Surface profile is important because it allows the coating to adhere to the substrate surface. Alternatively, if discolouration occurs on storage, use of a moisture barrier coating can also be effective. Eur J Pharm Biopharm, 71 (2009), pp. Advanced Defect Detection Film Inspection, Dynamic Evaluation, System Testing & Development. A practical guide for ensuring a defect-free coating and drying process. This is followed by a discussion of some of the applicatio… Balancing both spray rates and drying conditions to achieve good coating process efficiency (typically > 90% and ideally > 95%). In the case of modifi­ed-release dosage forms, coating process conditions can influence the degree to which phase separation can occur with a resulting impact on the size of pores created within the fi­lm structure (and hence drug release) when ethylcellulose is used as primary insoluble polymer and hydroxypropyl cellulose as the water-soluble pore former. Selecting a film coating formulation with increased hiding power (lighter colours tend to exhibit better “hiding power” than darker ones). Coatings and Inks formulators / developers with a need to solve & prevent film coating defects faster by better applying science behind film defects. However, potential discolouration issues are more effectively dealt with during product development, especially when past experience suggests that this kind of problem is likely to occur in the current product being developed. Dark Field focuses on industries and applications where high value products must be produced at high speed against rigorous quality standards and prevent plastics defects. This includes improper cleaning of the surface of contaminants, as well as inadequate surface profile. Formulating robust tablets is critical to minimizing defects that arise during film-coating application. optimizing coating process conditions to minimize use of excessively high temperatures (the key factor here will be tablet bed temperatures) when low melting point ingredients are used in the tablet core and. The development of suitable decision criteria based on objective and quantitative evaluation methods is therefore highly desired. Depending on the fracture characteristics of the tablets, and to some extent the adhesion of the coating to the tablet surface, the milling process may cause the coating to flake off so that it can be removed from the tablet core material by sieving. Thus, any rework procedure must be suitably validated so as to ensure that recompressed tablets perform within the specifications of the original product. Enter your email address to subscribe to this blog and receive notifications of new posts by email. Recovery of film-coated tablets thus typically involves milling of the tablets to produce “granules” that can be introduced (at a predetermined level) into other batches of compression mix (of the same product). The effects of pan speed and scale-up were also investigated as both may have detrimental impact when coating tablets of poor mechanical strength. However, the addition of alcohol, the use of spray nozzles capable of finer atomization, optimizing the mixing process either by setting mixer height correctly, choosing mixer blade of correct size (about 30% of tank diameter), choosing optimal mixer speed and incorporation powder into water as fast as possible to avoid excessive viscosity build-up before all powder has been wetted out have been found to be effective. Assessing the extent of these problems can be difficult because no objective criteria are currently available for this purpose. Despite advancements and innovations in tablet manufacture, film-coating processes continue to produce many challenges. Enter your email address to subscribe to this blog and receive notifications of new posts by email. Coated tablet dissolution problem can be solved by. Other coatin… Many common problems with film-coated products and processes are … Mishandling of tablets during loading/ emptying of coating pans. Effect of temperature on the adhesion, elasticity, and strength of the film. Improving tablet core robustness, either by addressing the core formulation or examining the tabletting process (slowing down press speeds to increase dwell time, increasing compaction forces, and possible use of precompression). Unlike logo bridging, infilling is caused by a buildup of dried coating solution within the logo. Infilling of Logos. Magnetically assisted impaction coating, electrostatic dry coating in solventless coatings, aqueous film coating and Supercell coating technology are also available recent technique of coating. © 2021 Pharmapproach Limited. All Rights Reserved . film coating defect, since it is aesthetically unpleasing, exposes active to environmental factors and gives the impression of sub–standard product (Figure 6). Once the foam/material has accumulated to a level approaching the outer contour of the tablet surface, normal attrition can occur, allowing the structure to be covered with a continuous film. While there are certain coating process changes that can be made to obviate this problem, including increasing pan speed to reduce the dwell time in the spray zone (thus reducing over-wetting), improving the drying conditions (such as increasing process air temperatures or volumes and/or decreasing spray rates) or expanding the spray zone (either by increasing gun-to-bed