Tablet coating is the application of a coating material to the exterior of a tablet to confer benefits over uncoated tablets. Common purposes are to mask taste/odor, protect drugs from environmental factors or gastric acid, and control drug release. Major types are sugar coating, film coating, enteric coating, and press coating. Film coating involves spraying a polymer solution onto tablets while sugar coating is a multistage process including sealing, subcoating, smoothing, coloring and polishing. Standard pans and perforated pans are commonly used coating equipment.
This document discusses three main types of tablet coating equipment: standard coating pans, perforated pan systems, and fluidized bed coaters. Standard coating pans include the Pellegrini pan system and immersion sword/tube systems. Perforated pan systems provide more efficient drying than standard pans and include the Accela cota system. Fluidized bed coaters suspend tablets in an upward-flowing column of air for coating, with spray nozzles introducing coating fluid. Each equipment type uses rotating pans/drums and spray nozzles to apply and dry coating materials on tablets.
Capsules are solid dosage forms that enclose one or more active ingredients within a soluble shell, typically made of gelatin. There are two main types: hard-shelled capsules containing dry powders, and soft-shelled capsules used for oils. Capsules are manufactured through a process involving dipping pins in gelatin solutions to form the shells, drying, stripping from the pins, trimming, joining the cap and body portions, and polishing. Various sizes of empty capsules are commercially available. Capsules offer benefits like ease of swallowing and unit dosing but require specialized filling equipment for industrial production.
This document discusses tablet coating, which involves covering tablet surfaces with a polymeric film to provide benefits like masking taste, protecting drugs, and controlling drug release. It describes the main types of tablet coating - sugar coating, film coating, enteric coating, vacuum film coating, electrostatic coating, and dip coating. For each coating type, it outlines the basic process and materials used. The document also explains the need for tablet coating and lists the ideal characteristics of coating materials.
Tablet coating serves several purposes: to mask unpleasant tastes, protect medications from environmental factors like light and moisture, control drug release, and improve appearance. There are several types of coatings including sugar, film, enteric, and press coatings. The sugar coating process involves multiple steps like sealing, sub-coating, syruping, finishing, and polishing to build up the coating and impart the desired color, texture, and shine. Skill is required during syruping to smoothly cover imperfections and apply color uniformly.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, and filling steps. It also discusses advantages like taste masking and disadvantages like incompatibility with hygroscopic drugs. Quality control tests for capsules include disintegration, weight variation, and dissolution testing.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
This document discusses three main types of tablet coating equipment: standard coating pans, perforated pan systems, and fluidized bed coaters. Standard coating pans include the Pellegrini pan system and immersion sword/tube systems. Perforated pan systems provide more efficient drying than standard pans and include the Accela cota system. Fluidized bed coaters suspend tablets in an upward-flowing column of air for coating, with spray nozzles introducing coating fluid. Each equipment type uses rotating pans/drums and spray nozzles to apply and dry coating materials on tablets.
Capsules are solid dosage forms that enclose one or more active ingredients within a soluble shell, typically made of gelatin. There are two main types: hard-shelled capsules containing dry powders, and soft-shelled capsules used for oils. Capsules are manufactured through a process involving dipping pins in gelatin solutions to form the shells, drying, stripping from the pins, trimming, joining the cap and body portions, and polishing. Various sizes of empty capsules are commercially available. Capsules offer benefits like ease of swallowing and unit dosing but require specialized filling equipment for industrial production.
This document discusses tablet coating, which involves covering tablet surfaces with a polymeric film to provide benefits like masking taste, protecting drugs, and controlling drug release. It describes the main types of tablet coating - sugar coating, film coating, enteric coating, vacuum film coating, electrostatic coating, and dip coating. For each coating type, it outlines the basic process and materials used. The document also explains the need for tablet coating and lists the ideal characteristics of coating materials.
Tablet coating serves several purposes: to mask unpleasant tastes, protect medications from environmental factors like light and moisture, control drug release, and improve appearance. There are several types of coatings including sugar, film, enteric, and press coatings. The sugar coating process involves multiple steps like sealing, sub-coating, syruping, finishing, and polishing to build up the coating and impart the desired color, texture, and shine. Skill is required during syruping to smoothly cover imperfections and apply color uniformly.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, and filling steps. It also discusses advantages like taste masking and disadvantages like incompatibility with hygroscopic drugs. Quality control tests for capsules include disintegration, weight variation, and dissolution testing.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
The document discusses tablet coating, including its purposes, principles, history, types and processes. Tablet coating involves applying a thin outer layer or film to tablets to improve characteristics like taste, moisture protection and drug release. There are two main types: film coating, which uses a polymer film, and sugar coating, which builds up layers of sucrose. The coating process aims to evenly apply and dry coating solutions or suspensions in rotating equipment. Factors like coating thickness, temperature and ingredients affect the quality and performance of coated tablets.
Aerosol , components for aerosol formulation by mariomakhter@yahoo.commariomS7
Aerosol are the products that depend on the power of a compressed or liquefied gas to expel the contents from the container. Aerosols are termed also pressurized package.
This document provides information about pharmaceutical suspensions. It defines a suspension as a coarse dispersion where an insoluble solid active ingredient is uniformly dispersed throughout an external aqueous or non-aqueous liquid phase. Suspensions are formulated when drugs are insoluble, to mask bitter tastes, increase stability, or achieve sustained release. Key factors in formulating stable suspensions include particle size, shape, wettability, and use of suspending agents to decrease interparticle attraction and impart viscosity. Proper manufacturing controls suspension quality.
This document discusses the design and formulation of capsules. It begins by defining capsules and describing their history. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have two pieces and typically contain powders, granules or pellets, while soft gelatin capsules are one piece and sealed and can contain liquids or suspensions. The document goes on to cover the advantages and disadvantages of capsules, as well as the formulation of the gelatin shell and capsule contents for both hard and soft gelatin capsules. Key components include gelatin, plasticizers, colorants, fillers and various other excipients.
