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Module Five

Routes & Formulations, Aseptic Technique,


Compounding

Table of Contents

1. Routes and Dosage Forms


A. Routes of Administration (p 3)
i. Enteral Routes (p 3)
ii. Parenteral Routes (p 3)
B. Dosage Forms
i. Enteral Forms (p 4)
ii. Parenteral Forms (p 5)
C. Oral Dosage Forms
i. Types of Tablets (p 7)
ii. Sublingual and Buccal Tablets (p 8)
iii. Types of Capsules (p 8)
iv. Size and Volume of Capsules (p 8)
v. Types of Liquid Forms (p 9)
vi. Other Types of Enteral Dosage Forms (p 9)
D. Sample Questions (p 10)
E. Parenteral Forms (p 12)
i. Routes of Parenteral Administration (p 13)
F. Sample Questions (p 16)

2. Aseptic Technique
A. Aseptic Technique Guidelines (p 17)
B. Laminar Flow Hoods (p 19)
C. Equipment Used Inside of A Laminar Flow Hood
i. Large Volume Parenteral Solutions (p 20)
ii. Small Volume Parenteral Solutions (p 21)
iii. Syringes (p 21)
iv. Needles (p 22)
v. Filters (p 23)

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vi. Vials (p 24)
vii. Ampules (p 25)
viii. Cassettes (p 25)
D. Chemotherapy (p 26)
E. Sample Questions (p 27)
F. Other Safety Guidelines and Special Solutions
i. Safety Guidelines (p 29)
ii. Total Parenteral Nutrition Solutions (p 29)
iii. Dialysis Solutions (p 29)
iv. Irrigation and Respiratory Solutions (p 30)
G. Sample Questions (p 31)

3. Compounding
A. Compounding Overview (p 32)
i. USP (p 32)
ii. Guidelines by Professional Compounding
Organizations (p 32)
iii. Facilities and Equipment (p 33)
iv. Packaging and Storage (p 33)
B. Documentation and Record Keeping (p 33)
i. Formulation Record (p 34)
ii. Compounding Record (p 35)
C. Stability (p 36)
D. Sample Questions (p 37)
E. The Four-Step Compounding Process (p 38)
F. Equipment Used in Compounding
i. Class A Balance Scale (p 40)
ii. Guidelines for Using a Class A Balance Scale (p 41)
iii. Electronic Balance Scale (p 41)
iv. Other Equipment Used in Compounding (p 42)
G. Common Terminology Used in Compounding (p 44)
H. Sample Questions (p 47)

4. Answer Key for Sample Questions (p 49)

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1. Routes and Dosage Forms

A. Routes of Administration

A Route of Administration is the way the body absorbs and distributes


drugs throughout our system.

i. Enteral Routes

Enteral refers to administration through the gastrointestinal tract.

When drugs are orally administered, they enter the stomach, which is very
acidic and has a pH around 1-2. The pH scale measures the acidity of a
substance; pH 7 is the neutral midpoint.

The Enteral Routes are:

! Oral by mouth
! Sublingual under the tongue
! Buccal inside of the cheek
! Rectal per rectum

ii. Parenteral Routes

Parenteral Routes refer to administration other than through the


gastrointestinal tract.

The Parenteral Routes are:

! Intraocular eye
! Intranasal nose
! Inhalation lungs
! Intramuscular muscle
! Intravenous venous circulatory
! Intradermal dermal layer of skin
! Dermal on the skin
! Subcutaneous subcutaneous layer of skin

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B. Dosage Forms

A Dosage Form is the type of effect desired when taking a


medication.

A local effect occurs when the activity of the drug is at the site of
administration. A systemic effect occurs when the drug is introduced into
the circulatory system and carried in the bloodstream to the site of activity.

i. Enteral Forms (local effect)

Oral (by mouth)

! Tablets
! Capsules
! Solutions
! Suspensions
! Elixirs
! Syrups
! Bulk powders

Buccal (inside the cheek)

! Tablets
! Solutions

Sublingual (under the tongue)

! Tablets

Rectal (per rectum)

! Ointments
! Solutions
! Suppositories

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ii. Parenteral Forms (systemic effect)

Intraocular (eye)

! Solutions
! Suspensions
! Inserts
! Ointments
! Contact lenses

Intranasal (nose)

! Sprays
! Inhalers
! Powders
! Aerosols
! Solutions
! Suspensions

Inhalation (lungs)

! Powders
! Solutions
! Aerosols

Intravenous, Intramuscular, Intradermal

! Emulsions
! Suspensions
! Solutions

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Dermal (skin)

! Tinctures
! Solutions
! Collodions
! Liniments
! Suspensions
! Ointments
! Creams
! Gels
! Lotions
! Pastes
! Plasters
! Aerosols
! Powders
! Transdermal patches

Subcutaneous

! Implants
! Solutions
! Emulsions
! Suspensions

Vaginal

! Suppositories
! Solutions
! Creams
! Ointments
! Aerosol foams
! Powders
! Tablets
! IUDs

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C. Oral Dosage Forms

Oral dosage forms are the most frequently used route of


administration.

