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COMPOUND GAY
| Question | Answer |
|---|---|
| Compounding | is the preparation of customized medications to meet the specific needs of an individual patient when commercially available drugs are not suitable. |
| Compounding | It involves combining, mixing, or altering ingredients according to a prescriber’s order and is performed by trained pharmacy professionals, with pharmacy technicians assisting under pharmacist supervision. |
| ● Extemporaneous compounding | ○ On-demand preparation of a drug product. |
| ● Extemporaneous compounding | ○ According to a physician’s prescription. |
| ● Extemporaneous compounding | Meets the unique needs of an individual patient. |
| Compound Manufacturing | ○ The production or processing of a drug in a LARGE quantity by various mechanisms. |
| ● Pediatric patients | requiring diluted adult strengths of drugs. |
| Patients ---- or suspension of a product that is only available in another form. | needing an oral solution |
| Patients with --- preservatives, or flavoring agents found in commercial formulations. | sensitivity to dyes, |
| Dermatological formulations | with fortified (strengthened) or diluted concentrations of commercially available products. |
| ● Specialized dosages for | therapeutic drug monitoring |
| Why Compound? | ● Care for hospice patients in pain management. |
| ● Compounding for ---. | animals |
| The U.S. Pharmacopeia (USP) | Established in the 1906 Pure Food and Drugs Act. |
| The U.S. Pharmacopeia (USP) | Develops STANDARDS where various topics are grouped into “CHAPTERS.” |
| The U.S. Pharmacopeia (USP) | Publishes its standards in the resource book called the USP/NF. |
| The U.S. Pharmacopeia (USP) | Chapters are assigned numbers. |
| The U.S. Pharmacopeia (USP) | The USP/NF has over 60 chapters. |
| The U.S. Pharmacopeia (USP) | The USP also publishes MONOGRAPHS of the most commonly compounded preparations used in practice. |
| ■ Chapters <795> | - called Pharmaceutical Compounding - Nonsterile Preparations ■ Published in 2000 ■ Enforceable |
| Chapter <797> | - called Pharmaceutical Compounding - Sterile Preparations, ■ Became official in 2004. |
| ■ Other Chapters | ■ Containers <661> |
| ■ Other Chapters | ■ Good Compounding Practices <1075> |
| ■ Other Chapters | ■ Pharmaceutical Stability <1150> |
| ■ Other Chapters | ■ Pharmaceutical Dosage Forms <1151> |
| Compounding Regulations Applies: ----- ● Ingredient Standards ● Quality Assurance and Quality Control ● Packaging and Storage ● Documentation and Record Keeping | ● Personnel ● Facilities and Equipment |
| Compounding Regulations Applies: ● Personnel ● Facilities and Equipment ----- ● Quality Assurance and Quality Control ● Packaging and Storage ● Documentation and Record Keeping | ● Ingredient Standards |
| Compounding Regulations Applies: ● Personnel ● Facilities and Equipment ● Ingredient Standards ----- ● Packaging and Storage ● Documentation and Record Keeping | ● Quality Assurance and Quality Control |
| Compounding Regulations Applies: ● Personnel ● Facilities and Equipment ● Ingredient Standards ● Quality Assurance and Quality Control ------ ● Documentation and Record Keeping | ● Packaging and Storage |
| Compounding Regulations Applies: ● Personnel ● Facilities and Equipment ● Ingredient Standards ● Quality Assurance and Quality Control ● Packaging and Storage ----- | ● Documentation and Record Keeping |
| ● Formulation Record | ○ Formulas and procedures (i.e., recipes) for what should happen when a formulation is compounded. |
| ● Compounding Record | ○ A record of what actually happened when the formulation was compounded. |
| Standard Operating Procedures (SOPs) | ○ Equipment maintenance, equipment calibration, handling and disposal of supplies, etc. |
| ● Material Safety Data Sheets MSDSs | ○ Ingredients records with certificates of purity. |
| Freezer = | -20 C to -10 C |
| Protect from Freezing = | Store above 0 C |
| Cold = | Any temperature not exceeding 8 C |
| Refrigerator = | Between 2 C and 8 C |
| Cool = | Between 8 C and 15 C |
| Room Temperature = | Temperature in the work area |
| Controlled Room Temperature = | Thermostatically controlled at 20C to 25 VC |
| Warm = | Between 30 and 40 C |
| Excessive Heat = | Any temperature above 40 Degree |
| ● Stability | ○ The extent to which a dosage form retains the same properties and characteristics that it possessed at the time of its manufacture. |
| ● Expiration date | ○ The date until which the manufacturer can guarantee of the safety and full potency of a drug- usually determined after extensive study of the product’s stability. |
| ● Beyond-use dates | ○ Used for compounded preparations only and are generally in the order of “days” or “months.” |
