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PubMed2001

Formulation of a reservoir-type testosterone transdermal delivery system.

A reservoir-type transdermal delivery system of testosterone (TS) was developed using an ethanol/water (70:30) cosolvent system as the vehicle. The maximum permeation rate achieved by 70% (v/v) of ethanol was further increased from 2.69 to 47.83 microg/cm(2)/h with the addition of 1.0% dodecylamine as the skin permeation enhancer. The permeation rate of TS through the ethylene vinyl acetate (EVA) membrane was observed to increase as the vinyl acetate content in the copolymer increased. Addition of 1.0% (w/w) gelling agent, hydroxypropyl methlycellulose (HPMC), in the reservoir formulation resulted in desirable rheological properties with an insignificant effect on the skin permeation rate of TS. Thus, a new transdermal delivery system for TS was formulated using EVA membrane coated with a pressure-sensitive adhesive (Duro-Tak 87-2510) and HPMC as a gelling agent. This experimental patch showed comparable plasma concentration profiles in the in vivo study when compared with a commercial product, Androderm(R). Moreover, the results suggested the possibility of further enhancing the permeation rate of TS by controlling the composition of the reservoir formulation.

Administration, Cutaneous↗
PubMed1993

Low doses of scopolamine increase cardiac vagal tone in the acute phase of myocardial infarction.

BACKGROUND: Reduced cardiac vagal tone in patients with myocardial infarction (MI) is associated with a high risk of sudden death. Muscarinic blocking agents in small doses induce a paradoxical increase in cardiac vagal activity in normal subjects. We tested whether low doses of scopolamine delivered transdermally enhance tonic and reflex cardiac vagal activity in patients in the acute phase of MI. METHODS AND RESULTS: Patients were randomized to a scopolamine (n = 17) or a placebo patch (n = 19) in a double-blind fashion 4.20 +/- 0.18 days after acute MI. Cardiac vagal activity was assessed by testing the arterial baroreflex sensitivity (BRS) using the phenylephrine method and by power spectral analysis of the RR interval variability. Twenty-four hours after scopolamine, we found a significant increase in BRS (from 7.05 +/- 1.21 to 13.99 +/- 2.33 ms/mm Hg, P < .05) and in RR variability, expressed as the mean standard deviation of 512 normal consecutive RR intervals (from 18.09 +/- 2.64 to 31.16 +/- 4.16 milliseconds, P < .05). The amplitude of respiratory sinus arrhythmia, measured by the absolute power of the high-frequency spectral component, was also enhanced (from 62.55 +/- 21.49 to 305.33 +/- 95.68 milliseconds squared, P < .05), whereas the power in the low-frequency spectral component of the RR variability, which results from the interaction between cardiac sympathetic and vagal activity, did not change significantly (from 73.12 +/- 24.44 to 126.46 +/- 44.29 milliseconds squared, P = .93). CONCLUSIONS: In patients in the acute phase of MI, low doses of scopolamine cause a sustained increase in cardiac vagal tone and improve the autonomic indices associated with mortality.

Arteries↗
PubMed1985

Sustained effects of transdermal nitroglycerin in patients with angina pectoris.

The antianginal efficacy of a transdermal therapeutic delivery system for nitroglycerin (TNG) was compared with that of placebo in a double-blind crossover study. Twenty-five patients with stable angina pectoris were evaluated. The transdermal system delivered 5 mg of nitroglycerin over a 24-hour period and was applied once every 48 hours. Treadmill exercise testing (Bruce protocol) was done 48 hours after the patch was applied in the first phase of the crossover and at the conclusion of the second phase of the crossover, 48 hours after the final dose of the second treatment. Exercise performance was significantly improved (P less than 0.05, analysis of covariance) with TNG as compared with placebo, as were frequency of episodes of angina and nitroglycerin consumption (P less than 0.05, analysis of variance). The incidence of mild-to-moderate headache in patients was greater during treatment with TNG (20%) than during placebo treatment (6.7%). Four cases of mild transient dermatitis and occasional reports of dizziness, lightheadedness, and nausea were noted.

Administration, Topical↗
PubMed2002

Preparation of cycles for cryopreservation transfers using estradiol patches and Crinone 8% vaginal gel is effective and does not need any monitoring.