Hard gelatin capsules are solid dosage forms where the drug is enclosed in a hard gelatin shell composed of two pieces called caps and bodies. Gelatin is derived from animal sources through hydrolysis. The manufacturing process involves dipping stainless steel pins in gelatin solution to form shells, drying, stripping shells from pins, trimming, joining caps and bodies. Powder drugs are filled using augers, dosators or direct measurement then scraped, capped and sealed. Capsules offer advantages like ease of swallowing, masking of unpleasant drug properties and quick dissolution.
Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
Soft gelatin capsules (SGCs) are hermetically sealed capsules containing liquids or semisolids without air. They are made of flexible gelatin and have gained popularity due to increased bioavailability of drugs and stability. Common manufacturing methods are rotary die and reciprocating die processes, which use gelatin ribbons to encapsulate fills. The rotary die process is most common, using rollers to converge ribbons around fills to seal and cut capsules continuously.
Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.
A detailed study on Tablets which describes about tablets, coating of tablets and then a study on the quality control of tablets. The chapter deals with the minute aspects of tablets and gives us an enlightenment of the solid dosage form which is commonly used all around the world
This presentation discusses tablet formulation and manufacturing. Tablets are defined as compressed solid dosage forms containing active ingredients with or without excipients. Tablets offer advantages for large scale production, packaging/shipping, stability, and dosage precision. Ingredients include active drugs and excipients like diluents, binders, disintegrants, lubricants. Tableting methods include direct compression, wet and dry granulation. Tablet presses include single-punch and multi-station rotary presses. Process steps are filling, compression, and ejection. Common problems are capping and lamination from air entrapment.
This document discusses common manufacturing defects that can occur during tablet production such as picking and sticking, capping and lamination, mottling, double impression, poor mixing, poor flow, weight variation, and hardness variation. For each defect, the document provides the reason for why the defect occurs and recommendations for how to correct the issue, such as using properly designed punches, adequate drying, uniform granule size distribution, and controlling punch movement. The overall goal of the document is to outline typical tablet defects, their causes, and methods for prevention.
This document discusses dispersed systems such as emulsions, colloids, and suspensions. It begins by defining dispersed systems as particulate matter distributed throughout a continuous medium and classifies them based on particle size into molecular, colloidal, or coarse dispersions. The document then covers topics such as interfacial phenomenon, wetting, adsorption, surface active agents, micellar solubilization, and the use of these concepts in pharmacy. It provides details on emulsions, including the theories of emulsification, methods to determine emulsion type, emulsifying agents, and emulsion stability.
This document summarizes formulations for various cosmetic preparations including lipsticks, shampoos, cold cream, vanishing cream, toothpastes, hair dyes, and sunscreens. It provides information on the definition, key ingredients, preparation methods, and evaluation of these products. The main formulations covered are lipsticks, shampoos, cold cream, and toothpastes. It also briefly discusses packaging materials science and factors that influence the choice of packaging for pharmaceutical products.
The document discusses tablet coating. It provides information on the types of coatings including film coating, sugar coating, press coating, and functional coatings. It describes the key components of coating formulations which include film formers like hydroxypropyl methylcellulose, solvents, plasticizers, and colorants. The principles and objectives of tablet coating are to protect drugs, mask tastes, control drug release and provide enteric properties. Equipment used includes pan coaters, printing machines for logos.
Tablet coating involves covering tablets with mixtures like resins, gums, and sugars to improve properties like taste, stability, and effectiveness. Common coating defects include twinning where tablets stick together, cracking or roughness of the film, and variations in color. The document outlines several specific coating defects like orange peel, bridging, chipping, and lists possible causes like inefficient drying, high viscosity, or improper application and remedies like reducing spray rates or changing plasticizer.
This document summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
“Pellets Technology: Special focus on Wruster Coating and Extruder
spheronization”
Basic introduction, various methods of pellets technology, Wruster process, equipments, various process parameters and equipment parameters, Extrusion-Spheronization, Equipments, process and equipment parameters
The document provides information about tablets, including their definition, advantages, disadvantages, types, ingredients, and manufacturing methods. It discusses that tablets are a solid dosage form containing medicaments that are manufactured by compressing powders into a solid mass using compression. The main methods of tablet manufacturing discussed are direct compression, dry granulation, wet granulation, and roller compaction. Excipients like diluents, binders, disintegrants, and lubricants are added to optimize the tableting process and tablet properties.
This document discusses tablet coating, which involves applying a coating material to tablets to confer benefits over uncoated tablets. There are three main types of coating: film coating, sugar coating, and press coating. Film coating sprays a polymer coating onto tablets using water as the solvent. Sugar coating is a multi-step process involving sealing, subcoating, smoothing, coloring, polishing and printing. Coatings can be used to mask taste, protect ingredients, or control drug release through the use of functional coatings. Standards require coated tablets to meet uniformity and disintegration testing.
Tablet coating is done to improve properties like taste, appearance, and drug release. There are several types of coatings including sugar coating, film coating, and enteric coating. Film coating involves spraying a polymer solution onto tablets to form a thin protective film. Important considerations for film coating include the polymer, plasticizer, colorants, and solvent used. Tablet coating is done using specialized coating equipment and any issues during coating like roughness, cracking or color variation must be monitored and addressed.
pellets can be defined as multi particulate system or multiunit system
They are spherical particulates manufactured by agglomeration of the powder granules containing drug substance and excipients.
Pellets can be prepared by a special technique called Pelletization.
This technique is referred to an agglomeration process that convert fine powder or granules of bulk drug or excipient in to small , free flowing , spherical or semi spherical pellets .
Multi particular drug delivery system especially suitable for achieving controlled delay released oral formulation with low risk of dose dumping, flexibility of blending to attain different release patterns as well as reproducible and short gastric residence time.
