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Chapter 9

Chapter 9 Compounding notes

QuestionAnswer
Extemporaneous Compounding The on demand preparation of a drug product according to a physicians prescription to meet the unique needs of the individual patient
What does extemporaneous compounding require? specialized knowledge of the physical and chemical properties of drugs and their vehicles, requiring proper training and skill
Why has pharmaceutical compounding grown substantially? the growth of home health care, the unavailability of certain drug products, orphan drugs, vet. compounding and biotechnology derived products
the reason it is suggested that compounding will become more common in pharmacy practice newly evolving dosage forms and therapies
USP/NF Chapter 795 established in 2000, Regulations pertaining to the nonsterile compounding of formulations
USP/NF Chapter 797 establisged in 2004Regulations pertaining to the sterile compounding of formulations
Reasons compounding might be done Diluted strength drugs for pediatric patients, availability of oral solution when only in other forms, sensitivities to dyes/preservatives/flavoring agents found in commercial formulations, fortified strength in dermatological solutions
Who regulates pharmacy compounding? state boards of pharmacy and US pharmacopeia
1906 pure food and drug act the authority of pharmacy regulating was established as part
Chapters in the USP/NF below 1000 are legally enforceable by the FDA
Chapters in the USP/NF above 1000 are considered guidelines
Overall, the USP/NF provides what a broad base of regulations and guidelines to direct the practice of compounding
What are the over 150 Monographs in the USP/NF useful for? the most commonly used compounded preperations, when used have the advantage of the USP/NF testing, Qual. Assurance, and beyond use date
What rules does the USP establish? standards of quality, strength, purity, packaging, and labeling for medications
What does the USP provide standards for? more than 3700 prescription and non prescription drugs, nutritional/dietary supplements and medical devices, and additional standards for personnel/facilities and record keping
how many grades of chemical purity are there? 9-Technical/commercial, CP(Chemically pure), USP/NF, FCC, ACS reagent, AR (analytical reagent), HPLC, Spectroscopic grade, Primary standard
Packaging considerations no chemical reaction, strength, visibility, moisture, protection, ease of use, and cost
Why Is documentation important when keeping records of formulations being compounded? they provide a basis for judgement and legal liability. they provide consistency when compounded over and over again, if needed they provide a mechanism to systematically review procedures and ingredients
what 4 kinds of records should be kept in the compounding room? Formulation record, compounding record, standard operating procedures and ingredients records with certificates or purity and Material safety data sheets
SOPs standard operating procedures
MSDS material safety data sheets
how many levels of storage temperature are there and what are they 9- freezer, protect from freezing, cold, refrigerator, cool, room temp, controlled room temp,war,. excessive heat
Formulation record formulas and procedures for what should happen when a formulation is compounded
Compounding record a record for what actually happened when the formulation was compounded
what questions should be asked when deciding whether to compound or not? is there a product already available, if yes, are the commercial products ingredients different from the prescription so the product cant be used, if no, can the purpose of the script be achieved without having to compound?
What should you ask before beginning the compounding process? Is pharmacy personnel qualified to prepare the script, do they have proper supplies, can the drug/ingredient identity/ quality and purity be assured, is there literature/info about the formulation to find beyond use date, quality control measures
As script is being compounded Read/interpret script, determine preliminary compounding procedure, collect and prepare required ingredients/drugs/supplies/equipment/clothing, package formulation in appropriate container w/ proper labels, perform quality control procedure
After compounding recheck all work, if new formulation to pharmacy- keep sample to access its stability or appearance over time, document compounding process, deliver to patient with proper consultation, return ingredients to proper locations
Stability the chemical and physical integrity of the dosage form, and when appropriate, its ability to withstand microbiological contamination
Beyond use dates are used for compounded prescriptions only, and are generally in the order of days or months
expiration dates are required on commercially manufactured products, determined after years of study of the products stability, most are in years
reasons a compounded formula would vary from a manufactured formulation different drug concentration, diluents, different fill volume, packaged in a different container
Where can you find the beyond use date and package requirement for an official USP/NF compound in the monographs inside the USP/NF
When you cant use the USP/NF monographs for compounding informion, what should be done? use drug specific and general stability documentation from reference books or primary literature
If the formulation of Nonaqueous liquid and solid is a manufactured drug the beyond use date is: no later than 25% of the time remaining until the drugs expiration date, or 6 months, whichever is earlier
When water containing formulations are prepaed from solid ingredients the beyond use date should be no later than 14 days when stored at cold temp
what are the 4 steps for a compounded prescription? measure, mix, mold, and package
Measuring equipment balance, weights, weighing container, volumetric glassware,
What constitutes volumetric glasswear? graduated pipets, flasks, syringes
mixing equipment beakers, Erlenmeyer flasks, spatulas, funnels, sieves, mortar and pestle
molding equipment hot plates, suppository molds, capsule shells, ointment slabs
packaging equipment prescription bottles, capsule vials, suppository boxes, ointment jars
what is a Class A Prescription balance used for? To determine the weight of a powder, dosage form, liquid, etc.