Supernumary pronucleated stage oocytes (PN) can be cryopreserved and later transferred in spontaneous, stimulated or artificial cycles. In this study, we re-evaluated 342 artificial cycles with a transdermal estradiol release system (Estraderm TTS 100) in combination with a vaginal progesterone delivery system (Crinone 8%). Endometrial thickness and serum estradiol on day 14 were correlated with clinical and ongoing pregnancy rates. Endometrial thickness between 7 and 15 mm did not relate to significantly different pregnancy rates. The estradiol serum level did not predict success. In conclusion, this method of endometrial preparation is comfortable for patients and monitoring is unnecessary.

Administration, Cutaneous↗
PubMed1997

The influence of smoking and of oral and transdermal nicotine on blood pressure, and haematology and coagulation indices.

Nicotine is helpful in stopping smoking but its influence on cardiovascular risk factors is incomplete. Our aim was to determine its effect on blood pressure, routine haematology indices, and coagulation indices relevant to thrombosis. Eighteen subjects were seen whilst smoking (cotinine levels 1119 +/- 414 ng/ml), again after stopping smoking but while using nicotine chewing gum and/or skin patches (392 +/- 198 ng/ml), and again when not using nicotine (cotinine undetectable). There were no significant changes in blood pressures, platelet count, mean platelet volume, viscosity or anti-thrombin III. However, white blood cell count (p = 0.003), lymphocyte count (p = 0.016), red blood cell count (p = 0.02), haemoglobin (p <0.001), fibrinogen (p <0.001) and von Willebrand factor (p = 0.001) all fell between the first and second samples (when still using nicotine) but not between the second and third samples (when off nicotine). Oral and/or transdermal nicotine does not influence blood pressure or the haematology and coagulation indices we have measured.

Administration, Cutaneous↗
PubMed2003

Effects of transdermal estrogens on endothelial function in postmenopausal women with coronary disease.

OBJECTIVE: Oral estrogens improve endothelial function, and for this reason may be considered cardioprotective; however, in women with coronary heart disease there may also be an increase in the risk of thrombosis. Although transdermal estrogen administration may decrease this adverse effect, there are few data on endothelial function in women with coronary heart disease treated using such therapy. This study aimed to report the endothelial response in postmenopausal women with coronary heart disease treated with transdermal estrogen. MATERIALS AND METHODS: This was a double-blind, prospective, randomized study. Eighteen patients with a history of acute coronary syndrome and nine healthy women were studied over 4 weeks. Coronary patients were assigned at random to receive a patch containing either 50 microg estradiol or placebo on a weekly basis. Endothelial function was assessed by flow-mediated vasodilatation of the brachial artery. Baseline blood flow (brachial artery diameter) was measured after 30 min rest and following ischemia, prior to treatment and after 4 weeks. RESULTS: Flow-mediated vasodilatation in normal patients was 17.8%, whereas in women with coronary disease it was 1.2% (p = 0.0001). Arterial diameter for the resting period in coronary disease subjects increased from 4.22 +/- 0.59 to 4.41 +/- 0.56 mm (p < 0.004) after 4 weeks of estrogen therapy, whereas, in women receiving placebo, it did not change. Flow-mediated vasodilatation in the estrogen group was 3.4% and in the placebo group was 0.5% (p = 0.05). CONCLUSIONS: Transdermal estrogen may improve endothelial function in women with coronary heart disease.

Administration, Cutaneous↗
PubMed2004

Transdermal nicotine use in postmenopausal women: does the treatment efficacy differ in women using and not using hormone replacement therapy?

This study of postmenopausal female smokers (N = 94) asked: During short-term smoking abstinence, do the beneficial effects of transdermal nicotine replacement therapy (NRT) on acute symptomatology (i.e., withdrawal, cigarette craving, smoking urges, mood, depressive symptoms, motor speed, and reaction time) differ in women who use and do not use hormone replacement therapy (HRT)? Participants were recruited according to HRT and non-HRT use (self-selecting), then randomized within strata to active nicotine or placebo nicotine patch. After 1 baseline week of smoking, participants quit smoking for 2 weeks. Women received cessation counseling and were monitored for abstinence. Dependent measures were collected during five clinic visits. Two-way analysis of covariance (ANCOVA) were run on change scores for dependent variables, with nicotine patch group (active/placebo) and HRT group (HRT/non-HRT) as independent variables and age as a covariate. No interactions were found between HRT and patch condition, but both showed specific effects. During the first abstinent week, women on active nicotine patch (compared with placebo) experienced less severe withdrawal, greater reductions in cigarette cravings, and lower (more favorable) Factor 1 scores on the Questionnaire of Smoking Urges. During the second abstinent week, women using HRT (compared with the non-HRT group) exhibited better mood (Profile of Mood States scores) and less depression (Beck Depression Inventory scores). These results suggest the following: First, the efficacy of transdermal nicotine replacement is not adversely modified by women's HRT use; second, ovarian hormones might influence women's responses to smoking cessation, and thus should be considered in developing effective strategies for women to quit smoking.

