This document discusses packaging and storage of pharmaceuticals. It covers various packaging materials like glass, plastics, and metals. It describes primary and secondary packaging as well as different types of containers, closures, and labeling requirements. The document also discusses stability studies, storage conditions, and establishing beyond-use dates to ensure pharmaceuticals maintain quality until the expiration date.
This document discusses pharmaceutical suspensions. It defines a suspension as a dispersion where an insoluble solid drug is uniformly distributed throughout an external liquid phase. Suspensions are used when drugs are insoluble, to mask taste, or control drug release. Key factors in formulation include particle size control, wetting, sedimentation, Brownian motion, and electrokinetics. Approaches to formulation include structured vehicles, controlled flocculation, or a combination. Common ingredients and preparation methods are also reviewed.
This document provides an introduction to pharmaceutical dosage forms and routes of drug administration. It defines key terms like pharmaceutics, dosage forms, active pharmaceutical ingredients and excipients. It also describes various solid dosage forms like tablets, capsules, lozenges and suppositories. Liquid dosage forms such as oral solutions, syrups, elixirs, emulsions and suspensions are also outlined. The document concludes by discussing solid and liquid dosage forms in detail.
The document discusses pharmaceutical solutions and their preparation. It begins with an introduction to different liquid dosage forms including solutions, suspensions, colloids, and emulsions. It then covers various topics related to solutions such as common solvents used, formulation considerations regarding solubility and stability, and classification of solutions based on route of administration or vehicle. Specific types of solutions are explained including those taken orally, used topically, and injected. Manufacturing considerations are also briefly mentioned.
This document discusses pharmaceutical emulsions. It begins with definitions of emulsions and their types, including oil-in-water and water-in-oil emulsions. Theories of emulsification like the surface tension theory and oriented-wedge theory are explained. Methods for determining the emulsion type, such as dilution, conductivity, and dye tests, are outlined. The key steps in emulsion preparation include selecting emulsifying agents, preservatives, and other additives. Common emulsifying agents include synthetic surfactants, semi-synthetic and natural hydrophilic colloids, and finely divided solid particles.
This document discusses key considerations for dosage form design and formulation. It explains that pharmaceutical formulation involves selecting excipients to solubilize, thicken, stabilize, flavor, and otherwise modify drug substances for patient delivery. Proper dosage form design requires considering the physical and chemical properties of drug substances and ensuring compatibility with excipients. Preformulation studies characterize the drug's properties including solubility, dissolution rate, and stability. Understanding these properties helps determine the appropriate dosage form and formulation to provide stable, effective delivery of the active drug to patients.
The document discusses co-processed excipients, which are combinations of two or more excipients designed to physically modify their properties without chemical change. It defines co-processed excipients and provides examples such as microcrystalline cellulose and mannitol. The document outlines the need for co-processed excipients, their manufacturing principles and processes like spray drying. It also discusses the advantages of co-processed excipients in improving flow properties and compressibility as well as their applications and evaluation parameters.
The document discusses preformulation of sterile products. It covers key areas of preformulation including bulk characterization, solubility analysis, and stability analysis. Bulk characterization involves assessing properties like crystallinity, polymorphism, particle size, powder flow, and hygroscopicity. Solubility analysis includes studying aqueous solubility, drug ionization at physiological pH, partition coefficient, and thermal effects. Stability analysis focuses on stability in toxicology formulations, solution stability, and solid state stability under various conditions. The goal of preformulation is to characterize important physicochemical properties of drug substances to aid in developing appropriate formulations.
The document discusses factors that affect the incorporation of pharmaceutical excipients in formulations. It lists several key factors: excipient functionality depends on the specific formulation and manufacturing process. Excipient grades have different performance characteristics. Impurity profiles include organic, inorganic and residual solvent impurities. Fewer ingredients are better for consistency, economics and reducing interactions. Drug-excipient and excipient-excipient interactions can impact properties. Formulators must consider multiple factors for a holistic formulation design.
This document discusses pharmaceutical suspensions. It defines a suspension as a dispersion where an insoluble solid drug is uniformly distributed throughout an external liquid phase. Suspensions are used when drugs are insoluble, to mask taste, or control drug release. Key factors in formulation include particle size control, wetting, sedimentation, Brownian motion, and electrokinetics. Approaches to formulation include structured vehicles, controlled flocculation, or a combination. Common ingredients and preparation methods are also reviewed.
This document provides an introduction to pharmaceutical dosage forms and routes of drug administration. It defines key terms like pharmaceutics, dosage forms, active pharmaceutical ingredients and excipients. It also describes various solid dosage forms like tablets, capsules, lozenges and suppositories. Liquid dosage forms such as oral solutions, syrups, elixirs, emulsions and suspensions are also outlined. The document concludes by discussing solid and liquid dosage forms in detail.
The document discusses pharmaceutical solutions and their preparation. It begins with an introduction to different liquid dosage forms including solutions, suspensions, colloids, and emulsions. It then covers various topics related to solutions such as common solvents used, formulation considerations regarding solubility and stability, and classification of solutions based on route of administration or vehicle. Specific types of solutions are explained including those taken orally, used topically, and injected. Manufacturing considerations are also briefly mentioned.
This document discusses pharmaceutical emulsions. It begins with definitions of emulsions and their types, including oil-in-water and water-in-oil emulsions. Theories of emulsification like the surface tension theory and oriented-wedge theory are explained. Methods for determining the emulsion type, such as dilution, conductivity, and dye tests, are outlined. The key steps in emulsion preparation include selecting emulsifying agents, preservatives, and other additives. Common emulsifying agents include synthetic surfactants, semi-synthetic and natural hydrophilic colloids, and finely divided solid particles.
