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Compounding Prescriptions

NAPLEX often includes compounding questions. You m ay be required to select a m ethod of preparation
for IV additives, topical preparations, oral solid dosage form s and preparation of oral liquids from drugs
obtained from capsules or tablets. For the Georgia Laboratory Practical, you will be required to compound
two prescriptions. Usually, one will be an IV preparation (piggyback or large volume IV drip) and the
other will be an extemporaneous topical or oral preparation. You are not allowed to use a calculator
during the Georgia Practical Examination but NAPLEX will provide a lim ited function calculator as part
of the computer based test.

These are generally considered to be EXACT equivalents when doing calculations.

1 grain 64.8 m illigram s (m g)


1 avoirdupois pound 453.6 gram s (g or gm )
1 avoirdupois ounce of weight 28.35 gram s (g or gm )
1 apothecary ounce of weight 31.1 gram s (g or gm )
1 fluid ounce 29.6 m illiliters (m l)
1 gram (g or gm ) 15.4 grains (som etim es gr)
1 gram of carbohydrate 3.4 calories (3.46 is exact)

You can do calculations using 65 m g = 1 grain, 454 grams = one pound, 1 fluid ounce = 30 m l, etc as
long as you realize your answer will be a little different from the answers given on a m ultiple choice list.
If the choice list has sufficient separation between answers, this will not be a problem. You might look
at the answer list first to be sure. The Georgia Board of Pharm acy often allows the use of approximate
equivalents during the laboratory com pounding exam ination. Specific instructions on this m atter are
given at the time of the com pounding exam ination.

Traditionally, calculations have been set up to com e out fairly even. That is, your answer will be a whole
num ber even if decim als are involved. For example, you may get 125, 1.25, 12.5 or even 0.125 for an
answer. You are not likely to com e out with 12.547 or any of its various form s.

A very handy tip for percentage calculations involves converting percentage to mg per m l or gram. Take
the percent value (e.g., 1% ), and m ove the decim al point one place to the right (e.g., 10). Thus, a one
percent solution contains 10 m g per m l or an ointment is 10 mg per gram . [Proof: a 1% solution is 1
gram (1000 mg) in 100 m l. 1000 m g divided by 100 m l is 10 mg per ml.] In the sam e manner,
concentrations can be converted to percent solutions by m oving the decim al to the left. Thus, a solution
with 25 mg per ml would be a 2.5% solution.

Some drug concentrations are expressed as ratios; e.g., 1:5000. This means 1 gram in 5000 m l. This can
be converted to 1000 m g in 5000 m l and, by dropping the zeroes, this becom es 1 m g in 5 m l. M aking
such a conversion can often m ake further calculations m uch easier than working in the ratio form. You
can also m ake a general rule for converting ratios by recognizing that m oving the decim al point behind
the zeroes three places to the left m akes the ratio of 1:5000 become 1:5 and that can then be expressed
as 1 m g in 5 m l. Thus, 1:2500 becom es l mg in 2.5 m l and also 1:100,000 becom es 1 m g in 100 ml.

Isotonicity. Some solutions, especially eye drops, m ust be m ade isotonic, generally by the addition of
sodium chloride to a drug solution. One liter of IV fluid is isotonic when it contains 154 m Eq of sodium
chloride (MW = 58.5). Thus, one liter of norm al saline is 0.9% NaCl and has 9 gm or 154 m Eq of NaCl
in 1000 ml). A solution will be isotonic if it contains 154 m Eq from virtually any source of electrolytes.
More correctly, a solution is isotonic if it contains 308 m Osm oles from all ingredients in the solution.

In the case of ophthalm ic solutions, it is com m on to add sodium chloride or boric acid to a solution to
m ake it isotonic (boric acid provides som e efficacy against bacteria). In this case, one uses the E value
of a drug to determ ine a NaCl equivalent.

Dissociation constants are som etim es used to calculate the am ount of m aterial needed to make a
solution isotonic. The general rule for dissociation constants is shown below.

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Calculating the E value for a drug can be done with the
Dissociation Constants for M edicinal Salts dissociation constants as shown. This exam ple uses
Non-Electrolytes (no dissociation) 1.0 NaCl (m olecular weight 58.5; 2 ions form ed, Na + Cl, so
Substances that form two ions 1.8
dissociation constant is 1.8) and atropine sulfate (MW
Substances that form three ions 2.6
is 695; 3 ions form ed, 2 atropines plus one sulfate, so
Substances that form four ions 3.4
dissociation constant is 2.6).
Substances that form five ions 4.2

X gm NaCl = MW NaCl 58.5 (x) 2.6 = 152.1 NaCl (x) 1 gm atropine = 0.12 gm NaCl
1 gm of atropine MW atropine 695 (x) 1.8 1251 atropine

Thus, 1 gram of atropine sulfate is equal to 0.12 grams of NaCl in making an isotonic solution. This
m eans the E-value for atropine sulfate is 0.12.

Rule: All sodium chloride equivalents are 1.0 or less (NaCl = 1.0). You will always need m ore of the other
drug to make som ething isotonic than you would if you were using only NaCl. E.g., to m ake 30 ml
isotonic requires 270 mg of NaCl or 520 mg of boric acid (E value = 0.52).

Using the E Value. Prepare 30 ml of 2.5% Cocaine HCl Solution for


NaCl Equivalents (E Values) use as an eye drop. Add enough NaCl to make the solution isotonic.
Atropine Sulfate 0.12
Boric Acid 0.52 2.5% = 25 m g of cocaine HCl per m l (x) 30 m l = 750 m g of cocaine HCl
Cocaine HCl 0.16 needed for the prescription.
Ephedrine Sulfate 0.23
Silver Nitrate 0.33 750 m g (x) 0.16 (E value of cocaine HCl) = 120 m g (thus, 750 m g of
Tobramycin 0.07 cocaine HCl is equivalent to 120 m g of sodium chloride).

An isotonic solution is 0.9% NaCl or 9 mg of NaCl per ml (x) 30 m l =


270 m g of NaCl needed to prepare 30 ml of an isotonic solution.

270 mg NaCl (m inus) 120 mg cocaine HCl sodium chloride Equivalent (equals) 150 mg of NaCl to be
added to the 750 m g cocaine HCl to make the solution of 2.5% cocaine HCl isotonic.

The final product could be prepared by weighing out 750 mg of cocaine HCl, using 16.7 ml of Normal
Saline to provide the 150 m g of NaCl and then adding enough water to make 30 m l. The final solution
would be passed through a 0.22 micron filter to sterilize the solution.

Making Oral Liquids

The best source of the drug for an oral liquid would be the drug in pure powdered form . If that is not
possible, then other sources can be used. If you are using the pure powdered form of a drug, then it is
only necessary to correctly weigh out the quantity desired and m ake sure it is finely powdered or is in
the form of water soluble crystals.

An injection can be used as the drug source if the drug is given orally as a tablet or capsule. For exam ple,
neither insulin or heparin could be used to make an oral liquid since neither drug can be given orally.
Cardizem Injection could be used to m ake an oral liquid since Cardizem does com e in an oral form.
Stability of the injection and taste of the final product m ay lim it the practical application of using
injections to prepare liquids. Some injections com e in much lower doses than their oral equivalents (due
to bioavailability differences). This m ay m ean that the num ber of am pules or vials required is so large
as to m ake this choice financially unacceptable.

Tablets and capsules can be used as drug sources to prepare an oral liquid. Remember, however, that
rarely will a tablet or capsule be com posed of pure drug. Fillers are alm ost always involved so that the
weight of drug will need to be adjusted for the weight of the fillers. For exam ple, the powder em ptied from

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a 250 m g tetracycline capsule will usually weigh 285 m g; an aspirin tablet of 325 m g will actually weigh
360 m g. You cannot ignore the weight contribution of fillers.

