DRY POWDER COATING: A NEW TREND IN COATING TECHNOLOGY

BHURA RG1, SHAH SK1, PATEL AJ1 1 Sardar Patel College of Pharmacy, Vadtal Road, Bakrol, V.V. Nagar, Anand 388001. Correspondence Email : rahil_aish@yahoo.co.in Abstract This review contains the primary principles and coating processes of various dry coating technologies, and thoroughly analyzed their advantages and disadvantages as well as commercialization potentials. Dry coating is a coating technology for solid pharmaceutical dosage forms derived from powder coating of metals. In this technology, powdered coating materials are directly coated onto solid dosage forms without using any solvent, and then heated and cured to form a coat. As a result, this technology can overcome such disadvantages occurred by solvents in conventional liquid coating as serious air pollution, high time- and energyconsumption and expensive operation cost encountered by liquid coating. quite a few dry coating technologies, including plasticizer-dry-coating, electrostatic-dry-coating, heat-dry-coating and plasticizer-electrostatic-heat-dry-coating have been developed and extensively reported. Keywords: Dry coating, plasticizer-dry-coating, electrostatic-dry-coating, heat-dry-coating

INTRODUCTION:
Typically in the pharmaceutical industry, drug products exist in two dosage forms, solid and liquid dosage forms. Included in solid dosage forms are tablets, pellets, pills, beads, spherules, etc. These solid dosage forms are often coated for various reasons, such as odor or taste masking, prevention from moisture, light and/or air, protection from destruction by gastric acid or gastric enzymes, enhanced mechanical strength, aesthetics or controlled release including controlling release sites and/or release rate. The main techniques employed in the pharmaceutical field for the manufacturing of coated solid dosage forms are based on the deposition of different materials onto substrate cores from solutions or suspensions. Therefore, the evaporation of large amounts of liquids (no less than 70% w/w with respect to coating material) is required. During the last two decades, pharmaceutical coating technology has been shifting from organic solvent-based systems to aqueous systems, which are advantageous from the View points of environmental pollution, safety and cost13. However, aqueous coating systems are not always applicable, for example if the active ingredient is sensitive to water. From the view point of cost, usage of water in place of organic solvent is highly beneficial. However, reduction of processing time and coating level are also important. A simple way to shorten coating time is to use a coating solution or dispersion of higher concentration, but this approach is limited by the viscosity increase of the solution or blocking of the spray nozzle. 4 In order to overcome these limitations of the liquid coating technology, new efforts have been made in recent years to develop solventless coating technologies. The developed solvent less coating technologies include hot-melt coating, supercritical fluid spray coating, photocuring coating and powder coating. The dry particle coating is defined as technology to coat the particles without using organic solvent or water dispersion.5 Advantages 6 1. Powder coatings emit zero or near zero volatile organic compounds (VOC).

2. Powder coatings can produce much thicker coatings than conventional liquid coatings without running or sagging. 3. Powder coating overspray can be recycled and thus it is possible to achieve nearly 100% use of the coating. 4. Powder coating production lines produce less hazardous waste than conventional liquid coatings. 5. Capital equipment and operating costs for a powder line are generally less than for conventional liquid lines. 6. Powder coated items generally have fewer appearance differences between horizontally coated surfaces and vertically coated surfaces than liquid coated items. 7. A wide range of specialty effects is easily accomplished which would be impossible to achieve with other coating processes.

Disadvantages While it is relatively easy to apply thick coatings which have smooth, texture-free surfaces, it is not as easy to apply smooth thin films. As the film thickness is reduced, the film becomes more and more orange peeled in texture due to the particle size and glass transition temperature (TG) of the powder. Also powder coatings will break down when exposed to UV rays between 5 to 10 years. On smaller jobs, the cost of powder coating will be higher than spray painting. For optimum material handling and ease of application, most powder coatings have a particle size in the range of 30 to 50 m and a TG above 40C .For such powder coatings, film build-ups of greater than 50 m may be required to obtain an acceptably smooth film. The surface texture which is considered desirable or acceptable depends on the end product. Many manufacturers actually prefer to have a certain degree of orange peel since it helps to hide metal defects that have occurred during manufacture, and the resulting coating is less prone to showing fingerprints. There are very specialized operations where powder coatings of less than 30 micrometres or with a TG below 40C are used in order to produce smooth thin films. One variation of the dry

powder coating process, the "Powder Slurry" process, combines the advantages of powder coatings and liquid coatings by dispersing very fine powders of 15 micrometre particle size into water, which then allows very smooth, low film thickness coatings to be produced

METHODS OF DRY COATING:

