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Compounding (8)
| Question | Answer |
|---|---|
| What is extemporaneous compounding | The on-demand preparation of a prescribed drug product to meet the unique needs of an individual patient |
| Why has the demand for pharmaceutical compounding has grown substantially | Home Health Care the unavailability of certain drug products orphan drugs veterinarian Erie compounding and biotechnology Dr drug products |
| Reasons for compounding | Pediatric patients patients who need oral Solutions patients with sensitivity to dies. Medications no longer available commercially |
| Manufacturing definition by USP NF | The production propagation conversion or processing of a drug or device by extraction of the drug from substances of natural origin |
| Compounding definition buy USP NF | The preparation mixing assembling altering and packaging and labeling of a device or drug in accordance with practitioners prescription or medication order |
| Buy USP definition pharmacies are allowed to do what | Pharmacies are allowed to make formulations in anticipation of prescription drug orders on the basis of routine regularly observe describing patterns |
| How is compounding regulated | By individual state boards of Pharmacy |
| Chapter <795> | Regulations from USP NF pertaining to compounding non sterile formulations |
| Chapter <797> | Regulations from USP NF pertaining to compounding sterile formulations |
| How are USP NF standards are published | Chapters with numbers less than a thousand or legally enforced by the FDA and those with numbers greater than 1000 are guidelines or informational chapters |
| What are the standards by the USP NF for personnel | Gives the responsibility to the pharmacist for managing the compounding area and outlines the duties of the pharmacist or other personnel |
| What are the USP NF standards for facility and equipment | Specifies the physical design and maintenance of the compounding area which should be away from the routine dispensing and counseling functions and high traffic areas of the pharmacy |
| what are the USP NF standards of ingredients | That the raw chemicals are supplied in many levels of purity |
| By definition what is quality assurance (QA)and quality control (QC) | QA is a program of activities used to ensure the compounding formulation meet specification and satisfied standards and QC is a set of testing procedures that determine the quality of a compounded formulation |
| What is the USP NF standards for Packaging | Packaging materials should not chemically react with any drug or ingredient in the formulation and it includes strength is ability moisture protection ease-of-use and cost |
| What is the USP NF standards for storage | Materials should be stored according to the manufacturer's labeling or USP NF requirement marked with the date of receipt and the date container is opened. Should be rotated to use the oldest stock first and not used beyond their expiration date |
| Formulation records | Formulas and procedures for what should happen when a formulation is compounded |
| A compounding record | A record of what actually happened when the formulation was compounded |
| Stability | As the extent to which a dosage form retains within specified limits and throughout its period of storage and use the same properties and characteristics it possessed when it was made |
| Beyond use date | Adata science of compounded prescription Beyond which the formulation should not be used |
| Aliquot | A portion of mixture |
| Calibrates | To set Mark or check the graduation of a measuring device |
| Sensitivity | The amount of weight that will move the balance points are one division mark on the marker plate |
| what are the compounding processes | Measuring mixing molding and packaging |
| What are the set of tools or equipment used for measuring in accordance with compounding | Balances weights weighing containers and volumetric glassware |
| What are the set of tools used for mixing in accordance with compounding | Beakers Erlenmeyer flask spatula fennel sieves and mortar and pestles |
| What are the set of tools used for molding in accordance with compounding | Suppository molds hot plates capsule shells and ointment slabs |
| What is the sensitivity requirement for a Class A torsion valance | 6 milligrams |
| What is the minimum wage of a quantity for a class A torsion balance | 120 milligram with A 5 percent error |
| What happens when a prescription calls for less than 120 milligrams of an ingredient on a Class A torsion balance | When this happens the ingredient is mixed with an inert powder so that the mixing results in at least a hundred and 20 milligrams |
| Besides putting in an ant powder how else can less than 120 milligrams be measured | by using analytical balance |
| what are the general rules for using and maintaining a balance in top condition | Use on a level surface, used weighing papers are weighing boats that are clean, Ares arrest of bounds before adding or removing weight from either pan, use a spatula to add or remove ingredients and always clean the balance |
