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9.
10.
The formula for a ciprofloxacin otic drop is given in the
literature as follows10:
How many grams of ciprofloxacin would be required to prepare
two hundred 15-mL bottles of the ear drop?
The formula for an analgesic ointment is as follows11:
How many grams of each ingredient would be needed to
prepare a dozen 30-g tubes of ointment?
CALCQUIZ
16.A. An ophthalmic solution has the following formula12:
Calculate the quantities of each ingredient required to prepare
twenty-four 7.5-mL containers of the ophthalmic solution.
16.B. The formula for “Lubow’s Solution” is as follows13:
1.
2.
3.
a.Calculate the quantities of each ingredient required to
prepare 2.5 mL of solution.
a. b.How many milliliters of propylene glycol (sp. gr. 1.04) are
needed to prepare a liter of the formula?
16.C. An ophthalmic solution for veterinary use has the following
formula14:
Calculate the quantities of each ingredient required to prepare
twelve 1.5-mL drop-containers of the medication.
a. If the PEG 40 castor oil has a specific gravity of 1.1,
calculate the grams present in (a).
b. Calculate the quantity, in milliliters, of pure (100%) lactic
acid in the formula.
16.D. A vial for injection contains 0.6 mL of solution. The dose is
0.5 mL, which contains 7.5 mg of drug. How many grams of drug
is needed to manufacture 5000 vials of the product?
ANSWERS TO PRACTICE PROBLEMS
1.875 g sertraline hydrochloride
37.5 g silica gel
25 g calcium citrate
7.2 g progesterone
22.32 g dimethyl-β-cyclodextrin
qs 360 mL, purified water
567.5 mg methylparaben
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4.
5.
6.
7.
8.
9.
10.
340.5 mg propylparaben
22.7 g sodium lauryl sulfate
272.4 g propylene glycol
567.5 g stearyl alcohol
567.5 g white petrolatum
838.99 g purified water
700 g sulfacetamide sodium
14 g prednisolone acetate
56 mg phenyl mercuric acetate
70 g mineral oil
6215.944 g white petrolatum
75 mg erythromycin lactobionate
15 mg dexamethasone sodium phosphate
0.375 mL glycerin
qs ad 15 mL sterile water for injection
600 g pegfilgrastim
3000 g sorbitol
2 g polysorbate 20
576.923 g calcium carbonate
115.385 g magnesium oxide
461.539 g sodium bicarbonate
346.154 g bismuth subcarbonate
10 g estriol
1.25 g estrone
1.25 g estradiol
1 kg polyethylene glycol 1450
1 kg polyethylene glycol 3350
30 g ciprofloxacin
269.798 mg menthol
35.97 g chloral hydrate
35.97 g camphor
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
287.78 g lanolin
References
US Pharmacopeial Convention, Inc. Calamine Topical Suspension. United States
Pharmacopeia 42 National Formulary 37 [book online]. Rockville, MD: US
Pharmacopeial Convention, Inc.; 2019.
Allen LV Jr. Artificial tears for dry eyes. International Journal of Pharmaceutical
Compounding 2000;4:376.
Allen LV Jr. Estradiol vaginal gel (0.2%). International Journal of Pharmaceutical
Compounding 1998;2:51.
Allen LV Jr. Dexamethasone phosphate 0.05% ophthalmic ointment. International
Journal of Pharmaceutical Compounding 2003;7:215.
Allen LV Jr. Sertraline 7.5-mg capsules. International Journal of Pharmaceutical
Compounding 1998;2:443.
Allen LV Jr. Progesterone nasal spray (2%). International Journal of Pharmaceutical
Compounding 1998;2:56.
Allen LV Jr. Erythromycin and dexamethasone ophthalmic solution. International
Journal of Pharmaceutical Compounding 2002;6:452.
U.S. Food and Drug Administration. NEULASTA (pegfilgrastim) injection [product
label information]. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125031s199lbl.pdf.
Accessed September 25, 2020.
Allen LV Jr. Triple estrogen 2.5-mg semisolid-filled hard-gelatin capsules.
International Journal of Pharmaceutical Compounding 1997;1:187.
Allen LV Jr. Ciprofloxacin 1% otic drops. International Journal of Pharmaceutical
Compounding 2002;8:47.
Allen LV Jr. Menthol, chloral hydrate, and camphor analgesic ointment. International
Journal of Pharmaceutical Compounding 2016;20:513.
Allen LV Jr. Tobramycin sulfate 0.3% and diclofenac sodium 0.1% ophthalmic
solution. International Journal of Pharmaceutical Compounding 2010;14:74.
Allen LV Jr. Lubow’s solution. International Journal of Pharmaceutical
Compounding 2009;13:558.
Allen LV Jr. Miconazole 1% ophthalmic solution, veterinary. International Journal of
Pharmaceutical Compounding 2009;13:559.
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17
Selected Calculations in
Contemporary Compounding
OBJECTIVES
Upon successful completion of this chapter, the student will be able to:
Differentiate between traditional in-pharmacy compounding and
compounding in outsourcing facilities.
Perform calculations for the constitution of dry powders for oral
solution or suspension.
Perform calculations for the constitution of dry powders for parenteral
use.
Perform calculations for the use of prefabricated dosage forms in
compounding procedures.
Perform calculations applied to the filling of capsules.
Perform calculations applied to the preparation of suppositories by
molding.
Perform calculations applicable to specialized formulas and their
methods of preparation.
