Human HRT Leads Compounding Renaissance

Compounding has had a tremendousimpact on the practice ofpharmacy over the years, butas pharmaceutical companies gainedthe technology to mass-produce theirproducts, the art of compoundingplayed a somewhat smaller role. Currently,compounding is experiencingsomething of a renaissance, thanks inlarge part to increased interest inhuman hormone replacement therapy(HHRT, previously referred to as BHRT).

When the Women?s Health Initiativestudy was halted abruptly in July 2002,long-held ideas about hormone replacementtherapy were suddenlychallenged and, in some cases, evenabandoned by patients and clinicians.Many women, however, were unwillingto suffer menopausal symptoms insilence and began to look for alternativetherapies. As a result, the practiceof compounding rose exponentially.

HHRT refers to hormones that arederived from plants and are identical instructure to human steroid hormones.A chemical conversion process isapplied to these plant derivatives, producingpharmaceutical-grade hormonesthat are a direct match to theirbiological counterparts.¹ The benefitsof HHRT for most patients are considerable.In addition to reducing symptomsof hormone imbalance, HHRT isthought to reduce the risk of cardiovasculardisease and osteoporosis.^2-5

Many pharmacists are taking on therole of educating clinicians andpatients about the origins and benefitsof HHRT.⁶ Some pharmacists are actingas consultants, meeting with patientsindividually to discuss symptoms andtreatment options, which are thenpassed along to clinicians for consideration.Continuing education programson HHRT are available for pharmacistsseeking to expand their knowledge,and many of these offer guidance onimplementing patient consultationsinto practice. Most patients embracethe idea of a treatment plan tailoredspecifically to their individual needs.

Because those needs are going to bepatient-specific, the compounding laboratoryshould be able to produce awide variety of dosage forms and combinations.Commonly used HHRT componentsinclude the following²:

• DHEA?a precursor to testosterone,available both by prescription andover the counter; plays a part inenergy levels and libido
• Estradiol?the second most importantcomponent of tri- and bi-estrogenformulas and the primaryestrogen secreted by the ovaries;protects against osteoporosis andcardiovascular disease
• Estriol?a weak estrogen, producedprimarily in the liver; benefits thelower urogenital tract by improvingincontinence and vaginal dryness;typically the largest component oftri-estrogen and bi-estrogen formulations
• Estrone?the third and often smallestcomponent of tri-estrogen formulations,a precursor to estriol andestradiol
• Progesterone?a hormone prevalentduring pregnancy, needed tooppose the stimulatory effects ofestrogen; often decreases symptomssuch as headache, fluid retention,and depression
• Testosterone?present in both menand women; plays a major role inmaintaining energy levels and libido

Dosage forms are individualized toeach patient, and because absorptionrates vary, dosage forms vary from onepatient to the next. Commonly useddosage forms include the following²:

• Capsules?typically made with micronizedpowder
• Sublingual drops?hormone suspendedinto an oil-based liquid
• Suppositories?most often vaginallyadministered and well-absorbed.Progesterone vaginal suppositoriesoften are prescribed for pregnantwomen with luteal-phase defect.
• Transdermal creams?can be a veryeffective route of administration forspecific therapies (such as testosteronecream for enhancing libido;tri- and bi-estrogen formulations;and progesterone)
• Troches?hormones suspended in asemisolid medium

HHRT has successfully brought theart of compounding back to mainstreampharmacy, particularly in thepast 5 years. Experienced pharmacistscan be an invaluable resource for patients,from preparation of compoundedformulations to counseling patientsto marketing HHRT to clinicians.References

1. Francisco L. Is bio-identical hormone therapy fact or fairy tale? Nurse Pract. 2003;28(7 pt 1):39-44.

2. Drisco JA. ?Natural? isomolecular hormone replacement: an evidence-based approach. International Journal of Pharmaceutical Compounding. 2000;4(6):414-420.

3. Granfone A, Campos H, McNamara JR, et al. Effects of estrogen replacement on plasma lipoproteins and apolipoproteins in postmenopausal, dyslipidemic women. Metabolism.1992;41(11):1193-1198.

4. Ettinger B, Genant HK, Steiger P, Madvig P. Low-dosage micronized 17 beta-estradiol prevents bone loss in postmenopausal women. Am J Obstet Gynecol. 1992;166(2):479-488.

5. Prior JC. Progesterone as a bone-trophic hormone. Endocr Rev.1990;11:386-398.

6. Hu FS, Reed-Kane D, Draugalis JR. Patient satisfaction with pharmacist intervention and consultation in hormone replacement therapy: an update. International Journal of Pharmaceutical Compounding. 2006;10(3):187-192.