Administration, Cutaneous↗
PubMed2006

Visual side-effects from transdermal scopolamine (hyoscine).

Transdermal scopolamine may be used to reduce drooling in children with disabilities. Side-effects include dilated pupils and a reduction in the near point of accommodation (the closest point at which clear vision is possible). Two male children with epilepsy, one with spinal dysraphism (aged 7y 6mo) and one with cerebral palsy (aged 5y 8mo), who have undergone treatment for drooling with transdermal scopolamine are described. Near visual acuity was reduced, and both children showed dilated pupils with reduced or no response to light. These responses became normal on cessation of the scopolamine patch. As the effect of this drug may be cumulative, and many patients are unable to communicate difficulties, clinicians need to be aware of these possible side-effects.

Administration, Cutaneous↗
PubMed1989

Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine.

The authors evaluated the antiemetic properties of transdermal scopolamine (TDS) in healthy patients undergoing elective cesarean section and receiving epidural morphine for postoperative analgesia. Prior to administration of anesthesia, 203 patients had either TDS or a placebo study patch applied behind one ear. All patients were hydrated with lactated Ringer's solution iv and given 2.0% lidocaine with 1:200,000 epinephrine epidurally for surgical anesthesia. Following delivery of the infant, 4 mg of morphine sulphate was injected through the epidural catheter. After the operation patients were evaluated by "blinded" observers at 2, 4, 6, 8, 10, 24, and 48 h for nausea, vomiting, retching, pain relief, itching, and adverse effects. In addition, medications received were noted. No differences were found between the groups in terms of severity or incidence of pain, or requests for analgesic or antipruritic medication. Although there was no difference between the groups in the first 2 h, patients with TDS had significantly less nausea, vomiting, and retching than patients in the placebo group in each time interval between 2 and 10 h. Additionally, the TDS group required less antiemetic medication. There was no difference in the frequency of retching or vomiting between groups. Side effects were minimal and equal in both groups. The authors conclude that TDS results in a decreased incidence of nausea and vomiting in patients who have delivered by cesarean section and received epidural morphine. TDS appears safe for continuous antiemetic administration.

Administration, Cutaneous↗
PubMed2002

Post-abortion depot medroxyprogesterone acetate continuation rates: a randomized trial of cyclic estradiol.

Irregular menstrual bleeding is a common reason for discontinuation of depot medroyprogesterone acetate (DMPA) contraception. We conducted a double-blind, randomized placebo controlled trial to estimate if transdermal estradiol used in a cyclic fashion could make DMPA bleeding patterns more acceptable and improve DMPA continuation rates. Women initiating DMPA contraception immediately post-abortion (N = 132) were randomized to receive either a low sustained dose of transdermal 17-beta estradiol (0.10 mg/day, Climara) or an identical placebo to be used in a cyclic manner for 3 months. Bleeding patterns, contraceptive use, and pregnancy rates were measured for 1 year after enrollment. Cyclic transdermal estrogen did not create regular bleeding patterns in new users of DMPA and had no effect on DMPA continuation rates (relative hazard = 0.93, 95%CI 0.65-1.33). By 12 months after enrollment, 19.4% of those randomized to estrogen and 23.9% of those randomized to placebo were still using DMPA for contraception. There was no difference in the frequency of DMPA discontinuation primarily for abnormal uterine bleeding between groups (relative risk ratio = 0.95, 95%CI 0.40-2.23). Few women who discontinued DMPA switched to highly effective methods of contraception and within 1 year of an abortion, there were 18 repeat pregnancies (21.9%). Compliance with the estrogen patches was poor resulting in early study termination and inadequate statistical power to detect a clinically significant difference in DMPA continuation rates. Continuation rates of DMPA were low and repeat pregnancy rates were high among women initiating DMPA at the time of abortion. Cyclic transdermal estradiol use is an unacceptable regimen for preventing the irregular bleeding associated with DMPA initiation.

Abortion, Induced↗
PubMedDate not supplied

Effects of transdermal nitroglycerin in children with congestive heart failure: a Doppler echocardiographic study.