difference, pattern air pressure or the number of spray guns) to minimize the risk of localized over-wetting, proactively dealing with the issue during product development provides a more effective solution. Optimizing spray gun setup so that there is no mis-spraying, that all spray guns are spraying at the same rate, and that each is providing the same area of coverage over the tablet bed surface. It’s also a common area for defects. Rosoff, M. and Sheen, P. (1983). Interference is simply the addition of the fields of the various waves involved. & THIN FILM COATINGS Low Defect Wafer Level Optical Solutions. Increasing the amount of coating applied to allow better and more consistent tablet coverage. Causes Remedies Inefficient drying. The majority of coating lines are designed to accommodate specific product and process needs. Film coating is also applicable to mask taste and improve patient compliance. The detection and localization of coating defects such as chipping at either the center or the edge of the tablet may be caused by different phenomena, such as twinning of tablets during film coating or insufficient flexibility of the coating film and thus allowing systematic adjustment of the defect-causing process parameters . 6 Common Causes of Conformal Coating Defects and Rework. Lieberman, H., Lachman, L. and Schwartz, J. For professionals in the coating and drying industry, the world is a demanding place. Here are the six most common causes of conformal coating defects we see, along with recommendations for how to avoid them: 1. Pan abrasion and polymorphism of titanium dioxide in coating suspensions. Coatings also extend shelf-life, mask bitter tastes and off-putting odors, and add flavor and color. The overall coating process, coating methods and operating variables, solution handling, drying, and web transport must be optimized for a thin coating to produce defect-free film at low cost. Reduction in the levels of titanium dioxide used in the coating formulations (as suggested by Ogasawara et al.) Optimizing pan loading to make sure the tablets are tumbling effectively, with no intermittent stalling of the tablet bed, and to ensure that a consistent gun-to-bed distance is maintained. Entrapment of gases or vapor in or under the film due to overheating either during spraying or at the end of the coating. For example, if a capsule-shaped tablet is required, changing from the more traditional design to one in which there is a small degree of curvature on the edges of the tablets can reduce the area of contact between tablets and greatly minimize the risk of twinning. Definition: Cratering happens when a defect on the film’s coating results in craters appearing on the tablet which in turn results in the exposure of the tablet’s surface. This website uses cookies. Additional solutions might include: Tablet pitting is the presence of small pits (indentations) in the surface of the coated substrate. Coating Deterioration Kenneth B. Tator, KTA-Tator, Inc. PAINTS AND COATINGS of all types are widely used to provide color and pleasing aes-thetics, and to prevent deterioration of the underlying substrate when exposed to various environments. Finally, poor dispersion of pigment ingredients within the coating formulation can also be a source of tablet discolouration; in which case, this must be dealt with at the time of preparation of the coating suspension to make sure pigments are effectively dispersed into the final coating suspension. Zeitler, L.F. GladdenIn-vitro tomography and non-destructive imaging at depth of pharmaceutical solid dosage forms. Tablet scuffi­ng has, at various times, been associated with the use of coating formulations based on polyvinyl alcohol (PVA). Common Defects A paint defect is in many cases due to a number of causes. Twinning of tablets during coating operation is commonly seen with capsule-shaped tablets and may be due to use of excessively tacky coating formulation or poor suspension evaporation. adjust film coatings to meet the customer’s desired CQAs of a strong film that resists edge wear and chipping and that provides a smooth surface and well-defined logo. The general buildup of prematurely dried material can be corrected by optimizing the atomization process to give a more uniform distribution of droplet sizes. preventing over-wetting conditions (potentially offset by reducing spray rates and/or increasing process temperatures) when the core contains very hydrophilic materials, especially super-disintegrants. For coating formulations prepared from powdered premixes made by a third party vendor, the issue of ineffective pigment dispersion must be dealt with by those vendors. Rowley, F. A. While ensuring that the surfaces of the coating equipment are perfectly clean, an approach that can be augmented by pan passivation is a relatively simple approach that can help reduce scuffing problems, a more proactive formulation approach can provide a long-term solution. New, technically complex products such as fuel cell membranes, thin film batteries, solar cells, and RFID chips require coatings of extreme precision. This topic is also addressed in NSTM Chapter 631, Section 6. Using binders that deform plastically, such as hydroxpropylcellulose (HPC), can be very beneficial, as shown below. Ogasawara, Y., Steffenino, R. and Cunningham, C. Scuf­fing measurement methodology and improved fi­lm coating