Parenteral drugs are sterile solutions or suspensions administered via injection outside of the gastrointestinal tract. They enter the body directly through routes like intravenous, intramuscular, or subcutaneous. Water for injection is a key vehicle used for parenterals and is produced through distillation, reverse osmosis, or vapor compression stills to ensure purity and sterility. Proper storage and distribution of water for injection is also important to prevent microbial growth and meet USP guidelines.
Parenteral- definition, type and advantages disadvantages Dheeraj Saini
This document discusses parenteral dosage forms, including their definition, types, advantages, and disadvantages. Parenteral dosage forms are those administered outside of the gastrointestinal tract, such as by injection. They include injections, infusions, powders for injection, and implants. Parenterals provide immediate onset of action and avoid first-pass metabolism. However, they require skilled administration and are more expensive than oral drugs. The main types are injections containing solutions or suspensions, infusions containing aqueous solutions, and powders that must be reconstituted before use. Parenterals offer advantages like rapid action and delivery of unstable compounds, but also have disadvantages like pain at the injection site and the inability to reverse effects.
This document discusses large volume parenterals (LVPs), which are sterile solutions intended for intravenous use that come in containers holding more than 100 mL. It describes the key characteristics of LVPs, including that they must be sterile, nonpyrogenic, isotonic, and free of preservatives. The document then outlines different types of LVPs, such as electrolyte solutions, carbohydrate solutions, nutritional solutions, fat emulsions, total parenteral nutrition, and intravenous admixtures. It also discusses some specialized LVPs like hyperalimentation solutions, cardioplegia solutions, peritoneal dialysis fluids, and irrigation solutions.
This document discusses percolation, which is the process of extracting soluble constituents from a drug by slowly passing a solvent through the drug. It provides examples of percolation like extracting soluble compounds from coffee. The process of percolation involves comminution, imbibition, packing, maceration, and percolation. It also discusses modified percolation methods like reserved, continuous hot, and continuous cold percolation. Different types of percolators are used depending on factors like the drug properties and desired extraction method.
This document summarizes different parenteral routes of drug administration including intravenous, intramuscular, and subcutaneous. It discusses key aspects of each route such as typical volumes administered, advantages, and disadvantages. It also covers pharmacokinetic concepts for intravenous bolus doses such as zero-order and first-order kinetics, and equations for calculating parameters like volume of distribution, half-life, loading dose, and time to steady-state.
Galenicals are herbal medicines prepared according to ancient formulas. They are made by extracting active plant constituents using solvents like water or alcohol. Infusions and decoctions are two common types of galenicals. Infusions are used for plants with water-soluble compounds and soft tissues, prepared by steeping the plant in water. Decoctions are used for plants with hard, woody tissues, prepared by boiling the plant in water to extract water-soluble compounds. The document provides details on the preparation, storage, and examples of infusions and decoctions.
This document describes the process of preparing homoeopathic mother tinctures using maceration and percolation methods. Maceration involves soaking plant or animal substances in alcohol over 2-4 weeks to extract active principles. Percolation uses an apparatus to pass alcohol through powdered plant material over time. Key steps include preparing the drug substance, assembling the percolator with layers of sand and cotton, moistening the drug and allowing the menstruum to slowly pass through. The resulting tinctures are filtered and potentized to create the initial mother tinctures used in homoeopathic medicine.
Different methods of extraction of essential oilChetanChauhan123
all about the different methods of oil extraction classical and modern extraction method on the basis of review and research paper by chetan kumar chauhan
1) Maceration is an extraction process where solid ingredients are placed in a container with a solvent and allowed to stand for a period of time, usually 3-7 days. The soluble matter dissolves in the solvent.
2) There are different types of maceration including simple maceration, double maceration, and triple maceration which involve macerating the ingredients multiple times with portions of the total solvent volume.
3) Double and triple maceration are used to produce more concentrated preparations, with the maceration process repeated using separate portions of the total solvent volume each time.
Parenteral- definition, type and advantages disadvantages Dheeraj Saini
This document discusses parenteral dosage forms, including their definition, types, advantages, and disadvantages. Parenteral dosage forms are those administered outside of the gastrointestinal tract, such as by injection. They include injections, infusions, powders for injection, and implants. Parenterals provide immediate onset of action and avoid first-pass metabolism. However, they require skilled administration and are more expensive than oral drugs. The main types are injections containing solutions or suspensions, infusions containing aqueous solutions, and powders that must be reconstituted before use. Parenterals offer advantages like rapid action and delivery of unstable compounds, but also have disadvantages like pain at the injection site and the inability to reverse effects.
This document discusses large volume parenterals (LVPs), which are sterile solutions intended for intravenous use that come in containers holding more than 100 mL. It describes the key characteristics of LVPs, including that they must be sterile, nonpyrogenic, isotonic, and free of preservatives. The document then outlines different types of LVPs, such as electrolyte solutions, carbohydrate solutions, nutritional solutions, fat emulsions, total parenteral nutrition, and intravenous admixtures. It also discusses some specialized LVPs like hyperalimentation solutions, cardioplegia solutions, peritoneal dialysis fluids, and irrigation solutions.
This document discusses percolation, which is the process of extracting soluble constituents from a drug by slowly passing a solvent through the drug. It provides examples of percolation like extracting soluble compounds from coffee. The process of percolation involves comminution, imbibition, packing, maceration, and percolation. It also discusses modified percolation methods like reserved, continuous hot, and continuous cold percolation. Different types of percolators are used depending on factors like the drug properties and desired extraction method.
This document summarizes different parenteral routes of drug administration including intravenous, intramuscular, and subcutaneous. It discusses key aspects of each route such as typical volumes administered, advantages, and disadvantages. It also covers pharmacokinetic concepts for intravenous bolus doses such as zero-order and first-order kinetics, and equations for calculating parameters like volume of distribution, half-life, loading dose, and time to steady-state.
