rs

prior
to and
The
Basics
of Compunding & Featured Excipient

Featured Excipient: Capsule and Tablet Lubricants

Capsule/tablet lubricants are included in formulations to assist in the mechanical handling of
powders prior to and during the encapsulation process. They can aid in eliminating electrostatic forces
that make handling some powders difficult during compounding. In the case of tablets, they also reduce
wear and friction in the equipment during the tableting operation. Some of the lubricants also aid in
enhancing the flow properties of the powders during mixing. Since the lubricants are generally lipophilic,
they may retard the disintegration/dissolution rates of the dosage form so they are generally only used in
very small amounts (0.25-1%).1 Some of the selected physicochemical characteristics of these
lubricants are shown in Table 1.
Official capsule/tablet lubricants include calcium stearate, glyceryl behenate, magnesium
stearate, mineral oil (light), polyethylene glycol, sodium stearyl fumarate, stearic acid, stearic acid
purified, talc, vegetable oil (hydrogenated Type I) and zinc stearate.
Calcium stearate (C 36H70CaO 4, MW 607, calcium distearate, stearic acid-calcium salt) is a
compound of calcium with a mixture of solid organic acids obtained from fats and consists primarily of
calcium stearate and calcium palmitate; it contains the equivalent of 9.0 to 10.5% of calcium oxide. It is
used in concentrations up to 1.0% w/w and has good antiadherent and lubricant properties but poor
glidant properties. It is also used as an emulsifier, stabilizing agent and suspending agent. It occurs as a
fine, white to yellowish white-colored, bulky powder with a slight, characteristic odor; it is unctuous and
free from grittiness. It is practically insoluble in 95% ethanol, ether and water.2
Glyceryl palmitostearate (glycerin palmitostearate) is a mixture of mono-, di- and tri-glycerides
of C16 and C18 fatty acids. It is not a USP/NF ingredient. It is used in concentrations of 0.5 to 5% w/w
as a tablet lubricant and in a concentration range of 10 to 50% as a matrix for sustained release tablets.
It occurs as a fine, white powder with a faint odor. It is freely soluble in chloroform and
dichloromethane; practically insoluble in 95% ethanol, mineral oil and water. It should be stored at
temperatures less than 35C, preferably at 5-15C in an airtight container, protected from light and
moisture. Glyceryl palmitostearate is incompatible with ketoprofen and naproxen.3

Glyceryl behenate (C69H134O6, MW 1060) occurs as a fine, white powder with a faint odor. It
is soluble, when heated, in chloroform and dichloromethane but is practically insoluble in 95% ethanol,
hexane, mineral oil and water.3,4
Magnesium stearate (C 36H70MgO4, MW 591.34, magnesium octadecanoate) is a compound of
magnesium with a mixture of solid organic acids and consists chiefly of variable proportions of
magnesium stearate and magnesium palmitate (C32H62MgO4). It is widely used as a tablet and capsule
lubricant in concentrations between 0.25 and 5.0% and in cosmetics and foods. It occurs as a fine,
white, precipitated or milled, impalpable powder with a low bulk density. It has a faint odor of stearic
acid and a characteristic taste; it is greasy to the touch and adheres to the skin. It is practically insoluble
in ethanol, ether and water and slightly soluble in warm 95% ethanol. It is listed as incompatible with
strong acids, alkalis and irons salts and cannot be used in products containing aspirin, some vitamins and
most alkaloidal salts. It should not be mixed with strong oxidizing materials. High purity magnesium
stearate has a melting range between 126 and 130C.5
Light mineral oil is a mixture of liquid hydrocarbons obtained from petroleum; it may contain a
suitable stabilizer. It has a lower specific gravity than mineral oil. It is used as an emollient, solvent,
tablet/capsule lubricant, therapeutic agent and oleaginous vehicle. It is described as a transparent,
colorless liquid, free from fluorescence in daylight. It is practically tasteless and odorless when cold but
has a faint odor when heated. It is soluble in chloroform, ether and the hydrocarbons, is sparingly
soluble in 95% ethanol and practically insoluble in water. It can be sterilized by dry heat and should be
stored in an airtight container in a cool, dry place and protected from light. It is listed as incompatible
with strong oxidizing agents. Light mineral oil is combustible and should not be handled or stored near
heat, sparks or flame.6
Polyethylene glycol (HOCH2(CH2OCH2)mCH2OH, where m represents the average number of
oxyethylene groups) is an addition polymer of ethylene oxide and water. The grades 200-600 are
liquids and grades 1000 and above are solids at ambient temperatures. The liquid grades are clear,
colorless or slightly yellow-colored liquids with a slight, but characteristic odor and a bitter, slightly
burning taste. The solids are white or off-white in color and range in consistency from pastes to waxy

