This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
1) Solubility is the maximum amount of a substance that dissolves in a solvent to form a saturated solution at a given temperature and pressure.
2) Solubility is ideally measured at 4°C and 37°C to ensure physical stability and support biopharmaceutical evaluation. Solubility below 1 mg/ml indicates poor absorption and need for preformulation studies.
3) Preformulation solubility studies focus on the drug solvent system and include determining properties like intrinsic solubility, pH solubility profiles, effects of surfactants, and temperature dependence to understand a drug's solubility and dissolution behavior.
The document discusses dissolution as a tool in pharmaceutics. It defines dissolution as the process where a solid substance solubilizes in a solvent, transferring from the solid surface to the liquid phase. This is the rate-determining step for poorly soluble drugs. The document discusses three main mechanisms of dissolution - the diffusion layer model, Danckwert's model, and the interfacial barrier model. It also covers factors influencing dissolution such as drug properties, apparatus factors, and dissolution media properties. Finally, it provides details on three common dissolution apparatus - the basket, paddle, and reciprocating cylinder methods.
Formulation and evaluation of Muco adhesive Buccal Tablets of Ramprildoddaapurupa
The buccal mucosa lines the inner cheek and Buccal formulations are placed in the mouth between upper gingiva(gums) and cheek to treat local and systemic conditions.
Drugs which undergoes Extensive first pass metabolism and drug degradation in acidic media, GI tract can be administered through buccal route.
The oral cavity has been used as a site for local and systemic drug delivery.
This document provides an overview of emulsions, including their definition, types, applications, theory, preparation methods, equipment, stability issues, and packaging/storage. An emulsion is an unstable mixture of two immiscible liquids stabilized by an emulsifying agent. There are several types including oil-in-water, water-in-oil, and microemulsions. Emulsions are used pharmaceutically to increase drug bioavailability and for topical delivery. Preparation methods include wet and dry gum methods. Stability can be improved by reducing interfacial tension and preventing droplet coalescence. Packaging and storage conditions aim to maintain emulsion stability.
Phase solubility analysis and pH solubility profileMohit Angolkar
A Brief presentation on the topic- phase solubility analysis and pH solubility profile, which covers the following aspects:
- Solubility introduction
- importance of solubility
- factors influencing solubility
- Phase solubility analysis introduction
- method of analysis
- purification technique
- introduction to pH solubility profile.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
1) Solubility is the maximum amount of a substance that dissolves in a solvent to form a saturated solution at a given temperature and pressure.
2) Solubility is ideally measured at 4°C and 37°C to ensure physical stability and support biopharmaceutical evaluation. Solubility below 1 mg/ml indicates poor absorption and need for preformulation studies.
3) Preformulation solubility studies focus on the drug solvent system and include determining properties like intrinsic solubility, pH solubility profiles, effects of surfactants, and temperature dependence to understand a drug's solubility and dissolution behavior.
The document discusses dissolution as a tool in pharmaceutics. It defines dissolution as the process where a solid substance solubilizes in a solvent, transferring from the solid surface to the liquid phase. This is the rate-determining step for poorly soluble drugs. The document discusses three main mechanisms of dissolution - the diffusion layer model, Danckwert's model, and the interfacial barrier model. It also covers factors influencing dissolution such as drug properties, apparatus factors, and dissolution media properties. Finally, it provides details on three common dissolution apparatus - the basket, paddle, and reciprocating cylinder methods.
Formulation and evaluation of Muco adhesive Buccal Tablets of Ramprildoddaapurupa
The buccal mucosa lines the inner cheek and Buccal formulations are placed in the mouth between upper gingiva(gums) and cheek to treat local and systemic conditions.
Drugs which undergoes Extensive first pass metabolism and drug degradation in acidic media, GI tract can be administered through buccal route.
The oral cavity has been used as a site for local and systemic drug delivery.
This document provides an overview of emulsions, including their definition, types, applications, theory, preparation methods, equipment, stability issues, and packaging/storage. An emulsion is an unstable mixture of two immiscible liquids stabilized by an emulsifying agent. There are several types including oil-in-water, water-in-oil, and microemulsions. Emulsions are used pharmaceutically to increase drug bioavailability and for topical delivery. Preparation methods include wet and dry gum methods. Stability can be improved by reducing interfacial tension and preventing droplet coalescence. Packaging and storage conditions aim to maintain emulsion stability.