Introduction
Traditional pharmaceutical compounding is the process by which
pharmacists combine therapeutically active ingredients with pharmaceutical
materials in the preparation of customized prescriptions and medication
orders to meet the specific needs of individual patients. This is in contrast to
compounding, which occurs in outsourcing facilities in which large
volumes of product are compounded, without individual prescriptions or
medication orders, for distribution to inpatient and outpatient pharmacies.
Differentiated further is pharmaceutical manufacturing, which is the largescale production of pharmaceutical products by the pharmaceutical research
and manufacturing industry.
The Authors’ Extra Point at the end of this chapter encapsulates the
regulation of pharmacy compounding under the federal Drug Quality and
Security Act of 2013.1 This section also provides a listing of the USP-NF
chapters relevant to the compounding of both sterile and nonsterile
products.
2
Compounding is an activity for which pharmacists are uniquely
qualified by virtue of their education, training, and experience. Many
pharmacists have developed specialized practices in compounding in order
to provide customized medications for their patients. In support of these
practices, a Pharmacy Compounding Accreditation Board and a number of
pharmacy compounding associations and organizations have been
established.
a
a
The Accreditation Commission for Health Care (https://www.achc.org/compounding-
pharmacy.html) develops and maintains standards to improve the quality of pharmacy
compounding; other pharmacy compounding organizations include Professional Compounding
Centers of America (https://www.pccarx.com/), Association of Compounding Pharmacists of
Canada (https://acpcrx.org/), and the Alliance for Pharmacy Compounding
(https://www.a4pc.org/).
The Need for Compounding
Compounded prescriptions and medication orders may be desired for a
number of reasons, including3,4:
The need to adjust the strength or dose of a commercially available
product to meet the specific requirements of a patient (e.g., a pediatric
patient)
The need to provide a product more organoleptically acceptable (e.g.,
taste) to a pediatric or veterinary patient
The need to prepare a different dosage form (e.g., a liquid) than the
commercially available product (e.g., a tablet) to meet the requirements
of a patient unable to swallow the existing dosage form (e.g., a
pediatric or elderly patient)
The need to prepare a dosage form free of an agent (e.g., sugar,
preservatives) in the commercially available product that cannot be
tolerated by a patient
The need to provide a patient with a specifically designed formulation
of an approved drug or drug combination, which is unavailable as a
commercial product
Constitution of Dry Powders
Constitution of dry powders for oral solution or
suspension
Some drugs, most notably antibiotics, lose their potency in a relatively short
period when prepared in a liquid dosage form. To enhance the shelf life of
these drugs, manufacturers provide products to the pharmacy in dry powder
form for constitution (or reconstitution) with purified water or special
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diluent at the time a prescription or medication order is received. Depending
on the product, the dry powder may be stable for about 24 months. After
constitution, the resultant solution or suspension is stable in the quantities
usually dispensed for the treatment period.
Dry powders for constitution are packaged in self-contained bottles of
sufficient size to accommodate the addition of the required volume of
diluent (Fig. 17.1). In addition to the quantitative amount of therapeutic
agent, the powder contains such pharmaceutical ingredients as solubilizing
or suspending agents, stabilizers, colorants, sweeteners, and flavorants.
FIGURE 17.1 Example of a dry powder for reconstitution to
prepare an oral solution. The label calls for the addition of 127
mL of water to prepare 200 mL of solution having a concentration
of 125 mg or 200,000 units of penicillin V per 5 mL of solution.
(From allmedtech.com; https://sep.yimg.com/ay/yhst-
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12533177228474/penicillin-vk-250mg-5ml-cherry-powder200mlbrand-name-v-cillin-k-250mg-5ml-teva-00093412774-23.gif.)
On receipt of a prescription order, the pharmacist follows the label
instructions for constitution, adding the proper amount of purified water or
other diluent to prepare the liquid form. Figure 17.2 presents an example of
such a label. Depending on the product’s formulation, constitution results in
the preparation of a clear solution (often called a syrup) or a suspension.
The final volume of product is the sum of the volume of solvent or diluent
added and the volume occupied by the dissolved or suspended powder
mixture. These products generally are intended for infants and children but
also can be used by adults who have difficulty swallowing counterpart solid
dosage form products.
FIGURE 17.2 Outer carton panel indicating the mixing directions
for the pharmacist in the reconstitution of an oral suspension.
(Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?
setid=d6f98d3c-5a20-4cbf-9a9c-abef10b9e465. Courtesy of
Pfizer, Inc.)
Manufacturer’s products generally are formulated to provide the usual dose
by teaspoon or calibrated dropper. Pharmacists may customize products for
individual patients, as demonstrated by the calculations that follow.
Example calculations for the constitution of dry
powders for oral use
1. The label for a dry powder package of cefprozil for oral suspension
directs the pharmacist to add 72 mL of purified water to prepare 100
mL of suspension. If the package contains 2.5 g of cefprozil, how many
milligrams of the drug would be contained in each teaspoonful dose of
the constituted suspension?
Or solving by dimensional analysis:
2. Label instructions for an ampicillin product call for the addition of 78
mL of water to make 100 mL of constituted suspension such that each 5
mL contains 125 mg of ampicillin. Calculate the volume represented by
the suspended powder in the product and the total content of
ampicillin.
Volume of powder: Because the addition of 78 mL of water results in
the preparation of 100 mL of product, the volume occupied by the
powder is:
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