flakes with a faint, sweet odor. Grades above 6000 are available as free-flowing milled powders. They
are used as ointment bases, plasticizers, solvents, suppository bases and tablet/capsule lubricants. They
are soluble in water and miscible in all proportions with others in the class. The solid grades are soluble
in acetone, dichloromethane, ethanol and methanol; are slightly soluble in aliphatic hydrocarbons and
ether, but insoluble in fats, fixed oils and mineral oil. Polyethylene glycols and their aqueous solutions can
be sterilized by autoclaving, filtration or gamma irradiation; sterilization of solid grades by dry heat at
150C for one hour may induce oxidation, darkening and the formation of acidic degradation products.7
Sodium stearyl fumarate (C22H39NaO 4, MW 390.5) is a fine, white powder with agglomerates
of flat, circular-shaped particles. It is used as a lubricant in capsule and tablet formulations at 0.5 to
2.0% w/w concentration. It is reported to be incompatible with chlorhexidine acetate.8
Stearic acid (C 18H36O2, MW 284.47, octadecanoic acid) is a mixture of stearic acid
(C 18H36O2) and palmitic acid (C16H32O2); the content of stearic acid is not less than 40.0% and the sum
of the two acids is not less than 90.0%. It is used as an emulsifying agent, solubilizing agent and as a
tablet/capsule lubricant. It is described as a hard, white or faintly yellow colored, somewhat glossy,
crystalline solid or as a white, or yellowish white, powder. It has a slight odor and taste suggesting
tallow. It is listed as incompatible with most metal hydroxides and may be incompatible with oxidizing
agents. It will form insoluble stearates with many metals and ointment bases made with it may show
evidence of drying out or lumpiness due to such a reaction when compounded with zinc or calcium salts.
It is freely soluble in benzene, carbon tetrachloride, chloroform and ether; it is soluble in ethanol, hexane
and propylene glycol and practically insoluble in water.9
Purified stearic acid (C18H36O2, MW 284.47) is manufactured from fats and oils derived from
edible sources and is a mixture of stearic acid (C 18H36O2) and palmitic acid (C16H32O2) which together
constitute not less than 96.0% of the total content. The content of the stearic acid portion is not less than
90.0%. It is used solely for external use and is exempt from the requirement that it be prepared from
edible sources. It is soluble one part in five parts benzene, six parts carbon tetrachloride, two parts
chloroform, 15 parts ethanol, three parts ether and is practically insoluble in water.9

