Dry Powders, Capsules, and Lozenges
Dry Powders, Capsules, and Lozenges
Dry Powders, Capsules, and Lozenges
Chapter 17
Dry Powders,
Capsules, and
Lozenges
OBJECTIVES
After completing this chapter, the student will be able to:
• Describe the topical effect of chemicals used in dry pow-
der formulations.
• Discuss the reasons for triturating topical dry powders
into fine, evenly mixed particles.
KEY TERMS • Describe the use of a fine mesh sieve to obtain evenly
• anesthetic sized particles.
• antibacterial
• List the advantages of using capsules as a compounded
• antifungal
dosage form.
• antipruritic
• capsule body • Demonstrate the punch method of making capsules.
• capsule lid
• Compare the punch method with the use of a capsule
• comminution
machine.
• demulcent
• dispersion • Describe three ways to make lozenges as a dosage form.
• eutectic mixture
• geometric dilution
• levigating agent
• mesh sieve
• mucilage
• protectant
• spatulation
• trituration
• tumbling
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There are many dermatologic conditions that can benefit from the application of a
dry powder formulation. The addition of an active ingredient, such as an
antifungal Agent used to antifungal, antibacterial, or antipruritic agent, to a finely divided powder formu-
treat fungal infections. lation can provide a soothing and effective topical treatment for a number of skin
antibacterial Agent used to conditions. Bulk powders can also be administered internally to dose antacids,
inhibit the growth of bacteria. bulk laxatives, and antidiarrhea medications. Compounded capsule formulations
antipruritic A drug or can facilitate the administration of oral medications by providing an accurate dose
chemical that reduces itching. of more than one medication and eliminating the problems involved with taking
unpalatable medications. Compounded lozenge formulations can incorporate spe-
cific medications for a patient and provide a palatable dosage form with both
topical and systemic effects. This chapter will discuss compounding issues and
preparation methods for these types of solid dosage forms.
Figure 17.1 Mesh sieve used to determine particle size when compound-
ing dry powders for topical use.
drugs with larger amounts of diluent. Hazardous substances can be effectively tumbling Mixing powders
mixed by a process called tumbling. The powders are sealed in zipper-sealed bags by placing them in a plastic
or clear bottles with a lid and tumbled until they are well mixed. The addition of bag or large jar and rotating it
a coloring agent can assist in determining when the mixture is homogenous. When until mixing is completed.
the powders being combined are unequal in quantity, geometric dilution is the pre- geometric dilution The
ferred method for mixing them. Begin by placing the powder with the smallest process of mixing two solid
quantity in the mortar and adding an equal amount of each of the other powders. chemicals together by taking
Continue adding each powder in an amount that is equal to the powder in the mor- equal parts of each in small
tar and triturate well after each addition to form a homogenous mixture. To mix amounts, mixing them thor-
powders of equal volumes, add small, equal amounts of each powder and mix well oughly, and continuing to add
after each addition. Equal dispersion of each ingredient is important to provide the small, equal parts of each until
proper therapeutic effect. both are thoroughly mixed.
James Anderson, MD
2901 Church Street, Brooks, IN 47604
Phone: (356) 443-0098 Fax: (356) 444-9800
Name: Sammy Smitz____________ Date: 05-03-07______________
Address: 2603 South Hampshire Road, Brooks, IN 53706_______________________ ___
RX:
Refills 3
(Reprinted with permission from Mohr ME. Lab Experiences for the Pharmacy Technician.
Baltimore, MD: Lippincott, Williams & Wilkins, 2006.)
