Ophthalmic products are sterile preparations meant for application to or administration into the eye. Common types include eye drops, lotions, ointments, and suspensions. They must meet certain requirements regarding particles, viscosity, tonicity, pH, and sterility. Formulations contain drugs, preservatives, and other excipients. Biologics include antigens that induce antibody responses and antibodies that recognize invading organisms. Major immunoglobulin classes are IgA, IgD, IgE, IgG, and IgM. Immunity can be natural or acquired through active or passive means.
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.
The presentation describes types advantages, disadvantages of parenteral preparations, route of administration, general requirement, evaluation, labeling & packaging, containers & their types etc
The document discusses the manufacturing process of parenteral preparations. It describes parenterals as sterile liquids or solids for injection or implantation. The manufacturing process involves planning, material management, production, quality control testing, filling, and packaging. Production areas are divided into strict zones based on cleanliness. Environmental controls and facility design aim to prevent contamination, with areas for filling, weighing, storage, and administration. Personnel flow and utility locations are also considered for efficiency.
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.
A sterile area is required for tissue culture labs to prevent contamination. The document outlines requirements for the sterile area including filtering air with HEPA filters, maintaining positive pressure, limiting windows and doors. It also lists essential equipment for cell culture like laminar flow cabinets, incubators, centrifuges, microscopes, and autoclaves. Proper hygiene is important as well, with researchers wearing protective coats, masks, gloves and goggles.
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.
The presentation describes types advantages, disadvantages of parenteral preparations, route of administration, general requirement, evaluation, labeling & packaging, containers & their types etc
The document discusses the manufacturing process of parenteral preparations. It describes parenterals as sterile liquids or solids for injection or implantation. The manufacturing process involves planning, material management, production, quality control testing, filling, and packaging. Production areas are divided into strict zones based on cleanliness. Environmental controls and facility design aim to prevent contamination, with areas for filling, weighing, storage, and administration. Personnel flow and utility locations are also considered for efficiency.
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.
A sterile area is required for tissue culture labs to prevent contamination. The document outlines requirements for the sterile area including filtering air with HEPA filters, maintaining positive pressure, limiting windows and doors. It also lists essential equipment for cell culture like laminar flow cabinets, incubators, centrifuges, microscopes, and autoclaves. Proper hygiene is important as well, with researchers wearing protective coats, masks, gloves and goggles.
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
Pharmaceutical water refers to various types of water used in pharmaceutical applications. There are bulk and packaged forms. Bulk forms include purified water and water for injection. Purified water is used to clean equipment and prepare some bulk pharmaceuticals, while water for injection must be pyrogen-free and protected from microbes for parenteral use. Packaged sterile forms include bacteriostatic water, sterile water for injection, sterile water for irrigation, sterile water for inhalation, and sterile purified water. Each has distinct formulations and uses such as diluting medications, irrigation, or inhalation solutions. Proper protection from contamination and adherence to specifications is important for safety.
Quality control test: Containers, Closures and Secondary packing materialsPranali Polshettiwar
This document summarizes quality control tests for containers, closures, and secondary packaging materials. It describes common materials used for each, such as glass, plastic, metal for containers and rubber, plastic, metal for closures. Key quality tests for containers include powdered glass test, water attack test, hydrolytic resistance test, and thermal shock test. Tests for closures include residue on evaporation, pH of extract, and sterility. Secondary packaging materials like paper and cardboard are also tested for quality.
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
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.
Parenteral products are unique dosage forms that are injected directly into the body, bypassing the gastrointestinal tract. They must be exceptionally pure and sterile to avoid contamination. Certain drugs can only be administered parenterally because they are degraded in the GI tract. Characteristics of parenteral products include being sterile, pyrogen-free, isotonic with body fluids, and stable both chemically and microbiologically throughout their shelf life. The preformulation properties of drugs and excipients used in parenterals, such as solubility, thermal profile, and particle size, must be evaluated to ensure quality, safety and efficacy.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
This document provides guidance on validating a liquid filling and sealing machine. It discusses the key stages of validation including user requirement specification, design qualification, installation qualification, operational qualification, and performance qualification. The performance qualification section provides specific tests to validate the machine's weight variation, filling volume accuracy, particle contamination levels, leak testing, and oxygen content. Requalification of the machine is recommended on a defined schedule or after any changes to ensure continued proper operation.
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.
Quality Control Of Parenteral PreparationsQurat Ul Ain
This document provides information about quality control of parenterals. It discusses key terms related to parenterals and routes of administration such as intravenous, intramuscular, and subcutaneous. The document outlines quality control tests performed on parenterals including leaker tests, pyrogen tests, particulate tests, sterility tests, and uniformity of content tests. Specific procedures for leaker tests and pyrogen tests using the LAL assay are described. The importance of quality control in ensuring parenterals are free from contamination and meet defined quality standards is also emphasized.