Phase solubility analysis and pH solubility profileMohit Angolkar
A Brief presentation on the topic- phase solubility analysis and pH solubility profile, which covers the following aspects:
- Solubility introduction
- importance of solubility
- factors influencing solubility
- Phase solubility analysis introduction
- method of analysis
- purification technique
- introduction to pH solubility profile.
Solid state stability and shelf-life assignment, Stability protocols,reports ...Durga Bhavani
This document discusses guidelines for solid state stability and shelf-life assignment studies as outlined by ICH. It provides definitions of stability, the need for stability studies, and factors that influence drug degradation like temperature, moisture, light and interactions. The document outlines the types of studies, including real-time and accelerated stability studies. It discusses stability protocols, reports, and test conditions recommended by ICH to determine a drug's shelf life.
This document discusses dissolution testing of pharmaceutical dosage forms. It describes the types of dissolution apparatuses, including basket, paddle, reciprocating cylinder, flow-through cell, and transdermal cell apparatuses. The key features and uses of each apparatus are outlined. Factors that influence dissolution rate, such as formulation components, processing methods, and test conditions, are also summarized. These include vehicles, diluents, disintegrants, and processing methods like granulation and compression force.
The document discusses drug delivery to the brain by bypassing the blood-brain barrier. It begins with the aim to study approaches to deliver therapeutics across the BBB. It then describes the structure and functions of the BBB, how it restricts drug delivery to the brain, and diseases related to it. Finally, it summarizes invasive, pharmacological, and physiological approaches to bypass the BBB, including marketed formulations that use these approaches.
The document discusses various techniques for improving the solubility and dissolution rate of poorly soluble drug compounds. It defines key terms like solubility, polymorphism, and solid dispersions. It describes three main methods for creating solid dispersions - hot melt method, solvent evaporation method, and hot melt extrusion. These methods aim to molecularly disperse the drug in an inert carrier in order to enhance solubility. The document also discusses other techniques like amorphous forms, solvates, and eutectic mixtures that can improve drug properties.
The document discusses parenteral dosage forms. Parenterals are sterile solutions or suspensions of drugs administered directly into veins, muscles, or under the skin. They do not utilize the alimentary canal and must meet general requirements including stability, sterility, isotonicity, and being free of pyrogens, toxins, and foreign particles. Evaluation tests for parenterals include sterility, pyrogen, clarity, and leakage tests.
The document discusses aseptic processing operations. It describes the characterization of the aseptic process including microbial environmental monitoring, testing of water and air, and media and incubation conditions. The key aspects of the aseptic process are the facility design and control systems, equipment, personnel training, process validation, and finished product testing like sterility testing. Microbiological testing of water, air and media fills is important to ensure the sterility of pharmaceutical products manufactured through aseptic processing.
This document discusses co-processed excipients. Excipients are added to active pharmaceutical ingredients to facilitate drug delivery and manufacturing. Co-processing involves combining two or more excipients through solvent dissolution and drying to create new excipients with improved properties. Co-processed excipients can improve flow, compressibility, reduce lubricant sensitivity and provide multiple functionalities from a single excipient. They are evaluated based on parameters like particle size distribution, Carr's index and Hausner ratio. Co-processing offers benefits like improved formulation properties and palatability.
This document provides an introduction to targeted drug delivery and summarizes key points about nanoparticles and liposomes. It discusses advantages of targeted delivery including reducing toxicity and maximizing therapeutic effects. Nanoparticles and liposomes are described as methods for targeted delivery. Key preparation techniques for nanoparticles include solvent evaporation, double emulsification, and nano precipitation. Evaluation parameters like particle size, zeta potential, and in vitro drug release are also summarized. The document concludes with describing applications of liposomes for drug and gene delivery.
The document discusses compendial methods of dissolution testing according to pharmacopoeia standards. It describes the need for dissolution testing to evaluate drug release from solid dosage forms and ensure bioavailability. The key compendial apparatuses discussed are the basket, paddle, flow-through cell, and dissolution testing methods for modified release forms. The document provides details on the components, operating conditions and applications of the various apparatuses specified in pharmacopoeias for testing common oral and other dosage forms.