This document discusses key considerations for dosage form design and formulation. It explains that pharmaceutical formulation involves selecting excipients to solubilize, thicken, stabilize, flavor, and otherwise modify drug substances for patient delivery. Proper dosage form design requires considering the physical and chemical properties of drug substances and ensuring compatibility with excipients. Preformulation studies characterize the drug's properties including solubility, dissolution rate, and stability. Understanding these properties helps determine the appropriate dosage form and formulation to provide stable, effective delivery of the active drug to patients.
The document discusses co-processed excipients, which are combinations of two or more excipients designed to physically modify their properties without chemical change. It defines co-processed excipients and provides examples such as microcrystalline cellulose and mannitol. The document outlines the need for co-processed excipients, their manufacturing principles and processes like spray drying. It also discusses the advantages of co-processed excipients in improving flow properties and compressibility as well as their applications and evaluation parameters.
The document discusses preformulation of sterile products. It covers key areas of preformulation including bulk characterization, solubility analysis, and stability analysis. Bulk characterization involves assessing properties like crystallinity, polymorphism, particle size, powder flow, and hygroscopicity. Solubility analysis includes studying aqueous solubility, drug ionization at physiological pH, partition coefficient, and thermal effects. Stability analysis focuses on stability in toxicology formulations, solution stability, and solid state stability under various conditions. The goal of preformulation is to characterize important physicochemical properties of drug substances to aid in developing appropriate formulations.
The document discusses factors that affect the incorporation of pharmaceutical excipients in formulations. It lists several key factors: excipient functionality depends on the specific formulation and manufacturing process. Excipient grades have different performance characteristics. Impurity profiles include organic, inorganic and residual solvent impurities. Fewer ingredients are better for consistency, economics and reducing interactions. Drug-excipient and excipient-excipient interactions can impact properties. Formulators must consider multiple factors for a holistic formulation design.
This document discusses drug stability and stabilization techniques. It defines drug stability and outlines the various types of instability drugs may experience, including physical, chemical, and microbial changes. It also discusses techniques for assessing stability through studies of solid state stability, compatibility with excipients, and solution phase stability. Specific degradation pathways like hydrolysis, oxidation, and photolysis are examined. Methods for establishing shelf life through accelerated stability testing and the Arrhenius equation are also covered. The document emphasizes the importance of stability studies in ensuring drug quality throughout storage and use.
The document summarizes the regulatory requirements for stability testing from various agencies like ICH, WHO, ASEAN, and EMEA. It discusses the three types of stability studies - physical, chemical, and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light, and concentration can affect a drug's stability. While the stability testing requirements of WHO, ASEAN, and EMEA are similar to ICH guidelines, there are some differences in parameters like selection of batches and storage conditions.
This document summarizes the formulation and evaluation of fast dissolving tablet dosages of felodipine. It discusses the drug profile, aim/objectives of developing fast dissolving tablets, materials/equipment used, preparation of formulations using different superdisintegrants (crospovidone, crosscarmellose sodium, sodium starch glycolate), and evaluation of tablet properties (thickness, hardness, friability) and performance (disintegration time, dissolution). 9 formulations were developed and evaluated, with F3 showing the fastest disintegration time of 116 seconds and highest drug release of 90.58% within 30 minutes. The study demonstrated the potential of using superdisintegrants to develop fast dissolving felodipine tablets for improved patient compliance and
PHYSICAL AND CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUCTS.
Physical Factors
Loss of volatile constituents
Loss of water
Absorption of water
Crystal growth
Polymorphism changes
Colour changes
Chemical factors
Hydrolysis
Oxidation
Carboxylation
Decarboxylation
Isomerization
Polymerization
This document discusses pharmaceutical dosage forms and their design. It defines key terms like active drug substance, excipients, and dosage forms. It classifies dosage forms based on physical properties into gases, liquids, semisolids, and solids. It also discusses important topics like prescription writing, controlled substances, and requirements for prescriptions of controlled substances.
Mechanism of drug degradation and protectionjyothiyagnam
This document discusses the mechanisms of drug degradation and methods for protecting drugs from degradation. There are three main types of drug degradation: chemical, physical, and microbial. Chemical degradation involves changes in the chemical structure of drugs, such as hydrolysis, oxidation, and isomerization. Physical degradation results from changes in a drug's physical properties during storage, like loss of volatile components or changes in crystal structure. Microbial degradation is caused by contamination of drugs by microbes like bacteria and fungi. Proper formulation, packaging, and storage conditions can help prevent degradation by controlling factors like temperature, moisture, oxygen, and light exposure. Understanding degradation pathways is important for ensuring drug stability and efficacy throughout a product's shelf life.
effect of various environment and processing on stability of formulationsManoj Kumar Tekuri
The document discusses various factors that can affect the stability of pharmaceutical formulations, including moisture, heat, light, radiation, and discusses physical and chemical degradation pathways like hydrolysis, oxidation, and techniques to stabilize formulations against degradation. It provides examples of drugs that can undergo hydrolysis or oxidation and discusses preventive measures like using buffers, complexation, suppressing solubility, antioxidants, chelating agents, and appropriate vehicles to inhibit degradation reactions like hydrolysis and oxidation.
Drug stability consideration and degradationJalal Uddin
This document discusses drug stability and factors that affect it. It defines drug stability as the ability of a drug formulation to remain within specified chemical, microbiological, therapeutic, physical and toxicological limits over a period of time. The main factors that can affect drug stability are pH, temperature, moisture, light, oxygen, and additives. Common types of drug degradation include hydrolysis, oxidation, photolysis, and isomerization. Proper packaging, inclusion of antioxidants and buffers, and controlling environmental conditions like temperature and humidity can help protect drugs and increase their shelf life.
This document provides an overview of sterile dosage forms for parenteral and ophthalmic drug administration. It discusses various routes of parenteral administration and key components of parenteral products, including vehicles, stabilizers, buffers, and antimicrobial agents. It also covers the formulation of solutions, suspensions, emulsions, and dry powders for injection, as well as sterilization methods and packaging considerations for sterile ophthalmic and parenteral preparations.