Eye, ear and nasal drops are sterile aqueous or oily solutions meant for instillation into respective areas. Eye drops contain drugs that are antiseptic, anesthetic, anti-inflammatory or cause pupil dilation/constriction. Ear drops and nasal drops contain medications to relieve conditions like congestion. All three include active ingredients, vehicles, preservatives and adjuvants in suitable containers. They must be free of particles, sterile, have proper pH, tonicity, viscosity, surface activity and not cause irritation. Thickening agents, isotonic solutions, and surfactants are added to meet these requirements.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
The document summarizes procedures for evaluating ophthalmic drug preparations. It discusses that evaluation includes sterility testing, clarity testing, leak testing, and testing for metal particles in ointments. It also describes that drug product quality tests assess attributes like identification, potency, purity, sterility and particulate matter, while performance tests evaluate drug release. Key quality tests discussed are identification, assay, pH, osmolarity, bacterial endotoxins, and uniformity of dosage units. Specific tests covered include viscosity and drop size.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
This document discusses pharmaceutical packaging technology. It defines pharmaceutical packaging and outlines ideal packaging requirements. The key functions of packaging are then described, including product identification, protection, facilitating use, promotion, marketing, convenience, barrier protection and security. Various packaging materials are also discussed, including glass, metals, rubbers, plastics, fibrous materials and films. Specific plastic materials like polyethylene, polypropylene, polyvinyl chloride and polyvinylidene chloride are explained in terms of their properties and uses in pharmaceutical packaging.
The document discusses various evaluation tests performed on parenteral products, including sterility testing, clarity testing, leakage testing, pyrogen testing, and assay. Sterility testing involves incubating samples in culture media to check for microbial growth. Clarity testing examines products for visible particles. Leakage testing checks for cracks in ampoules. Pyrogen testing involves injecting products into rabbits to monitor for fever responses. Assay is performed to quantify the active ingredient in the parenteral preparation according to pharmacopeia methods. Proper testing helps ensure parenteral products are free of contaminants and contain the correct amount of active pharmaceutical ingredient.
This document discusses coating pans used in the pharmaceutical industry. It describes two main types of coating pans - conventional and perforated. Conventional pans include Pelligrini, immersion sword, and immersion tube pans. Perforated pans have openings that improve mixing and drying efficiency, examples given are Accela-Cota, Hi-Coater, Dria Coater, and Glatt pans. The validation process for coating pans involves installation qualification to confirm proper installation, operational qualification to establish operating parameters, and performance qualification to verify operation as intended.
The document discusses sterile formulations and parenteral products. It covers key topics like routes of parenteral administration, pre-formulation of sterile products, physicochemical properties, general requirements, and sterility testing. The different routes discussed are subcutaneous, intramuscular, intravenous, and others. Ideal properties of sterile dosage forms include sterility, isotonicity, being pyrogen-free and particle-free. The document also differentiates between small volume parenterals and large volume parenterals.
Ophthalmic dosage forms are sterile dosage forms meant for instillation into the eye. Common types include eye drops, lotions, ointments, and suspensions. They must be sterile, isotonic, and the correct pH. Ideal characteristics include being clear, particle-free, and stable. Containers are typically multidose bottles with droppers or single-use. Quality is ensured through testing for sterility, clarity, leakage, and foreign particles.
Eye drops, lotions, ointments and other ophthalmic preparations must meet several requirements to be safely applied to the eyes. They must be sterile, isotonic to tears, and free of particles to avoid irritation. Various formulations exist, including liquids, gels and solids, which are prepared through clarification, sterilization and packaging in sterile containers. Common ingredients include drugs, preservatives, viscosity agents and buffers to maintain the correct pH, tonicity and stability for ocular administration.
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
Pharmaceutical water refers to various types of water used in pharmaceutical applications. There are bulk and packaged forms. Bulk forms include purified water and water for injection. Purified water is used to clean equipment and prepare some bulk pharmaceuticals, while water for injection must be pyrogen-free and protected from microbes for parenteral use. Packaged sterile forms include bacteriostatic water, sterile water for injection, sterile water for irrigation, sterile water for inhalation, and sterile purified water. Each has distinct formulations and uses such as diluting medications, irrigation, or inhalation solutions. Proper protection from contamination and adherence to specifications is important for safety.
Quality control test: Containers, Closures and Secondary packing materialsPranali Polshettiwar
This document summarizes quality control tests for containers, closures, and secondary packaging materials. It describes common materials used for each, such as glass, plastic, metal for containers and rubber, plastic, metal for closures. Key quality tests for containers include powdered glass test, water attack test, hydrolytic resistance test, and thermal shock test. Tests for closures include residue on evaporation, pH of extract, and sterility. Secondary packaging materials like paper and cardboard are also tested for quality.
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
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.
Parenteral products are unique dosage forms that are injected directly into the body, bypassing the gastrointestinal tract. They must be exceptionally pure and sterile to avoid contamination. Certain drugs can only be administered parenterally because they are degraded in the GI tract. Characteristics of parenteral products include being sterile, pyrogen-free, isotonic with body fluids, and stable both chemically and microbiologically throughout their shelf life. The preformulation properties of drugs and excipients used in parenterals, such as solubility, thermal profile, and particle size, must be evaluated to ensure quality, safety and efficacy.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
This document provides guidance on validating a liquid filling and sealing machine. It discusses the key stages of validation including user requirement specification, design qualification, installation qualification, operational qualification, and performance qualification. The performance qualification section provides specific tests to validate the machine's weight variation, filling volume accuracy, particle contamination levels, leak testing, and oxygen content. Requalification of the machine is recommended on a defined schedule or after any changes to ensure continued proper operation.
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.
