Polycarbophil-containing Bioadhesive Gel: It’s What Makes Crinone 8% Different
- Nonimmunogenic and hypo-allergenic
- Adheres to vaginal epithelium for controlled and sustained release1–4
- Assures diffusion of progesterone from cervix to uterine fundus3
- Avoids reliance on local moisture2
Adheres upon administration
A key ingredient in Crinone 8% vaginal progesterone gel, polycarbophil is a unique nonimmunogenic, hypo-allergenic, bioadhesive polymer. Polycarbophil adheres to the vaginal epithelial cells. Once in place, the bioadhesive gel releases the active drug in a controlled and sustained manner until it is discharged upon normal cell turnover.1–4
Benefits of controlled, sustained release
Controlled, sustained release ensures the full benefit from vaginal administration because progesterone requires approximately 4 to 5 hours to diffuse from the cervix to the fundus of the uterus and achieve steady-state tissue levels.3
Finally, Crinone 8% gel is formulated with an emulsion that promotes more reliable absorption because the water phase is inherently provided. This avoids reliance on local vaginal moisture, which is quite variable.2
References: 1. Anlar S, Capan Y, Hincal AA. Physico-chemical and bioadhesive properties of polyacrylic acid polymers. Pharmazie. 1993;48:285–287. 2. Warren MP, Biller BMK, Shangold MM. A new clinical option for hormone replacement therapy in women with secondary amenorrhea: effects of cyclic administration of progesterone from the sustained-release vaginal gel Crinone (4% and 8%) on endometrial morphologic features and withdrawal bleeding. Am J Obstet Gynecol. 1999;180:42–48. 3. Bulletti C, de Ziegler D, Flamigni C, et al. Targeted drug delivery in gynaecology: the first uterine pass effect. Hum Reprod. 1997;12:1073–1079. 4. Park H, Robinson JR. Physico-chemical properties of water insoluble polymers important to mucin/epithelial adhesion. J Control Release. 1985;2:47–57.
Important Safety Information
The most common side effects of CRINONE (progesterone gel) 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active, or a history of, thrombophlebitis or thromboembolic disorders, patients who have known sensitivity to CRINONE 8%, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. Should any of the earliest manifestations of thrombotic disorders occur, the drug should be discontinued immediately. No adequate evidence is available to show that progesterone and progestins are effective in preventing miscarriage in women with a history of recurrent spontaneous pregnancy losses. The pretreatment physical exam should include special reference to breast and pelvic organs as well as a Papanicolaou smear. Nonfunctional causes of breakthrough bleeding should be considered, and for undiagnosed vaginal bleeding, diagnostic measures should be undertaken. Special care should be taken with patients who have conditions that may be influenced by fluid retention, those who have a history of psychic depression, and those with diabetes.