COMPOUDING LAB MIDTERM Flashcards
How to operate a class A torsion balance
- Arrest torsion
- Screw both knobs (left or right) same directions until they are equal- check the right side of balance
- To “0” balance
- Small knob -> arrest to release turn left
- View the displace
- Adjust it by using bottom knobs (inwards to the left, outward to the right)
- Look to arrest position
Prescription Label
- Name of patient
- Prescription number
- Date written or dispensed
- Directions for use
- Name of prescriber
- Pharmacy info
- Special cautionary statements
Prescription Requirements
Prescriber information Patient information Date prescribed/written Medication prescribed and dosage (denoted as: Rx: drug name and dosage) Medication information (quantity, dosage form, etc.) Patient directions Refills Prescriber signature
BUD
Determined from the date when preparation is compounded
Manufacturer expiration date cannot be used as only source to determine bud
BUD general stability and drug specific considerations:
Nature of drug and degradation
Dosage form and components
Potential microbial growth
Final container
Storage conditions
Duration of therapy
OBRA-90 Info
- Name and description
- Dosage form, route, and duration
- Adverse effects
- Precautions
- Refill info
- Storage
- Missed doses
Oleaginous internal phase with aqueous external phase
Oil in water (o/w)
Compound White Ointment
White petrolatum and white wax over heat
Solutions
Liquid preparations that contain one or more chemical substances dissolved in a suitable solvent or mixture of mutually miscible solvents
Syrup
Aqueous solutions containing sugar
Solubility
Indicates the maximum concentration to which a solution may be prepared with that agent and that solvent
FDA recommendation for OTC alcoholic products
- Children under 6yrs 0.5%
- Children 6-12yrs 5%
- Over 12yrs 10%
Diluted alcohol
Prepared by mixing equal volumes of water and alcohol (strength approximately 49%)
Dry Mixtures for Solution
- Insufficient stability to meet extended shelf-life
- Once reconstituted, solution remains stable for 7-14 days
Flavored Vehicles
Non-medicated syrups containing flavoring agents
Syrup Components
- Sugar
- Antimicrobial preservatives
- Flavorants
- Colorants
Trituration
Process of grinding a drug in a mortar to reduce its particle size
Levigation
Used in ointments to reduce the particle size and grittiness of added powders
Transdermal
Designed to deliver drugs through the skin into circulation for system effects
Ointments
Semisolid preparations intended for external application to the skin or mucous membranes
Hydrocarbon Ointment Bases
- AKA oleaginous bases
- Protect against the escape of moisture
- Difficult to wash off with water
- Ex. Petrolatum, white ointment, etc
Water-Removable Absorption Bases
- Oil in water emulsions resembling creams
- Easily washed from skin
- Have the ability to absorb serous discharges
- Ex. hydrophilic ointment
Water-Soluble Absorption Bases
- Do not contain oleaginous components
- Completely water washable
- Referred to as greaseless
- Used mostly for incorporation of solid substances
Base Selection Factors
Factors
- Desired release rate
- Desirability for topical or percutaneous absorption
- Desirability of occlusion of moister from skin
- Stability in ointment base
- Effect of drug on consistency etc
- Desire for a base that is easily water-washable
Ointment Incorporation
- Solids or liquids
- Components are mixed until a uniform preparation is attained by using a mortar/pestle, or a spatula and ointment slab
Ointment Fusion
-All or some of the components are combined by being melted together and cooled with constant stirring
USP Ointment Requirements
- Microbial content
- Minimum fill
- Packaging, storage, and labeling
Creams
Semisolid preparations containing one or more medicinal agents dissolved or dispersed in either oil-in-water emulsion or in another water-washable base
Pluronic Lecithin Organogel (PLO)
- Two phases(Oil and water)
- Phospholipid liposomal microemulsion used for transdermal drug administration
- Usually 1 part oil phase/4 parts water phase
Pastes
- Semisolid preparations intended for application to the skin
- Contain larger proportion of solid material than ointments
Packaging for Semisolid Preparations
- Ointment tubes
- Ointment jars
CarBAMazepin
Carbatrol; Epitol; Equetro; TEGretol; TEGretol-XR
Anticonvulsant
IV ( 4 infusions (every 6 hours) over 30 minutes.) and oral : 1,600 mg/day.