Two basic techniques in dry coating: 1. Liquid based dry coating techniques: Liquid-based dry coating processes involve the deposition of molten formulations that are expected to solidify by cooling, curing or precursors that undergo polymerization directly on the core surface. Liquid-based dry coating processes involve the deposition of nonaqueous liquidSuch liquids may be molten formulations that are expected to solidify by cooling (hot melt coating technique), or liquid precursors that undergo polymerization directly on the core surface (polymerization coating technique). Hot melt coating processes are generally carried out in fluid bed equipment and require the liquid coating agent to be maintained at a temperature of 4060C above its melting point.7,8 Only thermally stable materials with a relatively low melting point (<80C) can be used, such as fats, waxes or high molecular-weight polyethylene glycols. The most common applications of this technique include the coating of pellets, granules and powder particles, particularly to obtain moisture-protected or modified-release dosage forms. The polymerization coating technique appears to have very limited potential for use in the pharmaceutical field because of technical and toxicological reasons. However, it has been employed to apply functional coatings onto drug particles and pellets. The polymerization process is caused by a UV-activated chemical reaction of functionalized liquid precursors (prepolymers or monomers) in the presence of an initiator. An extremely rapid transition of the system from liquid to solid, which occurs at or below room temperature, leads to the formation of the coating (photo curing phase). An analogous coating technique based on the use of gaseous formulations (vapours of monomers and primary radicals of initiators) has recently been described for the encapsulation of fine particles (initiated chemical vapour deposition, iCVD).9,10

According to the monomer selected, coatings with differing characteristics can be obtained, such as enteric films composed of acrylic resin. 2. Powder based dry coating techniques: During the traditional coating process based on organic solvent, the solvent needs to be recovered due to environmental pollution. Coating processes with aqueous dispersions are time and energy consuming caused by the low concentration of coating polymer and large amounts of water which need to be evaporated Pharmaceutical coating technologies are commonly wet process by spraying of a liquid phase solution of coating materials. But recently, in addition to this liquid-based coating, a new dry Powder coating has been introduced. This technique directly attaches polymer particles onto the Surface of a solid substrate without organic solvents and large volumes of water. Softening, melting and curing are the principal stages in the film formation during dry powder coating. During the traditional coating process based on organic solvent, the solvent needs to be recovered due to environmental pollution. Coating processes with aqueous dispersions are time and energy consuming caused by the low concentration of coating polymer and large amounts of water which need to be evaporated.11

TECHNIQUES OF DRY COATING:

Dry coating techniques are widely used to modify particulate interactions and improve the flow of cohesive powders. In general, dry coating is simpler, cheaper, safer and more environmentfriendly than solvent-based alternatives Dry particle coating, consists in coating relatively large particle size (core material or host) with fine particles (guest) In most cases, carriers with primary particle sizes arranging from 60 to 150 m are incorporated to improve the flow of cohesive micronized drug. It has been reported that binary formulations using carriers with smaller particle sizes have better delivery performance compared with those using larger carriers. Also, many researchers indicate that adding fine additives with particle sizes of 5-10 m into a binary formulation markedly alter the net adhesive forces experienced by the drug, and thus improved drug delivery efficiency. However, it is also well known that both reducing the carrier size and adding increased fine additives will result in poorer flow of the formulation.12 The film formation of solvent free coating processes occurs mainly during the curing step
13

. The dry

coating process can be divided in two phases, the coating an d the curing phases. During the coating phase polymer powder and plasticizer are added separately but simultaneously to the pellets and adhere on their surface achieving a homogeneous application of the coating material onto the pellets. During the curing step film formation is achieved by an increase in temperature14. Before the curing step, the coating consists mainly of adhered polymer particles and agglomerates. Obara et al. suggested to spray a small amount of water to the coated spheres triggering film formation by acting as a plasticizer 4. Film formation can be achieve d without water by adjusting higher curing temperatures, thereby decreasing the polymers melt viscosity, a major resisting force for film formation 15. Film formation can be further enhanced by increasing the plasticizer concentration
16

. Recently, studies of Terebesi et al.

17

showed that different

plasticizers also affect the film, formation. Since dry coating is conducted without any dispersion media it may be assumed that the film formation follows the theory of dry sintering. However, the application of liquid plasticizer has to be considered influencing the film formation by temporarily building capillary forces between the polymer particles before the plasticizer will have been taken up by the polymer. Nevertheless, the film formation of the dry coating process with its key parameters for achieving function al film formation is not described in the literature. RESEARCH AND APPLICATION OF DRY COATING Flow improvement: Some study indicates that it is possible to change the properties of silica gel particles by coating with hydrophobic magnesium stearate using both the Hybridizer and Cyclomix as dry coating devices. The ESEM images of the uncoated and coated particles in the two devices show that magnesium stearate was softened and smeared over host particles. But the silica gel treated alone in the Cyclomix was crushed whereas no difference was observed after processing in the Hybridizer. The coating of silica gel particles seems to be more uniform and the magnesium stearate is much more softened and smeared over the surface of silica gel particles processed in the Hybridizer than the surface coverage obtained after treatment in the Turbula mixer. The owability of the silica gel powder was not strongly affected by coating in the Hybridizer and remains good. The ow properties of silica gel are more signicantly decreased after treatment in the Turbula mixer than in the Cyclomix mixer. This is probably due to the quality difference in