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
The document discusses biorelevant dissolution media, which aims to simulate conditions in the gastrointestinal tract in vitro in order to predict in vivo drug performance. It notes the development of biorelevant media was necessary because compendial media did not adequately simulate in vivo dissolution. The summary discusses key points about biorelevant media simulating conditions in the stomach, small intestine, and colon. It also mentions factors considered in developing biorelevant media like fluid composition, hydrodynamics, drug properties, and their use in predicting plasma profiles and developing IVIVCs.
The document discusses co-processed excipients, which are combinations of two or more excipients designed to physically modify their properties without chemical change. It defines co-processed excipients and provides examples such as microcrystalline cellulose and mannitol. The document outlines the need for co-processed excipients, their manufacturing principles and processes like spray drying. It also discusses the advantages of co-processed excipients in improving flow properties and compressibility as well as their applications and evaluation parameters.
This document discusses microspheres and microcapsules. It defines microspheres as solid spherical particles ranging from 1-1000μm that can be matrix systems with drug dispersed throughout or reservoir systems with drug enclosed. The document describes various types of microspheres including bioadhesive, magnetic, floating, and radioactive. It also discusses common polymers used and various preparation techniques such as spray drying, solvent evaporation, and polymerization. Finally, the document outlines methods for evaluating properties of microspheres like particle size, drug loading, and in vitro drug release.
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
The document discusses large scale manufacture of emulsions and suspensions. It describes various equipment used such as ball mills, fluid energy mills, cutter mills, and colloidal mills. Quality control tests are outlined for suspensions and emulsions which evaluate parameters like sedimentation volume, rheology, zeta potential, particle size distribution, and response to stress conditions. Colloidal mills are explained in detail. They work by applying shear between a rotor and stator to reduce particle sizes down to 3 microns. Colloidal mills are commonly used to produce suspensions, emulsions, and other products in industries like pharmaceuticals, food, chemicals.
The document summarizes types of tablet coating materials. It discusses the history of tablet coating and principles and objectives of coating tablets. Some key points include:
- Tablet coating provides taste masking, physical/chemical protection, and controlled drug release.
- Common coating materials include polymers like hydroxypropyl methylcellulose and cellulose acetate phthalate, solvents, plasticizers, and colorants.
- Factors like tablet properties, coating composition, and process affect the coating. Tablets must be stable and spherical for optimal coating.
This document discusses microencapsulation. It begins by defining microencapsulation as coating small particles of solids, liquids, or gases to form microcapsules. It then discusses the core material to be coated, coating materials, and dimensions of microcapsules. Advantages and disadvantages of microencapsulation are provided. Various applications are mentioned including immobilizing bioactive compounds and protecting compounds from degradation. The key components and methods for microencapsulation are described at a high level. Finally, release mechanisms and references are briefly touched upon.
This document discusses different coating methods and techniques used in the pharmaceutical industry. It describes:
1) Rotating coating pans and fluidized bed coaters are commonly used to coat tablets by spraying coating solutions and evaporating the liquid. Traditional techniques include sugar coating and film coating.
2) Key steps in sugar coating include sealing, sub coating, smoothing/syrup coating and finishing. Film coating uses similar equipment and parameters as sugar coating.
3) Common coating equipment includes standard coating pans, perforated coating pans, and fluidized bed coaters. Top spray, bottom spray, and tangential spray are fluidized bed coating methods that differ in how the coating solution is applied.
4) Dry particle
Solid state stability and shelf-life assignment, Stability protocols,reports ...Durga Bhavani
This document discusses guidelines for solid state stability and shelf-life assignment studies as outlined by ICH. It provides definitions of stability, the need for stability studies, and factors that influence drug degradation like temperature, moisture, light and interactions. The document outlines the types of studies, including real-time and accelerated stability studies. It discusses stability protocols, reports, and test conditions recommended by ICH to determine a drug's shelf life.
This document discusses dissolution testing of pharmaceutical dosage forms. It describes the types of dissolution apparatuses, including basket, paddle, reciprocating cylinder, flow-through cell, and transdermal cell apparatuses. The key features and uses of each apparatus are outlined. Factors that influence dissolution rate, such as formulation components, processing methods, and test conditions, are also summarized. These include vehicles, diluents, disintegrants, and processing methods like granulation and compression force.
The document discusses drug delivery to the brain by bypassing the blood-brain barrier. It begins with the aim to study approaches to deliver therapeutics across the BBB. It then describes the structure and functions of the BBB, how it restricts drug delivery to the brain, and diseases related to it. Finally, it summarizes invasive, pharmacological, and physiological approaches to bypass the BBB, including marketed formulations that use these approaches.
