particles between their surfaces. Such high-energy impacts severely deform the particles and create atomically fresh, new surfaces, as well as a high density of dislocations and other structural defects [44]. A high defect density induced by HEBM can accelerate the diffusion process [56]. Alternatively, the deformation and fracturing of particles causes continuous size reduction and can lead to reduction in diffusion distances. This can at least reduce the reaction temperatures significantly, even if the reactions do not occur at room temperature [57,58]. Since newly created surfaces are most often very reactive and readily oxidize in air, the HEBM has to be conducted in an inert atmosphere. It is now recognized that the HEBM, along with other non-equilibrium techniques such as rapid quenching, irradiation/ion-implantation, plasma processing, and gas deposition, can produce a series of metastable and nanostructured materials, which are usually difficult to prepare using melting or conventional powder metallurgy methods [59,60]. In the next section, detailed structural and morphological changes of graphite during HEBM will be presented.

Ball milling and ultrasonication were used to reduce the particle size and distribution. During ball milling the weight (grams) ratio of balls-to-clay particles was 100:2.5 and the milling operation was run for 24 hours. The effect of different types of balls on particle size reduction and narrowing particle size distribution was studied. The milled particles were dispersed in xylene to disaggregate the clumps. Again, ultrasonication was done on milled samples in xylene. An investigation on the amplitude (80% and 90%), pulsation rate (5 s on and 5 s off, 8 s on and 4 s off) and time (15 min, 1 h and 4 h) of the ultrasonication process was done with respect to particle size distribution and the optimum conditions in our laboratory were determined. A particle size analyzer was used to characterize the nanoparticles based on the principles of laser diffraction and morphological studies.

mill for the pharmaceutical industry - all industrial manufacturers - videos

mill for the pharmaceutical industry - all industrial manufacturers - videos

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Grinding and Dispersing of Pharmaceuticals General The comminution or desagglomeration of active pharmaceutical ingredients (API) is called micronization and brings about several advantages. The increase ...

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pharma bead mills | dyno-mill pharma | wab group

pharma bead mills | dyno-mill pharma | wab group

Particle Size Reduction of Active Pharmaceutical Ingredients (API ). The wet milling technology of WAB allows for effectively reducing the particle size of API and excipients. With the DYNO-MILL PHARMA equipment, coarse particles are milled to establish the required particle size distribution. The DYNO-MILL PHARMA equipment line is capable of mechanical Micronization and Nanosization at current Good Manufacturing Practice (cGMP) level protocols. Realised through semi-automatic or fully automatic control units, and the 21 CFR part 11 compliant WAB SCADA-System. In addition, selected DYNO-MILL PHARMA units are available with Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) functionality. WAB supports its customers with great attention to detail from the initial definition of the User Requirement Specification (URS) throughout the IQ/OQ.

The Pharmaceutical Manufacturer first prepares a pumpable suspension of the solid API in a liquid medium. This raw suspension usually has a very wide particle size distribution and contains a high percentage of coarse particles. The coarse particles are mainly formed by aggregated and agglomerated API material. The main task of the DYNO-MILL PHARMA equipment is to disperse the aggregates and agglomerates to the desired particle size distribution. With the many stages and requirements in the API development process, a broad range of solutions is a helpful support. WAB has decades of experience in the Pharmaceutical Industry and a proven spectrum of equipment to supports its global customer base.DYNO-MILL PHARMA wet milling equipment:

ball mill: operating principles, components, uses, advantages and

ball mill: operating principles, components, uses, advantages and

A ball mill also known as pebble mill or tumbling mill is a milling machine that consists of a hallow cylinder containing balls; mounted on a metallic frame such that it can be rotated along its longitudinal axis. The balls which could be of different diameter occupy 30 50 % of the mill volume and its size depends on the feed and mill size. The large balls tend to break down the coarse feed materials and the smaller balls help to form fine product by reducing void spaces between the balls. Ball mills grind material by impact and attrition.

Several types of ball mills exist. They differ to an extent in their operating principle. They also differ in their maximum capacity of the milling vessel, ranging from 0.010 liters for planetary ball mills, mixer mills, or vibration ball mills to several 100 liters for horizontal rolling ball mills.

Im grateful for the information about using a ball mill for pharmaceutical products as it produces very fine powder. My friend is working for a pharmaceutical company and this is a good article to share with her. Its good to know that ball mills are suitable for milling toxic materials since they can be used in a completely enclosed for. Thanks for the tips!

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