Added substances for parenterals
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This document discusses various types of added substances or additives that are commonly used in parenteral preparations to enhance stability and appearance. It describes criteria for added substances, such as being non-toxic and not interfering with the drug's efficacy or assay. Several classes of additives are defined, including antimicrobials, antioxidants, buffers, solubilizing agents, and tonicity adjusting agents. Examples are provided for specific additives belonging to each class.
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Small volume parenterals
Small volume parenterals are sterile preparations intended for injection through the skin. They typically range from 1-30 mL in volume and are often given as multiple doses. Common types include ampules, vials, dry powders, and prefilled syringes. Parenterals contain water, solutes to maintain stability and efficacy, added substances like preservatives, and are sterilized using various methods like heat, filtration, or radiation to kill microbes and prevent contamination. They undergo testing for leaks, clarity, sterility, and presence of pyrogens before release and use.
Parenteral Products
The document discusses parenteral products and their administration. It defines parenteral as referring to administration by injection rather than orally, bypassing the gastrointestinal tract. It then discusses the advantages and disadvantages of the parenteral route, including faster systemic delivery but also risks of infection. The document outlines various routes of parenteral injection and provides details on procedures like subcutaneous, intramuscular, and intravenous injection. It also discusses formulation, processing, and quality testing of parenteral products.
Opthalmics Preparation and its Evaluation parameters
This document summarizes the packaging and evaluation of ophthalmic products. It discusses various containers like plastics and glass used for ophthalmic packaging. It also describes different types of ophthalmic products like eye drops, ointments, lotions and inserts. Key evaluation parameters discussed include sterility testing, clarity testing, leakage testing and testing for metal particles. Assay, pH, viscosity testing are also summarized as important evaluation methods. The document concludes with a brief overview of the definition, ideal properties and formulation of different ophthalmic preparations.
Hard gelatin capsules ppt B
Hard gelatin capsules are two-piece capsules consisting of a cap and body. They are manufactured through a dipping, spinning, drying, stripping, trimming and polishing process. The shell contains gelatin, dyes, opacifiers, plasticizers and preservatives. Capsules are filled using machines that separate the caps from bodies, fill the bodies with powders or granules, replace the caps and seal the capsule. Quality control tests include size, shape, content uniformity and dissolution. Capsules provide advantages like easy swallowing, taste masking and compatibility of multiple active ingredients.
Processing of tablet
This document discusses tablets as a type of solid oral dosage form used for drug delivery. It defines tablets as compressed powders or granules containing medicinal ingredients. The document outlines the advantages of tablets such as ease of administration and accurate dosing. It also discusses different types of tablets including compressed, enteric coated, and chewable tablets. The document provides details on the manufacturing process for compressed tablets including preparation of granules, compression, and coating. It also lists common excipients used in tablet formulations such as diluents, binding agents, and disintegrating agents.
Parenteral formulations
Parenterals are formulated as solutions, suspensions, emulsions, powders, or nano systems. They contain an active ingredient, vehicle, and added substances to maintain stability and sterility. Added substances include solubilizers, antioxidants, chelating agents, antimicrobial preservatives, buffers, tonicity contributors, and protectants. Parenterals are formulated to be sterile and in stable forms like suspensions, solutions, emulsions or powders for reconstitution to facilitate easy administration while maintaining purity and therapeutic activity. They undergo quality testing for leakage, clarity, pyrogenicity and sterility.
Formulation and Manufacturing of Aerosols and their Evaluation
This document discusses pharmaceutical aerosols, including their components, formulation, manufacturing, and evaluation. Aerosols contain one or more active ingredients that are emitted as fine droplets or particles upon actuation. They consist of a product concentrate and propellant. Common propellants include liquefied gases like CFCs and HFCs or compressed gases like CO2. Aerosols provide advantages like convenience and quick onset of action but also have disadvantages like potential for irritation and valve clogging.