The aim of this study was to evaluate by Doppler echocardiography whether administration of transdermal nitroglycerin (NTG) to children with congestive heart failure could modify mitral flow velocity profile with redistribution of left ventricular filling to late diastole, suggesting preload reduction of the left ventricle. Twelve children with congestive heart failure, aged from 6 months to 6 years (2.83 +/- 2.24 years; mean +/- SD), were recruited. Patients were randomly allocated either a NTG patch (study group; n = 6) or a placebo patch (control group; n = 6) in a double-blind procedure. The NTG patch was a 10-cm(2) patch releasing 5 mg of NTG per day. NTG patches were adjusted to a dose of 1 cm(2)/kg/day (0.5 mg/kg/day). Peak velocity and time--velocity integral (TVI) of E and A waves of transmitral flow, the ratio of the velocities of the A wave and E wave, and the ratio of the TVI of the A wave to the TVI of the E wave were measured. Doppler measurements were determined before treatment (H0) and 4 hours (H4) and 23 hours (H23) after the patch application. Relative changes of these parameters were not significantly different between these two groups. In the NTG group, mean NTG plasma concentration was 1.08 +/- 0.47 microg Liter(-1) at H4 (n = 5) and 1.18 +/- 0.81 microg Liter(-1) at H23 (n = 5). No patient had a NTG plasma concentration greater than 2 microg Liter(-1) either at H3 or at H24. These data suggest that 1 cm(2)/kg transdermal doses of NTG may have a limited bioavailability or a higher clearance and minimal hemodynamic effects in children with congestive heart failure already receiving other medications, implying that higher doses should be used.

Administration, Cutaneous↗
PubMed1997

Hemodynamic effects of transdermal estradiol alone and combined with norethisterone acetate.

A 24 weeks, randomized, two-period, placebo controlled study was conducted to compare the effects of continuous transdermal 17 beta-estradiol replacement therapy (0.05 mg/day once a week) with placebo on systemic hemodynamics and blood pressure in postmenopausal women. Twenty-nine postmenopausal women (47-62 years) free of hormone replacement therapy were randomized in two groups; group 1 received estradiol patches for the first 12 weeks and placebo patches for the second, and group 2 received the same treatments in the reverse order. The effect of combined estradiol plus oral norethisterone acetate (NETA) 1 mg was also evaluated in the subset of women with intact uteri (n = 24). Crossover analysis showed that stroke volume and cardiac output were significantly higher (P < 0.05) and blood pressure was significantly lower (P < 0.05) with estradiol, irrespective of the order in which the treatments were administered. Although correlations between plasma estradiol levels during active treatment and hemodynamic changes were not significant, hemodynamic changes were significantly greater above 63 pg/ml than below this level (P < 0.05). Oral norethisterone acetate administration either during transdermal placebo or estradiol arms tended to modify systemic hemodynamics in the same direction than estradiol but the changes did not attained statistical significance. In summary compared with placebo, transdermal 17 beta-estradiol, replacement to postmenopausal women, increased cardiac output and decreased blood pressure. Although the average magnitude of changes was small, the results suggest that plasma estradiol levels could be a source of individual variability in the hemodynamic response. Oral NETA administration tended to enhance rather than reverse the estradiol-induced changes.

Administration, Cutaneous↗
PubMedDate not supplied

Clinical experience with transdermal estradiol in the treatment of the climacteric.

Results of clinical studies have revealed that the transdermal therapeutic system of estrogen administration (Estraderm, Ciba Pharmaceutical Co., Summit, New Jersey) is both effective and well tolerated. Relief of hot flushes and vaginal atrophy has been shown to equal oral administration of conjugated equine estrogens and early experience suggests that the bone sparing effect is maintained. The patch has no effect on certain liver proteins; safety variables have shown no adverse biochemical changes. Moderate bleeding has occurred in some patients with an intact uterus but can be controlled by the addition of a progestogen. The incidence of endometrial hyperplasia and breast tenderness has been relatively low, and minor side effects (such as fluid retention) have been limited. Several investigators have evaluated skin irritation resulting from the systems. Some erythema has been reported but serious ulcerations or sloughing did not occur. A survey of patient attitudes comparing oral administration and transdermal systems indicated a preference for the transdermal method.

Administration, Cutaneous↗
PubMed1997

Transdermal nicotine suppresses cutaneous inflammation.

