VOLUME 12 NUMBER 3

Secundum
Artem Current & Practical Compounding
Information for the Pharmacist.

COMPOUNDING WITH
GLYCERIN AND PROPYLENE GLYCOL
GOALS AND OBJECTIVES
Goal: To provide information on the physical and chemical characteristics of glycerin and propylene glycol and their use in
pharmaceutical compounding.
Objectives: After reading and studying the article, the reader will be able to:
1. Describe the physical and chemical characteristics of glycerin and propylene glycol.
2. Discuss the properties of glycerin and propylene glycol that contribute to their widespread use in pharmaceutical
compounding.
3. List some of the therapeutic uses of glycerin and propylene glycol.
4. Describe some formulations using either glycerin or propylene glycol.

INTRODUCTION on a commercial scale, from the washings of lead plaster, by Shoemak-

er of Philadelphia.2
Many pharmacists and pharmacy technicians have a tendency to pay Glycerin (C3H8
C3H8O3 , 1,2,3-Propanetriol; glycerol; glycerine; 1,2,3
more attention to active drug substances in formulations and to min- propanetriol; trihydroxypropane glycerol; MW 92.10) occurs as a clear,
imize the importance of the excipients. However, excipients can colorless, syrupy liquid with a sweet warm taste, approximately 0.6
dramatically alter the physical and chemical stability as well as the times as sweet as sucrose. It has not more than a slight characteristic
therapeutic effectiveness of the final drug preparation. Excipients can odor, which is neither harsh nor disagreeable. It is hygroscopic and its
affect bioavailability, rate of drug release for all dosage forms, dura- solutions are neutral to litmus. It is miscible with water and with alco-
tion of action for many dosage forms, extent of penetration for many hol but is insoluble in chloroform, ether and in fixed and volatile oils.
topicals/transdermals, and one of the most important considerations, It has a solubility at 20º C as follows: acetone (slightly soluble); benzene
patient compliance. (practically insoluble); ethyl acetate (1 in 11); methanol (soluble). It
Two commonly used excipients in various dosage forms include glyc- boils at 290º C with decomposition and melts at 17.8º C. It has a specif-
erin and propylene glycol. These two substances are chemically ic gravity of not less than 1.249. A 2.6% v/v aqueous solution is
related as they both contain three carbons; the primary difference is iso-osmotic with serum.4,5,6 It should be preserved in tight containers.
that one contains two hydroxyl groups and the other contains three Glycerin USP contains not less than 99.0% and not more than 101.0% of
(See Figure 1). The series of substances that are official in the USP C3H8O3 calculated on the anhydrous basis. Official USP products
C3H8O3,
could be viewed as starting with isopropanol with one hydroxyl include Glycerin Ophthalmic Solution USP, Glycerin Oral Solution
group on the middle carbon atom, progressing to propylene glycol, USP and Glycerin Suppositories USP.4
with two hydroxyl groups, and then to glycerin with three hydroxyl
groups.1 Glycerin and propylene glycol have been used in pharmacy Uses
for over one hundred years and are extensively used in pharmaceuti- Glycerin is categorized in the NF as a humectant, plasticizer, solvent and
cal compounding today.2 tonicity-adjusting agent.4 It is listed as being used as an antimicrobial
preservative emollient, humectant, plasticizer, solvent, sweetening agent
GLYCERIN and tonicity-adjusting agent. Topically, it is used as a humectant and
emollient. Parenterally, it is used primarily as a solvent. In oral prepara-
Properties
tions, it is used as a solvent, sweetening agent, antimicrobial preservative
Glycerin is the simplest trihydric alcohol. It was discovered by Scheele
and viscosity-increasing agent. In film coatings and in the preparation of
in 1779, who called it the “sweet principle of fats”.3 Glycerin is the
soft gelatin capsules and gelatin suppositories, it is used as a plasticizer.
alcohol present in the esters (glycerides) of oils and fats from which it
It is also used in a number of therapeutic applications.4-6
may be released by saponification. It was more fully investigated by
Chevreul who named it “glycerine” and it came into use in medicine
and pharmacy about 1846.2 It was first obtained in the United States Quest Educational Services Inc. is accredited by the
Accreditation Council for Pharmacy Education as a
Loyd V. Allen, Jr., Ph.D., R.Ph., Professor Emeritus, provider of continuing pharmaceutical education.
