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PubMed2002

Evaluation of irritation and sensitisation of two 50 microg/day oestrogen patches.

OBJECTIVES: To comparatively assess the irritation and sensitisation of the Estradot transdermal oestrogen patch, in healthy postmenopausal women, using the Menorest transdermal oestrogen patch, as a comparator. METHODS: In an open-label, single-centre, randomised, active-treatment, within-patient controlled study, 208 healthy postmenopausal women, age range 40-70 years, received and completed simultaneous treatment with a 5 cm(2) (50 microg/day) oestradiol patch (Estradot) and a 14.5 cm(2) (50 microg/day) oestradiol patch (Menorest). The treatment was given for 72 h, then 96 h, for eight successive applications during an induction phase, and for 72 h during a challenge phase. There was a 14-day resting period between phases. Skin irritation (measured by erythema on a scale of 0-4), topical sensitisation, patch adherence and local skin reaction, were assessed and recorded immediately before or after removal of each patch, as appropriate. RESULTS: Most patients experienced a significant difference in irritation with Menorest than with Estradot (P < 0.0001) at the end of the induction phase. Patch loss was also significantly higher for Menorest as compared to Estradot (P = 0.0253) at the end of the induction phase. Most incidences of erythema were classified as slight (score of 1), and there was no significant difference in the percentage of topical sensitisation, or in the incidence of local skin reactions between Estradot and Menorest. Patch loss was low for both systems. CONCLUSIONS: Estradot demonstrates reduced skin irritation, superior adhesion and a lower rate of patch loss compared to Menorest.

Administration, Cutaneous↗

PubMed2004

Transdermal delivery controlled by a chitosan membrane.

The release of a drug from a transdermal delivery system with a rate controlling chitosan membrane was analyzed in vitro and in vivo. Lidocaine hydrochloride, a local anesthetic, was used as the model drug. The in vitro permeability of various chitosan membranes for the drug was investigated using a Franz diffusion cell. Drug release was slower through chitosan membranes with a higher degree of deacetylation (% DD) and with a larger thickness. A transdermal chitosan patch was developed using a chitosan membrane for rate control and a chitosan hydrogel as a drug reservoir. The most prolonged release in vitro was obtained with a 95% DD chitosan rate controlling membrane. The transport mechanism was found to be non-Fickian. The functionality of this transdermal patch was studied on the forearm of human volunteers by assessing the anesthetic effect. Patches with 70% and 95% DD membranes delayed the anesthetic effect, increasing the delay with increasing % DD. It was concluded that a combination of chitosan membrane and chitosan hydrogel is a good transparent system for controlled drug delivery and that the release kinetics in vitro at least for lidocaine have a predictive value for its anesthetic effect in vivo. The demonstration of a direct relationship between in vitro drug membrane permeability and its physiological effect might be considered as quite unique.

Administration, Cutaneous↗

PubMed1996

Recent problems with paracervical vasopressin: a possible synergistic reaction with nicotine.

Vasopressin is now commonly used to control bleeding during surgery of the cervix. In larger intravenous doses, vasopressin can cause coronary artery vasoconstriction and increase systemic vascular resistance. Nicotine has a similar effect on the coronary circulation. The effects of combining both these drugs has not been studied. We describe a 22-year-old woman who developed severe hypotension and bradycardia after receiving a small dose of paracervical vasopressin. She was using a transdermal nicotine patch at the time of her surgery. We suspect her cardiac problems, and recently reported cardiac events in other women receiving small doses of paracervical vasopressin, could be caused by a synergism of the vasoconstrictive properties of nicotine and vasopressin. Caution is urged when vasopressin is to be administered to patients who smoke or use nicotine transdermal patches.

Administration, Cutaneous↗

PubMed2001

[Quality of life and angina pectoris. Comparison of the effects of 2 nitrate derivatives administered discontinuously: transdermal 10 mg nitroglycerine patch (12 hours) and long-acting oral 40 mg isosorbide-5-mononitrate (once a day)].

A comparative, randomised, 12-week (two periods of six weeks) cross-over study including 150 patients (mean age: 63.4 years) suffering from stable but symptomatic (a minimum of three attacks per week) angina pectoris was performed in order to compare the effect on quality of life of two discontinuous nitrate treatments: transdermal 10 mg nitroglycerine patch (12 hours) and long-acting oral 40 mg isosorbide-5-mononitrate (once a day). The efficacy and safety were also compared. The two treatments equally and significantly improved patients' quality of life. The number of attacks and sublingual nitrate consumption significantly decreased under treatment. Attack severity was lower under nitroglycerine than isosorbide-5-mononitrate treatment. Finally, even though nitroglycerine more frequently induced headache than did isosorbide-5-mononitrate (13 cases versus 8), patients, and in particular those having received nitroglycerine treatment in the second period of the study, preferred the transdermal nitroglycerine treatment. In conclusion, results did not show any relevant difference in terms of efficacy or tolerability between the two treatments. Nevertheless, the facility of use and the feeling of protection were better under transdermal nitroglycerine patch than oral isosorbide-5-mononitrate treatment.

