This document discusses coloring agents used in pharmaceuticals. It notes that color is important for identification during manufacturing and distribution, and that patients use color to recognize medications and dosages. It describes types of colorants approved in different regions, including FD&C and D&C colorants in the US. FD&C colorants can be dyes or lakes, with lakes being insoluble pigments and dyes being water-soluble. The document also discusses considerations for colorant selection, including stability, particle size, and shade. Preservatives are discussed as substances that prevent microbial growth in pharmaceutical preparations. Common preservatives and their appropriate uses and concentrations are provided.
Colorants or coloring agents are mainly used to impart a distinctive appearance to the pharmaceutical dosage forms.
We can also say that the colorants are the cosmetics for the pharmaceutical preparations, because the aesthetic appearance of dosage forms can be enhanced by using suitable colorants.
Tablet excipients serve several important functions in tablet manufacturing including improving properties like flow, stability, and bioavailability. Common excipients include diluents, binders, disintegrants, and lubricants. Tablets can be classified based on their route of administration, drug delivery system, and manufacturing method. Key types include compressed, enteric coated, chewable, sublingual, and effervescent tablets. Excipients allow tablets to be designed for rapid or delayed drug release depending on the therapeutic need.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
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.
Excipients are inactive substances formulated with active pharmaceutical ingredients to create drug products. They serve important purposes like bulking up formulations, ensuring consistent drug release and stability, and determining properties of the final dosage form like tablet size and dissolution rate. Common excipients include diluents, binders, disintegrants, lubricants, and glidants. Diluents increase volume and include substances like lactose, starch and calcium phosphate. Binders promote adhesion while disintegrants facilitate breaking of tablets. Lubricants prevent adhesion during compression and glidants promote powder flow. Proper excipient selection is crucial for an efficacious and robust drug product.
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
Pharmaceutical excipients are inert substances included in drug products that alter the functions and properties of active pharmaceutical ingredients. Excipients convert active compounds into suitable dosage forms and are essential for acceptable drug delivery. They aid manufacturing, protect drugs, enhance stability and bioavailability, and improve patient acceptability. Excipients are classified based on their functionality, origin, physical form, and route of administration. Careful consideration of excipient selection is important to avoid interactions that could compromise drug stability, effectiveness, or safety.
Colorants or coloring agents are mainly used to impart a distinctive appearance to the pharmaceutical dosage forms.
We can also say that the colorants are the cosmetics for the pharmaceutical preparations, because the aesthetic appearance of dosage forms can be enhanced by using suitable colorants.
Tablet excipients serve several important functions in tablet manufacturing including improving properties like flow, stability, and bioavailability. Common excipients include diluents, binders, disintegrants, and lubricants. Tablets can be classified based on their route of administration, drug delivery system, and manufacturing method. Key types include compressed, enteric coated, chewable, sublingual, and effervescent tablets. Excipients allow tablets to be designed for rapid or delayed drug release depending on the therapeutic need.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
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.
Excipients are inactive substances formulated with active pharmaceutical ingredients to create drug products. They serve important purposes like bulking up formulations, ensuring consistent drug release and stability, and determining properties of the final dosage form like tablet size and dissolution rate. Common excipients include diluents, binders, disintegrants, lubricants, and glidants. Diluents increase volume and include substances like lactose, starch and calcium phosphate. Binders promote adhesion while disintegrants facilitate breaking of tablets. Lubricants prevent adhesion during compression and glidants promote powder flow. Proper excipient selection is crucial for an efficacious and robust drug product.
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
Pharmaceutical excipients are inert substances included in drug products that alter the functions and properties of active pharmaceutical ingredients. Excipients convert active compounds into suitable dosage forms and are essential for acceptable drug delivery. They aid manufacturing, protect drugs, enhance stability and bioavailability, and improve patient acceptability. Excipients are classified based on their functionality, origin, physical form, and route of administration. Careful consideration of excipient selection is important to avoid interactions that could compromise drug stability, effectiveness, or safety.
Pharmaceutical syrups are concentrated aqueous preparations containing 85% sugar or sugar substitute, with or without flavorings and active medicinal substances. They provide an easy to administer oral liquid dosage form. Syrups are prepared through various methods including solution with heat, agitation without heat, addition of sucrose to liquid medicaments, or percolation. They contain components like sweeteners, preservatives, viscosity modifiers, flavorings, and colorants. Syrups offer advantages like suitability for all ages and easy administration but have disadvantages like delayed onset of action and unsuitability for some patients. Proper packaging is also required to ensure the quality and safety of syrup products.
Aerosols Valve assembly & types of containersUnnati Garg
This presentation discusses types of containers and valve assemblies used in aerosol pharmaceutical technology. It describes common container materials like glass, tin-plated steel, aluminum and stainless steel, and limitations on maximum pressure and temperature for each. Glass containers are preferred for aesthetics and compatibility, while metals are stronger but heavier. The presentation also explains continuous spray valves and metering valves, how they work, and their uses for topical vs potent medications.
This document discusses various types of pharmaceutical excipients used in drug formulations. It defines excipients as pharmacologically inactive substances formulated alongside active pharmaceutical ingredients. Excipients provide bulk, facilitate drug absorption and stability, aid manufacturing, and improve handling. Common excipients include fillers, binders, disintegrants, coatings, preservatives, antioxidants, and solvents. Each excipient type has distinct functions and ideal properties. Proper excipient selection is important to ensure drug efficacy, stability, safety, and to avoid complications.
Tablet defects can come from any of the unit operations upstream and from the tablet press. The raw materials may be of poor quality or do not meet specifications, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material does not compress well or the processing step specified within the formulation fail to produce a powder with a good flow, compressibility, and ejection properties. The processing and granulation of powder are often the sources of the defect.
Every product behaves differently on a tablet press, even if it‘s the same product run on a different day. The variation often
stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally,
the goal is to minimize these changes. Tablet press operators, however, don‘t have any control over formulation and
granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems.
The document discusses diluents and disintegrants used in tablet formulations. It defines diluents as fillers that increase bulk and provide improved flow and compression properties. Common diluents include lactose, microcrystalline cellulose, starch, and calcium phosphates. Disintegrants help break up tablets and increase drug dissolution. Examples listed include starch, pregelatinized starch, microcrystalline cellulose, alginates, and ion exchange resins. The document outlines the ideal properties, classifications, advantages and disadvantages of both diluents and disintegrants.
Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.