Multi particulate drug delivery system are mainly oral dosage form consisting of a multiplicity of small discrete units each exhibiting some desire characteristics.
The document discusses tablet coating, including its purposes, principles, history, types and processes. Tablet coating involves applying a thin outer layer or film to tablets to improve characteristics like taste, moisture protection and drug release. There are two main types: film coating, which uses a polymer film, and sugar coating, which builds up layers of sucrose. The coating process aims to evenly apply and dry coating solutions or suspensions in rotating equipment. Factors like coating thickness, temperature and ingredients affect the quality and performance of coated tablets.
Aerosol , components for aerosol formulation by mariomakhter@yahoo.commariomS7
Aerosol are the products that depend on the power of a compressed or liquefied gas to expel the contents from the container. Aerosols are termed also pressurized package.
This document provides information about pharmaceutical suspensions. It defines a suspension as a coarse dispersion where an insoluble solid active ingredient is uniformly dispersed throughout an external aqueous or non-aqueous liquid phase. Suspensions are formulated when drugs are insoluble, to mask bitter tastes, increase stability, or achieve sustained release. Key factors in formulating stable suspensions include particle size, shape, wettability, and use of suspending agents to decrease interparticle attraction and impart viscosity. Proper manufacturing controls suspension quality.
This document discusses the design and formulation of capsules. It begins by defining capsules and describing their history. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have two pieces and typically contain powders, granules or pellets, while soft gelatin capsules are one piece and sealed and can contain liquids or suspensions. The document goes on to cover the advantages and disadvantages of capsules, as well as the formulation of the gelatin shell and capsule contents for both hard and soft gelatin capsules. Key components include gelatin, plasticizers, colorants, fillers and various other excipients.
Hard gelatin capsules are solid dosage forms where the drug is enclosed in a hard gelatin shell composed of two pieces called caps and bodies. Gelatin is derived from animal sources through hydrolysis. The manufacturing process involves dipping stainless steel pins in gelatin solution to form shells, drying, stripping shells from pins, trimming, joining caps and bodies. Powder drugs are filled using augers, dosators or direct measurement then scraped, capped and sealed. Capsules offer advantages like ease of swallowing, masking of unpleasant drug properties and quick dissolution.
Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
Soft gelatin capsules (SGCs) are hermetically sealed capsules containing liquids or semisolids without air. They are made of flexible gelatin and have gained popularity due to increased bioavailability of drugs and stability. Common manufacturing methods are rotary die and reciprocating die processes, which use gelatin ribbons to encapsulate fills. The rotary die process is most common, using rollers to converge ribbons around fills to seal and cut capsules continuously.
Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.
A detailed study on Tablets which describes about tablets, coating of tablets and then a study on the quality control of tablets. The chapter deals with the minute aspects of tablets and gives us an enlightenment of the solid dosage form which is commonly used all around the world
This presentation discusses tablet formulation and manufacturing. Tablets are defined as compressed solid dosage forms containing active ingredients with or without excipients. Tablets offer advantages for large scale production, packaging/shipping, stability, and dosage precision. Ingredients include active drugs and excipients like diluents, binders, disintegrants, lubricants. Tableting methods include direct compression, wet and dry granulation. Tablet presses include single-punch and multi-station rotary presses. Process steps are filling, compression, and ejection. Common problems are capping and lamination from air entrapment.
This document discusses common manufacturing defects that can occur during tablet production such as picking and sticking, capping and lamination, mottling, double impression, poor mixing, poor flow, weight variation, and hardness variation. For each defect, the document provides the reason for why the defect occurs and recommendations for how to correct the issue, such as using properly designed punches, adequate drying, uniform granule size distribution, and controlling punch movement. The overall goal of the document is to outline typical tablet defects, their causes, and methods for prevention.
This document discusses dispersed systems such as emulsions, colloids, and suspensions. It begins by defining dispersed systems as particulate matter distributed throughout a continuous medium and classifies them based on particle size into molecular, colloidal, or coarse dispersions. The document then covers topics such as interfacial phenomenon, wetting, adsorption, surface active agents, micellar solubilization, and the use of these concepts in pharmacy. It provides details on emulsions, including the theories of emulsification, methods to determine emulsion type, emulsifying agents, and emulsion stability.
This document summarizes formulations for various cosmetic preparations including lipsticks, shampoos, cold cream, vanishing cream, toothpastes, hair dyes, and sunscreens. It provides information on the definition, key ingredients, preparation methods, and evaluation of these products. The main formulations covered are lipsticks, shampoos, cold cream, and toothpastes. It also briefly discusses packaging materials science and factors that influence the choice of packaging for pharmaceutical products.
The document discusses tablet coating. It provides information on the types of coatings including film coating, sugar coating, press coating, and functional coatings. It describes the key components of coating formulations which include film formers like hydroxypropyl methylcellulose, solvents, plasticizers, and colorants. The principles and objectives of tablet coating are to protect drugs, mask tastes, control drug release and provide enteric properties. Equipment used includes pan coaters, printing machines for logos.
Tablet coating involves covering tablets with mixtures like resins, gums, and sugars to improve properties like taste, stability, and effectiveness. Common coating defects include twinning where tablets stick together, cracking or roughness of the film, and variations in color. The document outlines several specific coating defects like orange peel, bridging, chipping, and lists possible causes like inefficient drying, high viscosity, or improper application and remedies like reducing spray rates or changing plasticizer.
This document summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
“Pellets Technology: Special focus on Wruster Coating and Extruder
spheronization”
Basic introduction, various methods of pellets technology, Wruster process, equipments, various process parameters and equipment parameters, Extrusion-Spheronization, Equipments, process and equipment parameters
The document provides information about tablets, including their definition, advantages, disadvantages, types, ingredients, and manufacturing methods. It discusses that tablets are a solid dosage form containing medicaments that are manufactured by compressing powders into a solid mass using compression. The main methods of tablet manufacturing discussed are direct compression, dry granulation, wet granulation, and roller compaction. Excipients like diluents, binders, disintegrants, and lubricants are added to optimize the tableting process and tablet properties.
