Non-Sterile Compounding and sterile compounding
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Which of the following are used as ointments and can provide a protective barrier on the skin? Answer A Agar, carrageenan and gelatin B Aquaphor, Aquabase, Eucerin, petrolatum C Acacia D Arlacel, Span, Myrj, Tween E Dry gum
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Aquaphor, Aquabase, Eucerin, and petrolatum are examples of ointments
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Select the correct statement regarding the hydrophilic-lipophilic balance (HLB) number to choose a surfactant when preparing an emulsion: Answer A HLB value of 16; surfactant is oil-soluble B In an oil-in-water (o/w) emulsion, the surfactant has a low HLB number C The HLB scale range is 0 - 10 D Agents with a higher HLB number are more water-soluble E HLB value of 6; surfactant is water-soluble
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The HLB scale range is 0 - 20 and value of 10 is the midpoint. A value more than 10, therefore, is water-soluble.
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Which of the following definitions describes an emulsion? Answer A A liquid preparation of soluble chemicals dissolved in solvents such as water, alcohol, or propylene glycol. B A semisolid dosage form used externally on the skin or mucous membranes. C A solid dosage form used to deliver medicine into the rectum, vagina or urethra. D A two-phase system of two immiscible liquids, one of which is dispersed through the other as small droplets. E A two phased-system of a finely divided solid in a liquid medium.
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An emulsion is a two-phase system of two immiscible liquids, one of which is dispersed through the other as small droplets.
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Which of the following statements concerning mortars, pestles and spatulas is correct? Answer A Wedgewood has a smoother surface than porcelain and is preferred for blending powders or pulverizing soft materials. B Porcelain is used for liquids and chemicals that are oily or will stain. C Bond paper should be used for weighing ointments and creams. D Generally large stainless steel spatula blades are used to prepare the product, except plastic spatulas are used for chemicals (e.g. iodine) that can react with stainless steel blades, and small plastic spatulas are often used for placing the preparation into the container that will be provided to the patient. E Glass mortars are best for triturating rough powders.
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- Wedgewood is used for powders or crystals, inside can be coated to fill in the crevice -Porcelain has a smoother surface and is used for pulverizing or blending soft materials -Glass for oily and will stain -Glassine weighing paper not bond for weighing ointments and dry chemicals -Glass is for mixing liquids and semi-soft dosage forms
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Which of the following is not required of all non-sterile compounded products? (Select ALL that apply.) Answer A NDC numbers B FDA approval C Regulation by the Dietary Supplemental Health and Education Act (DSHEA) D Beyond use dates E Prepared under Current Good Manufacturing Practices (CGMPs)
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BYD is required - doesn't require all
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What is the term for the inactive ingredient that holds the tablet together and provides stability and strength? Answer A A disintegrant B A binder C A flavoring D A lubricant E A polymer
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Binder
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Sorbitol has many uses in drug delivery. Which of the following represent viable uses for sorbitol? (Select ALL that apply.) Answer A Sweetener (sugar substitute) B Thickening agent in liquids C Plasticizer for gelatin capsules D Treatment of GI distress in patients with irritable bowel syndrome (IBS) E Suspending agent
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Sorbitol can cause GI distress, including cramping. It may be particularly bothersome to patients with IBS. Sorbitol used to be given in a formulation of sodium polystyrene sulfonate (Kayexalate) for the treatment of hyperkalemia, but the use of Kayexalate with sorbitol can result in GI (colonic) necrosis and is not recommended. 'A Sweetener (sugar substitute) B Thickening agent in liquids C Plasticizer for gelatin capsules
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A pharmacist is preparing a compounded topical gel containing glycolic acid 5%, hydroquinone 1% and tretinoin 0.025% in a cream base. Select the maximum beyond use-date that can be applied to the label: Answer A 7 days B 10 days C 14 days D 30 days E 6 months
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30 days
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Which of the following statement/s concerning compounded medications is/are correct? (Select ALL that apply.) Answer A Compounding is different from manufacturing since it is patient-specific (ordered by a prescriber for the individual patient). B Compounded medications are regulated by the State Boards of Pharmacy. C Each compounded formula must be assigned a unique NDC number. D Compounds can only be prepared in specialty compounding pharmacies. E Prescriptions for compounded medications cannot be refilled.
