This is a seminar of my M Pharm Sem-II. It consist of nearly all information about the dosage form called Aerosol in briefly. It will be helpful for the students to get insights about this topic in very simple manner.
This document discusses dissolution testing, which involves measuring how quickly a solid drug substance dissolves in solution. It defines dissolution and factors that affect the rate. These include drug properties like solubility, particle size, and solid form, as well as dosage form properties and excipients. Common in vitro dissolution testing models are described, including basket, paddle, and flow-through methods. Acceptance criteria for dissolution testing and methods for comparing dissolution profiles are also summarized.
This document discusses drug dissolution, including definitions, theories, mechanisms, factors affecting dissolution, intrinsic dissolution rate, and in-vitro dissolution testing models. It defines dissolution as the mass transfer of a solid substance into a liquid solvent. The key theories discussed are the diffusion layer model, Danckwert's penetration model, and the interfacial barrier model. Factors affecting dissolution include properties of the drug, test conditions, and dosage form characteristics. Common in-vitro dissolution testing models described are non-sink and sink methods that utilize natural or forced convection with varying degrees of agitation.
This document provides information on pulmonary drug delivery systems and aerosols. It discusses the advantages of pulmonary drug delivery such as localized drug deposition reducing systemic exposure and avoidance of first-pass metabolism. Aerosols are defined as colloidal systems containing liquid/solid particles suspended in a propellant. The document outlines the manufacturing process, components, and quality control tests of aerosols including pressure filling, cold filling, and compressed gas filling apparatuses. Evaluation tests like flash point and flame projection are also mentioned.
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
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.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Niosomes are non-ionic surfactant-based vesicles that can be used for drug delivery. They consist of a nonionic surfactant bilayer enclosing an aqueous core. This document discusses the definition, structure, advantages, preparation methods and evaluation of niosomes. Niosomes can be prepared using methods like ether injection, film hydration, sonication, heating and extrusion. Their stability and ability to encapsulate and release drugs can be evaluated by measuring vesicle size, drug content, entrapment efficiency and in vitro drug release over time. Niosomes offer targeted drug delivery and improved oral absorption compared to other formulations.
This document discusses dissolution testing, which involves measuring how quickly a solid drug substance dissolves in solution. It defines dissolution and factors that affect the rate. These include drug properties like solubility, particle size, and solid form, as well as dosage form properties and excipients. Common in vitro dissolution testing models are described, including basket, paddle, and flow-through methods. Acceptance criteria for dissolution testing and methods for comparing dissolution profiles are also summarized.
This document discusses drug dissolution, including definitions, theories, mechanisms, factors affecting dissolution, intrinsic dissolution rate, and in-vitro dissolution testing models. It defines dissolution as the mass transfer of a solid substance into a liquid solvent. The key theories discussed are the diffusion layer model, Danckwert's penetration model, and the interfacial barrier model. Factors affecting dissolution include properties of the drug, test conditions, and dosage form characteristics. Common in-vitro dissolution testing models described are non-sink and sink methods that utilize natural or forced convection with varying degrees of agitation.
This document provides information on pulmonary drug delivery systems and aerosols. It discusses the advantages of pulmonary drug delivery such as localized drug deposition reducing systemic exposure and avoidance of first-pass metabolism. Aerosols are defined as colloidal systems containing liquid/solid particles suspended in a propellant. The document outlines the manufacturing process, components, and quality control tests of aerosols including pressure filling, cold filling, and compressed gas filling apparatuses. Evaluation tests like flash point and flame projection are also mentioned.
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
FORMULATION AND EVALUATION OF GELATIN MICROSPHERES LOADED WITH FENOFIBRATEReshma Fathima .K
The document summarizes the formulation and evaluation of gelatin microspheres loaded with the drug Fenofibrate. Two microsphere formulations were developed using a coacervation and phase separation method. Formulation F2 showed 97% drug encapsulation efficiency and released the drug over 12 hours, indicating it was suitable for oral sustained release. Evaluation tests on the microspheres showed they were spherical in shape, had good flow properties, and released the drug in a controlled manner without any burst release. The microspheres could facilitate the design of hard gelatin capsules for improved patient compliance.
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.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Niosomes are non-ionic surfactant-based vesicles that can be used for drug delivery. They consist of a nonionic surfactant bilayer enclosing an aqueous core. This document discusses the definition, structure, advantages, preparation methods and evaluation of niosomes. Niosomes can be prepared using methods like ether injection, film hydration, sonication, heating and extrusion. Their stability and ability to encapsulate and release drugs can be evaluated by measuring vesicle size, drug content, entrapment efficiency and in vitro drug release over time. Niosomes offer targeted drug delivery and improved oral absorption compared to other formulations.
This document discusses multiple emulsions, which are complex emulsion systems containing an internal oil droplet phase surrounded by an intermediate water phase and external oil medium. The key types are w/o/w and o/w/o emulsions. Multiple emulsions offer advantages like protecting actives, high encapsulation, and controlled release. However, they are thermodynamically unstable. The document outlines methods for producing and stabilizing multiple emulsions, including double emulsification and phase inversion techniques. Characterization methods and factors affecting preparation are also summarized. Applications include controlled drug delivery, targeting, and use in cosmetics, food, and oxygen delivery.
