Banikalabuan - Special Issue
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The Official Newsletter of PROPEGEMUS FOUNDATION, INC.
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Presentación formato uniminuto
This document provides information about a seminar on information and communication technologies for third semester psychology students. It lists the name of the educational institution, the program, the student's name and the date of the seminar.
Aerosol's
Pharmaceutical aerosols are therapeutic active ingredients packaged in a pressurized system. They have advantages like direct delivery to affected areas and reduced irritation. Components include a propellant, container, valve, and product concentrate. Propellants expel the product and include hydrocarbons or gases. Containers must withstand high pressure. Valves deliver the drug in the desired form. Formulations contain an active ingredient and propellant. Quality is ensured through testing of components, valves, spray pattern, and other parameters. Dry powder inhalers deliver drug particles without propellants. They must produce respirable aerosol clouds for lung deposition.
Gas chromatography
This document discusses gas chromatography and its various components. It describes four common detectors: flame ionization detector, thermal conductivity detector, electron capture detector, and nitrogen phosphorus detector. It also mentions advantages and disadvantages of gas chromatography.
Digital Citizenship
Digital citizenship refers to how individuals interact and participate in digital spaces. It encompasses several key components: digital access, which allows technology to be present in all people's lives; digital commerce, such as buying and selling goods online; digital communication through social media and online exchanges of information; digital literacy in learning about technology through its use; digital etiquette in behaving appropriately online; digital law and following internet rules; digital rights and responsibilities to enjoy online freedoms while following conduct guidelines; digital health and wellness to avoid physical or mental harms from technology overuse; and digital security in protecting oneself from online threats.
Four major immunologic methods
The document discusses four major immunologic methods: ELISA, immunofluorescence flow cytometry, Western blot, and immunoprecipitation. It also covers the structure of antibodies, the difference between polyclonal and monoclonal antibodies, antigen-antibody interactions, and techniques like ELISA, radioimmunoassay, immunoprecipitation, and Western blot.
Post approval of drugs
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Bioadhesive drug delivery system
These formulations are used to treat dry eyes and contain polymers that adhere to the eye's mucus membrane. Bioadhesive polymers are able to prolong the release of drugs by binding to mucosal surfaces. The eye presents challenges for drug delivery due to its protective mechanisms, so bioadhesive formulations are designed to be comfortable and maintain drug concentrations in the eye. Examples given are Hypotears and Sno Tears eye drops, which contain polyvinyl alcohol to lubricate the eyes and increase tear production.
Recommended
Presentación formato uniminuto
This document provides information about a seminar on information and communication technologies for third semester psychology students. It lists the name of the educational institution, the program, the student's name and the date of the seminar.
Aerosol's
Pharmaceutical aerosols are therapeutic active ingredients packaged in a pressurized system. They have advantages like direct delivery to affected areas and reduced irritation. Components include a propellant, container, valve, and product concentrate. Propellants expel the product and include hydrocarbons or gases. Containers must withstand high pressure. Valves deliver the drug in the desired form. Formulations contain an active ingredient and propellant. Quality is ensured through testing of components, valves, spray pattern, and other parameters. Dry powder inhalers deliver drug particles without propellants. They must produce respirable aerosol clouds for lung deposition.
Gas chromatography
This document discusses gas chromatography and its various components. It describes four common detectors: flame ionization detector, thermal conductivity detector, electron capture detector, and nitrogen phosphorus detector. It also mentions advantages and disadvantages of gas chromatography.
Digital Citizenship
Digital citizenship refers to how individuals interact and participate in digital spaces. It encompasses several key components: digital access, which allows technology to be present in all people's lives; digital commerce, such as buying and selling goods online; digital communication through social media and online exchanges of information; digital literacy in learning about technology through its use; digital etiquette in behaving appropriately online; digital law and following internet rules; digital rights and responsibilities to enjoy online freedoms while following conduct guidelines; digital health and wellness to avoid physical or mental harms from technology overuse; and digital security in protecting oneself from online threats.
Four major immunologic methods
The document discusses four major immunologic methods: ELISA, immunofluorescence flow cytometry, Western blot, and immunoprecipitation. It also covers the structure of antibodies, the difference between polyclonal and monoclonal antibodies, antigen-antibody interactions, and techniques like ELISA, radioimmunoassay, immunoprecipitation, and Western blot.
Post approval of drugs
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Bioadhesive drug delivery system
These formulations are used to treat dry eyes and contain polymers that adhere to the eye's mucus membrane. Bioadhesive polymers are able to prolong the release of drugs by binding to mucosal surfaces. The eye presents challenges for drug delivery due to its protective mechanisms, so bioadhesive formulations are designed to be comfortable and maintain drug concentrations in the eye. Examples given are Hypotears and Sno Tears eye drops, which contain polyvinyl alcohol to lubricate the eyes and increase tear production.
Aerosols
This document discusses aerosols, including their definition, history, components, how they work, types of propellants, and advantages/disadvantages. Specifically:
- Aerosols are pressurized dosage forms that contain active ingredients released via a valve system for topical or inhaled application. They were first developed in the 1950s.
- They consist of an active product and a propellant that provides pressure to expel the product. Common propellants include liquefied gases and compressed gases.
