What Sets Belmar Apart – The BLA™ System

The answer is Orally Effective Tablets

Belmar Pharmacy has been compounding bio-identical hormone replacement therapies for over 22 years.  Based upon the relationship we have with you and your practioneer we are able to formulate just the right combination of hormones and their dosages for you.  We offer the following forms of BHRT and Andropause:

• Orally effective tablets (efficacy achieved using a lipid matrix)
• Topical Creams and Gels
• Sublingual Tablets and Troches
• Vaginal and Rectal Suppositories and Creams

Orally Effective Tablets

What sets Belmar Pharmacy apart from all other compounding pharmacies is our oral tablet form of BHRT and Andropause.  Our oral tablets are formulated using a system we developed called BLA™.  The BLA™ system was developed so that any single or combination of steroid hormone prepared using this system will avoid the “first pass affect” of the liver so it can be systemically absorbed by the body.  Belmar Pharmacy is the only compounding pharmacy in the United States using the BLA™ system.   

The BLA™  System

BLA™ stands for Bio-Available Lymphatic Absorption.  The BLA™ system represents Belmar’s proprietary method used to prepare our formulations. Belmar tablets begin with natural hormones derived from soy or yam sources and purified by a major pharmaceutical company into bio-identical hormones. Bio-identical means identical to what your body produces. Ingredients included in the BLA™ system (in addition to the active ingredient) include binding and flow agents.  All materials in our tablets are gluten free, contain all natural ingredients and do not contain dyes.  For a discussion about the science behind the BLA™ System refer to The Science of Lymphatic Absorption below. 

The Benefits of Belmar Tablets

There are many conveniences associated with Belmar tablets when compared to other BHRT or Andropause dose forms.  Creams and Gels can be messy, time consuming, inconsistently applied and spread by direct contact to loved ones who don’t need a dose of your hormones. They may be rubbed off your skin or on to your clothes resulting in a partial loss of the needed dose.

Dissolvable dose forms like sublingual tablets and troches are limited by their size and often have a bitter taste. To some extent the’ juice’ formed when dissolving is swallowed and the drug is not absorbed orally. This results in loss of some of the dose. When a sublingual dose dissolves too rapidly part of the dose may also be lost by swallowing.   

Oral capsules compounded for BHRT or Andropause are involved in the “first pass affect” which means the dose is not adequate or metabolized to ineffective or inadequate metabolites. Belmar’s oral tablet formulation avoids the “first-pass affect” due to lymphatic absorption. 

Belmar BHRT Tablets—The History

During the early 1980’s Belmar Pharmacy set out to develop a bio-identical oral tablet for hormone replacement therapy knowing that if this could be done they would eliminate the inconveniences of typical forms of BHRT.  Belmar believed that an oral tablet would provide consistency and convenience.  It is generally accepted that the most convenient dosage form is an oral tablet. 

Accomplishing the goal of creating an oral dosage form of BHRT involved refuting some very entrenched beliefs about the body’s inability to effectively absorb bio-identical hormones from the intestine.  Even today a majority of practitioners believe that natural steroid hormones are not effectively absorbed when given by mouth due to portal uptake and the “first-pass affect”. 

The Science of Lymphatic Absorption

Figure 1: Structure of Villi showing arteries, veins and the Central Lacteal. Rhoades, R. and Pflanzer R., Eds. The Gastrointestinal System. Human Phisology, 2nd Ed. Saunders College Publishing; 1992: 777-822

The absorption process for BLA™ lipid system is a digestion method of micelle production and the lymphatic pathway.  These small micelles diffuse rapidly into the epithelial cells that line the villi of the intestinal wall. Inside the cell the micelle releases the BLA™ lipid system and a Chylomicron is formed.

Chylomicrons are much larger than a micelle and must enter the Central Lacteal of the villus instead of the portal veins to the liver. The chylomicrons are carried to the general circulation of the body by way of the thoracic duct and left jugular vein.1,2 (See figure 1)  This lymphatic absorption by passes the “first-bypass affect”.

Figure 2:  Structure of Lipid Absorption and Chylomicron entering the Central Lacteal (cellular phase). Rhoades, R. and Pflanzer R., Eds. The Gastrointestinal System. Human Phisology, 2nd Ed. Saunders College Publishing; 1992: 777-822

Belmar has been compounding BHRT and Andropause tablets using our proprietary BLA™ system for over 15 years.

Lymphatic to Systemic Absorption

It is known in the literature that topical, sublingual, rectal, vaginal and injections of BHRT and Andropause bypass the liver, “first pass affect”, by entering the systemic circulation first. It is also well known in the literature that steroid hormones taken orally enter the portal system directly to the liver and are metabolized before entering the systemic circulation and are not effective or are risky to take.

Moreover, it is well documented in the literature that fats and lipids are orally absorbed into the lymph system from the intestines. This is a way to emulsify the fat to effectively mix with the blood and bypass the portal system.

Therefore, it can be said taking a Belmar tablet of BHRT or Andropause ingredients formulated with the BLA™  system will “act like’ hormones given in topical, sublingual, rectal, vaginal or injection by virtue of going directly to the systemic circulation and avoiding the liver, “first bypass affect”.

Steroid hormone tablets formulated using the BLA™  system  follow the theory taught by Trevaskis et al.3

An oral capsule of Micronized Steroid Hormone, regular release or delayed release is only partially effective compared to a BLA™ lipid-matrix tablet prepared by Belmar. (data on file).

Steroid Hormones

The steroid hormones we tablet include both the individual hormone and / or combinations of the following:

• Pregnenolone
• Progesterone
• Estrogens (Estrone, Estradiol, Estriol)
• Testosterone
• DHEA

References:

1. Rhoades, R. and Pflanzer R., Eds. The Gastrointestinal System. Human Phisology, 2nd Ed. Saunders College Publishing; 1992: 777-822.
2. Guyton A.C. and Hall J. E. Digestion and Absorption in the Gastrointestinal Tract. Textbook of Medical Physiology, 9th Ed. W.B. Saunders Co. 1996: 833-844.
3. Trevaskis NL, Porter CJ, Charman WN. The lymph lipid precursor pool is a key determinant of intestinal lymphatic drug transport. J Pharmacol Exp Ther. 2006 Feb; 316(2):881-91.