PHM 520 Exam 1 | Questions with 100% Correct Answers

PHM 520 Exam 1 | Questions with 100% Correct Answers What is Pharmaceutics? Art, science and technology of dosage form design What is Physiochemical properties? stability, ionization, solubility, hydrolysis, oxidation, racemization What is Biological properties? absorption, transport, biotransformation What is Dosage form? physical form capsule, tablet, solution What is Dosage formulation? combination of different ingredient Who is responsible for approving drug? FDA Who approves drug based on safety and effectiveness (over the counter vs prescriptions status)? Center for Drug evaluation and Research. which phase test drug physical chemical properties on animal (ACTIVE drug in solution)? Preclinical Studies How is the drug being test on pre-clinical studies? Active drug in solution (water) Which phase test healthy volunteer (80 volunteer)? Phase I Which phase main assessment is safety? Phase I Which phase test on active drug in a capsule form? Phase I Which phase test hundreds of condition patient? Phase II Which phase test hundreds of condition patient on effectiveness? Phase II When is IND application submitted? After preclinical studies What application is submitted when all preclinical testing and plan for clinical test is determined safe to move on human? IND How many days does the FDA have to approve IND application? 30 days Which phase test thousands of patients and test different dosage and strength? Phase III What submission is given to the FDA if clinical trial demonstrates drug safety and therapeutic effectiveness? NDA How long does the FDA must response of the receipt of the DNA application? 180, but review clock can be extended What is the fastest dosage form? IV What is the second fastest dosage form? Sub-lingual Third fastest dosage form? Buccal Fourth fastest dosage form? Oral (swallowed) What are the mechanism of drug degradation? Physical, chemical and microbiological What is physical degradation? Change in physical properties that do not result in the loss of MOLECULES or decrease in the concentration of the drug What are example of physical degradations? Vaporization, polymorphism, adsorption What is vaporization? Loss of drug quantity due to volatilization What is polymorphism? Different crystal form of the same compound What is more stable crystalline insulin or amorphous counterpart? Crystalline What is adsorption? the surface of a solid can hold molecules of other substance that come in contact with it Drug accumulation on the plastic container is an example of what type of physical degradation? Adsorption This image is an example of what type of degradation? Hydrolysis What is the most important cause of drug decomposition? Hydrolysis What is chemical degradation? A process in which drug molecules interact with water molecule to yield breakdown product What is way of minimizing hydrolysis? Protecting from heat by refrigeration Adjusting the Ph and using buffer Rightly close container What is oxidation? Gaining electronegative atom or radical or losing electropositive atom What is auto oxidation? Series of chain reactions via free radical mechanism Free radical may form from presence of what? Heavy metals, peroxides, or atmospheric oxygen What is highly unstable species containing one or more unpaired electron? Free radical What are a ways to minimize oxidation? Antioxidant and synergist What is antioxidants (negative catalyst)? Precent oxidation caused by free radical What is example of aqueous system of antioxidant? Sodium sulfite and ascorbic acid What is synergist? Increases the activity of antioxidants What are example of synergist? EDTA derivatives What are other chemical degradation? Photolysis, dehydration, racemization What is photolysis? Saturated drug molecules that do not interact with light What is a way to prevent Photolysis? amber glass is a good in UV range What is racemization? the process of changing from an optical active compound into a racemic mixture What form show more pharmacological effect in racemization? Levo This is an example of what? Racemization Bacteria creating alkaline media is an example of what? Microbial degradation Mold and yeast create acidic media is an example of what? Microbial degradation What is a remedy for microbial degradation? Preservative Alcohol in vehicle 15-18% of alcohol What is interface? Boundary between the phases in heterogeneous system What are example of liquid interface? Liquid-liquid, liquid gas What is an example of solid interface? Solid liquid, solid gas What is surface tension?