Direct compression is one of the most advanced tablet manufacturing methods. It involves only blending and compressing API and excipients without pretreatment steps like granulation. This makes it an economical process suitable for heat- and moisture-sensitive drugs. However, it is not suitable for very low- or high-dose drugs. Granulation techniques like wet and dry granulation are used to improve properties of powders that are not suitable for direct compression. Wet granulation involves mixing powders with a liquid to form granules, then drying and milling the granules. Dry granulation uses mechanical forces like slugging or roller compaction to densify powders into granules.
Filtration is a physical, biological or chemical operation that separates solid matter and fluid from a mixture with a filter medium that has a complex structure through which only the fluid can pass
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.
Milling is a mechanical process that reduces the particle size of solids. It has several pharmaceutical applications such as increasing the surface area and dissolution rate of low soluble drugs. The size distribution of milled particles can be measured using microscopy, sieving, or sedimentation methods. There are different types of mills that operate via cutting, attrition, impact, or compression and produce varying degrees of particle size reduction from coarse to fine to microfine. Factors like the starting particle size, desired final size, material properties, and amount must be considered when selecting the appropriate mill for pharmaceutical processing.
This document discusses common processing problems that can occur during solid oral dosage form manufacturing and their potential remedies. It covers issues related to granulation, compression, and coating and provides solutions to problems like capping, lamination, chipping, cracking, sticking, and more. For each problem, it lists potential causes such as excess fines, improper drying, or machine settings and recommends remedies like adjusting formulation components, compression parameters, or equipment settings.
Transdermal drug delivery systems (TDDS) provide an alternative to oral administration and injections by delivering drugs through the skin. TDDS consist of a backing layer, drug reservoir, release liner, and adhesive layer. Drugs must have certain properties like molecular weight <1000 Daltons to permeate the skin. Permeation enhancers can temporarily increase skin permeability. The four main types of TDDS are membrane modulated, adhesive diffusion controlled, matrix dispersion, and microreservoir systems. The design objectives are to deliver drugs through the skin at therapeutic levels over time.
Working principle of compression machinePrashikHumane
The document discusses the working principle of compression machines used in pharmaceutical manufacturing. It describes the main components of compression machines including hoppers, dies, punches, and cam tracks. It explains the compression cycle which involves filling the die, weight adjustment, compressing the powder, and ejecting the tablet. Key process parameters that affect tablet quality such as filling depth, compression force, and turret speed are also summarized.
Granulation is the process of binding particles together to form larger granules. There are two main types: dry granulation which uses no liquid, and wet granulation which uses a liquid binding solution. Wet granulation methods include fluidized bed granulation where granulation and drying occur together, tumbling granulation using drums or pans where particles are set in motion by tumbling forces, and mixer-granulators which use high shear mixing to form agglomerates. Key steps in wet granulation are wetting, nucleation and binder distribution, consolidation and growth, and attrition and breakage. Granule size and properties depend on the specific granulation equipment used.
Tablet coating is a process that applies a dry outer layer to tablets to confer benefits like masking taste or controlling drug release. There are several components to the coating process, including tablet properties, coating equipment and methods, and coating compositions. Common coating equipment includes standard coating pans, perforated pans, fluidized bed coaters, and various specialized systems like immersion tubes. Tablet properties like shape and surface smoothness influence the coating process. Coating is applied using spray systems while heated air facilitates drying.
Filtration is a physical, biological or chemical operation that separates solid matter and fluid from a mixture with a filter medium that has a complex structure through which only the fluid can pass
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.
Milling is a mechanical process that reduces the particle size of solids. It has several pharmaceutical applications such as increasing the surface area and dissolution rate of low soluble drugs. The size distribution of milled particles can be measured using microscopy, sieving, or sedimentation methods. There are different types of mills that operate via cutting, attrition, impact, or compression and produce varying degrees of particle size reduction from coarse to fine to microfine. Factors like the starting particle size, desired final size, material properties, and amount must be considered when selecting the appropriate mill for pharmaceutical processing.
This document discusses common processing problems that can occur during solid oral dosage form manufacturing and their potential remedies. It covers issues related to granulation, compression, and coating and provides solutions to problems like capping, lamination, chipping, cracking, sticking, and more. For each problem, it lists potential causes such as excess fines, improper drying, or machine settings and recommends remedies like adjusting formulation components, compression parameters, or equipment settings.
Transdermal drug delivery systems (TDDS) provide an alternative to oral administration and injections by delivering drugs through the skin. TDDS consist of a backing layer, drug reservoir, release liner, and adhesive layer. Drugs must have certain properties like molecular weight <1000 Daltons to permeate the skin. Permeation enhancers can temporarily increase skin permeability. The four main types of TDDS are membrane modulated, adhesive diffusion controlled, matrix dispersion, and microreservoir systems. The design objectives are to deliver drugs through the skin at therapeutic levels over time.
Working principle of compression machinePrashikHumane
The document discusses the working principle of compression machines used in pharmaceutical manufacturing. It describes the main components of compression machines including hoppers, dies, punches, and cam tracks. It explains the compression cycle which involves filling the die, weight adjustment, compressing the powder, and ejecting the tablet. Key process parameters that affect tablet quality such as filling depth, compression force, and turret speed are also summarized.
Granulation is the process of binding particles together to form larger granules. There are two main types: dry granulation which uses no liquid, and wet granulation which uses a liquid binding solution. Wet granulation methods include fluidized bed granulation where granulation and drying occur together, tumbling granulation using drums or pans where particles are set in motion by tumbling forces, and mixer-granulators which use high shear mixing to form agglomerates. Key steps in wet granulation are wetting, nucleation and binder distribution, consolidation and growth, and attrition and breakage. Granule size and properties depend on the specific granulation equipment used.
Tablet coating is a process that applies a dry outer layer to tablets to confer benefits like masking taste or controlling drug release. There are several components to the coating process, including tablet properties, coating equipment and methods, and coating compositions. Common coating equipment includes standard coating pans, perforated pans, fluidized bed coaters, and various specialized systems like immersion tubes. Tablet properties like shape and surface smoothness influence the coating process. Coating is applied using spray systems while heated air facilitates drying.