Talc (powdered talc, purified French chalk, soapstone, steatite) is a purified, hydrated,
magnesium silicate, approximating the formula Mg6(Si2O5)4(OH)4; possibly containing small, variable
amounts of aluminum silicate and iron. It is used as an anticaking agent, glidant, tablet and capsule
diluent and tablet and capsule lubricant. As a lubricant, it is used in a concentration of 1 to 10%. It is a
very fine, white to grayish-white colored, odorless, impalpable, unctuous, crystalline powder that
adheres readily to the skin, is soft to the touch and is free from grittiness. It is not hygroscopic and is
practically insoluble in dilute acids and alkalis, organic solvents and water. It can be sterilized by heating
at 160C for not less than one hour and can also be sterilized by ethylene oxide or gamma irradiation. It
is incompatible with quaternary ammonium compounds. Concerning its use in orally administered
preparations, it is not absorbed systemically and is regarded as essentially a nontoxic material. 10
Vegetable oil, hydrogenated, Type I (Hard fat) has the general structural formula of
R1COOCH2-CH(OOCR2)-CH2OOCR3, where R1, R2 and R3 are primarily C15 and C17. Commercial
products available include hydrogenated cottonseed oil, hydrogenated palm oil and hydrogenated
soybean oil. It is described as a mixture of triglycerides of fatty acids and the two types listed in the
USP/NF are characterized by their physical properties. It is used as a lubricant in tablet and capsule
formulations at concentrations of 1 to 6%, usually combined with talc. It is also used as a matrix-forming
material in lipophilic-based controlled-release formulations and as a controlled release coating. Other
uses include the preparation of suppositories, oil-based liquids and semisolid formulations and in the
formulation of liquid and semisolid fills for hard-gelatin capsules. It is soluble in chloroform, petroleum
spirit and hot propan-2-ol and practically insoluble in water. It is listed as incompatible with strong
oxidizing agents. It must be labeled to state that it is Type I.11
Zinc stearate (C 36H70O4Zn, MW 732.33, zinc distearate) is a compound of zinc with a mixture
of solid organic acids obtained from fats. It consists primarily of variable proportions of zinc stearate
and zinc palmitate and contains the equivalent of 12.5 to 14.0% of zinc oxide. It is used as a tablet and
capsule lubricant in concentrations of 0.5 to 1.5%. It is also used in water-repellent ointments, as a
dusting powder and as a thickening and opacifying agent in cosmetic and pharmaceutical creams. It
occurs as a fine, white, bulky, hydrophobic powder that is free from grittiness and has a faint,

characteristic odor. It is practically insoluble in 95% ethanol, ether and water. It is decomposed by
dilute acids.12
REFERENCES
1.

Ansel HC, Allen Jr LV, Popovich NG. Pharmaceutical Dosage Forms and Drug Delivery

Systems, ed 7. Philadelphia, Lippincott Williams & Wilkins, 1999, pp 87, 91, 185, 197-198, 211,
216.
2.

Allen Jr LV. Calcium stearate. In Kibbe AH (ed). Handbook of Pharmaceutical Excipients,

ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp 70-72.

3.

United States Pharmacopeia XXIV/National Formulary 19. Rockville, MD, U.S.

Pharmacopeial Convention, Inc., 1999, pp 2462-2463.

4.

Armstrong NA. Glyceryl palmitostearate. In Kibbe AH (ed). Handbook of Pharmaceutical

Excipients, ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp 228-229.

5.

Allen Jr LV. Magnesium stearate. In Kibbe AH (ed). Handbook of Pharmaceutical

Excipients, ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp 305-307.

6.

Abramowitz R, ODonoghue D. Mineral oil, light. In Kibbe AH (ed). Handbook of

Pharmaceutical Excipients, ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp

347-348.
7.

Price JC. Polyethylene glycol. In Kibbe AH (ed). Handbook of Pharmaceutical Excipients,

ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp 392-398.

8.

Weller PJ. Sodium stearyl fumarate. In Kibbe AH (ed). Handbook of Pharmaceutical

Excipients, ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp 505-507.

9.

Allen Jr LV. Stearic acid. In Kibbe AH (ed). Handbook of Pharmaceutical Excipients, ed 3.

Washington, DC, American Pharmaceutical Association, 2000, pp 534-535.

10.

Kibbe AH. Talc. In Kibbe AH (ed). Handbook of Pharmaceutical Excipients, ed 3.

Washington, DC, American Pharmaceutical Association, 2000, pp 555-557.

11.

Moreton RC. Vegetable oil, hydrogenated, Type I. In Kibbe AH (ed). Handbook of

Pharmaceutical Excipients, ed 3. Washington, DC, American Pharmaceutical Association, 2000, pp

578-579.
12.

