Film coating process of tablets in pharma manufacturing. This is not the case for sugar coating where a tablet may weight more that 30%. Voltage and specificationstemperature ph conductivity solvent content solids pb uf flux rate are these parameters monitored and controlled. Film coating is a contemporary and widely used process for coating oral solid dosage forms in the pharmaceutical industry. This material may be organic or inorganic and, after application, may form a hard, impervious film, a soft porous. Glatt hp process for granulation and coating by fluidized. Application of a tablet film coating model to define a. Film coating process film coating process plays a very important role in film coating and a number of problems in tablet coating are related to process setup. Film coating has evolved with time keeping in pace with the demands of the pharmaceutical industry. Feb 08, 2015 film coating of tablets is a multivariate process, with many different factors, such as coating equipment, coating liquid, and process parameters which affect the pharmaceutical quality of the final product. Using the new solvent based, nontintable chemistry, labs can achieve extremely high scratchresistance previously not possible with spin coating technology. A thermodynamic film coating model was used to evaluate film coating process performance over a wide range of film coating equipment from pilot to industrial scale 2. The choice of which method is appropriate depends to an extent on how the tablets have been.
Film coating process in the pharmaceutical industry. Pharmaceutical tablets can be film coated in a single stage process that is rapid and results in minimal weight gain of at 2 3% compared with sugar coating which adds 60 to 80%. Modern tablet coatings are typically film coatings, flexible. The three coating techniques performed by dsi are designed to accommodate the varied and rigorous demands made on thin film coatings, and provide unique solutions, higher performance, increased volume, and more coating durability. Polymers are available in a range of colours, coverage qualities, opacities and finishes such as matt, shine and sparkle. Coating defects detection, causes and cures edward d. A very common finishing technique is actually chemical film coating.
These are heated in a stream of flowing air and time allowed for dust to settle and a steady temperature of the outlet air to be reached typically 40 to 46c. A typical process involves depositing a small puddle of a uid resin onto the center of a substrate and then spinning the substrate at high speed typically around. Tablets coated by pan pour method subjected to alternate solution application, mixing and. Process validation of nifedipine film coated tablet pharmagene 26vol. The aim of this study was to compare the coating processes using different types of perforation. The film coating is typically performed for cosmetic purposes, but the film coat is also sometimes used to modify the release of api and achieve the desired tablet performance. Film coating involves the deposition of a thin layer of film forming polymeric material on the tablet core. Understanding tablet coating process lfa tablet presses. Choose from a wide variety of coating materials including pure metals, metallic alloys, metallic blends, carbides and selffluxing materials, tailored to gas or liquid fuel systems. The film coat does not significantly affect the tablets disintegration process. It is the application of coating composition on to the moving bed of tablets.
By contrast, how the coating process is set up ranks as the most common cause o f problems in film coating. Aqueous diffusion coating formulations suitable for use on pharmaceutical dosage forms comprising an admixture of an insoluble polymer component of a copolymer of ethylacrylate and methylmethacrylate and as a hydrophilic component the polysaccharide pullulan. Electrophoretic deposition epd, is a term for a broad range of industrial processes which includes electrocoating, cathodic electrodeposition, anodic electrodeposition, and electrophoretic coating, or electrophoretic painting. It is a process that draws on technologies associated with polymer chemistry, industrial adhesives and paints, and chemical engineering. Tablet coating is a common pharmaceutical technique of applying a thin polymer based film to a tablet or granule containing active pharmaceutical ingredient api 3. When applied to the substrate of choice, said formulations provide coatings exhibiting good mechanical strength and flexibility. Thermodynamic film coating conditions provided in the tablet film coating process impact film coat formation and subsequent product quality.
Spraying a liquid is the most widely used process for filmcoating and typically includes three basic steps. Chemetall was the first company to introduce a multimetal thinfilm technology on the market long before most of the current developments had taken place. Rachel kamenetzky acting branch chief materials and processes branches4 date revisions version changes date original version 51496. The film coating involves coating the tablet core with thin film of polymer the film coating process is highly favored because the weight increases to 23%, only takes a single stage process, can be controlled with ease, easily retains the color of the original core, automation is possible and adaptability to gmp. The term is also widely used for the different process of coating a metal with solder before soldering. Introduction to pharmaceutical film coatings pharma. Tinning is the process of thinly coating sheets of wrought iron or steel with tin, and the resulting product is known as tinplate. The term is also widely used for the different process of coating a metal with solder before soldering it is most often used to prevent rust, but is also commonly applied to the ends of stranded wire used as electrical conductors to prevent oxidation which. Quality by design approach was explored to optimize the tablet coating process using opadry, an optimized one step film coating system.