This document provides a summary of validation requirements for pulverization machines. It discusses the need to validate equipment to ensure products for human use meet quality standards. The summary includes details on design qualification, installation qualification, operational qualification, and performance qualification activities. Specifically, it outlines elements that should be checked during installation qualification of a colloidal mill, such as utility requirements, component specifications, lubricants, and safety features.
The document discusses various tablet granulation techniques. It defines granulation as a process where small particles adhere together through bonding, forming larger aggregates called granules. The key granulation methods described are direct compression, dry granulation, wet granulation, and granulation by crystallization. Wet granulation is identified as the most versatile technique, imparting desirable physical properties to granules for tablet compression.
Direct compression is the most advanced technology. It involves only blending and compression. Thus offering advantage particularly in terms of speedy production. Because it requires fewer unit operations, less machinery, reduced number of personnel and considerably less processing time along with increased product stability.
Tablets are the most commonly used oral solid dosage form due to their ease of production, stability, and precise dosing. The document defines tablets and lists their advantages and disadvantages. It describes the key ingredients used in tablets, various tablet production processes like direct compression, wet granulation, and coating. Common tablet defects and evaluation tests are also discussed. The processing, formulation, and manufacturing of tablets allows for flexible drug delivery and reproducible dosing of medications.
Mixer Machines Mixer Machines are used in a number of different applications and industries in order to produce a final product that is the result of mixing or combining two or more materials.
This document discusses coating pans used in the pharmaceutical industry. It describes two main types of coating pans - conventional and perforated. Conventional pans include Pelligrini, immersion sword, and immersion tube pans. Perforated pans have openings that improve mixing and drying efficiency, examples given are Accela-Cota, Hi-Coater, Dria Coater, and Glatt pans. The validation process for coating pans involves installation qualification to confirm proper installation, operational qualification to establish operating parameters, and performance qualification to verify operation as intended.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
This document describes several key pieces of equipment used in the pharmaceutical manufacturing process. It discusses the Rapid Mixer Granulator, which performs fast mixing and wet granulation in a single step. It then describes the fluidized bed dryer, which dries granules using hot air in a fluidized bed. Tablet compression machines are also summarized, explaining how they compress granules into tablets using dies and punches. Finally, the document discusses coating machines, which apply coatings to tablets through a spraying process while tumbling and drying them using heated air.
COATING PROCESS : PRINCIPLE : Tablet Coating is the process of a coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of solvent . The distribution of coating is accomplished by the movement of tablets either perpendicular or vertical to the application of the coating composition
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
Granulation is a process that involves sticking small particles together to form larger, multiparticle structures called granules. This is commonly done in the pharmaceutical industry to produce granules that will later be used in tablet or capsule manufacturing. There are two main types of granulation - wet granulation, which uses a liquid to bind particles together, and dry granulation, which uses pressure without a liquid. Wet granulation is more common and involves mixing powder particles with a liquid and then forcing the wet mass through a sieve to form wet granules that are then dried. Shear granulators are a common type of granulator used for wet granulation that uses rotating blades to force the wet mass through a sieve to produce granules of a
This document provides an overview of tablets, including their history, types, ingredients, manufacturing processes, and evaluation. It begins with an introduction to tablets, noting they were first patented in 1843 and now represent over 2/3 of dosage forms. The main types of tablets discussed are compressed, multiple compressed (layered, compressed coated), sugar coated, film coated, and chewable tablets. Ingredients like drugs, diluents, binders, lubricants and disintegrants are explained. Tablet production methods like wet granulation, dry granulation and direct compression are covered. Common processing problems and methods of evaluation like weight variation, content uniformity and hardness testing are also summarized.
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 discusses tablet coating processes and components, including the decision factors for coating tablets, the main components of coating (tablet properties, coating process, and coating compositions), common coating equipment and processes, film forming materials and other additives used in coatings, quality control of coated tablets, potential film defects, and the sugar coating process.
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.
This document provides an overview of fluidized bed processing (FBP). It discusses the principle of fluidization, how FBP works, its components, and applications. FBP uses air to fluidize solid particles, allowing for high rates of heat and mass transfer. This makes it useful for granulation, drying, and coating processes. It has advantages like high drying rates and easy handling but also disadvantages like potential for product loss and requirement of skilled operators. FBP is widely used in pharmaceutical manufacturing for applications like granule drying, tablet coating, and functional powder coating.
The document discusses factors to consider for scaling up tablet manufacturing from the laboratory to a pilot plant or production scale. It outlines key stages in tablet production including material handling, dry mixing, granulation, drying, sizing, blending, compression, and coating. For each stage, it identifies parameters that must be established during scale up such as equipment type, processing rates, temperatures, and quality control tests. Maintaining consistency while increasing batch sizes is important for ensuring reproducible, high quality tablets at larger scales.
The document discusses problems that can occur during granulation and compression in tablet manufacturing. It describes two key processes - granulation, which binds powder particles together, and compression, which forms tablets. Common problems include tablets sticking to punches, picking, capping, lamination, and non-uniform content. The causes and solutions for each problem are explained, such as ensuring proper granule drying and lubrication to prevent sticking, and adjusting punch sizes and binder levels to prevent capping and breaking. Managing factors like equipment settings, ingredient properties, and processing parameters is important to produce tablets of good quality and strength.
The document discusses various granulation techniques used in pharmaceutical manufacturing. It begins with an introduction to granules and granulation. It then covers different granulation methods including dry granulation, wet granulation and advanced techniques like fluid bed granulation, extrusion-spheronization, steam granulation and melt granulation. The document provides details on the process, equipment used, advantages and disadvantages of each method. It aims to explain why granulation is important and the various ways it can be achieved.
The document discusses granulation as a process to combine particles into larger masses for improved flow and compression characteristics. It defines granulation and describes the objective of combining ingredients to produce quality tablets. Various techniques for granulation like wet and dry granulation are discussed along with common equipment used like fluid bed granulators, Littleford loaders, and Diosna mixers. Granule characteristics and factors affecting granulation are also summarized.
This document provides a summary of validation requirements for pulverization machines. It discusses the need to validate equipment to ensure products for human use meet quality standards. The summary includes details on design qualification, installation qualification, operational qualification, and performance qualification activities. Specifically, it outlines elements that should be checked during installation qualification of a colloidal mill, such as utility requirements, component specifications, lubricants, and safety features.