Allen Jr LV. Zinc stearate. In Kibbe AH (ed). Handbook of Pharmaceutical Excipients, ed

3. Washington, DC, American Pharmaceutical Association, 2000, pp 608-609.

Table 1: Physicochemical characteristics of capsule/tablet lubricants.

True

Bulk

Tapped

Density Density Density

(g/cm3) (g/cm3) (g/cm3) MP (C)

Container

Calcium stearate

1.064-1.096

0.16-0.38

0.20-0.48

149-160

WC

Glyceryl behenate

--

--

--

70

TC

Glyceryl palmito-

--

--

--

52-55

TC

Magnesium stearate

1.092

0.159

0.286

117-159

TC

Mineral oil, light

0.818-0.880

--

--

--

TC

Polyethylene glycol

1.15-1.21

--

--

varies

WC

stearate

Sodium stearyl 1.107

0.2-0.35

0.3-0.5

224-245

WC

fumarate
0.571

54

WC

0.847 (70C) --

--

66-69

WC

Talc

2.7-2.8

--

--

--

WC

Vegetable oil,

--

--

0.57

61-66

WC

1.09

--

0.26

120-122

WC

Stearic acid

0.980

Stearic acid,

0.537

purified

hydrogenated,
type I
Zinc stearate

*WC = well-closed, TC = tightly-closed

Basics of Compounding: Compounding Suppositories: Part II - Extemporaneous Preparation

Loyd V. Allen, Jr., PhD, RPh
Suppositories can be prepared by hand molding, fusion and compression. Extemporaneous
preparation generally involves hand molding and fusion, even though compression could be used.
Powders to be incorporated into suppositories should be in an impalpable form.
Hand molding requires considerable skill, but allows one to avoid heat, and is generally used
with cocoa butter, which can easily be manipulated, shaped and handled at room temperature. The

technique involves grating the cocoa butter, adding the active ingredient, mixing thoroughly utilizing either
a mortar/pestle or a pill tile/spatula, pressing the mix together until it becomes solid again, shaping into a
long cylinder the diameter of the suppository to be prepared, cutting into the desired length, rounding the
tips, packaging and labeling. During the forming process with the hands, the material can be worked
using plastic gloves, working through a filter paper or using corn starch or talc to decrease the tackiness
of the cocoa butter.
Cold compression is suitable for bases that can be formed into suppositories under pressure. It
is especially appropriate for ingredients that are heat labile. Example bases that can be used for cold
compression include a mixture of 6% hexanetriol-1,2,6 with polyethylene glycol 1450 and 12%
polyethylene oxide polymer 4000.
Fusion involves the gentle heating of a base material followed by the addition of the active
ingredients and any excipients with thorough mixing. The melt is poured into the molds and the
suppositories cooled. They are trimmed, packaged and labeled. Molds for urethral suppositories can be
fashioned from straws, glass tubes, disposable plastic syringes or commercially available molds.
Mold Calibration (Preparation of Blanks) for Fusion or Cold Compression
1.

Prepare the suppository molds and confirm that the cavities are clean and dry.

2.

Obtain and melt sufficient suppository base to fill six to 12 molds.

3.

Pour the molds, cool and trim.

4.

Remove the suppositories and weigh.

5.

Divide the total weight by the number of blank suppositories prepared to obtain the average

weight of each suppository for this particular base.

6.

Use this weight as the calibrated value for that specific mold using that specific lot of suppository

base.
Five different steps involved in the preparation of suppositories include (1) mold preparation,
(2) base preparation, (3) preparation of the active drug, (4) mixing and pouring, and (5) cooling and
finishing.
1.