Tablet coating serves several purposes: to mask unpleasant tastes, protect medications from environmental factors like light and moisture, control drug release, and improve appearance. There are several types of coatings including sugar, film, enteric, and press coatings. The sugar coating process involves multiple steps like sealing, sub-coating, syruping, finishing, and polishing to build up the coating and impart the desired color, texture, and shine. Skill is required during syruping to smoothly cover imperfections and apply color uniformly.
The document summarizes the specific roles of various excipients used in tablet production, including diluents, binders, disintegrants, lubricants, glidants, coloring agents, sweetening agents, and coating agents. It describes the mechanisms by which each excipient functions and provides examples. Key excipients discussed include lactose, microcrystalline cellulose, starch, polyvinyl pyrrolidone, sodium starch glycolate, talc, magnesium stearate, silicon dioxide, ferric oxide, sucrose, methyl cellulose, ethyl cellulose, and hydroxypropyl methylcellulose.
This document discusses common manufacturing defects that can occur during tablet production such as picking and sticking, capping and lamination, mottling, double impression, poor mixing, poor flow, weight variation, and hardness variation. For each defect, the document provides the reason for why the defect occurs and recommendations for how to correct the issue, such as using properly designed punches, adequate drying, uniform granule size distribution, and controlling punch movement. The overall goal of the document is to outline typical tablet defects, their causes, and methods for prevention.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, and filling steps. It also discusses advantages like taste masking and disadvantages like incompatibility with hygroscopic drugs. Quality control tests for capsules include disintegration, weight variation, and dissolution testing.
Capsules are solid dosage forms that contain a drug enclosed within a hard or soft soluble shell, usually made of gelatin. There are two main types: hard gelatin capsules, which consist of two pieces that are joined, and soft gelatin capsules, which have a soft, one-piece shell. Capsules offer benefits like being tasteless, odorless, and easy to administer, and allow for flexible dosing. However, some drugs are not suitable for capsules due to stability issues. Capsules are manufactured through various processes depending on the type, including dipping, spinning, drying, filling, and sealing. They must pass quality tests like weight variation and content uniformity testing.
This document provides information about tablets, including their definition, advantages, types, and manufacturing process. It begins with definitions of tablets from pharmacopoeias and discusses how they are the most popular dosage form, comprising 70% of pharmaceutical preparations. It describes various types of tablets including compressed, sugar-coated, film-coated, enteric-coated, and effervescent tablets. The document outlines the tablet manufacturing process using tableting machines and discusses characteristics and specifications of compressed tablets.
This document defines tablet diluents and describes the properties and purposes of common diluents lactose and calcium phosphate. It states that diluents are used to increase tablet bulk and weight while allowing direct compression manufacturing. Key properties of diluents include being inert, non-toxic, and not affecting drug bioavailability. Common diluents are classified as organic like lactose or inorganic like calcium phosphate. Lactose is the most widely used diluent and comes in several forms with different properties for tableting. Calcium phosphate and tribasic calcium phosphate are also described as inexpensive inorganic diluents.
The document discusses common defects that can occur during the tablet coating process and their potential causes and remedies. It describes defects such as blistering from overheating, chipping from high attrition, cratering from excessive coating solution, and pitting from excess core heating. Solutions include modifying drying conditions, adjusting coating formulations, and optimizing machine operating parameters. An understanding of tablet formulations and coating processes is necessary to identify and address coating defects.
This document discusses common tablet processing problems and their remedies. It describes visual defects like capping, lamination, cracking, chipping, sticking, picking, and binding that can occur during tablet manufacturing. The causes of each defect are explained in terms of formulation issues like moisture content, binder amount, granule size, and machine issues like die wear, concavity, and speed. Solutions provided include optimizing the formulation through proper drying, lubrication, and binder selection, as well as adjusting machine settings like tapered dies, lubricated punches, and reduced speed or pressure. Overall, the document aims to help industrial pharmacists address problems in tablet manufacturing.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
This document discusses different types of suspending agents used in pharmaceutical formulations. It classifies suspending agents into polysaccharides, inorganic salts, and synthetic compounds. Some examples of polysaccharides agents include acacia, tragacanth, and starches. Common inorganic salts are bentonite, aluminum magnesium silicate, and aluminum hydroxide. Synthetic agents include carbomers and colloidal silicon dioxide. Suspending agents help stabilize suspensions by increasing viscosity and slowing particle sedimentation according to Stokes' law. They prevent caking and can be resuspended with agitation.
This document discusses liquid oral dosage forms, specifically oral solutions and suspensions. It provides details on the formulation, ingredients, advantages, and types of oral solutions and suspensions. Key points include:
- Oral solutions are liquid preparations where the active ingredient and excipients are dissolved in a solvent system. Common types are oral solutions, syrups, elixirs, and mouthwashes.
- Excipients in oral solutions include vehicles, co-solvents, surfactants, preservatives, sweeteners, and viscosity modifiers. Water is a common vehicle and glycerol, alcohols, and propylene glycol are used as co-solvents.
- Oral suspensions are dispers
This document discusses the design and formulation of capsules. It begins by defining capsules and describing their history. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have two pieces and typically contain powders, granules or pellets, while soft gelatin capsules are one piece and sealed and can contain liquids or suspensions. The document goes on to cover the advantages and disadvantages of capsules, as well as the formulation of the gelatin shell and capsule contents for both hard and soft gelatin capsules. Key components include gelatin, plasticizers, colorants, fillers and various other excipients.
This document summarizes colors used in cosmetics. It discusses regulatory bodies that classify and approve color additives. Colors are classified as either organic or inorganic, and as subject to certification or exempt. Both natural and synthetic colors are permitted. Common natural colors discussed include annatto, beta-carotene, caramel, carmine, chlorophyllin copper complex, henna and guanine. Inorganic colors like mica, titanium dioxide, iron oxides and zinc oxide are also summarized. Specific regulations around various certified colors are provided in tables. Henna is highlighted for its hair coloring properties from Lawsonia inermis leaves.
The document provides information on liquid oral dosage forms. It discusses monophasic and biphasic liquid dosage forms, as well as the vehicles, excipients, and formulation considerations involved in producing liquid oral medications. Specifically, it covers emulsions, suspensions, syrups, and elixirs - the main types of liquid oral dosage forms. It also addresses the advantages and disadvantages of liquid dosage forms, as well as best practices for manufacturing, evaluating, and packaging these drug formulations.
