This document provides an overview of granulation techniques used in pharmaceutical manufacturing. It defines granulation and describes common granulation methods like wet and dry granulation. Wet granulation techniques like high shear and low shear mixing are explained in detail along with novel techniques like moisture activated dry granulation, thermal adhesion granulation, and freeze granulation. Key granulation process parameters and characteristics of granules are also summarized. The document concludes by discussing various granulation technologies and their applications in the pharmaceutical industry.
Granulation is the process of forming grains or granules from a powdery or solid substance, producing a granular material. It is commonly used in the pharmaceutical industry to improve powder flow and content uniformity, eliminate dust, and enhance compaction. There are three main methods of granulation: direct compression, compression granulation, and wet granulation. Wet granulation involves moistening powder with a binding solution to form granules between 0.2-4.0 mm in size, then drying and screening the granules. The goals of granulation are to avoid powder segregation, enhance flow, produce uniform mixtures, eliminate dust, and improve compaction characteristics.
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 discusses capsules and microencapsulation. It begins by defining capsules as solid dosage forms where the drug is enclosed in a gelatin shell. It describes hard capsules for solids and soft capsules for liquids/semisolids. Microencapsulation is described as coating small particles or droplets to sizes up to 5000 microns for various purposes like masking taste, sustained release, etc. Various techniques for microencapsulation and important components of capsules and microencapsules are also summarized.
Granulation is a process that converts small particles into larger agglomerates called granules. There are two basic types of granulation: dry granulation, which uses mechanical compression or compaction; and wet granulation, which uses a granulation liquid like a binder or solvent to form wet masses. Common granulation methods include slugging, roller compaction, fluidized bed granulation, and melt granulation. Granulation is a key unit operation in manufacturing pharmaceutical tablets and capsules to improve flow properties and uniformity.
Tablet Making: Training Resource for Tablet Making ProfessionalsTechceuticals LLC
Tablet Pro is exactly what our industry is about today; The methodology, documentation and mindset required to meet the needs of our changing industry.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
This document provides an overview of the solid dosage manufacturing process. It discusses the main unit operations used, including formulation, blending, milling, granulation, drying, tabletting, coating and encapsulation. The three main methods for developing powders for tablet making are described as direct compression, wet granulation and dry granulation. Each unit operation is explained in detail, outlining the typical equipment used and goals of each step to produce tablets with consistent weight, thickness, hardness and other quality attributes. Common tests for granule properties are also summarized.
This document provides an overview of granulation techniques used in pharmaceutical manufacturing. It defines granulation and describes common granulation methods like wet and dry granulation. Wet granulation techniques like high shear and low shear mixing are explained in detail along with novel techniques like moisture activated dry granulation, thermal adhesion granulation, and freeze granulation. Key granulation process parameters and characteristics of granules are also summarized. The document concludes by discussing various granulation technologies and their applications in the pharmaceutical industry.
Granulation is the process of forming grains or granules from a powdery or solid substance, producing a granular material. It is commonly used in the pharmaceutical industry to improve powder flow and content uniformity, eliminate dust, and enhance compaction. There are three main methods of granulation: direct compression, compression granulation, and wet granulation. Wet granulation involves moistening powder with a binding solution to form granules between 0.2-4.0 mm in size, then drying and screening the granules. The goals of granulation are to avoid powder segregation, enhance flow, produce uniform mixtures, eliminate dust, and improve compaction characteristics.
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 discusses capsules and microencapsulation. It begins by defining capsules as solid dosage forms where the drug is enclosed in a gelatin shell. It describes hard capsules for solids and soft capsules for liquids/semisolids. Microencapsulation is described as coating small particles or droplets to sizes up to 5000 microns for various purposes like masking taste, sustained release, etc. Various techniques for microencapsulation and important components of capsules and microencapsules are also summarized.
Granulation is a process that converts small particles into larger agglomerates called granules. There are two basic types of granulation: dry granulation, which uses mechanical compression or compaction; and wet granulation, which uses a granulation liquid like a binder or solvent to form wet masses. Common granulation methods include slugging, roller compaction, fluidized bed granulation, and melt granulation. Granulation is a key unit operation in manufacturing pharmaceutical tablets and capsules to improve flow properties and uniformity.
Tablet Making: Training Resource for Tablet Making ProfessionalsTechceuticals LLC
Tablet Pro is exactly what our industry is about today; The methodology, documentation and mindset required to meet the needs of our changing industry.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
This document provides an overview of the solid dosage manufacturing process. It discusses the main unit operations used, including formulation, blending, milling, granulation, drying, tabletting, coating and encapsulation. The three main methods for developing powders for tablet making are described as direct compression, wet granulation and dry granulation. Each unit operation is explained in detail, outlining the typical equipment used and goals of each step to produce tablets with consistent weight, thickness, hardness and other quality attributes. Common tests for granule properties are also summarized.
The document discusses capsule dosage forms. Some key points include:
1. Capsules can be used to mask unpleasant drug tastes, smells, or appearances. They also allow powders to be dispensed uncompressed, aiding faster drug dissolution and absorption compared to tablets.
2. Capsules offer versatility in preparing varied drug doses and administration routes like oral, inhalation, and others. They can also be easier than tablets for some patients to swallow.
3. Capsule production involves filling empty shells with powders, granules, beads, pastes, liquids or other formulations. Both manual and automated high-output filling machines exist. Quality control ensures proper capsule appearance, weight, content uniform
The document describes preparing and evaluating paracetamol granules using the wet granulation method. Key steps in the wet granulation process are outlined, including weighing and sifting powders, blending, wet granulation, drying, dry screening, and lubrication. Granules containing 500mg of paracetamol per tablet are prepared and submitted. The granules are then evaluated for bulk density, tapped density, Hausner's ratio, Carr's compressibility index, and angle of repose to determine flow properties before compression into tablets.
