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Contraceptive Technology Update. 2004 Feb; 25(2): p..Successful pill-taking is an important component for women who use oral contraceptives (OCs). Inconsistent use and method discontinuation are estimated to account for approximately 20% of the annual 3.5 million annual unintended pregnancies in the United States. Will a chewable contraceptive aid in pill-taking compliance? The Food and Drug Administration (FDA) has just approved the first such product. Look for the launch of Ovcon 35 in late spring, says Katie MacFarlane, PharmD, vice president of marketing for Galen Holdings and Warner Chilcott, based in Rockaway, NJ. When a pill is reformulated into a chewable form, it must be flavored to mask the chalky taste of the active ingredient, says Jeff Worthington, managing director of food and pharmaceutical technologies at Cambridge, MA-based TIAX, an independent and privately held technology development and consulting firm that aids companies in developing palatable pharmaceuticals, nutritional products, foods, and beverages. (excerpt)
Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?
CONTRACEPTION. 1991 Feb; 43(2):139-47.Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives (OCs) and brand name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, OC packaging is unique to each manufacturer, and any change in brands (and thus in packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons suggested for placing OCs into the critical drug category, where generic substitution and interchangeability of products should not be allowed. (author's)
Chestnut Hill, Massachusetts, Pathfinder Fund. 1975; 2.2 oral contraceptives provided by the Pathfinder Fund, Norinyl 1/50 and Norinyl 1/80, were discussed in a guide to their use, covering pharmacology, selection of dose, packaging, and management. These drugs, composed of 1 mg norethindrone, a moderately progestational agent and either 50 mcg or 80 mcg of mestranol, act through suppression of gonadotrophin release from the hypothalamus, altering the cervical mucus and interfering with transcervical sperm migration and sperm capacitation. For most women Norinyl 1/50 is an effective preparation. Spotting or breakthrough bleeding may occur in the first 2-3 months use. Persistent bleeding is treated by doubling the dose for 2 or 3 days in these patients and in patients treated with the larger dose having bleeding problems. Contraindications are a history of thromboembolism or cancer or clinically significant hypertension, and these contraceptives should be used with caution with hepatic disease or undiagnosed abnormal uterine bleeding. The pills come in packages of 28 pills - 3 rows of 7 white pills and 1 row of brown ferrous sulfate pills. Norinyl 1/80 is packaged with a diagonal blue line to distinguish it from 1/50. Pills are started on day 5 of the menstrual cycle and taken every day thereafter. Procedure for a forgotten pill is explained. Women should be informed of side effects that may occur in early days of use. Circumstances requiring withdrawal of this treatment were enumerated. This preparation provides almost complete contraceptive effectiveness with discontinuation rates for pill related reasons, 2-10%.
Piact Product News. 1983 Dec; 5(1):4.when a major donor of contraceptives changed the packaging specifications of norethindrone/mestranol oral contraceptives (OCs), the change raised some questions as to product shelf life. The new specifications called for the OCs to be packaged in bulk with 100 blister packs/aluminum/plastic overpack. These revised packaging specifications would lead to removal of the blister pack from the protective overpack at an earlier point in the supply chain, and therefore to earlier potential exposure to high temperatures and humidity. However, stability trials conducted by Kabalikat ng Pamilyang Pilipino in Manila have shown no significant deterioration in norethindrone or mestranol content, content uniformity, tablet hardness, disintegration time or blister pack integrity after blister packs without the protective overpack were exposed for 6 months to high humidity and temperatures as high as 60 degrees Celsius. Stability for longer than 6 months remains speculative and should be tested in actual field conditions. Within the limits of the study, however, these results suggest that OCs remain stable with or without the aluminum overpack. (full text)