Mold Preparation:

Molds should be clean and dry at the start. Good suppository bases, if prepared and heated
properly and if the mold is clean and dry, should require no lubricants. However, if it is absolutely
necessary to use a lubricant, the molds should be lubricated properly. If a water soluble base is used,
light mineral oil is a good lubricant. If an oil soluble base is used, glycerin or propylene glycol is a good
lubricant. It is critical to use only enough lubricant to provide a very thin layer on the walls of the mold.
Excessive lubricant will pool at the tip of the mold and result in deformed suppositories. Inadequate
lubricant will result in suppositories that are difficult to remove. The lubricant can be applied by spraying
or by using a cloth to which the lubricant has been added and wiping the molds. Some pharmacists have
reported satisfactorily using a commercial vegetable spray for mold lubrication. The mold should be
equilibrated at room temperature for the pouring procedure.
2.

Base Preparation
The preparation of the base will be determined by the type of base that will be used. Cocoa

butter must be grated for hand molding and may be grated if desired for the fusion method for melting
on a water bath. If fusion is used, caution must be observed to not exceed about 34-35C to prevent
the formation of an unstable polymorph of the cocoa butter base, which may result in formation of the
alpha form resulting in a low melting point suppository that would melt at room temperature and may
stick to the mold. Cocoa butter and fatty acid bases should be melted only to form a fluid, mixable,
pourable liquid that is still creamy-hazy in appearance.
Polyethylene glycol bases can be melted using a water bath or the judicious use of direct heat to
a temperature of approximately 55-60C. PEG bases are very heat stable, but should not be heated
excessively. They should be gently heated to just a few degrees above their melting range.
3.

Preparation of the Active Drug

The drug should be comminuted to a uniform, small particle size to ensure even distribution of

the drug throughout the base and to minimize settling in the melt. The best source of ingredients for the
extemporaneous compounding of suppositories is the pure drug powder. If pure powder is unavailable,
commercial dosage forms such as injections, tablets, capsules, etc. can be used. If these dosage forms
are used, the presence of any excipients must be considered as to the influence they might have on the

physicochemical properties and stability of the finished product, since it is rarely feasible to extract the
active drug from the dosage forms.
In general, a maximum quantity of excipient to be incorporated is about 30% of the blank
weight of the suppository. For example, for a 2 mL disposable mold, the maximum excipient would be
about 600 mg.
Liquids may occupy too much volume to be easily incorporated and the vehicles may not be
compatible with selected suppository bases. Tablets and capsules may contain excessive powder that
may result in suppositories that are too brittle. If a large quantity of liquid is to be incorporated into an
oily suppository base, it may be necessary to prepare a water-in-oil emulsion. For PEG bases, a higher
percent of the higher molecular weight PEGs can be used to accommodate the liquid.
4.

Mixing and Pouring

The drug is either mixed directly into the base or is "wetted" prior to incorporation. Mixing can

be done using a stirring rod or a magnetic stirring setup. Sufficient time is utilized for the mixing process
to obtain a uniform distribution of the drug but not too long to result in either drug or base deterioration.
When the melt is ready, it may be poured into the mold, which has been brought to room temperature.
A cold or frozen mold should not be used as fractures and fissures may occur throughout the
suppository. Starting at one end of the mold, each cavity is slowly filled, being careful not to incorporate
air bubbles into the suppository, and a small excess of material allowed to "build up" on the top of the
mold and the next cavity is filled, etc. Once pouring is initiated, do not stop the pouring process until all
the molds have been filled; this will prevent layering in the suppositories. A 10 mL syringe, or other
suitable size, can be filled with the melt and used to fill the molds if one is careful not to let the melt cool
too rapidly. The mold should be at room temperature so the melt does not prematurely solidify as it is
poured down the sides of the mold cavity. Premature solidification could result in unfilled mold tips and
deformed suppositories. If disposable molds are used, PEG melts should be poured at a minimum
temperature since some molds may collapse at about 70C. If the melt is poured around 60C, this
should not occur. Other bases should be kept near their respective melting temperatures.
5.