Quality Control Of Parenteral PreparationsQurat Ul Ain
This document provides information about quality control of parenterals. It discusses key terms related to parenterals and routes of administration such as intravenous, intramuscular, and subcutaneous. The document outlines quality control tests performed on parenterals including leaker tests, pyrogen tests, particulate tests, sterility tests, and uniformity of content tests. Specific procedures for leaker tests and pyrogen tests using the LAL assay are described. The importance of quality control in ensuring parenterals are free from contamination and meet defined quality standards is also emphasized.
Eye, ear and nasal drops are sterile aqueous or oily solutions meant for instillation into respective areas. Eye drops contain drugs that are antiseptic, anesthetic, anti-inflammatory or cause pupil dilation/constriction. Ear drops and nasal drops contain medications to relieve conditions like congestion. All three include active ingredients, vehicles, preservatives and adjuvants in suitable containers. They must be free of particles, sterile, have proper pH, tonicity, viscosity, surface activity and not cause irritation. Thickening agents, isotonic solutions, and surfactants are added to meet these requirements.
This document provides an overview of the formulation and development of parenteral products. It discusses the key components including containers, closures, processing, formulation, production facilities, and evaluation methods. The production area is divided into five sections - cleanup, preparation, aseptic, quarantine, and finishing/packaging areas. Parenteral formulations contain active drugs, vehicles, and adjuvants. Finished products undergo sterility, clarity, leakage, pyrogen, and assay testing to ensure quality control.
Ophthalmic dosage are the preparation designed for application to the eye:-
For treatment
For symptomatic release of symptoms
For diagnostic purpose
As aid to surgical procedures
They are the sterile products meant to instillation in to the eye in the space between eye lid and the eye ball
They are also prepared as parenteral product. Example
Eye drops, Eye lotion, Eye ointment, Eye suspension, Contact lens solution
The document summarizes procedures for evaluating ophthalmic drug preparations. It discusses that evaluation includes sterility testing, clarity testing, leak testing, and testing for metal particles in ointments. It also describes that drug product quality tests assess attributes like identification, potency, purity, sterility and particulate matter, while performance tests evaluate drug release. Key quality tests discussed are identification, assay, pH, osmolarity, bacterial endotoxins, and uniformity of dosage units. Specific tests covered include viscosity and drop size.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
This document discusses pharmaceutical packaging technology. It defines pharmaceutical packaging and outlines ideal packaging requirements. The key functions of packaging are then described, including product identification, protection, facilitating use, promotion, marketing, convenience, barrier protection and security. Various packaging materials are also discussed, including glass, metals, rubbers, plastics, fibrous materials and films. Specific plastic materials like polyethylene, polypropylene, polyvinyl chloride and polyvinylidene chloride are explained in terms of their properties and uses in pharmaceutical packaging.
The document discusses various evaluation tests performed on parenteral products, including sterility testing, clarity testing, leakage testing, pyrogen testing, and assay. Sterility testing involves incubating samples in culture media to check for microbial growth. Clarity testing examines products for visible particles. Leakage testing checks for cracks in ampoules. Pyrogen testing involves injecting products into rabbits to monitor for fever responses. Assay is performed to quantify the active ingredient in the parenteral preparation according to pharmacopeia methods. Proper testing helps ensure parenteral products are free of contaminants and contain the correct amount of active pharmaceutical ingredient.
This document discusses coating pans used in the pharmaceutical industry. It describes two main types of coating pans - conventional and perforated. Conventional pans include Pelligrini, immersion sword, and immersion tube pans. Perforated pans have openings that improve mixing and drying efficiency, examples given are Accela-Cota, Hi-Coater, Dria Coater, and Glatt pans. The validation process for coating pans involves installation qualification to confirm proper installation, operational qualification to establish operating parameters, and performance qualification to verify operation as intended.
The document discusses sterile formulations and parenteral products. It covers key topics like routes of parenteral administration, pre-formulation of sterile products, physicochemical properties, general requirements, and sterility testing. The different routes discussed are subcutaneous, intramuscular, intravenous, and others. Ideal properties of sterile dosage forms include sterility, isotonicity, being pyrogen-free and particle-free. The document also differentiates between small volume parenterals and large volume parenterals.
Ophthalmic dosage forms are sterile dosage forms meant for instillation into the eye. Common types include eye drops, lotions, ointments, and suspensions. They must be sterile, isotonic, and the correct pH. Ideal characteristics include being clear, particle-free, and stable. Containers are typically multidose bottles with droppers or single-use. Quality is ensured through testing for sterility, clarity, leakage, and foreign particles.
Eye drops, lotions, ointments and other ophthalmic preparations must meet several requirements to be safely applied to the eyes. They must be sterile, isotonic to tears, and free of particles to avoid irritation. Various formulations exist, including liquids, gels and solids, which are prepared through clarification, sterilization and packaging in sterile containers. Common ingredients include drugs, preservatives, viscosity agents and buffers to maintain the correct pH, tonicity and stability for ocular administration.
Anatomy of eye and adrena, absorption of drug in the eye, classification of ophthalmic
products, safety consideration of ophthalmic products, formulation, vehicles and additives,
manufacturing consideration, environment, manufacturing techniques, quality control of
ophthalmic products, packaging of ophthalmic products.