Generally, capsules are filled with the drug in a finely powdered form and no grinding to reduce particle
size is required. For tablets, however, it is necessary to crush a tablet and grind it in a m ortar and pestle
to reduce the particle size to as fine a powder as practical. The finer the powder form , the better liquid
product one can produce. A powder, from any source, can always be levigated with glycerin to form a
sm ooth paste to be used in making an oral liquid preparation.

Preservatives. In order to preserve extemporaneously prepared oral liquids against microbial


contam ination, one com m only adds preservatives. Preservatives provide protection against microbial
contam ination but do not extend the shelf life (stability) of a product. Preservatives can be found in many
form s, including sucrose and ethyl alcohol (ethanol). If you use 85 gram s of sucrose and enough water
to make 100 m l, then the resulting solution (85% ) is an effective preservative. This is the concentration
of sim ple syrup. Ethyl alcohol, at a concentration of 18% , will also act as a preservative. You can
combine both sucrose and ethanol to preserve a product. For exam ple, one could use 90 ml of simple
syrup, 6 m l of 95% ethanol and 24 ml of water to prepare 120 m l of a fully preserved liquid.

Preservatives used in oral liquids are listed below. You can combine mixtures of parabens to achieve a
m ixed concentration of 0.2% ; e.g. 0.15% m ethylparaben and 0.05% propylparaben.

Methylparaben, 0.2% Sorbic Acid, 0.1% Sodium benzoate, 0. 1%


Propylparaben, 0.2% Benzoic Acid, 0. 1%

Flavors. Nothing is absolutely tasteless, but palatability varies with different substances. W hen
preparing an oral liquid, it is often necessary to mask the unpleasant taste of som e com ponent of the
product. You can estim ate the taste of a drug product to be salty (due to both anions and cations being
present), sour (acidic drugs) or bitter (high m olecular weight compounds). The presence of unsaturated
side chains and arom atic ring structures tends to produce a sharp, biting version of the predicted taste.
The actual taste of a product is also a com ponent of the odor given off. A guide to flavoring drug classes
comm only com pounded into oral liquids is provided below.

Drug Class Flavoring Suggestions (in order) Comm only Preferred


Antibiotics Cherry Syrup, Vanilla Extract, Maple Syrup, Cinnam on Powder, Lem on or
Lim e Juice or Concentrate

Antihistamines Cherry Syrup, W ild Cherry Syrup, Cinnam on Powder, Honey, Grape Juice,
Root Beer, Lim e Juice

Barbiturates Lim e Juice, Orange Juice, Root Beer, Pepperm int Spirit, Grenadine, Vanilla
Benzodiazepines Extract (NOTE: These drug groups are traditionally acidic compounds and
Anticonvulsants so match the general flavoring statem ent m ade earlier.)

Antihypertensives Cherry Syrup, Peppermint Spirit, Lemon and Lim e, Grenadine

Salts or Electrolytes Cherry, Grape, Lemon, Lim e, W ild Cherry, Grenadine, Root Beer

An overly sweet taste can be covered best with tastes such as vanilla, fruit, grape, berry, or bubblegum.
An acid, or sour, taste (acidic drugs) is best handled by the addition of a lem on, lim e, orange, cherry,
grapefruit or raspberry taste. A salty taste (inorganic salts) responds best to coverage with a nut,
butterscotch, spice or m aple taste. Bitter tasting drugs (m ost drugs) can be smoothed by use of cherry,
orange, lem on, lim e, peach, chocolate, m int, or coffee flavors. You can obtain som e relatively exotic
flavorings in a pharm acy by using the flavor packs available with antacids or oral feeding supplements.
You can also use things like Sustacal Puddings or Liquid that are available in flavors and cut the
strength with water. Grocery stores also sell a wide range of flavorings in small containers. Most
comm ercial syrups and other oral liquids are acidic.

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Exam ples of com m ercially available liquids for oral com pounding are listed below.

Product Description pH Alcohol Content (% )


Aromatic Elixir 5.5 - 6.0 21 - 23
Cherry Syrup 3.5 - 4.0 1 -2
Citric Acid (Lem on) Syrup 2.0 - 3.0 <1
Coca-Cola Syrup 1.6 - 1.7 0
Iso-Alcoholic Elixir, High 5.0 73 - 78
Iso-Alcoholic Elixir, Low 5.0 8 - 10
(You can mix High and Low Iso-Alcoholic Elixir to obtained needed alcohol strength.)
Ora-Plus Suspension Vehicle 4.0 - 4.5 0
Ora-Sweet Syrup Vehicle 4.0 - 4.5 0
Ora-Sweet-SF (sugar free) 4.0 - 4.4 0
Orange Syrup 2.5 - 3.0 2 -5
Raspberry Syrup 3.0 1 -2
Sorbitol, 70% Solution 6.0 - 7.0 0
Suspendol-S Suspension Vehicle 5.3 - 6.0 0
Syrpalta Syrup Vehicle 4.5 0
Syrup, USP (Sim ple Syrup) 6.5 - 7.0 0
W ild Cherry Syrup 4.5 1 -2

Choosing What Form of Oral Liquid to Prepare

On the Georgia Laboratory Compounding you will be told what form to prepare. On the NAPLEX you are
usually asked to identify the form that results from a com pounding question.

A SOLUTION or SYRUP is a possible dosage form if a drug is water soluble at the concentration in the
form ulation. Rem em ber, however, that you cannot easily determ ine the nature or solubility of fillers in
tablets and capsules. Thus, even if a drug is very soluble in water, you m ay wind up with what looks like
a suspension unless you filter the drug solution to rem ove the fillers. From a practical standpoint, syrups
or similar solutions should only be prepared when using the pure powdered drug (or an injection) to
insure that no active drug is rem oved by filtration.

Drugs in the salt form are often soluble in water and one could prepare a solution. Drugs in the free acid
form will not generally be soluble in water and m ust either be dissolved in alcohol or in a basic solution
(so the salt will be form ed). If the drug cannot be dissolved in alcohol or in a basic vehicle, then a
suspension will be required. Drugs do not generally exist as a free base.

W ith few exceptions, there is a very sim ple system to determ ine if a drug is an acid or a base. This
system, based on the full, true generic nam e of a drug, works for virtually every drug except natural
chem icals (elements), proteins and some physiological substances. Most of the exceptions have trivial
nam es dating from hundreds of years ago rather than scientifically assigned nam es. Drugs that are
esters can confound the system (Ceftin is cefuroxim e (an acid) axetil and m ost of the forms of
erythromycin are esters).

Drugs are acids when the generic nam e of the drug is only one word; that is, it does not represent any
salt form of the drug. Exam ples include ibuprofen, glyburide and furosem ide. W hen the generic name
of the drug is two or more words and one of the words is acid, sodium, calcium, potassium, aluminum
or any other cation. Exam ples include valproic acid, magnesium esomeprazole, sodium ceftazidime,
sodium naproxen and docusate calcium .

Drugs are bases when the generic nam e has two or m ore words, and neither word is a cation or the word
are acid. Examples are diphenhydram ine HCl, dextropropoxyphene napsylate, and bases hydroxyzine
pam oate.

This system works for m ost drugs. The benzodiazepines are the one drug group that m ost violates this
system . They usually are single word generic nam es and so are acids (Tranxene; clorazepate

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dipotassium). Because of the side chains that have been hung on the basic ring structure, some are
bases (Librium is chlordiazepoxide HCI). The system will still hold for most benzodiazepines. There are
a few drugs where the original trade name has becom e a generic nam e (am inophylline is theophylline
ethylenediam ine). Natural body chem icals such as album in and insulin have trivial nam es. Each of these
is a protein, however, and proteins are usually bases.