Self Emulsifying Drug Delivery System (SEDDS)Ashutosh Panke
This document discusses Self-Emulsifying Drug Delivery Systems (SEDDS), which are isotropic mixtures of oils, surfactants, and co-solvents that can solubilize drugs and promote self-emulsification. SEDDS enhance oral drug bioavailability, protect drugs from the hostile gastrointestinal environment, and reduce variability. The document describes the components of SEDDS including oils, surfactants, co-surfactants and drugs. It also outlines the formulation process and methods to evaluate parameters like stability, dispersibility, droplet size and drug release. SEDDS are a promising approach for improving oral delivery of poorly soluble drugs.
Nasal drug delivery is a method of administering drugs through the nose for local or systemic effects. It avoids first-pass metabolism and provides rapid drug absorption. Liquid nasal formulations like solutions, suspensions, and sprays are most common. Powders can also be used with insufflators or dry powder inhalers. Various animal models are used to evaluate nasal absorption and bioavailability. Nasal delivery enhances drug bioavailability for molecules that are not well-absorbed orally.
Sunscreen is a topical product that protects skin from the sun's harmful ultraviolet rays. Sunscreens can be physical (reflect UV rays using ingredients like zinc oxide or titanium dioxide) or chemical (absorb UV rays using ingredients like avobenzone). Regulatory standards for sunscreen labeling and testing have been established by organizations like the FDA and EU to help consumers identify effective broad spectrum protection and proper application. Ongoing research evaluates sunscreen safety and ensures protection against sun damage while avoiding potential toxicity issues.
Nanostructured lipid carriers (NLCs) were presented as a topical drug delivery system. NLCs consist of a blend of solid and liquid lipids which can incorporate drugs at high loading capacities. They were summarized to have advantages over solid lipid nanoparticles including avoidance of drug expulsion and unpredictable gelation. Methods for producing NLCs like high pressure homogenization were described. NLCs were said to increase skin permeation of drugs while providing occlusive and moisturizing properties beneficial for skin care. Several drug-loaded NLC formulations were presented including ones for flurbiprofen, minoxidil, and tacrolimus to improve their topical delivery and stability.
This document discusses dissolution testing apparatus and methods. It defines dissolution as the process by which a solid substance enters the solvent phase to form a solution. Several theories of drug dissolution are described, including the diffusion layer theory, Danckwert's model, and the interfacial barrier model. Six common apparatus are summarized: the basket, paddle, reciprocating cylinder, flow-through cell, paddle over disk, and cylinder methods. Procedures for each apparatus are provided. Common dissolution media and factors affecting media selection are also outlined. The document provides an overview of key concepts and equipment in dissolution testing.
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
This document provides information on creams as a semisolid dosage form. It begins by defining creams and describing the two main types: oil-in-water (O/W) and water-in-oil (W/O) emulsions. The uses and manufacturing process of creams are then outlined. The document also includes details on specific types of creams, formulations, quality control testing using vertical diffusion cell methods, and concludes with a case study example of a betamethasone cream.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
This document provides an overview of aerosols for pharmaceutical use. It begins with introductions to aerosols and pharmaceutical aerosols. The main components of aerosols are then described, including propellants, containers, valves, and actuators. Various aerosol systems like solution, suspension, and foam systems are also outlined. The document concludes with sections on the formulation, manufacturing, and quality control of pharmaceutical aerosols.
The document discusses the physics of tablet compression. It describes the processes of compaction, consolidation and compression that tablets undergo in their production. It outlines the main stages of compression including particle rearrangement, deformation, fragmentation and bonding. It also discusses the forces involved and common compaction profiles and equations used to describe the process, including the Heckel and Kawakita equations. The document provides an overview of the key concepts and stages in understanding the physics behind tablet production through compression.
This document discusses dissolution testing of pharmaceutical dosage forms. It describes the types of dissolution apparatuses, including basket, paddle, reciprocating cylinder, flow-through cell, and transdermal cell apparatuses. The key features and uses of each apparatus are outlined. Factors that influence dissolution rate, such as formulation components, processing methods, and test conditions, are also summarized. These include vehicles, diluents, disintegrants, and processing methods like granulation and compression force.
This document provides an overview of pulmonary drug delivery systems. It discusses the anatomy and physiology of the lungs, advantages and disadvantages of pulmonary delivery, and different technologies used. Aerosols, propellants, and container types are described. Current pulmonary delivery devices discussed include metered dose inhalers, dry powder inhalers, and nebulizers. The document also covers evaluation methods for pharmaceutical aerosols and pulmonary drug delivery systems such as cascade impactors and in vitro and in vivo tests.
Preformulation studies characterize the physical and chemical properties of drug molecules to develop safe, effective, and stable dosage forms. The goals are to develop formulations that are stable, safe, and effective. Major areas of study include physical characterization of properties like crystallinity and polymorphism, hygroscopicity, particle size, and powder flow. Solubility is analyzed through measurements of ionization, partition coefficient, aqueous solubility, and pH-solubility profiles. Stability is analyzed through studies of photolytic stability, stability to oxidation, and drug-excipient compatibility.
This document discusses biopharmaceutical factors that can affect the bioavailability of drugs. It focuses on pharmaceutical factors including physicochemical properties of drug molecules and dosage form characteristics. Physicochemical properties like solubility, dissolution rate, particle size, polymorphism, salt form, and ionization state can impact drug absorption. The pH-partition hypothesis explains how a drug's pKa and lipid solubility relate to absorption based on gastrointestinal pH. Dosage form properties such as disintegration time, manufacturing methods, and ingredients are also discussed as formulation factors influencing bioavailability.
