Pharmacy Technicians Course. LaGuardia Community College

Introduction to CompoundingCompounding in Pharmacy refers to the special preparation of drug products that are uniquely tailored to a patients needs medically and otherwise.Extemporaneous is often an adjective that describes this unique characteristic of compounding.What is compounding?, what is Manufacturing?According to the FDA, compounding isMade to dispense a product on the basis of a Rx for a specific patients needsPharmacist can not compound a copy of a commercial available productPharmacist can not sell his/her product without an RxCant advertise the product (i.e. they can advertise their compounding service but not the product itself)

Extemperaneous CompoundingPharmacy makes a unique product dose form for a specific patient, i.e acetaminophen 2% creamUSP 795 says that expiration dating for these products should not exceed 25% of the time remaining among the manufacturer drug product or six months into the future which ever is earliestAny product where water is add to a solid dosage form is given 14 days under refrigeration unless published data state otherwiseCompounded items can be: creams, ointment, solutions, suspensions, intravenous solutions, capsules, suppository, etc.Solutions are homogenized mixtures of drug in aqueous medium.Suspensions are heterogeneous mixtures of a drug in aqueous medium. These mixtures often require the shaking of the drug before the suspension can be given.Intravenous solutions are aqueous drug mediums that are free of particles; they are sterile and pyrogen freeCapsules are oral dosage forms that are enclosed in a gelatin casing that dissolves in the stomach and small intestine Gelatin capsules come in sizes from 000 to 13.00o is the largest size13 is the smallest sizeSuppositories are dosage forms that are applied rectally. They are usually made of material like glycerin which melts at slightly below body temperature. Used for patients that cant swallow due to neurological disorders (dysphagia)Special Compounded Dosage FormsEmulsions are mixture of two non mixable liquids in a stabilized medium. Normally, oil in water do not mix; however, a compound can be made (an emulsion) where the two liquids can be mixed with each other.Examples in pharmacy are creams and lotions.Examples in food are mayonnaise and milk (fat mixed in water)Two types of emulsion are oil in water (o/w) or (w/o)References for CompoundingRemingtons Pharmaceutical SciencesTrissels Stability of Compounded FormulationsDrug Facts and ComparisonsUnited States PharmacopeiaThe International Journal of Compounding Pharmacists

Compounding Equipment A more complete list is mention in the textThe more important ones are followingBalance, class A, required in every pharmacy by the state boardBeakersFilter papersGraduated cylindersHotplatesMoldsMortar and pestleOintment slabSpatulasWeighing paperMortar and PestleVery important in compoundingrepresents a symbol of the pharmacy profession. Shown as

Used to comminutate or triturate a substance to smaller particle sizes. Smaller particle sizes are a key to make certain compounds more appealing to the touch and taste.Glass mortar is used to mix liquids with powder and porcelain is used for granular powders

SolutionsAqueous or Hydroalcoholic mixtures that are solvents for homogenized solute/solvent systemSolute : drug that is mixed into the systemSolvent: the vehicle or medium used to carry the soluteSolvents include:Purified water USP: contains no more than 10 ppm solidsSterile water for injection USP: same as purified water except for sterility and pyrogen free state: used to mix IV drugsSterile water for Irrigation USP: used to make oral solutionsTypes of solutionsSimple Syrup USP: 85% w/v sucrose in water.Excellent vehicle for a sweeten drug dosage form for childrenSelf Preserving: no antibacterialsElixirsWater and alcohol cosolvent systemsTypically as some sugar alsoUsually about 10%w/v to 40% w/v alcoholAromatic WatersMixture of water, alcohol, and a volatile oilJasmine water is water, alcohol and jasmine oilSpirits or EssenceMixture of water, alcohol and volatile oil where alcohol content is 50% to 90%TincturesHydroalcoholic mixtures where concentration of drug is 10% 10% is the concentration of the whole plant source; 1% is the active drugIe. Opium Tincture is 10% in opium and 1% or morphineCharacteristics of SolutionsBenefitsProvides an easy way to measure doses for small patients and babiesProvides a way to increase bioavailability of the drugDrugs can be sweeten and flavored to mask bad tasteDisadvantagesBulky dosage formSusceptible to hydrolysis with water