This document provides information on tablets, including their definition, ingredients, manufacturing methods, and equipment used. Tablets are solid preparations made by compressing particles into various shapes and sizes, consisting of one or more active ingredients. The main ingredients used are fillers, binders, disintegrants, lubricants, glidants, antiadherents, colors, flavors, and sweeteners. The three main manufacturing methods are wet granulation, direct compression, and dry granulation. Wet granulation involves mixing, granulating, drying, and milling steps while direct compression is a two-step process of screening/milling and mixing. Dry granulation uses roller compaction. Final blending is done to ensure content uniform
Spencer Peter Golden also known as Spencer P Golden who is a trader trades in Wall Street. Spencer mainly trades Golden, Crude Oil. Trading is his life. He made his fortune from trading, He is a multimillionaire. According to Peter Trading is something that you can do anywhere, you just need to learn, you have to learn Lip reading though.
The document discusses characterization techniques for pharmaceutical granules and compacts. It describes methods for analyzing granule particle size, shape, density, moisture content, flow properties, and friability. It also covers techniques for evaluating tablet properties like weight variation, disintegration, dissolution, hardness and thickness. The purpose is to ensure granules and tablets meet specifications for content uniformity, drug release and stability.
Powder According to the syllabus based on “PHARMACY COUNCIL OF INDIA”
“I Dedicate this work to all the
Students , Pharmacy Faculty & Family Members .”
MY TOPIC IS powder -
A Pharmaceutical powder is a mixture of finely divided drugs or chemicals in a dry form meant for internal or external use.
Powders are preparation consisting of solid, loose, dry particle of various forms that contain one or more active ingredients meant for either internal or external use.
It is the preparation in which drugs is blended with other powdered substances and used for internal or external purpose.
Powder is a dosage form permits drugs to be reduced to a very fine state of division, which often enhances their therapeutic activity or efficacy by an increase of dissolution rate and or absorption.
[ It is possible to include a spoon in a packet of powder drug. This may result in inaccurate amount of drug delivered].
https://www.linkedin.com/in/drx-shubhanshu-r-s-jaiswal-b16bb41aa/?lipi=urn%3Ali%3Apage%3Ad_flagship3_feed%3Bq0wXFRAYRx%2BHNqb7clj41g%3D%3D
This document provides an overview of tablets, including their definition, advantages, disadvantages, types, additives, granulation processes, equipment used, tableting procedure, and evaluation. Tablets are defined as a compressed solid dosage form containing medicaments with or without excipients. Their advantages include dose precision, low cost, stability, and masking of taste, while disadvantages can include difficulty swallowing and formulation challenges for some drugs. The document discusses various tablet types, additives used, granulation technologies and equipment, the tableting process, and methods for evaluating tablets.
Powders are solid dosage forms meant for internal or external use, available in crystalline or amorphous forms. They are more stable than liquids but less convenient than liquids. Powders can be simple, containing one ingredient, or compound, containing multiple ingredients. They are prepared through geometric dilution or direct weighing and mixing of ingredients before portioning into individual doses. Effervescent granules are powders meant to be dissolved in water, containing acid substances that react with carbonates to release carbon dioxide.
This document discusses capsules, including definitions, types (hard gelatin and soft gelatin), and manufacturing processes. It notes that capsules enclose medicinal substances within a shell, usually made of gelatin. Hard gelatin capsules are made through a dipping process where gelatin is used to form two halves that are later joined. Soft gelatin capsules use a concentric nozzle process to simultaneously form the shell and fill it. The document provides details on quality control and the various sizes of capsules used for humans.
This document provides information about powders as a pharmaceutical dosage form. It begins with learning objectives about powders and then covers content such as the definition of powders, advantages and disadvantages, preparation methods, mixing techniques, classifications, weighing, and special considerations for dispensing powders. Methods for preparing powders include spatulation, trituration, geometric dilution, sifting, and tumbling. Powders are classified based on their intended use and form, such as bulk powders, simple/compound powders, powders in capsules, and compressed powders. Weighing techniques and issues related to accuracy are also discussed.
This document discusses different types of powder dosage forms including their advantages and disadvantages. It describes bulk powders for internal and external use which contain multiple doses of powder in containers. Simple and compound powders for internal use contain individually dosed powders wrapped in paper. Powders can also be enclosed in cachets or capsules. Compressed powders refer to tablets which are made by compressing powder mixtures into flat discs. The document provides examples of different types of powders and details on their preparation and use.
This document summarizes research on developing a rapid disintegrating tablet formulation of fluoxetine hydrochloride using a sublimation technique. Tablets were prepared by direct compression and wet granulation methods using various excipients like crospovidone, mannitol, ammonium bicarbonate, and camphor. The wet granulation method was found to produce tablets with more rapid drug release compared to direct compression. The optimized formulation F7 prepared by wet granulation with 10% crospovidone and 20% ammonium bicarbonate showed 99.26% drug release within 4 minutes and disintegrated within 37 seconds. Overall, the study demonstrated that a palatable, fast-disintegrating tablet of
This document provides information about packing soft gelatin capsules. It discusses the advantages and disadvantages of soft gel capsules. The anatomy and composition of the capsule shell and content are described. The manufacturing process involves making the gelatin mass, filling the capsules, drying and packaging them. Quality is ensured through ingredient specifications, in-process testing of shell thickness, fill weight and moisture levels. Finished products are tested for appearance, assay, content uniformity and microbiology. Vegicaps are introduced as an animal-free alternative with benefits such as being natural and free of animal derivatives.