The document discusses various tablet granulation techniques. It defines granulation as a process where small particles adhere together through bonding, forming larger aggregates called granules. The key granulation methods described are direct compression, dry granulation, wet granulation, and granulation by crystallization. Wet granulation is identified as the most versatile technique, imparting desirable physical properties to granules for tablet compression.
Direct compression is the most advanced technology. It involves only blending and compression. Thus offering advantage particularly in terms of speedy production. Because it requires fewer unit operations, less machinery, reduced number of personnel and considerably less processing time along with increased product stability.
Tablets are the most commonly used oral solid dosage form due to their ease of production, stability, and precise dosing. The document defines tablets and lists their advantages and disadvantages. It describes the key ingredients used in tablets, various tablet production processes like direct compression, wet granulation, and coating. Common tablet defects and evaluation tests are also discussed. The processing, formulation, and manufacturing of tablets allows for flexible drug delivery and reproducible dosing of medications.
Mixer Machines Mixer Machines are used in a number of different applications and industries in order to produce a final product that is the result of mixing or combining two or more materials.
This document discusses coating pans used in the pharmaceutical industry. It describes two main types of coating pans - conventional and perforated. Conventional pans include Pelligrini, immersion sword, and immersion tube pans. Perforated pans have openings that improve mixing and drying efficiency, examples given are Accela-Cota, Hi-Coater, Dria Coater, and Glatt pans. The validation process for coating pans involves installation qualification to confirm proper installation, operational qualification to establish operating parameters, and performance qualification to verify operation as intended.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
This document describes several key pieces of equipment used in the pharmaceutical manufacturing process. It discusses the Rapid Mixer Granulator, which performs fast mixing and wet granulation in a single step. It then describes the fluidized bed dryer, which dries granules using hot air in a fluidized bed. Tablet compression machines are also summarized, explaining how they compress granules into tablets using dies and punches. Finally, the document discusses coating machines, which apply coatings to tablets through a spraying process while tumbling and drying them using heated air.
COATING PROCESS : PRINCIPLE : Tablet Coating is the process of a coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of solvent . The distribution of coating is accomplished by the movement of tablets either perpendicular or vertical to the application of the coating composition
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
Caleva Process Solutions
http://www.caleva.com
Another resourceful Powerpoint Presentation from Caleva Process Solutions. These selection of slides will provide you with some very useful information on Extrusion Spheronization. This includes general information, the process of Extrusion Spheronization, Wet Massing and Pelletization!
For more information on Extrusion Spheronization, visit:
http://caleva.com/
Granulation is a process that involves sticking small particles together to form larger, multiparticle structures called granules. This is commonly done in the pharmaceutical industry to produce granules that will later be used in tablet or capsule manufacturing. There are two main types of granulation - wet granulation, which uses a liquid to bind particles together, and dry granulation, which uses pressure without a liquid. Wet granulation is more common and involves mixing powder particles with a liquid and then forcing the wet mass through a sieve to form wet granules that are then dried. Shear granulators are a common type of granulator used for wet granulation that uses rotating blades to force the wet mass through a sieve to produce granules of a
This document provides an overview of tablets, including their history, types, ingredients, manufacturing processes, and evaluation. It begins with an introduction to tablets, noting they were first patented in 1843 and now represent over 2/3 of dosage forms. The main types of tablets discussed are compressed, multiple compressed (layered, compressed coated), sugar coated, film coated, and chewable tablets. Ingredients like drugs, diluents, binders, lubricants and disintegrants are explained. Tablet production methods like wet granulation, dry granulation and direct compression are covered. Common processing problems and methods of evaluation like weight variation, content uniformity and hardness testing are also summarized.
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 discusses tablet coating processes and components, including the decision factors for coating tablets, the main components of coating (tablet properties, coating process, and coating compositions), common coating equipment and processes, film forming materials and other additives used in coatings, quality control of coated tablets, potential film defects, and the sugar coating process.
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.
This document provides an overview of fluidized bed processing (FBP). It discusses the principle of fluidization, how FBP works, its components, and applications. FBP uses air to fluidize solid particles, allowing for high rates of heat and mass transfer. This makes it useful for granulation, drying, and coating processes. It has advantages like high drying rates and easy handling but also disadvantages like potential for product loss and requirement of skilled operators. FBP is widely used in pharmaceutical manufacturing for applications like granule drying, tablet coating, and functional powder coating.
The document discusses factors to consider for scaling up tablet manufacturing from the laboratory to a pilot plant or production scale. It outlines key stages in tablet production including material handling, dry mixing, granulation, drying, sizing, blending, compression, and coating. For each stage, it identifies parameters that must be established during scale up such as equipment type, processing rates, temperatures, and quality control tests. Maintaining consistency while increasing batch sizes is important for ensuring reproducible, high quality tablets at larger scales.
The document discusses problems that can occur during granulation and compression in tablet manufacturing. It describes two key processes - granulation, which binds powder particles together, and compression, which forms tablets. Common problems include tablets sticking to punches, picking, capping, lamination, and non-uniform content. The causes and solutions for each problem are explained, such as ensuring proper granule drying and lubrication to prevent sticking, and adjusting punch sizes and binder levels to prevent capping and breaking. Managing factors like equipment settings, ingredient properties, and processing parameters is important to produce tablets of good quality and strength.
The document discusses various granulation techniques used in pharmaceutical manufacturing. It begins with an introduction to granules and granulation. It then covers different granulation methods including dry granulation, wet granulation and advanced techniques like fluid bed granulation, extrusion-spheronization, steam granulation and melt granulation. The document provides details on the process, equipment used, advantages and disadvantages of each method. It aims to explain why granulation is important and the various ways it can be achieved.
The document discusses granulation as a process to combine particles into larger masses for improved flow and compression characteristics. It defines granulation and describes the objective of combining ingredients to produce quality tablets. Various techniques for granulation like wet and dry granulation are discussed along with common equipment used like fluid bed granulators, Littleford loaders, and Diosna mixers. Granule characteristics and factors affecting granulation are also summarized.
This presentation discusses dry granulation as an alternative to wet granulation for tablet manufacturing. Dry granulation involves compressing powders into dense sheets using mechanical pressure between counter-rotating rolls, then milling the sheets into uniform granules. Key advantages of dry granulation include avoiding heat, moisture, and additional ingredients used in wet granulation. The presentation traces the history and development of dry granulation techniques from early slugging methods to modern roller compaction. Factors in selecting between wet and dry granulation include material properties, stability requirements, process efficiency, and product specifications.