SuspensionsHeterogeneous mixture of drug into a medium that normally it does not dissolve in.System consists of water, drug powder, sweetener, flavorants, colorants and an agent called an surfactant which thickens the medium to allow particles of drug to remain suspendedIn systems with no surfactant the drug particles quickly settle to the bottom and aggregate.Surfactants allow the system to be uniform long enough to measure a doseShake before using is normally require as an auxiliary labelSurfactantsAcaciaMethylcelluloseCarboxymethylcelluloseXanthan gumCarrageenanAmylopectinBentonite magma 5% (exhibit thixotropy: gels on standing and liquefies on shaking)Other name for surfactants are Suspending agentsA Common commercially available suspending agent is OraPlus EmulsionA pharmaceutical system where two immiscible liquids are mixed together to form a stable systemNormally two immiscible liquids like water and canola oil dont mix and the less dense oil beads to the topPurpose of EmulsionIncreased drug stability (drug that under hydrolysis in water may be more stable in emulsion)Better applicability in topical administrationTwo phase of the emulsionInternal phase- the dispersed liquidExternal phase-the dispersion medium liquidIf water is the dispersed liquid you have a w/o emulsionIf oil is the dispersed liquid you have a 0/w emulsionThe type of emulsion formed depends on the phase volumes and the type of surfactant or emulsifier used to stabilize this systemEmulsion TypesA classic o/w emulsion is vanishing creamA classic w/0 emulsion is a lotionEmulsifying AgentsEmulsifier or surfactants are agents that stabilize an emulsion.As emulsions age, they destabilize and separate in two phase (i.e. milk that is old separates). This is called cracking and means the emulsion is destabilizedEmulsifiers can be natural or syntheticHLB (hydrophilic Lipophilic Balance) Scale is measure of what type of an emulsion is created when used a given emulsifierHLB9 tend to form 0/wEmulsifierNaturalAcaciaTragacanthAgarMethylcelluloseCarboxylmethylcelluloseSynthethicSodium Lauryl Sulfate medium HLBSorbitan esters (Spans) low HLBPolysorbates (Tweens) high HLBs (o/w)

Popular non medicated Emulsion basesAlamay Base0/wVanishing cream (moisturizer)Cetaphil0/wNon soap cleanerEucerinw/0Moisturizing creamKeri Lotion0/w Moisturizing creamOintment BasesOintment are semisolid mixture of a drug (in liquid) incorporated into a oily stiffen base.Oleaginous basePetrolatum is a high hydrocarbon mixture base used to carry water insoluble drug into the skinPetrolatum is not washable and cant absorb any waterForms occlusive layer and used as an emollientFor example : Vaselin Absorption baseCan absorb water Hydrophilic Petrolatum (Aquaphor )Water soluble baseCan absorb waterCan wash easily with soap and waterConsists of PEG 3350 and PEG 400, which are water soluble basesPropylene glycol-ethanol systems when mixed with 2% hydroxypropyl cellulose forms a clear gelA gel is emulsion system where a solid is the dispersed phase and water is dispersion mediumExhibit thixotrophy: shaking and agitation causes the honey like substance to flow more easily (like water)Absorbs considerable water into the gel sponge effectUsed in wound care to sieve pusIncorporation of drug into ointments or emulsions involves the following:ComminutionBreak down and crushing solid particles into smaller particle sizes to increase its surface areaTrituration is comminution by frictional shear force (rubbing)In practice comminution is done in a porcelain wedgewood mortar and pestleLevigation is the process of increasing particle size by an a small amount of mineral oil to the reduced drug powder. This act wets the powderThe drug/levigating oil mix is then incorporated into the base when heated to near molten state (Fusion method)Alternatively the drug/oil mix is incorporated little by little into the base via geometric dilution on an ointment slabGeometric dilution

PLO Organogel SystemPLO Organogel Systems are o/w type emulsion systemHas excellent skin penetration abilityDrugs can be incorporated into the organic phase or the aqueous phaseThe organic phase is a lecithin emulsifierThe aqueous phase contains a poloxamer polymer in waterPLO stands for Pluronic Lecithin Organogel. Pluronic is the trade name for poloxamer(s) compounds which were synthesize for the first time in the 1970sPrepacking and Unit dose systemsHelps in inventory management in hospitalsPrepacked and unit dose blister cards by law are permitted to be return to inventory upon returnExpiration dating are one of two systems50% of the expiration date on the manufacturer drug or 1 year whichever is sooner (my hospital uses this)25% or six months whichever is soonerMedications that should not be prepacked (unit dose)The standard unit dose prepackage machine as a mechanical dial that rotates between metal plates that are heated to high temperatures. Oral dose forms are placed on the dial and the metal plates seal the blister pack material around the medication with heatSome medications should not be prepacked with a standard machine because the machine will become contaminated with dust particles from these drugsAt times a dedicated machine can be used for some of these drugsCommon highly allergic potential drugs include:Penicillins, Cephalosporins, sulfa drugsMoisture Sensitive medicationsHIV medicationsPraxada Pyridostigmine (Mestinon)Prasugrel (Effluent)EmtrivaMost orally melting tablets : Risperdal M