Pharmaceutical aerosols
Pharmaceutical aerosols are therapeutic active ingredients packaged in a pressurized system. They have advantages like direct delivery to affected areas without contamination. Aerosols consist of a propellant, container, valve, and product concentrate. Common propellants include hydrocarbons and gases. Containers must withstand high pressure and are often metal or glass. Valves meter doses and come in types like spray or foam. Formulations contain an active ingredient and propellant to achieve desired properties. Quality is ensured through testing of components, dosage, leakage and other parameters.
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Small volume parenterals
Small volume parenterals are sterile preparations intended for injection through the skin. They typically range from 1-30 mL in volume and are often given as multiple doses. Common types include ampules, vials, dry powders, and prefilled syringes. Parenterals contain water, solutes to maintain stability and efficacy, added substances like preservatives, and are sterilized using various methods like heat, filtration, or radiation to kill microbes and prevent contamination. They undergo testing for leaks, clarity, sterility, and presence of pyrogens before release and use.
Parenteral Products
The document discusses parenteral products and their administration. It defines parenteral as referring to administration by injection rather than orally, bypassing the gastrointestinal tract. It then discusses the advantages and disadvantages of the parenteral route, including faster systemic delivery but also risks of infection. The document outlines various routes of parenteral injection and provides details on procedures like subcutaneous, intramuscular, and intravenous injection. It also discusses formulation, processing, and quality testing of parenteral products.
Opthalmics Preparation and its Evaluation parameters
This document summarizes the packaging and evaluation of ophthalmic products. It discusses various containers like plastics and glass used for ophthalmic packaging. It also describes different types of ophthalmic products like eye drops, ointments, lotions and inserts. Key evaluation parameters discussed include sterility testing, clarity testing, leakage testing and testing for metal particles. Assay, pH, viscosity testing are also summarized as important evaluation methods. The document concludes with a brief overview of the definition, ideal properties and formulation of different ophthalmic preparations.
Hard gelatin capsules ppt B
Hard gelatin capsules are two-piece capsules consisting of a cap and body. They are manufactured through a dipping, spinning, drying, stripping, trimming and polishing process. The shell contains gelatin, dyes, opacifiers, plasticizers and preservatives. Capsules are filled using machines that separate the caps from bodies, fill the bodies with powders or granules, replace the caps and seal the capsule. Quality control tests include size, shape, content uniformity and dissolution. Capsules provide advantages like easy swallowing, taste masking and compatibility of multiple active ingredients.
Processing of tablet
This document discusses tablets as a type of solid oral dosage form used for drug delivery. It defines tablets as compressed powders or granules containing medicinal ingredients. The document outlines the advantages of tablets such as ease of administration and accurate dosing. It also discusses different types of tablets including compressed, enteric coated, and chewable tablets. The document provides details on the manufacturing process for compressed tablets including preparation of granules, compression, and coating. It also lists common excipients used in tablet formulations such as diluents, binding agents, and disintegrating agents.
Parenteral formulations
Parenterals are formulated as solutions, suspensions, emulsions, powders, or nano systems. They contain an active ingredient, vehicle, and added substances to maintain stability and sterility. Added substances include solubilizers, antioxidants, chelating agents, antimicrobial preservatives, buffers, tonicity contributors, and protectants. Parenterals are formulated to be sterile and in stable forms like suspensions, solutions, emulsions or powders for reconstitution to facilitate easy administration while maintaining purity and therapeutic activity. They undergo quality testing for leakage, clarity, pyrogenicity and sterility.
Formulation and Manufacturing of Aerosols and their Evaluation
This document discusses pharmaceutical aerosols, including their components, formulation, manufacturing, and evaluation. Aerosols contain one or more active ingredients that are emitted as fine droplets or particles upon actuation. They consist of a product concentrate and propellant. Common propellants include liquefied gases like CFCs and HFCs or compressed gases like CO2. Aerosols provide advantages like convenience and quick onset of action but also have disadvantages like potential for irritation and valve clogging.