Pharmaceutical syrups are concentrated aqueous preparations containing 85% sugar or sugar substitute, with or without flavorings and active medicinal substances. They provide an easy to administer oral liquid dosage form. Syrups are prepared through various methods including solution with heat, agitation without heat, addition of sucrose to liquid medicaments, or percolation. They contain components like sweeteners, preservatives, viscosity modifiers, flavorings, and colorants. Syrups offer advantages like suitability for all ages and easy administration but have disadvantages like delayed onset of action and unsuitability for some patients. Proper packaging is also required to ensure the quality and safety of syrup products.
Aerosols Valve assembly & types of containersUnnati Garg
This presentation discusses types of containers and valve assemblies used in aerosol pharmaceutical technology. It describes common container materials like glass, tin-plated steel, aluminum and stainless steel, and limitations on maximum pressure and temperature for each. Glass containers are preferred for aesthetics and compatibility, while metals are stronger but heavier. The presentation also explains continuous spray valves and metering valves, how they work, and their uses for topical vs potent medications.
This document discusses various types of pharmaceutical excipients used in drug formulations. It defines excipients as pharmacologically inactive substances formulated alongside active pharmaceutical ingredients. Excipients provide bulk, facilitate drug absorption and stability, aid manufacturing, and improve handling. Common excipients include fillers, binders, disintegrants, coatings, preservatives, antioxidants, and solvents. Each excipient type has distinct functions and ideal properties. Proper excipient selection is important to ensure drug efficacy, stability, safety, and to avoid complications.
Tablet defects can come from any of the unit operations upstream and from the tablet press. The raw materials may be of poor quality or do not meet specifications, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material does not compress well or the processing step specified within the formulation fail to produce a powder with a good flow, compressibility, and ejection properties. The processing and granulation of powder are often the sources of the defect.
Every product behaves differently on a tablet press, even if it‘s the same product run on a different day. The variation often
stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally,
the goal is to minimize these changes. Tablet press operators, however, don‘t have any control over formulation and
granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems.
The document discusses diluents and disintegrants used in tablet formulations. It defines diluents as fillers that increase bulk and provide improved flow and compression properties. Common diluents include lactose, microcrystalline cellulose, starch, and calcium phosphates. Disintegrants help break up tablets and increase drug dissolution. Examples listed include starch, pregelatinized starch, microcrystalline cellulose, alginates, and ion exchange resins. The document outlines the ideal properties, classifications, advantages and disadvantages of both diluents and disintegrants.
Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.
Tablet coating serves several purposes: to mask unpleasant tastes, protect medications from environmental factors like light and moisture, control drug release, and improve appearance. There are several types of coatings including sugar, film, enteric, and press coatings. The sugar coating process involves multiple steps like sealing, sub-coating, syruping, finishing, and polishing to build up the coating and impart the desired color, texture, and shine. Skill is required during syruping to smoothly cover imperfections and apply color uniformly.
The document summarizes the specific roles of various excipients used in tablet production, including diluents, binders, disintegrants, lubricants, glidants, coloring agents, sweetening agents, and coating agents. It describes the mechanisms by which each excipient functions and provides examples. Key excipients discussed include lactose, microcrystalline cellulose, starch, polyvinyl pyrrolidone, sodium starch glycolate, talc, magnesium stearate, silicon dioxide, ferric oxide, sucrose, methyl cellulose, ethyl cellulose, and hydroxypropyl methylcellulose.
This document discusses common manufacturing defects that can occur during tablet production such as picking and sticking, capping and lamination, mottling, double impression, poor mixing, poor flow, weight variation, and hardness variation. For each defect, the document provides the reason for why the defect occurs and recommendations for how to correct the issue, such as using properly designed punches, adequate drying, uniform granule size distribution, and controlling punch movement. The overall goal of the document is to outline typical tablet defects, their causes, and methods for prevention.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, and filling steps. It also discusses advantages like taste masking and disadvantages like incompatibility with hygroscopic drugs. Quality control tests for capsules include disintegration, weight variation, and dissolution testing.
Capsules are solid dosage forms that contain a drug enclosed within a hard or soft soluble shell, usually made of gelatin. There are two main types: hard gelatin capsules, which consist of two pieces that are joined, and soft gelatin capsules, which have a soft, one-piece shell. Capsules offer benefits like being tasteless, odorless, and easy to administer, and allow for flexible dosing. However, some drugs are not suitable for capsules due to stability issues. Capsules are manufactured through various processes depending on the type, including dipping, spinning, drying, filling, and sealing. They must pass quality tests like weight variation and content uniformity testing.
This document provides information about tablets, including their definition, advantages, types, and manufacturing process. It begins with definitions of tablets from pharmacopoeias and discusses how they are the most popular dosage form, comprising 70% of pharmaceutical preparations. It describes various types of tablets including compressed, sugar-coated, film-coated, enteric-coated, and effervescent tablets. The document outlines the tablet manufacturing process using tableting machines and discusses characteristics and specifications of compressed tablets.
This document defines tablet diluents and describes the properties and purposes of common diluents lactose and calcium phosphate. It states that diluents are used to increase tablet bulk and weight while allowing direct compression manufacturing. Key properties of diluents include being inert, non-toxic, and not affecting drug bioavailability. Common diluents are classified as organic like lactose or inorganic like calcium phosphate. Lactose is the most widely used diluent and comes in several forms with different properties for tableting. Calcium phosphate and tribasic calcium phosphate are also described as inexpensive inorganic diluents.
The document discusses common defects that can occur during the tablet coating process and their potential causes and remedies. It describes defects such as blistering from overheating, chipping from high attrition, cratering from excessive coating solution, and pitting from excess core heating. Solutions include modifying drying conditions, adjusting coating formulations, and optimizing machine operating parameters. An understanding of tablet formulations and coating processes is necessary to identify and address coating defects.
This document discusses common tablet processing problems and their remedies. It describes visual defects like capping, lamination, cracking, chipping, sticking, picking, and binding that can occur during tablet manufacturing. The causes of each defect are explained in terms of formulation issues like moisture content, binder amount, granule size, and machine issues like die wear, concavity, and speed. Solutions provided include optimizing the formulation through proper drying, lubrication, and binder selection, as well as adjusting machine settings like tapered dies, lubricated punches, and reduced speed or pressure. Overall, the document aims to help industrial pharmacists address problems in tablet manufacturing.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
This document discusses different types of suspending agents used in pharmaceutical formulations. It classifies suspending agents into polysaccharides, inorganic salts, and synthetic compounds. Some examples of polysaccharides agents include acacia, tragacanth, and starches. Common inorganic salts are bentonite, aluminum magnesium silicate, and aluminum hydroxide. Synthetic agents include carbomers and colloidal silicon dioxide. Suspending agents help stabilize suspensions by increasing viscosity and slowing particle sedimentation according to Stokes' law. They prevent caking and can be resuspended with agitation.