The document discusses the mechanisms of granulation. It explains that granulation involves collecting particles together through compression or using a binding agent to form bonds. There are five primary bonding mechanisms: 1) adhesion and cohesion in immobile liquid films, 2) interfacial forces in mobile liquid films, 3) formation of solid bridges after solvent evaporation, 4) attractive forces between solid particles, and 5) mechanical interlocking. The objectives of granulation are to prevent segregation, improve flow and compaction characteristics, and produce uniform mixtures to enable tableting or spheronization.
Granulation is the process of binding powder particles together to form larger multi-particle granules. It is done to improve powder flow properties, enhance content uniformity, and eliminate segregation issues. The main granulation techniques are wet granulation, dry granulation, and direct compression. Wet granulation involves mixing powders with a liquid binder to form granules, then drying the granules. Dry granulation compresses powders directly into tablets. Direct compression tablets are made by compressing blended powders without granulation. Granulation improves flow, content uniformity, and compression properties.
Granules are agglomerates of powder particles that are larger in size, ranging from 0.2 to 4.0 mm. They are formed through a process called granulation where primary powder particles adhere together. Granules have better flow properties and compressibility compared to powders. They are often used as an intermediate step in tablet production since granules flow more evenly into tablet dies compared to powders. Granules can be prepared through wet or dry granulation methods.
Tablets are the most popular dosage form, comprising 70% of pharmaceutical preparations. Tablets can be produced in various types including compressed, sugar-coated, film-coated, gelatin-coated, enteric-coated, effervescent, chewable, and orally disintegrating tablets. Quality standards for tablets include specifications for weight, content uniformity, thickness, hardness, friability, and disintegration time. Proper control of these factors during manufacturing is necessary to ensure consistent and reliable dosing of the active pharmaceutical ingredient.
This document discusses the evaluation tests conducted on ointments, including tests to measure the rate of absorption, non-irritancy, rate of penetration, rate of drug release, rheological properties, content uniformity, and preservative efficacy. It describes the methodology for each test, including applying ointments to skin or in vitro to measure properties like absorption rate, penetration depth over time, and microbial growth inhibition. The goal is to ensure ointments deliver drugs safely and effectively through the skin at the intended rate.
Drug dosage forms can be liquid, solid, or semisolid. Common solid dosage forms include capsules, tablets, and powders. Capsules contain medications inside a gelatin shell while tablets are compressed powders. Powders can be divided into individual doses or bulk. Liquid dosage forms include solutions, suspensions, drops, emulsions, and injections. Semisolid forms such as ointments, creams, gels, and pastes are applied topically to the skin or mucous membranes.
Tablet manufacturing process created by Asadulla MullaAsad Mulla
The document summarizes the key steps involved in manufacturing oral solid dosage forms like tablets. It involves size reduction of raw materials, blending, granulation, drying, lubrication, compression into tablets, coating if needed, and final packaging. Precise control of critical process parameters is required at each stage to ensure quality, bioavailability and stability of the final tablets. Granulation is an important step for uniform distribution of drugs in the blend and influences tableting process. Drying is also critical to control residual moisture. Compression forms the tablets and critical parameters like hardness and disintegration time need to be monitored.
Granules are spherical aggregations of fine powder particles that are formed to avoid segregation of particles with different sizes/densities, enhance powder flowability, improve compressibility, and reduce hazards from toxic dust. Granules are used either as pharmaceutical dosages themselves that dissolve quickly or as intermediates in tablet production. Wet granulation is the most common production method, involving mixing powder with a liquid to form a paste, then granulating the paste using equipment like mixers. The liquid must mildly dissolve powder to form bonds between particles as it dries. Granule quality depends on the liquid, equipment, and powder properties.
This document provides information about powders and granules. It defines powders as solid materials in a finely divided state that can be used orally or externally. Powders are classified based on use as bulk powders for internal or external use, or divided doses. Granules are agglomerated powders made into larger, free-flowing particles. The document describes the mixing, preparation, advantages, disadvantages, storage, packaging, and uses of powders and granules. Common pharmaceutical applications include antacids, analgesics, and skin protectants.
Pharmaceutical industry and unit processibtihal osman
Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and coating. Quality is ensured through strict adherence to good manufacturing practices (GMP) regulations. Excipients are other ingredients included in drug products that aid processing and delivery of the active drug. Common processing routes for solid oral dosage forms are direct compression, dry granulation, and wet granulation which involve different sequences of unit operations.
The document discusses the design and layout considerations for pharmaceutical manufacturing facilities. It states that premises should be located to minimize risks of cross-contamination from external sources. The interior surfaces should be smooth and allow for easy cleaning. Specific areas for different processes like manufacturing, packaging, laboratories should be separated but laid out in a logical flow. Material and personnel flow should be organized to prevent mix-ups and cross-contamination. Tables and figures provide examples of suitable layouts for manufacturing tablets and liquid oral preparations.
The document discusses advanced granulation technologies such as pneumatic dry granulation, freeze granulation, foamed binder technologies, melt granulation, steam granulation, moisture activated dry granulation, and thermal adhesion granulation that can replace traditional wet granulation methods. Granulation is used to improve properties like flow, compressibility, and drug release from tablets. Novel techniques offer advantages like suitability for heat-labile drugs, faster manufacturing, lower costs, and ability to achieve high drug loading.
Wet granulation and dry granulation are two common methods for manufacturing tablets. Wet granulation involves mixing powders with a liquid to form granules, then drying the granules. It has advantages like improved flow and uniformity but requires more equipment and time. Dry granulation compresses powders without liquid into slugs or rolls, then mills the compacts into granules. It is faster but produces more dust. Direct compression can tablet powders without granulation if ingredients have suitable properties, saving time and costs versus wet granulation.
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
This document summarizes tablet coating techniques. It discusses the concepts of tablet coating including sugar coating, film coating, and enteric coating. Recent trends in tablet coating that are discussed include solventless coating techniques like electrostatic dry coating, magnetically assisted impaction coating, and supercritical fluid coating. The document provides details on the history of tablet coating techniques and components involved in the tablet coating process.
