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PubMed2000

Treatment of spit tobacco users with transdermal nicotine system and mint snuff.

The purpose of this study was to examine the effects of nicotine patch and mint snuff (a nonnicotine product) on craving, withdrawal symptoms, and treatment outcome. This study involved a 2 x 2 factorial design, with Active Nicotine Versus Placebo Patch as one of the factors and Mint Snuff Versus No Mint Snuff as the other factor. Spit tobacco users (N = 402, n = 100-101 in each condition) were randomly assigned to 1 of the 4 treatment conditions for a period of 10 weeks. Treatment outcome was measured up to 62 weeks. The results showed that the nicotine patch was effective in increasing short-term abstinence over the placebo patch and in reducing craving and withdrawal signs and symptoms from spit tobacco. Although mint snuff was not effective in enhancing treatment outcome, it reduced craving and withdrawal symptoms. No interaction effects were observed. At this time, the use of the nicotine patch and mint snuff should be primarily considered for the reduction of craving and withdrawal symptoms.

Administration, Cutaneous↗
PubMed1985

Transdermal scopolamine for peripheral vertigo (a double-blind study).

Transdermal scopolamine medication has been evaluated in 30 cases of acute peripheral vertigo. The double blind study revealed favourable effects, e.g. in Menière's disease. The best compromise between effect and side-effects was one active medication patch. The side-effects were those described for scopolamine, such as blurred vision and dryness of the mouth. Transdermal scopolamine seems to offer an alternative form of medication in acute peripheral vertigo.

Administration, Topical↗
PubMed2005

Scopolamine patch to prevent seasickness: clinical response vs. plasma concentration in sailors.

INTRODUCTION: Scopolamine is highly effective for the treatment of seasickness. Nevertheless, transdermal therapeutic system (TTS) scopolamine, despite high compliance on the part of persons treated by the drug, fails to provide protection against seasickness in 26-38% of patients. To the best of our knowledge, the correlation between scopolamine levels in plasma and its therapeutic effect under sailing conditions in the open sea is investigated for the first time in the present study. METHODS: Subjects were 61 crewmembers of naval vessels treated by TTS scopolamine. The therapeutic response at sea was documented by questionnaire. During a period ashore, a TTS scopolamine patch was applied in the same subjects. Blood samples were taken and an adverse effects questionnaire completed 8 h after scopolamine patch application. Scopolamine levels were determined using an established radio-receptor assay procedure. To verify the reproducibility of these measurements, blood samples were taken twice from most subjects, on separate days after different patch applications. Subjects were divided into "responders," who reported at least a moderate decrease in seasickness severity compared with their previous experience at sea without TTS scopolamine therapy, and "non-responders," who had only slight symptomatic relief or no relief at all. RESULTS: The mean scopolamine concentration in the plasma of the 37 responders (156.77 +/- 77.03 pg x ml(-1)) was significantly higher than the mean level in the 24 non-responders (97.03 +/- 73.34 pg x ml(-1); p = 0.005, simple t-test). CONCLUSIONS: Attempts to increase scopolamine levels in plasma by increasing the drug dosage or improving transdermal absorption should be considered for the treatment of "non-responders".

Absorption↗
PubMed1996

Allergic reactions to local glyceryl trinitrate administration.

To assess the exact cause and extent of transdermal glyceryl trinitrate (GTN)-induced allergic reactions, a study of continuous and intermittent use of GTN patches was conducted in 320 patients with New York Heart Association (NYHA) class II and III angina pectoris. Three commercially available GTN patch systems were used. Twenty-one patients (6.5%) developed cutaneous reactions. In 17 patients (5.3%), the reactions were confined to the area of application and were characterised as irritant reactions. Four patients (1.2%) developed both localised and remote from the area of application lesions and one patient developed a generalised anaphylactic reaction. The rate of discontinuation of therapy was 3.4%. The irritant skin reactions were mainly due to contaminants and additives. Changing to a different transdermal system reduced the incidence of local reactions--a particularly desirable effect in patients who respond well to GTN therapy.

Adhesives↗
PubMed1989

Transdermal scopolamine: a review of its effects upon motion sickness, psychological performance, and physiological functioning.