Galenicals are herbal medicines prepared according to ancient formulas. They are made by extracting active plant constituents using solvents like water or alcohol. Infusions and decoctions are two common types of galenicals. Infusions are used for plants with water-soluble compounds and soft tissues, prepared by steeping the plant in water. Decoctions are used for plants with hard, woody tissues, prepared by boiling the plant in water to extract water-soluble compounds. The document provides details on the preparation, storage, and examples of infusions and decoctions.
This document describes the process of preparing homoeopathic mother tinctures using maceration and percolation methods. Maceration involves soaking plant or animal substances in alcohol over 2-4 weeks to extract active principles. Percolation uses an apparatus to pass alcohol through powdered plant material over time. Key steps include preparing the drug substance, assembling the percolator with layers of sand and cotton, moistening the drug and allowing the menstruum to slowly pass through. The resulting tinctures are filtered and potentized to create the initial mother tinctures used in homoeopathic medicine.
Different methods of extraction of essential oilChetanChauhan123
all about the different methods of oil extraction classical and modern extraction method on the basis of review and research paper by chetan kumar chauhan
1) Maceration is an extraction process where solid ingredients are placed in a container with a solvent and allowed to stand for a period of time, usually 3-7 days. The soluble matter dissolves in the solvent.
2) There are different types of maceration including simple maceration, double maceration, and triple maceration which involve macerating the ingredients multiple times with portions of the total solvent volume.
3) Double and triple maceration are used to produce more concentrated preparations, with the maceration process repeated using separate portions of the total solvent volume each time.
This document provides information about small volume parenterals. It begins by defining parenterals as routes of administration other than the alimentary canal. It then discusses various parenteral routes including subcutaneous, intramuscular, intravenous, and large volume parenteral. The document outlines the advantages and disadvantages of the parenteral route. It provides details on containers, closures, formulation, production facilities, processing, and evaluation of parenteral preparations. Evaluation includes sterility testing, clarity testing, leakage testing, pyrogen testing, and assay testing. The document emphasizes the importance of aseptic conditions for parenterals due to risk of contamination.
Galenical Preparations .. by Dr. Duryab JamilDr. DURYAB
Galenical preparations are medicines prepared according to formulas of Galen that contain mainly herbal or vegetable matter. They are prepared through extraction of active plant principles using solvents like water or alcohol. Common types include infusions, decoctions, tinctures, oils, and extracts. Extraction methods involve comminution, penetration of the plant material by the solvent, dissolution and diffusion of active principles, and separation from insoluble material. Key terms include menstruum (solvent), marc (insoluble plant material), and various extraction techniques like percolation, expression, filtration, and distillation. Common classes of compounds extracted include volatile oils, resins, gums, glucosides, alkaloids
This document discusses parenteral products, which are sterile preparations meant to be administered via injection. It covers preformulation factors like pH and solubility that must be considered, as well as common routes of administration like intravenous, intramuscular, and subcutaneous. The main types of parenterals described are powders for injection, colloidal solutions, injectable emulsions, suspensions, and infusion fluids. Key aspects of parenteral formulation include choosing appropriate solutes, vehicles like water and oils, and added substances like antimicrobials and buffers. General procedures for production include cleaning, preparation, sterilization, filling and packaging using containers like vials, ampoules and cartridges.
The document discusses various extraction processes used to isolate active pharmaceutical ingredients from plant or animal sources. It describes liquid-liquid extraction and solid-liquid extraction processes. Ideal solvent properties are outlined. Common solvents used in extraction like water, alcohol, ether, chloroform and their advantages and disadvantages are highlighted. Infusion, decoction, maceration, percolation, and continuous extraction techniques are explained along with the equipment used. Different types of extracts produced including aqueous, tinctures, liquid extracts, soft extracts, and dry extracts are also summarized.
Extraction
Various methods
Extraction with reflux
Extraction with agitation
Counter current extraction
reserve percolation process, continuous hot percolation process
decoction
infusion
digestion
Extraction with agitation
Maceration with adjustment
This document discusses various extraction methods for active components from medicinal plants. It defines extraction as separating medicinally active portions from inactive components using selective solvents. Extraction methods include decoction, infusion, maceration, fluid extracts, and tinctures. Decoction involves boiling plant material in water. Infusion uses cold or boiling water to make dilute solutions. Percolation is commonly used to make tinctures and fluid extracts using a percolator. Distillation isolates essential oils by boiling plant material in water or steam. Expression physically crushes plant peels to release oils. Standardizing extraction procedures is important to obtain the desired therapeutic portions and eliminate inert material.
The document discusses various methods of extraction used in pharmacy, including partition, leaching, maceration, percolation, digestion and soxhlet extraction. It defines extraction as treating plant or animal tissues with solvent to dissolve medicinally active constituents. Various equipment used for extraction include infusion, decoction, maceration, and percolation. Infusion involves steeping plant material in water, while decoction involves boiling plant material in water. Maceration involves soaking plant material in solvent, and percolation involves packing plant material in a percolator and pouring solvent through it. [/SUMMARY]
The document describes the percolation process, which is a method of extracting active constituents from drugs using a solvent. It involves comminuting the drug into a fine powder, imbibing it with solvent, packing it into a percolator, macerating it for 24 hours, then slowly percolating more solvent through it while collecting the extract. The key steps are size reduction of the drug, moistening it with solvent, packing it uniformly in a conical percolator, macerating it overnight, then slowly draining more solvent through it over multiple days to extract the active compounds.
