Term
|
Definition
- bubbles can form and rise since VP can overcome atmospheric pressure
- BP is the T at which the vapor pressure of a liquid becomes equal to an external pressure of 760mmHg |
|
|
Term
|
Definition
| - the pressure that prevents flow of solvent from [low] to [high] |
|
|
Term
| what are the pharmaceutical forms commonly applied topically to the eye, nose or ear? |
|
Definition
| solns, suspensions, gels, and ointments |
|
|
Term
| most important considerations of opthalmic formulations |
|
Definition
- sterility and preservation
- isotonicity value
buffering
viscosity and thickening agents
ocular bioavailability
- free from particles |
|
|
Term
| what is the most important microorganism to consider which ophthalmic formulations |
|
Definition
|
|
Term
| most common method of streilization |
|
Definition
| - autoclaving - 121 degrees for 15 min |
|
|
Term
| what sterilization method is used for drugs sensitive to heat |
|
Definition
|
|
Term
|
Definition
| rbc is in hypertonic sln then rbc shrinks bc water leaves cells; if hypertonic sln place in eye, water will move from eye into the site of application |
|
|
Term
| what is the osmotic pressure of body fluids |
|
Definition
| corresponds to that of a 0.9% soln of NaCl |
|
|
Term
| two methods used to formulate an isotonic soln for ophthalmic solns |
|
Definition
- NaCl equivalent method
- freezing point depression method |
|
|
Term
|
Definition
- ophthalmic soln have to be isotonic w body fluids
- should not damage tissue or produce pain when administered
- most widely used method |
|
|
Term
|
Definition
| - amt of NaCl which has the same osmotic effects as 1g of drug |
|
|
Term
|
Definition
- must permit greatest activity and at the same time maintain stability
- buffers maintain pH |
|
|
Term
| why use viscosity and thickening agents |
|
Definition
| - make ophthalmic soln more viscous and therefore increase ocular retention and decrease freq of dosing and thus increase bioavailibilty |
|
|
Term
| examples of thickening agents used in ophthalmic solns |
|
Definition
|
|
Term
|
Definition
|
|
Term
| 3 physical factors affecting drug's ocular bioavailability |
|
Definition
- protein binding
- enzymes
- physicochemical characteristics of the drug |
|
|
Term
| why does protein binding affect the drug's ocular bioavailability |
|
Definition
- drug reacts w protein results in drug-protein complex
- drugs subject to protein binding have decreased bioavailability bc drug-protein complexes are bigger than just the drug |
|
|
Term
| why do enzymes affect a drug's ocular bioavailability |
|
Definition
| - lysozyme capable of metabolic degradation |
|
|
Term
| what physicochemical characteristics affect the drug's ocular bioavailability |
|
Definition
- lipophilic
- hydrophilic |
|
|
Term
|
Definition
| polymethylmethacylate (PMMA); impermeable to O2 and moisture which is a disadvantage in terms of comfor; advantage is they are more durable |
|
|
Term
|
Definition
| provide greater conform but less durable |
|
|
Term
| rigid gas-permeable (RGP) lenses |
|
Definition
| features both soft and hard contact lenses; slightly permeable to water and moisture but also durable |
|
|
Term
| what is a radiopharmaceutical |
|
Definition
| - radioactive pharmaceutical agent that is used for diagnostic or therapeutic purposes |
|
|
Term
| what three places must a preparer satisfy before classifying a product a radiopharmaceutical agent |
|
Definition
- BOP
- FDA
- nuclear regulation commission (NRC) |
|
|
Term
| are xrays a radiopharmaceutical agent |
|
Definition
| no bc source of radiation is not present in human body |
|
|
Term
| 3 types of ionizing radiation |
|
Definition
|
|
Term
|
Definition
| nucleus giving up energy resulting in ionizing radiation |
|
|
Term
|
Definition
| an atom w an unstable nucleus, which is a nucleus characterized by excess energy |
|
|
Term
|
Definition
- consists of 2 protons and 2 neurons identical w a helium nucleus
- has highest mass
- has highest charge
- 3-7 MeV
- speed is very low
- penetration depth is very small
- can be used therapeutically but not useful in diagnosis |