! When oral formulations are administered they will enter the


stomach, which is very acidic.
! Drugs administered in liquid dosage forms generally reach the
circulatory system faster than drugs in solid dosage forms.
! May be swallowed.
! Administration does not require special equipment.
! Does not hurt the patient.
! Less expensive than injectables.
! Have a longer expiration date.

i. Types of Tablets

Enteric Coated covered with a substance to resist the acid in the stomach
and dissolves in the intestinal track. Never Crush

Sugar Coated colored and covers up the taste or odor of the active
ingredient.

Film Coated has a thin layer or film of a water-soluble material.

Extended and Controlled Release provides a very slow release of the


active ingredient over a period of time.

Chewable medication should be chewed before swallowing.

Effervescent contains sodium bicarbonate and an acid along with the


active ingredient. Should be dissolved in water.

Tablets for Solutions use purified water to prepare solutions.

Scored Tablets if a tablet is scored (meaning a line down the center) it


maybe broken in half.

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ii. Sublingual and Buccal Tablets

Sublingual tablets are placed under the tongue. Ex: Nitroglycerin.

Buccal tablets are placed in the mouth, inside of the cheek.

iii. Types of Capsules

Hard Capsules contain powder in a soluble shell of gelatin.

Soft Capsules contain liquid in a soluble shell of gelatin.

Sustained, Extended, Controlled Release or Long Acting Capsules release


the drug so that a longer duration of action is achieved.

iv. Size and Volume of Capsules

It is important to know the sizes and corresponding liquid volumes of a


capsule.

They are as follows, from largest to smallest:

! Largest 000 1.37 ml


00 0.95 ml
0 0.68 ml
1 0.50 ml
2 0.37 ml
3 0.30 ml
4 0.20 ml
! Smallest 5 0.13 ml

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v. Types of Liquid Forms

Solutions contain simple salt water.

Aromatic medicated water containing oil that gives a distinctive odor or


taste of perfume.

Syrups contain large amounts of sugar and flavor.

Elixirs and Tinctures contain alcohol because the drug will not dissolve in
water.

Emulsions are not clear liquids and are made up of two liquids.

Suspension a liquid in which the active ingredient is dispersed but not


dissolved in the liquid.

vi. Other Types of Enteral Dosage Forms

Suppositories are solid dosage forms. They dissolve in body fluid releasing
the active ingredient. With different shapes and weights they are used in the
vagina, urethra, or rectum. Some must be kept refrigerated.

Ointments are used on the local area that is infected or inflamed. A common
rectal ointment is used for hemorrhoids.

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D. Sample Questions

1. What injection is given under the first layer of skin?


a. Intravenous
b. Intramuscular
c. Intradermal
d. Subcutaneous

2. A systemic effect occurs when a drug is introduced into what system?


a. Eyes and ears
b. Circulatory
c. Buccal
d. Skin

3. What is a route of administration?


a. The way drugs are absorbed and distributed throughout the body.
b. The tract from the mouth to the rectum.
c. Oral medication is used only.
d. None of the above.

4. What route is used to inject insulin and heparin into the body?
a. Intradermal
b. Intravenous
c. Intramuscular
d. Subcutaneous

5. Ophthalmic is related to what body part?


a. Ear
b. Eye
c. Nose
d. Mouth

6. What is the smallest size capsule?


a. 1
b. 5
c. 13
d. 000

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7. What formulation can not be totally dissolved in a liquid?
a. Solution
b. Elixir
c. Syrup
d. Suspension

8. What medication is administered sublingually?


a. Insulin
b. Nitroglycerin
c. Tylenol
d. Advil

9. What contains a powder in a soluble gelatin shell?


a. Tablet
b. Capsule
c. Bulk powder
d. Chewable tablet

10. Why are some tablets scored in the center?


a. Should not be broken in half.
b. For coding of the tablet by the manufacturer.
c. May be broken in half.
d. None of the above.

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E. Parenteral Forms

Parenteral drugs are used when a rapid drug response is needed in


emergency situations; or if the patient is unconscious, uncooperative,
or unable to take medication by enteral routes.

! Disadvantages of giving a parenteral drug are: cost, the requirement


that a skilled person administer the drug, discomfort to the patient,
and difficulty removing the dose given if the patient has a negative
reaction to the drug.