Most drugs are bases and are supplied in the water soluble salt form . Most pharm aceutical vehicles are
acidic (see the earlier table) and favor the solubility of basic drugs. Basic drugs can have their solubility
increased by using an acidic medium. The lower pH favors the form ation of a soluble salt form of the
drug. Conversely, acidic drugs are m ore soluble in vehicles of higher pH where they can form salts. If you
were doing this in a pharm acy, you would want to consult reference sources such as the Merck Index for
inform ation on solubility and stability of the drug. The drug package insert and the AHFS Drug
Information book are good sources for product stability. The AHFS Drug Information, in particular, is a
likely source of an oral form ulation with stability data. One should not sacrifice stability to obtain
solubility.

W hen preparing a syrup the active drug should first be dissolved in enough water to m ake a solution and
then use the syrup vehicle (or the addition of sugar and water) to m ake the final volum e. If you cannot
add enough sugar (or other ingredient) to preserve the product, then syrups must be stored in a
refrigerator to com bat m icrobial contam ination. It is a good idea to store any com pounded product in a
refrigerator to reduce m icrobial contam ination and to slow degradation unless there is som e reason the
drug cannot be refrigerated.

An ELIXIR is the choice if a drug is not water soluble and m ust be dissolved in alcohol. However, most
drugs are salts and the salt form is usually water soluble. If a free acid (or base) form of a drug must be
used, an elixir m ay be necessary. Use an alcohol content of at least 20% (Arom atic Elixir) as the vehicle
and you will achieve both solubility and preservation of the final product.

General Principle: Always add the liquid containing the diluent to the liquid containing the drug to
reduce the possibility of the drug com ing out of solution when two liquids are m ixed. This is true in
circumstances involving alcoholic solutions, pH sensitive products and several other situations.

In cases where a m ixture of alcohol and water soluble ingredients is required, prepare one solution with
the alcohol soluble ingredients and another solution with the water soluble ingredients. The active drug
is in the alcohol solution and the water solution only contains flavors or preservatives. Always add the
water soluble solution to the alcohol solution to m aintain the highest possible alcohol concentration and
avoid solubility problem s. If you try to pour the alcohol solution into the water, the initial alcohol
concentration is zero (0) and this may cause the drug to precipitate before the alcohol concentration
becom es high enough to keep the drug in solution.

An EM ULSION can be prepared if the prim ary ingredient is an oil, or oil soluble drug, that will not
properly m ix with alcohol to m ake an elixir. W ater soluble drugs can be used to m ake aqueous solutions.
Thus, the type of emulsion used most used for drug products is oil-in-water. There is no need to make
a water-in-oil emulsion since one could sim ply prepare a syrup or other dosage form. Oil-in-water
em ulsions for parenteral use are the most com m only encountered em ulsions (fat em ulsion, propofol and
diazepam ).

The form ula for a basic oil-in-water em ulsion is 4 parts oil, 2 parts water, and one part em ulsifier. In any
em ulsion, a single oil drop is only light covered with water; hence m ore oil is present than water in the
base em ulsion. Once the base em ulsion has been prepared, then additional external phase can be added
to make the final volum e. Exam ple: 100 ml of oil, 50 m l of water, 25 gram s of acacia to prepare the base
em ulsion. More water can be added to make the final volum e.

The order of m ixing an em ulsion is important. The critical volum e is that of the internal phase (in this
case, the oil). Measure the oil and put it in the mortar and pestle. Now add the entire quantity of
em ulsifying agent (e.g., acacia) and mix it with the oil. The external phase (usually water) can be added
with the minim um am ount used according to the 4-2-1 formula above. Once the base emulsion has been

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prepared, additional external phase (water) can be added to m ake the final product volume. If one
determ ines that more internal phase (oil) is needed, then additional emulsifier (acacia) and additional
external phase (water) must also be added to reach the proper ratio for the base em ulsion.

In addition to acacia, Spans and Tweens can be used for em ulsifying agents. Lim e W ater (calcium
hydroxide solution) can be used to m ake an em ulsion with cottonseed oil and m ost other vegetable oils
(m ineral oil is not a vegetable oil). Even dishwashing liquids or baby sham poos, in small am ounts, can
be used to m ake an em ulsion, particularly for topical use products. If you are going to m ake a lot of
liquid products in the form of an em ulsion, you should invest in a hand hom ogenizer to assist in
preparation, but a blender will work.

A Suspension is often the best choice to prepare for an oral liquid product. A suspension elim inates the
concern for solubility data, is usually more stable than any other choice and often lessens the need to
flavor a preparation. W hen preparing a suspension, the drug should be reduced to the finest particle size
possible. A tablet can be allowed to disintegrate in water and then ground into a paste as a m eans of
reducing the am ount of grinding required. Coated tablets and long acting dosage forms m ay require
special attention to get the drug into a form that can be used to m ake an oral liquid. Many of the -XL,
-XR and related products that use a GITS product will require crushing to release the active drug. In
some instances, it may not be possible to use one of these products to make an oral liquid.

Drug solubility and excipients included in a form ulation can be virtually ignored when preparing a
suspension. A suspension is usually m ore stable than a solution of the same drug. (Drugs m ust dissolve
to undergo chem ical changes leading to degradation.) A suspension is likely to have less of a taste
problem than a solution since insoluble material is more felt and sm elled, than tasted. The factors
favoring elixirs and syrups, versus suspensions, are a m ore uniform consistency and greater assurance
of dosage accuracy.

Comm ercial suspending agents are available and existing syrups can be "thickened"by the addition of
acacia (2-5% ), methylcellulose (1-5% ) or carboxym ethylcellulose (0.5 - 1.5% ). A product that is too thick
m ay be difficult to resuspend. Try to achieve a balance between m aintaining a suspension long enough
to measure a dose and having som ething too thick to shake. Most syrups are thick enough to provide
suspending properties and it is rarely necessary to add anything to thicken m ost syrups. Although not
suspending agents, glycerin and sorbitol are cheap ways to m ake a syrup or suspension thicker and still
provide a sweetened taste.

Suspensions should be stored in a refrigerator to retard microbial grow th and avoid bacterial
contamination. A drug in a refrigerator degrades slower than one at room tem perature so drug stability
is improved. Cold liquids may taste better than hot ones. Storing a drug suspension in container lying
flat in a refrigerator will facilitate resuspension by shaking due to the larger surface area that will result
from the flattened out liquid suspension.

In summ ary, extem poraneously prepared oral liquids can take several form s. Elixirs, syrups and
emulsions require drugs in pure form for proper preparation. However, the drug source is usually a
dosage form with added fillers and excipients. These inactive ingredients complicate the form ulation of
oral liquids. Often, the form prepared must be a suspension due to the insolubility of either the drug
itself or of excipients associated with a dosage form .

W hat about an expiration date for a com pounded prescription? There is no firm rule to establish an
expiration date unless actual stability data has been measured. If that is the case, then use the
scientifically determ ined inform ation. In the absence of actual expiration dating, the date you put on the
product cannot be longer than the shortest expiration dated ingredient in the product. One guideline is
that the expiration date cannot exceed the greater or six m onths or 25% of the shortest expiration dated
ingredient in the product. Another m ethod of selecting an expiration date is to consider the length of time
the product will be used. If you are preparing a 10-day supply of a product, then there is no need to put
a six m onths expiration date on the product when a 12- or 14-day expiration date will cover the length
of time the product is to be used.

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There are several textbooks on compounded form ulations that generally give a stability for the product
being compounded and these should be consulted for specific form ulas and inform ation on storage and
stability. Authors of several such texts are Lloyd Allen, Milhap Nahata and Lawrence Trissel.

Repackaging expiration dates are lim ited to six months or 25% of the remaining tim e on the original
container. Situation One expiration date on original container is 3 years away m axim um expiration
date on the repackaged container would be six m onths. Situation Two expiration date on the original
container is 16 m onths m axim um expiration date on the repackaged container would be four months
(25% of 16 m onths). This DOES NOT apply to dispensing drugs from bulk containers into patient
containers. If you have scientific data to demonstrate an expiration date varies from the guidelines given
above, then you can use that as an expiration date for a product. But rem em ber, no one has really
studied the effect of sim ply taking the tablets out of the bulk bottle and putting them into the patient
container.