Pharmaceutical aerosols
Pharmaceutical aerosols are therapeutic active ingredients packaged in a pressurized system. They have advantages like direct delivery to affected areas without contamination. Aerosols consist of a propellant, container, valve, and product concentrate. Common propellants include hydrocarbons and gases. Containers must withstand high pressure and are often metal or glass. Valves meter doses and come in types like spray or foam. Formulations contain an active ingredient and propellant to achieve desired properties. Quality is ensured through testing of components, dosage, leakage and other parameters.
Sterile Dosage Forms
This document provides an overview of sterile dosage forms, including parenteral products and ophthalmic preparations. It discusses various routes of parenteral administration and key components of parenteral products such as antioxidants, buffers, and solvent systems. It also covers topics like containers and closures, formulation of solutions and suspensions, and sterilization methods. The document serves as a reference for professionals working with sterile dosage forms and parenteral drug delivery.
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This document provides an overview of parenterals (injectable drugs), including:
- Definitions and routes of administration for parenterals
- General requirements like vehicles, additives, and ensuring isotonicity
- Methods for sterilization, formulation, packaging, and quality control testing of parenterals
- Considerations for facilities and production areas to ensure sterility during manufacturing
It discusses key aspects of developing parenteral drugs like pre-formulation studies, adjustment of tonicity, and precautions for aseptic work. Common sterilization techniques and packaging materials are outlined. Quality control tests evaluated include leakage, clarity, sterility, and pyrogen testing. Overall, the document serves as an introduction
Types of parenteral formulations
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
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.
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This document discusses enteric coatings, which are coatings that prevent the release of drugs in the stomach and allow release in the small intestine. It provides reasons for enteric coatings such as protecting drugs from stomach acid, preventing gastric irritation, delivering intended local action in the intestine, and providing delayed or prolonged release. It discusses materials commonly used for enteric coatings and their properties. Examples are given of drugs that benefit from enteric coatings and commercial products using this technology.
Sterilization methods of parenterals
The document summarizes various sterilization methods used for parenterals including dry heat, moist heat, filtration, radiation, and gas sterilization. Dry heat is used to sterilize glassware and some metals by heating to temperatures between 160-180°C. Moist heat sterilization with steam under pressure is commonly used for liquids and porous materials in an autoclave. Filtration through sterile membranes can sterilize heat-labile solutions. Radiation methods include UV, gamma rays, and electrons. Gaseous methods use ethylene oxide or formaldehyde gas.
Quality Control of Aerosols
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Propellants
This document provides an overview of inhalation aerosols, including the propellants used, packaging, and filling techniques. It discusses the main components of aerosols like propellants, containers, valves, and actuators. The two main types of propellants are liquefied gas propellants and compressed gas propellants. It also summarizes the advantages and disadvantages of aerosols as well as the pressure filling and cold filling methods used to manufacture pharmaceutical aerosols.
Pharmaceutical aerosols
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Opthalmic products
This document discusses various ophthalmic products including eye drops, eye lotions, eye suspensions, eye ointments, and contact lens solutions. It describes the ideal characteristics of ophthalmic products such as being sterile, isotonic, and having the proper pH and viscosity. It also discusses the types of microorganisms that can cause eye infections and how sterility is achieved. The document provides details on the formulation, preparation, and labeling of different ophthalmic products.
Additive substances for parenterals
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
suspension
Suspension is made of two phase system, consisting of a finely divided solid particles (Dispersed phase) distributed in a particular manner throughout another medium (Continuous phase).
Parenteral preparations
Parenterals are sterile solutions or suspensions of drugs administered through routes other than the gastrointestinal tract. This document discusses various aspects of parenterals including their routes of administration, requirements for stability and sterility, and types such as small volume parenterals and large volume parenterals. It provides details on the production of water for injection and various parenteral vehicles, formulations, and examples.
Opthalmic products
This document discusses ophthalmic preparations, which are sterile liquid or semi-solid preparations intended for application to the eye. It defines ophthalmic preparations and lists the main types, which include eye drops, eye lotions, eye ointments, eye suspensions, and contact lens solutions. It then discusses the key requirements for ophthalmic preparations, such as being free of foreign particles, having appropriate viscosity and tonicity, a suitable pH, and maintaining sterility. The document provides details on administering eye drops properly and packaging and caring for contact lenses and their solutions.