! All parenteral solutions must be pyretic (meaning sterile), and


pyrogen-free (free of microorganisms that can cause a fever).

! Intravenous solutions should have a physiological pH of about 7.4.

! The solution must be stable for its intended use according to the
package insert.

! All intravenous solutions formulated should have an osmotic pressure


similar to that of blood. This is called isotonic.

o A solution with greater osmolarity than blood is called


hypertonic.
o A solution with lesser osmolarity than blood is called
hypotonic.

! All solutions should be prepared using aseptic technique.

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i. Routes of Parenteral Administration

! Intraocular medications include eye drops with solutions or


suspensions, eye ointments, and eye inserts. The main problem with
eye medications is the loss of a dose because of spillage when
administering. All eye drops and ointments should be placed inside of
the lower eye lid. One factor to remember is that a container of eye-
drops holds 5 ml, 10 ml, or 15 ml, and ointment tubes hold
approximately 3.5 grams. They are put in small containers to help
prevent the tip of the container being contaminated so an infection is
not developed. Eye inserts are used for dry eyes.

! Intranasal formulations include solutions, sprays, suspension, inhalers,


and aerosols. Nasal inhalers should be administered by removing the
cap from the drug, holding one side of your nose closed, closing your
mouth, inserting the tip into the open nostril, and inhaling while
squeezing or spraying the medication into the nostril. Patients should
be advised not to exceed the recommended dose and frequency.

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! Inhalation medications are delivered to the lungs. Most inhalation
drugs are in the form of an aerosol powered by a compressed gas that
expels the drug from the container. Metered dose inhalers deliver a
fixed dose when the container is activated.

! Intradermal medications are for small volume injections into the top
layer of skin. These are administered in the center part of the forearm,
the upper chest, and back areas. They are primarily used for
tuberculosis testing and skin tests for allergies. A 3/8 inch, 27-28
gauge needle is used with no more than 0.1 ml of solution.

! Subcutaneous injections are administered below the skin and the layer
of fatty tissue. Injection sites are the lower abdomen, front of the
thigh, back of the upper arm, and upper back. These are primarily
used for heparin and insulin injections. A 3/8 to 1 inch, 24-27 gauge
needle is used with no more than 2 mls of solution.

! Intramuscular injections are administered into the muscle tissue under


the subcutaneous layer of skin. These are given when there is a need
for the medication to be rapidly absorbed into the body. These
injections can be uncomfortable and painful. Injection sites are the
gluteus (buttocks), deltoid (upper arm), and vastus lateralis (thigh)
muscles. A 1 to 1 inch, 19-23 gauge needle is used with 2-5 mls of
solution. Generally 5 mls is administered only in the gluteus.

! Intravenous injections are administered directly into a vein where they


travel in the blood stream throughout the body. The solution takes
about 20 seconds to circulate throughout the body. These are used in
pre-operative surgery, emergencies, total parenteral nutrition (TPN),
or when fluids are needed for an individual patient. The injection sites
are usually the metacarpal (back of hand), dorsal (foot), and
antecubital (in front of the elbow). A variety of types of needles can
be used. The most common being a butterfly set or an infusion set.

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! Dermal dosage forms are applied to the skin to deliver a medication
that is absorbed into the layers of skin. Formulations are ointments,
creams, gels, solutions, transdermal patches, tinctures, lotions,
liniments, pastes, aerosols, collodions, and powders.

! Vaginal dosage forms are creams, ointments, solutions, aerosol foams,


suppositories, tablets, and intrauterine devices.

! Powders have an active ingredient in them used to help absorb


moisture from the skin.

! Plasters contain active ingredients and are attached to the skin with a
dressing.

! Pastes are similar to ointments with an active ingredient.

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F. Sample Questions

1. What is the word used to describe free of microorganisms?


a. Sterile
b. Pyrogen-free
c. Fever
d. Particulate material

2. Why are eye drops and ointments put in a small container with no more
than 15 mls or 3.5 grams?
a. To prevent spillage loss.
b. Easier to administer.
c. To prevent infection.
d. Only should be used for 1 week.

3. What size gauge needles are used for subcutaneous injections?


a. 19-23
b. 16-19
c. 28
d. 24-27

4. What is the largest amount of drug that can be given in an intradermal


injection?
a. 0.5 ml
b. 0.1 ml
c. 1 ml
d. 0.2 ml

5. What route of administration is given in the vein?


a. Intradermal
b. Intramuscular
c. Subcutaneous
d. Intravenous

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2. Aseptic Technique
Aseptic technique is the method that maintains the sterile condition of
products.

Contamination can be from microorganisms or particulate material.


Working in a laminar hood does not guarantee sterility. Following the
guidelines will minimize contamination.