This document summarizes tablet coating techniques. It discusses the concepts of tablet coating including sugar coating, film coating, and enteric coating. Recent trends in tablet coating that are discussed include solventless coating techniques like electrostatic dry coating, magnetically assisted impaction coating, and supercritical fluid coating. The document provides details on the history of tablet coating techniques and components involved in the tablet coating process.
Direct Compression is the simplest form of oral dosage production as it contains the fewest process stages, leading to a shorter process cycle and faster production times.
VALIDATION OF SPECIFIC DOSAGEFORMS.pptxchinjuvineeth
This document discusses process validation for different dosage forms including tablets, capsules, and semisolids. For tablets, it describes the key steps in manufacturing including mixing, wet and dry granulation, lubrication, compression, coating and in-process testing. Critical parameters are identified for each step that should be considered during development and validation, such as mixing speed and time, binder concentration, drying temperature, compression force, coating spray rate and weight. The goal is to determine the optimal conditions for each step to produce tablets meeting specifications.
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.
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.
The document discusses the importance and objectives of pilot plants in the pharmaceutical industry. It explains that pilot plants are used to transform lab-scale formulas into viable products by developing reliable manufacturing procedures. The key objectives of pilot plants are to produce stable dosage forms, identify critical process features, provide manufacturing formulas, and find issues before large-scale production. The document also describes various unit operations involved in pilot plant scale-up like granulation, drying, blending, and compression. It emphasizes that the pilot plant helps evaluate these operations at a small scale to guide large-scale production.
1. This document discusses the scale up considerations for producing capsules in a pilot plant setting. It covers the various unit operations involved in capsule production like mixing, granulation, drying, lubrication, filling and finishing.
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This document provides an overview of pilot plant scale manufacturing of oral solid dosage forms like tablets and capsules. It discusses various unit operations involved like material handling, blending, granulation, drying, size reduction, compression, coating, and capsule filling. It explains that the purpose of a pharmaceutical pilot plant is to transform a lab-scale formula into a viable product by developing reliable manufacturing procedures. Key steps like blending, granulation, drying, milling and compression are described along with the equipment used in each step and important process parameters. Capsule manufacturing processes like dipping, drying, trimming and filling are also summarized.
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Tablet coating is technique which is use in different tablet formulation. It is well known technique to make a tablet protective and creative. Tablet coating is an art which develop creativity against different problems occurred in tablet manufacturing. Coating which was taken up towards its tablet formulation aim like controlled release, gastro retentive, gastro resistance, delayed release profiles. It is a way of making use of a skinny polymer primarily based totally movie to a tablet. The quantity of coating at the floor of pill is essential to the effectiveness of the oral dosage form. Tablet coating have range of benefits covering color, smell and flavor of drug additionally bodily and chemical protection, protects the drug from gastric environment. There are unique strategies for coating tablets, inclusive of sugar coating, film. In modern technology, coating materials are directly coated on the solid dosage type surface without using any solvent as different solvents with less Coating are available, together with electrostatic dry coating magnetically assisted impaction coating, compression coating, warm soften coating, powder. This review deals in detail recent tablet coating technique, materials and industry oriented. Lokhande Jyoti | More Smita "Tablet Coating: Not Only a Technical Work but also a Creative Art" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-6 , October 2020, URL: https://www.ijtsrd.com/papers/ijtsrd33357.pdf Paper Url: https://www.ijtsrd.com/pharmacy/pharmaceutics/33357/tablet-coating-not-only-a-technical-work-but-also-a-creative-art/lokhande-jyoti
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Granulation procedures
1. 1.8 Manufacturing methods
1.8.1 Direct compression(1-3,5,17)
What
will you gain?
1.8.1.1 Introduction.
1.8.1.2 The events that
motivates the industry people to use direct compression technique.
1.8.1.3 Merits
1.8.1.4 Merits over wet granulation process
1.8.1.5 Demerits
1.8.1.6 Manufacturing steps for direct compression
1.8.1.7 Direct compression Excipients
1.8.1.7.1 An ideal direct
compression excipient should possess
the following attributes.
2. 1.8.1.7.2 Major excipients required in direct
compression.
1.8.1.1 Introduction
In early days, most of the tablets require granulation of the powdered Active
Pharmaceutical Ingredient (API) and Excipients. At the availability of new
excipients or modified form of old excipients and the invention of new tablet
machinery or modification of old tablet machinery provides an ease in
manufacturing of tablets by simple procedure of direct compression.
Amongst the techniques used to prepare tablets, direct
compression is the most advanced technology. It involves only blending and
compression. Thus offering advantage particularly in terms of speedy
production. Because it requires fewer unit operations, less machinery, reduced
number of personnel and considerably less processing time along with increased
product stability.
Definition:
The term “direct compression” is defined as the process
by which tablets are compressed directly from powder mixture of API and
suitable excipients. No pretreatment of the powder blend by wet or dry
granulation procedure is required.
1.8.1.2 The events that motivates the industry people to use direct compression technique
3. I.Commercial availability of the directly compressible excipients possessing both good
compressibility and good flowability.
For example,
Spray dried lactose, Anhydrous lactose, Starch-1500, microcrystalline
cellulose, Di-PacÒ, Sorbitol
II.Major advances
in tablet compression machinery:
i)Improved positive die feeding,
ii)Precompression of powder blend.
1.8.1.3 Merits
i)Direct compression is more efficient and economical process as compared to other
processes, because it involves only dry blending and compaction of API and
necessary excipients.
ii)The most important advantage of direct compression is
economical process.
Reduced
processing time, reduced labor costs, fewer manufacturing steps, and less
number of equipments are required, less process validation, reduced consumption
4. of power.
iii)Elimination of heat and moisture, thus increasing not
only the stability but also the suitability of the process for thermolabile and
moisture sensitive API’s.
iv)Particle size uniformity.
v)Prime particle dissolution.
In case of directly compressed tablets after
disintegration, each primary drug particle is liberated. While in the case of
tablets prepared by compression of granules, small drug particles with a larger
surface area adhere together into larger agglomerates; thus decreasing the
surface area available for dissolution.
vi)The chances of batch-to-batch variation are negligible,
because the unit operations required for manufacturing processes is fewer.
vii)Chemical stability problems for API and excipient would be avoided.
viii)Provides
stability against the effect of aging which affects the dissolution rates.