Epilepsy
US Boxed Warning: Blood dyscrasias, Dermatologic toxicity
Adverse Reactions: dizziness, drowsiness, nausea
Dosage form: chewable, tablet, suspension
Escitalopram
Lexapro
10 mg once daily; dose may be increased to a maximum of 20 mg once daily after at least 1 week
Treatment of major depressive disorder; generalized anxiety disorders (GAD)
US Boxed Warning: Suicidal thinking/behavior
Adverse effect: headache, nausea
Dosage: oral and solution
no children
Oral: 5mg, 10mg, 20mg 5mg/5ml
lopid
Gemfibrozil
Oral: 600 mg twice daily 30 minutes before breakfast and dinner.
Treatment of hypertriglyceridemia in Fredrickson types IV and V hyperlipidemia
Adverse effect: Dyspepsia
no children
1 inch = ______ cm
2.54 cm
1 tsp = _______ mL
5mL
1 tbsp = ______ mL
15mL
1 fl. oz = _________ mL
30mL
1 pint = _______ fl.oz or ________ mL
16 fl.oz or 473mL
1 quart = ________ fl. oz or ________ mL
32 fl. oz or 946mL
1 gallon = ________ fl. oz or _________ mL
128 fl. oz or 3785mL
1 kilogram = _______ lb
2.2 lb
1 ounce = _________ g
28.4 g
1 grain = _________ mg
65 mg
Compounding
Preparation, mixing, assembling, packaging, or labeling of a drug or device
Manufacturing
- Production, preparation, propagation, conversion, and/or processing of a drug or device
- Any packaging or repackaging of substances
- Preparation and promotion of commercially available products from bulk compounds
Active Ingredients
Chemicals, substances, or other components of articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases/nutritional supplementation
Added Ingredients
Necessary for preparing dosage forms or for enhancing the stability of finished preparations
USP Ingredient
Certified to meet or exceed the specifications prescribed in the current edition of USP
NF Ingredient
Certified to meet or exceed the specifications prescribed in the current edition of NF
FCC Ingredient
Certified to meet or exceed the specifications listed in the current edition of the Food Chemical Codex
ACS Ingredient
Certified to meet or exceed the specifications listed in the current edition of Reagent Chemicals
AR Ingredient
- aka Analytical Reagent Grade
- Grade assigned to chemicals of high purity that is suitable for analytic laboratory work
CP Ingredient
- aka Chemically Pure
- Chemicals which are much more refined than technical grade, but for which only partial analytic information is available
Technical Ingredient
- aka Commercial Grade
- Grade assigned to chemicals of commercial or industrial quality
Food Grade
Grade assigned to chemicals that have clearance for use in foods
Cosmetic Grade
Designation can be given to chemicals approved for use in cosmetics
Freezer Storage Temp
-25 to -10 degrees celsius
Cold Storage Temp
Not exceeding 8 degrees celsius
Refrigerator Storage Temp
2 to 8 degrees celsius
Cool Storage Temp
8 to 15 degrees celsius
Controlled Room Storage Temp
20 to 25 degrees celsius
Warm Storage Temp
30 to 40 degrees celsius
Excessive Heat Storage Temp
Above 40 degrees celsius
Dry Place Storage
Controlled room temperature with relative humidity (not exceeding 40%)
Light-Resistant Container
Protect the article or product from the effects of light
Well-Closed Container
Provides protection from extraneous solids getting in, or the contents of the container getting out under normal conditions
Tight Container
Protects from contamination by extraneous liquids, solids, vapors, from loss of the article, and from efflorescence, deliquescence, or evaporation
Hermetic Container
- Most secure container type
- Impervious to air or other gas under normal conditions
Steps in Compounding Process
- Preparatory
- Compounding
- Final Check
- Sign Off
- Clean up
Handling Hazardous Materials
The Occupational Safety and Health Admin (OSHA) of the federal government protects the health and safety of all workers and is responsible for enforcing the HCS
Hazard Communication Standard (HCS)
- Pharmacies/Labs must maintain comprehensive inventory
- Material Safety Data Sheets must be maintained
- All containers of hazardous chemical must be labeled with warnings
- Students and employees must be informed of chemical hazards, and elements of HCS
Legend drug
A drug that is available to a patient by prescription only.
National drug code (NDC)
A permanent number (10 digits) assigned to a drug and registered with the FDA identifying the manufacturer or distributor, the drug identity and formulation, and the package size.