Microorganisms

A. Aseptic Technique Guidelines

! The Occupational Health and Safety Administration (OSHA) is the


federal agency that is responsible for workplace safety and
enforcement rules. This administrations primary concern is the
protection of employees from biological and chemical hazards.

! The health care employee has the responsibility to abide by the


employers safety policies and procedures set in the pharmacy.

! Always use a sterile technique during the preparation of drugs.

! Limit the air flow in the clean room by closing doors and windows.

! Maintain a direct path between the filter and the area inside the hood.

! HEPA filters must be replaced every 3 to 5 years and inspected


annually.

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A. Aseptic Technique Guidelines (cont.)

! The laminar hoods should be turned on 30 minutes before use.

! Clean the hood with 70% isopropyl alcohol. First clean the metal rod
used to handle containers of fluids. Then clean the back of the hood
using a side-to-side motion from the top to the bottom, following the
same motion for the sides. For the surface of the hood, start at the
back left corner and work your way towards the front of the hood
using a side-to-side motion. Cleaning the hood should be performed
throughout the day after hazardous medications are prepared, and
again at the end of the day.

! Hand washing is important before you start the preparation. Remove


all jewelry and scrub hands vigorously with an antibacterial soap.

! Protective clothing should be clean and should include a lint-free


barrier gown opening in the back, a mask, and gloves.

! Never cough, sneeze or talk directly into the hood.

! Check all drugs expiration dates before preparation.

! Place equipment and supplies at least 6 inches inside of the hoods


surface for the preparation of drugs.

! Prevent shadowing of equipment. Downstream all products and


supplies. Do not put large items to the back of the hood and smaller
ones in the front. This will interrupt the air flow.

! Swab all surfaces of vials or solutions that require entry with an


alcohol swab.

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B. Laminar Flow Hoods

Laminar Flow Hoods are systems of continuous, filtered air


movement, at a uniform rate, in one direction.

Laminar Flow Hood systems reduce the risk of airborne contamination and
exposure to chemical pollutants. Laminar hoods do not provide a sterile
environment but an ultra clean work area. There are 2 types of laminar
hoods: horizontal and vertical.

! Horizontal Laminar Flow Hoods blow air toward the operator and are
used to keep drugs sterile as they are prepared by the operator. The
air is drawn into the hood and is passed through a prefilter to remove
particles such as dust and lint. The air then passes through a HEPA
filter that removes particles larger than 0.3 microns. This prevents
room air from entering the work area. The surface is clean but not
sterile. This is why aseptic techniques are required during the
preparation of drugs. Such drugs as antibiotics, eye drops, heparin,
and insulin are just a few preparations performed under a horizontal
hood.

! Vertical Laminar Flow Hoods or biological safety hoods protect


both the operator and the environment from contamination. The air is
passed through a HEPA filter and directed down toward the work area
and is pulled through vents at the front, back, and sides of the hood.
The air is then circulated back into the cabinet and passed through a
second HEPA filter before being exhausted into the room. Such drugs
as chemotherapy and live viruses are prepared under a vertical or
biological safety hood.

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C. Equipment Used Inside of A Laminar Flow Hood

i. Large Volume Parenteral Solutions (LVP)

LVPs are intravenous solutions packaged in containers holding 100


milliliters or more.

! An administration set is used to deliver fluids and medication to the


patient.

! Common LVP solutions are sodium chloride, dextrose, ringer, and


lactated ringer.

! Infusion is the slow continuous introduction of a solution into the


blood stream.

! Piggybacks are small volume solutions used to connect with large


volume solutions over a period of 30-60 minutes.

! Flow rates are set in ml/hour or ml/minute in which the solution is


administered to the patient.

! A Heparin lock is an injection device used when an LVP solution is


not needed to deliver a small volume medication.

! LVPs may be dispensed in a glass container or a plastic bag. This


depends on the interaction of the medication.

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ii. Small Volume Parenteral Solutions (SVP)

SVPs are intravenous solutions packaged in containers holding 100


milliliters or less.

! Supplied in prefilled syringes, vials, ampules, and glass or plastic


minibags. Some manufactures also have ready-to-mix systems. For
example: Add-Vantage, Add-A-Vial, and Mini-Bag Plus.

! Vials may be for single dose (no preservative) or multidose


(preservation) use.

! Vials may contain either liquid or powder.

! Syringes are used to add medication to SVP and to LVP.

iii. Syringes

! Basic parts of a syringe are the tip, barrel, and plunger.

The Tip is where the needle fits onto the syringe.


The Barrel is a tube that is open at one end with the tip at the
other end.
The Plunger is a piston-type rod that passes inside of the barrel.

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! Never touch the tip or the plunger of a syringe.

! Syringes range in size from 0.5 ml to 60 mls.