1.8.1.4 Merits over wet granulation process
The variables faced in the processing of the granules
can lead to significant tableting problems. Properties of granules formed can
be affected by viscosity of granulating solution, the rate of addition of
granulating solution, type of mixer used and duration of mixing, method and
rate of dry and wet blending. The above variables can change the density and
the particle size of the resulting granules and may have a major influence on
5. fill weight and compaction qualities. Drying can lead to unblending as soluble
API migrates to the surface of the drying granules.
1.8.1.5 Demerits
Excipient Related
i)Problems in the
uniform distribution of low dose drugs.
ii)High dose drugs having high bulk volume, poor
compressibility and poor flowability are not suitable for direct compression.
For example, Aluminium Hydroxide, Magnesium Hydroxide
iii) The choice of excipients for direct compression is
extremely critical. Direct compression diluents and binders must possess both
good compressibility and good flowability.
iv) Many active ingredients are not compressible either
in crystalline or amorphous forms.
v) Direct compression blends may lead to unblending
because of difference in particle size or density of drug and excipients.
Similarly the lack of moisture may give rise to static charges, which may lead
to unblending.
6. vi) Non-uniform distribution of colour, especially in
tablets of deep colours.
Process Related
i)Capping, lamination, splitting, or layering of tablets is sometimes related to air
entrapment during direct compression. When air is trapped, the resulting
tablets expand when the pressure of tablet is released, resulting in splits or
layers in the tablet.
ii)In some cases require greater sophistication in
blending and compression equipments.
iii) Direct compression equipments are expensive.
1.8.1.6 Manufacturing steps for direct compression
Direct compression involves
comparatively few steps:
i)Milling of drug and excipients.
ii) Mixing of drug and excipients.
iii) Tablet compression.
7. Manufacturing Steps For Direct Compression
Figure.23. Manufacturing Steps For Direct Compression
1.8.1.7 Direct compression Excipients
Direct compression excipients mainly include
diluents, binders and disintegrants. Generally these are common materials that
have been modified during the chemical manufacturing process, in such a way to
improve compressibility and flowability of the material.
The physicochemical properties of the ingredients
such as particle size, flowability and moisture are critical in direct
compression tableting. The success of direct compression formulation is highly
dependent on functional behavior of excipients.
1.8.1.7.1 An ideal direct compression excipient should possess the following attributes
i)It should have
good compressibility.
ii)It should possess good hardness after compression,
that is material should not possess any deformational properties;
otherwise this may lead to capping and
lamination of tablets.
8. iii) It should have good flowability.
iv) It should be physiologically inert.
v) It should be compatible with wide range of API.
vi) It should be stable to various environmental
conditions (air, moisture, heat, etc.).
vii) It should not show any physical or chemical change in
its properties on aging.
viii) It should have high dilution potential. i.e. Able to incorporate high amount of API.
ix) It should be colourless, odorless and tasteless.
x) It should accept colourants uniformity.
xi) It should possess suitable organoleptic properties
according to formulation type, that is in case of chewable tablet diluent
should have suitable taste and flavor. For example mannitol produces cooling
sensation in mouth and also sweet test.
xii) It should not interfere with bioavailability and
biological activity of active ingredients.
9. xiii)It should be
easily available and economical in cost.
1.8.1.7.2 Major excipients required in direct
compression
I.Diluents
II.Binders
III.Disintegrants
Diluents
Selection
of direct compression diluent is extremely critical, because the success or
failure of direct compression formulation completely depends on characteristics
of diluents. There are number of factors playing key role in selection of
optimum diluent. Factors like- Primary properties of API (particle size and
shape, bulk density, solubility), the characteristics needed for processing
(flowability, compressibity), and factors affecting stability (moisture, light,
and other environmental factors), economical approach and availability of material.
After
all, one can say that raw material specifications should be framed in such a
10. way that they provide an ease in manufacturing procedures and reduce chances of
batch to batch variation. This becomes possible only when the raw material
specifications reflect most of properties of diluents as mentioned in section
1.5.
Binders (56)
Binders are the agents used to impart cohesive qualities
to the powdered material. The quality of binder used has considerable influence
on the characteristic of the direct compression tablets. The direct compression
method for preparing tablets requires materials which are not only free flowing
but also sufficiently cohesive to act as binder.
Key Phrases
Ø Direct
compression is one of the most advanced technologies to prepare tablets.
Ø It requires
only blending and compression of excipients.
Ø It is an
economical process.
Ø It is suitable
11. for heat and moisture sensitive API.
It is not
suitable for very low and very high dose drugs.
1.8.2 Granulation (1,4,5,57)
What will you gain?
1.8.2.1
Introduction
1.8.2.2
Wet granulation
1.8.2.2.1 Introduction
1.8.2.2.2 Important steps involved in the wet
granulation
1.8.2.2.3 Limitation of wet granulation
1.8.2.2.4 Special wet granulation techniques
1.8.2.2.4.1 High shear mixture granulation
12. 1.8.2.2.4.2 Fluid bed granulation
1.8.2.2.4.3 Extrusion and Spheronization
1.8.2.2.4.4 Spray drying granulation
1.8.2.2.5 Lists of equipments for wet granulation
1.8.2.2.6 Current topics related to wet
granulation
1.8.2.3
Dry granulation
1.8.2.3.1 Introduction
1.8.2.3.2 Advantages
1.8.2.3.3 Disadvantages
1.8.2.3.4 Steps in dry granulation
1.8.2.3.5 Two main dry granulation processes
1.8.2.3.5.1Slugging process
13. 1.8.2.3.5.2 Roller compaction
1.8.2.3.6 Formulation for dry granulation
1.8.2.3 Advancement in Granulations
1.8.2.3.1 Steam Granulation
1.8.2.3.2 Melt Granulation/Thermoplastic
Granulation
1.8.2.3.3 Moisture
Activated Dry Granulation
1.8.2.3.4 Moist
Granulation Technique (MGT)
1.8.2.3.5 Thermal Adhesion Granulation Process
(TAGP)
1.8.2.3.6 Foam Granulation
1.8.2.1 Introduction
Granulation may be defined as a size enlargement process
14. which converts small particles into physically stronger & larger
agglomerates.