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
The document discusses the general requirements and components of sterile pharmaceutical products, including parenteral and ophthalmic formulations. It describes various vehicles, additives, and agents commonly used in sterile formulations and their purposes. These include aqueous and non-aqueous vehicles, antimicrobials, antioxidants, buffers, stabilizers, tonicity adjusting agents, and protectants. It also differentiates between small and large volume parenterals and outlines ideal properties of sterile dosage forms such as sterility, isotonicity, and stability.
This document discusses various excipients used for stabilizing and preserving dosage forms, including antioxidants, chelating agents, buffering agents, and antimicrobial preservatives. It provides details on the functions and examples of different types of antioxidants, chelating agents like disodium edetate, common buffering agents including acetates and citrates, and antimicrobial preservatives such as sodium metabisulfite. Specific excipients like sodium metabisulfite are also described in terms of their applications, stability, safety, and regulatory status.
Sterile dosage forms are parenteral dosage forms that are free from microorganisms and intended for injection, infusion, or implantation into the body. They must be sterile, pyrogen-free, and free of particulate matter. Common sterile dosage forms include injections, saline solutions, and eye drops. Their production involves cleaning, filtration, filling, sealing, and sterilizing containers under aseptic conditions. Finished products are tested for sterility, pyrogens, clarity, and leaks before release.
The document discusses drug degradation and stability. It defines drug degradation as the chemical breakdown of drug molecules through collisions, affected by factors like oxygen, moisture, acidity, alkalinity and light. Degradation pathways include hydrolysis, oxidation, photolysis, and racemization. More processed and formulated drugs degrade faster than pure drugs due to the presence of excipients and processing. Common routes of chemical degradation are solvolysis, oxidation, dehydration, optical isomerization, and hydrolysis. Physical degradation involves changes in state like polymorphism, vaporization, and absorption or loss of water. Microbial contamination can also cause drug breakdown. Proper storage, packaging, and use of preservatives can help prevent
This document provides an overview of drug stability for a pharmaceutical chemistry and pharmaceutics course. It defines drug stability as the ability of a dosage form to maintain its physical, chemical, therapeutic, and microbial properties during storage and usage. It discusses factors that influence stability such as temperature, pH, moisture, light, and packaging. It also describes different types of instability like physical changes, chemical degradation through hydrolysis, oxidation, or isomerization, and microbial contamination. The document aims to help predict and ensure drug stability.
Improved and Novel Excipients – Need, sources of new excipients-co-processing and particle engineering, benefits of co-processed excipients, characterization, examples, regulatory aspects
Application of preformulation_consideration_in_the_development_ofSUJIT DAS
This document discusses preformulation considerations for developing parenteral dosage forms. It describes how preformulation studies involve characterizing the physicochemical properties and stability of new drug substances. This helps ensure the development of stable, effective, and safe dosage forms. The key types of parenteral dosage forms are injectable solutions, suspensions, and emulsions. Preformulation assessments gather important information on the drug's stability, solubility, and degradation profile to guide subsequent formulation studies. These studies aim to find the conditions under which the drug molecule is most stable.
This document provides an overview of a seminar presentation on drug stability given by Ms. Swati S. Bharati to Mumbai University. The presentation covers topics such as the importance of stability testing, degradation pathways including physical, chemical and microbial degradation, kinetic stability, and solution and solid state stability. It defines stability and the purpose of stability studies. Examples are provided to illustrate different types of degradation pathways and how they can be prevented.
This document discusses the importance of rheology in developing pharmaceutical formulations. Rheology considers how materials deform under stress, which directly impacts how drugs are formulated and how patients use medications. Viscosity and temperature dependence are key rheological concepts. Suspensions are multi-phase liquid dosage forms where particles are dispersed in a vehicle. Stabilizing suspensions requires controlling sedimentation, viscosity and rheology. Various excipients like thickeners, buffers, and preservatives are used to improve stability.
This document discusses drug stability and stabilization techniques. It defines drug stability and outlines the various types of instability drugs may experience, including physical, chemical, and microbial changes. It also discusses techniques for assessing stability through studies of solid state stability, compatibility with excipients, and solution phase stability. Specific degradation pathways like hydrolysis, oxidation, and photolysis are examined. Methods for establishing shelf life through accelerated stability testing and the Arrhenius equation are also covered. The document emphasizes the importance of stability studies in ensuring drug quality throughout storage and use.
The document summarizes the regulatory requirements for stability testing from various agencies like ICH, WHO, ASEAN, and EMEA. It discusses the three types of stability studies - physical, chemical, and microbial stability. Various factors like oxygen, water, temperature, pH, moisture, light, and concentration can affect a drug's stability. While the stability testing requirements of WHO, ASEAN, and EMEA are similar to ICH guidelines, there are some differences in parameters like selection of batches and storage conditions.
This document summarizes the formulation and evaluation of fast dissolving tablet dosages of felodipine. It discusses the drug profile, aim/objectives of developing fast dissolving tablets, materials/equipment used, preparation of formulations using different superdisintegrants (crospovidone, crosscarmellose sodium, sodium starch glycolate), and evaluation of tablet properties (thickness, hardness, friability) and performance (disintegration time, dissolution). 9 formulations were developed and evaluated, with F3 showing the fastest disintegration time of 116 seconds and highest drug release of 90.58% within 30 minutes. The study demonstrated the potential of using superdisintegrants to develop fast dissolving felodipine tablets for improved patient compliance and
PHYSICAL AND CHEMICAL DEGRADATION OF PHARMACEUTICAL PRODUCTS.