! Two types of syringes are the slip-lock and the luer-lock.

The slip-lock syringe holds the needle on by friction.


The luer-lock syringe holds the needle on by grooves that lock
the needle in place. Always use this type of syringe when
preparing chemotherapy.

! The volume of the solution in a syringe can be measured when the


syringe is held upright and all of the air has been removed. Measure
to the edge of the plungers stopper by the correct graduation mark.

! Liquids are drawn up into the syringe by pulling back on the plunger
to the desired mls.

! Plastic disposable syringes are generally used. However, some


medications require glass syringes.

iv. Needles

! Needles have three parts: the hub, the bevel, and the shaft.

The Hub attaches to the syringe.


The Bevel is the point at the end of the needle.
The Shaft is the long, slender stem of the needle and the
hollow bore of the shaft is called the lumen.

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! Needles have different sizes according to length and gauge.

The length can range from 3/8 inch to 3 inches.


The gauge ranges from 27 (smallest) to 13 (largest).

! Plastic disposable needles are used in the preparation of drugs.

v. Filters

Filters are used to remove particles or microorganisms from


solutions.

! The three filters used in preparation and dispensing of drugs are:

# Membrane filters filters a solution expelled from a syringe


and is a 0.22 micron filter. Membrane filters are used to filter
and sterilize compounded eye drops.

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# Depth filter is attached to a syringe and filter any particles of
2 mls or less. This filter is used in a 5 micron needle.

# Final filter used prior to starting an IV into a patients vein.

vi. Vials

There are two types of vials used in making admixtures. One contains a
ready-to-use solution and the other contains a powder for reconstitution with
a diluent.

! Coring is when the needle damages the rubber stopper of a vial,


causing fragments of the closure to fall into the container and
contaminate its contents.

! All vials have a rubber stopper. When a needle is inserted into the
vial, the needle needs to enter at a 45 degree angle with the beveled
edge of the needle facing up. Put downward pressure on the needle
while gradually bringing the needle up to a 90 degree angle. This will
prevent coring.

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! Vials either contain a liquid or a powder for reconstitution.

! Lyophilized powders are freeze-dried.

vii. Ampules

Ampules are sealed glass containers with an elongated neck that is


snapped off using an alcohol swab, pointing away from the operator.

! Always use a 5 micron needle when removing the medication from


the ampule. This is so that any glass that may have broken when
snapping off the neck will not get into the medication for
administration to the patient.

viii. Cassettes

Cassettes are plastic containers to fill with a solution holding 50 mls


or 100 mls.

! Cassettes are used mainly for chemotherapy drugs being administered


to a patient with a special connection to deliver the drug over a period
of days.

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D. Chemotherapy

Chemotherapy is for the treatment of cancer.

Special guidelines for chemotherapy and live viruses are needed when
preparing this type of drug.

! Always use a Vertical or Biological safety hood when preparing


chemotherapy or live viruses.

! Always use a luer-lock syringe when preparing chemotherapy.

! Special apparel is needed when preparing hazardous drugs.

! Wear clean, lint-free garments including a chemotherapy protective


gown opened in the back, a hair cover, gloves, and a mask.

! Follow the manufacturers guidelines for putting on and removing the


protective clothing.

! Apparel can be easily contaminated during the preparation of


chemotherapy and live viruses.

! All equipment and clothing needs to be disposed of in a biological


safety container for pick up by an incinerator company.

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E. Sample Questions

1. What type of laminar flow hood is used for Chemotherapy?


a. Biological
b. Horizontal
c. Vertical
d. a & c

2. How many inches into a laminar flow hood should you work?
a. 8
b. 2
c. 6
d. 12

3. What is needle damage to a vials rubber stopper called?


a. Unsafe
b. Filtering
c. Technique
d. Coring

4. What is aseptic technique?


a. Maintains sterile conditions.
b. To make drug solutions sterile.
c. Prevents the chemical from being hazardous.
d. All of the above.

5. If a laminar hood is turned off, how many minutes should it be turned


back on before use?
a. 10
b. 20
c. 30
d. 60

6. What are the two parts of a syringe you should never touch?
a. Tip and barrel.
b. Collar and barrel.
c. Tip and plunger.
d. Collar and plunger.

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7. Horizontal laminar hoods are used to prepare what type of medication?
a. Chemotherapy
b. Live viruses
c. Hazardous drugs
d. Insulin

8. In what size micron needle is a depth filter used to filter particles of


2 milliliters or less?
a. 2
b. 5
c. 0.22
d. 1

9. What does lyophilized mean?


a. Freeze-dried
b. Crystallized
c. Powder
d. Dilute

10. LVPs are intravenous solutions packaged in containers holding_____?


a. 100 mls or less.
b. 100 mls or more.
c. 500 mls or less.
d. 500 mls or more.