The document discusses various techniques for improving the solubility and dissolution rate of poorly soluble drug compounds. It defines key terms like solubility, polymorphism, and solid dispersions. It describes three main methods for creating solid dispersions - hot melt method, solvent evaporation method, and hot melt extrusion. These methods aim to molecularly disperse the drug in an inert carrier in order to enhance solubility. The document also discusses other techniques like amorphous forms, solvates, and eutectic mixtures that can improve drug properties.
The document discusses parenteral dosage forms. Parenterals are sterile solutions or suspensions of drugs administered directly into veins, muscles, or under the skin. They do not utilize the alimentary canal and must meet general requirements including stability, sterility, isotonicity, and being free of pyrogens, toxins, and foreign particles. Evaluation tests for parenterals include sterility, pyrogen, clarity, and leakage tests.
The document discusses aseptic processing operations. It describes the characterization of the aseptic process including microbial environmental monitoring, testing of water and air, and media and incubation conditions. The key aspects of the aseptic process are the facility design and control systems, equipment, personnel training, process validation, and finished product testing like sterility testing. Microbiological testing of water, air and media fills is important to ensure the sterility of pharmaceutical products manufactured through aseptic processing.
This document discusses co-processed excipients. Excipients are added to active pharmaceutical ingredients to facilitate drug delivery and manufacturing. Co-processing involves combining two or more excipients through solvent dissolution and drying to create new excipients with improved properties. Co-processed excipients can improve flow, compressibility, reduce lubricant sensitivity and provide multiple functionalities from a single excipient. They are evaluated based on parameters like particle size distribution, Carr's index and Hausner ratio. Co-processing offers benefits like improved formulation properties and palatability.
This document provides an introduction to targeted drug delivery and summarizes key points about nanoparticles and liposomes. It discusses advantages of targeted delivery including reducing toxicity and maximizing therapeutic effects. Nanoparticles and liposomes are described as methods for targeted delivery. Key preparation techniques for nanoparticles include solvent evaporation, double emulsification, and nano precipitation. Evaluation parameters like particle size, zeta potential, and in vitro drug release are also summarized. The document concludes with describing applications of liposomes for drug and gene delivery.
The document discusses compendial methods of dissolution testing according to pharmacopoeia standards. It describes the need for dissolution testing to evaluate drug release from solid dosage forms and ensure bioavailability. The key compendial apparatuses discussed are the basket, paddle, flow-through cell, and dissolution testing methods for modified release forms. The document provides details on the components, operating conditions and applications of the various apparatuses specified in pharmacopoeias for testing common oral and other dosage forms.
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
The document discusses biorelevant dissolution media, which aims to simulate conditions in the gastrointestinal tract in vitro in order to predict in vivo drug performance. It notes the development of biorelevant media was necessary because compendial media did not adequately simulate in vivo dissolution. The summary discusses key points about biorelevant media simulating conditions in the stomach, small intestine, and colon. It also mentions factors considered in developing biorelevant media like fluid composition, hydrodynamics, drug properties, and their use in predicting plasma profiles and developing IVIVCs.
The document discusses co-processed excipients, which are combinations of two or more excipients designed to physically modify their properties without chemical change. It defines co-processed excipients and provides examples such as microcrystalline cellulose and mannitol. The document outlines the need for co-processed excipients, their manufacturing principles and processes like spray drying. It also discusses the advantages of co-processed excipients in improving flow properties and compressibility as well as their applications and evaluation parameters.
This document discusses microspheres and microcapsules. It defines microspheres as solid spherical particles ranging from 1-1000μm that can be matrix systems with drug dispersed throughout or reservoir systems with drug enclosed. The document describes various types of microspheres including bioadhesive, magnetic, floating, and radioactive. It also discusses common polymers used and various preparation techniques such as spray drying, solvent evaporation, and polymerization. Finally, the document outlines methods for evaluating properties of microspheres like particle size, drug loading, and in vitro drug release.