Physical Factors
Loss of volatile constituents
Loss of water
Absorption of water
Crystal growth
Polymorphism changes
Colour changes
Chemical factors
Hydrolysis
Oxidation
Carboxylation
Decarboxylation
Isomerization
Polymerization
This document discusses pharmaceutical dosage forms and their design. It defines key terms like active drug substance, excipients, and dosage forms. It classifies dosage forms based on physical properties into gases, liquids, semisolids, and solids. It also discusses important topics like prescription writing, controlled substances, and requirements for prescriptions of controlled substances.
Mechanism of drug degradation and protectionjyothiyagnam
This document discusses the mechanisms of drug degradation and methods for protecting drugs from degradation. There are three main types of drug degradation: chemical, physical, and microbial. Chemical degradation involves changes in the chemical structure of drugs, such as hydrolysis, oxidation, and isomerization. Physical degradation results from changes in a drug's physical properties during storage, like loss of volatile components or changes in crystal structure. Microbial degradation is caused by contamination of drugs by microbes like bacteria and fungi. Proper formulation, packaging, and storage conditions can help prevent degradation by controlling factors like temperature, moisture, oxygen, and light exposure. Understanding degradation pathways is important for ensuring drug stability and efficacy throughout a product's shelf life.
effect of various environment and processing on stability of formulationsManoj Kumar Tekuri
The document discusses various factors that can affect the stability of pharmaceutical formulations, including moisture, heat, light, radiation, and discusses physical and chemical degradation pathways like hydrolysis, oxidation, and techniques to stabilize formulations against degradation. It provides examples of drugs that can undergo hydrolysis or oxidation and discusses preventive measures like using buffers, complexation, suppressing solubility, antioxidants, chelating agents, and appropriate vehicles to inhibit degradation reactions like hydrolysis and oxidation.
Drug stability consideration and degradationJalal Uddin
This document discusses drug stability and factors that affect it. It defines drug stability as the ability of a drug formulation to remain within specified chemical, microbiological, therapeutic, physical and toxicological limits over a period of time. The main factors that can affect drug stability are pH, temperature, moisture, light, oxygen, and additives. Common types of drug degradation include hydrolysis, oxidation, photolysis, and isomerization. Proper packaging, inclusion of antioxidants and buffers, and controlling environmental conditions like temperature and humidity can help protect drugs and increase their shelf life.
This document provides an overview of sterile dosage forms for parenteral and ophthalmic drug administration. It discusses various routes of parenteral administration and key components of parenteral products, including vehicles, stabilizers, buffers, and antimicrobial agents. It also covers the formulation of solutions, suspensions, emulsions, and dry powders for injection, as well as sterilization methods and packaging considerations for sterile ophthalmic and parenteral preparations.
Its not as good but still comprises outlines for added substances of parenteral in good.
All credit goes to Mr. Saifullah Khan.
Leave your comments to let us improve it for more.
The document discusses the general requirements and components of sterile pharmaceutical products, including parenteral and ophthalmic formulations. It describes various vehicles, additives, and agents commonly used in sterile formulations and their purposes. These include aqueous and non-aqueous vehicles, antimicrobials, antioxidants, buffers, stabilizers, tonicity adjusting agents, and protectants. It also differentiates between small and large volume parenterals and outlines ideal properties of sterile dosage forms such as sterility, isotonicity, and stability.
This document discusses various excipients used for stabilizing and preserving dosage forms, including antioxidants, chelating agents, buffering agents, and antimicrobial preservatives. It provides details on the functions and examples of different types of antioxidants, chelating agents like disodium edetate, common buffering agents including acetates and citrates, and antimicrobial preservatives such as sodium metabisulfite. Specific excipients like sodium metabisulfite are also described in terms of their applications, stability, safety, and regulatory status.
Sterile dosage forms are parenteral dosage forms that are free from microorganisms and intended for injection, infusion, or implantation into the body. They must be sterile, pyrogen-free, and free of particulate matter. Common sterile dosage forms include injections, saline solutions, and eye drops. Their production involves cleaning, filtration, filling, sealing, and sterilizing containers under aseptic conditions. Finished products are tested for sterility, pyrogens, clarity, and leaks before release.
The document discusses drug degradation and stability. It defines drug degradation as the chemical breakdown of drug molecules through collisions, affected by factors like oxygen, moisture, acidity, alkalinity and light. Degradation pathways include hydrolysis, oxidation, photolysis, and racemization. More processed and formulated drugs degrade faster than pure drugs due to the presence of excipients and processing. Common routes of chemical degradation are solvolysis, oxidation, dehydration, optical isomerization, and hydrolysis. Physical degradation involves changes in state like polymorphism, vaporization, and absorption or loss of water. Microbial contamination can also cause drug breakdown. Proper storage, packaging, and use of preservatives can help prevent
This document provides an overview of drug stability for a pharmaceutical chemistry and pharmaceutics course. It defines drug stability as the ability of a dosage form to maintain its physical, chemical, therapeutic, and microbial properties during storage and usage. It discusses factors that influence stability such as temperature, pH, moisture, light, and packaging. It also describes different types of instability like physical changes, chemical degradation through hydrolysis, oxidation, or isomerization, and microbial contamination. The document aims to help predict and ensure drug stability.
Improved and Novel Excipients – Need, sources of new excipients-co-processing and particle engineering, benefits of co-processed excipients, characterization, examples, regulatory aspects
Application of preformulation_consideration_in_the_development_ofSUJIT DAS
This document discusses preformulation considerations for developing parenteral dosage forms. It describes how preformulation studies involve characterizing the physicochemical properties and stability of new drug substances. This helps ensure the development of stable, effective, and safe dosage forms. The key types of parenteral dosage forms are injectable solutions, suspensions, and emulsions. Preformulation assessments gather important information on the drug's stability, solubility, and degradation profile to guide subsequent formulation studies. These studies aim to find the conditions under which the drug molecule is most stable.