what does a class A balance consist of 2 pan torsion type balance with internal and external weights
a class A balance scale is calibrated in Metric system- grams
what is the sensitivity requirement for a class A balance? 6 mg
What does the sensitivity of the class A balance mean? the amount of weight that will move the balance pointer one division mark on the marker plate
What is the capacity of a class A balance? minimum weighing quantity of 120mg, with 5% margin for error, max weighing of 60-120grams
Aliquot a portion of mixture
what happens when a prescription calls for less than 120 mg of an ingredient a precise amount of the drug greater than 120 mg is mixed with an inert powder so that a portion of the resulting mix weighing atleast 120 mg will contain the amount of drug that is needed
Electronic or analytical balances are used for weighing quantities smaller than 120mg, with acceptable accuracy an a sensitivity of about 1mg, designed to weight mg or mcg
What is a spatula used for to transfer solid ingredients, for mixing instruments
what are spatulas made of stainless steel, hard rubber, or plastic
what reaction will a stainless steel spatula have with iodine they can be corroded, so use rubber or plastic.
what are weighing papers and weighing boats made from nonabsorbable glassine paper, and polystyrene
when using weighing papers, what should be done the paper should be diagonally creased from each corner, then flattened and placed on the pan
what are mortars and pestles usually made from wedgewood, porcelain and glass
Wedgwood and porcelain mortar and pestles are earthenware and used for what grinding crystals and large particles into fine powders
trituration the process of grinding fine powders
what are glass morters and pestles preferred for mixing liquids and semisolid dosage forms
arrest knob the knob on a balance that prevents any movement of the balance pans
liquid drugs, solvents or additives are measured in what volumetric glassware or plastic ware
volumetric measures volume
where do you find the graduation marks on volumetric glassare etched on the side of the vessel
what are the 2 jobs volumetric glassware has? to contain or to delier
TC to contain
TD to deliver
To deliver means 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
what are graduated cylinders used for measuring and transferring liquid
what sizes do graduated cylinders come in 5ml to 4000ml
when measuring volumes of 20ml or less its preferable to use what a syringe or pipete
what are the main characteristics of a volumetric flask? they have slender necks and wide bulb like bases, single volume glassware ranging from 5ml to 4000ml
what should be done if using a volumetric flask for dissolving solids in liquids? partially fill the flask with liquid, dissolve, then fill the flask with more liquid to the calibration mark
characteristics of pipets thin glass tubes. TD volumes less than 5ml, required for delivery of less than 1ml
two types of pipettes single volume or transfer pipette, or a micropipette
a single vol. or transfer pipette comes in what sizes 1,2,5,10 and 25ml
a micropipette has 2 pieces a hand piece and a disposal tip
micropipettes come in what sizes calibrated for a range of volumes such as 1-20, 1-100, 1-200, or 1-1000 microliters
What sizes do syringes come in .5ml-60ml
What do liquids have when poured into a container a meniscus
What must be done before you can use a medicine dropper to deliver small doses of liquid must be calibrated
why must a dropper be calibrated before using to deliver small doses may produce drops of different sizes because of variations in the pressure, speed of ropping, and the angle at which the dropper is held
how do you calibrate a medicine dropper slowly drop the drug formulation into a cylindrical graduate (10ml), and count the number of drops needed to ad several ml to the graduated cylinder. calculate the average number of drops per ml
how long should you allow for aqueous and hydroalcoholic solutions to drain 15 sec
how long should you allow for viscous liquids such as syrups, glycerin, propylene glycol and mineral oil to drain 60 sec
meniscus the curved surface of a column of liquid
geometric dilution a technique when mixing powders of unequal quantity- the smaller powder is diluted in steps by additions of the larger amount of powder
spatulation mixes powders using a spatula- can be done in a mortar, on an ointment slab or in a plastic bag
Eutectic powders have what reaction when theyre mixed together they partially liquify
What happens when powders are triturated together with a pestle the overall size of the particles are reduced
With spatulation what happens to the particle size of the powders there is no particle size change so the powders must be of fine particle size and uniform before the process starts
levigation the trituration of a powder drug with a solvent in which the drug is insoluble, reduces particles size
What is done to reduce the grittiness in the final compounded formula drugs are levigated prior to being incorporated into formulation
what temp should a low temp hot plate be for melting solids for compounding 25 to 120 degrees celsius
what would you do if a low temp hot plate is not available for melting solids in compounding a water bath or steam bath- around 70 degrees celsius
What is the most commonly compounded? Aqueous solutions
Solutions are clear, but not necessarily colorless liquid, in which a drug is completely dissolved
what is the simplest compounded solution the addition of a drug form to a liquid base solution called a vehicle.