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F. Other Safety Guidelines and Special Solutions

i. Safety Guidelines

! Sharps containers are used for needles and syringes so that no one is
punctured or cut by anyone who handles them for disposal.

! Never recap a needle before disposal.

! A Spill Kit is the most important item to have readily available in


the pharmacy for use when staff is handling hazardous chemicals.
This is used to clean up spills such as chemotherapy drugs.

! The Occupational, Safety, Health Administration (OSHA) requires


pharmacies to have Material Safety Data Sheet (MSDS) on each
hazardous chemical used their pharmacy. This drug information
needs to be kept in a notebook in the pharmacy for use when
hazardous problems arise, such as exposure to hazardous chemicals.

ii. Total Parenteral Nutrition Solutions (TPN)

! TPNs are for patients who are unable to take in adequate nutrients
through their digestive tract.

! The additives used in TPN are dextrose, protein, fat, vitamins,


electrolytes, and trace elements.

iii. Dialysis Solutions

These solutions are used for patients with kidney failure, and for the removal
of toxic substances, excess body waste, and serum electrolytes from the
kidneys.

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iv. Irrigation and Respiratory Solutions

Irrigation solutions are used to wash instruments, moisten dressings,


moisten body tissues, and to remove blood to maintain a clear field of
vision.

! When medications are repackaged into syringes for use in respiratory


devices, the syringe must not be able to accept a needle.

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G. Sample Questions

1. What type of medication is put in a syringe that cant attach to a needle?


a. Antibiotic
b. Heart
c. Respiratory
d. Pain

2. What does TPN stand for?


a. Total parenteral nutrition.
b. Total parenteral neutrons.
c. Total parenteral necrosis.
d. None of the above.

3. When can a spill kit be used?


a. When a drug is spilt spilled on the floor.
b. When a drug has been accidentally injected into the operator.
c. When a hazardous drug has been spilt.
d. None of the above.

4. Who requires all pharmacies that carry hazardous chemicals to have


Material Safety Data Sheets (MSDS) maintained on each chemical?
a. Policy and procedure manual
b. OBRA
c. OSHA
d. HCFA

5. What are some of the additives in TPN?


a. Fat
b. Protein
c. Electrolytes
d. All of the above

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3. Compounding

Compounding is the preparation, mixing, assembling, packaging, or


labeling of a drug for dispensing from a practitioners prescription
drug order.

A. Compounding Overview

Extemporaneous compounding is the on-demand preparation of a


drug in a pharmacy by a pharmacist or pharmacy technician.

The ingredients for compounding should come from a registered drug


manufacturer with reference to the United States Pharmacopeias (USP) /
Non- Formulary (NF) grade drug substance.

i. USP

! Gives product monographs, standards, tests, quality control,


development, documentation, and preparation guidelines.

ii. Guidelines by Professional Compounding Organizations

! National Association of Boards of Pharmacy (NABP) establishes


good compounding practices and rules for sterile pharmaceuticals.

Good Compounding Practice Applicable to State Licensed


Pharmacies.
# Model Rules for Sterile Pharmaceuticals.

! American Society of Health-System Pharmacist (ASHP) produces a


technical assistance bulletin on compounding non-sterile products and
quality assurance for preparing sterile products in the pharmacies.

Technical Assistance Bulletin on Compounding Non-sterile


Products in Pharmacies.
Quality Assurance for Pharmacy-Prepared Sterile Products.

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iii. Facilities and Equipment

! The compounding area must be a designated area away from routine


dispensing and counseling functions and high traffic areas.

! Compounding equipment should be kept only in the compounding


area.

iv. Packaging and Storage

! Compounding formulations should be packaged in containers that


meet USP24 / NF19 standards.

! Materials used in compounding should be stored according to the


manufacturers labeling or USP / NF requirements.

B. Documentation and Record Keeping

! Personnel training and evaluation.

! Storage and handling of supplies.

! Prescription process.

! Compounding of sterile and non-sterile products.

! Quality control.

! Labeling.

! Clean room and laminar hood maintenance.

! Calibration and maintenance of equipment.

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i. Formulation Record

A formulation record contains the recipe of the formula and the


procedure used when a formulation is compounded.

The formulation record contains the ingredients, calculations, method of


preparation, description of product, quality control, storage requirements,
expiration date, label information, and any literature information.

This information is completed at the time of compounding:

! Calculations performed at the time of compounding.


! Equipment performance notes or alternative equipment used.
! Method of Preparation: Description of the formulation method of
preparation.
! Description of finished product.
! Ingredient records such as Material Safety Data Sheets (MSDS)
completed when applicable.
! The Beyond-Use Date: How long is the product stable.
! Quality Control Procedures: Detail of quality assurance test results
and data.
! Pharmacist has the last check on all compounding before dispensing.