Formulations of injections
Injections must be sterile, isotonic solutions or suspensions of drugs meant for introduction into the body via needle. Solutions contain dissolved drugs while suspensions contain insoluble particles dispersed in liquid. Both contain excipients like antioxidants, antimicrobials, buffers, and substances for adjusting tonicity or viscosity. Diazepam 5mg/ml and Amikacin 250mg/ml injections are examples provided, with details on active ingredients, excipients, uses, side effects and preparation methods involving strict aseptic techniques.
Hard gelatin capsules - a detailed study
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
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The document discusses parenteral formulations, which are sterile dosage forms administered directly into the body rather than orally. It defines parenterals and describes various types including small and large volume injections, powders, and implants. Key factors in parenteral design are discussed such as drug solubility, vehicle selection, dosage form, ingredients, pH, and color. Common vehicles like water and buffers are outlined. The document also covers routes of administration, isotonicity, production facilities and procedures, and quality control testing for parenteral products.
quality control test of parenteral product
This document summarizes the industrial training completed by a student at Park Benz Laboratories, a manufacturer and exporter of small volume parenterals located in Mandideep, Madhya Pradesh. The key activities of the company include manufacturing sterile injectable solutions of products like vitamins, antibiotics, and steroids. During the training, the student learned about the various sections of the company like production, quality control, and quality assurance. The quality control department conducts various tests on parenteral products to ensure sterility, pyrogen absence, uniformity of content and weight, and integrity of packaging.
Parenteral production and aseptic area
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
Application of preformulation consideration in the development of
This document discusses preformulation studies for developing parenteral dosage forms. Preformulation involves studying a new drug's physicochemical properties to create stable, effective formulations. Key aspects of preformulation include assessing solubility through methods like changing pH, adding co-solvents or complexing agents, and evaluating stability under various conditions like heat, light and pH to determine a drug's degradation profile. The goal of preformulation is to obtain information to guide formulation development and ensure the drug molecule is most stable.
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The document discusses liquid oral dosage forms such as syrups and elixirs. It covers formulation and manufacturing considerations for liquid orals including solubility enhancement techniques, preservation, viscosity control, sweetening agents, flavors, and stability testing. Specific types of oral liquids are described like solutions, suspensions, emulsions. The key steps in formulation of syrups and elixirs involve solubility of drugs, addition of preservatives, viscosity agents, sweeteners and flavors. Manufacturing involves selection of raw materials, equipment used for mixing, filling and packaging.
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This document provides an overview of sterile dosage forms, including parenteral products and ophthalmic preparations. It discusses various routes of parenteral administration and key components of parenteral products such as antioxidants, buffers, and solvent systems. It also covers topics like containers and closures, formulation of solutions and suspensions, and sterilization methods. The document serves as a reference for professionals working with sterile dosage forms and parenteral drug delivery.
Parentrals
This document provides an overview of parenterals (injectable drugs), including:
- Definitions and routes of administration for parenterals
- General requirements like vehicles, additives, and ensuring isotonicity
- Methods for sterilization, formulation, packaging, and quality control testing of parenterals
- Considerations for facilities and production areas to ensure sterility during manufacturing
It discusses key aspects of developing parenteral drugs like pre-formulation studies, adjustment of tonicity, and precautions for aseptic work. Common sterilization techniques and packaging materials are outlined. Quality control tests evaluated include leakage, clarity, sterility, and pyrogen testing. Overall, the document serves as an introduction
Types of parenteral formulations
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
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.
Enteric coated tablet
This document discusses enteric coatings, which are coatings that prevent the release of drugs in the stomach and allow release in the small intestine. It provides reasons for enteric coatings such as protecting drugs from stomach acid, preventing gastric irritation, delivering intended local action in the intestine, and providing delayed or prolonged release. It discusses materials commonly used for enteric coatings and their properties. Examples are given of drugs that benefit from enteric coatings and commercial products using this technology.