This document discusses liquid oral dosage forms, specifically oral solutions and suspensions. It provides details on the formulation, ingredients, advantages, and types of oral solutions and suspensions. Key points include:
- Oral solutions are liquid preparations where the active ingredient and excipients are dissolved in a solvent system. Common types are oral solutions, syrups, elixirs, and mouthwashes.
- Excipients in oral solutions include vehicles, co-solvents, surfactants, preservatives, sweeteners, and viscosity modifiers. Water is a common vehicle and glycerol, alcohols, and propylene glycol are used as co-solvents.
- Oral suspensions are dispers
This document discusses the design and formulation of capsules. It begins by defining capsules and describing their history. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have two pieces and typically contain powders, granules or pellets, while soft gelatin capsules are one piece and sealed and can contain liquids or suspensions. The document goes on to cover the advantages and disadvantages of capsules, as well as the formulation of the gelatin shell and capsule contents for both hard and soft gelatin capsules. Key components include gelatin, plasticizers, colorants, fillers and various other excipients.
This document summarizes colors used in cosmetics. It discusses regulatory bodies that classify and approve color additives. Colors are classified as either organic or inorganic, and as subject to certification or exempt. Both natural and synthetic colors are permitted. Common natural colors discussed include annatto, beta-carotene, caramel, carmine, chlorophyllin copper complex, henna and guanine. Inorganic colors like mica, titanium dioxide, iron oxides and zinc oxide are also summarized. Specific regulations around various certified colors are provided in tables. Henna is highlighted for its hair coloring properties from Lawsonia inermis leaves.
The document provides information on liquid oral dosage forms. It discusses monophasic and biphasic liquid dosage forms, as well as the vehicles, excipients, and formulation considerations involved in producing liquid oral medications. Specifically, it covers emulsions, suspensions, syrups, and elixirs - the main types of liquid oral dosage forms. It also addresses the advantages and disadvantages of liquid dosage forms, as well as best practices for manufacturing, evaluating, and packaging these drug formulations.
Alfa Chemistry offers a variety of synthetic chemical APIs which can be used in the pharmaceutical preparation. In addition, we offer pre-formulation drug discovery, formulation and process development, custom synthesis, and scale up services. Learn more at https://www.alfa-api.com/.
The document provides information about synthetic food colors. It discusses approved food color dyes and their classification. It also details the advantages of synthetic food colors compared to natural dyes. However, it notes some adverse effects from heavy metals that may be present in food colors like lead, mercury, and arsenic. The document gives permissible limits for these metals set by regulatory agencies. It includes a schematic diagram of the manufacturing process for azo food colors and provides examples of some commonly used mono azo dyes with their chemical structures and intermediates.
Impurities ICH Q3 Guidelines Au Vivek JainVivek Jain
This document provides an overview of ICH Q3 guidelines for impurities in pharmaceutical products. It defines impurities and discusses the objectives of controlling impurities. It describes different types of impurities including organic, inorganic, and residual solvents. It outlines ICH Q3A-Q3D guidelines and definitions related to impurities and degradation products. It also discusses thresholds for identifying, reporting, and qualifying degradation products in new drug products.
This document discusses liquid oral solutions, including their definition, types, advantages, disadvantages and formulation considerations. Key points include:
- Pharmaceutical solutions are homogeneous liquid preparations where the API and excipients are dissolved in a solvent system. Common types include oral, otic, ophthalmic, topical and parenteral solutions.
- Advantages include flexible dosing, easier swallowing and rapid onset of action. Disadvantages include potential issues with drug and excipient stability, taste masking and accuracy.
- Important formulation considerations for solutions include the solvent, preservatives, antioxidants, coloring agents, buffers, sweetening agents and other excipients to modify properties like viscosity, density and isot
ANTIMICROBIAL AGENTS USED AS PRESERVATIVES.pptxDivya Pushp
Preservativeis a substance or chemical that is added to cosmetic product to prevent decomposition by microbial growth or by undesirable chemical changes.
The document discusses various bleaching agents used in dental practice including hydrogen peroxide, sodium perborate, carbamide peroxide, and over-the-counter products. It provides details on the composition, mechanisms of action, concentrations used, and factors that influence the bleaching process such as temperature, pH, time, and a sealed environment. Concerns are raised about the availability and lack of regulation of over-the-counter bleaching kits.
The demand for specialty chemicals is increasing many fold due to the rising market of the pharmaceutical chemicals and fine chemicals. Chemcon Speciality Chemicals Pvt. Ltd. strives to be a market leader in domestic and global market to satiate the world wide demand for specialty chemicals and pharma intermediates like Chloromethyl Isopropyl Carbonate (CMIC) and Hexamethyl Disilazane (HMDS) which have a variety of applications and uses.
Sources and Types of Impurities by Professor BeubenzProfessor Beubenz
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Producing pigments or colors for food and beverage industries is a difficult task as it is necessary for the pigments to go well, first with the nutritional value and second with the flavor of the food or drink. https://bit.ly/3r9cnht
The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients
(APIs) or develop during formulation or upon aging of both API and formulation.
The document discusses the detection of toxic industrial dyes in imported foods. It provides details on the analytical methods used to identify dyes like Rhodamine B, which is a banned textile dye that is sometimes found in foods. Specifically, it outlines the process of paper and thin-layer chromatography to separate dyes and identify them by comparison to standards. It also discusses liquid chromatography-mass spectrometry methods used to detect Rhodamine B in samples by analyzing its fragmentation pattern. Several examples are given of Rhodamine B being found in foods in different countries in violation of regulations.
The document discusses the development of monographs for the Indian Pharmacopoeia. It outlines the Indian Pharmacopoeia Commission's vision of promoting high drug quality standards for medicines used in India. It describes the objectives in creating monographs that reflect India's pharmaceutical industry capabilities while safeguarding smaller manufacturers. The document provides guidance on the formats, contents and quality standards considered for monographs in different categories like active pharmaceutical ingredients, excipients, dosage forms and other drug products.
Preservatives are used in cosmetics to prevent spoilage from oxidation, microbial growth, and other causes of deterioration. There are several classes of preservatives used including organic acids, alcohols, aldehydes, phenolic compounds, esters, mercury compounds, surfactants, and miscellaneous agents. The effectiveness of preservatives can be affected by factors like pH, concentration, and ingredients in the cosmetic formulation. Guidelines for preservative selection include identifying materials that promote microbial growth and choosing the least toxic preservative. Some potential adverse effects of certain preservatives include skin irritation and allergic reactions.