The document discusses ophthalmic preparations, which are specialized dosage forms designed for administration to or around the eye. It covers ideal characteristics, types of formulations including solutions, suspensions, ointments and inserts. General considerations for safety, formulation, drugs used, evaluation tests and packaging are described. The key types are solutions, suspensions and ointments as the most commonly used ophthalmic dosage forms, with newer forms including gels, inserts and intraocular injections. Safety must ensure sterility, lack of toxicity and appropriate tonicity, pH and viscosity. Evaluation includes sterility testing, clarity assessment and checking for leaks or particles.
This document discusses the formulation of eye lotions. It begins by introducing ophthalmic preparations and their common dosage forms, including solutions, suspensions, and ointments. It then describes the different types of ophthalmic preparations - eye drops, eye ointments, and eye lotions. Eye lotions are defined as sterile aqueous solutions used for washing the eyes by applying a large volume of solution over the eye. The document provides details on formulating an eye lotion, including using purified water and sodium chloride to produce an iso-osmotic solution, filtering, sealing bottles, and autoclaving for sterilization. References are listed at the end.
Introduction to ophthalmic products useful as a basic & theoretical tool for pharmacy, medical & nursing students for their graduate and post graduate studies
This document provides an overview of parenteral products. It defines parenteral preparations as pyrogen-free preparations intended for administration by routes other than oral. It discusses the advantages and disadvantages of the parenteral route. It also covers essential requirements for parenteral dosage forms such as containers, glass types, closures, and aseptic areas. The document classifies parenteral preparations and discusses sterile powders and lyophilized products. It provides information on formulations, manufacturing processes, and quality control testing of parenteral products.
This document provides information about ophthalmic preparations. It discusses the types of ophthalmic preparations including solutions, suspensions, emulsions, ointments and lotions. It covers the formulation considerations for ophthalmic preparations such as tonicity, pH, viscosity and preservatives. It also discusses containers, labeling, evaluation and novel approaches for ophthalmic drug delivery. The document is authored by Anuj Singh Rajput and is about the guided work on ophthalmic preparations.
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.
This document discusses eye lotions, which are sterile aqueous solutions used to wash the eyes by allowing a large volume of solution to flow over the eye. Eye lotions should be isotonic and free of particles to avoid irritation. A method is provided for preparing a 1000 ml sodium chloride eye lotion by dissolving sodium chloride in purified water, adjusting the volume, filtering, transferring to amber bottles, sealing, and autoclaving for sterilization. Criteria for selecting ophthalmic drugs and other types of ophthalmic preparations such as drops and ointments are also summarized.
This document defines ophthalmic preparations as sterile liquid, semi-solid, or solid preparations intended for application to the eye. It discusses the requirements for bases, excipients, antimicrobial agents, and categories of ophthalmic preparations such as drops, ointments, and suspensions. The document also summarizes good manufacturing practices for production, in-process controls, sterilization methods, packaging, labelling, and storage requirements for ophthalmic preparations.
This document discusses ophthalmic (eye) drug formulations. It describes key considerations for ophthalmic preparations including that they must be sterile liquids, semisolids, or solids for application to eye tissues. Important formulation factors that are outlined include tonicity, pH, viscosity, stabilizers, surfactants, and preservatives. Common ophthalmic dosage forms like solutions, suspensions, ointments and their methods of preparation are also summarized.
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.
This document discusses various ophthalmic drug delivery systems including eye drops, ointments, gels, and inserts. It describes key considerations for ophthalmic formulations such as sterility, toxicity testing, and use of preservatives. Different types of ophthalmic preparations are covered like solutions, suspensions, and their inactive ingredients for pH adjustment, viscosity control, and preservation. Extended drug delivery methods like ocular inserts and iontophoresis are also summarized.
Eye, ear and nose formulations discusses various drug delivery formulations for the eye, ear and nose. It provides examples of common components and drugs used in eye drops, ointments, lotions and other ophthalmic preparations. Requirements for the formulations such as isotonicity and sterility are covered. The summary also discusses formulation aspects of ear preparations and examples of their dosage forms.
This document provides information on ophthalmic products including their definition, dosage forms, advantages, disadvantages and formulation considerations. It discusses key product types like eye drops, lotions and ointments. It describes essential characteristics for different preparations including sterility, isotonicity, pH and viscosity. The document outlines manufacturing techniques for solutions, suspensions and ointments. It also discusses packaging, storage and evaluation methods for assessing sterility, particles and leakage in final products.
This document discusses various ophthalmic products including eye drops, eye lotions, eye ointments, and contact lens solutions. It describes the essential characteristics of these products such as sterility, viscosity, pH, and tonicity. Formulation methods and key ingredients are provided for different types of ophthalmic preparations. Guidelines for proper handling and storage of eye drops and contact lens solutions are also outlined.
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2. OBJECTIVES:
A. TO KNOW THE DIFFERENT PREPARATIONS UNDER STERILE
PRODUCTS
B. OPTHALMIC PREPARATIONS
TYPES. REQUIREMENTS. FORMULATION. PACKAGING
C. BIOLOGICS
CATEGORIES & PROPERTIES. IG CLASSES. EFFECTIVES. TYPES.
DOSAGE FORM AND STRENGTH
4. STERILE PRODUCTS
Products that are going to be
administered using enteral route of
administration. The product are going
to be infused directly into the blood
stream or body tissue. It is extremely
important that they be “sterile” and
“pyrogen free”
7. Introduction
Ophthalmic dosages are preparations designed for
application to the eye:
for the treatment of disease
for symptomatic release of symptoms
for diagnostic purpose
as aid surgical procedures
8. Introduction
Ophthalmic dosages are preparations designed for
application to the eye:
for the treatment of disease
for symptomatic release of symptoms
for diagnostic purpose
as aid surgical procedures
9. Introduction
• Ophthalmic products are the sterile products
meant to installation in to the eye in the space
between eye lid and the eye ball.