Capsules as an Extemporaneous
Compound
A capsule is a solid dosage form in which the active ingredients and diluents are
contained in a two-piece hard shell, usually made of gelatin. Gelatin capsules
are available in various sizes and colors. See Figure 17.2 for capsule sizes. The
double-zero size is the largest size for oral use in humans, although the zero size
is more commonly used. The zero-size capsule has a capacity of 0.5 to 0.8 grams
of powder depending on the density of the chemical being used. Hard-shell cap-
sules consist of two pieces: the body and the cap (see Fig. 17.3). After the two
pieces are separated, the body piece is filled with the dry powder ingredients and
the cap is then replaced. The smallest capsule that will hold the ingredients
should be chosen for the compound. When several ingredients are being inserted
into the capsule, a powder that is near the average weight of all the ingredients
should be chosen to determine the capsule size that will best accommodate the
ingredients in a slightly packed form. Reference books can be used to find the
approximate capsule capacities for some common chemicals. If the amount of
drug needed for a single dose is below the minimum weighable quantity, a dilu-
ent should be added. If the single dose is too large for a capsule that can reason-
ably be swallowed by the patient, a diluent should be added and the dose divided
into two capsules.
Figure 17.3 The cap of the capsule fits snugly over the body
of the capsule after the capsules are filled.
RX:
Sig:
(Reprinted with permission from Mohr ME. Lab Experiences for the
Pharmacy Technician. Baltimore, MD: Lippincott, Williams & Wilkins, 2006.)
4. When a homogenous mixture has been prepared, place the powder on an ointment
slab or pad and form a rectangular block using a spatula. The height of the block
should be slightly shorter than the length of the capsule body to facilitate filling capsule body The bottom
the capsule using the punch method. At this point, the compounder should put on part of the capsule shell that
disposable gloves. Using bare hands can result in fingerprints on the finished cap- contains the solid ingredients.
sule or a slight melting of the gelatin capsule, and is not considered sanitary. (See
Fig. 17.4D.)
5. Prepare the balance by placing a weighing paper on each side of a properly leveled
balance and adding an empty capsule and the correct amount of weight to the
right-hand pan of the balance. (See Fig. 17.4E.)
6. Remove the cap from one of the capsules to be filled and begin punching the body
of the shell repeatedly into the block of powder until the capsule feels full or begins
to offer resistance. (See Fig. 17.4F.)
7. Replace the cap on the capsule and place it on the left pan of the balance. Add or
remove powder from the capsule according to whether the index pointer is to the
left or right of the center. Continue until the pointer moves an equal distance from
the left and the right of the center. Repeat this process for each capsule until all are
filled. As you progress, you will begin to get a feel for how many times you should
punch the capsule and how much resistance should be felt from the powder as the
capsule body is filled. The margin of error for each capsule should be no more than
⫾5%. (See Fig. 17.4G.)
8. If you are using an electronic balance to weigh the capsules, place an empty
capsule shell in a weighing boat on the balance pan. Press the tare button to
zero the balance with the weight of the capsule and the weighing boat. Remove
the empty capsule and place each completed capsule in the weighing boat to
determine the weight of the powder in the capsule. (See Fig. 17.4H.)
9. When all capsules are completed and the weights are acceptable, use a soft tissue
to remove any particles of powder and place the capsules in a prescription vial for
dispensing. Prepare the prescription label and any auxiliary labels, document the
compounding procedure and calculations on a master formula sheet, and place the
finished product in the checking area for the final check by the pharmacist. (See
Fig. 17.4I.)
A B C
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D E F
G H I
2. Pour the prepared powder ingredients over the top of the capsules and use a spe-
cial spatula to direct the powder into the capsules. A tamper is provided with the
machine to press the powder into the capsule compactly (See Fig. 17.5C.)
3. When each capsule has been filled, lower the platform of the capsule machine so
that the capsule lid can be applied. These machines can usually accommodate capsule lid The top part of
100 capsules at a time and are most efficient when used to compound the full a two-piece gelatin capsule
quantity of 100 capsules. (See Fig. 17.5D.) that fits over the capsule body.
4. After applying the capsule lids, randomly select 10 completed capsules for
weighing and document the weight for quality control. If all 10 capsules are
within the range of 85% to 115% of the labeled amount of the drug per capsule,
the capsules are considered to be satisfactory. (See Fig. 17.5E.)
