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PubMedDate not supplied

Evaluation of adhesive properties of transdermal therapeutic systems containing nitroglycerin.

The patch performances and the success of the transdermal drug delivery can be significantly affected by the quality of contact between the patch and the skin. Poor adhesion will dramatically reduce percutaneous delivery. In this study the adhesive properties (peel force and creep resistance) of three monolayer self-adhesive nitroglycerin (NTG) patches available on the market, Deponit, Minitran, and Triniplas, were compared. The patches were characterized also in terms of in vitro drug release and ex vivo skin permeation. The creep resistance values verified in the case of Deponit and Triniplas indicated a low cohesion of these matrices. The peel force values were in the accepted range, even if Triniplas and Deponit showed values double that shown by Minitran. The percentage of NTG released in vitro after two hours in all cases exceeded ninety percent. The ex vivo permeation profiles were similar, even if the three patches had different loaded amounts and surface areas. The measured permeated amount, 11 mg permeated in 24 h, was predictive of the claimed in vivo release (10 mg in 24 h).

Adhesiveness↗
PubMed1991

Transdermal nitrate therapy: bioavailability during exercise increases transiently after the daily change of patch.

Ten volunteers carried a 10 mg 24 h -1 transdermal glyceryl trinitrate (GTN) patch for 24 h before moderate exercise. Plasma GTN-concentration increased significantly (P less than 0.05) by 19% to peak value at 15 min. Two hours after patch renewal repeat exercise increased GTN concentration by 56% (P less than 0.001). The two nitrate-concentration curves differed significantly (P less than 0.0001). Thus, change of patch augmented nitrate availability during exercise.

Administration, Cutaneous↗
PubMed2005

Pharmaceutical development and clinical effectiveness of a novel gel technology for transdermal drug delivery.

Transdermal gels are designed to deliver sustained drug amounts, resulting in systemically consistent levels. They represent an improvement compared with transdermal delivery by patches because they offer more dosage flexibility, less irritation potential and a better cosmetic appearance. Advanced Transdermal Delivery (ATD) gel technology was developed in order to provide enhanced passive skin permeation of various active drugs for the treatment of many conditions, including hypogonadism, female sexual dysfunction, postmenopausal symptoms, overactive bladder and anxiety. The technology consists of a combination of solvent systems and permeation enhancers enabling systemic drug delivery, and is covered by many patents. Pharmaceutical development of formulations based on the technology allowed optimisation of physicochemical parameters (rheological profile, pH) as well as skin permeation properties (type and concentration of permeation enhancers, thermodynamic activity of the drug). This gel technology has demonstrated to be efficient for many drugs, as shown in the preclinical and clinical pharmacokinetic studies presented in this technology evaluation.

Administration, Cutaneous↗
PubMed1984

Transdermal clonidine application: long-term results in essential hypertension.

Skin patches of a clonidine transdermal therapeutic system (clonidine-TTS) with a constant release rate of either 0.1 or 0.2 mg clonidine/24 h continuously over 7 days were used in 32 essential hypertensives. These self-adhesive drug delivery systems (3.5 cm2), which were affixed to the upper outer arm, were changed by the patients at weekly intervals. During a mean observation period of 7 months (range 1-19 months) transdermal clonidine reduced the blood pressure from 162 +/- 15/107 +/- 5 mmHg to normal values (diastolic less than or equal to 95 mmHg) in 63% of our patients. However, chronic use of clonidine-TTS was accompanied by a high frequency of contact dermatitis (type IV allergy) in nearly half of our patients (n = 15, 47%). In 11 of these 15 patients transdermal clonidine administration had to be stopped because of intolerable local skin reactions (pruritus, erythema, vesiculation, and/or infiltration). Subsequent patch testing with all components of clonidine-TTS was performed in eight cases. Whereas in seven cases an allergic contact dermatitis to clonidine was found, only one patient showed an allergy to another component of clonidine-TTS (polyisobutylene). We conclude that this strikingly high incidence of local allergic skin reactions limits the use of clonidine-TTS in essential hypertension.

Administration, Topical↗
PubMed1993

Nicotine effects on eicosanoid formation and hemostatic function: comparison of transdermal nicotine and cigarette smoking.