This document provides an overview of a seminar presentation on drug stability given by Ms. Swati S. Bharati to Mumbai University. The presentation covers topics such as the importance of stability testing, degradation pathways including physical, chemical and microbial degradation, kinetic stability, and solution and solid state stability. It defines stability and the purpose of stability studies. Examples are provided to illustrate different types of degradation pathways and how they can be prevented.
This document discusses the importance of rheology in developing pharmaceutical formulations. Rheology considers how materials deform under stress, which directly impacts how drugs are formulated and how patients use medications. Viscosity and temperature dependence are key rheological concepts. Suspensions are multi-phase liquid dosage forms where particles are dispersed in a vehicle. Stabilizing suspensions requires controlling sedimentation, viscosity and rheology. Various excipients like thickeners, buffers, and preservatives are used to improve stability.
Packaging plays a crucial role in ensuring the safety, integrity, and proper dispensing of pharmaceutical products. There are several types of common pharmaceutical packaging: unit-dose packaging individually packages each dose of medication and is used in hospitals to reduce medication errors; blister packaging consists of individual cavities for each dose and is used for over-the-counter medications; bottle packaging varies in size depending on the quantity prescribed and is used for liquid medications. Proper packaging helps protect products from factors like light, moisture, and temperature fluctuations that can affect stability and efficacy.
This document discusses various aspects of pharmaceutical packaging. It begins by defining packaging and its purposes. It then discusses factors to consider when selecting packaging materials, desirable characteristics of materials, and barrier properties needed. The document outlines the primary uses of packaging and different types of packaging including primary, secondary and tertiary. It provides details on common packaging materials like glass, metals, plastics, rubbers and fibrous materials. For each material, it discusses advantages and disadvantages as well as examples of applications in pharmaceutical packaging.
This document discusses pharmaceutical packaging. It begins by defining pharmaceutical packaging and describing its ideal requirements, such as protecting products from environmental conditions while not reacting with or imparting tastes/odors to the product. It then discusses the functions of packaging including product identification, protection, promotion, and convenience. Next, it covers selection of packaging materials and types of packaging materials including glass, plastics, metals and others. It concludes by describing some common plastic materials used in pharmaceutical packaging like polyethylene, polyvinyl chloride, and polystyrene.
This document discusses pharmaceutical packaging. It defines pharmaceutical packaging and describes the primary and secondary/tertiary packaging systems. The key requirements for pharmaceutical packaging are to protect the product, be non-reactive, prevent contamination, and be FDA approved. Important criteria for selecting packaging materials include stability, compatibility with contents, strength, moisture protection, and cost. Common packaging materials include glass, plastic, metal, paper, rubber, and closures. Guidelines for quality control of packaging materials require containers and closures to meet pharmacopeial standards and be properly washed and sterilized.
This document discusses various aspects of pharmaceutical packaging, including packaging materials, packaging equipment, packaging areas, and how packaging influences product stability and quality. Key points:
1. Packaging protects pharmaceutical products from external influences like moisture, oxygen, light and contamination. It also provides product information and identification.
2. Packaging material selection considers barrier properties and compatibility with the product. Common materials include glass, plastic and aluminum foil.
3. Packaging equipment is used to package, label, seal and bundle products for distribution. Examples include blister packaging machines and strip packing machines.
4. Packaging areas must be clean, well-managed spaces for packaging processes. They protect product quality during packaging operations.
This document discusses pharmaceutical packing and packaging materials. It defines primary, secondary, and tertiary pharmaceutical packaging. Primary packaging has direct contact with the product and provides the first layer of protection. Secondary packaging protects primary packaging and displays product information. Tertiary packaging protects primary and secondary packaging during storage and transportation. Common primary packaging includes blister packs, vials, ampoules, and tubes. The document also discusses ideal qualities for pharmaceutical packaging materials and provides details on common materials like glass, plastic, paper, metal and their advantages and disadvantages for pharmaceutical use.
Packaging materials must protect sterile products, be non-reactive, and provide important product information to patients. There are primary, secondary, and associated packaging components. Primary components like vials and syringes contact the product directly, while secondary components provide additional protection. Glass, plastic, and rubber are common materials, each with advantages and limitations for packaging. Proper packaging selection is critical to avoid particulate, pyrogen, and stability issues.
The document discusses quality assurance and quality control procedures for pharmaceutical packaging and containers. It defines key terms like container, closure, and container closure system. It describes the roles and requirements of good packaging including protection, identification and compatibility with the drug. It outlines different types of containers and quality control tests performed on glass and plastic containers to ensure they meet standards. These include tests for breakage resistance, hydrolytic resistance and chemical purity. The document emphasizes the importance of packaging for drug quality and stability.
Packaging is the art of science & technology of enclosing or protecting products for distribution , storage, sale & use.
Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification, information, convenience compliance, integrity & stability of the product.
SELECTION AND EVALUATION OF PHARMACEUTICAL PACKAGING TECHNIQUE.pdfShankar Maind Patil
This document discusses the selection and evaluation of pharmaceutical packaging techniques. It begins with an introduction and then discusses the characteristics, roles, selection criteria, and ideal requirements of packaging materials. The main types of packaging materials discussed are glass, metal, plastic, and rubber. Specific packaging applications and the tests used to evaluate different packaging materials are also summarized. The key points covered include characteristics of ideal packaging materials, factors that influence packaging selection, common packaging types and the tests used to establish their suitability.
This document provides an overview of pharmaceutical packaging. It discusses the functions of packaging including protection, storage, identification and information provision. It describes common packaging materials like glass, plastic, metal and rubber and how they are used. Different dosage forms like solids, liquids, and parenterals are outlined along with their typical packaging. Recent trends in the industry toward devices like prefilled syringes and regulations from the FDA are also summarized.