An exam ple of an oral suspension.


Jennifer W ilford Age: 20 months
770 Ashebrook Drive W eight: 22 lbs Prepare from Captopril Tablets, 100 m g. Tablets weigh
180 mg (determ ined by being told that on NAPLEX or by
Captopril Suspension 2 mg per ml weighing the tablet for the Georgia Practical).
Sodium Ascorbate 5 mg per ml
Propylene Glycol 10 ml Sodium Ascorbate is available in a 25% solution.
Flavored Syrup qs ad 100 ml
Dispense: 28 day supply Propylene Glycol is a 100% pure liquid.
Many flavored syrups are available.
SIG: 0.5 mg / kg / dose give one dose
Q I D, A C & H S To check the dose (too high or too low):
An adult weighs about 75 Kg. Multiply 75 Kg (x) 0.5 mg/
No refills Ima Babydoc, MD Kg/dose = 37.5 mg per dose. Four doses a day would mean
Label 05-16-YYYY 150 m g a day. The usual adult dose of captopril is between
25 m g and 50 m g 4 tim es a day, so the dose is reasonable.

Calculate 22 pounds - divided by 2.2 pounds per Kg - gives 10 Kg body weight of child
the 10 Kg child tim es 0.5 mg per Kg per dose = 5 m g per dose
Dose 5 mg per dose (x) 4 doses per day = 20 m g per day
20 mg per day (x) 28 days therapy = 560 m g total am ount needed
560 m g - divided by 100 m g per tablet = 5.6 tablets needed, so use 6 tabs

By ratio X mg (of powdered 180 m g (weight of


and Captopril Tablets) = one Captopril Tablet) = 560 m g x 180 mg = 1008 m g
proportion 560 m g Captopril 100 mg Captopril 100 mg

Thus, 1008 m g of powdered Captopril Tablets will contain the needed 560 m g of Captopril.

The form ula calls for a concentration of 2 m g per ml so the 5 m g dose will require 2.5 ml per dose
(2 m g/ml (x) 2.5 ml = 5 mg).

You need to prepare 112 doses (4 doses per day (x) 28 days), so the total final volum e will be 280 ml (112
doses (x) 2.5 m l per dose).

Lime or Lemon Syrup can be used for the vehicle because captopril (one word generic nam e) would be
predicted to be an acid. (It is an acid, there is a carboxylic acid in the structure.)

The form ula provided is only for a volum e of 100 m l of Captopril Suspension and we need to make
280 m l (2.8 tim es 100 ml). Thus, all other quantities need to be enlarged.

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For the 5 m g per m l (x) 280 m l = 1400 m g needed 25% solution = 250 m g per m l
Sodium
Ascorbate 1400 mg (div by) 250 mg per m l = 5.6 m l of sodium ascorbate

Propylene The propylene glycol volum e should be 10 ml for 100 ml; but 28 ml will be needed
Glycol to make 280 ml.

Procedure: Grind 6 tablets to powder (total weight would be 1080 mg); weigh out 1008 m g (contains 560
m g of captopril). Levigate the powder in a m ortar with the proper quantity of propylene glycol to make
a paste and aid in reducing powder size. The captopril will probably be soluble in the propylene glycol.
Now add the sodium ascorbate solution and m ix it with the propylene glycol and captopril m ixture. Pour
into a 12 oz (360 m l) container (additional container volum e makes shaking easier). Use som e syrup to
rinse the m ortar and pour this into the bottle, then another rinse with a portion of the syrup and finally
QS to the total volum e with the syrup.

Shortcut you can use in practice (and on Georgia Lab Practical): Six tablets contain 600 m g of captopril.
Divide by 5 m g per dose, so could m ake 120 doses from 6 tablets. Each dose is to be 2.5 m l (x) 120 doses
= 300 ml that can be prepared from 6 tablets plus proper am ounts of Na ascorbate (1500 m g = 6 m l) and
propylene glycol (30 m l). Then discard the extra 20 m l of the m ixture. This elim inates the need to weigh
the tablets and only use part of the tablet powder.

M aking Topical Preparations

Topical preparations take the form of ointm ents, creams, lotions, suspensions and solutions. An
occasional dusting powder m ay be prepared. Ointm ents are used to protect the skin and to provide the
highest level of drug delivery into the skin. Ointm ents are m ore occlusive than any other product.
Ointm ents do not generally absorb significant am ounts of water unless som e additive is included. The
fact that ointments do not contain water also m eans they will not remove water from the skin and so are
not dehydrating. Cream s are water containing and are usually "softer" than ointments but do not deliver
as much drug into the skin as do ointm ents. Cream s will rem ove water from the skin or from weeping
lesions and so are dehydrating. Cream s provide greater lubrication than do ointm ents.

The characteristic m ost patients expect in a topical preparation is sm oothness; that is, no gritty feeling.
The ingredients in topical preparations should be as finely powdered as possible or made into a paste by
levigation with glycerin or another agent. Because of the stiffness of m ost ointm ent and cream bases, it
is often useful to warm the base (by heating or m icrowave) to m ake it easier to incorporate active
ingredients into the base. Rem em ber that heating can destroy any heat sensitive ingredients so caution
is advised. Plastibase is an exam ple of an ointm ent base that cannot be heated.

Heating, or some other liquification process, is about the only way to incorporate the quantity of powder
necessary to form a paste (e.g., Zinc Oxide Paste). W hen incorporating solids into a liquified base, stirring
should be done throughout the cooling tim e to insure uniform distribution of the ingredients. Devices
which can be adapted to the preparation of topical preparations include blenders and m ixers with
rotating blades. These are particularly useful when preparing quantities too large to handle with a m ortar
and pestle or with a pill tile and spatula.

W hen preparing ointm ents using OLEAGINOUS BASES, the active ingredients should be finely
powdered. Oleaginous bases tend to be stiff and difficult to m ix with the ingredients. The powders can
be levigated into a paste with glycerin or by m elting a sm all portion of the ointm ent base to use for the
levigation. Often, one can m elt the entire quantity of an oleaginous base, stir in the ingredients, and then
allow the ointment to resolidify. Be sure of the heat stability of the ingredients. Powders that are not
water soluble are often incorporated into oleaginous bases.

ABSORPTION BASES are created by adding a water-in-oil em ulsifying agent to an oleaginous base.
Spans are exam ples of water-in-oil em ulsifying agents. These bases will accept water in lim ited amounts
but are generally used to incorporate drugs with low water solubility (hydrocortisone, coal tar). It is also

Page 8 of 19
possible to add oil-in-water em ulsifying agents (Tweens, acacia, triethanolam ine) to form emulsion bases
for oil-in-water em ulsion bases.

If one adds water to an absorption base a W ATER-IN-OIL EMULSION BASE results. These bases are best
for incorporation of oils and insoluble powders. Sm all am ounts of water can be taken up by the formation
of additional em ulsion volum e. These are also known as Cream Bases.

OIL-IN-WATER EM ULSION BASES are the vanishing cream s of topical preparations. That m eans they
can be rubbed into the skin and will "disappear". Insoluble ingredients are added by directly mixing
powders into the base. Sm all am ounts of oils m ay be added directly to the base or additional em ulsifying
agent can be added. W ater soluble ingredients can be dissolved in water and then added to the base.

W ATER SOLUBLE OINTM ENT BASES are prepared by varying the content of polyethylene glycol to
achieve anything from stiff products to flowing lotions. Incorporating an oil into a water soluble ointment
bases requires mixing the oil in an intermediary solvent, such as glycerin.