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
The document discusses large scale manufacture of emulsions and suspensions. It describes various equipment used such as ball mills, fluid energy mills, cutter mills, and colloidal mills. Quality control tests are outlined for suspensions and emulsions which evaluate parameters like sedimentation volume, rheology, zeta potential, particle size distribution, and response to stress conditions. Colloidal mills are explained in detail. They work by applying shear between a rotor and stator to reduce particle sizes down to 3 microns. Colloidal mills are commonly used to produce suspensions, emulsions, and other products in industries like pharmaceuticals, food, chemicals.
The document summarizes types of tablet coating materials. It discusses the history of tablet coating and principles and objectives of coating tablets. Some key points include:
- Tablet coating provides taste masking, physical/chemical protection, and controlled drug release.
- Common coating materials include polymers like hydroxypropyl methylcellulose and cellulose acetate phthalate, solvents, plasticizers, and colorants.
- Factors like tablet properties, coating composition, and process affect the coating. Tablets must be stable and spherical for optimal coating.
This document discusses microencapsulation. It begins by defining microencapsulation as coating small particles of solids, liquids, or gases to form microcapsules. It then discusses the core material to be coated, coating materials, and dimensions of microcapsules. Advantages and disadvantages of microencapsulation are provided. Various applications are mentioned including immobilizing bioactive compounds and protecting compounds from degradation. The key components and methods for microencapsulation are described at a high level. Finally, release mechanisms and references are briefly touched upon.
This document discusses different coating methods and techniques used in the pharmaceutical industry. It describes:
1) Rotating coating pans and fluidized bed coaters are commonly used to coat tablets by spraying coating solutions and evaporating the liquid. Traditional techniques include sugar coating and film coating.
2) Key steps in sugar coating include sealing, sub coating, smoothing/syrup coating and finishing. Film coating uses similar equipment and parameters as sugar coating.
3) Common coating equipment includes standard coating pans, perforated coating pans, and fluidized bed coaters. Top spray, bottom spray, and tangential spray are fluidized bed coating methods that differ in how the coating solution is applied.
4) Dry particle
The document discusses tablet coating. It provides information on the types of coatings including film coating, sugar coating, press coating, and functional coatings. It describes the key components of coating formulations which include film formers like hydroxypropyl methylcellulose, solvents, plasticizers, and colorants. The principles and objectives of tablet coating are to protect drugs, mask tastes, control drug release and provide enteric properties. Equipment used includes pan coaters, printing machines for logos.
Tablet coating engineering is one of the prominent topics in pharmaceutical field.
This slide will help pharmacy student to become familiar with coating technology
Tablet coating is done to improve properties like taste, appearance, and drug release. There are several types of coatings including sugar coating, film coating, and enteric coating. Film coating involves spraying a polymer solution onto tablets to form a thin protective film. Important considerations for film coating include the polymer, plasticizer, colorants, and solvent used. Tablet coating is done using specialized coating equipment and any issues during coating like roughness, cracking or color variation must be monitored and addressed.
This document discusses tablet coating, which involves covering tablet surfaces with a polymeric film to provide benefits like masking taste, protecting drugs, and controlling drug release. It describes the main types of tablet coating - sugar coating, film coating, enteric coating, vacuum film coating, electrostatic coating, and dip coating. For each coating type, it outlines the basic process and materials used. The document also explains the need for tablet coating and lists the ideal characteristics of coating materials.
This presentation includes information related to the different technologies used for preparation of micro-capsules and also their evaluation parameters.
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.
Microencapsulation is a process of coating solid, liquid, or gaseous materials in tiny capsules or spheres ranging from 1 micron to 1000 microns in size. There are several methods of microencapsulation including air suspension, pan coating, spray drying, solvent evaporation, and spray congealing. These methods involve dispersing an active core material in a coating solution or melt and applying the coating as it solidifies through solvent evaporation, cooling, or thermal congealing to form microcapsules. Microencapsulation is used for various purposes like taste masking, controlled release, protecting unstable materials, and targeted delivery of drugs or nutrients.
Microencapsulation is a process in which tiny particles or droplets are surrounded by a coating to give small capsules, of many useful properties. In general, it is used to incorporate food ingredients, enzymes, cells or other materials on a micro metric scale.
Hot melt adhesives are thermoplastic polymers that become liquid when heated above 80-220°C and solidify when cooled. They are applied in liquid state without solvents or water, allowing for precise application. Common polymers used include styrene copolymers, polyamides, and polyacrylates. Hot melts have advantages like being solvent-free, producing less waste, and allowing for adjustment of viscosity through temperature variation.