Solution
a liquid preparation containing one or more drug substances that are evenly dispersed in a soluble solvent or mixture of miscible solvents.
Schedule I controlled substance
Drugs with NO ACCEPTED medicinal use that have a high potential for abuse
Schedule II controlled substance
Drugs with accepted medical uses and a HIGH potential for abuse, which if abused may lead to severe psychological or physiological dependence.
Schedule III controlled substance
Drugs with accepted medical uses and a lower potential for abuse when compared to schedule I and II agents. If abused may lead to moderate or low physiological dependence or high psychological dependence.
Schedule IV controlled substance
Drugs with accepted medical uses and a lower potential for abuse when compared to Schedule III agents. If abused may lead to limited physiological or psychological dependence.
Schedule V controlled substance
Drugs with accepted medical uses and a low potential for abuse relative to the agents in schedule IV. If abused may lead to limited physiological or psychological dependence.
• National formulary (NF)
- Formulary that contained many popular drugs and formulas denied admission to the usp
- USP purchased NF combining and creating one national Official compendia
• USP
Contains Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP (dietary supplements and ingredients appear in a separate section)
• NF
Contains Excipient monographs
• Monograph includes
name of the ingredient or preparation; definition; packaging, storage, and labeling requirements; and the specification (series of tests, procedures for the tests, and acceptance criteria according to official USP reference standards)
Medicinal ingredients and products will have the stipulated strength, quality, and purity
- Protection of a drug substance from the destructive influences of atmospheric oxygen or humidity
Example: Coated tablets, sealed ampules
- Protection of a drug substance from the destructive influence of gastric acid after oral administration
Example: Enteric-coated
- Conceal the bitter, salty, or offensive taste or odor of a drug substance
Example: Capsules, coated tablets, flavored syrups
- Provide liquid preparations of substances that are either insoluble or unstable in the desired vehicle
Example: Suspensions
- Provide clear liquid dosage forms of substances
Example: Syrups, solutions
- Provide rate-controlled drug action
Example: Controlled-release tablets, capsules, and suspensions
- Provide optimal drug action from topical administration sites
Example: Ointments, creams, transdermal patches, ophthalmic, ear, and nasal preparations
- Provide for the insertion of a drug into one of the body’s orifices
Example: Rectal or vaginal suppositories
- Provide for the placement of drugs directly into the bloodstream or into body tissues
Example: Injections
- Provide for optimal drug action through inhalation therapy
Example: Inhalants and inhalation aerosols
Compound vs manufacturing
- Compounding Preparation Packaging Labeling of a drug Result of a prescription drug order - Manufacturing Preparation Packaging Labeling a container Relabeling a container Repackaging Promotion Marketing
Aqueous solution
Medications dissolved in water along with any other necessary agents
Distilled or purified water should be used
Examples: Syrup
Nonaqueous Solution
Contain solvents other than water either alone or in addition to water
Alcohol most commonly used
Solubility
Degree of being able to dissolve
Maximum concentration to which a solution may be prepared with agent and solvent
Usually expressed as the number of mL of solvent required to dissolve 1 gram of drug
Unsaturated solution
more solute dissolves
Saturated solution
no more solute dissolves
Supersaturated solution
becomes unstable crystals form
Solvents
Capable of dissolving another substance
Completely dissolve the drug and other solid ingredients at desired concentration
Nontoxic
Safe for ingestion or topical application
Aesthetically pleasing
Syrups
Concentrated aqueous preparations of a sugar or sugar substitute with or without flavoring agents and medicinal substances
Concentrated sugar or sugar substitute aqueous liquids
Flavoring vehicle
Contains no medicinal substance
Any water-soluble drug that is stable in aqueous solution may be added to a flavored syrup
Antimicrobial Preservative
Protect against microbial growth
Amount varies with the proportion of water available for growth, the nature and inherent preservative activity of materials
Demulcent
relieving inflammation or irritation.
