Measuring potential interest in a postpartum contraceptive vaginal ring among breastfeeding women in India.

Access to safe and effective contraception for postpartum women is an important priority in India, where the unmet need for postpartum contraception is high. In this paper, we estimate the potential market size in India for the progesterone vaginal ring (PVR), a novel user-controlled contraceptive method that offers additional contraceptive choice for lactating women. We integrated results of a one-year phase-3 multicenter clinical trial for the PVR conducted in India with an analysis of the National Family Health Survey (2015-16) and 2019 United Nations Population Division data to generate three estimates of potential market size for the PVR among postpartum breastfeeding women in India. We estimate the potential market size for the PVR ranges from a low estimate of 543,262 women to a high estimate of 1.3 million women, with a separate intermediate estimate of 737,460 women. Our analysis indicates the PVR could play an important role in decreasing unmet need among postpartum women in India, thereby reducing risks to mothers and children associated with short birth intervals, helping to prevent unintended pregnancies, and helping to address access-related issues heightened by the COVID-19 pandemic.

Nestorone nanosuspension-loaded dissolving microneedles array patch: A promising novel approach for "on-demand" hormonal female-controlled peritcoital contraception.

"On demand" hormonal female-controlled pericoital contraception is one strategy which could be used to minimize the impact of unintended pregnancy. Nestorone (NES) is a potent contraceptive, with relatively few side effects in comparison with other contraceptives. NES presents an attractive option for "on demand" pericoital contraceptive. Unfortunately, the drug is inactive if taken orally, but it has high progestational activity and antiovulatory potency if administered parenterally. Current drug delivery systems, such as a transdermal hydrogel are not so satisfactory. Dissolving microneedles array (DMNs) are an attractive alternative, minimally-invasive, delivery system. In this study, we report, for the first time, development of tip-loaded NES-nanosuspension (NES-NS)-loaded bilayer DMNs to deliver NES intradermally for subsequent release. NES-NS was prepared and optimised, freeze-dried and then used to fabricate DMNs using a blend of two biocompatible polymers, namely poly(vinyl alcohol) and poly(vinyl pyrrolidone). Both NES-NS and the NES-NS-loaded DMNs were fully characterised and the performance of the DMNs was evaluated in vivo using Sprague Dawley rats. Results showed that the finalised NES-NS had particle size and PDI values of 666.06 ± 1.86 nm and 0.183 ± 0.01, respectively. The NES-NS-DMNs had relatively high tips-localised drug loading (approximately 2.26 ± 1.98 mg/array) and exhibited satisfactory mechanical and insertion properties. In Sprague Dawley rats, DMNs delivered NES into the skin, with the drug then appearing in blood and rapidly reaching its maximum concentration (Cmax of 32.68 ± 14.06 ng/mL) within 1 h post-DMNs application. Plasma levels above 3.4 ng/mL were maintained for 2 days. This suggests that DMNs are a promising drug delivery system that could be used to deliver NES as an "On demand" hormonal female-controlled pericoital contraceptive.

Estimating the market size for a dual prevention pill: adding contraception to pre-exposure prophylaxis (PrEP) to increase uptake.

INTRODUCTION: Uptake of oral pre-exposure prophylaxis (PrEP) remains low. The objective of this analysis was to estimate the potential market size in priority sub-Saharan African countries for a 28-day dual prevention pill (DPP) regimen containing the active pharmaceutical ingredients in oral PrEP and oral contraceptive pills (OCPs) for the prevention of HIV and unintended pregnancy. METHODS: We selected 15 countries in sub-Saharan Africa for analysis. Population estimates were based on United Nations Population Division data from 2017. Low, medium and high rates (range 0.25% to 25%) of estimated conversion from current contraceptive method to the DPP were applied by country based on HIV prevalence (≥10% vs <10%), current contraceptive method (OCP, condom or unmet need for contraception) and age group (15-24 or 25-49 years). RESULTS: In these 15 countries, between 250 000 and 1.25 million women could switch from their current contraceptive method to the DPP. Given that current PrEP use in the 15 countries combined is estimated to be 113 250 (women and men), the most conservative market size estimate would more than double the number of women currently using PrEP. CONCLUSIONS: By leveraging the existing market for OCPs and assuming modest conversion from condom users and women with an unmet need for contraception, the DPP could lead to a 2- to 10-fold increase in PrEP usage in these 15 sub-Saharan African countries, expanding the broader public health benefit of this proven HIV prevention strategy.