BACKGROUND: Cigarette smoking significantly alters the inflammatory response in the skin following application of irritants and rubefacients. The mechanism of this effect is unknown. There are thousands of components in cigarette smoke that may be pharmacologically important, but there is evidence to suggest that nicotine may play an important role in the observed effect on the inflammatory process. DESIGN: This was an interventional study to assess cutaneous responsiveness to different stimuli after transdermal nicotine administration in volunteer subjects. Cutaneous testing was performed at baseline and at weeks 2 and 4 (the end) of the study. SETTING: The department of Dermatology, University Hospital of Wales, Cardiff. PARTICIPANTS: Ten lifelong nonsmokers were recruited for the study. INTERVENTION: Nicotine patches were applied daily for 1 month. MAIN OUTCOME MEASURES: The following tests were performed: application of 2 times the minimal irritancy dose of sodium lauryl sulfate, irradiation with 2 times the minimal erythema dose of UV-B, measurement of cutaneous vasodilation following application of ethyl and hexyl nicotinate, and reactive hyperemia following arterial occlusion. RESULTS: There was a significant reduction in the cutaneous inflammatory response to sodium lauryl sulfate (P < .001) and irradiation with UV-B (P < .003) and a reduction in reactive hyperemia (P < .03) after 2 weeks of treatment, which returned values to normal at 4 weeks. There was no change in blood flow following application of topical nicotinates. CONCLUSIONS: Nicotine administration via a transdermal delivery system suppresses the cutaneous inflammatory response to sodium lauryl sulfate and UV-B, as well as triggers a transient suppression of reactive hyperemia following arterial occlusion. The apparent anti-inflammatory effects of smoking cigarettes can therefore only partially be explained as a long-term effect of nicotine.

Administration, Cutaneous↗
PubMed2006

Similar efficacy of low and standard doses of transdermal estradiol in controlling bone turnover in postmenopausal women.

OBJECTIVES: To investigate the effects of a low transdermal estradiol dose on bone metabolism and to compare it with both the standard dose and absence of treatment. METHODS: In this study performed in a third-level academic center, 66 healthy postmenopausal women underwent hormone therapy (HT) with patches containing estradiol at standard (0.050 mg/day, HT50, 33 women) or low dosage (0.025 mg/day, HT25, 33 women) and 70 women were without treatment (NT). The values (mean of three samples) of several bone biochemical parameters were compared between groups after adjusting for confounding factors. Bone mineral density (BMD) was assessed (by dual-energy X-ray absorptiometry) in the spine and hip in all cases, and a second densitometry scan was performed in 44 women. RESULTS: Bone turnover markers tended to show lower values in the treated groups, but significance was restricted to total alkaline phosphatase (NT vs. HT25, p < 0.05) and cross-linked N-telopeptides of type I collagen (NTX) (NT vs. HT25, p < 10(-6); NT vs. HT50, p < 10(-5)). The loss of BMD observed in NT women, as assessed by the annual percentage change, was blocked in both the HT25 and HT50 women. No significant differences were detected between both HT groups. CONCLUSIONS: Low and standard dosages of transdermal estradiol were equally effective in controlling bone metabolism, as assessed by turnover markers. Additionally, NTX was confirmed as the most sensitive marker for detecting changes in bone resorption.

Alkaline Phosphatase↗
PubMed1993

[The avoidance of early postmenopausal bone substance losses by transdermal estrogen substitution].

The effect of transdermal oestrogen replacement therapy on prevention of osteoporosis was investigated in a controlled randomized study of 38 healthy women (mean age 49.6 [45-54] years) in the early postmenopausal period (< or = 3 years). 19 women (hormone group) continuously used oestrogen patches with a mean daily estradiol delivery of 0.05 mg with addition of medroxyprogesterone acetate, 5 mg orally, for 14 days per month. The other 19 women (calcium group), whose baseline levels were identical, took 500 mg calcium daily. Climacteric symptoms improved significantly in the hormone group, and serum and urinary calcium levels and total serum cholesterol all declined, while the HDL cholesterol levels increased slightly. Bone density was measured by single photon absorptiometry at two points (1/3 and 1/10 of the forearm length from the distal end of the radius). After 6 and 12 months, the values at the proximal site (1/3) had risen in the hormone group by 1.1% and 0.46% and had fallen in the calcium group by 1.96% and 2.42% respectively (both P < 0.05 vs hormone group). At the distal radial site (1/10), the values increased by 2.14% and 5.3% in the same period and fell by 3.59% and 5.67% in the calcium group. The overall difference after 12 months was 11% (P < 0.01). Transdermal oestrogen appears to be as effective as oral oestrogen replacement for prevention of osteoporosis, and should help to prevent vertebral and limb fractures in the elderly.

Absorptiometry, Photon↗