Pharmaceutical packaging serves several important purposes: protection, identification, information, containment, integrity, and stability. Packaging design must consider factors like material selection, sterility, and regulations. There are three levels of pharmaceutical packaging: primary, secondary, and tertiary. Primary packaging has direct contact with the product, while secondary and tertiary packaging provide additional protection, grouping, and handling during storage and shipping. Proper packaging is essential for medical products to maintain quality and safety throughout distribution and use.
This document discusses pharmaceutical packaging. It begins by defining pharmaceutical packaging and outlining its main functions, which include protective, storage, identification, and marketing functions. It then describes different types of packaging including primary, secondary, and tertiary packaging. The main materials used for pharmaceutical packaging are discussed, including glass, plastic, metal, paper, and cardboard. Common container types and closures are also outlined. The document provides details on specific packaging materials like glass composition and plastic types. It concludes by emphasizing the importance of packaging for product protection and stability as well as its role in marketing.
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.
This document discusses various materials used for pharmaceutical packaging and equipment construction. It describes common container types like well-closed, single and multi-dose, light-resistant, and aerosol containers. Primary, secondary and tertiary packaging are defined. Common materials like glass, plastic, rubber, metals and paper are outlined. Specific plastics like polyethylene, PVC, and polystyrene are detailed. Closures like screw caps, crowns and friction fits are summarized. Standards for glass containers are provided.
The document discusses the importance of packaging for pharmaceutical products. It outlines several key functions of packaging including uniformity, purity, integrity, minimizing side effects, and ensuring stability and a defined shelf life. It also classifies different types of packaging materials like primary, secondary and tertiary packaging. Specific materials that are used include glass, plastics, polyethylene, polypropylene, and others. The role of packaging technology in preventing counterfeiting is also covered through various techniques like ink technology, RFID tags, tamper-evident stickers, and holograms. Packaging can also help promote patient compliance and provide informative labeling.
Metal chelating agents are used to treat toxicity from heavy metals like arsenic, lead, and mercury. Common chelating agents include dimercaprol, DMPS, EDTA, DMSA, penicillamine, and DTPA. They work by forming stable complexes with metals, allowing the metals to be removed from the body through excretion. While chelating agents are effective at removing metals, they must also have a low affinity for essential metals like calcium and zinc to avoid depleting these nutrients. Arsenic is one of the most toxic heavy metals and exposure can occur through contaminated water, pesticides, or occupational sources. After absorption, arsenic accumulates in tissues and symptoms of toxicity can appear with ingest
The document discusses several medical toxicants including acetaminophen, aspirin, sedatives/hypnotics, and opioids. It describes the basic mechanisms of toxicity for drugs, including direct overdose effects, repeated dose effects, and idiosyncratic reactions. For each toxicant, it outlines signs and symptoms of toxicity, as well as treatment approaches focusing on decontamination and enhancing elimination.
The document discusses the principles of analytic toxicology. It describes how analytic toxicology involves the detection, identification, and measurement of foreign compounds in biological specimens using tools from analytical chemistry. It has several applications, including in general toxicology, clinical toxicology, therapeutic drug monitoring, and forensic toxicology. In forensic toxicology, analytic toxicology is used to identify toxins in autopsy specimens to determine cause of death or injury and provide evidence for the courts.
- Solvents are widely used to dissolve, dilute, or degrease materials and are found in products like paints, degreasers, and fuels. Common classes include chlorinated hydrocarbons, aromatic hydrocarbons, and alcohols.
- Solvents and their metabolites can cause toxicity through various mechanisms like forming reactive intermediates, binding to lipids and proteins, and inhibiting enzymes. Toxic effects vary by compound but include effects on the liver, kidneys, blood, and central nervous system.
- The toxicity of many solvents is influenced by metabolic pathways involving cytochrome P450 enzymes like CYP2E1 and glutathione transferases, as well as compounds ability to be metabolized
This document provides information about pesticides for 4th year medical laboratory students. It discusses the definition and uses of pesticides, and classifies them into insecticides, herbicides, fungicides, and rodenticides. The document focuses on the mechanisms of action, toxicity, and treatment of poisoning for different classes of insecticides including organochlorines, organophosphates, carbamates, and those of biological origin. It also briefly discusses herbicides and some common herbicide classes.
This document discusses mutagens, carcinogens, and teratogens. It begins by defining mutagenesis as the process by which genetic information is changed, resulting in a mutation. This can occur spontaneously or due to exposure to mutagens. Mutagens are then defined as physical, chemical, or biological agents that cause mutations by altering genetic material. Examples of different types of mutagens are provided, including radiation, heat, base analogs, alkylating agents, and viruses. The effects of mutagens, such as changes at the chromosomal and molecular levels, are described. Some mutagens are classified as carcinogens, which induce cancer, or teratogens, which cause birth defects. While mutagens can cause harm, some
1. The document outlines the key steps in the mechanism of toxicity: delivery of the toxicant to its target, reaction with the target molecule, cellular dysfunction and toxicity, and repair or further damage.
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This document provides an introduction to toxicology for 4th year medical laboratory students. It defines key terms like toxicology, toxin, toxicant, toxicity and discusses the historical aspects and development of toxicology as a field. It outlines the chapter which covers the introduction, historical aspects, definitions, classification, scope, nature of toxic response, routes of poisoning and potential causes of toxicity. The document discusses in detail the definitions, classification based on research methodology and specific issues, scope, nature of toxic responses including terms like LD50, routes of exposure and reversibility.
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This document discusses rheology, which is the science of deformation and flow of matter under stress. It defines Newtonian and non-Newtonian systems, and their flow properties. Newtonian fluids obey Newton's law of viscosity, where viscosity is constant regardless of shear rate. Non-Newtonian fluids do not follow this law and can exhibit plastic, pseudoplastic or dilatant behaviors. Plastic fluids have a yield value and shear thinning fluids see decreasing viscosity with increasing shear rate. The document provides examples of pharmaceutical products that demonstrate different rheological behaviors and their structural causes. It emphasizes the importance of rheology in product development, manufacturing, and patient acceptability.
