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BHRT PELLET HORMONE THERAPY

What is Pellet Therapy?

Bio-identical Pellet Hormone therapy is an alternate type of bioidentical hormone replacement in which tiny slow release pellets are inserted into the subcutaneous tissue (just under the skin). The office procedure is quick and virtually painless, and last for 4-6 months depending on the person’s metabolism, physical activity, stress, and dosing.

Experience the Pellet Difference!

  • Avoid the mess of creams, gels, and lotions*
  • No more painful injections*
  • Available for Men and Women*
  • No more hormone “yo-yo” levels*
  • Experience a steady release of hormones*
  • Bio-identical plant based hormones (derived from yams), USP grade, PVP Free*
  • Last 4-6 months (so no more frequent office visits for injections*
  • *These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

Prescribers: Please contact us for pricing and order process information. Pavilion Compounding is licensed as a 503A compounding pharmacy. A valid prescription order for an individual patient is required. Prescriptions may be verbally called in, faxed, or e-prescribed.

Patients: If you need recommendations for providers in your area who are familiar with BHRT Fused Pellet Implants, please contact us for more information!

Pavilion Compounding Pharmacy preforms all of the following important quality control processes:

Sterilization: E-beam irradiation is currently the best method for sterilization. Autoclaving does not comply with USP Chapter <797> in regards to sterilization of this dosage form. E-beam irradiation is the only validated method to penetrate and sterilize the entire pellet. E- Beam irradiation is less harsh to the pellets, provides an environmentally friendly technique using on-off technology, faster turn-around time for timely delivery to our patients, and is less stressful to the active drugs.

Dose Map Verification: This report establishes the E-beam dose that is required to ensure pellet sterility and integrity.

Dose Audits: Dose audits are performed to ensure that pellets are sterilized at the minimum dose established in the Verification protocol and that the inherent product bio-burden has not changed. Bio-burden testing is preformed with each dose audit to ensure that the conditions in which the pellets are made meet the required regulations. Dose Audits are preformed quarterly.

Sterility Reports: These reports are generated by third party labs to ensure each batch of pellets is sterile.

Potency Reports: Potency testing analyzes the active pharmaceutical ingredient(s) in preparations and measures their concentrations or amounts. When testing for potency, the concentration of active ingredient is measured using a reference standard. Pavilion’s third party lab performs potency tests by using state of the art High Pressure Liquid Chromatography (HPLC) equipped to a PDA detector, Ultra High Pressure Liquid Chromatography (UHPLC) equipped to a PDA, and Corona Detector and Spectrographic instrumentation. These instrumentations are the preferred methods for pharmaceutical analysis. Protocols have been developed based on USP <621> Chromatography and USP <851> Spectrophotometry and Light-Scattering methodology.

Method Suitability: This important test is to ensure that false negatives do not occur with sterility testing. The suitability test verifies that microorganisms will grow in the test media if they are present in the preparation using the specified testing method process.

USP Quality: The highest quality pellets only contain USP grade hormone powder (testosterone or estradiol) and USP stearic acid. Fillers such as PVP should be avoided as they may cause local irritation.

Please ask to see our reports and documentation!

Have questions or concerns? Please call or email to get in touch with one of our experienced clinical pharmacists today!

Pavilion Compounding Pharmacy has over 20 years of experience compounding BHRT Fused Pellet Implants. We look forward to helping you achieve wellness!

p: 404-350-5780

f: 404-350-5640

Staff@pavilionrx.com

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