Sterilization methods of parenterals
The document summarizes various sterilization methods used for parenterals including dry heat, moist heat, filtration, radiation, and gas sterilization. Dry heat is used to sterilize glassware and some metals by heating to temperatures between 160-180°C. Moist heat sterilization with steam under pressure is commonly used for liquids and porous materials in an autoclave. Filtration through sterile membranes can sterilize heat-labile solutions. Radiation methods include UV, gamma rays, and electrons. Gaseous methods use ethylene oxide or formaldehyde gas.
Quality Control of Aerosols
Pharmaceutical aerosols have been playing a crucial role in the health and wellbeing of millions of people throughout the world for many years. These products include pressurized metered dose inhalers (MDIs), dry powder inhalers (DPIs), nebulizers, sublingual’s, skin sprays (coolants, anaesthetics, etc.) and dental sprays. The technology’s continual advancement, the ease of use, and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years.
Many of the tests required for the evaluation of MDIs are similar to those used for other dosage forms. These include description, identification, and assay of the active ingredient; microbial limits; moisture content; net weight, degradation products and impurities (if any); extractable; and any other tests deemed appropriate for the active ingredient.
Propellants
This document provides an overview of inhalation aerosols, including the propellants used, packaging, and filling techniques. It discusses the main components of aerosols like propellants, containers, valves, and actuators. The two main types of propellants are liquefied gas propellants and compressed gas propellants. It also summarizes the advantages and disadvantages of aerosols as well as the pressure filling and cold filling methods used to manufacture pharmaceutical aerosols.
Pharmaceutical aerosols
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
Opthalmic products
This document discusses various ophthalmic products including eye drops, eye lotions, eye suspensions, eye ointments, and contact lens solutions. It describes the ideal characteristics of ophthalmic products such as being sterile, isotonic, and having the proper pH and viscosity. It also discusses the types of microorganisms that can cause eye infections and how sterility is achieved. The document provides details on the formulation, preparation, and labeling of different ophthalmic products.
Additive substances for parenterals
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
suspension
Suspension is made of two phase system, consisting of a finely divided solid particles (Dispersed phase) distributed in a particular manner throughout another medium (Continuous phase).
Parenteral preparations
Parenterals are sterile solutions or suspensions of drugs administered through routes other than the gastrointestinal tract. This document discusses various aspects of parenterals including their routes of administration, requirements for stability and sterility, and types such as small volume parenterals and large volume parenterals. It provides details on the production of water for injection and various parenteral vehicles, formulations, and examples.
Opthalmic products
This document discusses ophthalmic preparations, which are sterile liquid or semi-solid preparations intended for application to the eye. It defines ophthalmic preparations and lists the main types, which include eye drops, eye lotions, eye ointments, eye suspensions, and contact lens solutions. It then discusses the key requirements for ophthalmic preparations, such as being free of foreign particles, having appropriate viscosity and tonicity, a suitable pH, and maintaining sterility. The document provides details on administering eye drops properly and packaging and caring for contact lenses and their solutions.
Formulations of injections
Injections must be sterile, isotonic solutions or suspensions of drugs meant for introduction into the body via needle. Solutions contain dissolved drugs while suspensions contain insoluble particles dispersed in liquid. Both contain excipients like antioxidants, antimicrobials, buffers, and substances for adjusting tonicity or viscosity. Diazepam 5mg/ml and Amikacin 250mg/ml injections are examples provided, with details on active ingredients, excipients, uses, side effects and preparation methods involving strict aseptic techniques.