In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug dispensing, manufacturing of parenteral preparations, drug information, patient
counselling, and therapeutic drug monitoring for improved patient care
Introduction, History types, manufacturing, Machinery used, filling by manual and automatic machines, Formulation, quality control test, Shape and sizes, properties of gelatin etc
Preparation and Evaluation of Aspirin tabletsSanket Kapadne
PREPARATION AND EVALUATION OF ASPIRIN TABLETS
Aim - Preparation and Evaluation of Aspirin Tablets.
Requirement –
Chemicals - Aspirin, HPMC, PVP, Sodium
Stearate, Talc
Glasswares - Granulating sieve, standard sieve set, etc.
Equipment - Tablet press
Principle
Aspirin tablet is prepared by wet granulation method. Aspirin belonging to the class of NSAID having analgesic, antipyretic, anti-inflammatory and antiplatelet activity at systematic standard doses. In this Lubricants in combination leads to better drug release kinetic. Aspirin tablets are obtained by wet Compression Method. The particles to be compressed consist of one or more medicaments, with or without excipients substance such as diluents, binders, and disintegration agents, lubricant, glidants.
Formula
Sr. No. Ingredients Quantity (1 Tab.)
1. Aspirin 250 mg
2. HPMC 50 mg
3. Microcrystalline Cellulose 70 mg
4. Polyvinyl Pyrrolidone Q.S.
5. Sodium Stearate+ Talc 1 mg + 5 mg
Method
Wet granulation forms the granulation by binding the powders together with an adheshive instead of by compaction.
Stages of granule development :
A. Pendular B. Funicular
C. Capillary D. Droplet Steps involved :
Step 1: Weighing and mixing of formulation ingredients.
Step 2: Preparing the damp mass.
Step 3: Screening the dampened powder into pellets or granules.
Step 4: Drying of moist granules.
Procedure
1. Tablets were prepared using wet granulation technique as per the composition given earlier.
2. The calculated amount which was required to prepare 400 mg aspirin tablets, containing 250 mg drug, HPMC polymer and PVP as a binder were mixed uniformly.
3. An enough granulating agent (water) was added slowly to prepare wet mass. Granules were prepared by sieving method using a 20# sieve.
4. Further, granules were dried at 35-45ºC for six hours. The dried granules were stored in desiccators until compression of tablets.
5.The required amounts of granules were weighed and compressed using automatically operated tablet punching machine having 12mm flat faced punch diameter and during the tablet preparation to maintain the low resistance between the solid and die wall, lubricants added in granules. Lubricant combinations are agents added in small quantities to the tablet during the tablet preparation.
6. The compressed tablets were stored in airtight container at room temperature for further evaluation.
Evaluation
1. Assay : Weigh and powder 20 tablets. Weigh accurately a quantity of the powder containing about 0.5 g of Aspirin, add 30.0 ml of 0.5M sodium hydroxide, boil gently for 10 minutes, cool and titrate the excess of alkali with 0.5 M hydrochloric acid using phenol red solution as indicator. Repeat the operation without the substance under examination. The difference
This presentation discusses moisture activated dry granulation technology (MADG). MADG is an advanced granulation technique that uses moisture to activate granule formulation but does not require heat drying. The presentation outlines the stages of MADG, including wet agglomeration where the powder blend is mixed with a small amount of water, and moisture absorption where moisture absorbents are added to redistribute moisture in the mixture and dry it. The presentation notes advantages of MADG such as short processing time and suitability for continuous processing, but also disadvantages such as difficulty developing formulations for moisture sensitive drugs or those with high drug loading.
This document provides information about tablet formulation and manufacturing. It discusses the different types of tablets, advantages and disadvantages of tablets, granulation process, tablet excipients including diluents, binders, disintegrants, lubricants and glidants. The key points covered are:
1) Tablets are solid oral dosage forms made by compressing powder mixtures into various shapes and sizes. They have advantages like precise dosing, stability and low cost of production.
2) Granulation is used to improve powder flow and compressibility. It can be done by wet or dry methods. Common excipients added to tablets include diluents, binders, disintegrants and lubricants which aid in tablet
This document provides information about tablets, including their formulation, design, manufacturing, types, advantages, and excipients. Tablets are solid oral dosage forms made by compressing powder mixtures into various shapes. They have advantages like precise dosing and ease of production. The document discusses different granulation and compression methods used in tablet manufacturing. It also describes common excipients like diluents, binders, disintegrants, lubricants and their functions in tablets.
The document discusses capsule dosage forms. Some key points include:
1. Capsules can be used to mask unpleasant drug tastes, smells, or appearances. They also allow powders to be dispensed uncompressed, aiding faster drug dissolution and absorption compared to tablets.
2. Capsules offer versatility in preparing varied drug doses and administration routes like oral, inhalation, and others. They can also be easier than tablets for some patients to swallow.
3. Capsule production involves filling empty shells with powders, granules, beads, pastes, liquids or other formulations. Both manual and automated high-output filling machines exist. Quality control ensures proper capsule appearance, weight, content uniform
The document describes preparing and evaluating paracetamol granules using the wet granulation method. Key steps in the wet granulation process are outlined, including weighing and sifting powders, blending, wet granulation, drying, dry screening, and lubrication. Granules containing 500mg of paracetamol per tablet are prepared and submitted. The granules are then evaluated for bulk density, tapped density, Hausner's ratio, Carr's compressibility index, and angle of repose to determine flow properties before compression into tablets.