Aquasomes are nanoparticle carrier systems composed of a solid nanocrystalline core coated with polyhydroxy oligomers. They are able to protect fragile biological molecules through water-like properties and high surface exposure. Aquasomes are prepared through a self-assembly process involving interaction of charged groups, hydrogen bonding, and structural stability. This allows active loading of molecules like proteins, antigens, and genes. Characterization techniques confirm the structure, drug loading, and release kinetics of aquasomes, which have applications in delivery of vaccines, hemoglobin, insulin, and enzymes orally and intravenously.
The document provides information about pharmaceutical aerosols. It discusses the history of aerosol development starting in the 1940s. It then defines aerosols and lists some of their advantages and disadvantages. The document outlines the key components of aerosols including propellants, containers, valves, and the product concentrate. It also describes the different types of propellant systems and manufacturing processes used to produce pharmaceutical aerosols. Finally, it discusses some quality control tests performed on the components and finished aerosol products.
This document provides notes on pharmaceutical aerosols. It defines a pharmaceutical aerosol and lists its advantages and disadvantages. It describes the key components of aerosols including propellants, containers, valves, and actuators. It discusses different types of propellants and containers. It explains the manufacturing process for aerosols including pressure filling, cold filling, and compressed gas filling. It outlines various aerosol formulation types and their applications in pharmaceutical products. Finally, it discusses how to evaluate the performance and safety of pharmaceutical aerosols.
This document discusses multiple emulsions, which are complex emulsion systems containing an internal oil droplet phase surrounded by an intermediate water phase and external oil medium. The key types are w/o/w and o/w/o emulsions. Multiple emulsions offer advantages like protecting actives, high encapsulation, and controlled release. However, they are thermodynamically unstable. The document outlines methods for producing and stabilizing multiple emulsions, including double emulsification and phase inversion techniques. Characterization methods and factors affecting preparation are also summarized. Applications include controlled drug delivery, targeting, and use in cosmetics, food, and oxygen delivery.
Self Emulsifying Drug Delivery System (SEDDS)Ashutosh Panke
This document discusses Self-Emulsifying Drug Delivery Systems (SEDDS), which are isotropic mixtures of oils, surfactants, and co-solvents that can solubilize drugs and promote self-emulsification. SEDDS enhance oral drug bioavailability, protect drugs from the hostile gastrointestinal environment, and reduce variability. The document describes the components of SEDDS including oils, surfactants, co-surfactants and drugs. It also outlines the formulation process and methods to evaluate parameters like stability, dispersibility, droplet size and drug release. SEDDS are a promising approach for improving oral delivery of poorly soluble drugs.
Nasal drug delivery is a method of administering drugs through the nose for local or systemic effects. It avoids first-pass metabolism and provides rapid drug absorption. Liquid nasal formulations like solutions, suspensions, and sprays are most common. Powders can also be used with insufflators or dry powder inhalers. Various animal models are used to evaluate nasal absorption and bioavailability. Nasal delivery enhances drug bioavailability for molecules that are not well-absorbed orally.
Sunscreen is a topical product that protects skin from the sun's harmful ultraviolet rays. Sunscreens can be physical (reflect UV rays using ingredients like zinc oxide or titanium dioxide) or chemical (absorb UV rays using ingredients like avobenzone). Regulatory standards for sunscreen labeling and testing have been established by organizations like the FDA and EU to help consumers identify effective broad spectrum protection and proper application. Ongoing research evaluates sunscreen safety and ensures protection against sun damage while avoiding potential toxicity issues.
Nanostructured lipid carriers (NLCs) were presented as a topical drug delivery system. NLCs consist of a blend of solid and liquid lipids which can incorporate drugs at high loading capacities. They were summarized to have advantages over solid lipid nanoparticles including avoidance of drug expulsion and unpredictable gelation. Methods for producing NLCs like high pressure homogenization were described. NLCs were said to increase skin permeation of drugs while providing occlusive and moisturizing properties beneficial for skin care. Several drug-loaded NLC formulations were presented including ones for flurbiprofen, minoxidil, and tacrolimus to improve their topical delivery and stability.
This document discusses dissolution testing apparatus and methods. It defines dissolution as the process by which a solid substance enters the solvent phase to form a solution. Several theories of drug dissolution are described, including the diffusion layer theory, Danckwert's model, and the interfacial barrier model. Six common apparatus are summarized: the basket, paddle, reciprocating cylinder, flow-through cell, paddle over disk, and cylinder methods. Procedures for each apparatus are provided. Common dissolution media and factors affecting media selection are also outlined. The document provides an overview of key concepts and equipment in dissolution testing.
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
This document provides information on creams as a semisolid dosage form. It begins by defining creams and describing the two main types: oil-in-water (O/W) and water-in-oil (W/O) emulsions. The uses and manufacturing process of creams are then outlined. The document also includes details on specific types of creams, formulations, quality control testing using vertical diffusion cell methods, and concludes with a case study example of a betamethasone cream.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
This document provides an overview of aerosols for pharmaceutical use. It begins with introductions to aerosols and pharmaceutical aerosols. The main components of aerosols are then described, including propellants, containers, valves, and actuators. Various aerosol systems like solution, suspension, and foam systems are also outlined. The document concludes with sections on the formulation, manufacturing, and quality control of pharmaceutical aerosols.