Preparation & stability of large & small volume parentralsROHIT
This document discusses parenteral formulations, including definitions, advantages, disadvantages, and classifications. It provides details on the preparation of small volume parenterals and large volume parenterals, including vehicles, buffers, preservatives, and other excipients used. It also covers the stability considerations for parenteral formulations and factors that influence syringeability, injectability, clogging, drainage, resuspendibility, and sedimentation of suspensions.
1. Extraction is the process of removing active constituents from plant or animal tissues using a solvent. Common extraction methods include maceration, percolation, digestion, decoction, and infusion.
2. Galenicals refer to medicinal preparations produced by extraction methods. Common galenicals include tinctures, extracts, and spirits.
3. Tinctures are alcoholic or hydroalcoholic solutions of plant or animal materials. They are typically produced by maceration or percolation to extract active constituents from the raw materials.
This document provides an overview of various extraction techniques used in galenical pharmacy including infusion, decoction, maceration, percolation, and digestion. Infusion involves steeping plant material in water, while decoction uses boiling water. Maceration soaks plant material in solvents like alcohol for weeks. Percolation packs plant material in a column and percolates solvent through it. Digestion heats plant material under pressure to aid extraction. Various factors like solvent, temperature, and pressure influence which technique is best for extracting different active compounds.
This document discusses parenteral suspensions and emulsions. It covers formulation considerations like choice of excipients, manufacturing methods, and evaluation. Suspensions require stabilization to prevent settling and caking. Emulsions are oil-water or water-oil dispersions used for total parenteral nutrition. Both require sterilization and maintenance of physical and chemical stability over shelf life.
extraction of bioactive compounds from plant sources using maceration processNivaasvignopathy
extraction of bioactive compounds from plant sources using maceration process.Maceration is a technique used in wine making and has been adopted in medicinal plant research.
This document discusses the process of percolation. Percolation is when a liquid passes slowly through a filter, coming from the Latin words meaning "through" and "to strain." Common examples given are coffee percolation. The process of percolation generally involves five steps - comminution, imbibition, packing, maceration, and percolation. Modified forms of percolation are also discussed, such as reserved, continuous hot, and continuous cold percolation which use specialized equipment.
Small volume parenterals are sterile preparations intended for injection that have volumes between 1-30 mL. They include ampules, vials, dry powders, and prefilled syringes. Key considerations for their formulation include using water for injection, appropriate solutes, added substances like antimicrobial agents or antioxidants, and ensuring sterility through various techniques like moist heat sterilization, filtration, or radiation. Their quality must be assured through testing for leaks, sterility, clarity, and presence of pyrogens.
This document discusses extraction and galenical processes. It defines extraction as separating active plant constituents from inactive ones using solvents. Common extraction methods described include infusion, decoction, maceration, percolation, and digestion. Water and alcohol are discussed as common solvents for extraction. The document also summarizes various maceration and percolation processes used to produce tinctures and extracts.
This document discusses parenteral drug delivery, which refers to drug administration through routes other than the oral route, such as injections. It provides details on various types of injections including intravenous, subcutaneous, intramuscular, and others. It describes why the parenteral route is used, advantages and disadvantages, necessary characteristics of parenteral preparations, production facilities, formulation, labeling requirements, and quality control tests. Common parenteral preparations discussed include intravenous fluids, intravenous admixtures, total parenteral nutrition, and dialysis fluids.
This document provides information about small volume parenterals (SVPs). It defines SVPs as injections packaged in containers of 100ml or less. SVPs can include pharmaceutical products, biological products, and more. They are commonly classified as single dose ampoules, single dose vials, multiple dose vials, and prefilled syringes. The document discusses vehicles, additives, processing, and more regarding the formulation and manufacturing of SVPs.
This document discusses preparing sterile formulations, including intravenous (IV) solutions and parenteral drugs. It covers topics such as large volume parenterals (LVPs), small volume parenterals (SVPs), laminar flow hoods, aseptic technique, working with vials and ampoules, and guidelines for preparing IVs. The goal is to prevent contamination and ensure sterility when preparing drugs and solutions that will be administered directly into the bloodstream.
Parenteral products are sterile preparations intended for administration outside of the gastrointestinal tract, such as by injection. They include small volume parenterals containing less than 100 mL and large volume parenterals of 100 mL or more. Parenteral formulations can be solutions, suspensions, emulsions, or other types and are administered via various routes like subcutaneous, intramuscular, intravenous, or intra-arterial injection. Proper formulation of parenterals requires they meet strict standards for sterility, pyrogen level, clarity, stability, and other factors to ensure safety upon administration.
This document provides information about small volume parenterals. It begins by defining parenterals as routes of administration other than the alimentary canal. It then discusses various parenteral routes including subcutaneous, intramuscular, intravenous, and large volume parenteral. The document outlines the advantages and disadvantages of the parenteral route. It provides details on containers, closures, formulation, production facilities, processing, and evaluation of parenteral preparations. Evaluation includes sterility testing, clarity testing, leakage testing, pyrogen testing, and assay testing. The document emphasizes the importance of aseptic conditions for parenterals due to risk of contamination.
Galenical Preparations .. by Dr. Duryab JamilDr. DURYAB
Galenical preparations are medicines prepared according to formulas of Galen that contain mainly herbal or vegetable matter. They are prepared through extraction of active plant principles using solvents like water or alcohol. Common types include infusions, decoctions, tinctures, oils, and extracts. Extraction methods involve comminution, penetration of the plant material by the solvent, dissolution and diffusion of active principles, and separation from insoluble material. Key terms include menstruum (solvent), marc (insoluble plant material), and various extraction techniques like percolation, expression, filtration, and distillation. Common classes of compounds extracted include volatile oils, resins, gums, glucosides, alkaloids
This document discusses parenteral products, which are sterile preparations meant to be administered via injection. It covers preformulation factors like pH and solubility that must be considered, as well as common routes of administration like intravenous, intramuscular, and subcutaneous. The main types of parenterals described are powders for injection, colloidal solutions, injectable emulsions, suspensions, and infusion fluids. Key aspects of parenteral formulation include choosing appropriate solutes, vehicles like water and oils, and added substances like antimicrobials and buffers. General procedures for production include cleaning, preparation, sterilization, filling and packaging using containers like vials, ampoules and cartridges.