The procedure of coating tablets is a complex process that results in the forming of a thin layer around the tablet. Rupture of liquid coating caused by contamination dirt, slivers etc. It mainly protects tablet core from the acidic environment in the stomach. Unit 4 metal coating processes metal coating processes.
Readytouse film coating materials, such as those my company supplies 1, are carefully designed to perform well wunder a wide range of coating conditions and are ver y seldom cited as the root cause of coating defects. For simplicity, this diagram demonstrates the 3d shape process only. The process of film coating involves the deposition of a thin, but uniform polymerbased formulations onto the surface of solid dosage forms such as tablets, capsules, powders. Seed coating polymers are used in the filmcoating process. Practical applications of process control in conformal coating michael a. Film forming polymer used in the formulation also achieves good. Sublimation technology film transfer 4 3 powder coating primer pretreatments 2 aluminum 1. To measure the dry film thickness, we use a device c. This process specification establishes the engineering requirements for the use.
It is most often used to prevent rust, but is also commonly applied to the ends of stranded wire used as. A characteristic feature of this process is that colloidal particles suspended in a liquid medium migrate under the influence of an electric field electrophoresis and. Mar, 20 the second way that a film coating may impact cqas of the drug product is via the coating process, i. There is a number of variables which should be controlled in a process and we will understand. A central composite design was chosen by considering independent.
Warm air is drawn through the bed as it enters inlet air and exist outlet air the drum through perforations. The film coating process begins with the loading of a batch of tablets into the coating drum. Online inspection systems can monitor process locate defects, identify, mark location. Minimal weight gain 23% as opposed to 6080 % for sugar coating coat is less likely to affect disintegration. In the last 25 years tablet coating has undergone several fundamental changes.
Process specification for dryfilm lubricant application. The filmcoating process consists of the application of a thin water permeable polymer based coating layer onto the seed, seed coating or pellet. Spin coating process theory spin coating has been used for several decades for the application of thin lms. Many available packaging substrates by themselves are not able to meet the specific requirements for a functional packaging film. Welcome to the process control for electrocoat systems. Tablets coated by pan pour method subjected to alternate solution application, mixing and drying steps are similar to pan pour sugar coating.
A quality by design approach for coating process parameter optimization film coating is a thin polymer layer applied on to a solid dosage form. Coating pinhole on film causes and cures description tiny clear spots indicating the absence of a coated layer size differentiates from bubbles much smaller typical causes. Process validation of nifedipine film coated tablet. A wide variety of pharmaceutical products, including pellets, granules, capsules, powders, and crystals are often film coated. Reighard asymtek amherst, oh abstract the development of automated selective coating systems was the first step in improving the conformal coating process. Sugar coating process and its problems in pharmaceuticals ankur choudhary print question forum no comments sugar coating is rarely used in pharmaceuticals these days but this has its importance so the problems and their solutions are given billow related to the pharmaceutical sugar coating.
Contents introduction aqueous film coating of dosage form film formation mechanism film formers plasticizers and colours process parameters how the coating process works coating equipments coating defects solvent film coating coating. But the principle means of applying a coating to pharmaceutical and nutraceutical tablets is called film coating, and it is the focus of this article. There are basically 2 methods of film coating they are i. A typical process involves depositing a small puddle of a uid resin onto the center of a substrate and then spinning the substrate at high speed typically around 3000 rpm. There is a number of variables which should be controlled in a process and we will understand how these variables are crucial for the film coating process. As you recall from the discussion during the coating application process \. For many years, the liquid component of coatings was a volatile solvent, such as alcohol or other quickdrying substances like methylene chloride. Film coating and the sugar coating share same equipment and the process parameters. This article describes the essential process steps and equipment required for film coating tablets. Film coating process is easy to automate, involves few procedures and increases the overall weight of tablets by only 3%.
Also, required is an air handling unit and dust collector, and the associated controls. Many modifications were advocated to improve the basic process. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. The process of film coating involves the deposition of a thin, but uniform polymer. Both have advantages and disadvantages, and the following table provides a comparison between the two methods. Sugar coating process and its problems in pharmaceuticals. The coater drum rotates and the baffles in the drum mix the tablets. Process control for electrocoat systems jeff paxon axalta coating systems process control coating characteristics, mainly film build, change as the operating parameters vary. Practical applications of process control in conformal coating. Wire spraying metal coating processes in this process, special type of spray gun is used. Figure 21 illustrates the productive activity of surface coating plastic parts.