The document discusses the physics of tablet compression. It describes the processes of compaction, consolidation and compression that tablets undergo in their production. It outlines the main stages of compression including particle rearrangement, deformation, fragmentation and bonding. It also discusses the forces involved and common compaction profiles and equations used to describe the process, including the Heckel and Kawakita equations. The document provides an overview of the key concepts and stages in understanding the physics behind tablet production through compression.
This document discusses dissolution testing of pharmaceutical dosage forms. It describes the types of dissolution apparatuses, including basket, paddle, reciprocating cylinder, flow-through cell, and transdermal cell apparatuses. The key features and uses of each apparatus are outlined. Factors that influence dissolution rate, such as formulation components, processing methods, and test conditions, are also summarized. These include vehicles, diluents, disintegrants, and processing methods like granulation and compression force.
This document provides an overview of pulmonary drug delivery systems. It discusses the anatomy and physiology of the lungs, advantages and disadvantages of pulmonary delivery, and different technologies used. Aerosols, propellants, and container types are described. Current pulmonary delivery devices discussed include metered dose inhalers, dry powder inhalers, and nebulizers. The document also covers evaluation methods for pharmaceutical aerosols and pulmonary drug delivery systems such as cascade impactors and in vitro and in vivo tests.
Preformulation studies characterize the physical and chemical properties of drug molecules to develop safe, effective, and stable dosage forms. The goals are to develop formulations that are stable, safe, and effective. Major areas of study include physical characterization of properties like crystallinity and polymorphism, hygroscopicity, particle size, and powder flow. Solubility is analyzed through measurements of ionization, partition coefficient, aqueous solubility, and pH-solubility profiles. Stability is analyzed through studies of photolytic stability, stability to oxidation, and drug-excipient compatibility.
This document discusses biopharmaceutical factors that can affect the bioavailability of drugs. It focuses on pharmaceutical factors including physicochemical properties of drug molecules and dosage form characteristics. Physicochemical properties like solubility, dissolution rate, particle size, polymorphism, salt form, and ionization state can impact drug absorption. The pH-partition hypothesis explains how a drug's pKa and lipid solubility relate to absorption based on gastrointestinal pH. Dosage form properties such as disintegration time, manufacturing methods, and ingredients are also discussed as formulation factors influencing bioavailability.
Aquasomes are nanoparticle carrier systems composed of a solid nanocrystalline core coated with polyhydroxy oligomers. They are able to protect fragile biological molecules through water-like properties and high surface exposure. Aquasomes are prepared through a self-assembly process involving interaction of charged groups, hydrogen bonding, and structural stability. This allows active loading of molecules like proteins, antigens, and genes. Characterization techniques confirm the structure, drug loading, and release kinetics of aquasomes, which have applications in delivery of vaccines, hemoglobin, insulin, and enzymes orally and intravenously.
The document provides information about pharmaceutical aerosols. It discusses the history of aerosol development starting in the 1940s. It then defines aerosols and lists some of their advantages and disadvantages. The document outlines the key components of aerosols including propellants, containers, valves, and the product concentrate. It also describes the different types of propellant systems and manufacturing processes used to produce pharmaceutical aerosols. Finally, it discusses some quality control tests performed on the components and finished aerosol products.
This document provides notes on pharmaceutical aerosols. It defines a pharmaceutical aerosol and lists its advantages and disadvantages. It describes the key components of aerosols including propellants, containers, valves, and actuators. It discusses different types of propellants and containers. It explains the manufacturing process for aerosols including pressure filling, cold filling, and compressed gas filling. It outlines various aerosol formulation types and their applications in pharmaceutical products. Finally, it discusses how to evaluate the performance and safety of pharmaceutical aerosols.
This document provides an overview of aerosols, including their advantages and disadvantages for drug delivery. It describes the key components of aerosol systems, including propellants, containers, valves, and actuators. It also discusses the different types of aerosol systems and the manufacturing process for pharmaceutical aerosols. The document serves as a comprehensive reference on the topic.
This document provides an overview of aerosols including their history, components, formulations, preparation, filling, types of sprays, packaging, storage and labeling. It discusses that aerosols utilize compressed or liquefied gases to expel product from a container. The document outlines the various aerosol systems including solution, water-based, suspension, foam and intranasal. It also describes the components of aerosols including propellants, containers, valves, actuators and formulations. The advantages and disadvantages as well as testing and types of aerosol sprays are summarized.
This document provides information about aerosols, including their definition, components, types, and applications. Some key points:
- Aerosols are suspensions of fine solid or liquid particles in a gas, used to deliver medication. They contain active ingredients, propellants, containers, valves, and actuators.
- Propellants include liquefied gases like CFCs and hydrocarbons or compressed gases like CO2. Containers are usually metal or glass. Valves control dosage delivery as sprays or foams.
- Aerosol systems include solutions, suspensions, and various foam types. Solution systems use soluble active ingredients while suspensions disperse insoluble drugs. Foam systems produce wet or
The document provides an overview of pharmaceutical aerosols, including their definition, types, components, propellants, containers, valves, manufacturing process, and drug delivery to the lungs. Key points include:
- Aerosols contain active ingredients that are released as a fine dispersion upon activation of a valve. They are used for topical, nasal, oral, or inhalation applications.