systems. Soft tablets will often result in a dull coating and risk the poten- tial for erosion. Rosoff and Sheen have commented on this phenomenon, linking it to polymorphism that exists with different forms of titanium dioxide. Pigmented, fully-formulated film coating systems, containing either hypromellose (HPMC) or polyvinyl alcohol (PVA) as the base polymers, were used in the study. The delivery of a sprayed coating solution onto a variable range of tablet surface hardness will net poor results at best. Normally, dried material that is deposited on the tablet surfaces would breakdown as tablets slide over each other but because the intagliation form a protected area, this will not occur for material that resides in the logo. In addition to unsuitable punch design, core surface erosion can be facilitated by over-wetting (which causes the tablet surface to soften and hence become less resistant to attritional effects), presence of centrally placed logo, insufficient film strength (to provide resistance to edge damage) and too high pan speed. All Rights Reserved . Required fields are marked *. In some cases, several defects may occur simultaneously and hinder the determination of the causes and redemption works. Keywords: substrate; centrifugal force; spin coating; thin film; photolithography; acceleration 1. While visually similar to logo bridging, infilling of logos typically occur during the spray application of aerated aqueous film-coating solutions. Intercoat adhesion failure(Dmitry Guzhanin / Dreamstime.com). Figure 1. The spraying air pressure affected the film-core interface and the occurrence of coating defects. MATERION BARR PRECISION OPTICS & THIN FILM COATINGS is a leading manufacturer and supplier of precision optical filters, hybrid circuits, flexible thin films and custom thin film coating services. Additionally, while all fi­lm coatings will develop some degree of adhesiveness during the drying process, not all coating formulations are equal in this regard. Excessive attritional conditions used during application of the applied coating. This website uses cookies. Avis, K., Shukla, A. and Chang, R. (1998). J.A. To achieve good painting work, applicators and site supervisors should understand the causes and preventive measures of common defects that occur at different stages of works. Coating Failures and Defects Coatings are a complex combination of raw materials that must be mixed, applied to a prepared substrate, and dried and cured correctly to perform to their maximum capability. Reducing coating solids to facilitate more even coating distribution. Course Outline . Changing logo location from the centre of the tablet faces to the periphery. Causes and Remedies of Blistering: Causes: Remedies: 1. Adjusting coating formulation to allow reduction in coating process temperatures. Coatings applied with poor surface preparation will peel, and in some c… This may be as a result of partially spray-dried material gradually building up within the logo or, the buildup of dried foamy material within the logo. Although a number of factors may be involved here, the most prominent one is the impact of coating process conditions on tablet core behaviour, rather than the impact of the applied coating itself (through chemical interaction with an ingredient in the core). Tablet Twinning. Capillary Flow. Toward a greater understanding of the scuffi­ng defect observed on Fi­lm-coated tablets. 2. Excessive tablet-to-tablet colour variability may be attributed to; This is the term for two tablets that stuck together, usually after becoming aligned along flat surfaces. Article Download PDF View Record in Scopus Google Scholar. This is another mechanical defect that occurs as tablets tumble during the coating process. Tablet Coating With Its Defects - Free download as Powerpoint Presentation (.ppt / .pptx), PDF File (.pdf), Text File (.txt) or view presentation slides online. Using high solids film-coatings systems (such as Aquarius Preferred HSP) that facilitates the use of lower processing temperatures, Adjusting core formulation to improve dissolution behaviour and offset sensitivity to processing conditions. Macleod ‐Thin Film Optics 2. Rowley, on the other hand, confi­rmed that the main issue is related to the level of titanium dioxide used. a film coating, tablets are stronger and tougher, so they can withstand the routine buffeting of transport and packaging. In the case in which foamy material tends to build up within the logo, it is interesting to note that the addition of conventional antifoam agents does not decrease the incidence of this defect. This problem can be eliminated by simply addressing over-wetting conditions (reducing spray rates, increasing processing temperatures, or both). can be quite effective; however, this approach will also reduce the opacity of the coating formulation, necessitating the use of higher levels of applied coating to achieve complete tablet core coverage. By continuing to use this website you are giving consent to cookies being used. in film coating is the consistency of tablet hardness. In fact, logo definition is a key CQA because it allows the manufacturer, pharmacist, and end-consumer to recognize the brand. Logo Bridging. Although variation in the amount of coating applied on each tablet within the batch will, on a weight basis, always exist, the challenge is to ensure that enough coating