Classifications of Ointm ent and Cream Bases - Based on Penetration of the Skin
Epiderm ic Bases Little or no penetration of the skin Oleaginous Bases

Endoderm ic Bases Penetration into the first internal Absorption Bases


skin layer, the derm is

Diaderm ic Bases Penetrate into & through the skin Em ulsion Bases and
W ater Soluble Bases

Classifications of Ointm ent and Cream Bases Based on Relationship with W ater

Base Type Reaction with W ater Consistency Nam ed Exam ples


Oleaginous Insoluble in W ater Em ollient W hite Petrolatum
(Hydrocarbon) Not W ater W ashable Occlusive W hite Ointm ent
W ill Not Absorb W ater Greasy Feel

Absorption Insoluble in W ater Em ollient Hydrophilic Petrolatum


(Oleaginous Base Not Water W ashable Occlusive Aquabase, Aquaphor
plus a water-in-oil Anhydrous Greasy Feel Polysorb, Anhydrous
em ulsifyiing agent) Can Absorb W ater Lanolin (W ool Fat)

Em ulsion Insoluble in W ater Em ollient Cold Cream


W ater-in-Oil Not W ater W ashable Occlusive Hydrous Lanolin
(Absorption Base W ill Absorb W ater Greasy Feel Hydrocream
with water added) Contains W ater Eucerin and Nivea

Em ulsion Insoluble in W ater Nonocclusive Hydrophilic Ointm ent


Oil-in-W ater W ater W ashable Nongreasy Dermabase
W ill Absorb W ater Velvachol
Contains W ater Unibase

W ater Soluble W ater Soluble Nonocclusive Polyethylene Glycol


W ater W ashable Nongreasy Ointm ent
W ill Absorb W ater Lipid Free
Anhydrous or Hydrous

How Much W ater Can You Add to 100 gram s of an Ointment Base?

White Petrolatum , 10 m l Hydrous Lanolin, 75 m l Aquaphor, 250 m l


Polyethylene Glycol Ointm ent, 15 m l Anhydrous Lanolin, 170 m l Hydrophilic Petrolatum, 290 ml
Cold Cream , 45 m l Velvachol, 190 m l Polysorb, 540 m l

Page 9 of 19
Specific Com pounding Issues for Topical Preparations

It is possible to increase the absorption of a drug from a topical dosage form above that which would
norm ally occur. The addition of water, alcohol, acetone or dim ethyl sulfoxide can be used to dissolve a
drug substance and increase its rate and am ount of absorption. Urea is also com m only used to enhance
drug absorption. Soaps and agents such as docusate and quaternary am m onium salts will also increase
drug absorption.

Eutectic Mixtures can occur when two substances are com bined. If two substances are m ixed, the
m elting point that results is lower than that of a pure material. If the melting point is less than room
temperature, then a eutectic m ixture results and a liquid is form ed by m ixing the two solids. This most
comm only occurs when m ixing substances that are waxy (m enthol, phenol, cam phor) in appearance.
W hen a eutectic m ixture is a possibility, always form the eutectic as a first step; do not attempt to keep
the two eutectic materials separate during the com pounding.

Oils often need to be incorporated into topical preparations. Glycerin will m ix with oil to make it easier
to mix an oil with a cream base. Oils will usually m ix easily with an ointment base. Remember to allow
for the weight of the glycerin added to the product. Since glycerin has a specific gravity of 1.25, then 4
m l of glycerin represents 5 gram s of weight.

Salts, in crystalline form , can be incorporated into topical preparations if first dissolved in a minimum
am ount of water and then incorporate the solution into the vehicle. You can always m ix a water solution
with glycerin to facilitate incorporating it into an ointm ent or cream base.

Most emulsion bases are likely to be adversely affected by the addition of significant am ounts of alcohol
(10% or m ore of volum e will crack an em ulsion). W ater-in-Oil em ulsion bases (cream s) are particularly
prone to damage from alcohol. If alcohol is necessary in a preparation, it is best to take it up into
oleaginous ointment base. Drugs dissolved in small volum es of alcohol can be incorporated into most
bases if done carefully.

Dry Powders, especially the fluffy ones, are best levigated with glycerin to form a paste before
incorporation into a topical preparation. Levigation with glycerin reduces the tendency of such powders
to m ove around and also insures reduction of powder clum ps into a sm ooth consistency.

In calculating am ounts for ointm ents, remem ber to allow for the weight of water (1 gm per 1 m l) and the
weight of any excipients that are in dosage form s used as a source of drug. Som e exam ples of specific
topical products follow.
Salicylic acid is available as fluffy, white crystals
Salicylic Acid 20%
Tetracycline HCl 1% Tetracycline is available in capsules of 250 m g; total weight of powder
70% Alcohol qs ad 30 m l 290 m g
Sig: Apply to wart B.I.D.
Alcohol is available as 95% ethanol

Calculations: 30 ml (x) 0.2 (for 20% ) = 6 Gm Salicylic Acid needed (weigh out)
30 ml (x) 0.01 (for 1% ) = 0.3 Gm (300 mg) of tetracycline HCl required
By ratio and X mg = 290 m g = 348 m g of powder from 2 capsules
proportion 300 mg 250 m g (weigh out 348 / 350 m g)

M ake at least 30 m l of 70% alcohol to insure adequate supply for the product. One way is to take 70 ml
of 95% Alcohol and QS to 95 m l with water. You could also take 35 ml of 95% Alcohol and QS with water
to 47.5 ml. Rubbing alcohol is alm ost always 70% alcohol, but be sure it contains ethyl alcohol, and not
isopropyl alcohol. You can calculate the quantity needed more precisely by using alligation as shown.
To make 30 ml of 70 % Alcohol from 95 % Alcohol and water (0% Alcohol) by alligation:

Page 10 of 19
What you Have W hat you W ant Relative Parts Absolute Am ounts

95% Alcohol 70 parts (70 - 0) 22.1 m l

70% Alcohol

0% Alcohol (water) 25 parts (95 - 70) 7.9 m l

Total Am ount Resulting 95 parts (70 + 25) 30 m l

Procedure: W eigh out the salicylic acid, put it in a graduate and dissolve it in as little of the alcohol
m ixture (70% ) as possible. Add the tetracycline powder to the salicylic acid. Add about half of the
rem aining alcohol and shake to dissolve or disperse the tetracycline (tetracycline is soluble in ethyl
alcohol, but the fillers may not be). Add enough alcohol to m ake 30 m l. The final product should be a
yellow (due to the tetracycline) solution.

An ointm ent com pounding issue with several factors.

Carbolic Acid 10% Liquified Phenol; Sp Gr 1.067, 90% w/w (also called phenol)
Menthol 1%
Menthol available as waxy crystals
ZnO 4%
ZnSO 4 0.1% Zn Oxide available as white, fluffy powder
Aquaphor qs ad 15 Gm
Zn Sulfate available as salt crystals
SIG: Apply to poison ivy rash TID Aquaphor available as ointment base

Calculations: 15 Gm (x) 0.1 (for 10% ) = 1.5 Gm Phenol needed

Liquid Phenol is 90% weight/weight (x) 1.067 = 96% Phenol weight/volum e

X ml = 100 m l = 1.56 ml of Liquid Phenol needed


1.5 Gm 96 Gm

The container of Liquified Phenol states that the dropper delivers 20 drops per m l. Thus, 20 drops per
m l (x) 1.56 m l needed m eans that 31 drops are needed for 1.5 Gm

Both the Menthol and the Menthol 15 gm . (x) 1% = 0.15 gm (150 m g)


Zinc Oxide can be weighed
out directly. Zinc Oxide 15 gm (x) 4% = 0.6 gm (600 m g)

The Zinc Sulfate is Zinc Sulfate 15 gm (x) 0.1% = 0.015 gm (15 m g)


a problem because
least am ounts measurable 120 m g -divided by- 15 m g = factor of 8 (m eans must use
are 120 m g and 2 ml. 8 (x) 2 m l, or 16 m l as least possible volum e to use).

To obtain the Zinc sulfate W eigh out 120 m g Zinc Sulfate, dissolve in enough water to
by an aliquot m ake 16 m l and use 2 m l to contain 15 m g Zinc Sulfate in a total
weight of 2 gram s (allows for weight of water).