- Aerosols offer advantages like ease of use, dose control, and avoiding irritation compared to other dosage forms, but also have disadvantages like potential toxicity and reactivity issues.
Asepting procesing
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
Preformulation testing of solid dosage forms
Preformulation testing involves investigating a drug's physical and chemical properties alone and with excipients. This helps formulators develop stable and bioavailable dosage forms. Tests examine properties like solubility, stability, and purity which provide information on developing solid dosage forms. Understanding these properties is the first step in rational drug development.
Preformulation
The document discusses key concepts and steps in preformulation testing. Preformulation involves investigating the physical and chemical properties of a drug substance alone and when combined with excipients. This generates useful information for formulating stable and safe dosage forms with good bioavailability. Some important properties discussed include solubility, particle size and shape, melting point, thermal analysis profile, hygroscopicity, and polymorphism potential. Determining these properties of a new drug substance is an important first step before developing drug formulations.
Drug development and clinical trial phases
The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
Semi solid dosage form
This document discusses formulation development of semisolid dosage forms. It describes the ideal properties of semisolids and different types of semisolid bases used in formulations. The key bases mentioned include oleaginous bases, absorbent bases, emulsion bases and water soluble bases. Various methods for preparing semisolids like ointments, creams and pastes are outlined. The document also discusses preparation of oil and aqueous phases, importance of homogenization and controlling factors like temperature, time and mechanical work in emulsion manufacturing.
Ria
Radioimmunoassay is an immunoassay technique that uses radiolabeled antigens or antibodies to detect and quantify antigens or antibodies in a sample. It involves competitive binding between the radiolabeled and unlabeled antigens or antibodies. The amount of radiolabeled antigen or antibody bound is inversely proportional to the concentration of the unlabeled antigen or antibody in the sample. RIA is highly sensitive and specific due to the immune reaction between antigens and antibodies. It has applications in endocrinology, pharmacology, oncology, and epidemiology to detect hormones, vitamins, drugs, and infectious disease markers.
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Aerosols
This document discusses aerosols, including their definition, history, components, how they work, types of propellants, and advantages/disadvantages. Specifically:
- Aerosols are pressurized dosage forms that contain active ingredients released via a valve system for topical or inhaled application. They were first developed in the 1950s.
- They consist of an active product and a propellant that provides pressure to expel the product. Common propellants include liquefied gases and compressed gases.
- Aerosols offer advantages like ease of use, dose control, and avoiding irritation compared to other dosage forms, but also have disadvantages like potential toxicity and reactivity issues.
Asepting procesing
This document discusses key considerations for the aseptic manufacturing of sterile pharmaceutical products. It covers classification of clean areas, environmental monitoring, preparation and filtration of solutions, personnel requirements, equipment sterilization, and validation of aseptic processes. The main objectives are to prevent microbial contamination and maintain sterility throughout manufacturing.
Preformulation testing of solid dosage forms
Preformulation testing involves investigating a drug's physical and chemical properties alone and with excipients. This helps formulators develop stable and bioavailable dosage forms. Tests examine properties like solubility, stability, and purity which provide information on developing solid dosage forms. Understanding these properties is the first step in rational drug development.
Preformulation
The document discusses key concepts and steps in preformulation testing. Preformulation involves investigating the physical and chemical properties of a drug substance alone and when combined with excipients. This generates useful information for formulating stable and safe dosage forms with good bioavailability. Some important properties discussed include solubility, particle size and shape, melting point, thermal analysis profile, hygroscopicity, and polymorphism potential. Determining these properties of a new drug substance is an important first step before developing drug formulations.
Drug development and clinical trial phases
The drug development process involves several phases of clinical trials overseen by regulatory agencies. Drugs must first show safety in pre-clinical animal and lab testing before entering human trials. Clinical trials involve 3 phases - Phase I tests safety in small groups, Phase II assesses efficacy and optimal dosing in larger groups of patients, and Phase III confirms efficacy in even larger groups. If results are positive, the drug company submits a New Drug Application to the regulatory agency which can take 2-3 years to review before approving the drug for the market. Post-market studies in Phase IV further monitor long-term safety and efficacy. The entire process from discovery to market approval takes an average of 10-15 years and over $1 billion
Semi solid dosage form
This document discusses formulation development of semisolid dosage forms. It describes the ideal properties of semisolids and different types of semisolid bases used in formulations. The key bases mentioned include oleaginous bases, absorbent bases, emulsion bases and water soluble bases. Various methods for preparing semisolids like ointments, creams and pastes are outlined. The document also discusses preparation of oil and aqueous phases, importance of homogenization and controlling factors like temperature, time and mechanical work in emulsion manufacturing.
Ria
Radioimmunoassay is an immunoassay technique that uses radiolabeled antigens or antibodies to detect and quantify antigens or antibodies in a sample. It involves competitive binding between the radiolabeled and unlabeled antigens or antibodies. The amount of radiolabeled antigen or antibody bound is inversely proportional to the concentration of the unlabeled antigen or antibody in the sample. RIA is highly sensitive and specific due to the immune reaction between antigens and antibodies. It has applications in endocrinology, pharmacology, oncology, and epidemiology to detect hormones, vitamins, drugs, and infectious disease markers.