CapsulesMost gelatin capsules will melt when exposed to heatRitonovirOmega 3 Fatty Acids capsulesChemotherapy drugs and Teratogenic drugsChlorambucil (Leukeran)Cyclophosphamide (Cytotaxan)Cyclosporin (Gengraf)Bosentan (Tracleer): Pregnancy category XIn general, always inquire about the pregnancy rating and the cytotoxic potential of drugs before you are asked to prepack anything. (especially if you are a woman of childbearing potential)For a more complete listing visit:http://www.ashp.org/s_ashp/docs/files/MedNO_unit-dosedpackage.pdfIntroduction to Sterile ProductsA sterile product is a product that is free of contamination, microorganism free, and pyrogen freeExamples of sterile products are intravenous products (IV), ophthalmic products (for the eye), and nasal products (for the nose), Intramuscular (into the muscle) and subcutaneous (under the skin)Aseptic technique refers to the procedure of properly performing the preparation of sterile products.Includes the environment, equipment, and personnel garbProvides guidelines for the procedureNormally any agent that bypasses the skin or the gastrointestinal tract must be both sterile and pyrogen free. This is because the skin and the GI tract have a protective role in filtering out damaging foreign substances or microorganisms.The blood is a sterile body fluid that requires sterile drug products. Blood is filtered by the spleen and then by the lymph nodes as its becomes lymph; however, when a drug is introduced directly into the blood it must be sterile.Consequences of contaminated IV products can be seriousMost IV drug products are contaminated by touch contamination.Bacteria, fungus, and other microorganism colonize the skinCommon skin microorganisms are: Candida, Dermatophytes, and Staphylococcus bacteria. Others are common as well. Contaminated products can colonize the blood and produce bacteremia and fungemia. Infections can evolve into septic shock and death.Watch : http://www.youtube.com/watch?v=KC8qgxNB2FAEnvironment for Sterile Products PreparationClass 100 environment is an environment that has air that contains no more than 100 particles (0.5 microns) or larger in one cubic foot of air.Laminar flow hoods provide this environment.Horizontal flow hoods filter air and pass it through a HEPA filter and outward out of the hood.Vertical flow hoods blow filtered air down towards the surface of the hood.Biological Safety Cabinets are vertical flow hoods that pulls air through vents in the front and back of the hood to prevent the preparer from receiving this air. It is used to make chemotherapy drugs.USP 797Introduced in 2004 by the US Pharmacopeia.Consists of standards for the environment to be considered in the preparation of sterile productsEndorsed by JCAHO and other regulatory agenciesFollowed in most hospitals with others moving towards compliance.Standards include wall/ceiling, wall/wall and wall/floor junction specifications, etc

In general, sterile products are prepared in laminar flow hoods in similarly compliance air quality roomsSuch rooms are called clean roomsUsually have partitions that separate areas of the room for storage of IV products, gloves, and needle and syringesRooms are usually positively pressurized to push contaminates out and to keep other particles from being pulled in.Other Sterile Product EquipmentNeedle are sterile puncturing devices meant to access drug solutions in vials and to administer drugs to patients.Normally are 3/8 of an inches to 3.5 inches in lengthThe diameter, or bore, of the needle is determined by its gauge.The larger the gauge the smaller the bore of the needleIn general, 25 or 27 gauge needles are under for subcutaneous injections, 22 gauge for IM injections with 18 gauge and 16 gauge meant for pharmacy compounding of IV products. 13 gauge is typically the larger bore needle you will find.Syringes are the containers that hold the drug solution after its been drawn from a vial.Consists of a tube with graduations marks, a piston, a plunger with grip collar and at the other end a luer lok tip (most syringes).This luer lok tip is designed to be a twist on to attached to a needle or to a injection port on a catheter to administer an injection

Author: William Rafti of the William Rafti Institute from Wikipedia

Source: wikimedia commons pageIntravenous SolutionsNormal saline (0.9%) is one of the most common because its isotonic with plasma. Isotonic means equal to it in terms of tonicity. i.e. plasma has a tonicity valve of about 290 mOsm. Normal saline or NS is about 300 mOsm. Tonicity of a solution determines if bodily fluid shifts will occurDextrose 5% in water (D5W) is the second most common type. Consists of glucose or dextrose in water to make it 285 mOsm (isotonic)D5WNS is a combination of the two and is used when some calories in the form of glucose is needed. Hypertonic (580 mOsm about) but it is Ok to use.3 % Saline (NaCL) is only used to treat certain brain conditions. Very hypertonic and can cause death if used improperly23.4% saline (NaCL) used only in certain rare conditions and in small volumes. Will cause death if used improperly (remember Emily Jerry?)Type of IV therapyIV primary infusion consists of a drug that is given continuously through a large volume parenteral solutionIV Piggyback is a IV administration of a drug that is normally piggybacked to another primary IV via a Y site connection on the primary IV tubing.IV Piggyback sets are designed to be small in volume usually 50 ml to 100 ml and are hung above the primary bag on the IV pole. (see next page)Rate of infusion can be controlled by gravity and a roller clamps or by an electronic pump

Picture of IV Piggyback set up

A word about filtersAt times a filter is needed to filter IV solutionsi.e. when breaking an ampule you need to use a filter needle to draw the solution to prevent glass particles from entering the IV.A 0.22 micron filter is a special filter that is called a sterilizing filter that can sterilize a fluid as it is passed through the filter.