Administration, Cutaneous↗

PubMed1996

Transdermal estrogen replacement therapy in normal perimenopausal women: effects on pituitary-ovarian function.

The effects of 6 months of hormone replacement therapy by transdermal estradiol patches (0.05 mg/day for 21 days) and oral progestogens (10 mg/day for 10 days) on hypothalamic-pituitary-ovarian function was evaluated in 32 perimenopausal women, aged 42-47 years, with irregular anovulatory cycles and menopausal symptoms. Hormone levels evaluated on the 8th and 24th day of the cycle preceding therapy showed follicle-stimulating hormone (FSH) levels above 15 mIU/ml, estradiol less than 45 pg/ml and progesterone less than 800 pg/ml. During therapy, there was an improvement in menopausal symptoms, a decrease in luteinizing hormone (LH) and FSH levels, an increase in estradiol levels and the transdermal patches were well tolerated. At the end of therapy, 19 women continued to have regular ovulatory cycles with progesterone levels similar to those in luteal phase. FSH and LH concentrations were significantly lower than before therapy. This study shows that hormone replacement therapy not only improves menopausal symptoms but may also restore the hypothalamic-pituitary-ovarian function.

Administration, Cutaneous↗

PubMed1996

Double blind placebo controlled trial of short term transdermal scopolamine on heart rate variability in patients with chronic heart failure.

OBJECTIVE: To test the hypothesis that short term application of transdermal scopolamine increases heart rate variability (HRV) and restores sympathovagal balance in patients with stable congestive heart failure (CHF). DESIGN: A double blind placebo controlled crossover study. SETTING: Tertiary referral centre. PATIENTS: Twelve patients (mean age 66 (10)) with New York Heart Association class II-IV CHF. All patients had coronary artery disease (mean left ventricular ejection fraction 26.7 (8.9) %). INTERVENTION: Patients were randomly assigned to receive either a placebo skin patch or a transdermal scopolamine patch (Transderm, 0.05 mg/h). Patches remained in place for 48 hours with a 24 hour washout period before crossover. OUTCOME MEASURES: HRV was derived from (a) 24 hour time domain indices (mean RR interval, standard deviation of interbeat interval, and the baseline width of the frequency distribution of RR intervals) and (b) short data set (2.2 mm) power spectral measurements using autoregressive modelling. Autospectral measures were performed in both resting supine and standing (orthostatic) states. The 24 hour Holter record was obtained during the second day of patch application. RESULTS: There was a small but significant (P < 0.05) increase in all time domain HRV variables with scopolamine. There was a paradoxical fall in low frequency (LF) spectral power induced by orthostasis during baseline (-30%) and placebo (-34%) states. Conversely, scopolamine was associated with a 14% increase in LF power during orthostatic stress. Scopolamine thus significantly reduced the orthostatic fall in LF (P < 0.01) compared with either baseline or placebo values. No difference in circadian rhythm was seen between the scopolamine and placebo treatment periods. However, the abrupt fall in the high frequency (vagal) power during the early morning sleep-wake hours was reduced by scopolamine. Scopolamine was also associated with a significant rightward shift in the resting LF central frequency consistent with a vagomimetic effect. CONCLUSION: Patients with chronic stable CHF showed a paradoxical fall in the low frequency (sympathetic) power during orthostatic stress. Transdermal scopolamine applied over a 48 hour period partially restored the balance between sympathetic tone and vagal activity in CHF patients and maintained this balance during orthostatic stress.

Administration, Cutaneous↗

PubMedDate not supplied

HRT dosing regimens: continuous versus cyclic-pros and cons.

The introduction of new products, lower dosages, and better continuous and cyclic regimens allows for individualized treatment aimed at minimizing risk and side effects, while maximizing confidence and compliance. Since the major side effect of HRT that discourages long-term use is vaginal bleeding, newer regimens are designed to minimize it. The lowest doses of estrogen currently approved by the FDA for prevention of osteoporosis include 0.3 mg esterified estrogens, 0.025 microg transdermal estradiol patch, and 0.5 mg micronized estradiol. In most naturally menopausal women or those over 65 years of age, conjugated estrogen 0.3 mg (with adequate calcium intake) is protective against bone loss and cardiovascular disease. These low doses are often used with cyclic progestins every 3 to 4 months. Advantages of cyclic therapy using low-dose estrogen include minimal progestin exposure, low rate of withdrawal bleeding, lowered side effects, and, often, higher comfort level. Cyclic estrogen regimens with higher doses have been in use longer, but they often necessitate more frequent progestin treatment and may result in cyclic bleeding or breast tenderness. While HDL- and LDL-cholesterol changes are greater and more beneficial during higher-dose oral cyclic therapy, the large increase in triglycerides is of concern. The most commonly used continuous combined regimens include conjugated estrogen plus daily progestin orally or the combination estradiol/norethindrone acetate transdermal patch. Continuous combined regimens are simple and easy-to-use, and are designed to minimize bleeding. Multiple studies suggest that the mechanism of benefit provided by estrogen goes beyond estrogen's favorable impact on lipoproteins, which is blunted by daily use of synthetic progestins.

Animals↗

PubMed1950