The document discusses various extraction processes used to isolate active pharmaceutical ingredients from plant or animal sources. It describes liquid-liquid extraction and solid-liquid extraction processes. Ideal solvent properties are outlined. Common solvents used in extraction like water, alcohol, ether, chloroform and their advantages and disadvantages are highlighted. Infusion, decoction, maceration, percolation, and continuous extraction techniques are explained along with the equipment used. Different types of extracts produced including aqueous, tinctures, liquid extracts, soft extracts, and dry extracts are also summarized.
Extraction
Various methods
Extraction with reflux
Extraction with agitation
Counter current extraction
reserve percolation process, continuous hot percolation process
decoction
infusion
digestion
Extraction with agitation
Maceration with adjustment
This document discusses various extraction methods for active components from medicinal plants. It defines extraction as separating medicinally active portions from inactive components using selective solvents. Extraction methods include decoction, infusion, maceration, fluid extracts, and tinctures. Decoction involves boiling plant material in water. Infusion uses cold or boiling water to make dilute solutions. Percolation is commonly used to make tinctures and fluid extracts using a percolator. Distillation isolates essential oils by boiling plant material in water or steam. Expression physically crushes plant peels to release oils. Standardizing extraction procedures is important to obtain the desired therapeutic portions and eliminate inert material.
The document discusses various methods of extraction used in pharmacy, including partition, leaching, maceration, percolation, digestion and soxhlet extraction. It defines extraction as treating plant or animal tissues with solvent to dissolve medicinally active constituents. Various equipment used for extraction include infusion, decoction, maceration, and percolation. Infusion involves steeping plant material in water, while decoction involves boiling plant material in water. Maceration involves soaking plant material in solvent, and percolation involves packing plant material in a percolator and pouring solvent through it. [/SUMMARY]
The document describes the percolation process, which is a method of extracting active constituents from drugs using a solvent. It involves comminuting the drug into a fine powder, imbibing it with solvent, packing it into a percolator, macerating it for 24 hours, then slowly percolating more solvent through it while collecting the extract. The key steps are size reduction of the drug, moistening it with solvent, packing it uniformly in a conical percolator, macerating it overnight, then slowly draining more solvent through it over multiple days to extract the active compounds.
Preparation & stability of large & small volume parentralsROHIT
This document discusses parenteral formulations, including definitions, advantages, disadvantages, and classifications. It provides details on the preparation of small volume parenterals and large volume parenterals, including vehicles, buffers, preservatives, and other excipients used. It also covers the stability considerations for parenteral formulations and factors that influence syringeability, injectability, clogging, drainage, resuspendibility, and sedimentation of suspensions.
1. Extraction is the process of removing active constituents from plant or animal tissues using a solvent. Common extraction methods include maceration, percolation, digestion, decoction, and infusion.
2. Galenicals refer to medicinal preparations produced by extraction methods. Common galenicals include tinctures, extracts, and spirits.
3. Tinctures are alcoholic or hydroalcoholic solutions of plant or animal materials. They are typically produced by maceration or percolation to extract active constituents from the raw materials.
This document provides an overview of various extraction techniques used in galenical pharmacy including infusion, decoction, maceration, percolation, and digestion. Infusion involves steeping plant material in water, while decoction uses boiling water. Maceration soaks plant material in solvents like alcohol for weeks. Percolation packs plant material in a column and percolates solvent through it. Digestion heats plant material under pressure to aid extraction. Various factors like solvent, temperature, and pressure influence which technique is best for extracting different active compounds.
This document discusses parenteral suspensions and emulsions. It covers formulation considerations like choice of excipients, manufacturing methods, and evaluation. Suspensions require stabilization to prevent settling and caking. Emulsions are oil-water or water-oil dispersions used for total parenteral nutrition. Both require sterilization and maintenance of physical and chemical stability over shelf life.
extraction of bioactive compounds from plant sources using maceration processNivaasvignopathy
extraction of bioactive compounds from plant sources using maceration process.Maceration is a technique used in wine making and has been adopted in medicinal plant research.
This document discusses the process of percolation. Percolation is when a liquid passes slowly through a filter, coming from the Latin words meaning "through" and "to strain." Common examples given are coffee percolation. The process of percolation generally involves five steps - comminution, imbibition, packing, maceration, and percolation. Modified forms of percolation are also discussed, such as reserved, continuous hot, and continuous cold percolation which use specialized equipment.
Small volume parenterals are sterile preparations intended for injection that have volumes between 1-30 mL. They include ampules, vials, dry powders, and prefilled syringes. Key considerations for their formulation include using water for injection, appropriate solutes, added substances like antimicrobial agents or antioxidants, and ensuring sterility through various techniques like moist heat sterilization, filtration, or radiation. Their quality must be assured through testing for leaks, sterility, clarity, and presence of pyrogens.
This document discusses extraction and galenical processes. It defines extraction as separating active plant constituents from inactive ones using solvents. Common extraction methods described include infusion, decoction, maceration, percolation, and digestion. Water and alcohol are discussed as common solvents for extraction. The document also summarizes various maceration and percolation processes used to produce tinctures and extracts.