Cooling and Finishing

The molds can be allowed to set for 15-30 minutes at room temperature followed by
refrigeration for an additional 30 minutes, if necessary. Excess material is removed from the top of the
mold (the back of the suppository). This can be easily accomplished by dipping the blade of a stainless
steel spatula in a beaker of warm water and using it to cut off the excess material. This will also serve to
place a nice smooth surface on the backside of the suppository. Suppositories can be removed carefully
from the molds, packaged and labeled. If the suppository mold is still cool, the suppositories should be
slightly contracted which will effect easier removal from the mold. Individual suppositories can be
wrapped using foil wrappers, if desired. Wrapping, though not necessary, does present an elegant
product to the patient.
PACKAGING
Suppositories are best individually wrapped or dispensed in the disposable molds in which they
are prepared. If suppositories are not packaged properly, they may become deformed, stained, broken
or chipped. Foil suppository wrappers are available in various colors for the compounding pharmacist.
Wrapped suppositories are usually placed in wide-mouth containers or in slide, folding or partitioned
boxes for dispensing to the patient. Suppositories that are dispensed in disposable molds are often
placed in cardboard sleeves or plastic bags, labeled and dispensed.
STORAGE/LABELING
Suppositories must be protected from heat and may be stored in a refrigerator. They should not
be frozen. Glycerin and polyethylene glycol-based suppositories should be protected from moisture, as
they tend to be hygroscopic.
It is usually a good idea, if the suppositories are wrapped, to add to the label, "Unwrap, moisten
and insert.." or "Unwrap and insert..".
CALCULATIONS
It has been stated that if the quantity of active drug is less than 100 mg, then the volume
occupied by the powder is insignificant and need not be considered. This is usually based on a 2 gram
suppository weight. Obviously if a suppository mold less than 2 gram weight is used, or the quantity of
powders to be added is greater than 100 mg, the powder volume may need to be considered.

Three different methods of either estimating or calculating the quantity of base that the active
medication will displace will be illustrated here; the 0.7 Estimated Density Factor, Determination of
Occupied Volume and the Density Factor-Paddock methods.
0.7 Estimated Density Factor
The 0.7 Estimated Density Factor method is based upon powders having an estimated average
displacement density of 0.7 g/cm3.
Example: Prepare 24 suppositories each containing 250 mg of acetaminophen. The weight of each
suppository using the desired mold and a fatty acid base is 1.8 g each.
Sufficient materials will be used to prepare 25 suppositories.
25 suppositories at 1.8 g each will weigh 45 grams.
250 mg of acetaminophen per suppository times 25 suppositories equals 6250 mg or 6.25 g of
acetaminophen for the total mix.
6.25 g times 0.7 estimated density factor equals 4.375 g volume actually occupied by the
acetaminophen.
45 grams less 4.375 g equals 40.625 g of fatty acid base required.
To prepare the suppositories, weigh 6.25 g of acetaminophen and 40.625 g of fatty acid base for a total
weight of materials of 46.875 g; therefore, each suppository will weigh 1.875 g.

Determination of occupied volume:

1.

Determine the average weight per mold (blank) using the suppository base of interest.

2.

Weigh the quantity of suppository base necessary for 10 suppositories.

3.

Divide the density of the active drug by the density of the suppository base to obtain a ratio.

4.

Divide the total weight of active drug required for the total number of suppositories by the ratio

obtained in step 3. This will give the amount of suppository base displaced by the active drug.
5.

Subtract the amount obtained in step 4 from the total weight of the prescription (number of

suppositories multiplied by the weight of the blanks) to obtain the weight of suppository base required.

6.

Multiply the weight of active drug per suppository times the number of suppositories to be

prepared to obtain the quantity of active drug required.

Ex: Prepare ten suppositories each containing 200 mg of a drug with a density of 3.0. The suppository
base has a density of 0.9 and a prepared blank weighs 2.0 g. Using the "determination of occupied
volume" method, how would the requested suppository be prepared?
These steps refer to those outlined above.
1.

The average weight per mold is 2.0 g.

2.