This document provides information on tablets, including their definition, ingredients, manufacturing methods, and equipment used. Tablets are solid preparations made by compressing particles into various shapes and sizes, consisting of one or more active ingredients. The main ingredients used are fillers, binders, disintegrants, lubricants, glidants, antiadherents, colors, flavors, and sweeteners. The three main manufacturing methods are wet granulation, direct compression, and dry granulation. Wet granulation involves mixing, granulating, drying, and milling steps while direct compression is a two-step process of screening/milling and mixing. Dry granulation uses roller compaction. Final blending is done to ensure content uniform
Spencer Peter Golden also known as Spencer P Golden who is a trader trades in Wall Street. Spencer mainly trades Golden, Crude Oil. Trading is his life. He made his fortune from trading, He is a multimillionaire. According to Peter Trading is something that you can do anywhere, you just need to learn, you have to learn Lip reading though.
The document discusses characterization techniques for pharmaceutical granules and compacts. It describes methods for analyzing granule particle size, shape, density, moisture content, flow properties, and friability. It also covers techniques for evaluating tablet properties like weight variation, disintegration, dissolution, hardness and thickness. The purpose is to ensure granules and tablets meet specifications for content uniformity, drug release and stability.
Powder According to the syllabus based on “PHARMACY COUNCIL OF INDIA”
“I Dedicate this work to all the
Students , Pharmacy Faculty & Family Members .”
MY TOPIC IS powder -
A Pharmaceutical powder is a mixture of finely divided drugs or chemicals in a dry form meant for internal or external use.
Powders are preparation consisting of solid, loose, dry particle of various forms that contain one or more active ingredients meant for either internal or external use.
It is the preparation in which drugs is blended with other powdered substances and used for internal or external purpose.
Powder is a dosage form permits drugs to be reduced to a very fine state of division, which often enhances their therapeutic activity or efficacy by an increase of dissolution rate and or absorption.
[ It is possible to include a spoon in a packet of powder drug. This may result in inaccurate amount of drug delivered].
https://www.linkedin.com/in/drx-shubhanshu-r-s-jaiswal-b16bb41aa/?lipi=urn%3Ali%3Apage%3Ad_flagship3_feed%3Bq0wXFRAYRx%2BHNqb7clj41g%3D%3D
This document provides an overview of tablets, including their definition, advantages, disadvantages, types, additives, granulation processes, equipment used, tableting procedure, and evaluation. Tablets are defined as a compressed solid dosage form containing medicaments with or without excipients. Their advantages include dose precision, low cost, stability, and masking of taste, while disadvantages can include difficulty swallowing and formulation challenges for some drugs. The document discusses various tablet types, additives used, granulation technologies and equipment, the tableting process, and methods for evaluating tablets.
Powders are solid dosage forms meant for internal or external use, available in crystalline or amorphous forms. They are more stable than liquids but less convenient than liquids. Powders can be simple, containing one ingredient, or compound, containing multiple ingredients. They are prepared through geometric dilution or direct weighing and mixing of ingredients before portioning into individual doses. Effervescent granules are powders meant to be dissolved in water, containing acid substances that react with carbonates to release carbon dioxide.
This document discusses capsules, including definitions, types (hard gelatin and soft gelatin), and manufacturing processes. It notes that capsules enclose medicinal substances within a shell, usually made of gelatin. Hard gelatin capsules are made through a dipping process where gelatin is used to form two halves that are later joined. Soft gelatin capsules use a concentric nozzle process to simultaneously form the shell and fill it. The document provides details on quality control and the various sizes of capsules used for humans.
This document provides information about powders as a pharmaceutical dosage form. It begins with learning objectives about powders and then covers content such as the definition of powders, advantages and disadvantages, preparation methods, mixing techniques, classifications, weighing, and special considerations for dispensing powders. Methods for preparing powders include spatulation, trituration, geometric dilution, sifting, and tumbling. Powders are classified based on their intended use and form, such as bulk powders, simple/compound powders, powders in capsules, and compressed powders. Weighing techniques and issues related to accuracy are also discussed.
This document discusses different types of powder dosage forms including their advantages and disadvantages. It describes bulk powders for internal and external use which contain multiple doses of powder in containers. Simple and compound powders for internal use contain individually dosed powders wrapped in paper. Powders can also be enclosed in cachets or capsules. Compressed powders refer to tablets which are made by compressing powder mixtures into flat discs. The document provides examples of different types of powders and details on their preparation and use.
This document summarizes research on developing a rapid disintegrating tablet formulation of fluoxetine hydrochloride using a sublimation technique. Tablets were prepared by direct compression and wet granulation methods using various excipients like crospovidone, mannitol, ammonium bicarbonate, and camphor. The wet granulation method was found to produce tablets with more rapid drug release compared to direct compression. The optimized formulation F7 prepared by wet granulation with 10% crospovidone and 20% ammonium bicarbonate showed 99.26% drug release within 4 minutes and disintegrated within 37 seconds. Overall, the study demonstrated that a palatable, fast-disintegrating tablet of
This document provides information about packing soft gelatin capsules. It discusses the advantages and disadvantages of soft gel capsules. The anatomy and composition of the capsule shell and content are described. The manufacturing process involves making the gelatin mass, filling the capsules, drying and packaging them. Quality is ensured through ingredient specifications, in-process testing of shell thickness, fill weight and moisture levels. Finished products are tested for appearance, assay, content uniformity and microbiology. Vegicaps are introduced as an animal-free alternative with benefits such as being natural and free of animal derivatives.