This document discusses parenteral drug delivery, which refers to drug administration through routes other than the oral route, such as injections. It provides details on various types of injections including intravenous, subcutaneous, intramuscular, and others. It describes why the parenteral route is used, advantages and disadvantages, necessary characteristics of parenteral preparations, production facilities, formulation, labeling requirements, and quality control tests. Common parenteral preparations discussed include intravenous fluids, intravenous admixtures, total parenteral nutrition, and dialysis fluids.
This document provides information about small volume parenterals (SVPs). It defines SVPs as injections packaged in containers of 100ml or less. SVPs can include pharmaceutical products, biological products, and more. They are commonly classified as single dose ampoules, single dose vials, multiple dose vials, and prefilled syringes. The document discusses vehicles, additives, processing, and more regarding the formulation and manufacturing of SVPs.
This document discusses preparing sterile formulations, including intravenous (IV) solutions and parenteral drugs. It covers topics such as large volume parenterals (LVPs), small volume parenterals (SVPs), laminar flow hoods, aseptic technique, working with vials and ampoules, and guidelines for preparing IVs. The goal is to prevent contamination and ensure sterility when preparing drugs and solutions that will be administered directly into the bloodstream.
Parenteral products are sterile preparations intended for administration outside of the gastrointestinal tract, such as by injection. They include small volume parenterals containing less than 100 mL and large volume parenterals of 100 mL or more. Parenteral formulations can be solutions, suspensions, emulsions, or other types and are administered via various routes like subcutaneous, intramuscular, intravenous, or intra-arterial injection. Proper formulation of parenterals requires they meet strict standards for sterility, pyrogen level, clarity, stability, and other factors to ensure safety upon administration.
Preparation & Stability of Large Volume Parenterals by PRINCE THAKURPrinceThakur50
This document provides information on the preparation and stability of large volume parenterals. It discusses the types of large volume parenterals including hyperalimentation solutions, cardioplegia solutions, peritoneal dialysis solutions, and irrigating solutions. The document outlines the contents, sources, and formulation of hyperalimentation solutions. It also discusses the preparation of large volume parenterals including the selection of therapeutic agents and aqueous vehicles. Further, it covers problems associated with parenterals such as syringeability and injectability. The document concludes by discussing stability studies for large volume parenterals including effect of temperature, water loss, and stress testing.
Large and small volume parenterals preparationsInNo Sutnga
Small and large volume parenterals are injectable drug formulations. Small volume parenterals have volumes less than 100mL and include solutions, suspensions, emulsions, and dry powders. Large volume parenterals have volumes over 100mL and are used to provide fluids, electrolytes, and nutrition intravenously. The document discusses the classification, formulations, manufacturing, and containers used for parenteral drug products.
QUALITY CONTROL OF PARENTERALS,STERILE PRODUCTMuhammad Arsal
This document discusses quality control testing of sterile products, particularly parenteral products. It begins by defining sterile products as dosage forms free from viable microorganisms, including parenterals, ophthalmics, and irrigating preparations. Parenterals are unique as they are injected directly into the body. The document then discusses various quality control tests performed on parenterals, including leaker testing to detect incomplete seals, clarity testing, pyrogen testing, sterility testing, and content uniformity testing. It provides details on each of these tests and their purposes in ensuring the safety and quality of sterile parenteral products.
The document discusses different types of parenteral formulations. Parenteral products must be sterile, free from toxins and pyrogens, and chemically pure. They can be administered through various routes including intravenous, intramuscular, subcutaneous, and others. Formulations include solutions, suspensions, emulsions, and freeze-dried powders. Key requirements for parenteral products are stability, sterility, isotonicity, and ensuring no irritation at the site of injection. Proper selection of vehicles, buffers, antioxidants and other components is important for developing parenteral formulations.
FORMULATION OF PARENTERAL PRODUCTS REQUIREMENTS, FORMULATION DEVELOPMENT, PRETREATMENT OF WATER ,REVERSE OSMOSIS ,STERILE WATER FOR INJECTION USP ,PYROGENS,
The document summarizes a seminar presentation on parenterals. Parenterals are sterile preparations that are administered through non-oral routes such as injection. The key routes of administration are subcutaneous, intramuscular, and intravenous injection. Parenterals offer advantages of quick onset of action and are suitable when oral administration is not possible, but have disadvantages like pain on injection and risk of allergic reactions. The document outlines the formulation, manufacturing, packaging, and quality control processes to ensure the sterility and safety of parenteral products.
Parenteral preparations are sterile solutions or suspensions of drugs administered through routes other than the gastrointestinal tract, such as intravenous, intramuscular, or subcutaneous injection. They must meet strict standards for sterility, pyrogen level, clarity, stability, isotonicity, and packaging to ensure patient safety. Common parenteral formulations include injections, infusions, and sterile powders for reconstitution. The choice of parenteral preparation and route of delivery depends on the nature of the drug and desired pharmacokinetic profile.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of parenteral formulation including the types of parenteral route for administration along withcomponents of parenteral formulation.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Parenterals are sterile solutions, emulsions or suspensions of drugs intended for administration through a non-oral route. This document discusses various aspects of parenterals including advantages and disadvantages, routes of administration, types, components, quality control, and sterilization. Parenterals can be small volume solutions, suspensions or emulsions packaged in vials or bags of 100ml or less, or large volume solutions contained in glass bottles or bags over 100ml including hyperalimentation, cardioplegic, and dialysis solutions. Quality is ensured through testing of sterility, clarity, leakage, pyrogens and other parameters.