Granulation method can be broadly classified into two
types:
Wet granulation and Dry granulation
Ideal characteristics of granules
The ideal characteristics of granules include spherical
shape, smaller particle size distribution with sufficient fines to fill void
spaces between granules, adequate moisture (between 1-2%), good flow, good
compressibility and sufficient hardness.
The effectiveness of granulation depends on the
following properties
i) Particle size of
the drug and excipients
ii) Type of binder (strong or weak)
iii) Volume of binder (less or more)
iv) Wet massing time ( less or more)
15. v) Amount of shear applied
vi) Drying rate ( Hydrate formation and polymorphism)
1.8.2.2 Wet granulation
1.8.2.2.1 Introduction
The most widely used process of agglomeration
in pharmaceutical industry is wet granulation. Wet granulation process simply
involves wet massing of the powder blend with a granulating liquid, wet sizing
and drying.
1.8.2.2.2 Important steps involved in the wet
granulation
i) Mixing of the
drug(s) and excipients
ii) Preparation of binder solution
iii) Mixing of binder solution with powder mixture to form
wet mass.
iv) Coarse screening of wet mass using a suitable sieve
(6-12 # screens).
16. v) Drying of moist granules.
vi) Screening of dry granules through a suitable sieve
(14-20 # screen).
vii) Mixing of screened granules with disintegrant,
glidant, and lubricant.
1.8.2.2.3 Limitation of wet granulation
i) The greatest
disadvantage of wet granulation is its cost. It is an expensive process because
of labor, time, equipment, energy and space requirements.
ii) Loss of material during various stages of processing
iii) Stability may be major concern for moisture sensitive
or thermo labile drugs
iv) Multiple processing steps add complexity and make
validation and control difficult
v) An inherent limitation of wet granulation is that any
incompatibility between formulation components is aggravated.
1.8.2.2.4 Special wet granulation techniques
17. i) High shear
mixture granulation
ii) Fluid bed granulation
iii) Extrusion-spheronization
iv)Spray drying
1.8.2.2.4.1 High shear mixture granulation
High shear mixture has been widely used in Pharmaceutical
industries for blending and granulation. Blending and wet massing is
accompanied by high mechanical agitation by an impeller and a chopper. Mixing,
densification and agglomeration are achieved through shear and compaction force
exerted by the impeller.
Advantages:
i) Short processing
time
ii) Less amount of liquid binders required compared with
fluid bed.
iii) Highly cohesive material can be granulated.
18. 1.8.2.2.4.2 Fluid bed granulation
Fluidization is the operation by which fine solids are
transformed into a fluid like state through contact with a gas. At certain gas
velocity the fluid will support the particles giving them free mobility without
entrapment.
Fluid bed granulation is a process by which granules are
produced in a single equipment by
spraying a binder solution onto a fluidized powder bed. The material processed
by fluid bed granulation are finer, free flowing and homogeneous.
1.8.2.2.4.3 Extrusion and Spheronization
It
is a multiple step process capable of making uniform sized spherical particles.
It is primarily used as a method to produce multi-particulates for controlled
release application.
Advantages:
i) Ability to
incorporate higher levels of active components without producing excessively
larger particles.
ii) Applicable to both immediate and controlled release
19. dosage form.
1.8.2.2.4.4 Spray drying granulation
It is a unique granulation technique that directly
converts liquids into dry powder in a single step. This method removes moisture
instantly and converts pumpable liquids into a dry powder.
Advantages:
i) Rapid process
ii) Ability to be operated continuously
iii) Suitable for heat sensitive product
1.8.2.2.5 Lists of equipments for wet granulation
High Shear granulation:
i)Little ford Lodgie granulator
ii)Little ford MGT granulator
iii)Diosna granulator
iv)Gral mixer
20. Granulator with drying facility:
i)Fluidized bed granulator
ii) Day nauta mixer processor
iii)Double cone or twin shell processor
iv)Topo granulator
Special granulator:
i)Roto granulator
ii)Marumerizer
1.8.2.2.6 Current topics related to wet granulation
I. Hydrate formation
For example, theophylline anhydrous during
high shear wet granulation transfers to theophylline monohydrate. The midpoint
conversion occurs in three minutes after the binder solution is added.
For online monitoring of the transformation from one form to another, Raman
21. spectroscopy is most widely used.
II. Polymorphic transformation
The
drying phase of wet granulation plays a vital role for conversion of one form
to another.
For
example, glycine which exist in three polymorphs that is a, β, g . g
is the most stable form and a
is the metastable form. The stable Glycine polymorph (g) converts to metastable form (a) when
wet granulated with microcrystalline
cellulose.
1.8.2.3 Dry granulation
1.8.2.3.1 Introduction
In dry granulation process the powder mixture is
compressed without the use of heat and solvent. It is the least desirable of
all methods of granulation. The two basic procedures are to form a compact of
material by compression and then to mill the compact to obtain a granules. Two
methods are used for dry granulation. The more widely used method is slugging,
where the powder is precompressed and the resulting tablet or slug are milled
to yield the granules. The other method is to precompress the powder with
pressure rolls using a machine such as Chilosonator.
22. 1.8.2.3.2 Advantages
The main advantages of dry granulation or slugging are
that it uses less equipments and space. It eliminates the need for binder
solution, heavy mixing equipment and the costly and time consuming drying step
required for wet granulation. Slugging can be used for advantages in the
following situations:
i) For moisture
sensitive material
ii) For heat sensitive material
iii) For improved disintegration since powder particles
are not bonded together by a binder
1.8.2.3.3 Disadvantages
i) It requires a
specialized heavy duty tablet press to form slug
ii) It does not permit uniform colour distribution as can
be
iii) Achieved with wet granulation where the dye can be
incorporated into binder liquid.
23. iv) The process tends to create more dust than wet
granulation, increasing the potential contamination.
1.8.2.3.4 Steps in dry granulation
i) Milling of drugs
and excipients
ii) Mixing of milled powders
iii) Compression into large, hard tablets to make slug
iv) Screening of slugs
v) Mixing with lubricant and disintegrating agent
vi) Tablet compression
1.8.2.3.5 Two main dry granulation processes
1.8.2.3.5.1 Slugging process
Granulation by slugging is the process of compressing dry
powder of tablet formulation with tablet press having die cavity large enough
in diameter to fill quickly. The accuracy or condition of slug is not too
important. Only sufficient pressure to compact the powder into uniform slugs
should be used. Once slugs are produced they are reduced to appropriate granule
24. size for final compression by screening and milling.