- Components include propellants, containers, valves/actuators, and product concentrate. Common propellants are hydrocarbons, chlorofluorocarbons, compressed gases like carbon dioxide.
- Manufacturing involves filling containers with concentrate then propellant using pressure or cold filling to minimize contamination. Metered dose inhalers precisely deliver
This document discusses pharmaceutical aerosols, including their definition, components, types of systems, manufacturing, and quality control. Key points include:
- Pharmaceutical aerosols are systems that use compressed gases to expel medication from a container via valves. They were developed in the 1950s for topical and respiratory treatments.
- They have components like propellants, containers, valves, and product concentrates containing active ingredients and additives. Common propellants are fluorocarbons and hydrocarbons.
- Manufacturing involves formulating product concentrates and blending propellants to achieve the desired vapor pressure and particle size. Quality control testing evaluates the aerosol's physical and chemical properties.
This document defines pharmaceutical aerosols and their key components. It discusses the different types of aerosol systems including solution, water-based, suspension, and foam. It outlines the containers, valves, propellants like CFCs, HFCs, and hydrocarbons that are used. Quality control testing is described including tests for containers, propellants, valves, weight checking, and leak testing. The advantages of aerosols in delivering medications to targeted sites are presented.
The document discusses pharmaceutical aerosols, including their introduction, advantages, disadvantages, components, and types of formulations. Some key points:
- Pharmaceutical aerosols contain active ingredients dissolved or suspended in a propellant and are intended for oral, topical, or inhalation administration.
- Advantages include dose sterility, direct delivery to affected areas, and ease of application. Disadvantages include expense, propellant toxicity/flammability, and ozone depletion.
- Components include propellants, containers, valves, and product concentrates. Common propellants are CFCs, hydrocarbons, and hydrofluoroalkanes. Formulations can be solutions, suspensions, foams
Pharmaceutical aerosols are pressurized dosage forms that emit a fine dispersion of liquid or solid drug particles upon actuation. They consist of an active drug concentrate, propellant, container and valve. Common propellants include hydrocarbons, chlorofluorocarbons and compressed gases. Aerosols offer advantages like direct delivery to target areas and uniform dosing but are costly to produce. Manufacturing involves cold filling the chilled drug concentrate into containers followed by the addition of chilled propellant through valves under cold conditions.
1) Aerosols use compressed gases or liquefied gases to expel product from containers through special valve systems. Common propellants include HFAs which are safer for the ozone layer than CFCs.
2) Aerosol formulations exist as solutions, suspensions, or emulsions depending on whether the product is soluble or dispersed in the propellant. Solution aerosols produce fine sprays while suspension and emulsion aerosols can produce foams.
3) Key aerosol components include propellants, containers which must withstand high pressures, valves for metering and actuating flow, and formulations incorporating active ingredients and propellants. Aerosols offer advantages like targeted delivery but also have fl
This document discusses aerosols, their components, manufacturing, and uses. Aerosols are formulations that use pressurized gases to deliver a contained product through small droplets. They have advantages like small droplet size and no contamination of remaining product. Components include propellants like fluorinated hydrocarbons, containers that withstand high pressure, and valves. Aerosols are manufactured through cold or pressure filling methods and evaluated through quality control testing. They have pharmaceutical uses like asthma inhalers and pain sprays as well as non-pharmaceutical uses such as deodorants, insecticides, and paints.
This document discusses pharmaceutical aerosols. It defines pharmaceutical aerosols as pressurized dosage forms that emit a fine dispersion of liquid and/or solid materials in a gaseous medium upon actuation. It describes how pharmaceutical aerosols work using propellants to exert pressure and force the product out in an even stream. It discusses the types of propellants and pressurized containers used, factors influencing drug absorption from aerosols, and advantages and disadvantages of aerosols.
The document discusses the components and manufacturing of pharmaceutical aerosols. It begins by defining aerosols and pharmaceutical aerosols. It then discusses the key components of aerosols including:
1) Propellants which provide the driving force to expel the product and include liquefied gases, compressed gases, chlorofluorocarbons, hydrocarbons, and hydrofluoroalkanes.
2) Containers which can be made of metal, glass or plastic and must withstand pressure.
3) Valves and actuators which control emission of the product and include metered dose and continuous spray valves as well as spray, foam and mist actuators.
4) The product concentrate containing
VANDANA SHARMA is an independent pharmaceutical tutor since 2008. Aerosol packages contain pressurized gases that can expel drug ingredients from the container. Common container materials are aluminum, steel, and glass. Valves contain components like the ferrule, valve body, stem, spring, and gasket. Actuators allow controlled opening of the valve to dispense products as sprays or foams. Common propellants are chlorofluorocarbons, hydrocarbons, compressed gases like nitrogen. Manufacturing involves cold filling or pressure filling methods.
This document discusses aerosols, including their types, components, advantages, and disadvantages. It describes the four main types of aerosols as space aerosols, surface coating aerosols, foam aerosols, and stream aerosols. The key components of aerosols are identified as the container, valve, propellant, and product concentrate. Common propellants discussed include liquefied gas propellants and compressed gas propellants. The document also outlines the advantages of aerosol therapy and reviews the parts that make up aerosol valves.
we covered all the topics related to pharmaceutical aerosol in a clear and easily understandable manner with some of the pictorials attached to it. I think it will be sufficient for both your exams as well as for you seminar purpose even i also gave presentation on this.