Sterile formulations – large and small volume parenterals (1).pptxMamtanaagar1
This document discusses the manufacture of small volume parenterals (SVPs) and large volume parenterals (LVPs). SVPs have volumes less than or equal to 100mL and are used to dispense most drugs, while LVPs have volumes over 100mL and are used to provide electrolytes and nutrition. The document covers formulation aspects like therapeutic agents, vehicles, additives, and containers used. It also discusses production processes like water purification using reverse osmosis or distillation, terminal sterilization, and blow-fill-seal technology. Key differences between SVPs and LVPs are volume, route of administration, use of preservatives and buffers, and isotonicity requirements.
This document provides information on sterile products and admixtures. It discusses parenteral routes of administration such as subcutaneous, intramuscular, intravenous, and venoclysis. It describes the advantages and disadvantages of parenteral administration. It outlines the processing steps for parenteral products including cleaning, preparation, filtration, filling, sealing, sterilization, evaluation, labeling and packaging. It discusses various container and closure materials used and describes the formulation of parenteral products. It also summarizes the evaluation tests conducted on parenteral preparations including sterility, clarity, leakage, pyrogen and assay testing.
This document discusses various extraction and isolation techniques for plant constituents. It describes extraction processes like maceration, infusion, digestion, decoction, percolation, Soxhlet extraction, counter-current extraction, ultrasound extraction, and supercritical fluid extraction. Fractional crystallization, distillation, chromatography techniques and other methods are used to separate and identify plant constituents. Chromatography methods discussed include thin layer chromatography, column chromatography, gas chromatography and high performance liquid chromatography. The document also covers types of solvents used, factors in solvent selection, types of extracts produced, and applications of gas chromatography and high performance liquid chromatography.
This document discusses the manufacture of small volume and large volume parenterals. Small volume parenterals have volumes less than or equal to 100ml and are supplied in single or multiple doses, while large volume parenterals have volumes greater than 100ml and are delivered via intravenous route. The key aspects of formulation include therapeutic agents, vehicles like water for injection, and added substances like antimicrobials, antioxidants and buffers. Terminal sterilization is used to assure sterility of the finished products.
This document discusses sterile products and parenteral admixtures. It begins by defining parenteral as referring to injectable routes of drug administration other than oral. The primary parenteral routes are described as subcutaneous, intramuscular, intravenous, and venoclysis. Containers, closures, and the intravenous admixture system are then outlined. The document summarizes the processing of parenterals including cleaning, preparation, filtration, filling, sealing, and sterilization. Methods for evaluating parenteral preparations such as sterility testing, clarity testing, leakage testing, pyrogen testing, and assay are also summarized.
This document provides information about small volume parenterals (SVPs), which are injections packaged in containers of 100ml or less. It discusses the formulation, ingredients, containers, sterilization, and manufacturing of SVPs. Specifically, it describes that SVPs can be aqueous or non-aqueous solutions administered intravenously. It also outlines various additives used in SVP formulations, including vehicles, solvents, buffers, and preservatives. The document discusses sterilization methods like heat, filtration, and radiation. It provides details on terminal sterilization and blow-fill-seal technology for SVP production.
This document presents information on parenteral depot systems for long acting drug formulations. It discusses various approaches for controlled drug release including the use of viscous vehicles, polymeric microspheres, and drug derivatives. Common polymers used in depots are described as well as desirable characteristics. The main types of depot formulations are discussed - dissolution controlled, adsorption, encapsulation, and esterification. Examples of specific long acting preparations are provided for antibiotics, insulin, vitamin B12, and contraceptives. Evaluation methods and the development of depots are outlined.
This document provides an overview of aerosol drug delivery systems. It defines aerosols and discusses their advantages and disadvantages. The key components of aerosols are described including propellants, containers, valves, actuators, and product concentrates. Different types of propellants, containers, valves and actuators are summarized. The document also discusses various aerosol formulation systems including solutions, suspensions, and foam systems. It provides examples of marketed aerosol drug products and considerations for ensuring physical stability of aerosol suspensions.
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Denis is a dynamic and results-driven Chief Information Officer (CIO) with a distinguished career spanning information systems analysis and technical project management. With a proven track record of spearheading the design and delivery of cutting-edge Information Management solutions, he has consistently elevated business operations, streamlined reporting functions, and maximized process efficiency.
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Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
3. 3
The term derived from Greek word ‛Para’ outside &
‛Enterone’ intestine.
Parenterals are sterile solutions or suspension of drug in
aqueous or oily vehicle.
Parenteral drugs are administered directly in to the
veins, muscles or under the skin , or more specialized
tissues such as spinal cord.
Term parenteral used for any drug/fluid whose delivery
doesn’t utilize the alimentary canal for entering in to the
body tissues.
4. 4
• Stability
• Sterility
• Free from pyrogens & toxins
• Free from foreign particles
• Isotonic
• Chemical purity
5. 5
PARENTERAL ROUTES
The term parenteral literally means to avoid the
gut (gastrointestinal tract) and refers to any route of
administration outside of or beside the alimentary tract.
Thus, parenterals are injectable drugs that enter the body
directly and are not required to be absorbed in the
gastrointestinal tract before they show their effect.
Parenteral routes of administration usually have a more rapid
onset of action than other routes of administration.
7. Intravenous
• The injection of a drug
directly into the patient's
veins, resulting in the
most rapid onset of action.
7
8. 8
Intradermal
The drug is injected into the top
few layers of the skin. Ideally,
the drug is placed within the
dermis. Used for diagnostic
agents.
Subcutaneous
The injection of the drug under
the skin into the fatty layer,
but not into the muscle.
Absorption of the drug is rapid.
Eg; insulin
9. 9
Intramuscular
Drugs are injected deeply into
muscle tissue. If the drug is in
aqueous (water) solution,
absorption is rapid. However, if
the drug is in an oily liquid or in
the form of a suspension, it can
prolong the release of the drug.