the particle coating. It is also found that the coating by hydrophobic magnesium stearate in both the Hybridizer and Cyclomix can also reduce the high affinity between silica gel and water.18 The treatment of silica ge l powder with 5% and 15 % of magnesium stearate in the Turbula mixer also reduce its afnity with water.To summarize, it has been demonstrated that a dry particle coating technique can be used to modify the properties of silica gel powder by coating with small quantities of hydrophobic magnesium stearate in both the Hybridizer and the Cyclomix. The more uniform coating is obtained after treatment in the Hybridizer device. Some study of the ageing of the coated silica gel powder has demonstrated the influence of storage conditions, in particular, the relative humidity on the stability of the coated surfaces. Indeed, for relative humidities varying between 30 % and 50 %, the surface coverage by magnesium stearate disappears after only 36 days storage. The surface of silica gel particles finds its initial hydrophilic characteristic. Under these conditions of relative humidity, the silica gel powder absorbs water vapor and silanol groups (SiOH) are formed onto the surface 19. On the other hand, the storage under drier air (relative humidity below t o 12%) preserves the coated surfaces. Some thermo gravimetric analysis evidence that the magnesium stearate material is still in the silica gel particles. To explain the disappearance of magnesium stearate from the surface of silica gel, the mechanism of diffusion of magnesium stearate from the surface into the pores of silica gel particles may be considered. This ageing mechanism is enhanced by high relative humidity. Finely, it is important to confirm by other analysis techniques the validity of this hypothesis of diffusion and what are the major mechanisms to explain the rapid ageing of the coated silica gel powder under humid atmospheres.

Dry enteric coating method: S Obara et al examined dry coating for tablets using a commercially available coating machine. In order to deliver the powder uniformly onto the tablets in the pan, compressed air was used to force the powder out of the tube, like a liquid spray under a controlled condition. The outlet temperature was controlled at approximately 420 C during the coating process, as in the other

experiments. During the process, no blocking was observed in the powder feed line. Before the curing process, the coated surface was rough, and film formation was not observed, but after it, the surface layer formed a continuous film. Surprisingly, the film formed within a very short time, approximately 10 min, after the addition of a small amount of water (3% of dry core). They also have studied that the required coating level for sufficient gastric resistance was 8% with respect to the core weight. Uptake of the gastric fluid was 2.1%, which was almost the same level as that of tablets with aqueous coating. The disintegration time at pH 6.8 was 10 min, again similar to that of tablets with the conventional coating. The appearance of the tablet surface is important for pharmaceutical products, and the surface of the tablets obtained by dry coating was slightly rougher than that of the samples with conventional coating, but was regarded as being in the acceptable range. The surface appearance depended on the oily additive used, and was smoothest when acetylated monoglyceride was used. In this study, the core tablets were coated with HPMC prior to dry coating. Without the sub-coating, the gastric resistance after dry coating was not satisfactory. This may be because the sub-coating layer prevents from the penetration of plasticizer into the core, or because the uncoated surface was damaged and became rougher during the curing process. The beads did not require sub-coating. 4 Dry powder coating to provide extended drug release. N Pearnchob et al studied that Micronized ethyl cellulose powder can be coated on pellets by a dry powder coating technique to provide extended drug release. The process has many advantages when compared to classical coating techniques (e.g. coating with organic polymer solutions or aqueous dispersions), such as shorter processing times. A novel coating technique with ethyl cellulose based on the coating with micronized ethyl cellulose powder was investigated in order to achieve extended drug release. Ethyl cellulose has a high glass transition temperature of approximately 130oC. A plasticizer therefore had to be sprayed in parallel to the feeding of the polymer powder into the coating chamber in order for the micronized polymer particles to coalesce into a film. The plasticizer was added to an aqueous HPMC solution, which also assisted in the adhesion of the polymer particles to the surface of the pellets prior to film formation.20 Immediate release coatings

Qiao M at al. studied novel electrostatic dry powder coating technique based on liquid pan coater was developed and applied form immediate release coatings with Opadry, AMB and Eudragit EPO. Liquid plasticizer was used to decrease Tg of coating polymers and to promote powder deposition on the tablet surface by increasing electrical conductivity of tablets. Even though the enhanced electrical conductivity of tablets met the requirements for electrostatic coating, it is still necessary to further improve the electrical conductivity in order to make full use of electrical attractive force. The dry coating particles fused into a complete lm on the tablet surface after curing at elevated temperatures. The electrostatic powder coating technique is able to produce smooth and uniform coating lm and has been demonstrated as a promising alternative to traditional aqueous-based coating process. However, the electrostatic dry powder coating process is still new and requires further validation through more experiments.21

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