In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug dispensing, manufacturing of parenteral preparations, drug information, patient
counselling, and therapeutic drug monitoring for improved patient care
Introduction, History types, manufacturing, Machinery used, filling by manual and automatic machines, Formulation, quality control test, Shape and sizes, properties of gelatin etc
Preparation and Evaluation of Aspirin tabletsSanket Kapadne
PREPARATION AND EVALUATION OF ASPIRIN TABLETS
Aim - Preparation and Evaluation of Aspirin Tablets.
Requirement –
Chemicals - Aspirin, HPMC, PVP, Sodium
Stearate, Talc
Glasswares - Granulating sieve, standard sieve set, etc.
Equipment - Tablet press
Principle
Aspirin tablet is prepared by wet granulation method. Aspirin belonging to the class of NSAID having analgesic, antipyretic, anti-inflammatory and antiplatelet activity at systematic standard doses. In this Lubricants in combination leads to better drug release kinetic. Aspirin tablets are obtained by wet Compression Method. The particles to be compressed consist of one or more medicaments, with or without excipients substance such as diluents, binders, and disintegration agents, lubricant, glidants.
Formula
Sr. No. Ingredients Quantity (1 Tab.)
1. Aspirin 250 mg
2. HPMC 50 mg
3. Microcrystalline Cellulose 70 mg
4. Polyvinyl Pyrrolidone Q.S.
5. Sodium Stearate+ Talc 1 mg + 5 mg
Method
Wet granulation forms the granulation by binding the powders together with an adheshive instead of by compaction.
Stages of granule development :
A. Pendular B. Funicular
C. Capillary D. Droplet Steps involved :
Step 1: Weighing and mixing of formulation ingredients.
Step 2: Preparing the damp mass.
Step 3: Screening the dampened powder into pellets or granules.
Step 4: Drying of moist granules.
Procedure
1. Tablets were prepared using wet granulation technique as per the composition given earlier.
2. The calculated amount which was required to prepare 400 mg aspirin tablets, containing 250 mg drug, HPMC polymer and PVP as a binder were mixed uniformly.
3. An enough granulating agent (water) was added slowly to prepare wet mass. Granules were prepared by sieving method using a 20# sieve.
4. Further, granules were dried at 35-45ºC for six hours. The dried granules were stored in desiccators until compression of tablets.
5.The required amounts of granules were weighed and compressed using automatically operated tablet punching machine having 12mm flat faced punch diameter and during the tablet preparation to maintain the low resistance between the solid and die wall, lubricants added in granules. Lubricant combinations are agents added in small quantities to the tablet during the tablet preparation.
6. The compressed tablets were stored in airtight container at room temperature for further evaluation.
Evaluation
1. Assay : Weigh and powder 20 tablets. Weigh accurately a quantity of the powder containing about 0.5 g of Aspirin, add 30.0 ml of 0.5M sodium hydroxide, boil gently for 10 minutes, cool and titrate the excess of alkali with 0.5 M hydrochloric acid using phenol red solution as indicator. Repeat the operation without the substance under examination. The difference
This presentation discusses moisture activated dry granulation technology (MADG). MADG is an advanced granulation technique that uses moisture to activate granule formulation but does not require heat drying. The presentation outlines the stages of MADG, including wet agglomeration where the powder blend is mixed with a small amount of water, and moisture absorption where moisture absorbents are added to redistribute moisture in the mixture and dry it. The presentation notes advantages of MADG such as short processing time and suitability for continuous processing, but also disadvantages such as difficulty developing formulations for moisture sensitive drugs or those with high drug loading.
This document provides information about tablet formulation and manufacturing. It discusses the different types of tablets, advantages and disadvantages of tablets, granulation process, tablet excipients including diluents, binders, disintegrants, lubricants and glidants. The key points covered are:
1) Tablets are solid oral dosage forms made by compressing powder mixtures into various shapes and sizes. They have advantages like precise dosing, stability and low cost of production.
2) Granulation is used to improve powder flow and compressibility. It can be done by wet or dry methods. Common excipients added to tablets include diluents, binders, disintegrants and lubricants which aid in tablet
This document provides information about tablets, including their formulation, design, manufacturing, types, advantages, and excipients. Tablets are solid oral dosage forms made by compressing powder mixtures into various shapes. They have advantages like precise dosing and ease of production. The document discusses different granulation and compression methods used in tablet manufacturing. It also describes common excipients like diluents, binders, disintegrants, lubricants and their functions in tablets.
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.
Tablet, Tablet as a dosage form, tablet as a solid unit dosage form, tablet t...RajkumarKumawat11
Tablet, Tablet as a dosage form, tablet as a solid unit dosage form, tablet topic for pharma student, presentation of tablet, tablet by raj kumar kumawat
this presentation slide has been prepared to add valuable information about tablet (solid dosage form). I hope that it will surely help the pharma aspirants for their examination.
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.
This document discusses tablets as a solid oral dosage form. It defines tablets and describes their advantages such as precise dosing, low cost, and stability. The document outlines common tablet ingredients like diluents, binders, disintegrants, and lubricants. It also discusses different types of tablets based on route of administration and describes various tableting methods including wet and dry granulation and compression. The document provides a detailed overview of the key components and processes involved in manufacturing tablets.