11. Eye Drops
Eye drops are sterile aqueous
or suspensions of drug that are
instilled into the eye with the
dropper. They usually contain
drugs having antiseptic, anti
anesthetic, anti inflammatory,
mydriatic or meiotic properties.
12. Eye Lotion
Eye lotion are the aqueous
solution for washing the eye.
The eye lotions are supplied in
concentrated form and are
required to be diluted with
warm water immediately
before use.
13. Eye Ointment
Are sterile preparations meant
for application to the eye.
These are prepared under
aseptic conditions and packed
in sterile collapsible tubes
which keep the preparation
sterile until whole of it is
consumed.
14. Eye Suspension
Are not commonly used as
compared to eye drops. They
are prepared only in those
cases, when the drug is
insoluble in the desired vehicle
or unstable liquid form.
15. Contact lens solution
are usually made from
“polymethyl-methacrylate” a
hard hydrophobic plastic, nut
some softer hydrophilic lenses
have been developed and are
coming to use.
16. Types of ophthalmic products
Ophthalmic products may be categorized into a
number of groups:
Liquid preparations for application to the surface
of the eye such as eye drops and eye lotions.
Semi solid preparations such as eye ointments,
creams, and gels for application to the margin eye
lid or for introduction in to the conjuctival sac.
17. Types of ophthalmic products
Solid preparations such as ocular inserts
intended to be placed in contact with the
surface of the eye to produce modified release
of medicament over a prolonged period.
Parenteral products for sub conjuctival or intra
ocular injection
Liquid products for irrigation of the eye during
surgical procedures
19. Foreign Particles
All the ophthalmic products should be clear and free
from foreign particles, fibers and filaments.
Ophthalmic solutions should be clarified very carefully
by passing through bacteria proof filters such as
membrane filters, sintered glass filters.
20. Foreign Particles
The particle size of the eye suspension should be in
an ultrafine state of subdivision to minimize irritation.
A separate filter should be used for different
ophthalmic products in order to avoid the
contamination.
21. VISCOSITY
The particle size of the eye suspension should
be in an ultrafine state of subdivision to
minimize irritation.
In order to prolong the contact time of the
drug in the eye, various thickening agents are
added in the ophthalmic preparations.
22. VISCOSITY
An ideal thickening agent should posses the
following properties:
it should be easy to filter
it should be easy to sterilize
it should be compatible with other ingredients
it should posses requisite refractive index and clarity
level.
23. TONICITY
Ophthalmic product should be isotonic with
lachrymal secretions to avoid discomfort and
irritation.
It has been observed that eye can tolerate a
range of tonicity 0.5-2% NaCl. There are certain
isotonic vehicles which are used to prepare
ophthalmic products like 1.9% boric acid, sodium
acid phosphate buffer.
24. pH of Preparations
pH plays an important role in therapeutic activity,
solubility, stability, and comfort to the patient.
Tears have a pH of about 7.4 eye can tolerate
solution having wide range of pH provided they
are not strongly buffered, since the tear will
rapidly restore the normal pH of the eye.
26. Sterility
Pseudomonas aeroginosa is very
common gram negative bacteria which
are generally found to be present in
ophthalmic products. It may cause serious
infections of cornea. It can cause
complete loss of eye sight in 24-48 hours.
27. Sterility
To maintain sterility in multi dose container,
containing ophthalmic products, a suitable
preservative is added. The preservative should
be non-toxic, non-irritant and should be
compatible in medicaments.
28. Sterility
The ophthalmic products are generally
sterilized by autoclaving, filtration through
bacteria proof filters and addition of
bactericides at low temperature.
29. Surface Activity
Vehicles used in ophthalmic preparations must
have good wetting ability to penetrate the
cornea and other tissues. Certain surfactants
or wetting agents added which are found
suitable for ophthalmic products. It should
not cause any damage to the tissue of eye.
34. FORMULATION
Isotonicity
all the solutes including drug
contribute to the osmotic pressure of
the eye drop, therefore isotonicity of
the formula should be calculated and
adjusted with sodium chloride.
39. Packaging
Eye drops have been packaged almost entirely in plastic
dropper bottles.
The cap is made of harder resin than the bottle.
The glass bottle is made sterile by dry-heat or steam
autoclave sterilization.
Amber glass is used for light resistance.
41. Biologics…
a preparation, such as a drug a vaccine, or an
antitoxin, that is synthesized from living
organisms or their products and used as a
diagnostic, preventive, or therapeutic agent.
42. 2 Categories of Biologics
1st category
- ANTIGEN
a toxin or other foreign substances that induces an
immune response in the body, especially the production
of antibodies.
43. 3 categories of Antigens:
1. Biologically – an antigen is a substance that when
introduced into the tissue of human or other vertebrates
that causes formation of antibodies.
“2 Biologic Properties”
a. Immunogenicity - capacity to induce antibody formation
b. Specificity - governed by small chemical sites on the
antigen molecule called antigenic determinants.
44. 3 categories of Antigens:
2. Chemically - antigens are usually
protein, however, some high molecular
weight polysaccharides are antigenic.