Hard gelatin capsules - a detailed study
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
Parenterals
The document discusses parenteral formulations, which are sterile dosage forms administered directly into the body rather than orally. It defines parenterals and describes various types including small and large volume injections, powders, and implants. Key factors in parenteral design are discussed such as drug solubility, vehicle selection, dosage form, ingredients, pH, and color. Common vehicles like water and buffers are outlined. The document also covers routes of administration, isotonicity, production facilities and procedures, and quality control testing for parenteral products.
quality control test of parenteral product
This document summarizes the industrial training completed by a student at Park Benz Laboratories, a manufacturer and exporter of small volume parenterals located in Mandideep, Madhya Pradesh. The key activities of the company include manufacturing sterile injectable solutions of products like vitamins, antibiotics, and steroids. During the training, the student learned about the various sections of the company like production, quality control, and quality assurance. The quality control department conducts various tests on parenteral products to ensure sterility, pyrogen absence, uniformity of content and weight, and integrity of packaging.
Parenteral production and aseptic area
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
Application of preformulation consideration in the development of
This document discusses preformulation studies for developing parenteral dosage forms. Preformulation involves studying a new drug's physicochemical properties to create stable, effective formulations. Key aspects of preformulation include assessing solubility through methods like changing pH, adding co-solvents or complexing agents, and evaluating stability under various conditions like heat, light and pH to determine a drug's degradation profile. The goal of preformulation is to obtain information to guide formulation development and ensure the drug molecule is most stable.
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The document discusses liquid oral dosage forms such as syrups and elixirs. It covers formulation and manufacturing considerations for liquid orals including solubility enhancement techniques, preservation, viscosity control, sweetening agents, flavors, and stability testing. Specific types of oral liquids are described like solutions, suspensions, emulsions. The key steps in formulation of syrups and elixirs involve solubility of drugs, addition of preservatives, viscosity agents, sweeteners and flavors. Manufacturing involves selection of raw materials, equipment used for mixing, filling and packaging.
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Analysis of excipients of interest
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Pharmaceutical Additives
These are the substances which are added in the formulation along the therapeutic agent so as to impart specific qualities in the formulation.
These are have very little or no therapeutic value but are necessary in the manufacture of various dosage forms.
Purposes served by Additives:
Provide bulk to the formulation.
Facilitate drug absorption or solubility and other pharmacokinetic considerations.
Aid in handling of “API” during manufacturing .
Provide stability and prevent from denaturation etc
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PARENTERAL ROUTES OF DRUG ADMINISTRATION
PARENTERAL ROUTE OF DRUG ADMINISTRATION
The term parenteral refers to injectable routes of administration of drug.
So as a hole it means outside of intestine.
PARENTRAL MEDICATIONS AND STERILE FLUIDS:
The parenteral route of drug administration are:
1. Intravenous IV
2. Intramuscular IM
3. Intradermal
4. Subcutaneous
PYROGENS: The water used in parenteral should be free of pyrogens.
METHODS OF REMOVING PYROGENS:
1. Distillation
2. Reverse osmosis
3. Heating at 180 degree celcius for 3 to 4 hours
4. Adsorption method
OFFICIAL TYPES OF INJECTIONS:
SOLVENTS AND VEHICLES USED FOR INJECTIONS:
STERILE WATER FOR INJECTION USP
BACTERIOSTATIC WATER FOR INJECTION
NaCl injection USP
BACTERIOSTATIC SODIUM CHLORIDE INJECTION USP
RINGER INJECTION USP
LACTATED RINGER INJECTION USP
NON AQUEOUS VEHICLES
ADDED SUBSTANCES USED IN PARENTERALS
SOLUBILIZING AGENTS
STABILIZERS
ANTIMICROBIAL AGENTS
ANTI OXIDANTS USED IN PARENTERALS.
General requirements of parenteral preparations
General requirements of parenteral preparationsDr. Prashant L. Pingale GES's Sir Dr. M. S. Gosavi College of Pharmacy, Nashik
The document discusses the general requirements and components of sterile pharmaceutical products, including parenteral and ophthalmic formulations. It describes various vehicles, additives, and agents commonly used in sterile formulations and their purposes. These include aqueous and non-aqueous vehicles, antimicrobials, antioxidants, buffers, stabilizers, tonicity adjusting agents, and protectants. It also differentiates between small and large volume parenterals and outlines ideal properties of sterile dosage forms such as sterility, isotonicity, and stability.Excipients sb
An excipient is a pharmacologically inactive substance formulated along with the active pharmaceutical ingredient to provide bulk, improve solubility and stability, aid manufacturing, and enhance the finished dosage form. Excipients include fillers, binders, disintegrants, coatings, lubricants, glidants, preservatives, antioxidants, flavorings, colors, solvents, and buffers. Each excipient type has distinct purposes and properties to facilitate drug delivery and product performance.