This document discusses tablet coating, which involves applying a coating material to tablets to confer benefits over uncoated tablets. There are three main types of coating: film coating, sugar coating, and press coating. Film coating sprays a polymer coating onto tablets using water as the solvent. Sugar coating is a multi-step process involving sealing, subcoating, smoothing, coloring, polishing and printing. Coatings can be used to mask taste, protect ingredients, or control drug release through the use of functional coatings. Standards require coated tablets to meet uniformity and disintegration testing.
Tablet coating is done to improve properties like taste, appearance, and drug release. There are several types of coatings including sugar coating, film coating, and enteric coating. Film coating involves spraying a polymer solution onto tablets to form a thin protective film. Important considerations for film coating include the polymer, plasticizer, colorants, and solvent used. Tablet coating is done using specialized coating equipment and any issues during coating like roughness, cracking or color variation must be monitored and addressed.
This document provides an overview of coating technology and problems encountered in coating processes. It discusses the objectives of coating, including masking taste and odor, providing physical and chemical protection for drugs, and protecting drugs from gastric environments. The key coating techniques of film coating, sugar coating, and enteric coating are described. Common coating equipment like coating pans and fluidized bed coaters are also outlined. Finally, potential coating defects are defined and causes and remedies are provided.
This document provides information about tablet coating. It discusses the purposes of tablet coating such as avoiding irritation, bad taste, and drug inactivation in the stomach. It describes aspects of tablet coating related to therapy, technology, and marketing. It also outlines the basic principles and types of tablet coating including sugar coating, film coating, enteric coating, and more. The document discusses equipment used for tablet coating and provides examples of sugar coated tablets.
This document provides information about tablet coating. It discusses the purposes of tablet coating such as avoiding irritation, bad taste, and drug inactivation in the stomach. It describes aspects of tablet coating related to therapy, technology, and marketing. It also outlines the basic principles and types of tablet coating including sugar coating, film coating, enteric coating, and more. The document discusses equipment for tablet coating and describes processes like polishing. It provides examples of coated tablets and compares film coating and sugar coating processes.
This presentation includes basics of coating operation of pharmaceutical tablets.
The following are discussed in detail:
1. What is coating
2. Reason for Tablets coating
3. Types of coating
4. Differences between sugar coating and film coating.
5. Steps of sugar coating
6. Advantages of Sugar coating
7. Disadvantages of Sugar coating
8. Advantages of pigment over dye
9. Mechanism of film formation in film coating
10. Materials used in film-coating
11. Immediate release coating
12. Modified release coating
13. Polymer characterization
The document discusses tablet coating technology and processes. It begins by outlining the objectives of tablet coating, such as masking taste or odor, providing physical protection, and controlling drug release. It then describes various coating equipment like standard coating pans, perforated coating pans, and fluidized bed systems. The coating processes of sugar coating, film coating, and enteric coating are explained. Finally, potential film defects in tablet coating like sticking, roughness, capping, and cracking are reviewed along with methods to prevent or correct them.
This document provides an overview of tablet coating. It discusses the historical development of tablet coating from the 16th century to modern developments. The objectives and benefits of tablet coating are to mask taste/color, provide protection, control drug release, and improve appearance. The major types of coating processes and equipment discussed are conventional coating pans, perforated pans, and fluidized bed coaters. Key parameters that affect the coating process like air flow, temperature, and spray application are also covered. The document concludes by describing sugar coating and film coating methods in detail.
Tablet coating is done to improve the quality, taste, and performance of tablets. The basic principle is applying a coating to tablets in a rotating bed with heated air to evaporate solvent. Objectives include protecting ingredients from environment, masking unpleasant tastes, making tablets easier to swallow, and adding functional properties like controlled release. Common coating types are film, sugar, enteric, controlled release, and specialized coatings. Process parameters must be optimized to produce an even, intact coating and avoid defects.
The document discusses various coating techniques used in pharmaceutical manufacturing. It describes common coating processes like sugar coating, film coating, enteric coating, and organic film coating. Recent coating technologies like electrostatic coating, vacuum film coating, compression coating, and dip coating are also summarized. The key equipment used for tablet coating include standard coating pans, perforated coating pans, and fluidized bed coaters. Coating is done to mask taste/odor, provide protection, control drug release, and incorporate incompatible drugs among other objectives.
1. Tablet coating is applied to tablets to provide benefits like protection from light and moisture, improved mechanical strength and taste masking. The main types of tablet coating are film coating, sugar coating, and press coating.
2. Film coating uses a single-stage process to apply a thin polymer coating for purposes like functional coatings. Sugar coating is a multi-stage process used mainly for taste masking and bulking.
3. Important polymers used in film coatings include cellulose derivatives, acrylic polymers, and shellac which are chosen based on properties like solubility and permeability for desired drug release.
Tablet coating is a process that applies a coating to tablets to improve properties like taste, release profile, or protection. There are three main coating equipment types - standard pans, perforated pans, and fluidized beds. Process parameters like air flow, spray rate, and temperature must be controlled. Tablet properties like shape, surface, and hardness influence coatability. Film coatings are applied using pan and spray methods while sugar coatings involve sealing, subcoating, smoothing, finishing, and polishing steps. Variables in the coating process like pan design, speed, and load as well as spray pattern and rate must be optimized for consistent results.
Tablet coating engineering is one of the prominent topics in pharmaceutical field.
This slide will help pharmacy student to become familiar with coating technology
This document discusses different coating methods and techniques used in the pharmaceutical industry. It describes:
1) Rotating coating pans and fluidized bed coaters are commonly used to coat tablets by spraying coating solutions and evaporating the liquid. Traditional techniques include sugar coating and film coating.
2) Key steps in sugar coating include sealing, sub coating, smoothing/syrup coating and finishing. Film coating uses similar equipment and parameters as sugar coating.