University of Oklahoma, HSC College of Pharmacy, ACPE No. 748-999-04-001-H04 (0.1 CEU)
Oklahoma City, OK 73190
This lesson is no longer valid for CE credit after 2/28/07.
Glycerin is also used in the manufacturing of dynamite, cosmetics, glyceroboric acid that is a stronger acid than boric acid.2,5
soaps, confectioneries, blacking, printing and copying inks, lubricants,
elastic glues, lead oxide cements, antifreeze, gas meters, hydraulic jacks,
shock absorber fluid, ice collars, ice bags and as a fermentation nutrient PROPYLENE GLYCOL
in the production of antibiotics.7 Properties
Glycerin is an excellent solvent, but its range is not as extensive as that Propylene glycol came into use as a suggested replacement for glycerin
of water or alcohol. It is a solvent for fixed alkalies, a large number of when glycerin was in short supply during World War II.3 Its solvent
salts, vegetable acids, pepsin, tannin, some active principles of plants, and preservative properties at least in some instances combine the
gums, soluble carbohydrates and starch. advantages of both glycerin and ethyl alcohol. It is often a better sol-
Orally, glycerin is readily absorbed from the intestine and is metabo- vent than glycerin and also has greater power to inhibit mold growth
lized to carbon dioxide and glycogen or is used in the synthesis of body and fermentation, being equal to ethyl alcohol for the latter purposes.
fats.5 Therapeutically, glycerin is used in large doses (70-80 g over 30- An example of where propylene glycol has replaced glycerin is shown
60 minutes) to reduce cranial pressure.5 Slow administration has no in a prior formulation for Hydrophilic Ointment, USP. Glycerin
deleterious effects, but rapid administration can cause hemolysis, imparted a “softening” effect to the ointment when it was triturated;
hemoglobinuria and renal failure. Glycerin is used orally in doses of 1.0 the use of propylene glycol corrected this problem.4,6,8
to 1.5 g/kg body weight to reduce intraocular pressure and vitreous Propylene Glycol USP (C3H8O2, C3H8O3 1,2-Propanediol; 1,2-Dihydrox-
volume before and after ophthalmic surgery, and as an adjunct in the ypropane, 2-hydroxypropanol; methyl ethylene glycol; methyl glycol;
management of acute glaucoma. Glycerin is also applied topically to C3H8O3 It
propane-1,2-diol, MW 76.09) contains not less than 99.5% of C3H8O2.
reduce corneal edema but this effect is only transient, primarily for should be preserved in tight, light-resistant containers in a cool, dry
facilitating ocular examination and diagnosis.5 Oral doses are demul- place. It has a specific gravity between 1.035 and 1.037. It has a boiling
cent and can be mildly laxative, promoting fecal evacuation in the point of 188º C and a melting point of -59º C. It occurs as a clear, color-
management of constipation; usually acting within 15 to 30 minutes. It less, viscous, practically odorless liquid with a slight, characteristic
is classified as an osmotic laxative but may also act through local irri- taste resembling that of glycerin. It absorbs moisture when exposed to
tant effects. Glycerin has lubricating and fecal softening effects as well. moist air. It is miscible with water, acetone and with chloroform. It is
Glycerin is used in ear drops for the removal of ear wax for its lubricat- soluble in ether (1 in 6 parts) and will dissolve many essential oils but
ing and softening action. is immiscible with fixed oils and light mineral oil. It is miscible with
acetone, chloroform, ethanol (95%), glycerin and water. A 2.0% v/v
Adverse Effects aqueous solution is iso-osmotic with serum.4,6-8
Often the adverse effects of glycerin are due to its dehydrating proper-
ties.6 In contact with mucous membranes, glycerin absorbs moisture Uses
and causes temporary irritation; this is the action primarily responsible Propylene glycol is classified in the NF as a humectant, plasticizer and
for the effectiveness of glycerin when applied rectally in suppository solvent. Its functional category is as an antimicrobial preservative, dis-
form to produce fecal discharge in habitual constipation. Glycerin sup- infectant, humectant, plasticizer, solvent, stabilizer for vitamins and as
positories contain 91% glycerin and 9% sodium stearate. Headache, a water-miscible cosolvent.4
thirst, nausea, vomiting and hyperglycemia can be caused by oral Propylene glycol has been used as an aerosol antiseptic; when dis-
administration of large doses.6 persed in air in concentrations as low as 1 part in 2,000,000 propylene
glycol kills air-borne staphylococci.3
Safety In film-coating formulations, propylene glycol is used as a plasticizer.