OBJECTIVES: The purpose of this study was to examine the possible role of nicotine in enhancing coagulation and to assess the potential cardiovascular toxicity of transdermal nicotine therapy for smoking cessation. BACKGROUND: Cigarette smoking increases the risks of acute coronary events. A likely contributing mechanism is activation of coagulation. The role of nicotine in enhancing coagulability has not been resolved. METHODS: We compared in a crossover study the effects of cigarette smoking, transdermal nicotine and placebo transdermal nicotine, each for 5 days, in 12 healthy smokers. RESULTS: Cigarette smoking increased the urinary excretion of 11-dehydro-thromboxane B2 (reflecting thromboxane A2 generation) and increased plasma concentration of the platelet alpha-granule constituents, platelet factor 4 and beta-thromboglobulin, compared with placebo treatment, indicating in vivo platelet activation. Cigarette smoking was also associated with higher levels of fibrinogen in plasma. Transdermal nicotine produced plasma levels of nicotine in the same range as those during smoking but had no effect on thromboxane A2 metabolite excretion, platelet alpha-granule release or plasma fibrinogen, compared with placebo. Excretion of 2,3-dinor-6-keto-PGF1 alpha (reflecting prostacyclin generation) was not significantly influenced by any treatment. These results suggest that nicotine as such is not responsible for the platelet activation or elevation of plasma fibrinogen seen in smokers. However, we cannot exclude the possibility that intermittent bolus-like dosing of nicotine from cigarettes could have different effects from those produced by continually released transdermal nicotine. Other findings were that cigarette smoking and transdermal nicotine treatment were both associated with a higher white blood cell count compared with the placebo patch condition, suggesting a direct effect of nicotine to increase circulating white cells. Factor VII coagulant activity (VIIc) was significantly lower during cigarette smoking, than during either nicotine or placebo patch conditions. CONCLUSIONS: Transdermal nicotine has less effect on platelet activation and catecholamine release than does cigarette smoking, and its use in smoking cessation treatment of patients with coronary heart disease is likely to be safer than cigarette smoking.

6-Ketoprostaglandin F1 alpha↗
PubMed1991

Attenuation of nitrate effect during an intermittent treatment regimen and the time course of nitrate tolerance.

The long-term efficacy of transdermal nitrate therapy, in particular the ability of a single patch to provide 24 h prophylaxis against angina, has been questioned. Two mechanisms have been suggested for this loss of effect: the development of pharmacological tolerance, and premature patch exhaustion. This study was designed to investigate this problem, and in particular to investigate the time course of treatment failure. It comprised a randomized, double-blind, cross-over comparison of transdermal glyceryl trinitrate and matching placebo transdermal patches. Significant treatment effects were demonstrated by several criteria for 8 h of continuous therapy, with some limited effect persisting for 15 h. Loss of effect began to develop very soon after treatment was initiated and progressed in a steady, linear fashion so that there was virtually no treatment effect after 24 h. In contrast, during intermittent therapy, treatment effects were maintained on the second day following a nitrate-free interval. Significant benefit was demonstrated for up to 32 h (i.e. 8 h of treatment on day 2). Both nitrate-free intervals (12 and 16 h) seemed to be equally effective in maintaining efficacy after 3 h of treatment on the second day, although this was still somewhat attenuated compared with day 1. These results confirm that loss of therapeutic efficacy of transdermal nitrate is due to the development of tolerance and not premature patch exhaustion. In contrast to previous studies, however, they suggest that tolerance can only partly be reversed by intermittent therapy and also that the onset of tolerance is so rapid that it is well established in less than a day's treatment.

Administration, Cutaneous↗
PubMed1988

Acute and sustained antianginal effects of nitroglycerin patches: objective evaluation with training-effect-eliminated exercise performance index.