Factors which determine how well a material may slug
i) Compressibility
or cohesiveness of the mater
ii) Compression ratio of powder
iii) Density of the powder
iv) Machine type
v) Punch and die size
vi) Slug thickness
vii) Speed of compression
viii) Pressure used to
produce slug
1.8.2.3.5.2 Roller compaction
The compaction of
powder by means of pressure roll can also be accomplished by a machine called
25. chilsonator. Unlike tablet machine, the
chilsonator turns out a compacted mass in a steady continuous flow. The powder
is fed down between the rollers from the hopper which contains a spiral auger
to feed the powder into the compaction zone. Like slugs, the aggregates are
screened or milled for production into granules.
1.8.2.3.6 Formulation for dry granulation
The excipients used for dry granulation are basically
same as that of wet granulation or that of direct compression. With dry
granulation it is often possible to compact the active ingredient with a minor
addition of lubricant and disintegrating agent. Fillers that are used in dry
granulation include the following examples: Lactose, dextrose, sucrose, MCC,
calcium sulphate, Sta-Rx® etc .
Examples of some tablet
formulation prepared by dry granulation:
Aspirin tablet Aspirin effervescent
tablet
Rx Rx
Starch Sodium
bicarbonate
27. 1.8.2.3 Advancement in Granulations
1.8.2.3.1 Steam
Granulation
It is modification of wet granulation. Here steam is used as a binder instead
of water. Its several
benefits includes higher
distribution uniformity, higher diffusion
rate into powders, more
favourable thermal balance
during drying step, steam
granules are more spherical, have large surface
area hence increased
dissolution rate of
the drug from
granules, processing time is
shorter therefore more
number of tablets are
produced per batch, compared to
the use of
organic solvent water vapour
is environmentally friendly,
no health hazards
to operators, no restriction
by ICH on
28. traces left in
the granules, freshly distilled
steam is sterile
and therefore the
total count can
be kept under
control, lowers dissolution rate
so can be
used for preparation
of taste masked
granules without modifying
availability of the
drug. But the limitation is that it is unsuitable for thermolabile
drugs. Moreover special equipments
are required and
are unsuitable for
binders that cannot
be later activated
by contact with
water vapour.
1.8.2.3.2 Melt Granulation / Thermoplastic Granulation (24)
Here granulation is achieved by the addition of meltable binder. That is
binder is in solid state at room temperature but melts
in the temperature range of 50 – 80˚C. Melted binder then acts like a binding
29. liquid. There is no need of drying phase since dried granules
are obtained by cooling it to room temperature. Moreover, amount of liquid
binder can be controlled precisely and the production and
equipment costs are reduced. It is useful for granulating water
sensitive material and producing SR granulation or solid dispersion. But this
method is not suitable for thermolabile
substances. When water soluble
binders are needed, Polyethylene Glycol (PEG) is used
as melting binders. When water
insoluble binders are
needed, Stearic acid, cetyl or stearyl
alcohol, various waxes and
mono-, di-, & triglycerides are used
as melting binders.
1.8.2.3.3 Moisture
Activated Dry Granulation (MADG) (58)
It involves moisture distribution and
agglomeration. Tablets prepared using MADG method has better content
uniformity. This method utilizes very little granulating fluid. It decreases
drying time and produces granules with excellent flowability.
1.8.2.3.4 Moist Granulation Technique (MGT) (59)
A small amount granulating fluid is added
to activate dry binder and to facilitate agglomeration. Then
30. a moisture absorbing material like Microcrystalline Cellulose (MCC) is
added to absorb any excess moisture. By adding MCC
in this way drying step is
not necessary. It is applicable for developing a controlled release formulation.
1.8.2.3.5 Thermal
Adhesion Granulation Process (TAGP) (60)
It is applicable for preparing direct tableting formulations. TAGP is
performed under low
moisture content or low content
of pharmaceutically acceptable
solvent by subjecting
a mixture containing
excipients to heating
at a temperature
in the range
from about 30ºC
to about 130ºC
in a closed
system under mixing
by tumble rotation
until the formation
of granules. This
method utilizes less
water or solvent
31. than traditional wet
granulation method. It
provides granules with
good flow properties
and binding capacity
to form tablets
of low friability, adequate hardness
and have a
high uptake capacity
for active substances
whose tableting is
poor.
1.8.2.3.6 Foam
Granulation (61)
Here liquid binders are added as aqueous foam. It
has several benefits
over spray(wet) granulation
such as it
requires less binder
than Spray Granulation, requires less
water to wet
granulate, rate of
addition of foam
is greater than
32. rate of addition
of sprayed liquids, no
detrimental effects on
granulate, tablet, or invitro
drug dissolution properties, no plugging
problems since use
of spray nozzles
is eliminated, no overwetting, useful for
granulating water sensitive
formulations, reduces drying time, uniform
distribution of binder
throughout the powder
bed, reduce manufacturing time, less
binder required for
Immediate Release (IR) and
Controlled Release (CR)
formulations.
Key Phrases
Ø In wet granulation process a granulating liquid is
used to facilitate the agglomeration process. Wet granulation has been and
continues to be the most widely used agglomeration process. Typically wet
massing of pharmaceutical powder is carried out in the high shear mixture
before wet screening and dried in fluidized bed equipment.
33. Ø In the dry granulation process granulation takes
place without utilizing liquid. In this process dry powder particles may be
brought together mechanically by compression into slug or by rolled
compaction.
Ø
Steam Granulation, Melt Granulation, MADG, MGT,
TAGP, Foam Granulation are some of the new advancements in
granulation and show better quality granule formation as compared
to conventional granulation
methods.
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Tablet
Tablets Book Chapter
Tablets Advantages and Disadvantages
Types of tablets
Formulation of tablets
Activie Ingredient
Manufacturing
Manufacturing methods of tablets
Tablet coating
Problems in tablet manufacture and related remedies
Quality Control tests for tablets
References
Tablet Evaluation Tests : Book Chapter
Brief Notes on Evaluation of tablet
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