Glycerin is Generally Recognized as Safe (GRAS) and is listed in the As a carrier, it is used with emulsifiers and as a vehicle for flavors,
FDA Inactive Ingredients Guide for use in inhalations; injections; nasal rather than using ethanol, since it is nonvolatile. Propylene glycol is
and ophthalmic preparations; oral capsules, solutions, suspensions and also used in veterinary medicine as an oral glucogenic in ruminants.8
tablets; otic, rectal, topical, transdermal, and vaginal preparations.5 Other uses include as a nontoxic antifreeze in dairy establishments,
substitute for ethylene glycol and glycerin, in the manufacture of syn-
Dosage Forms thetic resins and de-icing solutions, emulsifier in foods, solvent for
Glycerin is used in almost every dosage form available today. From a food colors and flavors, humectic, solvent, as a mist to disinfect air and
plasticizer in film coatings of tablets, to a solvent, preservative and to create artificial smoke and mist for theatrical use.7
sweetener in oral liquid dosage forms and in injections. An older Overall, propylene glycol is a better solvent than glycerin and will dis-
dosage form, the glycerogelatins, were actually the forerunner of some solve a variety of drugs, including corticosteroids, phenols,
contemporary dosage forms containing glycerin. sulfonamides, barbiturates, vitamins (A and D), most alkaloids and
Glycerogelatins are plastic masses, composed of gelatin, glycerin and many local anesthetics. It is similar to ethanol as an antiseptic and is
water, and a medicament suitable for application to the skin. For appli- similar to glycerin in its activity against molds. It is only slightly less
cation, they are softened using heat and then painted on the surface effective than ethanol.
with a brush. The combination of glycerin, gelatin and water has been
further refined and the combination is now used as the basis of glycerin Adverse Effects
suppositories and soft, chewable gummy bears or chewable troches. Propylene glycol is generally regarded as a relatively nontoxic materi-
Glycerinated gelatin suppositories have been used as vaginal supposi- al and is extensively used in foods, drugs and cosmetics. Orally
tories for the local application of antibacterial agents.2 ingested propylene glycol is rapidly absorbed and is metabolized in
the liver, primarily to lactic and pyruvic acids, and is also excreted
Stability unchanged in the urine.8,9
Pure glycerin, under ordinary storage conditions, is not prone to oxida- Topically, propylene glycol is more irritant than glycerin, but is regard-
tion by the atmosphere. However, it does decompose on heating ed as minimally irritant. When applied to mucous membranes, it may
evolving toxic acrolein. Mixtures of glycerin with water, ethanol produce some local irritation as well as when it is used under occlusive
and/or propylene glycol are chemically stable. It should be stored in an conditions. Otic preparations using propylene glycol have been report-
airtight container in a cool, dry place. If stored at low temperatures, it ed to cause some local sensitivity.6 Injections containing high
may crystallize; but it will become a solution when warmed to 20º C. concentrations of propylene glycol may produce pain or irritation.