The quantity required for 10 suppositories would be 2 gm X 10 supp = 20 g.

3.

The density ratio is 3.0/0.9 = 3.3

4.

The amount of suppository base displaced by the active drug is 2.0 g/3.3 = 0.6 g.

5.

The weight of the suppository base required is 20 g - 0.6 g = 19.4 g.

6.

The quantity of active drug required is 0.2 g X 10 = 2.0 g.

The required weight of the suppository base is 19.4 g and the active drug is 2 g.

Determination of Density Factor: Paddock Method:

1.

Determine the average blank suppository weight, A, per mold using the suppository base of

interest.
2.

Weigh the quantity of suppository base necessary for 10 suppositories.

3.

Weigh 1.0 g of medication.

The weight of medication per suppository, B, is then equal to
1 g/10 supp = 0.1 g/supp.

4.

Melt the suppository base and incorporate the medication, mix, pour into molds, cool, trim and

remove from the molds.

5.

Weigh the 10 suppositories and determine the average weight C.

6.

Determine the density Factor as follows:

Density Factor =

B
A- C+B

where A = average weight of blank

B = weight of medication per suppository.
C = average weight of medicated suppository.
7.

Take the weight of the medication that is required for each suppository and divide by the density

factor of the medication to find the replacement value of the suppository base.
8.

Subtract this quantity from the blank suppository weight.

9.

Multiply by the number of suppositories required to obtain the quantity of suppository base

required for the prescription.

10.

Multiply by the weight of drug per suppository by the number of suppositories required to

obtain the quantity of active drug required for the prescription.

Ex:

Prepare twelve acetaminophen 300 mg suppositories using cocoa butter where the average

weight of the cocoa butter blank is 2 g and the average weight of the medicated suppository is 1.8 g.
DF

0.3
2 - 1.8 + 0.3

0.6

Step 7:

(0.3 g)/0.6 = 0.5 (the replacement value of the base)

Step 8:

2.0 g - 0.5 g = 1.5 g

Step 9:

#12 X 1.5 g = 18 g cocoa butter required

Step 10:

#12 X 0.3 g = 3.6 g acetaminophen

CONTINUING EDUCATION

Featured Excipient: Capsule and Tablet Lubricants

Goal: To provide compounding pharmacists supportive information on the application and appropriate
use of capsule and tablet lubricants.

Objectives: After reading and studying the article, the reader will be able to:
1.

discuss the purpose and use of lubricants in capsules and tablets.

2.

select an appropriate lubricant based upon the active ingredient(s) and the desired density

characteristics.
3.

determine whether or not an active ingredient may be incompatible with a selected lubricant.

4.

select a proper storage container for a specific lubricant.

Basics of Compounding Suppositories, Part II

Goal: To provide pharmacists, pharmacy students and pharmacy technicians supportive information on
the basics of extemporaneous compounding various types of suppositories.

Objectives: After reading and studying the article, the reader will be able to:
1.

discuss the methods of extemporaneously preparing rectal, urethral and vaginal suppositories.

2.

detail the preliminary steps involved in preparing to extemporaneously compound suppositories.

3.

prepare and appropriately package various types of suppositories using appropriate equipment

and techniques.
4.

demonstrate example calculations for determining the quantity of suppository base displaced by

the active drug.

Featured Excipient: Capsule and Tablet Lubricants

1.

Lubricants are often included in capsule formulations to:

A.

minimize electrostatic forces

B.

aid in powder flowability

C.

make encapsulation easier

D.

all the above

2.

An excessive quantity of a capsule lubricant can increase the dissolution rate of the capsule

contents.
A.

True

B.

False

3.

The "solid" lubricants tend to be "mixtures" rather than defined chemical entities.

A.

True

B.

False

4.

Which of the following lubricants is not a USP/NF item?

A.

Calcium stearate

B.

Glyceryl behenate

C.

Glyceryl palmitostearate

D.

Magnesium stearate

E.

Talc

5.

Which of the following lubricants is also used as a matrix for sustained release tablets?

