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PHA 5933 Advanced Compounding: April 16, 2001

This document provides instructions for compounding a testosterone propionate gel using methylcellulose. It discusses the ingredients, directions, packaging, labeling, counseling points, stability concerns, and potential uses for compounded testosterone gels.

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Vinicius Alves
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51 views25 pages

PHA 5933 Advanced Compounding: April 16, 2001

This document provides instructions for compounding a testosterone propionate gel using methylcellulose. It discusses the ingredients, directions, packaging, labeling, counseling points, stability concerns, and potential uses for compounded testosterone gels.

Uploaded by

Vinicius Alves
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PHA 5933

Advanced Compounding

April 16, 2001


Testosterone Propionate
Gel

Lynne Ciardulli
Shannon Fuller
Stephanie Martin
Donald Pierson
Jason Ransom
Formulation

Testosterone propionate 2 g
Polysorbate 80 1 g
Mineral oil, light 10 g
Methylcellulose 2% gel 87 g
How to make
Methylcellulose 2% Gel?
Contents:
Methylcellulose 1500 cps 2g
Purified water qs 100 ml
Directions:
Weigh and measure each ingredient
Add the Methylcellose to about 50 ml of
boiling water and disperse well.
Add remaining water (ice cold) to bring
volume to 100 ml
Stir until uniformed and thickened
Testosterone Gel Directions
1. Accurately weigh/measure each of the
ingredients.
2. Levigate the testosterone propionate with
the light mineral oil.
3. Add the polysorbate 80 to the testosterone
propionate:mineral oil mixture.
4. Add the methylcellulose 2% gel and
thoroughly mix until homogenous.
5. Package and label.
Packaging and Labeling
Package gel in a tight, water resistant
container.
Label to refrigerate and for external use
only.
Beyond use date is 14 days.
Patient Counseling

Applications in women:
wash hands
apply gel in thin layer to affected area
(around vagina) twice daily
report side effects to prescriber
store gel in refrigerator and discard in 2
weeks
wash hands after application
Patient Counseling

Application for men:


Wash hands
Apply once daily (morning) to clean dry intake
skin of the shoulder, upper arms, and/or abdomen.
Recommend to rotate sites, and wait till
application is dry before dressing
Wash hands after application, do not apply to
genitals
Adverse Effects

decreases HDL Bladder irritability


menstrual hirsutism
problems
Hepatic
acne dysfunction
breast soreness hyperandrogenis
m (enlarged
priapism clitoris, voice
changes)
Recommend monitoring testosterone levels
Why Compound
Testosterone Gel?
Well absorbed from topical preparations
Less expensive than commercial
testosterone ($170 for 30 packets of
Androgel)
To obtain desired strength
Androgel is not intended for women
Oral forms undergo high first pass
metabolism
IM administration is unpleasant
Advantages of Methylcellulose
Gel Formulation

Does not readily support bacteria or


mold growth
Aesthetically pleasing
Clear, colorless, and odorless
Neutral pH and stable over wide pH
range
Disadvantages of Methylcellulose
Gel Formulation

Drugs or chemicals that strongly


associate with water can dehydrate
methylcellulose molecules and cause
solution separation.
Products may be time consuming to
prepare, if mellylcellulose needs to be
pre-prepared (~4 hours).
Compounding Problems
Preparing a gel when commercial product is
available
Stability problems with Methylcellulose gel
(~14 days)
Testosterone is a controlled substance
Takes approximately 4 hours to prepare
methylcellulose gel
Uses

Lichen Sclerosis
Decreased Libido
Hypogonadal Disease
Andropause
Lichen Sclerosis
Inflammatory disease of unknown origin
Incompletely understood pathogenesis
Affects males and females, in both genial and
extragenital sites
Presents as pruritic, white papules that
coalesce into plaques
Topical Testosterone is effective in treatment
and improves volvodynia.
Lichen Sclerosis

Joura, et al
n = 10, women with lichen sclerosis
dose = testosterone proprionate 0.02 g
BID
Pts had improved vulvodynia and
resolution of symptoms
SE - Enlarged clitoris, voice changes, and
increased libido
Authors suggest to prevent virulization to
use as low a dose as possible.
Decreased Libido

Some clinicians are prescribing


androgens in low doses for women to
combat decreased libido after
menopause.
The addition of androgen appears to be
beneficial in terms of increased energy
and increased sense of wellbeing.
Doses are lower than what is available
in Androgel.
Hypogonadal Disease
Total testosterone less than 200ng/dL
Replacement improves: Adverse Effects
sexual function slightly lowers HDL
decreases body fat increase in
increases lean muscle HMT/HMG
mass and function
increases bone mass
Hypogonadal Disease
Advantages over the patch:
scrotal patch requires large surface of scrotal
skin and clipping of the hair
non-scrotal body patches may not adhere well in
some patients
testosterone gel rarely causes skin irritation
References
www.paddocklabs.com/publications/secundum/secart
82.html
Lacy, C, Armstrong, L, et al, Drug Information
Handbook, Lexi-Comp Inc. Hudson. 2000.
Joura E, Zeisler, H, et al, Short-Term Effects of
Topical Testosterone in Vulvar Lichen Sclerosus.
Obstet Gynecol 1997;89:297-9.
Clifton, M, Garner, I, et al, Immunohistochemical
evaluation of Androgen Receptors in Genital and
Extragenital Lichen Scleroses: Evidence for Loss of
androgen Receptors in Lesional Epidermis. J Am
Acad Dermatol. 1999;41:43-46.
References
Tompson, J. Practical Guide to Contemporary
Pharmacy Practice. Williams and Wilkens, Baltimore,
1998.
Allen, L, The Art, Science, and Technology of
Pharmaceutical Compounding. APHA, Washington
DC, 1998.
Wang, C, et al. Transdermal Testosterone Gel
Improves Sexual Function, Mood, Muscle Strength,
and Body Composition Parameters in Hypogonadal
Men. J Clin Endocrinol and Metab. 2000;85:2839-
2853.

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