When mixed with strong oxidizing agents, glycerin may explode. Propylene glycol is approximately one-third as intoxicating as ethanol;
Examples of strong oxidizing agents include chromium trioxide, potas- administration of large volumes has been associated with adverse effects
sium chlorate and potassium permanganate. In contact with zinc oxide on the central nervous system as well as ototoxicity, cardiovascular
or basic bismuth nitrate, black discoloration of glycerin occurs. Some- effects, seizures, hyperosmolarity and lactic acidosis. The World Health
times glycerin may contain an iron contaminant that can cause a Organization has set an acceptable daily intake at up to 25 mg/kg of
darkening in color of mixtures containing phenols, salicylates and tan- body weight. For intravenous administration, formulations containing
nin. With boric acid, glycerin forms a boric acid complex called 35% propylene glycol can cause hemolysis in humans.8
Safety necessary, add hydrochloric acid 2 N solution drop by drop to achieve a
Propylene glycol has not been demonstrated to be teratogenic or pH of 3.0, which is necessary to convert the midazolam to midazolam
mutagenic in humans. It is GRAS listed and is included in the FDA hydrochloride and continue to mix for 15 to 20 minutes. Add the stevia
Inactive Ingredients Guide (dental preparations, IM and IV injections, powder and sodium benzoate and mix well. Add the flavor to the glycerin
inhalations; ophthalmic; oral, otic, percutaneous, rectal, topical and and then to the mixture. Add the sorbitol and sufficient purified water to
vaginal preparations).8 volume and mix well. Package and label.

Stability Dispersing/Wetting/Levigating/Sweetening
Propylene glycol is stable when stored in a well-closed container but
at high temperatures and exposed to air, it will oxidize yielding prod- Rx Radiation Burn Mouth Rinse (100 mL)
ucts such as propionaldehyde, lactic acid, pyruvic acid and acetic Misoprostol 2.4 mg
acid.7 Glycerin 10 mL
It should be stored in a well-closed container, protected from light, in Diphenhydramine hydrochloride
a cool, dry place. Propylene glycol is chemically stable with ethanol oral liquid 40 mL
(95%), glycerin and water. Its aqueous solutions may be autoclaved. Lidocaine hydrochloride 1g
Propylene glycol is incompatible with oxidizing reagents such as Methylcellulose 1g
potassium permanganate.8 Flavor qs
Preserved water qs 100 mL
Pulverize the misoprostol tablets to a fine powder. Incorporate the lido-
COMPOUNDED FORMULAS USING caine hydrochloride and methylcellulose powders together and add the
GLYCERIN glycerin to form a smooth paste. Add about 45 mL of preserved water and
Vehicle-Plasticizer mix well. Add the diphenhydramine hydrochloride oral liquid, flavors
and sufficient preserved water to volume and mix well. Package and label.
Rx Chewable Lozenges/Troches/Gummy Bears
Gelatin Base (100 g) Vehicle-Topical
Glycerin 75 g Rx Glycerogelatin/Glycerinated Gelatin (100 g)
Gelatin 17 g
Methylparaben 440 mg Gelatin 50 g
Purified water qs 100 g Glycerin 50 g
Product (100 g) Purified water qs 100 g
Gelatin base 92.5 g Pour upon the gelatin sufficient distilled water to cover it, allow it to stand
Bentonite 1.7 g for one hour, pour off the water and allow the gelatin to drain for a few
Aspartame 1.95 g minutes. Transfer to a dish, add the glycerin and heat on a water bath until
Acacia powder 1.55 g the gelatin is dissolved. Strain the solution while hot, transfer to a tared
Citric acid monohydrate 2.3 g dish and heat on a water bath until the product weighs 100 g. When
Flavor qs cooled, cut into pieces.