A randomized within-patient double-blind acute and sustained study was performed to compare transdermal nitroglycerin (NTG) patches (5 and 10 mg) and matching placebo in 10 patients with chronic stable angina pectoris confirmed on exercise thallium scintigraphy or coronary angiography, or both. Patients performed treadmill tests 2 and 24 hours after application of patches on the first and last days of each of the 3 treatment periods. Effects caused by sequence of treatments and training with serial testing were prominent so the changes in the well-known parameters did not favor either of the active doses over placebo. Quantification of training effects and its subtraction from performance index disclosed that 10 mg of transdermal NTG caused significant increase in performance in both the acute and sustained stages of therapy in comparison to pretreatment performance. This was not observed with 5 mg and placebo treatments. To our knowledge, this is the first trial to study the efficacy of transdermal NTG with a more objective parameter that permitted elimination of training effects of serial exercise testing.

Administration, Cutaneous↗
PubMed1992

Clonidine transdermal system for treatment of spasticity in spinal cord injury.

Clonidine tablets have been used in the past for treatment of spasticity with some success. The use of clonidine, however, has been limited by adverse effects, mainly hypotension. Over a two-year period, 17 patients were started on clonidine transdermal delivery system. They were followed for up to 18 months. Twelve of the 17 patients had a beneficial response and have continued on the patch. In ten of these 12 patients, other antispasticity drugs were either reduced or discontinued. In another three of the 17 patients, the response was good, but the patch was discontinued. No patient demonstrated persistent problematic hypotension. Clonidine Transdermal Patch appears to be an effective treatment for spasticity after a spinal cord injury. Adverse effects appear to be minimized using this mode of delivery.

Administration, Cutaneous↗
PubMed1988

The effect of transdermal estradiol on hormone and metabolic dynamics over a six-week period.

Seventeen healthy postmenopausal women who had subjectively noted eight or more hot flashes per day and who objectively demonstrated four or more vasomotor flushes of 1.0C or more during eight hours of continuous thermography were studied. They were randomly allocated in a double-blind fashion to either 50 micrograms/day of transdermal estradiol (E2) patch or placebo. Application of the first patch was followed immediately by repeat eight-hour thermography, with hourly measurements of E2 and luteinizing hormone (LH). In the transdermal E2 group only, significant elevations of E2 (mean 91 pg/mL) were noted at two hours, and LH was suppressed after eight hours (P less than .05). There was no immediate effect on vasomotor flushes. Treatment was continued for six weeks, with daily subjective recording of hot flash frequency. Patients on transdermal E2 reported a significant (P less than .001) fall in hot flashes over four weeks, after which the rate stabilized. An initial decline in the placebo group was not statistically different from baseline. Eight-hour thermography was repeated after six weeks of treatment. Patients on transdermal E2 demonstrated an 85% decrease from baseline in vasomotor flushes (P less than .01). No effect on total cholesterol or its subfractions, renin substrate, or aldosterone was found. Serum E2 levels fell by 50% in 24 hours after patch removal. Endometrial histology and vaginal cytology showed an estrogen effect.

Administration, Cutaneous↗
PubMed2004

A study of transdermal fentanyl in cancer pain at Aichi-Cancer Center.

In Japan, transdermal fentanyl (Durotep Patch) was launched in March 2002, and it was regarded as making opioid rotation possible. When changing from morphine to transdermal fentanyl, the efficacy ratio of 1:150 is used in Japan as well as in many other countries. However, the ratio of 1:100 is used in Germany. As a result, a dose increase in transdermal fentanyl is often required to control pain. We studied transdermal fentanyl use in the Aichi Cancer Center (ACC) to investigate the actual conversion ratio and appropriate switching by following up 144 patients (81 men, 63 women) who had received transdermal fentanyl in the ACC from March 19, 2002, to April 30, 2003. Transdermal fentanyl improved pain control in patients who had difficulty in tolerating oral medication or in continuing morphine because of side effects. Regression analysis indicated that the efficacy ratio of oral morphine to transdermal fentanyl was 1:78. As the fentanyl dosage was excessive even in some patients who followed the recommended morphine/fentanyl conversion of 150:1, it is dangerous to use the conversion ratio of 78:1 at first. Morphine side effects were reduced in some patients who changed to transdermal fentanyl, but there was no reduction in those who needed high-dose morphine for rescue analgesia. Therefore it is safe and effective to use low-dose transdermal fentanyl in the beginning and to control pain promptly using rescue morphine based on the present recommended dosage. For opioid rotation, quick-acting opioids other than morphine are expected to be launched in Japan.