45. 3 categories of Antigens:
3. Physically - antigens must
possess high molecular weight. A
weight more than 10,000 daltons is
required.
46. 2 Categories of Biologics
2ND category
- ANTIBODIES
specialized cells of the immune system which can be
recognize organisms that invade the body ( such as bacteria,
viruses, and fungi). The antibodies are then able to set off a
complex chain of events designed to kill these foreign
providers.
47. Immunoglobulin Classes:
IgA (alpha heavy chains)
IgD (Delta heavy chains)
IgE (Epsilon heavy chains)
Igm (Mu heavy chains)
IgG (Gamma heavy chains)
48. IMMUNITY
is the state of having sufficient biological
defenses to avoid infection, disease, or other
unwanted biological invasion. It is the capable
of the body to resist harmful microbes from
entering it.
49. IMMUNITY
Natural immunity- is the natural resistances with
which a person is born
Acquired Immunity- immunity obtained either
from the development of antibodies in response to
exposure to an antigen, as from vaccination or an attack
of an infectious disease, or from the transmission of
antibodies, as from month to fetus through the
placenta or the injection of anti serum
50. Acquired Immunity
1. Active Immunity
a. Naturally acquired active immunity- receive by the
body in a natural manner
b. Receive by the body through the administration of
a vaccine or toxoid.
51. Acquired Immunity
2. Passive Immunity – is the transfer of active immunity, in
the form of readymade antibodies, from one individual to another
a. Artificially acquired passive immunity- a short-term
immunization by the injection of antibodies, such as gamma
globulin, that are not produced by the recipient’s cells
b. Naturally acquired passive immunity- occurs during
pregnancy, in which certain antibodies are passed from the
maternal into the fetal bloodstream.
52. Vaccine
a substance used to stimulate the
production of antibodies and provide
immunity against one or several diseases ,
prepared from the causative agent of a
disease, its product or a synthesis
substitute, treated to act as an antigen
without inducing the disease.
53. Vaccine
Vaccines create the immunity that protects
you from the an infection sometimes
vaccines are called immunization, needled,
or shots. They boost your body’s own
defense system which is called the immune
system.
55. Small Pox Vaccine
is the living virus vaccinla(cowpox) that has
been grown in the skin of a vaccinated bovine
calf. It was the first vaccine for small pox
invented by Edward Jenner to treat small pox
disease caused by Variola major and Variola
minor viruses.
56. Small Pox Vaccine
Who should get small pox vaccine?
1. Anyone who is allergic to the vaccine or any of its component
(streptomycin, chlortetracycline, neomycin)
2. Pregnant women
3. Lactating women
4.Persons with skin problems (i.e eczema and atopic dermatitis)
5. People with weakened immune system such as those with
received transplant.
6. HIV positive
57. Small Pox Vaccine
Side Effects of small pox vaccine
I. Feeling usually cold
II. Shivering
III. Swollen painful of lymph glands in the neck, armpit, or groin
Dose:
It is administered by making punctures in the skin with special needle.
Re – vaccination is recommended at least every 10 years.
59. Rabies Vaccine
The pre exposure schedule for rabies
vaccine in 3 doses given the ff. time:
Dose 1 – As appropriate
Dose 2-7 – Days after 1 dose
Dose 3-7 – Days or 28 days after 1 dose
60. Influenza Vaccine
a sterile aqueous suspension inactive
influenza virus type A and B. It is also
contains a suitable preservative and
may contain an adsorbent such as
aluminum phosphate or protamine.
61. Influenza Vaccine
2 types of influenza Vaccine:
1. The injection (with killer virus)
2. Nasal spray Vaccine ( containing live
but weakened virus)
62. Influenza Vaccine
How long is flu vaccination good for?
- The flu vaccination will protect you for only one flu
season
Does the vaccine work right away?
- It takes two weeks after the vaccination for antibodies to
develop in the body and provide protection against virus
infection.
63. Poliomyelitis Vaccine
is an active immunizing agent used to
prevent polio. It work by causing your body
to produce its own protection ( antibodies)
against the virus that causes polio.
64. Poliomyelitis Vaccine
“Polio” is a very serious infection that
causes paralysis of the muscles that
enable you to walk and breathe.
65. Poliomyelitis Vaccine
Immunization against polio is recommended
for:
1. All infants from 6 to 7 weeks of age.
2. All children.
3. All adolescence 18 years old of age
4. Adults who are greater risk of exposure to polio
virus.
66. Poliomyelitis Vaccine
3 types of Polio Virus
Type 1 (Brunhilde) – most often isolated from
paralytic cases
Type 2 (Lansing) – concerned in sporadic
disease
Type 3 (Leon) – proved to be etiologic agent in
less frequent epidemics
67. Polio Virus Vaccine Live Oral
Oral polio vaccine was developed by Albert
Sabin.
It is also called “trivalent oral polio vaccine”
or “sabin vaccine”
Doses: 2 doses not less than 8 weeks
intervals
68. Measles Vaccine
a highly effective vaccine used against measles that
contain live attenuated rubella (german measles)
virus. The vaccine acts by stimulating the adaptive
immune response and provides long term protection
against the disease.
Stored in temperature of between 2 and 8 degrree
and have 1 year expiration.