Active ingredient qs
Gelatin Base: Rx Glycerogelatin with Active Ingredient (100 g)
Using a water bath heated to boiling, insert a beaker or other suitable Glycerinated gelatin 34 g
container and add the water, glycerin and methylparaben. Stir and Glycerin 27 g
heat for 5 minutes. Very slowly, over about 3 minutes, add the gelatin Distilled water 39 mL
with stirring until it is thoroughly dispersed and free of lumps. Con- Active ingredient qs
tinue to heat for 45 minutes; remove from the heat, cool and Mix the active ingredient with the glycerin, add the water and incorporate
refrigerate until used. this mixture with the glycerinated gelatin, which has been previously
Product: melted on a water bath. Continue to heat and stir until a homogeneous
Calibrate the mold to be used for the prescription. Using a water bath, mixture is obtained. Pour into chilled molds and allow to congeal. Pack-
melt the gelatin base. Triturate all the powders together and add to age and label.
the melted base and mix until evenly dispersed. Add the desired fla-
vor, mix and pour into appropriate molds and allow to cool. Package Vehicle-Rectal
and label.
Rx Glycerinated Gelatin Suppositories
Dispersing/Wetting/Levigating Agent (100 g; number depends upon the mold used)
Active drug qs
Rx Rifabutin 20 mg/mL Oral Liquid (100 mL)
Purified water 10 mL
Rifabutin 2.1 g Gelatin 20 g
Glycerin 10 mL Glycerin 70 g
Ora Plus 45 mL Mix the active drug with the water; add the glycerin and mix well. Add
Ora Sweet qs 105 mL the gelatin and heat on a water bath and mix well without incorporating
Empty 14 Mycobutin 150 mg capsules into a glass mortar. Pulverize air into the mixture. When the gelatin has dissolved, pour the melted mix-
the powder until uniform. Add the glycerin and mix until uniform. ture into chilled molds and allow to solidify. Package and label.
Add the Ora Plus in small portions and mix well. Add sufficient Ora
Sweet to volume and mix well. Package and label. Active Ingredient, Vehicle-Rectal
Rx Midazolam 2 mg/mL Oral Solution (100 mL) Rx Glycerin Suppositories
Midazolam 200 mg (105 g; number depends upon the mold used)
Stevia 300 mg Glycerin 91 g
Sorbitol 70% solution 10 mL Sodium stearate 9g
Glycerin 10 mL Purified water 5g
Flavor qs Heat the glycerin in a suitable container to about 120º C. Dissolve the sodi-
Sodium benzoate 200 mg um stearate in the heated glycerin. Add the purified water, mix and
Purified water qs 100 mL immediately pour into suitable molds. Cool until solidified and remove, if
Disperse the midazolam powder in about 70 mL of purified water. If appropriate. Package and label.
Continued.......
 Send this completed form in for CE credit Today!
Please circle the most appropriate answer for each of the following questions. There is only ONE correct answer per question.
1. Glycerin and propylene glycol differ only by: 7. Which of the following concentrations of propylene glycol will
a. the number of “C” atoms. kill air-borne staphylococci?
b. the number of “OH” groups. a. 1:10,000,000
c. the number of “H” atoms. b. 1:20,000,000
d. the number of double bonds. c. 1:5,000,000
e. the number of ethoxy groups. d. 1:25,000,000
2. The specific gravities of glycerin and propylene glycol are e. 1:2,000,000
______ and ______, respectively.
8. The purpose of propylene glycol in diazepam injection is:
a. 1.036, 1.249
a. as a preservative
b. 1.115, 1.125
b. as a cosolvent
c. 1.249, 1.036
c. for pH adjustment
d. 1.294, 0.986
d. for penetration enhancement
e. 0.854, 0.965
e. as a dispersing agent
3. Which of the following uses are shared by both glycerin and
propylene glycol? 9. Approximately what concentrations of glycerin and propylene
a. solvent glycol can serve as a preservative?
b. emollient a. <5
c. preservative-antibacterial b. approximately 8
d.vehicle c. approximately 10
e. all the above d. approximately 20
e. none of the above
4. To reduce intraocular pressure, glycerin is used orally at a
dose of ____ g/kg body weight. 10. Glycerin and propylene glycol would be miscible with all but
a. 0.1 to 0.3 which of the following?
b. 0.3 to 0.5 a. water
c. 0.6 to 0.9 b. ethanol
d. 1.0 to 1.5 c. mineral oil
3. 2.5 to 5 d. acetone
5. Glycerin may explode when mixed with which of the following? e. it is miscible with all the above
I. potassium chlorate II. potassium permanganate III. sodium salicylate 11. My practice setting is:
a. I only a. Community-based c. Hospital-based
b. III only b. Managed care-based d. Consultant and other
c. I and II only 12. The quality of the information presented in this article was:
d. II and III only a. Excellent b. Good c. Fair d. Poor
e. I, II and III 13. The test questions correspond well with the information presented.