3) Common coating equipment includes standard coating pans, perforated coating pans, and fluidized bed coaters. Top spray, bottom spray, and tangential spray are fluidized bed coating methods that differ in how the coating solution is applied.
4) Dry particle
This document provides information on tablet coating. It discusses why coating is necessary, the main types of coatings including sugar coating, film coating and enteric coating. It outlines important coating parameters and compositions. It also describes some common coating defects and how to troubleshoot them. Finally, it introduces some coating equipment and Ideal Cures coating products, including their Instanute and Instamodel lines.
The document summarizes film coating techniques and problems. It discusses the purposes of film coating including masking taste, controlling drug release, and protecting ingredients. It then describes the mechanisms of film formation for aqueous and non-aqueous coatings. Key coating process parameters like spray pressure, temperature and pan speed are outlined. Common materials used include film formers like hydroxypropyl methylcellulose, plasticizers, pigments and solvents. Finally, potential defects in film coating like picking or mottling are briefly mentioned.
A Review on TABLET COATING & A DETAILED STUDY OF ENTERIC COATING OF TABLETVishal Shelke
This document discusses tablet coating and enteric coating of tablets. It provides an overview of tablet coating, including the history and types of coating techniques. Sugar coating, film coating, and enteric coating are described in detail. The key steps and components involved in enteric coating of tablets are explained. Enteric coatings are described as necessary to protect active ingredients from stomach acid and ensure drug release in the small intestine. Evaluation methods for coated tablets are also mentioned.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
2. DEFINITION
• Tablet coating is the application of a coating material to the
exterior of a tablet with the intention of conferring benefits
and properties the dosage form over the uncoated variety.
8/20/2020 2
3. PURPOSE OF TABLET COATING
• Cover the unpleasant taste, odor and color.
• Physical and chemical protection in medicine from environment (light, moisture, and air).
• Control of drug release as in enteric coating or sustained release or more usually to coated
multi particulates.
• To protect drug from the gastric environment of the stomach with an acid-resistant enteric
coating.
• Improve the appearance of tablets.
• Assist and facilitate the identification of drug.
• Easing the process of blistering.
8/20/2020 3
4. TYPES OF TABLET COATING
• Sugar coating
• Film coating
• Enteric coating
• Press coating
8/20/2020 4
5. SUGER COATING
• Sugar coating is a multistage process and can be divided into the following steps:
1. Sealing of the tablet cores
2. Sub coating
3. Smoothing
4. Coloring
5. Polishing
1. Sealing/Water proofing: Provides a moisture barrier and harden the tablet surface.
• e.g. :Shellac, Zinc, Cellulose acetate phthalate (CAP), Polyvinyl acetate phthalate,
Hyroxypropylcellulose, Hyroxypropylmethylcellulose etc.
8/20/2020 5
6. 2. Subcoating: Causes a rapid buildup to round off the tablet edges.
Generally two methods are used for subcoating:
a) The application of gum based solution followed by dusting with powder and
then drying. This routine is repeated until the desired shape is achieved.
b) The application of a suspension of dry powder in gum/sucrose solution
followed by drying.
3. Grossing/Smoothing: It is specifically for smoothing and filing the
irregularity on the surface generated during sub coating. It also increases the
tablet size to a predetermined dimension.
4. Coloring: Gives the tablet its color and finished size.
5. Polishing: Produces the characteristics gloss. Polishing is achieved by
applying the mixture of waxes like beeswax, carnubawax, candelila wax or hard
paraffin wax to tablets in polishing pan. 8/20/2020 6
7. FILM COATING
• Involves spraying a solution of polymer + pigments + plasticizers on to a
rotated, mixed tablet bed forms a thin, uniform film on tablet surface.
• Coating suspension formulation:
• Typically this comprises:
1. Polymer
2. Plasticizer
3. Colorants
4. Solvent.
8/20/2020 7
8. IDEAL CHARACTERISTICS A FLIM COATING POLYMER
• Solubility: For conventional film coating the polymer should have good solubility in
aqueous fluids to facilitate the dissolution of the active ingredient from the finished
dosage form. However, where a modified-release action is required then a polymer
system of low water solubility or permeability will be chosen.
• Viscosity: Polymers should have a low viscosity for a given concentration. This will
permit the easy, trouble- free spraying of their solutions in industrial film coating
equipment.
• Permeability: Film coating can be used to optimize the shelf-life of a tablet
preparation, as some polymers are efficient barriers against the permeability of water
vapour or other atmospheric gases. These properties vary widely between the
individual polymers.
8/20/2020 8
9. PLASTICIZER
• Plasticizers are generally added to film coating formulations to modify the
physical properties of the polymer to make it more usable. One important
property is their ability to decrease film brittleness.
• Examples of plasticizers are:
• Polyols, such as polyethylene glycol 400
• Organic esters, such as diethyl phthalate
• Oils/glycerides, such as fractionated coconut oil. Ingeneral, only water-
miscible plasticizers can be used for aqueous-based spray systems.
8/20/2020 9
10. COLOURANTS
• Any permitted colorants in a film coat formula are invariably water-insoluble colors
(pigments).
• Pigments have certain advantages over water-soluble colors: they tend to be more
chemically stable
• towards light, provide better opacity and covering power, and optimize the
impermeability of a given film to water vapour.
• Examples of colorants are:
• • Iron oxide pigments
• • Titanium dioxide
• • Aluminum Lakes.
8/20/2020 10
11. SOLVENTS
• Modern techniques now rely on water as a polymer solvent because of the significant
drawbacks that readily became apparent with the use of organic solvents.
• The disadvantages of organic solvents for the process:
1. Environmental: the venting of untreated organic solvent vapor into the
atmosphere is ecologically unacceptable, and efficient solvent vapor removal from
gaseous effluent is expensive.
• 2. Safety: organic solvents provide explosion, fire and toxic hazards to plant
operators.