5 Parenteral preparations; Formulation and packaging.pdf
This document provides information on parenteral preparations, which are drug formulations that are administered via injection. Key points include:
- Parenteral formulations must be sterile, pyrogen-free, and free of particulate matter to safely administer drugs directly into the body.
- They include solutions, suspensions, emulsions, and other dosage forms that can deliver drugs like peptides and proteins that would otherwise be destroyed in the gastrointestinal tract.
- Components include active ingredients, additives, vehicles, and sterile containers/closures. Characteristics include sterility, stability, isotonicity, and compatibility.
- Common parenteral vehicles include water, oils, and alcohols. Additives include preservatives,
suspension.ppt
This document discusses pharmaceutical suspensions. It defines a suspension as a coarse dispersion containing finely divided insoluble material suspended in a liquid medium. Suspensions contain dispersed particles above the colloidal size of 1μm. Common examples include antacid, antibiotic, and analgesic oral suspensions. Suspensions are used for insoluble or poorly soluble drugs to provide liquid oral dosage forms. They can also be used topically, parenterally, and ophthalmically. Proper formulation requires the use of suspending agents, wetting agents, dispersing agents, and flocculating agents. Stability and routes of administration are also discussed.
suspension of medicated syrups for industry ppt
This document discusses pharmaceutical suspensions. It defines a suspension as a coarse dispersion containing finely divided insoluble material suspended in a liquid medium. Suspensions contain dispersed particles above the colloidal size of 1μm. Common examples include antacid, antibiotic, and analgesic oral suspensions. Suspensions are used for insoluble or poorly soluble drugs to provide liquid oral dosage forms. They can also be used topically, parenterally, and ophthalmically. Proper formulation requires the use of suspending agents, wetting agents, dispersing agents, and flocculating agents. Stability and routes of administration are also discussed.
EXCIPIENTS
This document provides information on excipients used in pharmaceutical formulations. It defines excipients as inactive ingredients that serve various purposes such as providing bulk, aiding drug absorption, protecting active ingredients, and contributing to product stability and patient acceptability. Common excipients are classified based on origin, function in dosage forms, and physicochemical properties. Specific excipients like lactose, sorbitol, propylene glycol and citric acid are described in detail including their uses, safety and toxicity.
LIQUID DOSAGE FORMS.pptx
Liquid dosage forms: Advantages and disadvantages of liquid dosage forms. Excipients used in formulation of liquid dosage forms. Solubility enhancement techniques
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5 Parenteral preparations; Formulation and packaging.pdf
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Added substances for parenterals
- 2. PREPARED BY MASH' HOOD MAHMOOD KHAN SHAHID UZAIR SAIF ULLAH KHAN D14E121 D14E122 D14E12 3
- 3. ADDED SUBSTANCES:- “Added substances or additives are generally employed in parenteral preparation to enhance its physical and chemical stability i.e shelf life or esthetic appearance.”