69. Mumps Vaccine
prepared with the B- level Jeryl Lynn Strain from
the virus which is growth in cell cultures of
chicken embryo tissue and provides active
immunity for at least 10 years after
immunization and its particular valuable to
susceptible individuals approaching puberty and
to adults
70. Hepatitis Vaccine
the vaccine contains one of the viral envelope
proteins, hepatitis B surface antigen. It is produced by
yeast cells, into which the genetic code for HBsAg has
been inserted. Atlease 2 to 3 vaccine injections is
given, the second injection at least one month after
the first dose and the third injection being
administered six months after the first dose.
71. Rickettsial Vaccine
cultured in chicken embryo or in monkey kidney
tissue cultures in a manner similar to that for
viruses. They cannot be grown in artificial
culture media and must be subjected to the
same precautions as viruses.
73. Typhoid Vaccine
any of several preparations of Salmonella typhi
used for immunization against typhoid fever.
Recommended for persons who have
household contact with known typhoid carrier or
for travelers going to areas of the world where
typhoid fever is endemic
74. Cholera Vaccine
a sterile suspension of killed cholera vibrios
(vibrio cholera) in isotonic sodium chloride
solution or other suitable diluents
75. Plague Vaccine
a preparation of killed Yersinia pestis bacilli,
administered intramuscularly as an active
immunizing agents against plague
76. Pertussive Vaccine
a preparation of killed Bordetella pertussis
bacilli or purified antigenic components thereof,
used to immunize against pertussis; generally
used in combination with diphtheria and tetanus
toxoids
77. Pneumococcal Vaccine
causing the majority of pneumococcal disease;
used as an active immunizing agent in persons
over 2 years of age, administered
intramuscularly
79. Dialysis
a method of removing toxic substances
( impurities or wastes) from the blood
when the kidney are unable to do so.
80. Dialysis
most frequently used for patients who have
kidney failure, but may also be used to
quickly remove drugs or poisons in acute
situation. This techniques can be life saving
in people with acute or chronic kidney
failure.
81. Type of Dialysis
Hemodialysis- requires a machine to
transport the blood and dialyzing fluid on
either side of semi-permeable membrane to
effect the removal of toxic metabolites and
excess water.
82. Functions:
cleanses the blood of accumulated waste
products
removes the by- products of protein metabolism(
urea, creatinine and uric acid)
removes excessive fluids
maintains or restores the buffer system of the
body
maintain or restores electrolyte levels
83. Access:
Subclavian and femoral catheter- may be
inserted for short term or temporary use in
acute renal function. May be left in place for
up to 6 weeks if complications do not occur.
84. Access:
External arteriovenous shunt- formed by
surgical insertion of 2 silastic cannulas into
an artery or vein in forearm or leg to form an
external blood path
85. ADVANTAGES:
can be used immediately after insertion
no venipuncture necessary for dialysis
less danger of clotting and bleeding
can be used indefinitely
decreased incidence of infection
no external dressing required
86. DISADVANTAGES:
external danger of disconnecting or dislodging
the shunt
risk of hemorrhage, infection or clotting
skin erosion around the catheter site
Internal arteriovenous fistula- for chronic dialysis
clients. Created surgically by anastomosis of a
large artery and large vein the arm
87. DISADVANTAGES:
cannot be used immediately after insertion
venipuncture is required for dialysis
infiltration of needle- hematoma
aneurysm in the fistula
arterial steal syndrome
Internal arteriovenous graft- for chronic dialysis clients who do not
have adequate blood vessels for the creation of a fistula. Can be used
2 weeks after insertion.
Complication: clotting, aneurysm and infection
89. What is an injection?
Injections are sterile solutions, emulsions or
suspensions. They are prepared by
dissolving, emulsifying or suspending an
active ingredient and any other substances in
water for injection.
90. What is an injection?
Injecting the act of giving medication by use
of syringe and needle to obtain the desired
therapeutic effect taking into account the
patients safety and comfort.
91. How does drug for injection
presented?
1. Single dose preparation- prepared volume of measured
drug, in a syringe for single dose use
i.e Flu vaccines, pneumovax and B12.
92. How does drug for injection
presented?
2. Multiple dose preparation- multi dose preparations contain
a antimicrobial preservative, are used on more than the one
occasion and great care is required for its administration but
especially it’s storage between successive withdrawals
i.e Insulin
93. Why give drugs in an injection
form?
Injections usually allow rapid absorption
Can produce blood levels comparable to those
of intravenous bolus injection
Drugs that are altered or not absorbed by other
methods of administration
94. Routes of Administration
Subcutaneous (SC)- into tissue below dermis
of skin
Intramuscular (IM)- into the body muscle
Intravenous (IV)- into a vein
Intradermal- into the dermis just under the
epidermis
95. Intradermal Injections
Most often used for PPD
Site: the inner aspect of the forearm
Needle size is 25-27 gauge, ½ to 5/8 inch
Insert needle at 15 degree angle
Injection made just below the outer layer of skin
96. Intradermal Injections
If injection does not form a wheal or if bleeding is
noted, the injection was probably too deep and
should be repeated.