This document discusses films and strips for pharmaceutical formulations. It begins by introducing oral dissolving and transdermal films, then discusses the advantages of oral soluble thin films which include larger surface area, precision dosing, and improved patient compliance. Manufacturing methods for films are also covered, such as solvent casting and hot melt extrusion. The document provides examples of drugs that can be formulated into films and lists technologies used to produce oral delivery films. It concludes by discussing formulation aspects of orodispersible films including active ingredients, sweetening agents, and flavors.
The document discusses impurities in pharmaceutical substances and limit tests. It provides context on the history of pharmacopoeias and defines impurities as unwanted chemicals that can remain with active pharmaceutical ingredients or develop during formulation. Potential sources and types of impurities are discussed.
Key limit tests for common impurities like chloride, sulfate, iron, and heavy metals are described. The principles, reactions, procedures, observations and reasons for the tests are explained. Limit tests are designed to identify and control small quantities of impurities using quantitative or semi-quantitative comparisons. The document emphasizes that even small amounts of impurities can impact product quality, efficacy, and patient safety.
Profitable Business Ideas that’ll make you MillionaireAjjay Kumar Gupta
Profitable Business Ideas that’ll make you Millionaire. List of Businesses with huge Profits
Anhydrous Ferric Chloride
Iron (III) chloride (Ferric Chloride, FeCl3) has been used in the synthesis of Au/Fe nanoparticles. It has been used as oxidative etching agent during the preparation of platinum nanostructures. Iron (III) chloride, also called ferric chloride, is an industrial scale commodity chemical compound, with the formula FeCl3 and with iron in the +3 oxidation state.
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Viruses are obligate intracellular parasites that infect all types of cells. They consist of nucleic acid surrounded by a protein coat and in some cases an envelope. Viruses hijack the host cell's machinery to replicate themselves and are then released to infect new host cells. There are many variations in the viral life cycle depending on whether the virus has DNA or RNA as its genome and whether it is enveloped. Viruses are classified based on their structure, composition and genetics.
Mycology is the branch of biology concerned with the study of fungi, including their genetic and biochemical properties, their taxonomy and their use to humans as a source for tinder, traditional medicine, food, and entheogens, as well as their dangers, such as toxicity or infection.
In the late 16th century several Dutch lens makers designed devices that magnified objects, but in 1609 Galileo Galilei perfected the first device known as a microscope. Dutch spectacle makers Zaccharias Janssen and Hans Lipperhey are noted as the first men to develop the concept of the compound microscope.
In the late 16th century several Dutch lens makers designed devices that magnified objects, but in 1609 Galileo Galilei perfected the first device known as a microscope. Dutch spectacle makers Zaccharias Janssen and Hans Lipperhey are noted as the first men to develop the concept of the compound microscope.
Microbial Spoilage include the contamination of Pharmaceutical products with the microbes which lead to spoilage of the product affecting Drug safety and quality, and is not intended for use. Shortly Microbial Spoilage is defined as deterioration of pharmaceutical products by the contaminant microbe.
In the late 16th century several Dutch lens makers designed devices that magnified objects, but in 1609 Galileo Galilei perfected the first device known as a microscope. Dutch spectacle makers Zaccharias Janssen and Hans Lipperhey are noted as the first men to develop the concept of the compound microscope.
Bacteria are a type of biological cell. They constitute a large domain of prokaryotic microorganisms. Typically a few micrometres in length, bacteria have a number of shapes, ranging from spheres to rods and spirals. Bacteria were among the first life forms to appear on Earth, and are present in most of its habitats
Microbiology is the study of organisms that are usually too small to be seen by the unaided eye; it employs techniques—such as sterilization and the use of culture media—that are required to isolate and grow these microorganisms.
Louis Pasteur in 1859 used swan-necked flasks to disprove the theory of spontaneous generation by showing that liquids in the flasks did not grow microbes due to being protected from dust and microbes in the air. Edward Jenner developed the first vaccine for smallpox in the late 1700s by inoculating people with material from cowpox lesions. Alexander Fleming discovered penicillin in 1928 after observing a mold that produced a chemical clearing surrounding bacteria on a culture plate.
Bacteria are microscopic, single-celled organisms that thrive in diverse environments. These organisms can live in soil, the ocean and inside the human gut. Humans' relationship with bacteria is complex. Sometimes bacteria lend us a helping hand, such as by curdling milk into yogurt or helping with our digestion
Bacteria are microscopic, single-celled organisms that thrive in diverse environments. These organisms can live in soil, the ocean and inside the human gut. Humans' relationship with bacteria is complex. Sometimes bacteria lend us a helping hand, such as by curdling milk into yogurt or helping with our digestion
Diuretics, also called water pills, are medications designed to increase the amount of water and salt expelled from the body as urine. There are three types of prescription diuretics. They're often prescribed to help treat high blood pressure, but they're used for other conditions as well.
The main site of diuretic action is well established for the different groups of diuretics: carbonic anhydrase inhibitors act on the proximal tubulus, loop diuretics on the diluting segment, thiazides on the cortical diluting segment/distal tubulus, and potassium-sparing agents on distal tubulus/collecting ducts.
Diuretics, also called water pills, are medications designed to increase the amount of water and salt expelled from the body as urine. There are three types of prescription diuretics. They’re often prescribed to help treat high blood pressure, but they’re used for other conditions as well.
Proton-pump inhibitors are a group of medications whose main action is a pronounced and long-lasting reduction of stomach acid production. Within the class of medications, there is no clear evidence that one agent works better than another. They are the most potent inhibitors of acid secretion available.
Synthesis of Naproxen, Ketoprofen, Ketorolac, Diclofenac and IbuprofenPharmacy Universe
This document summarizes the synthesis of several common nonsteroidal anti-inflammatory drugs (NSAIDs) including naproxen, ketoprofen, ketorolac, diclofenac, and ibuprofen. It outlines the key reaction steps for producing each compound, starting from various aromatic precursors and involving reactions such as acylation, alkylation, hydrolysis, bromination, reduction, chlorination, and hydrolysis.
The main site of diuretic action is well established for the different groups of diuretics: carbonic anhydrase inhibitors act on the proximal tubulus, loop diuretics on the diluting segment, thiazides on the cortical diluting segment/distal tubulus, and potassium-sparing agents on distal tubulus/collecting ducts.