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The key difference between compounding and manufacturing is that compounded products are prepared for a specific patient. Compounded medications are regulated by the State Boards of Pharmacy. - can be refilled, we can make it at Kmart
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Which of the following terms is used to determine the amount of surfactant required for an emulsion? Answer A The Noyes-Whitney Number B The Hydrophilic-Lipophilic Balance (HLB) number C The Degredation Coefficient (DC) D The Surfactant Coefficient Variable (SCV) E The pH
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The amount of surfactant required is determined by the hydrophilic-lipophilic balance (HLB) number, which determines the relative degree of lipophilic and hydrophilic parts of the compound and (therefore) how much surfactant will be required to form the mixture together.
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A pharmacist is making an oral preparation that contains water, glycerin, sorbitol, coloring and a preservative in an aromatic solution which contains 22% alcohol. Select the most accurate statement below that matches this formulation: Answer A The mixture is an emulsion. B The mixture is a suspension. C The mixture is a simple syrup. D The mixture is being delivered in a troche formulation. E The mixture is an elixir.
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Elixirs are non-aqueous (hydroalcoholic) liquids that can contain substantial alcohol concentrations (up to 40%). A common alcohol concentration in elixirs is 22%. The alcohol is used to help a carbon-containing compound dissolve in the solution. In practice, there is often overlap between the terms syrup and elixir; however, to be defined as an elixir, the mixture must contain alcohol.
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Which of the following statements concerning emulsions and surfactants are correct? (Select ALL that apply.) Answer A An emulsion is two or more liquids blended together into a suspension. B Surfactants, such as Tween, can be used when preparing emulsions. C Common examples of emulsions include propofol and mayonnaise. D An emulsion is two or more liquids which are not able to be blended together (they are immiscible). E Emulsions can be given IV.
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B Surfactants, such as Tween, can be used when preparing emulsions. C Common examples of emulsions include propofol and mayonnaise.- yes D An emulsion is two or more liquids which are not able to be blended together (they are immiscible). E Emulsions can be given IV. An emulsion is a mixture of two or more liquids which are immiscible (the two substances do not form a suspension-which means they stay separate when you combine them). Oil-in-water emulsions are used for oral formulations; patients could not tolerate an emulsion that was water-in-oil due to poor taste. However, oil-in-water (o/w) (or water-in-oil, or w/o) emulsions are suitable for topical drugs applied to the skin. Surfactants (with their hydrophilic and lipophilic ends) exist at the interface between the oil and water phases to keep the preparation together. In addition to o/w and w/o, emulsions can also be water-in-oil-in-water (w/o/w). Emulsions are always liquid in liquid. The term does not refer to solids in liquids, which are generally solutions or suspensions.
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Which of the following statements concerning FDA approved manufactured drug products is/are correct? (Select ALL that apply.) Answer A FDA approved drugs must have an approved NDA. B They must be manufactured under Current Good Manufacturing Practices (CGMPs). C They must have a manufacturer's expiration date on the bottle/package label. D They must each have an NDC number. E They include compounded preparations.
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FDA approved drug products must have an approved NDA, be produced under Current Good Manufacturing Practices, and have an NDC number. They must also have a manufacturer's expiration date on the bottle/package label.
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Which of the following statements is correct regarding the labeling, storage and stability of non-sterile compounded products? (Select ALL that apply.) Answer A The BUD for nonaqueous formulations is the earliest expiration date of any active pharmaceutical ingredient (API) or 12 months, whichever comes first. B Store all bulk products off the floor and rotate the stock so that the nearest expiration date is in front and used first. C Guidelines for handling and storing hazardous drug are provided by the National Institute of Occupational Safety and Health (NIOSH). D A statement that the product has been compounded by the pharmacy must be placed on the label of the container. E Beyond use dates (BUDs) must not be later than the expiration date on the container of any of the individual components.
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The BUD for nonaqueous formulations is the earliest expiration date of any active pharmaceutical ingredient (API) or 6 months, whichever comes first. In pharmacies, the vaccines or components or drugs with the nearest expiration dates are placed in front of the same products with longer expiration dates so that the products that are expiring the soonest are used first. all r true except a
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Select the agent/s used as thickeners: Answer A Acacia B Lanolin, Aquaphor, Aquabase C Agar, carrageenan and gelatin D Arlacel, Span, Myrj, Tween E Petrolatum
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Agar, carrageenan, and gelatin are common thickening agents used in compounds.
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A patient who receives a compounded product must be counseled to report any adverse reactions to the pharmacist. Where does the pharmacist record each adverse report they receive? Answer A To the FDA's MedWatch, either online or by phone or fax. B To the Institute for Safe Medication Practices (ISMP). C In the pharmacy's compounding record (log book). D In the pharmacy's record of adverse reactions. E In the pharmacy's master formulation record.