Administration, Cutaneous↗
PubMed2006

Transdermal treatment options for neurological disorders: impact on the elderly.

As people grow old, their need for medications increases dramatically because of the higher incidence of chronic pain, diabetes mellitus, cardiovascular and neurological diseases in the elderly population. Furthermore, the elderly require special consideration with respect to drug delivery, drug interactions and adherence. In particular, patients with chronic neurological diseases often require multiple administration of drugs during the day to maintain constant plasma medication levels, which in turn increases the likelihood of poor adherence. Consequently, several attempts have been made to develop pharmacological preparations that can achieve a constant rate of drug delivery. For example, transdermal lisuride and apomorphine have been shown to reduce motor fluctuations and duration of 'off' periods in advanced Parkinson's disease, while rotigotine allows significant down-titration of levodopa without severe adverse effects. Thus, parkinsonian patients with long-term levodopa syndrome or motor disorders during sleep could benefit from use of transdermal lisuride and apomorphine. Moreover, transdermal dopaminergic drugs, particularly rotigotine, seem the ideal treatment for patients experiencing restless legs syndrome or periodic limb movement disorder during sleep, disorders that are quite common in elderly people or in association with neurodegenerative diseases. Unlike dopaminergic drugs, transdermal treatments for the management of cognitive and behavioural dysfunction in patients with Parkinson's disease and Alzheimer's disease have inconsistent effects and no clearly established role. Nevertheless, because of their favourable pharmacological profile and bioavailability, the cholinesterase inhibitors tacrine and rivastigmine are expected to show at least the same benefits as oral formulations of these drugs, but with fewer severe adverse effects. Transdermal delivery systems play an important role in the management of neuropathic pain. The transdermal lidocaine (lignocaine) patch is recommended as first-line therapy for the treatment of postherpetic neuralgia. Furthermore, in patients with severe persistent pain, transdermal delivery systems using the opioids fentanyl and buprenorphine are able to achieve satisfactory analgesia with good tolerability, comparable to the benefits seen with oral formulations. Transdermal administration is the ideal therapeutic approach for chronic neurological disorders in elderly people because it provides sustained therapeutic plasma levels of drugs, is simple to use, and may reduce systemic adverse effects. Several transdermal delivery systems are currently under investigation for the treatment of Parkinson's disease, Alzheimer's disease and neuropathic pain. Although most transdermal delivery systems treatments cannot be considered as first-line therapy at present, some of them provide clear advantages compared with other routes of administration and may become the preferred treatment in selected patients. In general, however, most transdermal treatments still require long-term evaluation in large patient groups in order to optimise dosages and evaluate the actual incidence of local and systemic adverse effects.

Administration, Cutaneous↗
PubMed1992

Endometrial effect of transdermal estradiol and progestin ST-1435 in postmenopausal women.

OBJECTIVE: To study the endometrial effect of the transdermal synthetic progestin ST-1435. DESIGN: Prospective. SETTING: City Maternity Hospital, Helsinki, Finland. PATIENTS: Eleven postmenopausal women used transdermal estradiol (E2) patches for 6 weeks immediately before a vaginal operation for prolapse. For the last 10 days, 1 mg of ST-1435 transdermally in a gel was combined to the treatment. MAIN OUTCOME MEASURES: Blood samples were taken to follow serum concentrations of E2, follicle-stimulating hormone, and ST-1435. Endometrial samples for histologic examination were collected during the operation to evaluate the effect of the progestin. RESULTS: Transdermal absorption of ST-1435 resulted in reasonably constant serum concentrations of ST-1435 in each subject. A progestin effect on the endometrium was seen in 9 of 10 samples obtained. One sample did not show any progestin effect in spite of adequate ST-1435 levels, but this patient's E2 concentrations were low. CONCLUSIONS: When the estrogen stimulation was adequate, the transdermal ST-1435 induced a progestin effect on the endometrium, i.e., it had an end-organ effect.

Administration, Cutaneous↗
PubMed2005

Assessment of serum concentrations and sedative effects of fentanyl after transdermal administration at three dosages in healthy llamas.