|
|
Term
|
Definition
- may be electrons w a negative charge
- or positive electrons
- moderately penetrating
- can be used therapeutically more often than alpha
- not useful in dx |
|
|
Term
|
Definition
- most penetrating
- used for dx bc can be easily converged into imaging data |
|
|
Term
| energy of gamma rays for dx |
|
Definition
- pure gamma
- 100-250 KeV (outside of this range, the gamma rays cannot be used for dx)
- 99mTc and 123I are the two most commonly used for dx |
|
|
Term
|
Definition
| - time req'd for a radionuclide to decay to 1/2 of its original activity |
|
|
Term
|
Definition
|
|
Term
|
Definition
| - that which allows acquisition of the desired info w the least amt of radiation dose or exposure to the pt |
|
|
Term
| radionuclide's physical properties |
|
Definition
- radiation
- energy
- 1/2-life |
|
|
Term
| when do you have the best imaging? |
|
Definition
- low radiation dose
- low half-life
- emitting only gamma radiation |
|
|
Term
|
Definition
| - time req'd for compounds to lose 1/2 radiactivity through radiactive decay |
|
|
Term
|
Definition
| - time for 1/2 material to be eliminated from body |
|
|
Term
|
Definition
| - time req'd for compound to be decreased by 50% due to physical and biological half-lives |
|
|
Term
| effective half-life for dx |
|
Definition
| - it should be short enough to minimize the radiation dose to pts and long enough to perform the procedure |
|
|
Term
| ideal effective half-life for dx |
|
Definition
| - effective 1/2 life should be 1.5x the procedure time |
|
|
Term
| what is the fx of the thyroid gland |
|
Definition
| - takes up iodine from food which allows secretion of TH |
|
|
Term
| what 2 most common radionuclides are used to localize the thyroid gland |
|
Definition
|
|
Term
|
Definition
| most commonly used for imaging studies bc of useful gamma emision |
|
|
Term
|
Definition
| emits both beta and gamma radiation |
|
|
Term
| what happens if the TH takes up radionuclides |
|
Definition
| the thyroid gland is less likely to be malignant |
|
|
Term
| properties of ideal therapeutic radiopharmaceutical |
|
Definition
- types of emission
- energy
- effective half-life
- target to non-target ratio |
|
|
Term
| pure beta emiting radiation |
|
Definition
|
|
Term
|
Definition
removal of abnormal growth; high beta energy needed
- increased 1/2 life and increased cumulation radiation dose leads to better ablation |
|
|
Term
| target to non-target ratio |
|
Definition
| - high target to non-target ratio is mandatory for therapeutic purposes (increases safety) |
|
|
Term
| drug antidote for radiation exposure |
|
Definition
- prussian blue
- used to treat pts from harful effects of cesium or thalium |
|
|
Term
| what is most commonly used to form radionuclides |
|
Definition
|
|
Term
| what is the most commonly used radionuclide in diagnostic imaging |
|
Definition
|
|
Term
|
Definition
|
|
Term
|
Definition
| percent of total radioactivity present as the stated radionuclide |
|
|
Term
|
Definition
- fraction of stated radionuclide in the stated chemical form
- minimal acceptable purity is 95% |
|
|
Term
|
Definition
| - when 99mTc is eluted, it is possible to elute aluminum ion along w 99mTc |
|
|
Term
| dispensing of a radiopharmaceutical |
|
Definition
| - should never go directly to pt |
|
|
Term
| what are novel drug delivery systems |
|
Definition
| - drug delivery systems which are modifications of currently available dosage forms and which are new to the market |
|
|
Term
| why do we use novel drug delivery systems |
|
Definition
| - reduces limitations of existing therapies |
|
|
Term
|
Definition
- most widely applied processing techniques in the plastics industry; developed over the last century
- more than one half of all plastic products today are manufactured by the HME process
- not originally developed for pharmaceuticals; originally for plastics industry |
|
|
Term
|
Definition
| materials are mixed intimately under controlled conditions of T and pressure to generate a wide variety of in-process and finished products using pieces of equipment collectively known as an extruder |