| What are the rules for using an electronic balance | Move the balance to place-won't be moved again turn the leveling feet all way into the balance & then move them in same direction until level bubble is w/in black circle of the sight glass & for the first use of the day check internal weight calibration |
| Steps one two and three for using a torsion balance | Lock balance by turning arrest knob. Set internal weights to zero. Unlock balance and level it left to right by adjusting the leveling screw feet in opposite directions. |
| Steps for 4 5 and 6 for using a torsion balance | Lock the balance Place away boat or paper on each weighing pan unlock by using the arrest nob |
| Arrest knob | The knob on a balance that prevents any movement of the balance pans |
| In compounding what are measured in volume metric glassware or plastic ware | Liquid drugs solvents and additives |
| Volumetric | Measures volume volumetric vessels are either TD (to deliver)or TC(to contain) |
| To deliver | Means that the vessel must be completely emptied to dispense the needed volume |
| To contain | Means that the vessel does not need to be completely emptied to dispense the needed volume |
| Syringes come in what sizes | And sizes from 0.5 ml to 60 ml |
| What is a meniscus | The curved surface of a column of liquid |
| Syringes are especially useful for measuring and delivering what | Viscous liquid |
| What are oral syringes available for | Accurately administering liquid medication to a patient |
| What are examples of oral syringes | Adapt a cap |
| what are mortars and pestles used for | For mixing solids and semi-solids which are made up of three different materials glass Wedgwood and porcelain |
| Trituration | The process of grinding powders to reduce particle size |
| Sieves | Are used when comp out of powdered needs to be fine particles the powder is passed through a mesh screen that will allow only particles smaller than the measure openings to pass through |
| Geometric dilution | A technique for mixing two powders of unequal quantity |
| Spatulation | mixing powders with a spatula |
| Ointments slabs | Where mixing compounds are done with a spatula |
| Levigation | A technique used to reduce the particle size of a powder by triturating with a solvent |
| Hot plates | This is where solids and semi-solids are mixed by melting them together in a beaker with a special low temperature 25 Celsius to 220 degrees Celsius |
| Most solids and semi-solids used in Pharmaceutical compounding will completely melt by what temperature | 70 degrees Celsius |
| Why should you never Force cooling on semi-solids and regular solids | Because it will change the consistency and texture of the final product |
| In Aqueous Solutions what is a vehicle | the simplest compounded solution that is added of a drug in liquid form to a liquid base solution |
| Sonication | Exposure to high frequency sound waves |
| Flocculating agents | Electrolytes used in the preparation of suspensions to form products that can be easily be dispersed |
| Thickening agent | an ingredient used in the preparation of suspensions to increase the viscosity of the liquid |
| How many taste buds does the human tongue contain | 10000 taste buds |
| What are the perspectives of coloring agents in every formulation | Dark colors are rejected because they are often associated with poisons and more pleasant fruity colors are generally preferred |
| Emulsifiers | A stabilizing agent in emulsions |
| Hydrophilic emulsifier | A stabilizing agent for water-based dispersion mediums |
| Immiscible | Cannot be mixed |
| Lipophilic emulsifier | A stabilizing agent for oil based dispersion mediums |
| Mucilage | A wet slimy liquid formed as an initial step in the wet gum method |
| Oil in water emulsion | An Emulsion in which oil is dispersed in a water base |
| Primary emulsion | The initial emulsion to which ingredients are added to create the final product |
| Water and oil emulsion | An emulsion in which water is dispersed in an oil base |
| Miscible | Capable of being mixed together |
| What are the different types of ointment | Where is homogenious bases absorption bases, Water oil Emulsion bases oil water Emulsion bases and water miscible bases |
| Why do drugs in powder or Crystal form need to be triturated or levigated in a mortar with a pestle | This will prevent a gritty texture in the final product |
| What are some suggestions for compounding an ointment base | Use a water bath/special low temperature hot plate to melt ingredients. It is best to heat aqueous solution faced a few degrees higher be/cuz it cools faster thanmoleagineous phsse. when melting ingredients melt with the highest melting point first |
| What what should you know in the cooling step in an ointment preparation | Do not accelerate the cooling process if adding volatile ingredients at them only when the product is cool and pointment should be cooled just a few degrees above solidification |
| What are the three types of suppository bases defined by their composition and physical properties | Oleaginous bases, watersoluble/miscible bases and hydrophilic base |
| What is example of an oleaginous base | Cocoa butter |
| What is an example of water soluble bases | PEG PLOMYERS |
| Hydrophilic bases | |
| Compression molding | |
| Fusion molding | |
| Punch message | |
| finger cots | |
| Rapid dissolve tablets RDT |
Created by:
MelB85