Review the provider’s order for accuracy
Ask the patient/parent if the patient is allergic to the
medication
Select proper needle size, length and gauge
97. Intradermal Injections
Explain procedure to the patient
Ask for assistance with children
Position patient appropriately
Prepare injection site with alcohol- air dry
Support skin with thumb
With bevel up, completely insert bevel at a15 degree
angel
98. Intradermal Injections
Inject medication gently, place a cotton ball over the
site after needle removal
A visual wheal will be produced at the site
Dispose of needle as per policy
Wash Hands
Document procedure and patient’s response
101. Subcutaneous Injections
Dosing:
starting daily dose: 0.5-1 unit/kg/day in divided doses
Adjust according to fasting (premeal) blood glucose of 80-130
mg/dL and peak postprandial blood glucose < 180 mg/dl
Provide 50% as long acting insulin and 50% as prandial insulin
1 unit of an account for 30 grams of carbohydrates(14-50)
1 unit can lower 50 mg/dL blood glucose (10-100)
103. Intramuscular Injections
Factors that can cause pain are:
The needle
The technique
The speed of the injection
The solution and comparison of the drug
the volume of the drug
The approach and attitude of person administering the
injection
104. Intravenous Injections
injecting in the vein is considerably more
dangerous than other types of injection, the
said proper technique can be at least
minimize the possible damage.
105. Intravenous Injections
Tourniquet:
To get the veins to rise to a level at which you can hit
you will need a tourniquet.
It is important to choose a gentle tourniquet, as something
too tight or hard could damage your delicate veins
When trying the tourniquet, tuck it in upon itself or use a
self tightening loop. You want the technique to be slip off.
106. The 7 Right’s of Drug
AdministrationRight client
Right medication
Right dose
Right route
Right time
Right reason
Right documentation
107. Needle length and size
When choosing the needle it is important to
assess the amount of muscle, subcutaneous fat
and weight of the patient-which in the majority
of cases will be blue needle
108. Syringes
3 main parts:
Barrel -chamber that holds the medication
Plunger- part within the barrel that moves back and forth to
withdraw and instill medication
Tip- part that the needle is attached to
Calibration:
Syringes sizes from 1ml to 50ml
Measure to a 1/10th or 1/100th depending on calibration
109. Needle
Shaft of the needle
length chosen depends on the depth o which medication
will be instilled
Tip of shaft id beveled or slanted to pierce the skin more
easily
Gauge: width of the needle (18-27 gauge)- a smaller
number indicates a larger diameter and larger lumen inside
the needle
110. Considerations when choosing
a syringe and a needle
Type of medication
Depth of tissue penetration required
Volume of medication
Viscosity of medication
Size of the client
111. Basic injection techniques
Tell patient what to expect
Do not drill
Anchor heel of your hand on patients hip, leg, arm so you
can move with patient
Do not recap used needle
Ampule
use an alcohol pad to open
Use a filter needle
No air into ampule
113. Pellets
A small, sterile tablet used by implantation when
prolonged and continuous absorption is desired.
Ranges between (0.5-1.5mm)
114. Types of Pellets
1. Implants (pellets) Ex. Contraceptives
2. Orally Multiple-Unit Pellet System
(MUPS) Ex. PPIs
are kind of multi particulate system that has
become an important and successful dosage
form for immediate or modified drug release.
115. Methods of Preparation
1. Agitation ( balling)
it is known as spherical agglomeration. In
this method, particles are converted to
spherical pellets by continuous rolling or
tumbling blender using a rotating drum or
pan.
116. Methods of Preparation
2. Drug layering
layering involves the deposition of
successive layers of dry powder or liquid
droplets of drug and binding into inert seed.
117. Methods of Preparation
3. Globulation
Spray drying- a drug solution or suspension is
sprayed, with or without excipients, into a hot air
stream, generating dry and highly spherical
particles.
Spray Congealing- also called spray-chilling, a
technique similar to spray- drying but no source
of heat is required.
118. Methods of Preparation
4. Compact (compression)
in this process mixtures of active ingredients and
excipients are compacted under pressure under
pressure to generate pellets of defined shape and size.
During compression at high pressure, particles of a
packed mass are forced against each other so that
elastic and plastic deformation can take place and
create strong inter particle contact.
119. Methods of Preparation
5. Compact ( Extrusion-spheronization)
in this process the powder is formed into a wet
mass, which is forced through restricted area
(extrusion) to form strands of extrudate that are
broken into short lengths and rounded by
placement on a rotating plate with an a cylinder.
120. Methods of Preparation
6. Cryopelletization
a process whereby droplets of a liquid
formulation are converted into spherical
pellet by using liquid nitrogen as fixing at
160° medium
These products must be sterile and are prepared under the same condition and by the same methods as other parenteral preparations.
IgA ( alpha heavy chains)- is the predominate immunoglobulin that found external bodily secretion9 ( as saliva, tears,sweat)
IgD ( Delta heavy chains)- is primarily found on B cell surfaces where it functions as a receptor for antigen
IgE ( Epsilon heavy chains)- function in allergic reaction
Igm (Mu heavy chains)- is the first Ig to be made by the fetus and the cells when it is stimulated by antigen.
IgG (Gamma heavy chains)- most abundant serum in immunoglobulin. IgG is the only class of Ig that crosses the placenta
Use to treat flu virus that infect our respiratory system as nose, throat and sometimes lungs.
Also known as enteric vaccine because it prevents the effect of the disease on the intestinal tract
an active immunizing agent in the development of immunity to the disease.
During compression at high pressure, particles of a packed mass are forced against each other so that elastic and plastic deformation can take place and create strong inter particle contact.
The resulting spherical granules or pellets are form of uniform shape, size and density.