In conclusion, the present study found that esomeprazole 40 mg daily may be more effective than either omeprazole 20 mg daily, pantoprazole 40 mg daily or lansoprazole 30 mg daily for the rapid relief of heartburn symptoms in patients with endoscopically proven reflux esophagitis.
Mechanisms of diuretic drugs. Diuretic drugs increase urine output by the kidney (i.e., promote diuresis). This is accomplished by altering how the kidney handles sodium. If the kidney excretes more sodium, then water excretion will also increase.
- 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
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
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Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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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.
2. Coloring Agents for Use in Pharmaceuticals
The Need for Color in Pharmaceuticals:
The psychological effects of color have long been recognized
The coloring of pharmaceutical dosage forms is extremely useful
for identification during manufacturing and distribution.
Many patients rely on color to recognize the prescribed drug
and proper dosage.
Unattractive medication can be made more acceptable to the
patient by the careful selection of color.
Color, in combination with flavoring agents, can be used to
provide taste masking of disagreeable components of a
pharmaceutical preparation.
2
3. TYPES OF COLORANTS APPROVED IN VARIOUS REGIONS
U.S. Certified Synthetic Colorants
The FD&C Act divided the synthetic colors into three categories:
colors for foods, drugs, and cosmetics (FD&C), colors for drugs
and cosmetics (D&C), and colors for externally applied drugs and
cosmetics (external D&C). All synthetic colorants approved for
use today must meet the specifications, uses, and restrictions as
described in Title 21 of the CFR (Parts 74, 81, and 82). Certified
synthetic colorants are the primary source of colorants used in
the pharmaceutical industry.
3
4. FD&C colorants
The present list of FD&C certified colorants consists of both dyes
and lakes. Lakes are pigments. They are insoluble materials that
color by dispersion and reflected light. FD&C dyes are water-
soluble and exhibit their color by transmitted light.
FD&C dyes: Today, FD&C dyes are synthetic organic molecules
produced from highly purified intermediates derived from
petrochemicals and other sources. They are marketed in a
number of physical forms, such as powder, granular, pastes,
liquids, and dispersions. Many of these forms are customized for
specific uses and are selected by the user for their particular
application.
4
5. They are marketed in a number of physical forms, such as
powder, granular, pastes, liquids, and dispersions. Many of these
forms are customized for specific uses and are selected by the
user for their particular application.
Dyes are relatively unstable because of their chemical structures.
They are subject to instability as a result of: 1) light energy; 2)
oxidizing and reducing agents; 3) microorganisms; 4) trace
metals; 5) pH; and 6) high temperatures.
FD&C lakes: The only lakes permitted for use in all three
categories—foods, drugs, and cosmetics—are the aluminum
lakes. These are manufactured through the adsorption of an
aluminum salt of an FD&C dye on a base of alumina hydrate.
5
6. The properties of these lakes can be controlled by variations in
process conditions during manufacturing (for example, starting
materials, order of additions, pH, and temperature). The most
important attributes of aluminum lakes are the shade and
particle size.
The shade of the lake may be influenced by the quantity of dye
adsorbed onto the alumina hydrate and the particle size
distribution. The particle size also affects the tinting strength
(that is, coloring power) of the pigment. Smaller particles result
in increased surface area, which allows for an increase in
reflected light and hence more color.
6
7. D&C and external D&C colorants
D&C and external D&C colorants may be used to color drugs and
cosmetics with certain restrictions. A basic regulatory difference
between FD&C, D&C, and external D&C colorants is that D&C
and external D&C colorants have specific uses and restrictions.
The classifications of D&C and external D&C mean little today,
because many of the colorants listed as D&C are restricted to
external uses.
D&C and external D&C colorants may also exist in either the dye
or lake form; however, the majority of the commercially
significant D&C and external D&C colorants are lakes.
7
8. D&C and external D&C dyes: The starting materials used in the
manufacture of this class of colors are similar to those used for
FD&C colors. D&C and external D&C dyes may or may not be
soluble in water. Some are insoluble metal salts, and others are
insoluble because they contain no water solubilizing groups.
Several, however, are soluble in organic solvents.
Analogous stability problems exist between D&C, external D&C,
and FD&C dyes, although there are a few D&C colors that are
considerably more stable than the FD&C colorants.
8
9. D&C and external D&C lakes: These lakes are usually
manufactured by precipitating a soluble dye onto an approved
substrate. In the case of D&C colors, the substrate may be
alumina, blanc fixe, gloss white, titanium dioxide, zinc oxide,
talc, rosin, aluminum benzoate, calcium carbonate, or any
combination of these materials.
A notable difference between FD&C and D&C lakes is that FD&C
lakes must be manufactured using previously certified dyes,
whereas D&C lakes are not restricted by this requirement.
The important physical properties of the FD&C lakes, such as
particle size and shade, are equally important characteristics of
the D&C and external D&C lakes.
9
10. Color Additives Approved for Use in Drugs
Title 21 of the Code of Federal Regulations
Part 73, Subpart B: Color additives exempt from batch certification
Alumina (dried aluminum hydroxide), Caramel, β-Carotene, Cochineal
extract, Potassium sodium copper chlorophyllin (chlorophyllin-copper
complex), Synthetic iron oxide, Chromium hydroxide green, Talc,
Titanium dioxide etc.
Part 74, Subpart B: Color additives subject to batch certification
FD&C Blue No. 2, D&C Blue No. 4, FD&C Green No. 3, D&C Green No. 5,
D&C Orange No. 4, D&C Orange No. 5, FD&C Red No. 3, D&C Red No. 36,
D&C Violet No. 2, FD&C Yellow No. 5, Ext. D&C Yellow No. 7 etc.
10
12. A preservative is a substance that prevents or
inhibits the growth of microorganisms and is
added to pharmaceutical preparation to avoid
consequent spoilage of the preparation by
microorganism.
e.g. Methyl paraben
Ethyl Paraben
Propyl paraben
Benzoic acid
12
13. Some Definitions
Disinfectants: Chemical agents or formulations that are too
irritant or toxic on body surfaces, but are used to reduce the
level of microorganisms from the surface of inanimate
objects to one that is safe for a defined purpose.
Preservatives: Chemical agents or formulations that are
capable of reducing the number of viable microorganisms
within an object or field to a level that is safe for its
designated use and will maintain the numbers of viable
microorganisms at or below a level for the use/ shelf-life of
the product.