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This document summarizes key concepts about interfacial phenomena from a chapter in a pharmacy textbook. It discusses the different types of interfaces that can exist depending on whether two adjacent phases are in solid, liquid, or gaseous states. Important concepts covered include surface tension, interfacial tension, measurement methods, factors that affect surface tension like temperature and additives, and the spreading coefficient. Real-world examples of interfacial phenomena in various processes are provided.
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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Ch5.packaging of pharmaceuticals
1. Bule Hora University
College of Health and Medical Sciences
Department Of Pharmacy
INTEGRATED PHYSICAL PHARMACY AND PHARMACEUTICS I
CHAPTER 5
Packaging and storage of
pharmaceuticals
By: Aliyi Gerina [BSc, B.pharm]
2. Out Line:
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
2
Introduction (definitions and terminologies)
Packaging materials
Closures
Labeling pharmaceutical dosage forms
Storage, stability of pharmaceuticals and
Beyond use date
3. Introduction
3
Packaging
is defined as the collection of different
components
which surround the pharmaceutical product from the
time of production until its use.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
4. Functions of packaging
4
Containment
Not to leak, nor allow diffusion and permeation
Strong enough to hold the contents during
handling
Protection
light
moisture
oxygen
microbial contamination
mechanical damage
adulteration
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
5. Functions of packaging (cont’d)
5
Information
Labels fixed on containers provide information
about the product such as
composition,
appropriate use,
storage conditions, etc.
Identifies the product from competitors
products.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
6. Primary and secondary package
6
Primary packaging materials
are in direct contact with the product.
This also applies to the closure
which is also part of primary pack.
Secondary packages
are additional packaging materials
aid transportation and handling of the product
Include
cartons and
boxes that do not make direct contact with the product.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
7. Packaging materials
7
Glass
It is the preferred packaging material for many
pharmaceutical products.
It is composed principally of silicon dioxide with
varying amount of other oxides such as sodium,
potassium, calcium, magnesium, aluminium, boron
and iron.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
8. Advantages of glasses
8
It is inert to most medicinal products.
It is impervious to air and moisture.
It allows easy inspection of the container
contents.
It can be colored to protect contents from
light.
It is easy to clean & sterilize by heat.
It is available in variously shaped containers.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
9. The disadvantages of glasses
9
It is fragile.
Certain types of glasses release alkali into
the container contents.
It is expensive when compared to the price
of plastic.
It is heavy resulting in increased transport
costs
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
10. USP glass types and uses
10
Type General description General use
I Highly resistant
borosilicate
glass
Buffered and unbuffered aqueous
solutions.
All other uses.
II Treated soda –
lime glass
Buffered aqueous solutions with pH
below 7.0,
dry powders, oleaginous solution.
III Soda-lime glass Dry powders, oleaginous solutions.
NP Soda-lime glass Not for parenterals.
For tablets, oral solutions and
suspensions, ointments and external
liquids.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
11. Types of glass containers
Dropper bottles Jars
11
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
12. Types of glass containers
Ampoules Vials
12
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
13. Plastics
13
Chemically plastics are synthetic polymers of
high molecular weight.
In more recent times, plastic has been
developed
for the packaging of parenteral products
including infusion fluids & small volume injections.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
14. Advantages of plastics
14
Are flexible & not easily broken
Are low density & thus light in weight
Can be heat sealed
Are easily moulded into various shapes
Are suitable for use as container, closure & as
secondary packaging
Are cheap
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
15. Disadvantages of plastics
15
They are not as chemically inert as type I glass.
Some plastics undergo stress cracking &
distortion from contact with some chemicals.
Plastics are heat sensitive.
They are not as impermeable to gas & water
vapor as glass.
They may possess an electrostatic charge
which will attract particles.
Additives in the plastic are easily leached into
the product.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
16. Metals
16
Metals used for various pharmaceutical
packaging include
aluminum and
tinplate.
Tinplate is a steel composite material that uses a
steel core coated with tin.
Aluminum and tinplate cans need to be coated or
painted with an organic lining
to separate the product from bare metal.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
17. Metals……………cont’d
17
General properties
Metal is
strong,
opaque, and
impermeable to moisture, gases, light, etc.
Metal is resistant to high and low
temperatures.
Disadvantages
Metal is not inert and
can be attacked by acids and alkalies.
18. Closures
18
Any closure system should provide an effective
seal
to retain the container contents & exclude external
contaminants.
Child-Resistant Containers (CRCs) commonly
consist of a glass or plastic vial or bottle with a
specially designed closure.
closures
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
19. Closures (cont’d)
19
The CRCs in most common use with dispensed
medicines
is the push down & turn (Clic-loc® closure).
The Clic-loc® closure are based on the
assumption that young children are unable to
coordinate two separate and dissimilar actions;
that is, applying pressure and rotating the closure top.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
20. Closures (cont’d)
20
In recent years greater awareness of the
vulnerability of products has led
to the development of tamper-evident closures.
Tamper-evident closures are available in
various designs suitable for different containers.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
21. Collapsible tubes
21
These are used to contain semisolid and liquid
based products.
They are made of metal or plastic.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
22. Collapsible tubes (cont’d)
22
Metal tubes
are airtight, light-proof and impermeable to moisture
and offer superior protection.
Plastic tubes
are light-weight, leak-proof, and relatively non
breakable.
In contrast to collapsible metal tubes that flatten as
the product is removed,
plastic tubes retain their original shape after
squeezing.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
23. Blister packs
These are
used for packaging unit doses of
tablets and capsules
can act as an
aid for patient compliance.
The medication is placed in a
compartment in a base material
made of plastic such as PVC lined
on the top with aluminum.
Blister packs are rigid unlike strip
packs that are flexible.