A B C
D E
Compounded Lozenges
Lozenges are solid dosage forms that are intended to be dissolved slowly in the
mouth. They contain one or more active ingredients and are flavored and sweet-
ened so as to be pleasant tasting. They are generally used for their topical effect,
but may also have ingredients that produce a systemic effect. A lozenge may con-
tain an anesthetic, a demulcent, or an antiseptic. The fact that lozenges dissolve
slowly in the mouth enhances the topical effect because the medication will be in
contact with the mouth and throat tissues for a longer period of time. The drug may
also be absorbed in the mouth or swallowed for a systemic effect. Lozenges pro-
vide a pleasant dosage form for patients who are unable to swallow other types of
solid dosage forms. Because lozenges are formulated to taste good, they must be
kept out of the reach of children, who may view them as candy.
Types of Lozenges
Hard Candy Lozenges
Hard candy lozenges are made of sugars and syrups with flavorings added, in much
the same manner as candy is made. Recipes can be gathered from candy-making
books, and molds, sticks, and wrappers can be obtained from stores that sell candy-
making supplies. Just as when making hard candies, it is imperative to ensure that
the temperature of the mixture reaches 149 to 154°C (called the hard crack stage).
This makes hard candy lozenges unsuitable for drugs or chemicals that are unstable
at high temperatures. The hard candy formulas are especially suitable for placing the
ingredients in a lollipop mold and adding a lollipop stick to produce an esthetically
pleasing and palatable dosage form for children who may be resistant to other solid
dosage forms.
Chewable Gummy Gel Lozenges
Chewable gummy gel lozenges began to be used as a dosage form after gummy
bears and worms became very popular as a candy for children. The gummy base can
be formulated in the lab or pharmacy using glycerin and gelatin, but it does require
some effort to heat the mixture for the proper length of time and add the correct
amount of flavorings to mask the bitter taste of glycerin. A simpler way to prepare
gummy gel lozenges is to use a commercial gummy gel base (available from com-
pounding supply companies) or actual gummy bears, which can be melted in a
beaker and a water bath, and add the active ingredients. The liquid can then be
placed into molds to solidify because the flavorings and color are already present.
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RX:
Sig:
Refill 0 1 2 3
(Reprinted with permission from Mohr ME. Lab Experiences for the Pharmacy Technician.
Baltimore, MD: Lippincott, Williams & Wilkins, 2006.)
1. Place the lozenge mold on the balance pan and tare the balance to zero out the
weight of the mold. (See Fig. 17.6A.)
2. Melt the gummy gel base in a beaker placed in a water bath (See Fig. 17.6B).
3. Add enough of the melted gummy base liquid to nearly fill each of the cavities of
the mold and place on the balance pan. (See Fig. 17.6C.)
An oral syringe can be used to fill each of the cavities in the mold without overflow- TIP
ing them.
A B C
D E F
G H
Hand-Rolled Lozenges
Hand-rolled lozenges require a few simple ingredients and only basic compound-
ing equipment. However, it does take some experience on the part of the com-
pounder to produce a pharmaceutically elegant lozenge. Even when they are well
made by an experienced compounder, hand-rolled lozenges will not have a profes-
sional appearance like that of a hard candy or molded lozenge.
RX:
Sig:
(Reprinted with permission from Mohr ME. Lab Experiences for the Pharmacy Technician. Baltimore,
MD: Lippincott, Williams & Wilkins, 2006.)
1. Calculate and weigh of each ingredient needed for the total number of lozenges
weighing 2 grams each plus two extras to account for material loss during mixing.
(See Fig. 17.7A.)
10 mg of clotrimazole ⫻ 12 lozenges ⫽ 120 mg clotrimazole
22.18 g of powdered sugar
1.7 g of acacia
Total weight of ingredients ⫽ 24 g/12 lozenges ⫽ 2 g/lozenge
2. Place acacia in mortar with 2 ml water, food coloring, and flavor (See Fig. 17.7B)
3. Mix the weighed active ingredient and powdered sugar together using geometric mucilage A mixture used to
dilution. Sift the mixture before adding it to the mucilage to form a light, homoge- hold powders together when
nous mixture. (See Fig. 17.7C.) compounding lozenges.
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4. Gradually add the powdered sugar mixture to the acacia mucilage in the mortar
and triturate until it is evenly mixed and dough-like. Wearing gloves, use a
spatula to help form the dough mass into a cylinder on the ointment pad.