13
14. Bacteriostatic: A chemical antimicrobial agent that can
prevent the growth of microorganisms within an otherwise
nutritious environment. This term is meaningless without
specifying the concentration at which this effect is
achieved. Bacteriostatic concentrations do vary between
different species of microorganisms.
Bactericide: A chemical antimicrobial agent that reduces
the viability of a population of microorganisms exposed to
it. This term is meaningless without specifying the
concentration range over which this effect is obtained; such
concentration ranges will vary between different species of
microorganisms.
14
15. Sources of microbial contamination in pharmaceutical
products
Raw materials
Packaging materials
Manufacturing environment
Manufacturing equipments
Personnel
Pharmaceutical water
Vehicles
External air
15
16. Types of dosage form
Preservative required Not required
Liquid dosage form Solid dosage form Tablet, capsule)
Injectables Very hypertonic liquid dosage form
Topical On time use Injectables
Semisolid 100% non aqueous liquid dosage form
Aerosols
Name of dosage form where preservatives required
17. Example of widely used preservatives
Dosage form Name of Preservatives Concentration(%)
For oral use
Benzoic acid 0.1
Sodium benzoate 0.1-0.2
Methyl Paraben and salts 0.1
Propyl Paraben and salts 0.05
Butyl Paraben and salts 0.02
Alcohol 15-20
Glycerin 45
Sorbic acid and salts 0.1
Propionic acid and salts
Dehydroacetic acid
18. Dosage form Name of Preservatives Concentration(%)
For Injectables
and ophthalmic
Benzalkonium chloride 0.01
Benzothonium chloride 0.01
Benzyl alcohol 2
Chlorobutanol 0.5
Phenyl ethyl alcohol 0.5
Cresol 0.3-0.5
Chlorocresol 0.1-0.2
Methyl paraben 0.1
Propyl paraben 0.02
Phenol 0.5
Phenyl mercuric nitrate 0.002
Phenyl mercuric acetate 0.002
Thiomerosal 0.01
Polymyxin-B-Sulfate 1000 USP unit
19. Dosage form Name of Preservatives
Topical use
Benzoic acid
Phenol
Sorbic acid
Alcohols (ethyl and Propyl)
Quaternary ammonium salts
Mercurals
20. Classification of antimicobial preservatives
A. On the basis of their action in bacteria
I. Bacteriostatic
II. Bactericidal
B. On the basis of their chemical structure
II. Ester group
Methyl paraben
Ethyl paraben
Propyl paraben
III. Phenol group
Phenol
Cresol
Chlorocresol
Benzyl alcohol
I. Acid group
Benzoic acid
Sorbic acid
Propionic acid
21. VII.85% concentrated sugar solution
IV. Aldehyde group
Formaldehyde
V. Mercurials group
Phenyl mercuric acetate
Phenyl mercuric nitrate
VI. Quaternary ammonium compound
Cetyl trimethyl ammonium bromide
Benzalkonium chloride
22. VII.85% concentrated sugar solution
IV. Aldehyde group
Formaldehyde
V. Mercurials group
Phenyl mercuric acetate
Phenyl mercuric nitrate
VI. Quaternary ammonium compound
Cetyl trimethyl ammonium bromide
Benzalkonium chloride
23. I. Modification of membrane permeability
II. Denaturation of enzymes or other cellular proteins
III.Oxidation and reduction of cellular constituents
IV.Hydrolysis
V. Interference with essential metabolites
Basic mechanism of action of preservatives
24. 1. A wide spectrum of activity against all bacteria, yeasts
and moulds.
2. Bactericidal rather than Bacteriostatic .
3. Freedom from toxic, irritant or sensitizing activity.
4. Compatibility with other ingredients and with the
container.
5. High water solubility.
6. Stability and effectiveness over a wide range of pH and
Temp.
7. Freedom from color and odor.
8. Well within its solubility to avoid crystallization at low
temperature
9. Stable during sterilization and storage
10. Should be effective at low concentration
11. Should be non volatile
Desirable features of a preservative
25. Phenol
Chemistry: It is also called carbolic acid.
Structure:
OH
• Physical Properties:
Description: Colorless to light pink,
needle shaped crystals, characteristic
odor.
26. Solubility: 1g in 15 ml water, very soluble in
alcohol, glycerin, chloroform & ether.
Use: It is used as a preservative for
injectable preparations at 0.5% w/v.
Phenol
28. Solubility: 1g in 125 ml water; 1 ml
alcohol or 10 ml glycerin; freely soluble
in chloroform, ether or volatile oils.
Use: It is primarily used as preservative
in ophthalmic and parenteral
preparations as it has antimicrobial &
germicidal properties.
Chlorobutanol
29. Methyl Paraben
Chemistry: It is the methyl ester of parahydroxybenzoic
acid.
CH3
Physical properties
Description: Colorless crystals or white powder.
Solubility: soluble in water, ethanol, slightly
Uses: It is used as preservative in pharmaceutical
formulation to inhibit the growth of
microorganisms.
Structure:
32. Characteristics of Antioxidants
The major antioxidants currently used in foods are
monohydroxy or polyhydroxy phenol compounds with
various ring substitutions. These compounds have low
activation energy to donate hydrogen. The resulting
antioxidant free radical does not initiate another free radical
due to the stabilization of delocalization of radical electron.
The resulting antioxidant free radical is not subject to rapid
oxidation due to its stability.
The antioxidant free radicals can also react with lipid
free radicals to form stable complex compounds
33. Ideal Antioxidants
No harmful physiological effects
Not contribute an objectionable flavor, odor, or color to the fat
Effective in low concentration
Fat-soluble
Carry-through effect No destruction during processing
Readily-available
Economical
Not absorbable by the body
34. Choices of Antioxidants
Different antioxidants show substantially different
antioxidant effectiveness in different fats and oils and food
systems due to different molecular structures.
We should consider the following:
Safety
Antioxidant effectiveness
Off-odor
Off-color
Convenience of antioxidant incorporation to foods
Carry-through effect
Stability to pH and food processing
Availability
Cost
Non-adsorbable, if possible
35. Factors Affecting the Efficiency of
Antioxidant
1. Activation energy of antioxidants to
donate hydrogen should be low
2. Oxidation potential should be high
3. Reduction potential should be low
4. Stability to pH and processing.
5. Solubility in oil.
37. Preventive Antioxidants
Superoxide dismutase
Catalase
Glutathione peroxidase
Singlet oxygen quencher
Transition metal chelators (EDTA)
Preventive antioxidants minimize the formation
of initiating radicals
38. Radical Scavenging Antioxidant
• Vitamin C
• Tocopherol
• Quercetin
• Anthocyanin
Radical scavenging antioxidants break free radical chain
reaction by donating hydrogen to free radicals
39. Mechanism of Antioxidants
Hydrogen donation to free radicals by
antioxidants.