what is involved in the addition of a drug to a liquid base? careful measurement of the drug using graduated cylinders or syringes, and then diluting the drug to the final volume with the liquid vehicle, then the result should be thoroughly shaken or stirred for adequate mixing.
What is the most common liquid used in pharmacy solutions purified water
combinations of what liquids are used in pharmacy solutions? purified water, ethanol,glycerin, propylene glycol, or a variety of syrups
what needs to happen to many solids before they will dissolve correctly they should be triturated
what happens if you heat a drug too much it will decompose
sonication the application of sound waves using sonic mixing equipment
what must be known before attempting to dissolve a drug into a solution? the solubility of a drug
references generally express what the solubility of a drug in terms of volume of solvent required to dissolve one gram of the drug
how are the solubilities of a drug given as grams of solute per milliliter of solvent
how are the solubilities of a drug not given grams of solute per millileter of final solution
7 terms of solubility very soluble, freely soluble, soluble, sparingly soluble, slightly soluble, very slightly soluble, practically insoluble or insoluble
Syrup a concentrated or nearly saturated solution of sucrose in water
what do syrups contain flavoring agents, known as flavoring syrups and medicinal syrups containing medicines
when a reduction in calories or sucrose properties is desired what can be done syrups can be prepared from sugars other than sucrose, non-sugar polyols or other non-nutritive artificial sweetners
examples of sucrose glucose, fructose
examples of non-sugar polyols sorbitol, glycerin, propylene glycol, manitol
examples of non-nutritive artificial sweetners aspartame, saccrin
which sweeteners do not have the same viscosity as sugar sweeteners? non nutritive sweeteners
what is used when the viscosity isn't right viscosity enhancers such as methyl cellulose
good things about Polyols less sweet than sucrose, good viscosity, have some good preservative and solvent qualities
when overheating sucrose what can occur it can become darker in color and be more likely to ferment
when making syrups without heat, what produces the energy needed to make the syrups stirring or shaking
what size mixing vessel should be used when stirring or shaking a syrups to get a final product a mixing vessel that is about twice as large as the final volume of the product
nonaqueous solutions those that contain solvents other than water, either alone or in addition to water
name some nonaqueous solutions elixir, tincture, spirits, fluid extract, gycerates, collodions, liniments, oleaginous solutions
elixir clear, sweetened, hydroalcoholic liquids intended for oral use
oleaginous solutions can be used for oral, topical application or parenteral administration
examples of oleaginous solutions corn oil, peanut oil, mineral oil
what solutions can be used to dissolve either water or alcohol soluble drugs? elixirs
what would you use to dissolve oil loving ingredients? collodions and oleaginous solutions
lipophilic oil loving
When compounding separate formulas like water based drugs and alcohol based drugs, what do you do separately dissolve the water soluble ingredients into the water portion, and the alcohol ingredients in the alcohol portion, then ad the aqueous solution to the alcohol
why would you add the water based portion to the alcohol based portion in compounding? so the alcohol portion does not become turbid
Suspensions refers to a two phase system consisting of a finely divided solid dispersed liquid
what is the smallest size that can be suspended 0.1 micrometer
primary concern with suspensions? they settle over time, so the dose unevenly disperses in the liquid
what are the settling properties of a suspension controlled by? the addition of flocculating agents to enhance dispersability, the addition of thickening agents to reduce the settling/ sedimentation rate of the suspension
flocculating agents electrolytes which carry an electrical charge; they impart the electrical charge on the suspended paticle
why are thickening agents added to suspensions? to thicken the suspended medium thereby reducing the sedimentation rate of the floccules
typical thickening agents in suspensions carboxymethylcellulose, methylcellulose, bentonite, tragacanth
steps to compounding a suspension solid drug to be suspended is levigated in a mortar w/ a pestle, then a portion of the vehicle is added to the mortar and mixed to the levigated drug until a uniform mixture results, then put in appropriate container and label
