Pellecome Re3™ Advanced Pellet Formulation

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Description

Pellecome provides BHRT pellets for the most common medical problems associated with endocrine imbalance. The hormones associated with endocrine imbalance include estradiol (estrogen), progesterone and testosterone. Subcutaneous implants have been identified as a convenient and practical method for delivering drugs that provides greater assurance that patients will take the prescribed medication and may have a more predictable therapeutic outcome than other delivery methods. [Lin, AAPS PharmSciTech 2001 /p1 A].

Estradiol (estrogen)

Postmenopausal women may suffer from issues associated with aging and estrogen loss that may negatively affect their health. [Hoffman, “The Mature Woman,” Williams Gynecology 2016 /p1 A]

Hormone therapy is usually prescribed using the lowest effective dose and for only the amount of time that is needed based on clinical judgement and the needs of the individual patient. [“The Mature Woman,” Williams Gynecology 2016 /p3 A] Pellecome’s estradiol pellets are available in the following strengths: 10 mg, 15 mg, 20 mg and 25 mg.

Progesterone

Progesterone is a female steroid sex hormone that is secreted by the corpus luteum to prepare the endometrium for implantation and later by the placenta during pregnancy to prevent rejection of the developing embryo or fetus. It is also the name used for any synthetic steroid resembling progesterone in action.

Progesterone is the human hormone made by a woman’s ovaries. Manufactured Progesterone is plant based and acts the same as what is made in the body, hence “bio-identical”. In hormone replacement therapy,  progesterone is combined with an estrogen to lower risks of endometrial cancer in women who still have a uterus. Progesterone may be prescribed daily with estrogen, and this dosing is termed continuous therapy. Pellecome’s progesterone pellets are available in the following strengths: 50 mg, 100 mg and 200 mg.

Testosterone

Testosterone is the main sex hormone (androgen) in men. It is responsible for male physical characteristics. Although it is considered to be a “male” sex hormone, it is present in the blood of both men and women.

Testosterone exerts effects on the male body throughout the life cycle. This process is regulated and stimulated by hormones originating in parts of the brain (the hypothalamus) and the pituitary gland. [Oh, Urological Nursing 2006 /p1 A /p2 A]

A diagnosis of testosterone deficiency may be more likely in men who present with lower than normal testosterone levels and all three of following symptoms: [Khera, Journal of Sexual Medicine 2016 /p1790 A]

  • Erectile dysfunction
  • Decreased libido
  • Decreased frequency of morning erections

Pellecome’s testosterone pellets are available in the following strengths: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg.

All three hormone formulations dissolve and release hormones as well or better than currently available pellets. Tests for testosterone, estradiol (estrogen) and progesterone show no degradation after incorporation into the pellets.

One of the key features of Pellecome’s pellet formulations is that they are manufactured and tested in a regulated manner using rigid quality standards. Pellets and other hormone formulations that are created in a compounding pharmacy may not adhere to the same standards. Thus, what Pellecome provides is a strong measure of predictability and reliability with regard to their manufacturing process and performance once implanted.

The Re3™ Advanced Pellet Formulation provides the clinician with several desirable features:

Feature

Benefit

Hormone pellets are produced under strict manufacturing and quality standards

  • Each pellet delivers a predictable dose of the desired hormone
  • The clinician can be assured that the pellets have been tested rigorously to meet the highest standards

Hormone pellets are available in multiple dosages

  • Patients with different needs can be accommodated
  • Different doses can be provided simply by adding or removing pellets

Pellets are inserted for subcutaneous absorption

  • Variations in blood levels due to gastrointestinal absorption are eliminated
  • Injection-site reactions are minimized as compared to injections

Pellets are inserted using a customized pellet insertion tool

  • Infection rate can be decreased
  • The insertion procedure can be conducted efficiently in a minimal amount of time
  • The kit increases efficiency and provides the confidence that all components have been rigorously tested
  • Sterilization and testing are the responsibility of the operator