Formation of a complex between the lipid radical
and the antioxidant radical (free radical acceptor).
40. Reaction of antioxidants with radicals
R·
+ AH RH + A
RO + AH ROH + A
ROO + AH ROOH + A
R + A RA
RO + A ROA
ROO + A ROOA
Antioxidant + O2 Oxidized Antioxidant
·
· ·
·
·
· ·
·
··
·
41. Minimization of Lipid Oxidation
If a compound inhibits the formation of free alkyl radicals in
the initiation step, or if the chemical compound interrupts
the propagation of the free radical chain, the compound
can delay the start or slow the chemical reaction rate of
lipid oxidation.
The initiation of free radical formation can be delayed by the
use of metal chelating agents, singlet oxygen inhibitors, and
peroxide stabilizers.
The propagation of free radical chain reaction can be
minimized by the donation of hydrogen from the
antioxidants and the metal chelating agents.
45. Defination:
Flavor is a complex effect of taste, odour, and feeling factor
i.e., touch, sight, and sound, to produce physicochemical and
psychological actions that influence the perception of a
substance.
Taste- primary effects of taste are sweet, sour, and salty.
There is a close co-relation ship between chemical structure
and taste.
Sour taste is due to acidic nature. Examples: Lemon, Vinegar,
Citric acid, Malic acid, Apple.
46. Salty taste is due to cationic species, halide salts. Example:
Sodium chloride, sodium bromide, sodium iodide.
Increase in molecular weight of halide results in increase in bitter
taste. example: potassium bromide, Ammonium salts.
Sodium chloride is salty, whereas , potassium chloride is bitter.
Sweet taste is due to polyhydroxy compounds.
Example: sugar, glycerin, alpha amino acids, etc.
Odour- Odour is defined as ‘Taste from a distance’, it is very
closely allied to taste. Without odour most of substances lack in
taste appeal.
47. Odourous volatile substances generate vapors these interact
with olfactory cells and elicit receptors and exit. The brain
receives impulses from group of microscopic olfactory
receptors in the nose which it co-ordinates with the gustatory
stimuli to produce the mingled sensation that is recognized as
the flavour of the substance.
Feeling factor :-feeling factor is combination of sight, sound,
and touch i.e., texture(soft/hard) , Viscosity, cooling / warmth ,
irritation sensation, etc.
Examples: flavored viscous multi-vitamin liquid gives
mouthfeel effect, Menthol in mouthwash gives cooling effect.
48. Purpose:
To mask unpleasant taste or odour.
To make it more palatable.
50. Types of flavoring agents:
Natural Flavoring agents
Nature Identical Flavoring Agents
Artificial flavoring agents
Flavors are combined with the sweetening agents
like sucrose, sorbitol, invert syrup, saccharine, etc.
to enhance the flavoring effect.
51. Natural flavors:
Volatile oils such as anise, caraway, cinnamon, clove, dill, ginger, lemon, orange
and peppermint are used as flavoring agents in a variety of forms.The vehicles
of mixtures are often aromatic waters while alcoholic or hydroalcoholic
solutions of oils(tinctures or, more often, spirits) provide convenient
concentrated preparations for flavoring purposes (lemon, peppermint and
compound orange spirits, and strong ginger tincture are examples)
Flavors containing aromatic oils(except lemon and orange) are more suitable
than fruit syrups for neutral preparations. Fruit flavors are prepared from fruit
juices, peel of citrus fruits. Lemon and orange oils keep badly and develop an
unpleasant turpentine-like taste. By removing most of the terpenes, terpeneless
oils are produced which, compared with the natural oils, are about 20 times
stronger in flavor and odour, are more readily soluble and have better stability.
For solid dosage form- vanillin crystals,dried lemon extract
For liquid dosage form- Alcoholic , aqueous, hydroalcoholic (tinctures and spirits
are used.
Limitations of natural flavors:
These are chemically and microbiologically unstable.
Extracts vary in nature or composition.
Removal of water, resinous material, terpenes and sesquiterpenes improves stability of
flavors.(fractional distillation required)
52. Nature-identical flavoring substances:
Nature identical substances means flavoring substances that
are obtained by synthesis or isolated through chemical
processes, which are chemically identical to flavoring
substances naturally present in products intended for human
consumption. They cannot contain any artificial flavoring
substances.
53. Synthetic flavors:
These are prepared by chemical reactions. Inaddition to synthetic
sweeteners other synthetic chemicals are used in flavoring. These are
often preferred to natural materials because of their more constant
composition, More ready availability,lower cost, greater stability, and
more predictable incompabilities.
Examples: Ester (methylsalicylate), Aldehydes( Synthetic vanillin,
benzaldehyde, cinnamaldehyde) fatty alcohols, ketones , lactones and
alcohols are used. Chloroform has an agreeable, warm, sweet taste
and used as a vehicle Chloroform water BP.
For emulsified products, Soft flavors like benzaldehyde and vanillin are
most suitable. Benzaldehyde has the odour of bitter almonds and is a
substitute for wild cherry syrup and volatile bitter almond oil. Vanillin
is useful when, as with liquid paraffin emulsions , the medicament has
bland taste. Fractionated coconut oil, a non-aqueous vehicle for oral
preparations, is difficult to flavor because of its oily nature; imitation
ground almond oil and olive oil are suitable flavors.
Exact duplication of natural flavor is impossible because it is not
possible to detect and prepare all components which are present in
natural flavor and hence it is blended with natural flavors.
54. Taste-Masking Agents
The flavoring industry has many proprietary products purported to
have excellent taste-masking properties, which have been used with
some success. Yet, there are a number of natural and artificial flavors
that can be generally described to possess similar taste-masking
effects. Of the many tastes that must be masked in pharmaceuticals,
bitterness is most often encountered; to mask it completely is
difficult. A tropical fruit has been used for centuries in central Africa
to mask the bitter taste of native beers. This so-called ‘‘miracle
berry’’ contains a glycoprotein that transiently and selectively
binds to bitter taste buds. Due to stability challenges, attempts to
isolate the compound for commercial exploitation have been
unsuccessful. Yet, many fruit syrups are relatively stable in
pharmaceuticals if formulated with antimicrobial preservative
agents, e.g. syrups of cinnamon, orange, citric acid, cherry, cocoa
etc.