Hope this will be helpful for your reference purpose.
This document summarizes a presentation on aerosols. It defines aerosols as pressurized dosage forms containing active ingredients that emit a fine dispersion when activated. It outlines the advantages and disadvantages of aerosols. The key components of an aerosol package are described as the propellant, container, valve, and product concentrate. Common propellant types and container materials are identified. The document also provides an overview of the manufacturing process for pharmaceutical aerosols and evaluation tests performed.
This document provides an overview of aerosol drug delivery systems. It defines aerosols and discusses their advantages and disadvantages. The key components of aerosols are described including propellants, containers, valves, actuators, and product concentrates. Different types of propellants, containers, valves and actuators are summarized. The document also discusses various aerosol formulation systems including solutions, suspensions, and foam systems. It provides examples of marketed aerosol drug products and considerations for ensuring physical stability of aerosol suspensions.
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Aerosol : as drug delivery system.
1. 7/01/2021 1
AEROSOLS, PROPELLANTS,
CONTAINERS TYPES,
PREPARAION AND EVALUATION
Guided By :
Dr. L. R. Zawar
(HOD, Dept. of Pharmaceutics)
DEPT.OF PHARMACEUTICS/HRPIPER ,SHIRPUR
Presented By:
Gaurav Shriram Patil
M Pharm I Year (SEM II)
H.R. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH ,SHIRPUR (MH)
2. I. INTRODUCTION
II. COMPONENTS OFAEROSOL PACKAGE
III. TYPES OF SYSTEM
IV. MANUFACTURING OF PHARMACEUTICAL
AEROSOLS
V. QUALITY CONTROL OF PHARMACEUTICAL
AEROSOLS PACKAGE
VI. EVALUATION TESTS OF PHARMACEUTICAL
AEROSOLS
VII. NEWER DEVELOPMENTS
VIII. REFERENCES
7/01/2021 2
CONTENTS
3. DEFINITION – PHARMACEUTICAL AEROSOLS
• Pharmaceutical aerosols are the products that are packed under
pressure and contain therapeutically active ingredient that
releaseupon activationof appropriatevalve system.
• A system that depends on the power of a compressed to expel
the contentsfrom the container.
• Development of pharmaceutical aerosolsis occurred in 1950s.
• These aerosol products were intended for burns , minor cuts and
bruises , infections and various dermatologic conditions.
• Aerosol products intended for local activity in the respiratory
tract appeared in 1955 , when Epinephrine was made available
in a pressurized package.
I INTRODUCTION
7/01/2021 3
5. The propellant is responsible for developing the
proper pressure within the container
• The propellant is responsible for developing the
proper pressure within the container.
• Expels the product when the valve is opened.
• It aids in atomization or foam production of the
product.
VARIOUS TYPES OF PROPELLANTS:
A) Liquefied Gases Propellants
B) Compressed Gases Propellants
7/01/2021 5
I PROPELLATNS
6. A) Liquefied Gases Propellants:
• These are Gases at room temp and atmospheric
pressure.
• They are liquefied by lowering the temp.
• When they are place in the container they are
immediately separated into Liquid and Vapor phase.
• They are of Following types:
CHLOROFLURO
CARBONS
FLORINATED HYDRO
CARBONS
HYDROCARBONS
EX- di-chloro-di-
flouro-methane(12)
EX- Di-flouroethane EX- Butane ,Propane
Used for Oral
Inhalation
preparation.
Used for Oral
Inhalation
preparation.
Used for Topical
preparation.
7/01/2021 6
7. B) Compressed Gas Propellants:
Some gases can be compressed in small volume and
remain in the gaseous form. When these are used to
provide pressure to remove product from the aerosol they
can called as compressed gas propellants.
• These are having High Purity
• Also, Having High Stability.
• Nitrogen, Nitrous Oxide, Carbon Dioxide are some of
its example.
7/01/2021 7
9. The containers, must withstand pressures as
high as 140 to 180 psig at 1300 F
7/01/2021 9
II CONTAINERS
V
arious materials
Were used as
containers A. Metal –
• 1.Tinplatedsteel
• A. Side – seam(three
– piece )
• B . Two – piece or
drawn
• C .Tin – free steel
• 2. Aluminum
• a. Two – piece
• b.One – piece (extruded
or drawn)
• 3. Stainless steel
B. Glass
• a. Uncoated glass
• b.Plastic –
coated glass
10. I .Tinplated containers
• They consists of a sheet of steel plate that has
been electroplated on both sides with tin
• The thickness of the tin coating is described in terms
of its weight , e.g.-#25,#50 and #100
• Tinplated steel is obtained in thin sheets, and when
required, it is coated with an organic material
• These are most used containers as they are light
In-expensive and durable.
7/01/2021 10
A METAL
11. II. Aluminum containers
II. Aluminum Containers (canisters)
• Aluminum is used to manufacture extruded
(seamless) aerosol containers.
• Manufactured by impact extrusion process.
• Used for Inhalation and Topical aerosols.
• Light weight, Less Compatible to corrosion, less
fragile are some of advantages of Aluminum
Containers.
• Disadvantages-
a. Corroded by pure water and pure ethanol.
b. High Cost
7/01/2021 11
12. III. Stainless Steel Containers
• These containers are limited to the smaller sizes ,
owing to production problems as well as cost.
• They are extremely strong and resistant to most
materials.
• Stainless steal containers have been used for
inhalation aerosols.