Scopolamine is the most effective single drug for the prophylaxis and treatment of motion sickness. However, oral or injected scopolamine displays a comparatively short duration of action (5-6 hours), and leads to deleterious side effects on autonomic and central nervous system cholinergic functions. The transdermal scopolamine system was designed to reduce these problems, but while it does deliver scopolamine over a prolonged time period (72 h), deleterious side effects are also produced. Transdermal scopolamine provides significant motion sickness protection, similar in extent to that provided by oral scopolamine or dimenhydrinate. Its autonomic nervous system effects comprise reduced salivation, bradycardia, and blurred vision due to reduced visual accommodation. The visual problems increase following repeated patch applications, with hypermetropic ("long sighted") individuals particularly at risk. Central nervous system effects comprise reduced memory for new information, impaired attention, and lowered feelings of alertness. Variation in response to transdermal scopolamine has also been reported, both between individuals, and between different patch applications on the same individual.

Accommodation, Ocular↗
PubMedDate not supplied

Effects of 24-hr nicotine replacement on sleep and daytime activity during smoking cessation.

BACKGROUND: This study uses wrist actigrapy to assess the effects of 24-hr transdermal nicotine replacement on the sleep and daytime activity of smokers during smoking cessation. METHODS: Seventy-one subjects grouped as light (n = 23), moderate (n = 24), or heavy (n = 24) smokers were randomly assigned to placebo or 11, 22, or 44 mg/day doses of transdermal nicotine for 1 week of intensive inpatient treatment of nicotine dependence. Outpatient patch therapy continued for 7 weeks following the inpatient stay. Those initially on placebo were randomly assigned to 11 or 22 mg/day, and those initially on 44 mg/day were reduced to 22 mg/day at Week 4. RESULTS: There was a significant decrease in daytime wrist activity during patch therapy and the 1st week off patch therapy. These changes in daytime wrist activity were positively correlated with percentage of nicotine and cotinine replacement. No changes from baseline in sleep (sleep efficiency or wrist activity) were detected, nor were there differences in sleep among the four patch doses. CONCLUSIONS: Using wrist actigraphy, this study failed to show any disturbing effects of 24-hr high-dose nicotine replacement on sleep. Lower levels of nicotine replacement were associated with a decrease from baseline in daytime wrist activity.

Administration, Cutaneous↗
PubMedDate not supplied

Coping with space motion sickness in Spacelab missions.

A substantial number of persons, around 75%, making their first transition into orbital flight will need to adapt to this unique environment. The two most powerful instruments in the prevention of space motion sickness reside in the selection process and in acquiring adaptation-prelaunch. Today, neither of these means is practical. One logical alternative is to administer preventative medication to all or none. One candidate drug is a high-potency transdermal therapeutic system (TTS)-scopolamine. This is marketed in the nature of a patch that is affixed to the skin behind the ear 12 hr before need and delivers scopolamine into the blood stream for three days. We are systematically evaluating all claims for its high potency and low side effects. We are also evaluating new antimotion sickness remedies and new combinations of homergic drugs.

Administration, Cutaneous↗
PubMed2001

HPLC evaluation of diclofenac in transdermal therapeutic preparations.

High-performance liquid chromatography (HPLC) was selected for analytical evaluation of sodium diclofenac in original transdermal therapeutic preparations containing adjuvant substances (capsaicin, hyoscyamine). After isolation from laminated adhesive patches, diclofenac was analysed on columns with reversed phase, using the mobile phase ethanol and phosphate buffer (pH 6.5) with an addition of tetrabutylammonium iodide and detection at 284 nm. Not only the total amount of diclofenac in the patch was evaluated, but HPLC methodology was also employed to select a suitable acceptor medium for permeation experiments. In patches manufactured in the tested series, HPLC was also employed to examine the release of diclofenac and its in vitro permeation through the human skin.

Adhesives↗
PubMed2002

Transdermal application of prostaglandin E1 ethyl ester for the treatment of trophic acral skin lesions in a patient with systemic scleroderma.

An early dinical symptom in scleroderma patients is Raynaud's phenomenon. Later cutaneous manifestations of the disease include oedematous swelling in the extremities and in more extreme cases often very painful, refractory acral necroses. We report on a 56-year-old female patient who participated in a prospective, double-blind, multicentre comparative pilot study because of her severe Raynaud symptoms, with dystrophic skin lesions on both hands. The goal of the study was to evaluate the efficacy and safety of prostaglandin E1 ethyl ester in a transdermal drug delivery system compared with placebo in patients with secondary Raynaud's phenomenon associated with systemic scleroderma or mixed connective tissue disease. After 2 weeks of verum treatment the patient experienced a marked improvement of Raynaud's attacks, with increased capillary flow velocity, reduced blood stasis and dinical healing of the acral trophic lesions. For this patient the transdermal application of prostaglandin E1 ethyl ester in the form of a medicated patch proved to be a simple and effective therapy for the acral trophic skin lesions associated with systemic scleroderma.