This document discusses factors that influence gloss control in radiation curable coatings. It investigates various process conditions and formulation parameters to identify the dominant factors for controlling gloss. Key parameters studied include UV energy dose, irradiance, photoinitiator level, and curing temperature. The results show that photoinitiator level is the most influential parameter, with an optimum level existing where gloss is minimally affected by irradiance. Higher UV energy dose and temperature also decrease gloss by providing more energy to the coating.
Tablet coating is the application of a coating material to the exterior of a tablet to confer benefits over uncoated tablets. Common purposes are to mask taste/odor, protect drugs from environmental factors or gastric acid, and control drug release. Major types are sugar coating, film coating, enteric coating, and press coating. Film coating involves spraying a polymer solution onto tablets while sugar coating is a multistage process including sealing, subcoating, smoothing, coloring and polishing. Standard pans and perforated pans are commonly used coating equipment.
This document discusses various aspects of tablet coating. It begins by defining coated tablets and describing the main objectives of tablet coating as related to therapy, technology, and marketing. It then discusses different coating techniques like sugar coating, film coating, enteric coating, and other advanced techniques. The document also covers coating materials like polymers, plasticizers, colorants, and solvents used in various coating methods. It provides details on the coating process and factors affecting the choice of coating materials.
This document provides an overview of tablet coating. It discusses the historical development of tablet coating from the 16th century to modern developments. The objectives and benefits of tablet coating are to mask taste/color, provide protection, control drug release, and improve appearance. The major types of coating processes and equipment discussed are conventional coating pans, perforated pans, and fluidized bed coaters. Key parameters that affect the coating process like air flow, temperature, and spray application are also covered. The document concludes by describing sugar coating and film coating methods in detail.
Easy & to the point Topics are clearly given in this presentation..
Thanks & Best Regard
(Anurag Pandey) B.Pharm
Contact :- anurag.dmk05@gmail.com (Facebook & Gmail both)
The document discusses tablet coating technology and processes. It begins by outlining the objectives of tablet coating, such as masking taste or odor, providing physical protection, and controlling drug release. It then describes various coating equipment like standard coating pans, perforated coating pans, and fluidized bed systems. The coating processes of sugar coating, film coating, and enteric coating are explained. Finally, potential film defects in tablet coating like sticking, roughness, capping, and cracking are reviewed along with methods to prevent or correct them.
This document discusses liquid penetrant inspection (LPI), a non-destructive testing method used to locate surface-breaking defects. It describes the 6 key steps of LPI: 1) pre-cleaning the surface, 2) applying penetrant, 3) removing excess penetrant, 4) applying developer, 5) inspection under UV or white light, and 6) post-cleaning. It also covers the principles of LPI, properties required for good penetrants and developers, types of penetrants, and provides examples of LPI applications and limitations.
Polymer coatings can be applied through various methods like dip coating, spin coating, fluidized bed coating, roll coating, calendering, and transfer coating. These coating methods allow for the application of protective and decorative polymer layers to substrates through techniques such as submerging, rolling, spraying, or transferring coated films. The coating method used depends on factors like the substrate material, desired coating thickness and properties, and production efficiency.
Enteric coating of pharmaceutical productsAshish Garg
1) Enteric coating is used to protect drugs from gastric fluid and release them in the intestines. It uses polymers that are insoluble in acid but dissolve in basic pH.
2) Common enteric coating polymers include polymethacrylates, cellulose esters, and polyvinyl derivatives. They require plasticizers to make the coating flexible and prevent premature drug release in acid.
3) Factors like coating temperature, coating method, and storage conditions must be carefully controlled to ensure a uniform coating layer and stable drug release.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
2. SOLVENTLESS COATING:
solventless coating avoids the use of water/solvent or it reduces to very small
amounts and hence it overcomes limitation of conventional coating such as need for
time, energy consuming, drying steps.
RATIONALE:
Organic solvents used in liquid coating are flammable and toxic.
Solvent residue in the formulation.
High cost of solvents.
Strict environmental and occupational safety regulations.
Heat and water involved in coating process can degrade the drug.
Validation of coating dispersion for controlling microbial presence.
Solvent removal process is time consuming and requires more energy.
4. COMPRESSION COATING:
PROCESS OF COATING:
o Punches form cup of coating material in lower die.
o Drug is filled in that cup using another modified punch.
o Coating material is compressed on the cup.