Dry coating is the technique of making a tablet within a tablet. The process was introduced in the 1950s as improvement on the traditionally sugarcoating process. Process specification for dryfilm lubricant application engineering directorate structural engineering division. In this present article, we will concentrate on the filmcoating of tablets. Additional functional layers are often coated on the substrate to meet the requirements. Film coating usually involves a process where tablets are sprayed with a pigmentcontaining polymer solution while being rotated in a dry air stream. At the heart of a modern film coating facility is the coating pan or drum and a spraying system. For a smooth tablet surface and a cost efficient manufacturing process. There has been tremendous and necessary modification like improved production equipment and the development of highly efficient filmcoating formulations and polymers which has accelerated the acceptance of filmcoating technology. All coatingswhether used for corrosion protection, to provide good aesthetics or a pleasing appearance, or for any other purposewill contain a filmforming material. Filmcoating of tablets is a multivariate process, with many different factors, such as coating equipment, coating liquid, and process parameters which affect the pharmaceutical quality of.
Overview of the film coating process and difference. Immediately removable film coating with moisture barrier to prevent solid dosage forms from absorbing moisture. Many modifications were advocated to improve the basic process and film coating chosen in place of sugar coating. Jan 22, 2014 contents of the powerpoint on tablets aqeuos film coating include. Film coating has proved successful as a result of the many advantages offered, including. A quality by design approach for coating process parameter. Coatings, thin film process chemetall north america. U tes s purpose fully perforated and partially perforated coating pans eare. The second way that a film coating may impact cqas of the drug product is via the coating process, i. The filmcoating process film coating, especially the aqueous process, is a complex, critical process. Fully perforated and partially perforated coating pans eare commonly used for film coating processes.
The purpose of application of coating is the value enhancement of the substrate by improving its appearance, corrosion resistant property, wear resistance, etc. The transferrable film is preprinted with almost any pattern you require. If you are wondering what is chem film, this post should help. Watch our newest animation video about glatt tablet coating technology. Process specification for dry film lubricant application prepared by. Signature on file 122 daila gonzalez materials and processes branches4 date signature on file 122 approved by. Detailed study and controlled of the manufacturing process batch validation is necessary if. Coating solutions film coatings are a mixture of solids and liquids. With enteric coating, the tablet will not disintegrate. There are times that we will think of the final coat on a product we purchase as being paint or metal, the finishing techniques that are on a manufactured product will vary. Variables in the process can cause defects if not detected and compensated. Mar 08, 2016 watch our newest animation video about glatt tablet coating technology.
Wood grain is the most popular pattern for this process. For example, coating color development and uniformity may be significantly affected by coating process parameters such as tablet bed temperature, pan speed, and spray rate. Tablet coating is a process that can be summarized as the application of an edible paint to the surface of a pharmaceutical dosage form. Comparison of film coating process using fully perforated and partially perforated coating pans lirong liu1,timothy j. Unit 4 metal coating processes metal coating processes structure 4. Spin coating is the right choice for labs that want less complex production and a low investment with the highest process speed and the option to fully automate their hard coating process. The process was introduced in the 1950s as improvement on the traditionally sugar coating process. Film coating involves the deposition of a thin layer of filmforming polymeric material on the tablet core. The appropriate quantities of labor services, materials, energy, and. Hot melt coating is a solvent free technology grants rapid, additionally economical coating process with reduced risk of dissolving drug during process and provide uniform application rate of.
Introduction to pharmaceutical film coatings pharma excipients. In the past, sugar coating was a common solution for coating tablets, but this process has many disadvantages. Complexity is derived from the potentially large number of process variables that can impact the quality in its broadest sense of the final product. Enteric coating is of choice when the drug has to remain intact in the stomach, but dissolve and release the contents once it reaches. Process optimization of a novel immediate release film. Methods a commercial pva polyvinyl alcohol based film coating formulation colorcon, opadry yellow 85f12383 was used for this. Overview of the film coating process and difference between solvent and aqueous coating film coating process pharmaceutical tablets can be film coated in a single stage process that is rapid and results in minimal weight gain of at 2 3% compared with sugar coating which adds 60 to 80%.
The coating process is an essential technology in the successful development and commercialization of flexible packaging films. Burnishing of the cured dryfilm coating is standard. While solventbased coatings performed well in many respects, they presented. Designed to meet the need of our customers for tougher, more wear and corrosion resistant surfaces, our diamond.
The film coating process film coating, especially the aqueous process, is a complex, critical process. Film coating technology is now a days very important in the field of pharmacy particularly in formulation development. Overview of filmcoating technologies in the pharmaceutical. The functional material may be metallic or nonmetallic. Process of coating involves application of thin film of functional material to a substrate.