To get the Phenol weight is 1.5 Gm


am ount of M enthol weight is 0.15 Gm
Aquaphor Zn Oxide weight is 0.6 Gm
needed Zn Sulfate weight is 2.0 Gm (allows for weight of water)
Total weight of active ingredients 4.25 Gm

Thus, 15 Gm minus 4.25 Gm = 10.75 Gm of Aquaphor needed

Page 11 of 19
Procedure: W eigh out menthol crystals and place on pill tile. Drop liquefied phenol on the m enthol to
m ake a eutectic m ixture. This m ay require grinding with a RUBBER spatula (phenol will stain a metal
spatula). W eigh out the ZnO powder and m ix with Menthol-Phenol eutectic to form a paste. Now use the
Aquaphor to incorporate the m ixture of Menthol-Phenol-Zinc Oxide and make this into a sm ooth product.
Add the 2 m l of Zinc Sulfate solution into the Aquaphor and other ingredients.

One thing you must do on the Georgia Practical is determ ine if there are errors in a prescription. In the
exam ple given, the Carbolic Acid concentration is too high. The usual concentration for topical Carbolic
Acid (Phenol) is 1 per cent. W hen writing up your procedure on the Georgia Laboratory Practical, you
would note that the concentration of Carbolic Acid was too high; if you know the correct answer, put that
down as well. But you still would make it at 10% .

M aking Capsules

W hen packing capsules by hand you need to choose a capsule that is large enough for you to handle and
yet small enough for the patient to swallow. Capsules of the sizes Num ber 0, Num ber 1, and Number 2
are within the appropriate range. Num ber 0 capsules are the largest listed and Num ber 2 is the smallest.
Capsules do com e, however, in sizes ranging from 000 (big) to 5 (sm all).

A No. 1 capsule will hold about 400 m g w hen firmly packed with a typical powdered drug. You can
determine the am ount you will put in a capsule by packing 3 or 4 caps with lactose and then weighing
the caps to determ ine the am ount in each. Ideally, you would run a test packing of the actual material
you will be using but that is often im practical. Remember to use an empty capsule on the opposite pan
of the balance to offset the weight of the capsule shell in the capsule that has been packed. An em pty
No. 1 capsule shell will weigh about 80 mg. Since you allow a 5% error when com pounding, if your target
weight is 400 m g, then a capsule containing between 380 mg and 420 m g would be acceptable. This level
of accuracy is attainable by touch packing.

W hen packing capsules, it is best to get all of the ingredients m ixed in one pile. Then use the top of one
capsule to place over and pick up the bottom of another capsule. Pack a capsule by punching the capsule
shell into the pile of powder. You can, if necessary, scoop som e powder into the capsule shell to begin
the process. Once the bottom of the capsule is full, then place the top of the capsule on tightly enough
to stay on, but loose enough to be rem oved in the event the am ount of powder in the capsule needs to
be adjusted.

After packing the first capsule, weigh it for accuracy. Rem em ber to use an em pty capsule on the opposite
pan of the balance to offset the weight of the capsule shell in the capsule that has been packed. If the
capsule is within the target weight range, then you can pack the rest of the capsules to the sam e packing
pressure. Once all the capsules have been packed, divide them into equal am ounts and put half on each
weighing pan of the balance. If the pans are in close balance, then you do not have any capsules that
are remarkably out of the range allowed.

M orphine 0.005 gram s An exam ple of a prescription requiring the preparation of


Aspirin 0.325 gram s capsules and that requires an aliquot.
Atropine 0.0005 gram s Morphine Sulfate Tabs, 10 mg (weigh 100 mg)
Aspirin Tabs, 325 mg (weigh 350 mg)
DTD Caps # X Atropine Sulfate Powder
SIG: i or ii caps q 3 h for pain Lactose powder
Em pty No. 1 capsules

DTD = give of such doses, the formula is for one Dose or capsule. The other possibility is MFT = mix and
m ake, the form ula is for M any capsules. NOTE: Many current com pounding and calculations pharm acy
texts have stopped distinguishing between DTD and MFT to the extent that MFT is included in all
instructions as sim ply to m ix and make som e product. Use your knowledge of doses to check for the
intent of a given prescription on a licensing exam ination.

Page 12 of 19
Calculations: You cannot make exactly 10 capsules so calculations m ust be for at least one extra. Also,
as will be determined below, six tablets of m orphine contain sufficient drug to make 12 capsules.
Therefore, you are not avoiding drug waste by doing your calculations for 11 capsules. By doing the
calculations for 12 capsules you also eliminate the need to weigh a portion of the morphine tablets (as
we did with the Captopril). So, we will do the calculations for 12 capsules. On the GA Laboratory
Practical Exam ination you will be told the num ber of capsules to use when doing your calculations.

M orphine: 5 mg per dose (x) 12 caps = 60 m g needed; 6 tablets of 10 m g each;


each tablet weighs 100 mg so the total weight will be 600 mg

Aspirin: 325 m g per dose and 325 m g per tablet m eans you need 12 tablets that weigh 350 m g per
tablet (x) 12 = 4200 mg total weight of 12 tablets

Atropine: 0.5 mg per dose (x) 12 = 6 mg needed (cannot w eigh less than 120 m g) An aliquot is
needed to obtain the atropine. One m ethod of doing aliquots is outlined below.

120 mg is least am ount weighable (LAW ) = Factor of 20 (120 m g is 20 tim es 6 m g)


6 mg
120 mg (LAW ) (x) 20 (Factor) = 2400 m g (Total weight of m ixture to be prepared)
W eigh out 120 mg of atropine
W eigh out 2280 mg of lactose [2400 m g (total m ixture weight) m inus 120 m g (atropine)]
Mix the atropine and the lactose by geom etric dilution
W eigh out 120 mg of mixture; this contains 6 mg of atropine (120 mg Factor of 20)

Procedure: 600 mg total weight of Morphine Tablets


Combine weights 4200 mg total weight of Aspirin Tablets
of ingredients 120 mg total weight of Atropine aliquot (6 m g atropine + 114 m g filler)
4920 mg total weight of ingredients

4920 mg divided by 12 = 410 m g of ingredients per capsule


Target weight is 410 mg per capsule so range (5% error) is 390 mg to 430 mg

Pack 10 capsules; label rem aining powder as "Remains of Rx containing approximately 10


m g of m orphine sulfate" (am ount that should be in the 2 extra capsules). Your prescription only
authorized the use of 50 mg of morphine, not the 60 m g you actually used. By saving the leftover powder
for a drug inspector to destroy, you elim inate concerns about undocum ented loss of narcotics.

Com pounding IV Fluids

The key in making an IV fluid is proper sterile technique. Never get any contam inated item (most
comm only the pharm acist) between the lam inar flow HEPA filter and the products being used. In the GA
Laboratory Practical Examination you m ay be asked to describe sterile technique in the interview, but
preparation of the IV is done at your workstation and not in a lam inar flow hood.

Generally, drugs are added to IV fluids and flow rates and concentrations are listed on the label without
any concern for the volum e of fluid added to the bag. For exam ple, if one adds 500 mg of
am inophylline (20 m l) to 500 m l of IV fluid, the label will state that the resulting concentration is 1 mg
per 1 ml. A flow rate of 25 m l per hour would result in each bag lasting 20 hours. If the drug was ordered
at 30 m g per hour, then the flow rate would be 30 m l per hour. A rule of thumb on when to consider the
extra volum e added to the bag is to consider the am ount of fluid added if the am ount of fluid added is
greater than 10% of the volum e of the IV bag.

NOTE. IV bags are usually over filled to allow enough extra fluid to fill the administration set and still
permit administration of the total volum e of fluid specified on the bag. For example, a 1000 m l bag may

Page 13 of 19
contain 1040 m l, 1000 m l for the patient and 40 ml for the IV set. This extra volum e is rarely used in
calculating concentrations or flow rates of IV fluids. If you are to allow for the extra volum e in the IV bag
and/or the volum e of drug added to the IV bag when doing your calculations, this will be made clear to
you during the exam ination.

