2/7/22, 12:46 AM Minoxidil 10%, Finasteride 0.1%, Biotin 0.2%, and Caffeine Citrate 0.

05% Hydroalcoholic Solution

 COVID-19 Resources 

PUBLISHED JUNE 18, 2020

Minoxidil 10%, Finasteride 0.1%, Biotin 0.2%, and

Caffeine Citrate 0.05% Hydroalcoholic Solution

Loyd V. Allen, Jr., PhD

Professor Emeritus

College of Pharmacy, University of Oklahoma

Oklahoma City

US Pharm. 2020;45(6):48-CV3.

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2/7/22, 12:46 AM Minoxidil 10%, Finasteride 0.1%, Biotin 0.2%, and Caffeine Citrate 0.05% Hydroalcoholic Solution

Method of Preparation: Calculate the required quantity of each ingredient for

the total amount to be prepared. Accurately weigh or measure each
ingredient. Mix the propylene glycol, ethyl alcohol (40 mL), and purified water.
Add the minoxidil while stirring. Slowly and dropwise, add the sulfuric acid
20% solution to a pH between 4.5 and 5.0. Add the biotin, finasteride, and
caffeine citrate; mix well. Add sufficient ethyl alcohol to final volume and mix
well. Package and label.

Use: This preparation has been studied and used in the treatment of male
androgenetic alopecia.1

Packaging: Package in tight, light-resistant containers.

Labeling: Keep out of reach of children. For external use only. Discard after
____ [time period].

Stability: A beyond-use date of up to 30 days may be used for this

preparation.2

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2/7/22, 12:46 AM Minoxidil 10%, Finasteride 0.1%, Biotin 0.2%, and Caffeine Citrate 0.05% Hydroalcoholic Solution

Quality Control: Quality-control assessment can include weight/volume, pH,

specific gravity, active drug assay, color, rheologic properties/pourability,
physical observation, and physical stability (discoloration, foreign materials,
gas formation, mold growth).3

Discussion: Minoxidil (Loniten, Rogaine, C9H15N5O, MW 209.25) is used as an

antihypertensive and as a topical hair growth stimulant. Minoxidil occurs as a
white or off-white, odorless, crystalline solid that is slightly soluble in water to
the extent of approximately 2 mg/mL; is readily soluble in propylene glycol or
ethanol; and is almost insoluble in acetone or ethyl acetate. It melts at 248°C
to 268°C with decomposition. Minoxidil is commercially available as a 2%
topical solution and a 5% foam, with different presentations.

The 2% minoxidil topical solution contains minoxidil in a solution composed

of alcohol (63%), propylene glycol (20%), and water. It is a clear, colorless to
slightly yellow-colored solution. The yellow color will not alter its
effectiveness. The 5% foam contains minoxidil along with SD alcohol 40B,
purified water, butylated hydroxytoluene, lactic acid, citric acid anhydrous,
glycerol anhydrous, cetyl alcohol, stearyl alcohol, polysorbate 60, and
propellant. The foam is creamy in appearance. The commercial foam is
available in a container with 60 g of product.4

Finasteride (Propecia, Proscar, C23H36N2O2, MW 372.54) occurs as a white to

off-white, crystalline solid that melts at about 257°C and is freely soluble in
alcohol and very slightly soluble in water. It is a 5-alpha reductase inhibitor
indicated for the treatment of male pattern hair loss (androgenetic alopecia)
in men only and is a medication mainly used to treat an enlarged prostate or
hair loss in men. Women and children should not use this medication.5

Biotin (Bioepiderm, coenzyme R, vitamin B7, vitamin H, W factor,

C10H16N2O3S, MW 244.31) occurs as a practically white, crystalline powder
that is very slightly soluble in water and alcohol. Biotin, a vitamin, is also
commonly used to treat for hair loss, brittle nails, and other conditions.6

Caffeine citrate (Cafcit, C14H18N4O9, MW 386.31) occurs as a white, odorless

powder with a slightly bitter, acid taste. It is soluble 1 g in approximately 4 mL
warm water.7

Propylene glycol (C3H8O2) occurs as a clear, colorless, viscous, practically

odorless liquid with a sweet taste and somewhat resembles glycerin. It has a
specific gravity of 1.038 g/mL and is miscible with acetone, chloroform, 95%
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2/7/22, 12:46 AM Minoxidil 10%, Finasteride 0.1%, Biotin 0.2%, and Caffeine Citrate 0.05% Hydroalcoholic Solution

ethanol, glycerin, and water.8

Ethyl alcohol (alcohol, ethanol, grain alcohol, C2H5OH, MW 46.07) is a clear,

colorless, mobile, and volatile liquid with a slight, characteristic odor and a
burning taste. It is miscible with chloroform, glycerin, and water.9

REFERENCES
1. Marotta JC, Patel G, Carvalho M, Blakeney S. Clinical efficacy of a topical compounded formulation
in male androgenetic alopecia: minoxidil 10%, finasteride 0.1%, biotin 0.2%, and caffeine citrate 0.05%
hydroalcoholic solution. IJPC. 2020;24(1):69-76.

2. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial

Convention, Inc; May 2020.

3. Allen LV Jr. Summary of quality-control testing for sterile and nonsterile compounded preparations,
part 1: physical and chemical testing. IJPC. 2019;23(3):211-216.

4. Drugs.com. Minoxidil (topical). www.drugs.com/ppa/minoxidil-topical.html. Accessed May 6, 2020.

5. WebMD. Finasteride. www.webmd.com/drugs/2/drug-1548-167/finasteride-oral/finasteride-

oral/details. Accessed May 6, 2020.

6. WebMD. Biotin. www.webmd.com/vitamins/ai/ingredientmono-313/biotin. Accessed May 6, 2020.

7. Caffeine, citrated. In: Allen LV Jr. Remington: The Science and Practice of Pharmacy. 22nd ed.
London, England: Pharmaceutical Press; 2013:1281-1283.

8. Driver S. Propylene glycol. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical
Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:795-798.

9. Fenton ME. Ethanol. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical
Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:356-359.

The content contained in this article is for informational purposes only. The
content is not intended to be a substitute for professional advice. Reliance on
any information provided in this article is solely at your own risk.

To comment on this article, contact rdavidson@uspharmacist.com.

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