6. Iso-osmotic concentrations of glycerin and propylene glycol a. Yes b. No
occur at ___ % v/v and ___ % v/v, respectively. 14. Approximately how long did it take you to read the Secundum Artem
a. 2.6, 2.0 article AND respond to the test questions?
b. 1.9, 0.9 __________________________________________________________
c. 2.0, 0.5
d. 3.5, 0.4 15. What topics would you like to see in future issues of Secundum
e. 1.0, 1.2 Artem? ___________________________________________________

Please print address clearly below OR

affix an address label here if available

Name_____________________________________________________________________________________________________
Home Address _____________________________________________________________________________________________
City______________________________________________State______________ Zip___________________________________
Primary State Licensure _____________________________________________________________________________________
License No._________________________________________________________________________________________________
Home Phone ( )_________________________________ Bus. Phone ( ) ____________________________________
Email Address:_____________________________________________________________________________________________
ACPE No. 748-999-04-001-H04
To receive credit, send completed registration form and test answer sheet (original or a photocopy of the page), *to: QUEST
EDUCATIONAL SERVICES, INC., P.O. BOX 1092, GROTON, CT 06340. One contact hour (0.1 CEU) awarded for a passing grade
of 70%. Please retain a copy for your records. Fee paid for by Paddock Laboratories, Inc. Participants will receive a statement of
credit in the mail within 6-8 weeks upon the receipt of this quiz and evaluation.
*Please note that QUEST EDUCATIONAL SERVICES, INC. will only issue credit to quizzes completed in one’s own handwriting. No quizzes
completed by others and duplicated for others will be graded.
Solvent-Emollient Benzyl alcohol 1.5 g
Rx Nasal Decongestant Gel (100 mL) Sterile water for injection qs 100 mL
Dissolve the diazepam in a mixture of the propylene glycol and
Phenylephrine hydrochloride 500 mg ethyl alcohol. Add the sodium benzoate, benzoic acid and benzyl
Methylcellulose 2g alcohol to about 30 mL of sterile water for injection. Combine the
Methyl salicylate 0.01 mL two liquids. Adjust the pH if necessary to the range of 6.2 to 6.9.
Eucalyptol 0.1 mL Add sufficient sterile water for injection to volume and mix well.
Pine needle oil 0.01 mL Filter through a sterile 0.2 µm filter into sterile vials. Package and
Glycerin 15 g
label; test appropriately.
Purified water qs 100 mL
Dissolve the phenylephrine hydrochloride in about 40 mL of the
Vehicle-Solubilizer-Penetration Enhancer
purified water. Mix the methylcellulose with about 10 g of glycerin.
Add the phenylephrine hydrochloride solution to the methylcellu- Rx Hydrocortisone Gel
lose mixture with stirring. Dissolve the oils in 5 g of the glycerin and Hydrocortisone 1g
slowly incorporate into the methylcellulose dispersion. Add suffi- Carbomer 934 1.5 g
cient purified water to volume and mix well. Package and label. Trolamine 250 mg to 350 mg
Active Drug Propylene glycol qs 100 g
Accurately weigh the hydrocortisone and carbomer 934. Mix the
Rx Glycerin 50% Injection (100 mL) hydrocortisone with about 95 g of propylene glycol. Add the car-
Glycerin 50 g bomer 934 and mix well. Slowly add the trolamine until the desired
Sterile water for injection qs 100 mL viscosity is obtained. Add additional propylene glycol to make 100 g
Using aseptic technique, place the glycerin in a suitable, clean, and mix well. Package and label.
depyrogenated graduated cylinder. Add sufficient sterile water for
injection to volume and mix well. Filter through an appropriate Vehicle-Solubilizer-Penetration Enhancer
sterile 0.2 µm filter into single-dose, sterile USP Type I glass vials.