• 3. Financial: the use of organic solvents necessitates the building of flame- and
explosion-proof facilities. Ingredient cost is also comparatively high, and the
associated costs of storage and quality control must also be taken in to consideration.
8/20/2020 11
12. ENTERIC COATED TABLET
• This technique is used to protect the tablet core from disintegration in the acid
environment of the stomach for one or more of the following reasons:
• Prevention of acid attack on active constituents unstable at low pH.
• To protect the stomach from the irritant effect of certain drugs.
• To facilitate absorption of a drug that is preferentially absorbed distal to the stomach.
• Polymer are insoluble in aqueous media at low pH, but as the pH rises they
experience a sharp, well defined increase in solubility at a specific pH.
8/20/2020 12
13. PRESS COATING
• Use of compression to form coat around a pre-formed core.
Fig: Press coated tablet
• Used mainly to separate chemically incompatible materials.
• Also dual release patterns possible
• Compression coating is a dry process. 8/20/2020 13
14. MAJOR DIFFERENCES BETWEEN SUGER & FILM COATING
FEATURES FILM COATING SUGAR COATING
Appearance Retain contour of original core.
Usually not as shiny as sugar coat
type
Rounded with high degree
of polish
Weight increase because of
coating material
2-3% 30-50%
Logo or ‘break lines’ Possible Not Possible
Process stages Usually single stage Multistage process
Typical batch coating
time
1.5 to 2.0 Hours Eight hours but easily
longer
Functional coatings Easily adaptable for controlled
release
Not usually possible apart
from enteric coating
8/20/2020 14
16. COATING PROCESS
COATING COMPOSITION
IS APPLIED TO
MOVING BED OF TABLETS
HEATED AIR IS INTRODUCED
EVAPORATION OF THE SOLVENT
Tablet coating is
accomplished by the
movement of tablets in
Perpendicular or vertical
direction to the
application of the coating
composition
8/20/2020 16
17. COATING MACHINE
1=Inlet air, 2=Inlet air filter and air heater
3=Coating pan, 4=Compressed air,
5=Pneumatic spray 6=Outlet air
7=Container with pneumatic stirrer 8=Peristaltic pump
(Control pressure 5-6 bar, Atomizing air pressure 1-2 bar)
8/20/2020 17
19. EQUIPMENTS
• The Equipments used for the tablet coating are :-
1. Standard coating pan
2. Perforated coating pan
3. Fluidized bed coater
8/20/2020 19
21. STANDARD COATING PAN
• It is also known as conventional pan system.
• Circular metal pan(mounted angularly on a stand.)
• 8-60 inches in diameter.
• Rotated on its horizontal axis by a motor.
• Heated air is directed into the pan & on to the tablet bed surface
and is exhausted by means of ducts through the front of the pan.
• Coating solution are applied to the tablets by spraying the material
on to the rotating tablet bed.
8/20/2020 21
22. USE OF SPRAYING SYSTEMS
• Produces a faster, more even distribution of the solution or
suspension.
• Reduces drying time between solution application in sugar coating .
• Allows continuous application of the solution in film coating.
8/20/2020 22
23. • In standard coating pan ,the drying efficiency is
improved by:-
1.Pellegrini pan
2.The immersion sword
3.Immersion tube systems
8/20/2020 23
25. Pellegrini pan-
• Baffled pan
• Diffuser(distributes the drying air uniformly over the tablet bed surface).
IMMERSION- SWORD SYSTEM-
• Perforated metal sword device immersed in the tablet bed.
• Drying air is introduced through this device and flows upward from the sword through the tablet
bed.
IMMERSION-TUBE SYSTEM-
• Tube immersed in the tablet bed.
• Tube delivers the heated air.
• In immersion tube system the coating solution is applied with the heated air from the immersed
tube
8/20/2020 25
27. PERFORATED PAN SYSTEMS
• Perforated or partially perforated drum.
• Rotated on its horizontal axis in an enclosed housing.
• The coting solution is applied to the surface of the rotating bed of tablets
through spraying nozzles, which are present inside the drum.
• Perforated pan coaters are efficient drying systems with high coating capacity.
8/20/2020 27
28. PERFORATED PAN SYSTEM HAS
1. Accela-cota system
2. Hi coater system
3. Dria coater pan
4. Glatt coater
8/20/2020 28
30. 1. ACCELA COTA & HI COATER SYSTEM
• Drying air is directed in to the drum,
• Passed through tablet bed,
• Exhausted through perforations in drum.
2. DRIA COATER PAN
• Drying air enters through hollow perforated ribs ,located on inside periphery of
the drum.
• As the coating pan rotates, the ribs dip into the tablet bed and drying air passes up
through
• Exhaust is from the back of pan.
8/20/2020 30
34. GLATT COATER
• It is the latest perforated pan coater to be introduced in the industry.
• In this, drying air can be directed from inside the drum through
tablet bed
• Exhausted out through an exhaust duct.
8/20/2020 34
35. C. FLUIDIZED BED SYSTEM
• In this system fluidization of the tablet mass is achieved in a columnar chamber by the upward
flow of drying air.
• The air flow is controlled, so that more air enters the center of the column, causing the tablets
to rise in the center.
• The movement of tablets is upward trough the center of the chamber.
8/20/2020 35
37. FLUIDIZED BED SYSTEM
• They then fall towards the chamber wall,
• Move downwards to reenter the air stream At the bottom of the chamber.
• Coating solutions are applied from a spray nozzle which is located at the
bottom of the chamber.
{Or }
• are sprayed onto the top of the Cascading tablet bed by nozzles located in the
upper region of the chamber.
8/20/2020 37
38. SPRAY APPLICATION SYSTEM
• Two Basic systems used to apply a finely divided (atomized) spray of coating
solutions or suspensions on to tablet are-
I. High pressure, airless
II. Low pressure, air atomized
8/20/2020 38
39. I. AIR LESS SPRAY SYSTEM
• Liquid is pumped at high pressure{250-3000 pounds per square inch gauge(psig) },
• through a small orifice (0.009 inch to 0.020 inch) in the fluid nozzle Which results in a finely
divided spray.