• They do not require coating like other containers.
• Expensive, Restricts its size to smaller size are some
of its disadvantages.
7/01/2021 12
13. • Glass containers are available with or without plastic
coatings.
• Corrosion problems are eliminated and allows a greater
degree of freedom in design of the container.
• Their use is limited due to brittleness property.
• Use in MDI and Topical Aerosols
• Advantages: Less chemical compatibility, Corrosion Free
etc.
• Disadvantages: Accidental breakage, Not suitable for
Photosensitive material.
• Two types are available in them;
1)Uncoated glass containers.
2) Plastic Coated containers.(prevent shattering)
7/01/2021 13
B. GLASS CONTAINERS
15. Defined as a device that is used to seal the aerosol
container and to permit controlled discharge of the
contents.
Components of Valve:
The normal aerosolvalvehas 7 basicparts:
1. Actuator: Controls pattern.
2. Stem: Controls flow
3. Stem Gasket: The “ON/OFF” Switch
4. Housing (Body): Encloses spring/stem &
controls flow.
5. Spring Mounting: Closes Valve
6. Mounting Cup (With mounting & gasket): The
link between the can & valve.
7. Dip Tube: Draws product valve upward.
7/01/2021 15
III VALVE
16. Formulation of pharmaceutical Aerosols
Contains two essential components
Product concentrate
Propellant
Product concentrate contains ingredients or mixture of
active ingredients and other such as solvents,
antioxidants and surfactants.
Propellant may be single or blend of various
propellants
7/01/2021 16
17. Solution system (Two Phase System)
Water based system ( Three Phase System)
Suspension or Dispersion systems
Foam systems
1. Aqueous stable foams
2. Non aqueous stable foams
3. Quick-breaking foams
4. Thermal foams
Intranasal aerosols
7/01/2021 17
TYPES OF SYSTEM
18. Contains both vapor & liquid phase.
Drug soluble in propellant – no other solvent is
required .
Propellant 12 orA– 70 – single or mixture
Example:
Weight %
Active ingredients To 10 -15
Propellant To 100
7/01/2021 18
TWO PHASE SYSTEM
19. Large amounts of water can be used to replace all or
part of non – aqueous solvents
The products are emitted as a spray or foam
Contains water phase, vapor phase and the propellant.
Water immiscible with propellant – solubility increased
by adding,
Co – solvent (ethanol)
Surfactants (0.5% - 2.0%) – non polar ( esters
of oleic acid, palmitic acid, stearic acid)
7/01/2021 19
20. Using suspending agent.
Oral inhalation aerosols.
Active ingredients dispersed in propellant or mixture
Physical stability by,
- Control of moisture content
- Active ingredients with minimum solubility in propellant.
- Propellant density
- Suspending agents
7/01/2021 20
21. Consists of aq. or non aq. vehicles, propellant &
surfactants.
Four types ,
Aqueous stable foams
Non aqueous stable foams
Quick breaking foams
Thermal foams
7/01/2021 21
22. Intended for the deposition of medication into the nasal
passage ways
Drugs intended to produce local or systemic effect can
be used
A new alternative is pressurized metered nasal aerosols
Advantages:
Excellent depth of penetration
Reduced droplet or particle size
Example: Oxytocin Nasal Spray.
7/01/2021 22
25. MethodA
Product concentratechilledto -30 to -40o F.
Chilled product added to chilled container.
Chilled propellantadded through inlet valve.
Method B
Product concentrateand propellant chilledto -30 to - 40o F.
Mixture added to chilled container.
The valves are set in place.
Filled containerspassed through water bath (contentsheated to
130o F).
7/01/2021 25
26. Containers dried, capped and labeled.
Advantage
Easy process
Disadvantage
Aqueous products, emulsions cannot be filled.
For non aqueous systems, moisture appears in final
product.
7/01/2021 26
28. Consists of metering burette – measures the
amount of propellant to be filled.
Method
Product concentrate is filled through the burette at
room temperature.
Propellant is added through the inlet valve.
Flow of propellant stops when pressure of filling
propellant become equal to the pressure within the
container.
7/01/2021 28
29. Propellant – compressed gas
Pressure reduced by pressure reducing valve
Pressure used – 150 psig
METHOD
Product concentrate placed in container
Valve crimped in its place
Air evacuated by vacuum pump
Filling head inserted into valve opening
& gas allowed to flow into container.
Container shaken during and after filling by
mechanical shakers.
7/01/2021 29
COMPRESSED GAS FILING APPRATUS
30. It Includes Tests of:
Propellants
V
alves, Actuator and Dip Tubes
Containers
Weight Checking
Leak Testing
Spray Testing
7/01/2021 30
31. Vapor pressure is determined and compared to
Specifications
The density is determined by hydrometer.
PARAMETER TESTED BY
Identification
(of propellant and when
a blend of propellant is
used , to determine its
composition)
Gas Chromatography
Purity and acceptability Moisture, Halogen,
Non-VolatileResidue
Determinations
7/01/2021 31
32. Take 25 valves and placed on containers
Filled with specific test solution
Actuator with 0.020 inch orifice is attached.
(containers placed at temp. 25±10 C)
Valve is actuated to fullest extent for 2 sec.
Repeat for total of 2 individual delivery from each
25 test units.