Rx Antipruritic Clear Lotion (100 mL)
Package and label; test appropriately.
Liquified phenol 0.4 mL
COMPOUNDED FORMULAS USING Tannic acid
Benzocaine
8.4 g
2.2 g
PROPYLENE GLYCOL Ethanol 65 mL
Dispersing/Wetting/Solubilizing Agent Propylene glycol 20 mL
Purified water qs 100 mL
Rx Acyclovir and Chlorhexidine Cold Sore Gel (10 g) Add the liquefied phenol to a clean mortar. Add the ethanol and
Acyclovir 1g mix well. Add the tannic acid and mix until finely dispersed. Add
Chlorhexidine digluconate 200 mg the benzocaine and propylene glycol. Add sufficient purified water
Hydroxypropyl methylcellulose 300 mg to volume and thoroughly mix. Package and label.
Propylene glycol 1 mL
Preserved water 8 mL Vehicle-Penetration Enhancer-Viscosity Enhancer
Accurately weight or measure each of the ingredients. Mix the acy- Rx Psoriasis Lotion (100 mL)
clovir and hydroxypropyl methylcellulose with the propylene Coal tar solution 5 mL
glycol. Slowly incorporate the preserved water and the chlorhexi- Salicylic acid 5g
dine digluconate solution (1 mL of a 20% solution) and mix well. Urea 10 g
Package and label. Note: In this formula, the propylene glycol is Triamcinolone acetonide 160 mg
used as an aid in incorporating the acyclovir and hydroxypropyl Propylene glycol qs 100 mL
methylcellulose into the aqueous system. Dissolve the urea and salicylic acid in about 75 mL of propylene
Vehicle/Solubilizer/Viscosity Enhancer glycol; this may take 30 to 45 minutes. Add the triamcinolone ace-
tonide and mix well. Incorporate the coal tar solution and mix well.
Rx 5-Aminosalicylic Acid Enema (100 mL) Add sufficient propylene glycol to make 100 mL and thoroughly
5-Aminosalicylic acid 4g mix. Package and label.
Sodium phosphate dibasic, anhydrous 400 mg
Sodium phosphate monobasic anhydrous 4.5 g Vehicle-Solubilizer-Penetration Enhancer
Sodium chloride 9g Rx Progesterone 50 mg/mL Topical Solution (100 mL)
Sodium ascorbate 500 mg
Tragacanth 4g Progesterone 5g
Methylparaben 2g Benzyl alcohol 20 mL
Propylparaben 500 mg Dimethylsulfoxide 20 mL
Propylene glycol 25 mL Absolute alcohol 20 mL
Distilled water qs 100 mL Propylene glycol qs 100 mL
Dissolve the parabens in the propylene glycol with stirring. Add Combine the benzyl alcohol, dimethylsulfoxide and absolute alco-
the tragacanth to this solution and thoroughly disperse. Add hol and mix well. Add the progesterone and sufficient propylene
approximately 75 mL of distilled water to this mixture, followed by glycol to volume and mix well. Package and label.
the remaining ingredients, with continued stirring. Add sufficient Wetting-Dispersing Agent/Solubilizer/Penetration Enhancer
distilled water to volume and mix well. Package and label. Note:
The propylene glycol is used to increase the viscosity of the prod- Rx Testosterone 2% Cream (100 g)
uct and as an aid in dissolving the parabens and dispersing the Testosterone 2g
tragacanth. Propylene glycol 2 mL
Dermabase qs 100 g
Solubilizer-Vehicle Mix the testosterone with the propylene glycol. Incorporate this
Rx Diazepam 5 mg/mL Injection (100 mL) mixture into the Dermabase and mix well. Package and label.
