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Intravaginal rings (VRs) have been widely reported for administration of pharmaceutical drugs - most notably estrogens, progestogens and antiretrovirals - to the vagina for clinical benefit. Here, for the first time, we describe the design, manufacture and preclinical testing of VRs for sustained/controlled release of the cervical ripening agents isosorbide mononitrate (ISMN) and misoprostol (MP), either singly or in combination. Matrix-type silicone elastomer VRs containing ISMN showed declining daily release rates, ranging from 31-168 mg (Day 1) to 3-25 mg (Day 11). Novel orifice-type rings, in which a MP-containing silicone elastomer core is partially exposed to the external environment by overmolding with a non-medicated silicone elastomer sheath containing orifices, provided relatively constant daily MP release rates over 14 days (∼20 or 60 μg/day depending on the formulation type). Combination vaginal rings offered simultaneous release of both ISMN and MP over 14 days, with an almost constant MP release rate (60 μg/day) and steadily declining daily ISMN release (295 mg on Day 1 and 24 mg on Day 11). The VR design can be readily tailored to provide sustained or controlled release of ISMN and MP at rates potentially useful for cervical ripening.
This article was published in the following journal.
Name: International journal of pharmaceutics
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This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
A change in the CERVIX UTERI with respect to its readiness to relax. The cervix normally becomes softer, more flexible, more distensible, and shorter in the final weeks of PREGNANCY. These cervical changes can also be chemically induced (LABOR, INDUCED).
Single preparations containing two or more active agents, for the purpose of their concurrent administration as a fixed dose mixture.
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
The insertion of drugs into the vagina to treat local infections, neoplasms, or to induce labor. The dosage forms may include medicated pessaries, irrigation fluids, and suppositories.
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.