Administration, Cutaneous↗
PubMedDate not supplied

Transdermally administered scopolamine vs. dimenhydrinate. I. Effect on nausea and vertigo in experimentally induced motion sickness.

The effect of transdermally administered scopolamine (TTS-scopolamine) (2.5 cm2 surface area, one and two patches) and dimenhydrinate (100 mg) on experimental motion sickness was examined in 16 healthy volunteers in a randomized double-blind study. Nausea was induced by Coriolis manoeuvre and vertigo by calorization of the ear. In all subjects, scopolamine was found in urine in concentrations indicating adequate absorption of the drug. One TTS-scopolamine, two TTS-scopolamine and dimenhydrinate caused a statistically significant reduction in nausea when compared with placebo. Dimenhydrinate was somewhat more effective against nausea than one TTS-scopolamine. Vertigo was significantly reduced after dimenhydrinate and two TTS-scopolamine. Side effects of both drugs were negligible, though gait disturbances and vertigo could occur occasionally after two TTS-scopolamine. No dose-response relationship was found between the urinary excretion of scopolamine and alleviation of nausea. Dimenhydrinate and TTS-scopolamine are both effective against motion sickness, the latter provided it is applied 6 to 8 hours before exposure to the stimulus causing the motion sickness.

Adult↗
PubMedDate not supplied

Transdermally administered scopolamine vs. dimenhydrinate. II. Effect on different types of nystagmus.

The effects of transdermally administered scopolamine (TTS-scopolamine) (release rate 5 micrograms/h, one and two patches) and dimenhydrinate (100 mg) on caloric, angular acceleration induced and optokinetic nystagmus were examined in 16 volunteers in a randomized double-blind study. All drugs induced a statistically significant decrease in maximum velocity of caloric nystagmus, as compared with placebo. In the rotatory test, two TTS-scopolamine and dimenhydrinate reduced the vestibular gain significantly. No changes were observed in time constant. In the optokinetic test, all drugs tended to reduce the responses, but a statistically significant reduction was found only after two TTS-scopolamine. The results indicate that the drugs effective against motion sickness reduce the nystagmic response, which at least partly explains the mode of action of the drugs. The target organ of the drugs is presumably the vestibular nucleus, where vestibular and visual impulses are integrated to ensure optimal gain for vestibular orientation reflexes.

Acceleration↗
PubMed1998

[Study of the general and topical tolerance of Trinipatch and its clinical efficacy in the therapy of chronic stable angina in 5078 coronary disease patients].

Nitrates still play an important role in the treatment of coronary heart disease after more than hundred years of use in this indication. Following oral administration, they undergo intense gastric hydrolysis, and are largery destroyed by the first-pass effect. The development of an attenuation phenomenon of the therapeutic effect has been frequently reported during continuous treatments at fixed doses. Percutaneous administration of nitroglycerin due to the development of transdermal devices palliates these various obstacles. Trinipatch is a small, transparent, matricial, monolayer patch with an absorption promoter, marketed in two dose-strengths (5 mg/24 h and 10 mg/24 h) by Laboratoires Synthelabo. Its systemic and local safety and clinical efficacy were studied by 383 private cardiologists and 2,294 general practitioners in 5,079 coronary patients, between the ages of 19 and 91 years, in two open, multicentre trials lasting 3 months. The systemic safety, assessed by adverse event reporting, was good. 2.7% of patients experienced adverse events, but only 0.3% of patients presented a serious adverse event. The effects most frequently encountered were vasodilator effects. A very good stability of cardiovascular parameters was observed, with no reflex tachycardia. The local safety, evaluated by the Draize scale, was also satisfactory; after 1 month and 3 months of treatment, 6.6% and 5.7% of patients presented erythema, usually isolated and moderate. The clinical efficacy was evaluated by subjective criteria in the 740 patients included by cardiologists. A significant reduction of the number of angina attacks and the numbers of doses of nitroglycerin was observed. The percentage of pain-free patients increased from 18.2% at the start of the study to 76% at the end of the trial. These two trials confirmed the good systemic and local safety and clinical efficacy of Trinipatch.