23
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
24. Strip packaging
With strip packaging, two webs of
material sandwich various types of
dosage forms
such as tablets, capsules,
suppositories, and pessaries.
Each of these dosage forms is
contained within its own compartment.
Aluminum foil is
commonly used to manufacture strip
packs.
24
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
25. Labeling pharmaceutical
25
The label on dispensed medicines has two main
functions:
to uniquely identify the contents of the
container.
to ensure that patients have clear & concise
information
which will enable them to take or use their
medicine in the appropriate way.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
26. Labeling………..
26
The label of a pharmaceutical product must be
in the right place and
contain the right information.
The following need to be taken into
consideration:
Appearance
• Correct position
• Clean
• Secure
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
27. Labeling………….
27
Information should be:
Legible
Concise
Adequate
Intelligible
Accurate
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
29. Stability of Pharmaceuticals
29
Stability
– Definition: (according to USP)
Stability is defined as the extent to which a product
retains,
within specified limits, and throughout its period of storage
and use (i.e. Shelf life),
the same properties and characteristics that it possessed at the
time of its manufacture.
Stability of drugs is the major criterion in
determining the suitability of the dosage forms or drug
products.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
30. Types of drug stability
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
30
1. Chemical stability:
Each active ingredient retains its chemical
integrity and
labeled potency within the specified limits
2. Physical stability:
The original physical properties
including appearance, palatability, dissolution,
and suspendability are retained
31. Types of drug stability,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
31
3. Microbiological stability:
Sterility or resistance to microbial growth is
retained according to the specified requirements.
Antimicrobial agents/preservatives should retain
their effectiveness
4. Therapeutic stability:
The therapeutic effect remains unchange
5. Toxicological stability :
No significant increase in toxicity occurs
32. Reason for studying stability
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
32
Patient safety and acceptance
– Toxic products may be formed in the decomposition
– Substantial change in physical appearance
Drug activity
– May lead to a substantial lowering of the quantity of
the therapeutic agent in the dosage form
– Decrease in its bioavailability
Legal requirement
– Preparations must comply with specifications of
identity, strength, purity, and quality of the drug
33. Reason for ,….
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
33
Bad image for the manufacturer
• Poorly formulated or unstable product
– Fading or darkening of colors
– Caking of suspensions
– Breaking of emulsions
=> Non-acceptance by the user community.
• Economy point of view:
=> Financial loss due to reformulation, non sale, withdrawal
Patient economy
“A patient is entitled to receive what he/she is paying for!”
34. Types of stability studies
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
34
Accelerated stability study
Long term stability study
35. Accelerated stability study
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
35
Accelerated stability study is designed
to predict stability of a formulation
by carrying out the study under accelerated conditions of T, moisture
and light.
This information is then
projected to predict shelf life or
used to compare the relative stability of alternative formulations.
36. Accelerated stability,...
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
36
Objectives of accelerated stability study
– To serve as a rapid means of selecting the best
formulation from amongst a series of similar
formulations of the product
– To predict the shelf life of the product
– To serve as a rapid means of quality control
37. Accelerated stability,...
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
37
Drug products - General case
Study Storage condition
Minimum time period
covered by data at
submission
Long term
25°C ± 2°C or
30°C ± 2°C
12 months
Accelerated 40°C ± 2°C 6 months
38. Accelerated stability,...
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
38
Drug substances - intended for storage in a Refrigerator
Drug substances/Product- intended for storage in Freeze
Study Storage condition
Minimum time period
covered by data at
submission
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C / 60% ± 5% r.h. 6 months
Study Storage condition
Minimum time period
covered by data at
submission
Long term -20°C ± 5°C 12 months
Accelerated 5°C ± 3°C 6 months
39. Storage Condition
39
All medicines must be stored and handled in accordance
with the manufacturer’s guidelines
in order to maintain the quality of the product.
Inappropriate storage and handling practices of medicines
may result in
potential spoilage of the medicines
consequent financial impact for the facility
Classified into three
Normal storage condition
Cold storage condition
Special storage condition
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
40. Storage Condition,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
40
Normal storage condition
Unless special storage conditions are stated,
it is vital that drugs be stored in
a dry,
adequately ventilated shady and
cool store room
– Protect from moisture:
Store the product in a space with no >60% relative humidity.
– Photosensitive products:
Do not store or pack products in sunlight.
41. Storage Condition,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
41
Cold storage conditions
Products that may be degraded rapidly when kept at
room temperature or even at cool places.
– e.g. vaccines, insulin
Storing in
refrigerators(2-8oC )and
freezers (-20oC)
Cold chain
42. Storage Condition,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
42
Special storage conditions
Drugs like
narcotic and psychotropic substances, and
combustibles (alcohol and ether)
Narcotic drugs, psychotropic substances, and their
documents
should be kept in securely locked rooms or cupboards.
44. Beyond-use date
44
Provide the date after which a compounded preparation
shall not be used.
determined from the date when the preparation is compounded.
Beyond-use date
is an expiry date assigned by a pharmacist for compounded
products.
Use of a product after beyond-use date
may not provide the desired therapeutic effect and
may even lead to severe side effect or death.
All compounded preparations must contain a beyond-use
date.
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
45. Beyond-use date,…
Packaging and Storage of Parmaceuticals byAliyi Gerina
Bule Hora University
45
Non sterile preparation Beyond use date
• Non-aqueous Formulations • Not later than 6 months.
For water-containing oral
formulations (prepared from
ingredients in solid form)
Not later than 14 days (for
liquid preparations when
stored at cold temperatures
between 2 and 8 oC ).
For all other formulations (water
containing topical liquid and
semisolid, cream, gel, ointment)
not later than the intended
duration of therapy or 30
days, whichever is earlier.
Beyond use dating for non sterile extemporaneous preparation
according to USP <795> .