Tablets are one of the most common oral drug delivery forms, comprising around half of all pharmaceutical products. Tablets offer advantages like high patient compliance and ease of production and marketing. However, some substances may not be well absorbed in the gastrointestinal tract. Tablets are compressed dispersions of particles that come in various types depending on if they are taken intact or not. Their manufacture involves steps like raw material procurement, formulation, granulation, compression, coating and packaging. Granulation can improve properties like flow and compressibility and is usually done by wet or dry processes. Tablets contain active substances and excipients like fillers, disintegrants, binders, lubricants and coatings to provide the desired properties.
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 the manufacturing process and quality control testing of tablets. It begins with an introduction to tablet manufacturing methods such as direct compression, dry granulation, and wet granulation. It then outlines the typical manufacturing flowcharts and unit processes for each method. The document also describes in-process quality control tests conducted on tablets including weight variation, content uniformity, disintegration, dissolution, hardness, and friability testing. Common excipients and techniques for tablet coating are also discussed. The document provides a detailed overview of the key considerations and steps involved in tablet production and quality assurance.
This document discusses the process of manufacturing tablets. It begins by defining tablets and outlining the main steps in tablet formation, which include weighing, milling, mixing, granulation, drying, compression, coating and packaging. It then describes the goals and categories of tablets and provides more detail on specific unit operations like granulation processing, compression, and evaluation methods. The document also lists common equipment used in each step and discusses packaging and storage considerations. The overall manufacturing process involves accurately weighing ingredients, reducing particle size, blending powders, granulating to improve flow, compressing into tablets, optionally coating, and automated packaging.
The document discusses pharmaceutical powders, including their advantages and disadvantages as a dosage form. It defines powders as intimate mixtures of dry, finely divided drugs and chemicals that can be used internally or externally. The document outlines different types of powders like bulk powders, simple powders, compound powders, and effervescent granules. It also describes methods of preparing powders, including particle size reduction, homogeneous mixing, packaging, and addressing special issues like volatile, hygroscopic, or efflorescent ingredients. Quality control testing of powders is also summarized.
This document discusses powders and granules used in pharmaceutical preparations. It defines powders as finely divided solids and describes their advantages as flexibility, good chemical stability, and rapid dispersion due to small particle size. Granules are agglomerates of powder particles that have better flow properties than powders. The document discusses methods for preparing powders and granules, including wet and dry granulation techniques. It also covers topics like particle size analysis, blending powders, and special powder formulations like effervescent granules.
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.
This document discusses different types of tablets and the tablet manufacturing process. It begins by defining what a tablet is and listing some key advantages such as precise dosing, low cost, and stability. It then describes different types of tablets including compressed, coated, chewable, and those for different routes of administration. The document outlines common excipients used in tablets and their functions. It explains the importance of granulation and describes different granulation methods including dry, wet, and direct compression. The wet granulation process is outlined in detail including mixing, granulation, and drying steps.
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.
This document validates the innovative SeDeM methodology for use as a galenical preformulation tool according to quality by design (ICH-Q8) criteria. The investigation demonstrates that the SeDeM methodology is an easy to apply innovative tool for galenical preformulation studies, especially for powder formulations. It allows predicting if a formulation is suitable for tablet manufacturing by direct compression after several simple physical tests. Four APIs and five coprocessed excipients were analyzed using the SeDeM methodology. The analysis provides a profile of each product to determine characteristics like dimensions, compressibility, lubrication/stability and lubrication/dosage. This characterization can identify parameters that need improvement for direct compression tablet manufacturing and constitute
A continuación os anexo un summary del trabajo que nos permitio obtener un Accesit en el Concurso Cientifico Dr. Esteve 2009 de la Real Academia de Farmacia de Cat - España
Autores: Johnny Aguilar, Encarna G, Pilar P. de la Universidad de Barcelona Departamento de Tecnología Farmacéutica
Este documento presenta una nueva estrategia de validación de procesos propuesta por la FDA en 2008. La nueva estrategia enfatiza el diseño del proceso, la calificación del proceso y la verificación continua del proceso en lugar de un enfoque basado en lotes. La industria farmacéutica ha reaccionado de manera mixta a los cambios propuestos, con algunas compañías que no planean cambiar sus programas de validación existentes.
El documento presenta una nueva estrategia de validación de procesos propuesta por la FDA en 2008. Esta estrategia se centra en el diseño del proceso, la calificación del proceso y la verificación continua del proceso a lo largo del ciclo de vida del producto, en lugar de enfocarse únicamente en la validación retrospectiva. La industria farmacéutica ha reaccionado positivamente a los nuevos principios, aunque todavía existe cierta desconexión entre las regulaciones de la FDA y la UE.
El documento presenta una introducción a las Buenas Prácticas de Manufactura (BPM) en la industria farmacéutica. Explica que las BPM, junto con las Buenas Prácticas de Laboratorio y las Buenas Prácticas Clínicas, forman parte de las normas GxP y son importantes para garantizar la calidad, seguridad y eficacia de los medicamentos. Asimismo, proporciona algunos antecedentes históricos que llevaron al desarrollo de las BPM y describe brevemente los principales capítu
Este documento propone integrar los sistemas de gestión de calidad GMP con la norma ISO 9000:2000 en la industria farmacéutica para mejorar la eficacia. Describe los pasos para concebir, diseñar, implementar y monitorear un sistema de gestión de calidad que cumpla con ambos estándares, incluyendo la identificación de requisitos, el diagnóstico del estado actual, y las acciones para mejorar continuamente el sistema.
