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by Deborah H. Clark, RPh, FACVP, PCCA Clinical Compounding Pharmacist
Bacterial vaginosis (BV) is the most common vaginal infection that affects women around the globe. In addition to its effects on total health, BV can significantly impact reproductive wellness. The condition is thought to originate from a decrease of Lactobacilli in the vagina, resulting in an imbalance in the natural vaginal microbiome.1 In the following article, we explore the pathogens associated with BV and challenges with commercial treatments, as well as compounding options and an innovative base that may potentially improve patient compliance.
One of the more common pathogens associated with BV is Gardnerella; however, other pathogens can be present. According to researchers, many studies have demonstrated the relation of Gardnerella vaginalis with other bacteria in causing BV, such as Lactobacillus, Prevotella and anaerobes. In addition, patients with BV may be infected with Mobiluncus, Bacteroides, Peptostreptococcus, Fusobacterium, Veillonella, Eubacterium, Mycoplasma hominis, Ureaplasma urealyticum, Streptococcus viridans and Atopobium vaginae. In many cases, the infecting pathogen will form a biofilm that makes the infection persistent and treatment challenging.2
Most patients present with a complaint of a malodorous discharge; a diagnosis of BV is then made through physical exam and testing. In some cases, physicians will treat empirically, using commercially available antibiotic vaginal suppositories, gels or creams. Clindamycin and metronidazole are two agents that are commonly selected and administered in these patients. When these agents fail to resolve the infection, many practitioners will consult a compounding pharmacist to discuss test results; the compounding pharmacist may then suggest more culture and sensitivity testing for specific bacterial strains.
Additional culture and sensitivity testing will confirm what organisms are present to employ a more targeted approach when choosing active pharmaceutical ingredients (APIs). As stated earlier, a biofilm is normally present, so the addition of a biofilm disrupting agent, such as edetate disodium in a 0.5% concentration, would be a smart addition to the formulation.3
Using the right base vehicle is important when compounding preparations for BV patients. Ellage Anhydrous Vaginal is an excellent option due to its consistent delivery of APIs and potential improvement of compliance.
Ellage contains a self-emulsifying drug delivery system that creates a microemulsion when it contacts vaginal fluid. This emulsion releases APIs from the base into the mucosa. Once the APIs are released, the emulsification system holds the APIs to the surface, prolonging contact time. The combination of excellent release properties and prolonged contact time helps facilitate the action of the antimicrobials used in treating BV patients.
Leakage is a common complaint from patients using vaginal preparations and may affect compliance. In vitro testing (PCCA Document #99816) showed Ellage is likely to adhere to vaginal tissue for a long period of time without leakage or messiness, despite vaginal secretions. In vitro testing (PCCA Documents #99817 and #99818) also showed safety with minimal irritation on the vaginal mucosal tissue and no effect on vaginal pH (PCCA Document #99815). Ellage is an anhydrous vehicle, offering the option of longer beyond-use dates (BUDs*).
Commonly requested formulas for patients with BV include PCCA Formula #13836, PCCA Formula #13858, PCCA Formula #14396 and PCCA Formula #14584.
PCCA members with clinical services access may view and/or download PCCA Ellage formulations — including formulas with FormulaPlus™ BUD and stability studies — after logging on to our Members-Only Website. Clinical services access also allows members to contact our Clinical Services team for additional information on compounding Ellage preparations for patients with BV and other compounding concerns.
*USP 795 establishes BUD limits by type of preparation in the absence of a USP−NF Compounded Preparation Monograph or CNSP-specific stability information.
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These statements are provided for educational purposes only. They have not been evaluated by the Food and Drug Administration, and are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care or encourage its abandonment.