|
|
Term
| what does extrusion involve |
|
Definition
| - raw materials into a product of uniform shape by forcing these materials through a die under controlled conditions |
|
|
Term
| what are the steps involved in HME |
|
Definition
- drug is embedded in a carrier formulation consisting of one or more meltable substances and optionally other functional excipients. The meltable substances may be polymeric materials or low MP waxes
- recent studies demostrate potential continuous formulation process for the production of tabs or films |
|
|
Term
|
Definition
- FDA process analytical technology initiative (PAT)
- systems for the analysis and control of manufacturing processes based on timely measurements, during processing of critical quality parameters to assure acceptable product quality at the completion of the process
- environmental (no organic solvents)
- less labor and equipment demands
- single equipment (extruder)
- shorter and mroe efficient processing times
- favorable cost
- "continuous process"
- can produce "solid solns or dispersions"; improved bioavailability |
|
|
Term
|
Definition
- not applicable for heat labile drugs (i.e. proteins)
- non-traditional equipment (education and training)
- dictates a non-aq system (cannot use solvents); must be relatively moisture free |
|
|
Term
|
Definition
- feeding hopper
- force feeder
- barrel
- screw (single or twin)
- heating/cooling device |
|
|
Term
| monitoring toosl for performance and product quality |
|
Definition
- T gauges
- screw speed controller
- pressure gauges |
|
|
Term
| downstream auxiliary equipment |
|
Definition
| - for collection and shaping of extrudate (films, tabs, pellets, etc) |
|
|
Term
|
Definition
- before extrusion, powder blend is dried at 50 degress for 1 day to get ride of moisture
- powder blend is then fed into hopper, melted in barrel, and is released from film die, where it is then cooled in chill roll
- the molten mix that is released from film die is also called extrude. The shape of the extrude depends upon the shape of the film die |
|
|
Term
|
Definition
| have high mixing efficiency |
|
|
Term
|
Definition
| used to process certain materials in an extruder w erratic powder flow |
|
|
Term
| materials used in pharmaceutical HME |
|
Definition
- polymeric carriers (most common)
- plasticizers
- bioadhesive agents
- surface modifiers or penetration enhancers |
|
|
Term
| 3 important polymers for HME |
|
Definition
- hydroxypropylcellulose
- polyethylene oxide
- hydroxypropyl methylcellulose |
|
|
Term
| which two bioadhesives are also used as polymers for HME |
|
Definition
- hydroxypropylcellulose
- hydroxy propyl methyl cellulose |
|
|
Term
| examples of drug substances processed via HME |
|
Definition
- drugs used in HME tech must be stable at high T
- antifungals commonly made using HME tech |
|
|
Term
| examples of drug substances processed via HME |
|
Definition
- drugs used in HME tech must be stable at high T
- antifungals commonly made using HME tech |
|
|
Term
| tools for selection and stability of drug/excipients |
|
Definition
- DSC
- TGA
- XRD
- SEM
- Bioadhesion testing
- mechanical testing
- analytical |
|
|
Term
|
Definition
|
|
Term
|
Definition
| determines moisture content of film |
|
|
Term
|
Definition
| determines physical properties of drug |
|
|
Term
|
Definition
| - tests bioadhesion on skin |
|
|
Term
| analytical tools for selection and stability of drug/excipients |
|
Definition
|
|
Term
|
Definition
- chronic fungal infection of the finger nails/toenails
- increased risk with age |
|
|
Term
| nail permeability studies |
|
Definition
- etched nails - human nails treated w phosphoric acid (an example of a penetration enhancer)
- drug permation through etched nails is higher than drug permeation through control nails |
|
|
Term
| tartaric acid (TTA) and bioadhesion |
|
Definition
- films with TTA have higher bioadhesion than films wo TTA
- TTA is a surface modifier |
|
|
Term
| bt HC and CPM which is more sensitive to T |
|
Definition
|
|
Term
|
Definition
- available in 6 diff grades
- higher HPC MW = less in drug release |
|
|