Este documento describe emulsiones y microemulsiones obtenidas mediante la polimerización de monómeros y sus aplicaciones. Explica que las emulsiones son dispersiones coloidales de partículas de polímero en agua que se utilizan en adhesivos, pinturas y otros productos. También describe los procesos de polimerización en emulsión y microemulsión y algunos polímeros comunes obtenidos como poli(acetato de vinilo), poliestireno y polibutadieno. Finalmente, señala posibles aplicaciones de los microl
The document discusses pharmaceutical stability and factors that affect the stability of medications. It defines stability as maintaining key quality characteristics like active substance content, pharmaceutical form, and toxicity over time. The period of validity for a medication is typically 5 years or until active substance content decreases by 10%, whichever is sooner. Stability can be impacted by physical, chemical, and microbial changes over time. Chemical stability depends on reaction kinetics and is affected by temperature, with higher temperatures generally increasing reaction rates according to the Arrhenius equation. The document also provides examples of calculating reaction kinetics, half-life, and shelf life for different reaction orders.
El documento trata sobre estudios de liberación y correlaciones in vitro in vivo. Explica los ensayos de disolución "in vitro" y su uso para control de calidad y para predecir el comportamiento in vivo. También describe los modelos cinéticos como orden cero, primer orden y ecuación de Weibull para analizar los perfiles de disolución.
El documento proporciona una introducción al proceso de liofilización. Explica que la liofilización elimina el agua de un producto húmedo mediante la congelación y sublimación del hielo bajo vacío, evitando la etapa líquida. También describe las ventajas e inconvenientes del proceso y algunas de sus aplicaciones comunes en la industria farmacéutica y alimentaria.
The document summarizes a case study on the implementation of Quality by Design (QbD) principles in developing a film-coated tablet with an active layer to protect an unstable drug. Key aspects included identifying critical quality attributes of content uniformity and potency. Design of experiments was used to establish a design space. In-line monitoring techniques like Raman spectroscopy were utilized to ensure consistent coating quality during scale-up.
The document discusses various methods for granulation of ceramic powder including spray drying, extruding, and mixing with a perforated plate. It explains that granulation aims to produce free-flowing particles and may require a binder. The critical liquid content range for granulation depends on the particle system. Spray drying is a common granulation method that can produce spherical particles around 20 micrometers in size with high productivity. Key parameters for spray drying include droplet size, viscosity, feed rate, drying rate, and temperature.
De las 35.000 toneladas de medicamentos donados a Bosnia y Herzegovina entre 1992 y 1996, 17.000 toneladas no fueron utilizables debido a que estaban vencidos, en mal estado, etc. y tuvieron que ser descartadas. Con el dinero necesario para su destrucción apropiada se podrían haber cubierto las necesidades básicas de salud de 2 millones de refugiados durante 5 años. La calidad es fundamental en los productos farmacéuticos y está regulada por normas como las Buenas Prácticas de Manufactura y Almacenamiento.
El documento discute los riesgos de prescribir medicamentos solo por su principio activo. Explica que aunque medicamentos con el mismo principio activo pueden parecer equivalentes, pueden diferir en su calidad farmacéutica, perfil de liberación y biodisponibilidad, lo que puede afectar la eficacia y seguridad del tratamiento. También destaca la importancia de la bioequivalencia y el ensayo de disolución para garantizar la equivalencia terapéutica entre medicamentos genéricos.
a) Es posible automatizar el método analítico de disolución USP-II validado manualmente, obteniendo resultados equivalentes. b) La calificación del equipo automatizado siguió el modelo "V" de GAMP y demostró ser apto para su uso bajo GxP. c) Se validaron los ensayos más desfavorables incluyendo diferentes productos farmacéuticos.
This document discusses tableting processes and scale-up considerations. It summarizes differences between tablet presses, including mode of die fill, compression mechanism, speed, and dwell time. Dimensional analysis techniques are presented for characterizing wet granulation and tableting using dimensionless groups. The current SUPAC guidelines for manufacturing changes are outlined, with a call to re-evaluate based on mechanistic understanding using dimensional analysis.
This document discusses emerging issues in manufacturing quality control and assurance of drug products. It covers three key areas: 1) shelf life determination and stability testing, 2) acceptance tests of finished products, and 3) in vitro equivalence tests. For each area, it outlines statistical challenges and opportunities to move from traditional approaches to quality-by-design using process analytical technology. The goal is to better understand and control manufacturing processes to ensure consistent quality.
Granulation is done to improve the flow and compression properties of powder mixes by preventing segregation and reducing toxic dust. It increases convenience of transport. Granulation works through adhesion, cohesion, and interfacial forces between particles when a liquid is added to form bridges or films between them. There are three main types of wet granulation equipment: shear granulators, high speed mixer/granulators, and fluidized bed granulators.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
This presentation was provided by Racquel Jemison, Ph.D., Christina MacLaughlin, Ph.D., and Paulomi Majumder. Ph.D., all of the American Chemical Society, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
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Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
This presentation was provided by Rebecca Benner, Ph.D., of the American Society of Anesthesiologists, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
2. The Tablet
The Tablet is the final report card for how
well all previous operations performed
within the process.
Keep this objective in mind. There are
many really good process operators that
never really understand their role is to
make a good tablet, not just to complete a
function on a machine.
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Six Reasons to Granulate
There are six key reasons to granulate!
All six are based on the need to tablet or
encapsulate a product.
These six “reasons” are the key to
improving and optimization of an existing
blend or of individual ingredients.
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2
3. 1.To Improve Flow
Powder flow is important throughout the
entire tablet making process.