Diazepam 500 mg
Vehicle-Penetration Enhancer
Propylene glycol 40 mL
Ethyl alcohol 10 mL Rx Analgesic Stick (100 g)
Sodium benzoate and Methyl salicylate 35 g
Benzoic acid 5g Menthol 15 g
 Sodium stearate 13 g 1616-1617, 1655,
Water 12 g 7. O’Neil MJ, Ed., The Merck Index 13th ed. 2001, Whitehouse Sta-
Propylene glycol 25 g tion NJ. Merck & Co., Inc. pp 799, 1405,
Gently heat and melt the sodium stearate. Mix the water with the 8. Weller PJ. Propylene Glycol in Rowe RC, Sheskey PJ, Weller PJ.
propylene glycol and add to the melted sodium stearate. Mix thro- Handbook of Pharmaceutical Excipients, 4th ed., Washington
roughly, remove from heat, and allow this base to cool slightly. DC, American Pharmaceutical Association, 2003, pp 521-523.
Dissolve the menthol in the methyl salicylate and add to the base 9. Yu, DK, Elmquist WF, Sawchuk RJ. Pharmacokinetics of Propy-
slowly, with thorough mixing. As the product begins to thicken, lene Glycol in Humans During Multiple Dosing Regimens. J
continue mixing and pour into stick-type containers. Pharm Sci 74(8):1985, pp 876-879.

Wetting/Dispersing/Levigating Agent Figure 1:

Chemical structures of isopropanol,
propylene glycol and glycerin.
Rx Clonidine, Gabapentin, Ketamine and Lidocaine PLO (100 mL)
Clonidine hydrochloride 200 mg Isopropanol
Gabapentin 6g
Ketamine hydrochloride 10 g
Lidocaine hydrochloride 2g
Propylene glycol 10 mL
Lecithin-Isopropyl palmitate 1:1 22 mL Propylene Glycol
Poloxamer 407, 20% gel qs 100 mL
Mix the four powders together and add the propylene glycol, mix-
ing to form a smooth paste. Add the lecithin-isopropyl palmitate
solution and mix well. Add the poloxamer 407, 20% gel to volume
and mix thoroughly using a mechanical shearing force method. Glycerin
Package and label.

REFERENCES Table 1:
Comparison of the Uses of Glycerin and Propylene Glycol
1. Anon. USP Dictionary of USAN and International Drug Names.
Rockville MD. U.S. Pharmacopeial Convention, Inc. 2003, pp Use Dosage Concentration Propylene
Form (%) Glycerin Glycol
407, 467, 717.
2. Martin WE, et al. Eds. Remington’s Practice of Pharmacy, 12th Emollient Topicals < 30
Ed., Easton PA, Mack Publishing Company, 1961, pp1344-45. Humectant Topicals < 30 ~15
3. Osol A, Pratt R. U.S. Dispensatory 27th Ed., Philadelphia PA, J.B. Preservative Solutions, < 20 15-30
Lippincott Co., 1973, pp 560-561. Semisolids
4. Anon. U.S. Pharmacopeia 26-National Formulary 21. Rockville Solvent/Cosolvent Aerosol solutions -- 10-30
MD. U.S. Pharmacopoeial Convention, Inc. 2003, pp 867-868, Oral solutions -- 10-25
Parenterals < 50 10-60
1582, 2562-2563, 2578.
Topicals -- 5-80
5. Price JC. Glycerin in Rowe RC, Sheskey PJ, Weller PJ. Handbook
Ophthalmic
of Pharmaceutical Excipients, 4th ed., Washington DC, Ameri- Formulations 0.5-3.0 --
can Pharmaceutical Association, 2003, pp 257-259. Plasticizer Tablets Variable --
6. Sweetman SC. Ed. MARTINDALE The Complete Drug Refer- Sweetener Elixirs < 20 --
ence, 33rd ed., London. The Pharmaceutical Press, 2002, pp

PRSRT STD
U.S. POSTAGE
PAID
3940 Quebec Avenue North Minneapolis, MN
Minneapolis, MN 55427 Permit No. 1700