| ● Shelf life | ○ Length of time a packaged drug will last without deteriorating |
| ● Nonaqueous liquids and solid formulations | ○ If the source of the active drug is a manufactured drug product, the beyond-use date is not later than 25% of the time remaining until the drug product expiration date, or 6 months, whichever is earlier. |
| ● Nonaqueous liquids and solid formulations | ○ If the source of the active drug is a USP or NF substance, the beyond-use date is not later than 6 months. |
| ● Water containing formulations | ○ When prepared from ingredients in solid form, the beyond-use date should be not later than 14 days when stored at cold temperature. |
| ● For all other formulations | ○ The beyond-use date is not later than the intended duration of therapy or 30 days, whichever is earlier. |
| Measuring (Types of Equipment) | Balance, weights, weighing containers, volumetric glassware (graduates, pipets, flasks, syringes). |
| Molding (Types of Equipment) | ● Hot plates, suppository molds, capsule shells, ointment slabs. |
| Mixing (Types of Equipment) | ● Beakers, Erlenmeyer flasks, spatulas, funnels, sieves, mortar and pestle. |
| Packaging (Types of Equipment) | ● Prescription bottles, capsule vials, suppository boxes, ointment jars. |
| Weighing the exact amount prescribed is essential in compounds for several reasons: | • The product cannot be “checked” for content once mixed. |
| Reason for Accurate Weighing | • The quantities weighed out are often very small, and a slight overage could mean a serious overdose for the patient. |
| • Spatulas | • Used to transfer solid ingredients or prepare ointments and creams or loosening material from the surfaces of a mortar. |
| Types of Spatulas | • Stainless steel • Hard rubber • Plastic |
| Spatulation | ■ Mixes powders using a spatula. |
| Spatulation | Mixing can be done in a mortar, on an ointment slab, or in a plastic bag. |
| Mortar and Pestle | • The coarser the surface of the mortar and pestle, the finer the triturating, or grinding, that can be done. |
| Mortar and Pestle | Types • Glass • wood • Porcelain |
| Mortar and Pestle | Trituration • The process of grinding powders to reduce the particle size. |
| Compounding Slab | This is an ideal surface for mixing compounds because of its nonabsorbent surface. |
| Levigation | Technique used to reduce the particle size of a powder drug by triturating it with a solvent in which the drug is insoluble. |
| Volumetric Equipment Graduated Cylinders | ● Cylindrical and cone shaped. |
| Volumetric Equipment Graduated Cylinders | ● Used for measuring and transferring liquids. |
| Volumetric Equipment Graduated Cylinders | ● Available in sizes ranging from 5 ml to 4,000 ml. |
| Volumetric Equipment Graduated Cylinders | ● Selecting a graduated cylinder. |
| ● Selecting a graduated cylinder. | ○ Choose the smallest one capable of containing the volume to be measured. |
| ● Selecting a graduated cylinder. | ○ Rule: Avoid measurements of volumes that are below 20 percent of the capacity of the graduated cylinder. ■ Example, a 100 ml graduated cylinder cannot accurately measure volumes below 20 ml. |
| When measuring small volumes, such as 20 ml and less, | use a syringe or pipet. |
| Syringe | Measure volume to edge of stopper. |
| Volumetric Equipment Syringes | Range from 0.5 ml to 60 ml and in a variety of materials and styles. |
| Volumetric Equipment Syringes | Contain graduation marks on the barrel for measuring partial volumes. |
| Volumetric Equipment Syringes | A disposable hypodermic syringe or an oral syringe made of plastic is used for most compounding tasks involving small volumes. |
| Volumetric Equipment Syringes | Always choose the smallest syringe capable of containing the volume to be measured. |
| Used to deliver small doses of liquid medication. | Liquid Measurement Droppers |
| Medicine dropper must first be calibrated because | Liquid Measurement Droppers |
| ○ The drop size will vary from | dropper to dropper. |
| ○ Personal factors can also contribute to the ----- | inaccuracy of droppers. |
| Measuring Liquid Volumes | Pour the liquid to be measured slowly into the graduate, watching the level of the liquid in the graduate as you do so. |
| Measuring Liquid Volumes | If the liquid is viscous, or thick, then you should attempt to pour it toward the center of the graduate to avoid having some of the liquid cling to the sides. |
| Liquid Measurement. Oral Syringes | Available for accurately administering liquid medication to the patient. |
| Liquid Measurement. Oral Syringes | Have tips that are larger than tips on hypodermic syringes so needles cannot be placed on these syringes. |
| Liquid Measurement. Oral Syringes | After the dose is drawn into the syringe, a cap is placed on the tip to prevent leakage and prevent contamination. |