Intravenous secondary or sm all volume fluids, such as piggyback m edications (m ost com m only loading
doses and antiinfective agents), are usually infused in either 50 m l or 100 m l of IV fluid (D5W or NSS).
The adm inistration tim e is typically 15 to 30 m inutes. Some drugs are given over one hour
(am inoglycosides, vancom ycin) or even 4 hours (am photericin B, co-trim oxazole, azithrom ycin). If in
doubt, run an IVPB drug over one hour. D-5-W ater m ust be used as the diluent for co-trim oxazole,
norepinephine, sodium nitroprusside, am photericin B and am iodarone. Norm al saline is required for
abciximab, inam rinone and tirofiban. Norm al saline is preferred if the patient is diabetic if the drug is
compatible in both normal saline and Dextrose-5% -in W ater.

If you are com pounding a product that represents, for example, a 7-day supply of m edication, then an
expiration date greater than 7 days is required. An expiration date of 10 days would be adequate. If you
were preparing a 10-day supply, then use 14 days as an expiration date. Both of these assume you do
not have data to the contrary on the stability of the product. Unless there is inform ation to the contrary,
compounded products should be stored in a refrigerator to delay decom position.

Powder Volum e in IV Vials

Many drugs come in powdered form and m ust be reconstituted prior to use. There is a guide for mixing,
usually on the side of the vial, butoften in the package insert. The following is an exam ple of such a
m ixing guide. The package insert provides the amount of diluent to add and the concentration that
results, but you must calculate the total volume created from the other inform ation.

ml of Diluent to Add Concentration Resulting Total Volum e Created


Am ount of Drug 9.5 100 m g per ml 10 m l
(powdered form ) 7.5 125 m g per ml 8 ml
in the drug vial 4.5 200 m g per ml 5 ml
is 1 gram 1.5 500 m g per ml 2 ml

An IV Fluid Problem
James Huckleberry Room 346 A
56 year old adult male W eight 176 lbs Prepare using Am inophylline Injection, 25 m g per ml, 20
m l vial and m ake a concentration of 1 m g of theophylline
1-6 Theophylline 0.3 mg per Kg per hour per 1 m l of IV solution. This m akes flow rate calculations
(loading dose given in ER) by IV drip and dose adjustments easier.

Choice of D-5-W or NSS (500 m l), for diluent


IV set delivers 60 drops per m l

Calculations: 176 pounds divided by 2.2 lbs per kg = 80 kg


80 kg (x) 0.3 mg/kg/hr = 24 m g of theophylline per hour

Is the dose Check an IV dose by referencing to the oral dose. Theo-Dur Tabs, 300 m g BID is a
reasonable? com m on oral dose of theophylline. This is 600 m g per day, or 25 m g per hour. This is
close to 24 mg per hour, so the ordered dose is considered a reasonable dose.

Procedure: Add 500 m g of theophylline to 500 m l of NSS (greater stability than D5W ; pH of D5W is 4.5,
pH of NSS is 6.0, pH of Am inophylline Injection is 9.0 so it is more stable at the higher pH
of Norm al Saline.) A concentration 1 m g theophylline per m l, m eans the flow rate in
m l/hour will be sam e num ber as the dose in m g of theophylline per hour.

To convert the 500 m g of theophylline to am inophylline multiply tim es 1.25 to get 625 m g of
am inophylline (= 500 m g theophylline). So, add 625 m g of am inophylline injection (25 m l of 25 mg per

Page 14 of 19
m l) to the IV bag. To be absolutely correct, you should rem ove 25 ml of the NSS from the bag to keep the
concentration of drug accurate.

Flow rate: 24 ml per hour (sam e as the dose of theophylline per hour)
24 ml (x) 60 drops per m l = 1440 drops per hour
1440 drops per hour divided by 60 m inutes per hour = 24 drops per m inute

Flow rates for large volum es (prim ary fluids) are


Jam es Huckleberry 990004325 346-A
expressed in volum e per unit of tim e, such as m l per
DUE: 1500 06-06-YY HUNG
hour or drops per m inute. Small volum e (piggybacks)
are often stated sim ply as the am ount of time for
Norm al Saline 500 m l
infusion of the dose and volum e per unit of time is
Am inophylline 625 m g
not calculated. You must, however, follow the
(Concentration is 1 m g of theophylline per m l,
instructions given for the exam ination.
equivalent to 1.25 m g of am inophylline per m l)

The IV label (shown to the left) is prepared and


Flow Rate: 24 m l per hour
should be stuck on the back of the bag (so it does not
Prepared: 1300 06-06-YY Prepared CPT
cover any labeling) and positioned so the label can be
Exp Date: 1300 06-08-YY Checked RPH
read when the bag is hanging. The label should also
be placed low enough on the bag to be easily read;
particularly for large volum e IV fluids.

The nam e of the IV fluid is traditionally listed first and the m edications (or additives) are added as a list.
Rem ember that the IV tech will use the label to prepare the IV solution and the nurse will use the same
label to check the IV against the physicians order. Each m ust receive sufficient inform ation to do their
job. This is the reason to list concentrations of both am inophylline (drug used to prepare) and
theophylline (nam e drug ordered by) on the label.

Unless you know differently (actual stability data) do not put m ore than 48 hours as the expiration date
sim ply because most hospitals pick up any IV m eds that have not been adm inistered and recycle them
for future use. The maxim um tim e m ost hospitals allow for IV m eds to be on the patient floor is 48
hours. Putting a shorter tim e on the label would be better than a longer tim e.

Prescription No. 1
Cost of Ingredients: $14.50
Ronald Parker, MD Medical Associates, Inc. Cindy Smart, MD
AP2464217 2340 Hospital Circle AS 6283450 Price Calculated
Examination, GA 30303
Paula Lewis, MD Phone 555 555-8300 Jack Thurston, MD
The key is to not lose money. Good
AL 3485672 FAX 555 555-8308 AT 8934754
form ula is to use or double cost of
Nam e Tony Titanic Age 44 yr ingredients and then add $1.00 per
m inute for tim e spent doing the
Address 170 Ashwood Drive Date MM DD YY com pounding.

Rx Hydrocortisone 1.5% Hydrocortisone Injection is 100 mg


per 1 m l; specific gravity is 1.5
Cold Cream qs 30 gms
Cold Cream in pound jars
Sig: apply to rash Q I D
Prepare exactly as written and make
no changes. If there are errors in the
Label YES NO prescription or m aterials supplied,
note them in your write up.
Refill 0 1 2 3 4 5 Paula Lewis

Page 15 of 19
Prescription No. 2

Date Tim e Physicians Orders

MMDDYY 800 AM Septra Injection 0.2 mg trimethoprim content / kg / day


give via IVPB 4 doses per day 2 weeks total
Ronald Parker, MD
Allergies 6990010234 W eight 132 pounds
TITANIC, Tony Male Age 44
Sulfonamides Adm itted M m DdYy Medicine Service
Novocaine, Aspirin Dr. R. Parker Blue Shield Cross

Cost of all ingredients: $ 22.00 Materials Septra Injection that is


IV Com pounding Fee: $ 40.00 Provided: 80 m g sulfam ethoxazole per m l
16 m g trim ethoprim per m l
Price Charged: $
(Minimum would be cost of ingredients IV bag, 50 m l, Norm al Saline
plus IV Com pounding Fee.) Needles, syringes, IV seal, etc

Page 16 of 19
Community Pharmacy Patient Profile
Nam e Anthony R. (Tony) TITANIC Soc Sec No 099-99-9990