7/01/2021 32
33. Valve delivery per actuation in µL =
Individual delivery wt in mg
Specific gravity of test solution
Valve Acceptance
The test procedure applies to two categories of metered
aerosol valves having the following limits
For valves Delivering The limits are
54µL or less ± 15%
55 to 200 µL ± 10%
7/01/2021 33
34. Of 50 individual deliveries
(1)If four or more are outside limits : the valves are
rejected
(2)If three individual deliveries are outside limits :
another 25 valves are sampled and the test is
repeated
Lot is rejected if more than one delivery is outside the
specification.
7/01/2021 34
35. Both uncoated and coated metal Containers are
examined for defects in lining.
Quality control aspects include specifications for the
degree of conductivity of an electric current as a
measure of exposed metal.
Glass containers examined for Flaws.
7/01/2021 35
CONTAINERS
It is done,
»To clear the dip tube of pure propellant and Concentrate.
»To check for defects in the valve and spray pattern.
SPRAY TESTING
36. WEIGHT CHECKING
Add tared empty aerosol container to filling lines which after filling with
concentrate are removed and then weighed.
Same procedure is used for checking weight of Propellants.
The finished container is weighed to check the accuracy of filling.
For metal containers done by measuring the Crimp dimensions & ensure
that they meet specifications.
Final testing of the valve closure is done by passing filled
containersthrough water bath.
Periodic checks are made of the temperatureof the water bath.
7/01/2021 36
LEAK TEST
37. A. Flammability & Combustibility
1. Flash point
2. Flame Extension / Projection
B. Physicochemical characteristics
1. V
apor pressure
2. Density
3. Moisture content
4.Identification of Propellants
5.Concentrate– propellant ratio
7/01/2021 37
C. Performance
1. Aerosol valve discharge rate
2. Spray pattern
3. Dosage with metered valves
4. Net contents
5. Foam stability
6. Particle size determination
7. Leakage
D. Biological testing
1.Therapeutic activity
2.Toxicity studies
EVALUATION TEST OF PHARMACEUTICALAEROSOLS
38. Flash Point Flame Projection
The aerosol product is chilled
to a temperature of about-250F
and transferred to the test
apparatus
Test liquids temperature is
allowed to increase slowly and
the temperature at which
vapours ignite is taken as Flash
Point.
Apparatus : Open Cup Tag
This test indicates effect of
aerosol formulation on the
extension of open flame.
Product is sprayed for 4 sec
into a flame & exact length is
measured with ruler.
Below is the Apparatus used for
Flame Projection test.
A. FLAMABILITY AND COMBUSTIBILITY
7/01/2021 38
40. 1 Aerosol valve discharge rate
Aerosol product of known weight is taken and discharged for a given
period of time.
By reweighing the container after time limit has expired, the change in weight
per time dispensed is the discharge rate (g/sec).
2 Spray Pattern
The method is based on the impingement of spray on piece of paper that
has treated with Dye-Talc mixture
The particle that strike the paper cause the dye to go solutionand to be
absorbed onto the paper
This gives a record of the spray can be used for comparison purposes.
7/01/2021 40
41. 3. Dosage with Metered Valve
Reproducibilityof dosage determinedby
»Assay Techniques
Where one or two doses are dispensed into a solvent or onto a
material that absorbs the active ingredients.
These solutionscan then be assayed , and the amount of
active ingredients determined.
4. Net contents
Several methodscan be used.
Tared cans have been placed onto the filling lines are
reweighed and the difference in weight is equal to the net
content.
7/01/2021 41
42. Methods :
Visual Evaluation
Rotational Viscometer
6.Partical size determination
Methods :
Light Scatter Decay
Cascade Impactor
7/01/2021 42
a) Light ScatterDecay
As aerosol settles under turbulent conditions, the changes
in light intensity of a Tyndallbeam is measured
43. 1.TherapeuticActivity 2.Toxicity
• For Inhalation Aerosols : Depends
on the particle size distribution.
• For TopicalAerosols: Is applied to
test areas and adsorption of
therapeutic ingredients can be
determined.
• For Inhalation Aerosols : Exposing
test animals to vapor sprayed from
aerosol container.
• For Topical Aerosols : Irritation &
chilling effects are determined.
• Degree of chilling depends on the
type and amount of propellant
present.
• Thermistor probes attached to
recording thermometers used to
indicate the change in skin
temperature.
7/01/2021 43
44. 7/01/2021 44
NEWER DEVELOPMENTS
• At present, there is much interest in developing MDIs
for a variety of conditions, including asthma,
emphysema, diabetes, AIDS, cancer, heart disease, and
cystic fibrosis.
• Many of these compounds have been developed using
biotechnology processes, and their delivery to the
respiratory system via an MDI is an extremely
challenging undertaking.
• With the introduction of newer, alternative propellants,
the challenge becomes even greater and presents a
unique opportunity for the delivery of these compounds.
45. Lachman, L., Lieberman, HA., 2009. The theoryand practiceof
industrial pharmacy, special Indian ed. CBS publishersand
distributorsPVT. LTD, New Delhi , 589-618.
Sciarra, JJ., Stoller, L., 1998. The science and technology of
aerosol packaging .AWiley – interscience publication, Newyork,
247-255.
John J Sciarra and Christhopher J Sciarra, Remington Essentials
of Pharmaceutics, Edited by Linda Felton, 633-651.
Search Engine: Google and You tube.
Wikipedia.
7/01/2021 45
REFERENCES