Hard sticks
Ex: Styptic pencil (razor cuts)
Soft Opaque sticks
Ex: Lip balm
Soft Clear sticks
Ex: Deodorant stick
Eutectic Liquid
Mixture of substances that melts and solidifies at a single temperature that is lower than the melting points of the separate constituents
Suspension
Preparations containing finely divided drug particles distributed somewhat uniformly throughout a vehicle with minimum degree of solubility
Suspension Physical Features
- Particle diameter 1-50 micrometers
- Slower sedimentation as particle size decreases
Sustained Release Suspension
-Uses ion-exchange resin complex and particle coating
Elderly Suspension Considerations
Cautious with alcohol containing products
USP/NF background: Pharmacopeia
- Any recipe or formula or other standards required to make or prepare a drug
- 1st united states pharmacopeia (Usp) published in 1820
Compounding Suspensions
- Capsule contents are emptied and crushed in mortar
- Selected vehicle is slowly added to create paste
- Dilute to desired volume
Neonate Considerations
Avoid preservatives, colorings, flavorings, or alcohol
Suspension Packaging
- Wide mouth, tight containers
- Protected from freezing, excessive heat and light
- Shake well before use
- Most will need to be refrigerated
Emulsion External Phase
Dispersion medium
Emulsion
A dispersion in which the dispersed phase is composed of small globules of a liquid distributed throughout a vehicle in which it is immiscible
Patient Counseling Steps (5)
- Greeting
- Open ended questions
- Educate
- Summarize
- Follow up/closing
Emulsion Internal Phase
dispersed phase
What is needed to prepare a stable emulsion?
Third phase emulsifying agent
Emulsifying Agents Carbs
Acacia, agar pectin
Emulsifying Agents Proteins
Gelatin, egg yolk, casein
Emulsifying Agents High molecular weight alcohols
Stearyl alcohol, cetyl alcohol, glyceryl monostearate
Methods of Emulsion Preparation
- Continental or Dry Gum Method
- English or Wet Gum Method
- Bottle or Forbes Bottle Method
When are emulsions physically unstable?
- Internal phase upon standing tends to form aggregates of globules
- Large globules rise to top or fall to bottom
- If all or part of the liquid of the internal phase becomes unemulsified and forms layer
Emulsion Examples
- Mineral oil
- Castor oil
- Simethicone
Gel
Semisolid system consisting of dispersions made up of either small inorganic particles or large organic molecules enclosing and interpenetrated by a liquid
Magma
The gel mass consists of small distinct particles and is classified as a two-phase system
Inhibition
Taking up of a certain amount of liquid without measurable increase in volume
Swelling
Taking up of a liquid by a gel with an increase in volume
Syneresis
Interaction between particles of the dispersed phase becomes so great that the medium is squeezed out in droplets and the gel shrinks
Thixotrophy
Reversible gel-sol formation with no change in volume or temperature
Xerogel
Formed when the liquid is removed from a gel and only the framework remains
Types of Gels
- Inorganic
- Organic
- Hydrogels
- Organogels
- Animal/Vegetable Fats
- Soap base
- Hydrophilic Organogels
Aerosols
Pressurized dosage forms containing one or more active ingredients which upon actuation emit a fine dispersion of liquid and/or solid material
Space Sprays
Used to provide airborne mist(room disinfectants)
Surface Sprays
Used to carry the active ingredient to a surface (dermatologic aerosols)
Elixir
Sweetened hydroalcoholic solutions
Spirits
The solvent is alcoholic
Aromatic waters
The solvent is acqueous
Tincture
Solution of chemical substances dissolved in alcohol or in a hydroalcoholic solvent
Solution Absorption
Occurs more rapidly than from suspension or solid dosage forms
Spatulation
Small amounts of powders may be blended by the movement of a spatula through the powders on a sheet of paper
Sifting
Powder is passed through a sifter. Results in a light fluffy product
Tumbling
Powder is enclosed in a rotating container
Internal Medicated Powders
- Taken orally after mixing with water
- Faster rates of dissolution and absorption
- Taste disadvantage
External Medicated Powders
- Dusted on the affected area
- Should have EXTERNAL USE ONLY label
Inhalation Medicated Powders
- Administered with the aid of dry-powder inhaler
- Particle size must be small in order to reach deep into the lungs
Bulk Powders
- Antacid
- Laxative
- Douche
- Antifungals
- Limited to nonpotent substances
Granules
- Smaller particles of powder that are irregularly shaped
- Prepared by wet methods and dry methods
- Flow better than powders
- More stable to effects of humidity
- More easily wetted by liquids
Divided Powders
- After blending a powder it may be divided into individual dosing units
- Headache powders
- Powdered laxatives
- Douche
- We used folding paper method
Topical
Designed to deliver a drug into the skin (skin is target organ)
Intrathecal
Injection into the meninges of the spinal cord