OBJECTIVE: To determine the serum concentrations and sedative effects of fentanyl after transdermal administration at 3 dosages in llamas. ANIMALS: 9 healthy adult female llamas (mean age, 8 +/- 3 years; mean weight, 150 +/- 18 kg). PROCEDURE: Llamas were allocated to 1 of 3 groups (3 llamas/group). Fentanyl patches (each providing transdermal delivery of 75 microg of fentanyl/h) were placed on shaved areas of the antebrachium of all llamas. In group 1, llamas were treated with 1 patch (anticipated fentanyl dosage, 75 microg/h). In group 2, llamas were treated with 2 patches (anticipated fentanyl dosage, 150 microg/h). In group 3, llamas were treated with 4 patches (anticipated fentanyl dosage, 300 microg/h). For each llama, the degree of sedation was assessed by use of a subjective scoring system and a blood sample was collected for determination of serum fentanyl concentration at 12, 24, 36, 48, 60, and 72 hours after patch placement. RESULTS: Following the placement of 4 patches, mean +/- SD serum fentanyl concentration in group 3 llamas reached 0.3 +/- 0.08 ng/mL within 12 hours. This concentration was sustained for 72 hours. In group 2, application of 2 patches provided inconsistent results; in group 1, application of 1 patch rarely provided measurable serum fentanyl concentrations. No llamas became sedated at any time. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggest that application of four 75 microg/h fentanyl patches provides consistent, sustained serum fentanyl concentrations without sedation in llamas. However, the serum concentration of fentanyl that provides analgesia in llamas is not known.

Administration, Cutaneous↗
PubMed2002

Buprenorphine in a transdermal therapeutic system--a new option.

Advanced patch technology has yielded a novel transdermal therapeutic system (TDS) for the rate-controlled systemic delivery of buprenorphine. Buprenorphine TDS is available in three strengths with release rates of 35, 52.5 and 70 microg/h over 72 h, corresponding to daily doses of 0.8, 1.2 and 1.6 mg, respectively. In total, 445 patients with chronic pain of malignant or non-malignant origin requiring long-term treatment with potent opioid analgesics were enrolled in the clinical trial programme. The patients were treated with buprenorphine TDS in one of three dosage strengths or with placebo TDS in a randomised double-blind setting. Greater pain relief was documented in patients treated with buprenorphine TDS than in those treated with placebo. The benefit of buprenorphine TDS was further reflected in the larger number of patients who slept for longer than 6 h per night. Patients switching from Step 2 or Step 3 opioids to buprenorphine TDS encountered no problems with the conversion. Typical opioid-related adverse events were reported with a low incidence and mild intensity. In an open follow-up study 239 patients elected to continue treatment with buprenorphine TDS. The confirmation of clinical benefit, coupled with a high level of patient compliance and improved quality of life, substantiate the usefulness of buprenorphine TDS in a practical setting.

Administration, Cutaneous↗
PubMed1984

Transdermal continuous antihypertensive therapy.

Self-adhesive patches containing a 7-day supply of transdermal clonidine were used to treat twenty patients with mild essential hypertension. These skin patches (3.5 cm2), which were changed by the patients every week, reduced diastolic blood-pressure to less than 90 mm Hg in twelve patients. When placebo-containing patches were substituted in these twelve patients after 3 months of treatment, blood-pressure rose slowly to its pretreatment level. Side effects appeared to be milder than those experienced during conventional oral antihypertensive treatment. Plasma clonidine concentrations were lower than peak levels after oral administration. This new method for treating hypertension was convenient and well tolerated, and may increase patient compliance.

Administration, Topical↗
PubMed1996

Clonidine prophylaxis for narcotic and sedative withdrawal syndrome following laryngotracheal reconstruction.