12. 12
Useful for patients who cannot take drugs orally
Rapid onset of action
Useful for emergency situations
Providing sustained drug delivery (implants, im depot inj)
Avoid first pass metabolism
Can inject drug directly in to a tissue (target drug delivery)
Useful for delivering fluids, electrolytes, or nutrients (TPN)
Can be done in hospitals, ambulatory infusion centers and
home health care centers
Complete bioavailability.
13. 13
Pain on injection
Difficult to reverse an administered drug’s effect.
Sensitivity or allergic reaction at the site of injection.
Requires strict control of sterility & non pyrogenicity than
other formulation.
Trained person is required.
Require specialized equipment, devices, and techniques
to prepare and administer drugs.
More expensive and costly to produce.
15. 15
USP defn: An injection that is packed in containers labeled as
containing 100 ml or less.
Defn: LVP are parenterals designed to provide :-
Fluid
Calories (dextrose solution )
Electrolytes
Combenation of these
Volume 101- 1000 ml
16. 16
parameter SVP LVP
volume 100 ml or less 101-1000 ml
Routes IV, IM & SC IV- LVP & non IV- LVP
Dosage unit Single or multiple Single
preservative Used Not used
Buffers Used Not used
Formulation Soln, emulsion,suspension. Soln & o/w nutrient
emulsion
Isotonicity Not essential must
Pyrogenicity Not essential must
use Therapeutic & diagnostic Nutrition,detoxification,
And during surgery
17. 17
AQUEOUS VEHICLE :
WATER FOR INJECTION (WFI) USP :
Highly purified water used as a vehicle for injective
preparations which will be subsequently sterilized.
USP requirement include not more than 10 parts per million
of total solids.
pH of 5.0 – 7.0 .
WFI may be prepared by either distillation or reverse osmosis.
Stored in chemically resistant tank.
18. 18
BACTERIOSTATIC WATER FOR INJECTION
This type of water used for making parenteral
solutions prepared under aseptic conditions and not
terminally sterilized.
Need to meet USP sterility test.
It can contain an added bacteriostatic agent when
in containers of 30 ml or less.
19. 19
STERILE WATER FOR INJECTION
SWFI containing one or more suitable bacteriostatic agent.
multiple – dose containers not exceeding 30 ml.
They are permitted to contain higher levels of solid than
WFI because of possible leaching.
Used for washing wounds , surgical incisions, or body
tissues.
20. 20
WATER MISCIBLE VEHICLES
The number of solvents that are miscible with water has
been used as a portion of a vehicle.
Primarily to affect solubility of drugs and to reduce
hydrolysis.
Example:
Ethyl alcohol,
Liquid propelene glycol
Glycerine
Ethyl alcohol used in the case of cardiac glycoside.
22. 22
ANTIBACTERIAL AGENTS
These are added in multiple dose containers.
To prevent microorganism growth
Limitted concenteration of agents are used.
Phenyl mercuric nitrate and thiomersol 0.01%.
Benzethonium chloride & benzalkonium chloride 0.01%.
Phenol & cresol 0.05%.
Chlorobutanol 0.05%.
23. 23
BUFFERS
Added to maintain pH.
To stabilize a solution from chemical degradation.
Citrate and acetate buffer.
Sodium benzoate and benzoic acid
Sodium tartarate and tartaric acid
Phosphate buffer.
25. 25
SURFACTANTS
Solubilise the active ingredient
Polyoxythylene sorbitan monooleate & Sorbitan
monooleate TONICITY AGENTS
Need isotonic solution to avoid destruction of red blood
cells, irritation, and tissue damage
More important for large volumes, rapidly administered,
and extravascular injections
Reduces the pain on injection
NaCl & KCl
Dextrose
Mannitol & Sorbitol Effect of different solutions on blood cells
26. CHELATING AGENTS
To remove trace elements that catalyse oxidative
degeneration
Ethelene diamine tetra acetic acid
26
CO-SOLVENT
Improve solubility
Prevent potential for hydrolysis
28. A clear and colorless liquid; odorless.
Water for injections is pyrogen -free.
It contains no added substance.
Water for injections is obtained from potable or Purified
water by distillation in an apparatus.
The distillate is collected and stored in conditions
designed to prevent growth of microorganisms and to
avoid any other contamination.
28
29. • The source water usually must be pretreated by one
or a combination of following treatment:
• Chemical softening, filtration, deionization, carbon
absorption, or reverse osmosis purification.
• There are three types of distillation still to produce
water for injection.
1. Compression distillation
2. Multiple-effect still
3. Reverse osmosis
29
30. • Vapor compression still is primarily designed for the
production of large volumes of high purity distillate with low
consumption of energy and water.
• Vapor compression processes produce water 5 to 10 times
more cost effectively than multiple effect distillers.
• PROCEDURE:
• Step 1: In a Vapor Compression still, the boiling process
begins with both heating elements turned on. As the water in
the boiling chamber reaches near boiling temperatures, the
compressor turns on.
30
31. • Step 2: In the compressor, the steam is pressurized, which
raises the steam's temperature before it is routed through a
special heat exchanger located inside the boiling chamber.
• Step 3: The pressurized steam gives off its heat to the tap
water inside the boiling chamber, causing this water to boil,
which creates more steam.
31
32. • Step 4: While the pressurized steam is giving up its
latent heat, the steam will condense. One of the
heating elements will cycle on and off periodically as
needed.
• Step 5: At this stage, the condensed steam is
considered distilled water but is still very hot--only
slightly cooler than boiling temperature.
32
34. • It is also designed to conserve energy and water usage.
• In principle, a series of single effect stills running at different
pressures.
• A series up to seven effect may be used, with the first effect
operated at a highest pressure and the last effect at
atmospheric pressure.