MECHANISM:
o The core containing active pharmaceutical ingredients is
compacted with granular materials.
COMPRESSIBLE EXCIPIENTS:
Mcc, lactose, mannitol….
ADVANTAGES:
Two or more dosage forms can be physically seperated
producing tablet with in a tablet.
DISADVANTAGES:
Mechanical complexity, difficult to place the core exactly in
the center of the tablet.
5. MAGNETICALLY ASSISTED IMPACTION COATING:
The magnetically assisted impaction coating devices can coat
soft organic host and guest particles without causing major
changes in the material shape and size.
MECHANISM:
o Excitation of magnetic particles
o Deagglomeration of guest particles
o Spreading and shearing of guest particles on the surface of
the host particles
o The interaction of magnetic host-host-particles
o Magnetic host wall interaction
o Formation of coated products
ADVANTAGES:
Rise in temperature is negligible.
Most suitable for temperature sensitive materials.
6. HOT- MELT COATING:
o In hot melt coating method, the coating material is applied in its molten state on the substrate
then solidified by cooling.
o The necessity of the application of any solvent is fully eliminated.
o The choice of the coating excipients depends primarily on its function (e.g., retarding the drug-
release rate, preventing environmental degradation and masking unpalatable taste) in the
dosage form.
Hot melt coating
Fluidized bed coating Spray coating Pan coating
7. “
”
SUPERCRITICAL FLUID COATING:
o In this method, the coating material is dissolved in supercritical CO2 (has liquid like density &
solvating power, gas like transport properties, low critical temperatue - 31C, pressure - 74 bar) in
which the drug particles are dispersed. The solvent power of CO2 is gradually reduced to enable the
coating material to precipitate onto drug particles.
Advantages:
o Prevent agglomeration of fine particles.
Disadvantages:
o Requirement of core to be soluble.
8. POWDER/DRY COATING:
PROCESSES:
1. Electrostatic spraying
2. Fluidized bed
3. Electrostatic fluidized bed
4. Flame spray
METHODS:
1. Plasticizer dry coating- adhesion by wetting with plasticizer
2. Heat dry coating- Eudragit E-PO particles were continuously spread onto the tablet
3. Electrostatic dry coating- spraying of a mixture of finely grounded particles and polymers on to a
substrate surface
4. Plasticizer electrostatic heat dry coating-combination of plasticizer, Heat dry, electrostatic dry coating
9. PHOTOCURABLE COATING:
Photo curing is a chemical approach proposed to rapidly coat tablets at or below room
temperature with an extremely rapid rate.
Major components:
o UV/Visible light source.-efficient in rupturing chemical bonds
o Pre-polymers or monomers-siloxanes and enethiols
o Photo initiators-unsaturated compounds
o Poreforming agents-lactose,sodium chloride
Advantages:
This process can be performed under room temperature.
Disadvantage:
Not suitable for photosensitive drugs.
10. MACHINERY USED FOR SOLVENTLESS COATING:
o Silicon coating machine
o Solvent less laminating machines
o Extrusioncoating machines
o Hot melt coating machines
o Pressure sensitive coating machine
o 5-roll coating machine
o Dry laminating machine
11. CONCLUSION:
The solventless coating techniques mentioned above exterminate numerous drawbacks accomplying with the
conventional solvent based coating mechanism.
Although these methods have greater assistance than conventional coating methods, before commercialization of
these methods further work should be focused on scale-up tests, functional detection of coated solid dosage forms
such as drug release profile and clinical tests to make them more useful, cost effective and safe.
REFERENCES:
Solventless coating-A pliable Technique for future coating prospects, Palllavi.k*, B.Gayathri, K.Chandralekha,
K.Tejaswi, Vignan Pharmacy college, Vadlamudi,Guntur.Pharma Times-vol.47-no.12-december-2015.
Solventless coating for tablets :An alternative to conventional coating technique, Manish Jaimini*,Arpit jain,
Sanjay K.Sharma, Shailender Mohan. Jaipur college of pharmacy,ISI-15,RIICO,Jaipur,Indian journal of
pharmaceutical and Biological research(IJPBR).issue 2,2014.
Review solventless coating technology , Hardhik L.patel*,Hiren B.patel, Chandrababu davuluri, Moin
K.Modasiya. American Journal of Pharmtech Research,vol-1,issue4,2011.