OBJECTIVE: To determine the efficacy of transdermal clonidine hydrochloride for prophylaxis of withdrawal syndromes that are common following more than 7 days of deep sedation after single-stage laryngotracheal reconstruction (LTR) surgery. DESIGN: Consecutive case series. SETTING: Pediatric intensive care unit at tertiary care referral center, university-affiliated children's hospital. PATIENTS: Ten consecutive patients who had undergone single-stage LTR and received sedation with a combination of narcotics and benzodiazepines. INTERVENTIONS: A sustained release transdermal clonidine hydrochloride patch (50-100 micrograms/d; mean, 5.8 micrograms/kg per day; range, 4.2-8.5 micrograms/kg per day) was applied to 8 consecutive patients before discontinuation of sedative infusions and elective extubation. Physicians continued to treat patients for withdrawal symptoms, if seen, at their discretion. MAIN OUTCOME MEASURES: Seventeen characteristic narcotic and sedative withdrawal symptoms recorded at baseline and serially for at least 48 hours following discontinuation of deep sedation. RESULTS: No severe symptoms of narcotic or sedative withdrawal (seizure, choreoathetosis, tremors, or dehydration) were seen in any patient during treatment with clonidine. Not more than 2 minor withdrawal symptoms (lethargy and respiratory rate > 40 breaths/min) occurred simultaneously during treatment with clonidine in any patient. Two of 8 patients had clonidine patches removed prematurely. Both patients experienced withdrawal symptoms within hours, and these symptoms subsided in the 1 patient whose clonidine patch was reinstituted. No significant sustained side effects, bradycardia, or dysrhythmia necessitated discontinuation of clonidine therapy, and no rebound withdrawal was seen with routine discontinuation of clonidine after 7 days of therapy. CONCLUSIONS: Transdermal clonidine prophylaxis may be a safe and efficacious adjunct to prevent withdrawal symptoms in pediatric patients who have undergone single-stage LTR. Use of a validated withdrawal symptom scoring tool is indicated for patients undergoing single-stage LTR and requiring prolonged, deep sedation in the pediatric intensive care unit.

Administration, Cutaneous↗
PubMed2005

Comparison between meloxicam and transdermally administered fentanyl for treatment of postoperative pain in dogs undergoing osteotomy of the tibia and fibula and placement of a uniplanar external distraction device.

OBJECTIVE: To compare the efficacy of meloxicam administered perioperatively with transdermal administration of fentanyl via a patch placed preoperatively in dogs undergoing orthopedic surgery. DESIGN: Prospective study. ANIMALS: 16 dogs. PROCEDURE: Unilateral or bilateral osteotomy of the tibia and fibula was surgically performed, and a uniplanar external distraction device was placed in each limb. Postoperative pain and lameness were assessed 24, 48, and 72 hours after administration of the first of 3 doses of meloxicam (0.2 mg/kg [0.09 mg/lb], IV, given preoperatively, followed by 0.1 mg/kg [0.045 mg/lb], IV, after 24 hours, and 0.1 mg/kg, PO, after 48 hours) or preoperative placement of a transdermal fentanyl patch (50 microg/h) left in place for 72 hours. RESULTS: No significant differences in total pain scores were detected between groups. Mean +/- SD lameness scores assessed at 24 and 72 hours were lower in dogs in the meloxicam group than dogs in the fentanyl group. Lameness scores decreased with time in a similar manner in both treatment groups. CONCLUSIONS AND CLINICAL RELEVANCE: Perioperative administration of meloxicam or preoperative placement of a transdermal fentanyl patch provided effective and similar postoperative analgesia in dogs undergoing orthopedic surgery. However, because of its anti-inflammatory effects, treatment with meloxicam reduced the degree of lameness and resulted in rapid functional recovery of the limb.

Administration, Cutaneous↗
PubMed1990

Skin acceptance of transcutaneous nitroglycerin patches: a prospective study of 33 patients.

Transdermal nitroglycerin is commonly used and may induce contact dermatitis. The frequency of adverse skin reactions is controversial and may vary from 10% to 75%, according to various authors. 33 patients using transdermal nitroglycerin for more than 7 days were examined and patch tested (nitroglycerin 0.5% aq., 2% pet. and TTS in toto). 5 patients (15%) had adverse reactions. The patch tests were all negative in the 33 patients. Contact dermatitis occurs in many cases, about 15% of the cases with the newly available TTS, and even if patients respect the conditions for using TTS. These contact dermatitides are mainly irritant reactions and do not require transdermal nitroglycerin treatment to be stopped. Nevertheless, since some cases of allergic contact dermatitis have been reported, a contact dermatitis from transdermal nitroglycerin should lead to patch testing.

Administration, Cutaneous↗