A.

Calcium stearate

B.

Glyceryl palmitostearate

C.

Magnesium stearate

D.

Light mineral oil

E.

Talc

6.

Which of the following lubricants are water soluble?

A.

Calcium stearate

B.

Glyceryl palmitosterate

C.

Polyethylene glycol

D.

Stearic acid

E.

Talc

7.

Talc contains primarily:

A.

calcium stearate

B.

calcium sulfate

C.

calcium silicate

D.

magnesium stearate

E.

magnesium silicate

8.

Which of the lubricants may contain small amounts of iron.

A.

Calcium palmitostearate

B.

Magnesium stearate

C.

Light mineral oil

D.

Sodium stearyl fumarate

E.

Talc

9.

Most capsule/tablet lubricants are used in formulations within what concentration range?

A.

<1%

B.

1-5%

C.

6-10%

D.

11-15%

E.

>15%

10.

Which of the lubricants has the highest true density?

A.

Calcium stearate

B.

Magnesium stearate

C.

Mineral oil

D.

Sodium stearyl fumarate

E.

Talc

11.

According to Table 1, which of the lubricants has the lowest melting point?

A.

Calcium stearate

B.

Glyceryl palmitostearate

C.

Magnesium stearate

D.

Vegetable oil, hydrogenated, Type I

E.

Zinc stearate

12.

Of the polyethylene glycols, which of the following grades would be a liquid?

A.

300

B.

1540

C.

3350

D.

6000

E.

20,000

Basics of Compounding Suppositories: Part II-Extemporaneous Preparation

13.

Which of the following methods of preparing suppositories uses heat?

A.

Hand molding

B.

fusion

C.

compression

14.

The powders to be incorporated into suppositories should be in a(n) _____________ form.

A.

granular

B.

efflorescent

C.

deliquescent

D.

impalpable

E.

hygroscopic

15.

Suppository molds should be equilibrated at room temperature for the pouring process.

A.

True

B.

False

16.

It is generally best to just heat the suppository bases a few degrees above their melting point

and avoid excessive heat.

A.

True

B.

False

17.

During the pouring process, it is best to pour continuously to minimize any layering that might

occur in the suppository that may make it susceptible to breakage.

A.

True

B.

False

18.

The maximum quantity of powders to be incorporated into a suppository should generally be:

A.

5%

B.

10%

C.

20%

D.

30%

E.

50%

19.

If a lubricant is required for a suppository mold and the suppository base is cocoa butter, the

best choice would be:

A.

olive oil

B.

mineral oil

C.

PAM vegetable spray

D.

vitamin E oil

E.

glycerin

20.

Since powders will dissolve in the suppository bases, it is not necessary to consider the volume

they will occupy in the finished suppository.

A.

True

B.

False

21.

If a mold is too cool during the pouring process, which of the following might occur?

A.

The powders may settle out after pouring is complete.

B.

Cracks will occur in the suppositories.

C.

There may be unfilled tips due to premature solidification of the melt.

D.

The contraction dimples will be exaggerated at the back of the suppositories.

E.

The suppository will dissolve too quickly.

22.

If cocoa butter is used as the base, it should be melted at about 70C until it is a clear, yellow

liquid prior to incorporating the drug and pouring the suppositories.

A.

True

B.

False

23.

The best source of active drug substances for extemporaneous compounding of suppositories is:

A.

capsules

B.

tablets

C.

injections

D.

ointments

E.

pure powder

24.

Using the 0.7 Estimated Density Factor method, how much fatty acid base would be required to

prepare 12 suppositories, each containing 100 mg of pentobarbital, if the blank suppository mold weight
is 1.9 g?
A.

0.84 g

B.

1.2 g

C.

21.6 g

D.

21.96 g

E.

22.8 g

25.

It is important to not heat the melt too high as some of the plastic suppository molds will melt or

deform above what temperature (C)?

A.

30

B.

40

C.

50

D.

60

E.

70