Address 170 Ashewood Drive Examination, GA 30303 Phone 555 555-9753

Age 44 Sex Male Race W hite HT 5 ft 8 in W T 132 lbs Spouse Martha

Allergies Sulfonam ides, Novocaine, Aspirin

Diseases HIV positive with AIDS; Type I diabetes mellitus; Severe headaches

Date RX Num Doctor Drug, Form and Strength AM T SIG Ref

3-2-YY 131040 Parker Retrovir Tabs, 300 m g 120 one tab B I D 1

3-2-YY 131041 Parker Epivir Tabs, 150 m g 120 one tab B I D 1

3-2-YY 131042 Parker Crixivan Caps, 400 m g 120 2 caps q 8 hrs AC 3

3-8-YY 132853 Cefalo Cafergot Tabs 30 2 at start of HA; m ay 2


repeat q 3 h x 2

3-8-YY 132854 Cefalo Im itrex Inj, 6 m g 5 6 m g SQ at start of 3


HA; m ay repeat once

3-8-YY 132855 Cefalo Percodan Tabs 30 1-2 q 4 hrs prn HA 0

3-15-YY 135066 Sweet Hum alog Insulin 1 For sliding scale 1

3-15-YY 135067 Sweet Hum ulin 70/30 Insulin 1 30u in AM; 15u in PM 2

3-23-YY 141111 Cefalo Inderal Tabs, 80 m g 60 I BID to prevent HA 0

Over-the-Counter Medications and Health Item s

Date Product Purchased AM T Purpose of Purchase

3-6-YY Excedrin Migraine 100 For headache pain; appointm ent next week

3-7-YY PeptoBism ol 8 oz Antacid and/or diarrhea

3-14-YY Dulcolax Tabs 24 Constipation

Date Lab Results Pharmacist Notes Counseling Information

3-2-YY Sm okes 1.5 packs per day; sedentary life style due to AIDS problem s

3-15-YY Saw Dr Sweet for routine check up BP 154/90; SMA-7 norm al; blood glucose 88;
Hgb A-1-C 8; W BCs elevated and chest congested; previous IV site inflam ed

3-23-YY Trying Inderal as possible m igraine prophylactic

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Usual Practical Examination Instructions

You will have 1.5 hours to do two prescriptions. If you finish earlier, you will be interviewed earlier. You
will also have tim e to study the patient profile handed out after you turn in your com pounded products.
The profile will be used as part of the Clinical Com prehension Exam ination and the Board Member who
interviews you will cover that with you.

General Rules. Complete both prescriptions before you turn anything in to the proctors. You are not
finished until you have been interviewed by a Board Member. You m ust clean up your work area before
you leave the lab. This includes washing and drying any equipm ent you used and putting all trash into
trash cans.

If you have questions, raise your hand and som eone will com e to you. If you do not know how to use the
typewriter, please ask rather than delay everyone else as well. Label typing will be the slowest part of this
exam ination. You m ay wish to type your labels once you have done enough calculations to allow you to
do so. Again, if you do not know how to use a typewriter, please ask.

Specific Prescriptions. Open your exam set and look at Prescription No. 1. You should have the
following materials available: a list of the needed item s is read aloud. Is anyone m issing anything? Any
m issing item s are provided. [Note that you are told what you need to have and asked that you have it.
This m eans you have enough supplies at your work area when you begin the exam .]

The cost of ingredients is given on the writeup sheet. Use this figure when calculating the price you
would charge for the prescription. [There is no m agic form ula here. People comm only double the cost of
the ingredients and then add a dollar a m inute for preparation tim e. The key thing is to not loose money
on the product.]

You are to fill this prescription and type a label. For your prescription num ber use your candidate
number dash one (e.g., 9999- 1). The label m ust m eet all requirem ents of Georgia pharm acy law and the
prescription block area m ust be completed as required by Georgia pharm acy law and rules. This refers
to inform ation normally generated by the com puter to put on to the prescription to indicate it has been
filled. W hen com pleted, you will turn in the properly labeled container and the product. [Minimum info
to add is RX number, RPh initials, Date dispensed and Quantity dispensed, especially if this is different
from the amount ordered on the RX.]

Do not m ake any changes in the prescription dose or directions as written. Fill the prescription as
written, even if it would be wrong to do so. If you find errors in the prescription or in the m aterials
provided [often out-of-date], note those errors in your procedure writeup and be prepared to discuss
solutions with your interviewer. You do not, however, m ake any changes in dose, drug or m aterials.

Do your calculations on scratch paper and later rewrite them neatly onto your sheet with the
prescription. This will m ake sure that the Board member doing your interview can follow your work when
grading it. Briefly, write up how you prepared the prescription. If you w ould have liked to use any
auxiliary labels or some m aterial that was not provided, just mention those in your description of errors
in the prescription.

Open your exam booklet to prescription No. 2 a hospital form at order. This is for the sam e patient as
prescription No. One. You should have the following m aterials: List of required m aterials is read aloud.
Is anyone missing anything? Missing items will be provided.

You will fill the IV medication order exactly as written, even if there are errors in the order. If you do find
errors, either in the prescription or in the m aterials provided, m ention the error(s) in your writeup and
be prepared to discuss solutions with your interviewer. The cost of ingredients is indicated on the
prescription sheet as is the am ount your pharm acy charges as an IV preparation fee. Use these figures
when calculating the price you would charge for the prescription.

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Do your calculations on scratch paper and the neatly rewrite them on the order sheet. You can use the
back of a sheet for m ore writing area for either calculations or your procedure writeup. Make no changes
in the m edication order and dispense what is ordered even if you would have contacted the prescriber
about errors. W hen com pleted, you prepare an appropriate label and attach it to the bag. Use your
candidate num ber dash 2 (e.g., 9999-2) for the IV Num ber. Your used syringe goes into the trash box
and the used needle into the sharps container indicated. Turn in your drug vial when you turn in your
IV bag. The quantity rem aining in the vial is used to determ ine accuracy in calculations and
m easurem ent. If you needed to prepare the product twice, tell that to the Board mem ber who does your
interview so you will not be penalized for using an inappropriate am ount of drug.

On the bottom half of each prescription sheet, clearly indicate the calculations you used and describe
how you filled the prescription. You m ay use the back of the prescription sheet if necessary. This writeup
will be used to determ ine if you prepared the product correctly.

Clinical Com prehension Exam ination

This examination is conducted one-on-one between the candidate and a present or form er m ember of
the Georgia Board of Pharmacy. You will be playing the role of a pharmacist. You will be interviewed by
a Board Member who will be playing the role of the patient. In your role as the pharmacist, you will be
expected to do everything that is required to fill the prescription and counsel the patient on its proper
use. You will be graded on your knowledge, skill and ability to com ply with patient counseling
regulations.

Once you com plete the com pounded prescriptions you will receive the patient profile (if it was not given
out with the prescriptions). You will have at least 15 minutes to review that profile. The prescriptions
you com pounded may, or may not, be related to profile. The profile will be used to allow you to review
past and current drug therapy of both prescription and over-the-counter m edications that relate to the
patient's medical problems. You should initiate the counseling and attempt to meet all OBRA 90
requirements for the medications being dispensed.

In addition, the Board Mem ber will have questions for you to answer. These m ay, or m ay not, be multiple
choice and can be based on the profile and prescriptions presented that day. Often the questions will
be open ended and m ultiple choice answers will not be provided. Partial credit may be allowed an these
questions if you can be led into the correct answer by the Board m ember. There will be 10 correct
answers, each worth 10 points, in this m odule.

You will be expected to tell the Board member what you would tell the patient about the new
prescriptions as they relate to other m edications and the patients disease state. You can use the profile
to rem ind you of things to say, but you will not be given a list of answers to choose from . This is not
a traditional m ultiple choice test. Please be active in this session; the Board members want you to do
the talking about the drugs rather than to answer questions they ask.

Be sure and wear your lab coat to the Practical Examination. Dress neatly as that can be part of your
grade, especially if you com e across as looking non-professional.

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