• In this ,the degree of atomization & the spray rate are controlled by
a) Fluid pressure,
b) orifice size and
c) Viscosity of the liquid.
8/20/2020 39
40. II. LOW PRESSURE AIR- ATOMIZED SYSTEM
• Liquid is pumped through a somewhat large orifice (0.020 inch-0.060 inch in diameter ) at
relatively low pressure(5-50 psig)
• Low pressure air contacts with the liquid stream at the tip of the atomizer,& a finely divided
spray is produced.
• The degree of atomization is controlled by the
a) fluid pressure ,
b) Fluid cap orifice
c) Viscosity of liquid
d) Air pressure
e) Air cap design.
8/20/2020 40
41. FILM FORMING AGENTS
• The film forming agents tablet coating are classified into:
1.Non - enteric film formers
2.Enteric film formers
8/20/2020 41
42. NON-ENTERIC FILM FORMERS
• They are incorporated to give uniform film with desired mechanical strength which are as
follows:
1. HPMC(Hydroxy propyl methyl cellulose)
2. MHEC(Methyl hydroxyl ethyl cellulose)
3. EC(Ethyl cellulose)
4. HPC(Hydroxy propyl cellulose)
5. POVIDONE
6. SCMC (sodium carboxy methyl cellulose)
7. PG (propylene glycol)
8. ACRYLATE POLYMERS
8/20/2020 42
43. 1. HPMC-
• It is prepared by reacting alkali treated cellulose with methyl chloride with propylene
oxide.
• As it forms bridging & rough Tablet surface, it has to be mixed with other polymers
or plasticizers.
2. MHEC-
• It is prepared by reacting alkali treated cellulose with methyl chloride & then with
ethylene oxide.
• It has similar properties as that of HPMC,
• But it is soluble in fewer organic solvents, it is not used as frequently as HPMC.
• These polymers used in combinations with other polymers to modify film Properties.
• FOR EXAMPLE -
• Combinations of PG waxes with Cellulose acetate phthalate provide film that are
soluble in GI fluids.
8/20/2020 43
44. 3. EC-
• It is manufactured by the reaction of ethyl chloride with cellulose dissolved in NaOH.
• It is available in different viscosity grades.
• Unplasticized EC forms brittle films & requires film modifiers to obtain acceptable film.
• It is water insoluble & thus Cannot be used alone for tablet coating.
• It is usually combined with water Soluble additives
• E.G.- HPMC to prepare film with reduced water soluble Properties &This combinations are
widely Used in sustained release coating.
4. HPC-
• It is manufactured by the treatment of cellulose with NaOH followed by the reaction with
propylene oxide at Elevated temperature and pressure.
• It forms tacky films.
• Used in combinations with other polymers to improve film characteristics.
• It is soluble in water (below 40 ͦ c & insoluble above 45°𝒄) ,
• GI fluids & in many polar Organic solvents.
8/20/2020 44
45. 5. POVIDONE-
• It is synthetic polymer consisting of linear 1-vinyl-2-pyrrolidinone groups.
• It gives clear, glossy, hard films when dry.
• It give tacky films which can be overcome by plasticizer or other polymer.
6. ACRYLATE POLMERS-
• These are marketed under the trade Name of Eudragit.
• Eudragit RL & RS are copolymers of Acrylic and meth acrylic acid esters.
• These films produce pH independent, delayed actions.
• Preparation is similar to that of EC formulations.
8/20/2020 45
46. ENTERIC FILM FORMERS
• REASONS FOR ENTERIC FILM FORMERS-
• To protect acid-labile drugs from gastric fluid e.g. Enzymes & certain
Antibiotics.
• To prevent gastric distress or nausea due to irritation from the drug . e.g.,
Sodium salicylate.
• To deliver drugs intended for local Action in the intestines, e.g. Intestinal
antiseptics.
• To deliver drugs that are optimally Absorbed in the small intestine to their
primary absorption site.
• To provide a delayed-release component for repeat-action tablets.
8/20/2020 46
47. PROPERTIES OF AN IDEAL ENTERIC COATING
MATERIAL
• Resistance to gastric fluids.
• Susceptibility or permeability to intestinal fluids.
• Compatibility with most coating solution components & the drug substrates.
• Stability alone and in coating solution. The film should not change on aging.
• Formation of a continuous film, nontoxicity, with low cost.
• Ease of application without Specialized equipment.
• Ability to be readily printed and allow film to be applied to debussed tablets.
8/20/2020 47
49. 1.CAP
• It is widely used.
• As it is hygroscopic and relatively permeable to moisture and gastric Fluids,
film formed are brittle and hence formulated with hydrophobic- Film forming
materials to achieve better enteric films.
• Aquateric coating is a reconstituted colloidal dispersion of latex particles. It is
Composed of solid or semisolid polymer spheres of cap ranging in size from
0.05-3 Microns with an a average particle size of 0.2 microns.
8/20/2020 49
50. 2. ACRYLATE POLMERS
• 2 forms of commercially available Enteric acrylic resins are
Eudragit L and Eudragit S.
• Eudragit l is available as an organic Solution, solid or aqueous dispersion.
• Eudragit s is available only as an organic solution and solid.
• Eudragit l & s are soluble in intestinal Fluid at pH 6 & 7.
8/20/2020 50
51. 3. HPMCP
• It is derived from HPMC by esterification with phthallic anhydride.
• These are stable than cap and dissolve At lower pH compared to cap and
acrylate polymers.
• The solubility characteristic may result in Higher bioavailability of some
specific drugs.
• It is available in various grades- HP55,HP50 etc.
8/20/2020 51
52. 4. PVAP
• It is manufactured by the esterification of partially hydrolyzed Polyvinyl
alcohol with phthallic Anhydride.