Reference Materials:

! Product availability.
! Compounding technique.
! Pharmaceutical calculations.
! Drug stability and compatibility.

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ii. Compounding Record

Compounding records are kept on each product being compounded


in the pharmacy. It will give the name, strength, dosage, route,
quantity, date, and person preparing and checking the completed
compound.

The Compounding Record documents what actually happened when


the formulation was compounded.

Name:_________________________________________________
Strength:_______________________________________________
Dosage Form:___________________________________________
Route of Administration:__________________________________
Quantity Prepared:_______________________________________
Date of Preparation:______________________________________
Person Preparing Formulation:______________________________
Person Checking Formulation:______________________________

All records should be kept on file in the pharmacy according to the


requirements of the State Board of Pharmacy.

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C. Stability

Stability in compounding is the extent to which a dosage form retains


its effect with the same properties and characteristics that it
possessed at the time of the original compounding of the drug.

! The chemical and physical to retain their original properties and


integrity to withstand microbiological contamination.

! To maintain the therapeutic effect.

! To have no significant increase in toxicity.

Failure to retain levels of physical, chemical, and microbiological stability is


the most common cause of product instabilities.

Example of instabilities are:

! A drug precipitates out of the solution.

! A drug is absorbed into the container wall.

! Dispensing an old stock of ingredients.

! Storing products under the wrong conditions.

! The break-down of ingredients, crystallization, or shrinking due to the


evaporation of water.

Professional Compounding Organizations:

! National Association of Boards of Pharmacy (NABP)


! American Society of Health-Systems Pharmacists (ASHP)

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D. Sample Questions

1. What is Extemporaneous Compounding?


a. A medication prepared in advance of a written prescription.
b. The on-demand preparation of a drug.
c. A special order prepared by a manufacturer.
d. A prepared over-the-counter drug.

2. What does the USP / NF define?


a. Documentation
b. Monographs
c. Testing
d. All of the above

3. What organization oversees good compounding practices applicable to


state licensed pharmacies?
a. NABP
b. ASHP
c. FDA
d. DEA

4. Compounded formulations should be packaged in containers to meet


what standards?
a. State Board of Pharmacy
b. HPLC
c. FCC
d. USP24/NF19

5. Why is stability in compounding drugs important?


a. To prevent microbiological contamination.
b. To maintain the therapeutic effect.
c. To prevent any toxicity.
d. All of the above.

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E. The Four-Step Compounding Process

Preparing compounds is a lot like carefully following the directions in a


recipe. Can you follow a recipe for cooking? If yes, you will be able to
perform compounding.

Each compounding prescription order is prepared with a four-step process


using the equipment specified for each step:

1) Measure using:

$ Balance scale, weights, graduates, pipettes, syringes,


flasks, and weighting containers.

2) Mix using:

$ Beakers, Erlenmeyer flasks, funnels, spatulas, mortar and


pestles.

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E. The Four-Step Compounding Process (cont.)

3) Mold using:

$ Hot plates, capsule shells, ointment slabs, and


suppository molds.

4) Package using:

$ Prescription vials, bottles, suppository boxes, and


ointment jars.

F. Equipment Used in Compounding

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i. Class A Balance Scale

A Class A Balance Scale is a two-pan torsion type scale which uses


internal and external weights.

! Weights: Weights should be handled with forceps to prevent


erosion and soiling of the weights. The weights are always put on
the right pan and the ingredient is put on the left pan of the scale.

! Degree of Error: An acceptable degree of error is 5% of 120 mg


and over.

! Aliquot: Less than 120 mg is when a precise amount of the drug is


mixed with an inert (inactive) powder. This fraction of the mixed
powders is called an aliquot.

! Sensitivity: A Class A Balance scale has sensitivity up to 6 mg


and a capacity of 120 mg to 60 grams.

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ii. Guidelines for Using Class A Balance Scales

$ Always use the balance scale in a draft-free area, on a level surface.

$ Always level the scale from front to back and side to side before
weighing an ingredient.

$ Always cover both pans with weighting papers, boats, or foil.

$ Always use clean papers, boats, and foil for each new ingredient.

$ The balance arrest knob should be readjusted after a new weighting


paper, boat, or foil has been placed on the pans.

$ Use a spatula to add or remove ingredients from the balance scale. Do


not pour ingredients directly out of their bottle onto the scale.

$ Always clean the balance scale after each use.

iii. Electronic Balance Scales

Electronic Balance Scales have digital displays. Always follow the


same type of care listed above for the Class A Balance Scale.