Adult↗
PubMed2004

Prevention of postmenopausal bone loss by pulsed estrogen therapy: comparison with transdermal route.

OBJECTIVE: To compare the efficacy of pulsed estrogen therapy following intranasal 17beta-estradiol (E2) (S21400) with patch E2 in preventing postmenopausal bone loss and on bone turnover. METHODS: In this multinational open study, 361 postmenopausal women aged 51.5 (S.D. 4.6) years were treated with S21400 300 microg per day or patch E2 (delivering 50 microg per day), two patches per week, for 56 weeks. Bone mineral density (BMD) was assessed at the spine and hip using dual X-ray absorptiometry at baseline and week 56 (W56). Bone turnover markers (osteocalcin, bone alkaline phosphatase, urinary type I collagen C-telopeptides) were measured at baseline and weeks 12, 28 and 56. RESULTS: Spine and hip bone mineral density significantly increased in both groups (P < 0.001 versus baseline). Mean (S.D.) percent increases were 2.1 (3.0) at the spine (both groups), and 1.2 (2.4) and 1.1 (2.2) at the hip in the S21400 and patch E2 groups, respectively. Bone mineral density also significantly increased (P < 0.001 versus baseline) in osteopenic patients following S21400 and patch E2: 3.1 (3.5) and 2.4 (3.5) at the spine, and 2.0 (2.6) and 1.2 (2.7) at the hip, respectively. Bone metabolism was normalized at week 56 with a significant decrease (P < 0.001) from baseline in all markers: 56% and 53% for type I collagen C-telopeptides, and 24% and 25% for osteocalcin in the S21400 and patch E2 groups, respectively. CONCLUSION: Pulsed estrogen therapy was as effective in normalizing bone turnover and preventing postmenopausal bone loss as a reservoir patch.

Administration, Cutaneous↗
PubMed1994

Transdermal delivery of buprenorphine through cadaver skin.

The skin permeation of buprenorphine base and HCl salt through cadaver skin was investigated. The octanol-water partition coefficient and solubilities of both buprenorphine free base and HCl salt were determined at 32 degrees C. As expected, buprenorphine free base was more lipophilic than its HCl salt and was practically insoluble in aqueous buffer at pH 8.7. The drug solubility decreased exponentially as the pH of the solution increased, whereas the permeability coefficient increased as the donor solution pH decreased. The skin flux of buprenorphine.HCl was significantly higher than that of the free base from propylene glycol/lauric acid vehicle mixtures. Buprenorphine base permeation through tape-stripped epidermis suggested that in addition to stratum corneum, viable epidermis presented a significant diffusion barrier because of the very low aqueous solubility of the free base observed. The mean steady-state skin fluxes of buprenorphine.HCl were 20.3 and 29.7 micrograms/cm2/h from propylene glycol:lauryl alcohol: ethanol (80:15:5) and propylene glycol: propylene glycol monolaurate: water (80:15:5) vehicle mixtures, respectively. The skin flux of buprenorphine.HCl from various monolithic matrix patches was also evaluated. When capric acid, lauric acid, and lauryl alcohol were separately incorporated into an adhesive matrix, the skin flux of buprenorphine.HCl was enhanced by a factor of 2 to 3.5. Finally, based on the total body clearance and minimum effective concentration of buprenorphine, a transdermal delivery rate of 2.5 micrograms/cm2/h from a 20-cm2 patch was estimated. The in vitro skin permeation data clearly suggest that transdermal delivery of buprenorphine is feasible to achieve a desired systemic analgesic effect.

Administration, Cutaneous↗
PubMed1999

Long-term substitution therapy of hypogonadal men with transscrotal testosterone over 7-10 years.