• The capacity of still can be increased by adding effects. The
quantity of distillate will also be affected by inlet steam
pressure 34
35. PRODEDURE:
Steam from the external source is used in the first effect
to generate steam under pressure from feed water, it is
used as a power source for second effect.
The steam used to drive the second effect condenses
as it gives up its heat of vaporization and forms a
distillate.
The process continues until the last effect, when the
steam is at atmospheric pressure and must be
condensed in a heat exchanger. 35
37. REVERSE OSMOSIS:
• The natural process of selective permeation of molecule
through a semi-permeable membrane separate two aqueous
solutions of different concentration is reversed.
• Pressure, usually between 200 to 400 psig, is applied to
overcome osmotic pressure and force pure water to
penetrate through the membrane.
• Membrane composed of cellulose esters or polyamides.
37
38. 38
•. It provide effective rejection of contaminant molecules in
raw water.
•Sodium chloride is most difficult to remove.
•Passage through two membranes in series is sometimes
used to increase the efficiency of removal of small
molecules.
• ex. Aqua chem , Finn-aqua, Meco , Milipore etc.
40. STORAGE AND DISTRIBUTION
• Distillate is collected in holding tanks for subsequent use.
• USP permit the storage of WFI at room temp. maximum for
only about 24hr.
• When the water can not be used at 80º c , heat exchangers
must be installed to reduce the temperature at the point of
use.
40
41. 41
LARGE VOLUME PARENTERALS
REQUIREMENTS
Sterile, non pyrogenic, free from particulate matter
Volume 101- 1000ml
Single dose unit
No preservative
Clear solution except fat emulsion
Isotonic, but hypertonic also administered in TPN
42. TYPES OF LARGE VOLUME PARENTERALS
1.HYPER
ALIMENTATION
SOLUTIONS
2. CARDIOLPAGIC
SOLUTIONS
3. PERITONIAL
DIALYSIS SOLUTION 4. IRRIGATING SOLUTIONS
42
43. 43
HYPERALIMENTATION SOLUTION
Admin. Of large amount of nutrients to patients who unable
to take food orally.
Formulation: mix. Of dextrose, amino acids , lipids,
electrolytes,& vitamines.
44. 44
TOTAL PARENTERAL NUTRITION
Def. :A method of feeding patients by infusing a mixture
of all necessary nutrients into the circulatory system, thus
bypassing the GIT.
CONTENT SOURCES
1. calories Dextrose
2. Nitrogen Crystalline amino acids
3. Electrlyte Na , K, Cl , Po4,
4. Vitamines Water soluble & Fat soluble
5. Elements Traces of Zn, Cu, Mn, Cr
45. 45
2. CARDIOLPLEGIC SOLUTIONS
Are LVP used in heart surgery to prevent injury to
myocardium during reperfusion, as well as to maintain
bloodless operating field.
Maintains the diastolic arrest.
Administerd in cold form.
Slightly alkaline to compensate metabolic acidosis,
Hypertonic
USE:
To minimize reperfusion injury resulting from tissue
edema.
46. 46
3. PERITONEAL DIALYSIS SOLUTION
Infused continuously into abdominal cavity, bathing
peritonium & are then continously withdrawn.
USE
Removal of toxic substances from body.
To aid & accelerate excretion normal.
To treat acute renal insufficiency.
47. 47
4. IRRIGATING SOLUTIONS
To irrigate ,flush, & aid in cleaning body activities &
wounds.
Certain IV solution ( normal saline ) may be used as
irrigating solution , but solution designed as irrigating soln
should not be used parenterally.
Use: Treatment of serious wounds infused in to blood
stream.
49. 49
Small volume parenterals
• Small volume intravenous injection is applied to an injection that is
packaged in containers labelled as containing 100 ml or less.
49
1. Solution:
2. Suspension:
3. Emulsion:
4. Dry powders:
50. solutions
• Typically used for delivering medications at a controlled infusion rate
• Most commonly solutions of 5% dextrose, normal saline, 45% normal
saline, or 5% dextrose with normal saline.
• Dextrose contributes glucose to meet energy needs and saline
contributes sodium, an electrolyte that maintains fluid balance and
cellular functions.
51. SUSPENSION
• They should be sterile, pyrogen free, stable,
re‐suspendable, syringeable, injectable, isotonic &
non‐irritating.
• They are usually administered by either subcutaneous
(S.C.) or intramuscular (I.M.) route.
• These suspensions usually contain between 0.5% and
5.0% solids & should have particle size less than 5
micrometer for I.M. or S.C. administration.
• Certain antibiotic preparations (For example procaine
Penicillin G) may contain up to 30% solids
51
52. • Advantages of Parental suspension
• It is better for the therapeutic use of drugs that are
insoluble in convention solvents.
• In this dosage from there is increased resistance to
hydrolysis & oxidation as drug is present in the solid
from.
• Formulation of controlled released drug is possible in
this dosage form.
• There is elimination of hepatic first pass effect.
52
53. Injectable Emulsion-
• An emulsion is a heterogenous dispersion of one
immiscible liquid in another.
• This inherently unstable system is made possible
through the use of an emulsifying agent, which prevent
coalescence of the dispersed droplet.
• Parenteral emulsion are rare because it is necessary
(and difficult) to achieve stable droplet of less than 1
micron meter to prevent emboli in blood vessels and it is
not usually necessary to achieve an emulsion for drug
administration. 53
54. 54
Dry Powders
Purpose: To overcome the intrinsic instability of the drug, be
reconstitute before use.
• Production Method:
– Freeze-drying
–Aseptic crystallization and dry powder filling
– Spray-drying
55. • Pharmaceutical product development by
N K Jain.
• Theory and practice of industrial pharmacy by
Lachman and Leiberman.
• www. Google.com.
55
REFERENCE