• It is similar to HPMCP(HP55) in stability and pH dependent solubility.
8/20/2020 52
54. 1.SOLVENT
• It is to dissolve or disperse the polymers and other additives and convey them to the
substrate surface.
• The ideal requirements of the solvent are-
• It should either dissolve or disperse the polymer system.
• It should have no environmental impact.
• It should easily disperse other coating solution components in to the solvent system.
• It should have rapid drying rate(ability to coat 300kg load in 3-5 hours)
• It should be Colorless, tasteless, odorless, Inexpensive, nontoxic, inert and
Noninflammable and rapid drying Rate.
• Examples- Water, Ethanol, Methanol, Isopropanol, Chloroform, Acetone,
Methylene chloride , Methylene ethyl ketone.
8/20/2020 54
55. 2. PLASTICIZERS
• It is used to modify the quality of the film .
• Plasticizing techniques involve internal plasticizers and external plasticizers.
• Internal plasticizers:- involves Chemical modification of the basic polymer
that alters the physical properties of the polymers.
• Chemical plasticizers :- Additives of the Coating solution to achieve the
desire effect of the film (flexibility ,tensile Strength, adhesive properties)
• Level of plasticizers ranges from 1-50% by weight of film former.
• Examples:- Castor oil, Propylene glycol, Glycerin, Surfactants
• e.g., Polysorbate(tweens),sorbitan esters(spans), organic acid esters.
8/20/2020 55
56. 3.COLORANTS
• It is to provide the distinct color and Elegance to the dosage form.
• To achieve the proper distribution of suspended colorants in the coating solutions requires Use
of fine powdered colorants (<10 microns)
• The concentration of colorants in the coating solution depends on the color shade, desired the
type of dye and the concentration of the opaquqnt extenders
• For very light shade:- conc. Lt 0.01%
• For dark shade:- Conc. Mt 2.0% is required.
• The most common colorants in use are certified by FOOD DRUG AND COSMETICS
(FD&C) or DRUG AND COSMETIC (D&C) Colorants.
• These are lakes and dyes.
• Lakes are derived from dyes by precipitating with carriers e.g., Alumina or talc.
8/20/2020 56
57. • The inorganic materials and the natural colorants are-
• Iron oxides, Caramel, Carotenoid, Chlorophyll, indigo, Flavones, Turmeric and
carminic acid.
• A variety of products that are Commercially available are-
• Opalux- Opaquqnt color concentrate for sugar coating.
• Opaspray -for film coating.
• Opadry- complete film coating concentrate.
8/20/2020 57
58. 4. OPAQUANT-EXTENDERS
• These are very fine inorganic powders used In the coating solution formulation
to provide more pastel colors and increase film coverage.
• Provide white coating or mask the color of the tablet core.
• Examples:-Titaniundioxide
• Silicates like (Talc, Aluminium silicate)
• Carbonates like-magnesium carbonate,
• Sulphates like calcium sulphate
8/20/2020 58
59. DEFECTS IN COATING
• Sticking and picking
• Roughness
• Orange peel
• Color variation
• Cracking
• winning
• Capping
• Lamination
• Blistering 8/20/2020 59
60. STICKING AND PICKING
• Over wetting or excessive film thickness causes tablets to stick and piece of
film may remain adhere to pan or tablet. i.e “picking”
• Remedies:
Reduction in liquid application rate.
Increase in drying air temperature and air volume.
8/20/2020 60
61. ROUGHNESS:
• A rough or gritty surface observed when the coating is applied by spray.
• Causes : Some of the droplets may dry too rapidly before reaching the tablet
bed and deposits on tablet surface.
• Remedies :
Moving the nozzle closer to the tablet bed.
Reducing the degree of atomization can decrease the roughness due to spray
drying.
8/20/2020 61
62. ORANGE PEEL
• Inadequate spreading of coating solution before drying causes a bumpy or
Orange –peel effects on the coating
• Causes : Indicates that spreading is impaired by rapid rate of drying or by high
solution viscosity.
• Remedies : Thinning of coating solution with additional solvents may correct
this problem.
8/20/2020 62
63. COLOUR VARIATION
• Colour variation Problem caused by or the formulation Improper mixing,
uneven spray pattern and insufficient coating may results in color variation.
• Remedies : Proper mixing of coating solution
• Spray uniformly
• Use of lake dyes eliminates dye migration.
• A reformulation with different plasticizer and additives is the best way to solve
film instability.
8/20/2020 63
64. Cracking :
• Cracking occurs if internal stresses in the film exceed the tensile strength of
the film. The tensile strength of the film can be increased by using higher
molecular –weight polymers or polymer blends.
• Remedies: Adjusting the plasticizer types and concentration can minimize
internal stresses Also adjusting the pigment types and concentration can
minimize internal stresses
Blistering :
• Evaporation of solvents from the core in the oven. And effect of high
temperature on the strength, elasticity and adhesion of the film may results in
blistering.
• Remedies : Controlled drying conditions.
8/20/2020 64
65. • Twinning:
• Two or more tablets are stick together.
1. Unbalancing the pan speed.
2. Hi spray rate.
Fig: Twinning effect
• Remedies: This problem can be solve by balancing the pan speed and spray
rate
8/20/2020 65
66. IDEAL CHARACTERISTICS OF COATED TABLETS
• Film-coated tablets must comply with the uniformity of mass test unless otherwise
justified and authorized
• Film-coated tablets comply with the disintegration test.
• Film-coated tablets should display
• An even coverage of film and colour.
• No scraping of tablet edges or crowns.
• Logos and break lines should be distinct and not filled in.
• The tablet must also be within specifications.
• Tablets must comply with finished product specifications
• Sugar-coated tablets should ideally be of a perfectly smooth rounded contour with even
colour coverage and polish to a high gloss.
• Any printing should be distinct, with no broken print. 8/20/2020 66