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The pharmacist will record the adverse reaction with the record of that compounded product in the cmpding record/logbook. Depending on the reaction, further reporting may be required.
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Which of the following statement/s are correct regarding the preparation of ointments? (Select ALL that apply.) Answer A Glycerin can be used a wetting agent to better incorporate the drug into the delivery vehicle. B Cooling the preparation with ice can help speed the process and make the product more consistent. C Creams are more water-based when compared to ointments. D If using heat, melt the ingredient with the highest melting point first and use the lowest temperature that will work for the shortest duration of time. E Homogenous preparation of an ointment relies on incorporating the drug on an ointment slab with spatulation into the vehicle using geometric dilution.
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Cooling should not be sped up with ice or cold water, as it alters the consistency of the final product.
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Which of the following correctly describes the use of Tween (polysorbate)? (Select ALL that apply.) Answer A It is used most commonly as a thickening agent. B Tween is a surfactant. C Surfactants are compounds with polar sides and nonpolar sides. D Surfactants are used as wetting agents. E Surfactants are used most often in ointments.
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Tween is a commonly used hydrophilic (water-loving), non-ionic (the head is not charged) surfactant. Tween surfactants are usually used for oil in water emulsions. Surfactants decrease the surface tension of a liquid or between a liquid and a solid. They are used as detergents, wetting agents, emulsifiers and dispersants. Surfactants have polar and non-polar sides.
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A 9 year-old boy with juvenile rheumatoid arthritis has developed white patches on the tongue, palate and corners of the mouth. The pharmacist will prepare a formulation to provide an adequate dosage of clotrimazole to treat the infection inside the patient's mouth. Select the most suitable formulation: Answer A Compressed oral tablet B Rectal suppository C Troche D Sublingual oral tablet E Ointment
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Besides using a troche that dissolves slowly in the mouth (a parent will need to make sure the child does not swallow it or spit it out), an antifungal suspension can be swished in the mouth and swallowed. The antifungal nystatin is sometimes given in an ointment to treat thrush on the sides of the mouth, but is not appropriate to apply inside the mouth.
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Which of the following definitions describes a solution? Answer A A liquid preparation of soluble chemicals dissolved in solvents such as water, alcohol, or propylene glycol. B A solid dosage form used to deliver medicine into the rectum, vagina or urethra. C A semisolid dosage form used externally on the skin or mucous membranes. D A two-phase system of two immiscible liquids, one of which is dispersed through the other as small droplets. E A two phased-system of a finely divided solid in a liquid medium.
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A solution is a liquid preparation of soluble chemicals dissolved in solvents such as water, alcohol, or propylene glycol.
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Ethanol (alcohol) is used in tinctures (such as iodine tincture) because it can dissolve organic substances and in many other oral solutions, including some cough medicines. The pharmacist should be concerned with the following risks when using alcohol in medications: (Select ALL that apply.) Answer A Toxicity B Interaction with prescription drugs, such as oral hypoglycemics and agents that can cause disulfiram-like reactions C Renal damage D It is illegal to dispense these preparations to minors E These preparations are regulated by the DEA
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When one substance is dissolved in another, it forms a solution. Ethylene glycol (antifreeze) would also work as a solvent, but it has a high risk of toxicity. Alcohol can cause liver damage, but renal function decline is not caused by alcohol ingestion. a,b
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Rank the following steps used to prepare compounded tablets using the dry granulation method. Left-click the mouse to highlight, drag, and order the answer options; ALL options must be used. Answer A Assemble all materials needed to prepare the tablets (API, excipients, equipment, log books, etc.) B Garb, wash hands, clean equipment. C Mix the tablet components using geometric dilution. D Compress the slug into a tablet machine to form individual tablets. E Check the prescription for adequacy, content and consistency and make sure the compounding record is complete. Affix the label to the container and a second copy of the label to the compounding log.
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nswer A Garb, wash hands, clean equipment. B Assemble all materials needed to prepare the tablets (API, excipients, equipment, log books, etc.) C Mix the tablet components using geometric dilution. D Compress the slug into a tablet machine to form individual tablets. E Check the prescription for adequacy, content and consistency and make sure the compounding record is complete. Affix the label to the container and a second copy of the label to the compounding log.
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What is the density factor used to calibrate? Answer A An oral tablet punch. B A torsion balance. C An electronic balance. D An ointment slab. E A suppository mold.
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suppository mold