(See Fig. 17.7D.)
5. Measure the cylinder with a ruler and divide into 12 even pieces. Each piece should
weigh 2 g for an individual lozenge. (See Fig. 17.7E.)
6. Calculate the percent weight variation from the prescribed amount for each
lozenge. Use the lozenges closest to the correct amount and discard the two extra
lozenges. (See Fig. 17.7F.)
7. Wrap each lozenge in a foil wrapper and place in a vial. Apply the prescription label
with the weight of active ingredient in each lozenge and the expiration date on the
label. (See Fig. 17.7G.)
8. Apply any auxiliary labels. Document the compounding procedure and calculations
on the master formula sheet and leave for the final check by the pharmacist.
A B C
D E G
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Mr. Joseph arrives at the pharmacy with prescriptions for ketoprofen 25 mg, met-
formin 500 mg, and glyburide 5 mg. Each medication is to be taken two times a
day. Mr. Joseph is an elderly male and states that he has trouble keeping track of
three different medicines. He doesn’t like having to swallow three tablets and
wishes there could be one dosage form for all his medical needs. Jim, the pharmacy
technician, conveys Mr. Joseph’s concerns to the pharmacist.
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Chapter Summary
• Topical powders usually contain starch or talc in addition to an active
ingredient, such as an antifungal, antibacterial, or antipruritic agent.
• It is important to reduce the particle size of topical powders to produce a product
that will be soothing to irritated skin.
• Comminution processes include trituration, levigation, and spatulation.
• Mixing powders to form a homogenous mixture can be accomplished by
spatulation, tumbling, and geometric dilution.
• Dry powders can be packaged in shaker-top containers, wide-mouth jars, and
individually in small plastic bags or folded powder papers.
• Hard-shell gelatin capsules have a body and lid that can be separated to add
active ingredients and diluents.
• The punch method for hand-filling capsules involves placing a homogenous
mixture of powders in a rectangular block on an ointment slab and punching
the body of the capsule until it is filled.
• Each compounded capsule should be weighed for accuracy.
• Capsule-filling machines can facilitate compounding for large numbers of
capsules.
• Lozenges are solid dosage forms intended to be dissolved slowly in the mouth.
• Lozenges can be effective for both topical and systemic effects.
• Lozenges must be kept out of the reach of children because they may be
mistaken for candy.
Review Questions
Multiple Choice
Circle the best answer to the following statements.
1. The following procedure is used to reduce the particle size of powders:
a. trituration
b. geometric dilution
c. tumbling
d. none of the above
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7. When using the punch method to fill capsules, the rectangular block of pow-
der should be _____________________(higher) or (lower) than the height of
the capsule body.
True/False
Mark the following statements True or False.
11. _________ Bulk powders can be administered internally to dose antacids,
bulk laxatives, and antidiarrheals.
13. _________ With a mesh sieve, the larger the mesh number, the larger the par-
ticles that can pass through it.
14. _________ In geometric dilution, the powder with the largest quantity is
placed in the mortar and the powders with smaller quantities are added slowly;
mixing is repeated after each addition.
15. _____ Bulk powders for internal use are sometimes called dusting powders.
Matching
Match the terms in column A with the definitions in column B.
Column A Column B
16. _____ levigating agent A. Particle size reduction.
B. Agent such as starch or talc added to ingre-
17. _____ demulcent dients that may form a eutectic mixture
when mixed together.
18. _____ dispersion
C. Substance such as mineral oil or glycerin
19. _____ protectant added to slightly wet powdered ingredients
before mixing.
20. _____ comminution D. Uniform distribution of each ingredient in a
powder mixture.
E. Agent used topically to soothe irritated
tissue in the mouth and throat.
Suggested Readings
Allen LV, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems.
Philadelphia: Lippincott, Williams & Wilkins, 2004.
Shrewsbury R. Applied Pharmaceutics in Contemporary Compounding. Englewood, CO: Morton
Publishing, 2001.
Thompson J, Davidow L. A Practical Guide to Contemporary Pharmacy Practice, 3rd ed. Philadelphia:
Lippincott, Williams & Wilkins, 2004.