| ■ Oral syringes can be used with a device called an Adapt-a-Cap® | ■ An example of an oral syringe cap the screws onto the bottle containing the liquid, and the oral syringe is fitted into the other side of the cap. |
| When mixing powders of unequal size, the smaller amount is mixed (triturated) with an equal amount of the other. | That mixture is then mixed with an equal amount of the larger amount powder. This process is repeated until the mixture is completed. |
| Solutions | ■ The most commonly compounded products. |
| Clear (but not necessarily colorless) liquids | ■ ----- in which the drug is completely dissolved. |
| solubility | The ---- of the drug must be known before attempting to dissolve it in a solution. If a drug is not soluble in a vehicle, then no amount of mixing will help. |
| Some solids need to be ---- before mixing in a solution. | triturated |
| Suspension | A two phase system consisting of a finely divided solid dispersed in a liquid. |
| Flocculating Agent | ○ Electrolytes used in the preparation of suspensions to form particles that can be easily redispersed. |
| Thickening Agent | ○ Ingredient used in the preparation of suspensions to increase the viscosity of the liquid. |
| ■ Flavoring | ■ The human tongue contains about 10,000 taste buds which distinguish salty, bitter, sour, and sweet tastes. |
| Sweeteners | Colorless, odorless, solubility in water at the concentrations needed for sweetening, pleasant tasting with no “after-taste,” and stable over a wide pH range. |
| ■ Coloring | ■ Not required in every formulation. |
| ■ Coloring | ■ Contraindicated in all sterile solutions. |
| ■ Coloring | ■ Dark colors, such as dark purple, navy, black, and brown may also be rejected because they are often associated with poisons. |
| Unstable system consisting of at least two immiscible liquids. | One is dispersed in the form of small droplets throughout the other. ○ The other is a stabilizing agent. |
| Emulsion Types | Types ○ Oil-in-water (o/w) emulsion ○ Water-in-oil (w/o) emulsion |
| Emulsifier - | a stabilizing agent in emulsions. |
| Emulsions | commonly used emulsifying agents include tragacanth, sodium lauryl sulfate, sodium dioctyl sulfosuccinate, and polymers known as the Spans® and Tweens®. |
| Ointments | Used for many different purposes, e.g., antiseptics, emollients, antipruritics, keratolytics, and astringents. |
| Ointments are generally compounded on an ointment slab | Transferring ointment into a jar |
| Suppositories | Three Types of Basis: Oleaginous Water Soluble Hydrophillic |
| ● Oleaginous: | primarily synthetic triglycerides. |
| Water soluble: | containing glycerinated gelatin or polyethylene glycols (PEGs). |
| Hydrophilic | : mixtures of oleaginous and water soluble bases. |
| ■ Cocoa butter (Theobroma Oil) USP | ■ A well-known oleaginous base. |
| ■ Cocoa butter (Theobroma Oil) USP | ■ At room temperature, cocoa butter is a solid. |
| ■ Cocoa butter (Theobroma Oil) USP | ■ At body temperature, it melts to a bland, non-irritating oil. |
| ■ Cocoa butter (Theobroma Oil) USP | ■ No longer the base of choice because preparing suppositories with it is difficult, and the suppositories require refrigeration. |
| Synthetic triglycerides | can be used that do not have the formulation difficulties of cocoa butter, but they are more expensive. |
| Suppositories | ■ There are newer bases composed of mixtures of fatty acids that do not have the formulation problems or the expense (e.g., FattiBase®, Witepsol®). |
| There are newer bases composed of mixtures of fatty acids that do not have the formulation problems or the expense | (e.g., FattiBase®, Witepsol®). |
| Capsules | Hard gelatin capsules consist of a body and a cap which fits firmly over the body of the capsule. |
| Capsules | ● For human use, eight sizes of capsules are available. |
| Punch Method | Used when filling a small number of capsules. |
| • After compounding | • The product must be labeled with a prescription label, and a careful record of the compounding operation should be kept. |
| • Once the compounding operation is finished | • The equipment and area should be cleaned. • Everything should be returned to their proper places in storage. |
| • Compounding | should never be rushed. |
| Regardless of their apparent stability, all suspensions | ○ Should be dispensed with an auxiliary label reading “Shake Well.” |
| The qs abbreviation means to add “as much as necessary” to the specified amount. | ○ JCAHO recommends using text words rather than abbreviations to minimize a medication error. |
| Refer to a standard reference work on the subject. | ○ Example: Remington: The Science and Practice of Pharmacy |
Created by:
Russells3709