what auxillary label should be on a suspension shake well
what is needed before some commercially available suspensions are dispensed? water should be added to reconstitute the drug
how many taste buds does your tongue have 10,000
5 things patients require with medicinal flavoring immediate flavor recognition, rapid full flavor development, acceptable mouth feel, short after taste, no undesirable sensation
6 tastes salty, sweet, bitter, sour/acid, oily,metallic
examples of sweeteners sorbitol, mannitol, saccharin, sodium saccharin, aspartame, stevia
why do flavoring agents need sweetening? they are bitter
what is perceived from colorless solutions? inert and lack potency
what is perceived from dark colors, such as dark purple, navy, black, and brown often associated with poisons
why would flesh colored tones be added to some solutions? to reduce staining on the skin
Emulsion an unstable system consisting of atleast two immiscible liquid, one of which is dispersed in droplets throughout the other, and a stabilizing agent
what is the dispersed liquid in an emulsion known as? the internal or discontinuous phase
what is the liquid serving as a dispersion medium known as the external or continuous phase
oil in water emulsion when oils, petroleum hydrocarbons, and/or waxes are the dispersed phase or an aqueous solution is in the continuous phase
an oil in water emulsion is generally formed if what the aqueous phase makes up greater than 45% of the total weight, and a hydrophilic emulsifier is used
water in oil emulsion when water or aqueous solutions are dispersed in a oleaginous medium
water in oil emulsions are generally formed when the aqueous phase constitutes less than 45% of the total weight and a lipophilic emulsifier is used
2 things that happen to emulsions over time 1. separation, where the emulsion needs to be shaken 2. breaking- where the drugs cannot be redispersed
emulsifier provide a protective barrier around dispersed droplets; help stabilize emulsions
common emulsifying agents tragacanth, sodium lauryl sulfate, sodium dioctyl sulfosuccinate and polymers known as Spans and Tweens
immiscible cannot be mixed
hydrophilic emulsifier a stabilizing agent for water based dispersion mediums
lipophilic emulsifier a stabilizing agent or oil based dispersion mediums
stabilizing agents use in emulsions are called what 3 things emulsifiers, surfactants, or surface active agents
the continental method is also referred to as: the dry gum method
primary emulsion the initial emulsion to which ingredients are added to create the final product
mucilage a wet slimy liquid formed as an initial step in the wet gum method
5 types of ointment bases oleaginous base, absorption base, water/oil emulsion base, oil/water emulsion base, water miscible base
things to consider with ointments water content, spreadability, washability, greasiness, occlusiveness
why is a particular ointment chosen? because of its fundamental properties or for its potential to serve as a drug delivery vehicle
if the base ointment is to be a drug delivery vehicle, what is the primary consideration? its ability to release the drug
some bases used for ointments include carnuba wax, cetyl alcohol, cetyl esters wax, cholesterol, cocoa butter, gyceryl monostearate, stearic acid, stearyl alcohol, white wax, PEG 1500,3350 and 6000
3 kinds of suppositories oleaginous bases, water soluble or miscible bases, hydrophilic bases
popular oleaginous base for suppository cocoa butter (theobrama oil)
why is cocoa butter not preferred for suppositories preparation is difficult and they require refrigeration
what are newer suppository bases made from fatty acids that do not have formulation problems or expense
what do water soluble based suppositories contain glycerinated gelatin or polyethylene glycol
PEG polyethelyneglycol
hydrophilic based suppositories contain both oleaginous and water miscible bases. small % of cholesterol or lanolin to assist in water absorption
Low moleculer weight PEG <1,000 are liquids and impart softer texture to formulation
high molecular weight PEG >1,000 are solids and add stiffness to the formulation
how many size capsules are available 8 sizes from capsule size 000 to 5
what method is used to fill a capsule the punch method
what size are capsule filling machines available in 100 or 300 capsules
000 cap size 1.37ml
00 cap size .95ml
0 cap size .68ml
1 cap size .50
2 cap size .37 ml
3 cap size .30 ml
4 cap size .20 ml
5 cap size .13 ml
Created by: megancarter