is applied to prevent visible differences in amount of coating applied or even affecting fi­nal product functionality. Similarly, when ingredients that become liquid and bleed through the coating do so as a result of high processing temperatures, an increase in spray rate and/or reduction in processing temperature can be helpful. Ensuring that the coating process is optimized with respect to, Spray rate (increased spray rate provides protection for tablets), Pan loading (underloaded pans potentially create more attritional problems, especially because tablets can strike the exposed edges of baffles), Pan speed, which can be reduced to minimize mechanical stress. Causes: Cratering can occur in certain instances where there is insufficient drying time to seal the film or a high volume of coating solution is applied. Related Keywords: film coating defects slideshare, defects in film coating, film coating defects pdf, tablet coating defects colorcon, defects in film coating, tablet coating process, sugar coating and film coating, defects in film coating, logo bridging in tablet coating, tablet defects with pictures, tablet coating slideshare, Your email address will not be published. Tablet-to-tablet colour variability corresponds to inter-tablet variation of coating. As more coating is applied to tablet surfaces, the stresses that develop within the coating as it dries overcome the forces of attachment of the... Read More. Regulations, Guidelines and Clinical Trials, Advantages and Disadvantages of Pharmaceutical Emulsions, Problems Encountered During Trituration and Possible Solutions, Mechanisms Involved in the Mixing of Pharmaceutical Powders, Mixing of Pharmaceutical Powders in Small-Scale Operations, Rectal Route of Drug Administration: Advantages and Disadvantages, Intravenous Route of Drug Administration: Advantages and Disadvantages, Customer Loyalty: How To Build Trust With Your Customers, Parenteral Route of Drug Administration: Advantages and Disadvantages, Advantages and Disadvantages of Hard Gelatin Capsules, National Agency for Food & Drugs Admin & Control, Journal of Pharmaceutical Development and Industrial Pharmacy, Inadequate uniformity of coating distribution. Tablet scuffi­ng involves the generation of grey-to-black marks on the surface of white (or lightly coloured/ pastel) film-coated tablets. coating defects on a soft and friable multivitamin tablet. Usually, however, a portion of the coating will remain in the compression mix. Conventional solvent-based film coating involves deposition of a thin polymer film on the surface of the tablet core, typically using a spray method. Shah, in one of his publications, discussed the use of the Crackulator for recovery of film-coated tablets. On occasion (particularly during application of aqueous-coating formulations), if cohesive failure (cracking) of the coating occurs, that coating may subsequently peel back from the surface of the substrate. Regular Access to Part 1 + Part 2: 650 € 520 € On purchasing the course, you'll get: Recording of Part 1; Recording of Part 2; Exclusive Preview . This is the term for two tablets that stuck together, usually after becoming aligned … Dissolution problems occur when there is a statistically significant change in dissolution behaviour after film coating (comparing film-coated tablets to uncoated ones). As dip coating is affordable, easy to master, and easily adaptable to suit different needs, the process is often used in research for simple thin-film coatings. Tablet breaking force (or tensile strength) must be maximized, while minimizing tablet friability. common defects 30 6. Article Download PDF CrossRef View Record in Scopus Google Scholar. Unlike with sugar-coated tablets, film-coated tablets cannot be readily recovered (should a batch be rejected) by simply washing off the coating. New Offer Price . Variations in die fill uniformity during the tabletting process, possibly due to variations in hopper fill. Higher rate of application of coating solution. CRATERING • It is defect of film coating whereby volcanic-like craters appears exposing the tablet surface • Reason: The coating solution penetrates the surface of the tablet, often at the crown where the surface is more porous, causing localized disintegration of the core and disruption of the coating. For example, interaction of ingredients in the core, often in the presence of moisture derived from the coating process, can create dark spots that remain visible through the coating. Contaminants can include water-soluble salts, dust from abrasive blasting of the substrate surface, as well as environmental dirt and dust that was not properly cleaned off the surface. This section describes coating defects and failures commonly encountered aboard Navy ships, particularly on metal surfaces. When edge wear occurs, the coating process conditions, the tablet core and the coating for-mulation can all be considered in the effort to eliminate the problem. Film coating is a thin polymer layer applied on to a solid dosage form. In a similar vein, migration/ bleeding of ingredients from the tablet core, through the coating can also be a factor. optimizing blending process (prior to tabletting) to minimize the chance of producing agglomerates. 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This defect is commonly seen with nutraceutical products and may be alleviated using...