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iv. Other Equipment Used in Compounding

Small Volumetric Equipment

Used either to deliver (TD) or to contain (TC).

# Graduated Cylinders (Graduates)


# Volumetric Flasks
# Syringes
# Pipettes (Calibrated and Single Volume)

Liquid Measurements When using this measurement always use the


smallest equipment to accommodate the volume needed.

# Droppers
# Graduated Cylinders
# Small volume calibrated Pipettes
# Syringes
# Oral syringes

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Solids and Semisolids are mixed together using Geometric Dilution
technique. Geometric Dilution is used when mixing two ingredients of
unequal quantity to reduce the particle size. Equipment used in Geometric
Dilution are:

# Mortar & pestle used to grind powders to reduce the particle


size. This method is called trituration.

# Ointment slabs using a levigation technique reduces the particle


size of a powder by triturating it with a solvent in which the
drug is insoluble. A spatula is used in this technique.

# Hot plates are used to mix solids by melting them together in a


beaker on a hot plate.

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G. Common Terminology Used in Compounding

Sonication the exposure to high frequency sound waves used to heat


solutions, syrups, elixirs, glycerates, tinctures, spirits, collodions, and
oleaginous solutions.

Levigation used when mixing a powder with a cream, ointment,


suspension or suppository base.

Triturate the process of grinding a particle to a smaller size.

Meniscus is the surface of the liquid curve downward toward the center of
the graduate. This is where you read the correct measurement.

Suspension consists of a finely divided solid dispersed in a liquid.

Flocculating used in the preparation of a suspension to form particles for


easy redispersement.

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Thickening used in the preparation of a suspension to increase viscosity of
the liquid.

Miscible capable of being mixed together with ointments and creams.

Immiscible cannot be mixed and is called an emulsion.

Emulsifier a stabilizing agent used in emulsions.

Suppositories bases have three classes:

Oleaginous (theobroma oil, cocoa butter);


Miscible / Water soluble (glycerin gelatin or
polyethylene glycol polymers, PEG);
Hydrophilic (oleaginous and water miscible).

Capsules can be prepared with a capsule filling machine with at least 100
capsules at one time. When preparing less volume, use the Punch Method.

Punch Method First the ingredient is triturated to the smallest particle


size and then mixed by geometric dilution. The powder is placed on an
ointment slab and smoothed with a spatula half the height of the capsule.
The top of the capsule is the smallest part. Use the bottom of the capsule
and start punching it into the powder. Each capsule filled is weighed using
an empty capsule as a counterweight. The weight of the filled capsule must
be the correct volume. Use a disposable glove or finger cot during the punch
method. Once the capsule is complete you may spray 70% alcohol on a
towel and wipe the outside of the capsules off for appearance.

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Capsules Final Product:

46
H. Sample Questions

1. A Class A Balance scale has a sensitivity requirement of up to how many


milligrams?
a. 5
b. 6
c. 10
d. 12

2. An intravenous solution that is formulated to have an osmolarity similar


to that of blood is called?
a. Hypotonic
b. Hypertonic
c. Isotonic
d. Sensitivity

3. What protects the balance pans before weighing an ingredient?


a. Boats
b. Weighing papers
c. Foil
d. All of the above

4. What is the largest size syringe?


a. 50 ml
b. 60 ml
c. 65 ml
d. 70 ml

5. The application of sound waves using sonic mixing equipment is called?


a. Sonication
b. Supersaturation
c. Saturation
d. Levigation

6. What is the smallest size capsule?


a. 000
b. 0
c. 1
d. 5

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7. When a liquid is poured into a graduate, the surface curves downward
toward the center. This is called?
a. Viewing the level
b. Desired volume
c. Meniscus
d. Calibrated

8. What is the technique used to reduce the particle size of two powdered
drugs of unequal quantity?
a. Aliquot
b. Levigation
c. Mixing
d. Geometric Dilution

9. What is being compounded when you use the punch method?


a. Tablet
b. Capsule
c. Suppository
d. Ointment

10. What is used in the preparation of suspensions to form particles that can
easily be redispersed?
a. Thickening
b. Flocculating
c. Syrup
d. Oleaginous

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4. Answer Key for Sample Questions

1. D. 1. F. 2. E. 2. G. 3. D. 3. H.

1. c 1. b 1. d 1. c 1. b 1. b
2. b 2. c 2. c 2. a 2. d 2. c
3. a 3. d 3. d 3. c 3. a 3. d
4. d 4. b 4. a 4. c 4. d 4. b
5. b 5. d 5. c 5. d 5. d 5. a
6. b 6. c 6. d
7. d 7. d 7. c
8. b 8. b 8. d
9. b 9. a 9. b
10. c 10.b 10.b

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