Weighing/Batching - accuracy
Milling- consistency
Blending- content uniformity
Granulating - repeatability
Tablet Compression – to meet the objectives
Flow performance is relative to speed and
capacity of the equipment
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2. Compressibility
Tablet Press speeds vary from 48 tablets
per minute to over 15,000 tablets per
minute.
The average press runs at 3000 tpm or 50
tablets per second.
The ability for a powder to compress
quickly is imperative.
The Press knows Weight, Thickness,
Speed…Hardness is a result.
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3
4. 3. Fines & Control Dust
Fine particles & dust are often the main
cause of poor flow, poor compression,
cross contamination, and poor content
uniformity.
Tablet compression and capsule filling
machines perform best with a particle size
distribution within a range of 40-200 mesh
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Particle Size Distribution
70
60
50
40
30
20
10
0
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4
5. Fines
Large Particles Intermediates Fines
<20 Mesh 40-120 Mesh >200 Mesh
850 μm/.0331” 425-125 μm 75 μm/.0029”
10-20% .0165”-.0049” 10-20%
70-80%
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4. Control Segregation
Segregation means that powders are not
staying mixed and are separating. This
leads to content uniformity issues and
table weight & hardness control.
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6. 5. Density Control
Density variation
within a single
ingredient equates to
major problems with
tablet & capsule
manufacturing across
the board.
Bulk density variation
Each item in the above photo weighs
of ingredients within the same!
the blend is a recipe
for trouble. 11
6. Capture & fuse “Active”
There are 2 things “Actives and
Excipients” within a formulation.
Sometimes we granulate the entire blend
and other times we granulate individual
ingredients.
The Active Ingredient can represent a very
small percentage of the final formulation
or a very high percentage of the
formulation.
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6
7. Which Pathway?
Direct Compression
Wet Granulating
Dry Granulating
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Direct Compression
Why not just weigh the powder, mix it and put it on the tablet press?
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8. Granule Formation
Granules can be formed by
adding a liquid “Binder “
into the dry powder mass,
much like combining water,
milk or egg with flour when
cooking.
Granules can be formed
through dry compaction;
compaction;
some powders are sensitive to
liquid addition and high
temperatures from the drying
process.
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What is a Binder?
A binder is an “excipient” (non-active
ingredient) that forms a bridge and locks
particles together…aka a pharmaceutical
glue.
There are dry binders and wet Binders and
there are a few binders like “Avicel
PH102” by FMC that can work as a dry or
wet binder
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8
10. Process Pathways
Wet Granulation Dry Granulation Direct Blending
Pre-mix Pre-mix
Wet Massing Slugging/Chilsonating
Drying Milling
Milling Final Blending Charge and Blend
Powde rs
Final Blending
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5 Steps
There are 5 steps to follow which will help
to Determine if granulating is necessary
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10
11. 1. Is Direct Compression
Feasible?
If yes = Direct Compress
If no= The product must be Granulated
Many products are successful at a slow
speed on a tablet press, but not fast.
Can your product run as fast as the press
can go? If the answer is No, then your
product is non-optimized and is limited in
some way?
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2. Is the Blend Cohesive
If yes = Direct Compress
If no= The product must be Granulated
Products need to be cohesive (sticky). If
the answer is no something must be
added to help lock the particles together.
If products are too cohesive then we have
another problem which is commonly
referred to as “sticking & picking”.
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11
12. 3. Is the Flow acceptable?
If yes = Direct Compress
If no= The product must be Granulated
Flow is critical and it can change from
product variation, environmental changes,
and it can be impacted by time.
Good flow is like granulated sugar
Bad flow is like flour
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4. Is Content uniformity
acceptable?
If yes = Direct Compress
If no= The product must be Granulated
What is “content uniformity”?
Content Uniformity means that each and
every tablet has the same quantity of
ingredients within an acceptable range.
Is it possible to blend powders and then
have them come unblended? YES.
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12
13. 5. Is the Bulk Density
acceptable?
If yes = Direct Compress
If no= The product must be Granulated
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Granulate
If the answer to any of the above was YES
then the formula or ingredients within the
blend must be granulated.
Which method of granulation should you
choose? Wet or Dry Granulating?
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13
14. Summary
Remember that the purpose of Granulating is
to simply make a better tablet. If there is a
problem such as weight, hardness, thickness,
friability, appearance, disintegration,
dissolution, content uniformity, just to name
the major ones…then the need to granulate or
the need to improve they way you are
granulating must be carried out.
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Granulating series
Granulating Basics 101 – Dec 4th
Granulating 201 – Feb 26th
Granulating 301- April 23rd
If you would like to attend future
Granulating programs please email a
request for a discount coupon after this
presentation and we will email a 10%
discount coupon good for future sessions.
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15. Special Request
Please send photos and examples of
defects or examples of common problems
at your facility.
In return we will send you a free pass to a
future seminar.
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Questions and Thank You!
Open for Questions
If you don’t get the answer, email or call me to
discuss
Please join us next week for our QA/QC session
Thank You for joining me….Mike Tousey
Techceuticals
36 Persimmons Street, Suite 303
Bluffton, South Carolina, USA 29693-4519
Phone: 843 815 7441 Fax: 843 815 7446
E-mail: sales@techceuticals.com Web: www.techceuticals.com
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16. Thank You for attending today!
We hope you enjoyed today’s program
and will join us again soon.
If you need help, let the professionals at
Techceuticals bring their practical
solutions to your company! Ask us how
today!
Techceuticals
36 Persimmons Street, Suite 303
Bluffton, South Carolina, USA 29693-4519
Phone: 843 815 7441 Fax: 843 815 7446
E-mail: sales@techceuticals.com Web: www.techceuticals.com
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