OBJECTIVE: Testosterone (T) substitution of hypogonadal men by conventional intramuscular injection of T esters is not considered optimal because it induces unphysiologically fluctuating serum T levels. In contrast, scrotal T patches produce normal serum (T) levels mimicking diurnal variations. In order to assess the quality of this new form of T substitution we followed hypogonadal men treated by transdermal T up to 10 years. PATIENTS: Eleven men aged 35.9 +/- 9.8 years (mean +/- SD) at the beginning of the study were treated with transscrotal T patches (Testoderm) because of primary (n = 4) or secondary (n = 7) hypogonadism. Clinical examinations were performed every 3 months during the first 5 years and every 6 months thereafter. All 11 patients were seen for 7 years and some for longer periods: eight for 8 years, six for 9 years and four for 10 years. MEASUREMENTS AND RESULTS: With daily application of one patch T levels rose from 5.3 +/- 1.3 nmol/l (mean +/- SE) to 16.7 +/- 2.6 nmol/l at month 3 and remained in the normal range throughout treatment. Serum 5 alpha-dihydrotestosterone (DHT) rose from 1.3 +/- 0.4 nmol/l to 3.9 +/- 1.4 nmol/l and oestradiol from 52.3 +/- 9.3 to 71.3 +/- 9.6 pmol/l and remained stable without significant variations throughout the observation period. Patients reported absence of local side-effects except for occasional itching. No relevant changes occurred in clinical chemistry, including total cholesterol levels and triglycerides. Haemoglobin and erythrocyte counts remained normal. Bone density measured by QCT increased slightly from 113.6 +/- 5.4 to 129.7 +/- 9.3 mg/cm3 during the observation period (P = 0.028). In the nine patients aged < 50 years prostate volumes showed a small but insignificant increase from 16.8 +/- 1.5 to 18.8 +/- 2.1 ml during transscrotal T therapy. In the two older patients prostate volume remained constant or decreased slightly during T therapy after an initial increase in the previously untreated patient. Prostate specific antigen levels were constantly low in all patients. CONCLUSION: Transscrotal testosterone patches are well-accepted and safe in long-term testosterone substitution therapy for male hypogonadism.

Administration, Cutaneous↗
PubMedDate not supplied

Transdermal administration of piribedil reverses MPTP-induced motor deficits in the common marmoset.

The ability of transdermal administration of the dopamine D2/D3 agonist piribedil (1-[3,4-methylenedioxybenzyl)]-4-[(2-pyrimidinyl)]piperazine) to reverse hypokinesia and other motor deficits observed in MPTP-treated common marmosets was investigated. Piribedil (2.5-10.0 mg/animal), applied directly to the skin of the abdomen as a paste, produced a long-lasting and concentration-dependent reversal of motor deficits. The antiparkinsonian actions of piribedil occurred within 10 minutes of drug administration and lasted as long as 10 hours. Transdermally applied piribedil produced a pattern of locomotor activity characteristic of normal motor behavior in this species. Symptoms of nausea (marked excessive salivation, retching, and/or vomiting) were not observed after transdermal application of piribedil. Additionally, pretreatment with the peripheral dopamine antagonist domperidone enhanced the antiparkinsonian effects of piribedil. Application to the skin of monolayer or bilayer patches impregnated with piribedil also produced a marked increase in locomotor activity and reversal of motor deficits. After application of various patch fractions (whole, one-half, or one-fourth), the increase in locomotor activity and reversal of disability correlated well with the surface area of skin covered. Measurement of serum levels of piribedil after single application of bilayer patches showed a positive relationship between drug levels and antiparkinsonian activity. Repeated daily application of piribedil bilayer patches for 5 days to MPTP-treated common marmosets primed to show dyskinesia by previous exposure to L-Dopa produced antiparkinsonian activity accompanied by dyskinetic movements. Transdermal administration of dopamine agonists such as piribedil may provide a useful means of producing a long-lasting reversal of motor deficits in Parkinson's disease while avoiding acute adverse effects such as nausea.

1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine↗
PubMed1995

Physical exercise increases plasma concentrations of nicotine during treatment with a nicotine patch.

The effect of physical exercise on plasma nicotine concentrations was studied in eight healthy subjects treated with a nicotine patch releasing 14 mg 24 h-1. After 11 h of patch application, plasma nicotine concentrations were measured before and after 20 min of moderate bicycle exercise, or 20 min of rest. Mean plasma nicotine concentration increased from 9.8 to 11.0 ng ml-1 (P = 0.015) during physical exercise, and fell non-significantly from 10.5 to 10.2 ng ml-1 during rest. The increase in plasma nicotine concentration during exercise is similar to that observed for transdermal nitroglycerin, and may be related to an exercise-induced increase in blood flow in the patch area.

Administration, Cutaneous↗