- 4. CRITERIA OF ADDED SUBSTANCE:- • It must be non toxic in quantity administered to the patient • It should not interfere with therapeutic efficacy nor with the assay of active therapeutic compound • It must be prevented from adversely affecting the product
- 5. TYPES OF PARENTERAL ADDITIVES:- Antimicrobials Antioxidants Buffers Bulking agent Chelating agent Protectants Solubilizing agent Surfactants Tonicity adjusting agents Antifungal agents Hydrolysis inhibitors Antifoaming agents
- 6. ANTIMICROBIALS AGENTS:- A suitable preservative system is required in all multiple dose parenteral products to inhibit the growth of microorganism accidentally introduced during withdraw of individual doses. Preservatives may be to single dose parenteral products that are not terminally sterilized as a sterility assurance measure i.e. to prevent the growth of any microorganism that could be introduced of there were any inadvertent breach of asepsis during filling operations
- 7. EXAMPLE:- • Benzalkonium chloride • Benzethonium chloride • Benzyl alcohol • Phenol • Metacresol
- 8. ANTIOXIDANTS:- Many drugs in solutions are subject to oxidative degradation. Such reaction are mediated by free radicals or by molecular oxygen or removal of hydrogen . Oxidative decomposition is catalyzed by metal, hydrogen and hydroxyl ions. Drugs possessing a favorable oxidation potential will be especially vulnerable to oxidation. For example, a great number of drugs are formulated in the reduced form (e.g. epinephrine,morphine,ascorbic acid,e.t.c.) and are easily oxidized. By increasing the oxidation potential of the drug oxidation can be minimized.
- 9. EXAMPLES:- . Salts of sulfur dioxide including bisulfite , metabisulfite and sulfite are the most common antioxidant used in aqueous parenterals.
- 10. BUFFERS:- Many drugs require a certain pH range to maintain product stability. Drug stability strongly depend on the pH of the solution. Change in pH may occur during storage by the following ways:- • By dissolving gas constituent in the product • By releasing of constituents from rubber closures or plastic components in contact with the product • By dissolving of gas and vapours from airspace in the container • Reactions within the product Buffer system for parenterals consist of either a weak base or a salt of weak base or a weak acid or salt of weak acid
- 11. EXAMPLES:- • Acetic acid • Adipic acid • Citric acid • Sodium bicarbonate • Sodium carbonate
- 12. CHELATING AGENT:- Chelating metals are added to complex and thereby inactivate metals such as copper, iron , zinc that generally catalyze oxidative degradation of drug molecules. Sources of metal combination include raw material impurities solvents such as water, rubber stoppers, and containers and equipment employed in the manufacturing process.
- 13. EXAMPLES:- • Edetate disodium • Edetate tetrasodium
- 14. INERT GASES:- Another means of enhancing the product integrity of oxygen sensitive medicaments is by displacing the air the solution with nitrogen or argon. This technique may be made more effective by first purging with nitrogen or boiling the water to reduce dissolved oxygen. The container is also purged with nitrogen or argon before filling and may also be topped off with gas before sealing.
- 15. SOLUBILIZING, WETTING AGENTS:- Solubilizing agents are used to increased drug solubility by using non aqueous solvents Examples:- • Polyethlene glycol (PEG) • Ethyl alcohol(C2H5OH) • Glycerin • Lecithin • povidone
- 16. SURFACTANTS:- Surfactants are used :- • To dispose a water insoluble drugs as a colloidal dispersion • For wetting powder • To prevent crystal growth in a suspension • To provide acceptable syringability • For solubilizing steroids and fat soluble vitamins
- 17. EXAMPLE:- • Polyethylene • Sorbitan monooleate
- 18. TONICITY ADJUSTMENT AGENTS:- Isotonicity is important for parenteral preparation because the possibility that the product may penetrate red blood cell and cause hemolysis is greatly reduced if the solution is isotonic with blood i.e. the cells maintain their tone. Solution that less osmotic pressure than the blood plasma called hypotonic and solution that more osmotic pressure than the blood plasma called hypertonic. When introduce hypotonic solution cell may swell and offers brust because of diffusion of water into the cell i.e. hemolysis, if introduce hypertonic solution ,the cell may lose water and shrink. In isotonic solution the cell maintain their tone and the solution is isotonic with human erythrocytes.
- 19. EXAMPLES:- • Sodium chloride • Gelatin • Lactose • Dextrose • Sorbitol
- 20. PROTECTANT:- Protectants are used:- • To protect against loss of activity caused by some stress • To prevent the loss of active ingredients by adsorption to process equipment or to primary packaging material Protectants are used in the formulations of proteins.
- 21. EXAMPLE:- • Sucrose • Glucose • Maltose • Lactose