Improvement of stability of polidocanol foam for nonsurgical permanent contraception

BackgroundOur objective was to conduct a pilot study to determine if transcervical administration of polidocanol foam (PF) with or without doxycycline or benzalkonium chloride (BZK) would prevent pregnancy in baboons.MethodsIn study phase 1, adult cycling baboons underwent a hysterosalpingogram to evaluate tubal patency prior to transcervical infusion of 20 mL of 5% PF followed by 1 mL of saline containing 100 mg doxycycline (5%/doxy; n=5), 3% PF plus doxycycline (3%/doxy; n=4), 3% PF with 0.01% BZK (3%/BZK; n=4) or no additional treatment (control; n=9). Immediately following treatment, animals received intramuscular depot medroxyprogesterone acetate (DMPA, 2 mg/kg) to suppress cyclicity during healing and were then socially housed with males of proven fertility. The primary outcome was pregnancy within six cycles of resumption of menses (efficacy phase 1). During study phase 2, PF-treated females from study phase 1 contributed additional cycles (6–8) of exposure (efficacy phase 2), and 5 control females who had recovered from medical abortion (after study phase 1 pregnancy) were subsequently treated with 5% PF (with DMPA) and exposed to breeding (efficacy phase 1; n=3 six cycles, n=2 five cycles).ResultsAll females resumed normal menstrual cycles and mating activity after DMPA. During efficacy phase 1, 7/9 (78%) control females became pregnant. In contrast, fewer pregnancies occurred in PF-treated females: 5% PF 0/5 (0%), 5%/doxy 1/5 (20%), 3%/doxy 1/4 (25%) and 3%/BZK 1/4 (25%). During efficacy phase 2, only one additional pregnancy occurred (3%/BZK).ConclusionsA single transcervical treatment with 5% PF prevented pregnancy in most baboons. Cotreatment with doxycycline or BZK did not improve results.ImplicationsTranscervical intrauterine administration of PF resulted in a high rate of tubal occlusion with prevention of pregnancy; refinements are needed to increase the contraceptive rate following a single treatment to near 100%.

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“…To prepare polidocanol solution containing 0.01% BZK, we added BZK (Sigma-Aldrich 234427) to 3% stock polidocanol solution mixing overnight [9].…”

Section: Methodsmentioning

confidence: 99%

“…We previously reported that the addition of dilute (0.01%) benzalkonium chloride (BZK) (a common preservative) to polidocanol improves the stability of the resulting foam [9]. While unproven, we hypothesize that duration of foam exposure may be associated with greater tissue effects.…”

Section: Introductionmentioning

confidence: 99%

Transcervical administration of polidocanol foam prevents pregnancy in female baboons

et al. 2016

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“…11 Other workers have expressed the foam onto a microscope slide to capture the images. 12 The durability measurements were made in an upturned syringe as described by others. 7,8 Liquid reformation from foams has been shown to be more rapid in vertical rather than horizontal bodies of foam 6 and drainage increases the coarsening rate of foams resulting in drier foam higher in the column.…”

Section: Discussionmentioning

confidence: 99%

Physiochemical properties and reproducibility of air-based sodium tetradecyl sulphate foam using the Tessari method

Watkins

Oliver

2016

Phlebology

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Objectives The objectives were to examine the density, bubble size distribution and durability of sodium tetradecyl sulphate foam and the consistency of production of foam by a number of different operators using the Tessari method. Methods 1% and 3% sodium tetradecyl sulphate sclerosant foam was produced by an experienced operator and a group of inexperienced operators using either a 1:3 or 1:4 liquid:air ratio and the Tessari method. The foam density, bubble size distribution and foam durability were measured on freshly prepared foam from each operator. Results The foam density measurements were similar for each of the 1:3 preparations and for each of the 1:4 preparations but not affected by the sclerosant concentration. The bubble size for all preparations were very small immediately after preparation but progressively coalesced to become a micro-foam (<250 µm) after the first 30 s up until 2 min. Both the 1% and 3% solution foams developed liquid more rapidly when made in a 1:3 ratio (37 s) than in a 1:4 ratio (45 s) but all combinations took similar times to reach 0.4 ml liquid formation. For all the experiments, there was no statistical significant difference between operators. Conclusions The Tessari method of foam production for sodium tetradecyl sulphate sclerosant is consistent and reproducible even when made by inexperienced operators. The best quality foam with micro bubbles should be used within the first minute after production.

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“…However, in recent years, researchers have been working on changing the physical state of such materials and combining them with other substances in order to achieve the high contraceptive effect with significantly reduced side effects. Guo et al proposed that polidocanol were regarded as a detergent-based hardener in the form of foams rather than liquids, which can improve the contact area of the material with the epithelium, increase foam stability while reducing drug concentrations and potentially toxic epithelium-damaging activity [ 121 ]. The addition of benzalkonium chloride (BZK) has been shown to improve the stability of PF.…”

Section: Advanced Biomaterials For Contraception By Various Routesmentioning

confidence: 99%

Recent progress in advanced biomaterials for long-acting reversible contraception

Yan

Zhang

et al. 2022

J Nanobiotechnol

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Unintended pregnancy is a global issue with serious ramifications for women, their families, and society, including abortion, infertility, and maternal death. Although existing contraceptive strategies have been widely used in people's lives, there have not been satisfactory feedbacks due to low contraceptive efficacy and related side effects (e.g., decreased sexuality, menstrual cycle disorder, and even lifelong infertility). In recent years, biomaterials-based long-acting reversible contraception has received increasing attention from the viewpoint of fundamental research and practical applications mainly owing to improved delivery routes and controlled drug delivery. This review summarizes recent progress in advanced biomaterials for long-acting reversible contraception via various delivery routes, including subcutaneous implant, transdermal patch, oral administration, vaginal ring, intrauterine device, fallopian tube occlusion, vas deferens contraception, and Intravenous administration. In addition, biomaterials, especially nanomaterials, still need to be improved and prospects for the future in contraception are mentioned. Graphical Abstract

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Improvement of stability of polidocanol foam for nonsurgical permanent contraception

Cited by 6 publications

References 14 publications

Transcervical administration of polidocanol foam prevents pregnancy in female baboons

Transcervical administration of polidocanol foam prevents pregnancy in female baboons

Physiochemical properties and reproducibility of air-based sodium tetradecyl sulphate foam using the Tessari method

Recent progress in advanced biomaterials for long-acting reversible contraception

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