Pharmacokinetic bioequivalence, safety and acceptability of Ornibel<sup>®</sup>, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring<sup>®</sup> (etonogestrel/ethinylestradiol 11.7/2.7 mg)

Algorta, Jaime; Diaz, M.S; Benito, Raquel de; Lefebvre, Marc; Sicard, Étienne; Furtado, Milton; Regidor, Pedro‐Antonio; Ronchi, Celestino

doi:10.1080/13625187.2017.1413179

Cited by 33 publications

(19 citation statements)

References 9 publications

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“…As the composition of the ring (core containing evatane 28% and skin containing evatane 9%) is different not only a more gradual and constant release because both drugs, but especially etonorgestrel, are in an under-saturation concentration, but also an avoiding of a cold chain for the storage of the ring is possible. This improves the feasibility of the ring making Ornibel ® an evolution in ring technology [ 34 ].…”

Section: New Developments and Future Perspectivesmentioning

confidence: 99%

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

Regidor¹

2018

Oncotarget

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The contraceptive pill is an effective and very safe method to control pregnancies. It was developed 60 years ago, and despite, that the composition has been the same since it was first developed (estrogen and progestogen), along the years the concentration of ethinyl estradiol has been reduced to improve tolerability. Nevertheless, progestogens are the basic active agent of hormonal contraception. The mechanism of progestogens is a multimodal one and basically three modes of contraceptive action can be distinguished:(a) A strong antigonadotrophic action leading to the inhibition of ovulation. The necessary dosage of ovulation inhibition per day is a fixed dosage that is inherent to each progestogen and independent of the dosage of estrogen used or the partial activities of the progestogen or the mode of application. (b) Thickening of the cervical mucus to inhibit sperm penetration and (c) Desynchronization of the endometrial changes necessary for implantation.The on the market available progestogens used for contraception are either used in combined hormonal contraceptives (in tablets, patches, or vaginal rings) or as progestogen only contraceptives. Progestogen only contraceptives are available as daily oral preparations, monthly injections, implants (2-3 years), and Intrauterine Systems (IUS). Even the long acting progestogens are highly effective in typical use and have a very low risk profile, with few contraindications.According to their introduction into the market progestogens, in combined hormonal contraceptives, have been described as first, second, third and fourth generation progestogens. Also, progestogens can be derived from testosterone, progesterone, and spironolactone that determine pharmacodynamic and pharmacokinetic differential effects. These effects contribute to the tolerability and additional beneficial or therapeutic effects whether used in combined oral contraceptives COC or as progestogen only drugs enhancing the individual options for different patient profiles.The new development of polymers for vaginal rings allowed on one side the improvement of the estrogen/progestogen combination in these rings especially regarding the comfort of use for women (avoiding of cold chain use or packages with up to six-month rings e.g.) and on the other side the development of progestogen only formulations. Another future development will be the introduction of new progestogen only pills that will provide effective contraceptive protection with more favourable bleeding patterns and a maintenance of ovulation inhibition after scheduled 24-h delays in pill intake than the existing pop with desogestrel.

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Section: New Developments and Future Perspectivesmentioning

confidence: 99%

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

Regidor¹

2018

Oncotarget

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“…Silicone elastomers are soft, flexible rubber-like materials that have a long history of use in topical and implantable products for a wide range of biomedical and pharmaceutical applications [127,128]. NuvaRing ® is manufactured using two different grades of thermoplastic ethylene vinyl acetate (EVA) copolymer (9 and 28% vinyl acetate grades), while Ornibel ® contains a thermoplastic polyurethane in its drug-loaded core and a 28% vinyl acetate EVA copolymer for the rate-controlling membrane (Table 1) [129,130].…”

Section: Silicone Elastomersmentioning

confidence: 99%

“…Although Ornibel ® has the same active pharmaceutical ingredients, overall dimensions and appearance as NuvaRing ® (Table 1) and provides pharmacokinetic equivalence [130], the polymers used in both the core and sheath are different. With NuvaRing ® , the rate-controlling outer membrane comprises a 9% vinyl acetate EVA, while that for Ornibel ® comprises a 28% vinyl acetate EVA (Table 1).…”

Section: Ornibel ®mentioning

confidence: 99%

The Vaginal Microbiota, Bacterial Biofilms and Polymeric Drug-Releasing Vaginal Rings

et al. 2021

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The diversity and dynamics of the microbial species populating the human vagina are increasingly understood to play a pivotal role in vaginal health. However, our knowledge about the potential interactions between the vaginal microbiota and vaginally administered drug delivery systems is still rather limited. Several drug-releasing vaginal ring products are currently marketed for hormonal contraception and estrogen replacement therapy, and many others are in preclinical and clinical development for these and other clinical indications. As with all implantable polymeric devices, drug-releasing vaginal rings are subject to surface bacterial adherence and biofilm formation, mostly associated with endogenous microorganisms present in the vagina. Despite more than 50 years since the vaginal ring concept was first described, there has been only limited study and reporting around bacterial adherence and biofilm formation on rings. With increasing interest in the vaginal microbiome and vaginal ring technology, this timely review article provides an overview of: (i) the vaginal microbiota, (ii) biofilm formation in the human vagina and its potential role in vaginal dysbiosis, (iii) mechanistic aspects of biofilm formation on polymeric surfaces, (iv) polymeric materials used in the manufacture of vaginal rings, (v) surface morphology characteristics of rings, (vi) biomass accumulation and biofilm formation on vaginal rings, and (vii) regulatory considerations.

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“…The steroid content was etonogestrel 11.7 mg + EE 2.7 mg. Very recently Laboratorios Leon Farma, SA (Chemo Group, Spain), has developed a ring (Ornibel ® ) of the same shape and size with steroid content of 11 mg etonogestrel + 3.474 mg EE (Algorta et al 2013) (Table 9).…”

Section: Vaginal Ringmentioning

confidence: 99%

Hormonal Contraception

Bruni¹,

Dei²,

Pampaloni³

2020

Endocrinology

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Pharmacokinetic bioequivalence, safety and acceptability of Ornibel^®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring^® (etonogestrel/ethinylestradiol 11.7/2.7 mg)

Abstract: Ornibel is bioequivalent to Nuvaring in terms of efficacy, safety, tolerability and acceptability. The new polymer composition provides Ornibel with more stability and gradual hormonal release during the first day of use, particularly for ethinylestradiol.

Cited by 33 publications

References 9 publications

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

The Vaginal Microbiota, Bacterial Biofilms and Polymeric Drug-Releasing Vaginal Rings

Hormonal Contraception

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Pharmacokinetic bioequivalence, safety and acceptability of Ornibel®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring® (etonogestrel/ethinylestradiol 11.7/2.7 mg)

Abstract: Ornibel is bioequivalent to Nuvaring in terms of efficacy, safety, tolerability and acceptability. The new polymer composition provides Ornibel with more stability and gradual hormonal release during the first day of use, particularly for ethinylestradiol.

Cited by 33 publications

References 9 publications

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

The clinical relevance of progestogens in hormonal contraception: Present status and future developments

The Vaginal Microbiota, Bacterial Biofilms and Polymeric Drug-Releasing Vaginal Rings

Hormonal Contraception

Contact Info

Product

Resources

About

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel^®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring^® (etonogestrel/ethinylestradiol 11.7/2.7 mg)