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PubMed2004

Discovery of transdermal penetration enhancers by high-throughput screening.

Although transdermal drug delivery is more attractive than injection, it has not been applied to macromolecules because of low skin permeability. Here we describe particular mixtures of penetration enhancers that increase skin permeability to macromolecules (approximately 1-10 kDa) by up to approximately 100-fold without inducing skin irritation. The discovery of these mixtures was enabled by an experimental tool, in vitro skin impedance guided high-throughput (INSIGHT) screening, which is >100-fold more efficient than current tools. In vitro experiments demonstrated that the mixtures delivered macromolecular drugs, including heparin, leutinizing hormone releasing hormone (LHRH) and oligonucleotides, across the skin. In vivo experiments on hairless rats with leuprolide acetate confirmed the potency and safety of one such mixture, sodium laureth sulfate (SLA) and phenyl piperazine (PP). These studies show the feasibility of using penetration enhancers for systemic delivery of macromolecules from a transdermal patch.

Administration, Cutaneous↗
PubMed2006

Drug insight: testosterone preparations.

Testosterone has been used for substitution therapy in testicular and hypothalamopituitary diseases for almost six decades, with injectable testosterone esters and implanted testosterone pellets being the mainstay of treatment. Growing interest in the possible use of testosterone in nonclassical situations such as male contraception, aging (late-onset hypogonadism), muscle-wasting conditions like HIV, erectile dysfunction, and female hypoactive sexual disorder has stimulated research, leading to the development of several new modes of administration of testosterone. Transdermal patches, gels, mucoadhesive sustained-release buccal tablets and long-acting testosterone esters are designed to provide testosterone levels that approximate normal physiologic levels, to improve patient acceptability, and to further increase the number of treatment options available. In this Review, we briefly describe the chemistry, mechanism of action, and metabolism of testosterone. We then discuss the pharmacokinetics, advantages, and disadvantages of various formulations and summarize the various preparations currently available.

Chemistry, Pharmaceutical↗
PubMed2006

Precise microinjection into skin using hollow microneedles.

Hollow needles of micron dimensions have previously been fabricated and envisioned for use with transdermal patches or infusion pumps to achieve painless delivery of drugs to the skin for local and systemic effects without the need for hypodermic needles. However, little work has been carried out to identify methods to effectively use hollow microneedles for drug delivery. To address this need, we inserted hollow, glass microneedles into hairless rat skin in vivo and human cadaver skin in vitro and then imaged infusion of dye molecules, insulin, polymer microparticles, and cells into the skin by brightfield and fluorescence microscopy. The depth of needle penetration into skin was controlled by inserting needles with a rotary drilling device, which enabled localized injection within the epidermis or dermis with +/-60 microm resolution. Although small quantities of fluid could be injected after needle insertion into skin, partial retraction of the needle by withdrawing back 100-300 microm or vibrating the microneedle array dramatically increased infusion flow rate. We conclude that hollow microneedles can be used for precise microinjection into skin, especially when a single needle is inserted by rotary drilling and then retracted part way before infusion or a microneedle array is inserted by mechanical vibration.

Cell Transplantation↗
PubMed2004

Medical management of urinary incontinence.

Treatment options for urinary incontinence include behavioral techniques, pharmacologic agents, and surgical procedures. Caregivers use pharmacotherapy heavily because of its availability, immediacy of results, and convenience. However, only pharmacotherapy for urge incontinence has advanced to the level at which several drugs that have undergone rigorous scientific testing using randomized controlled trials have received FDA approval; these are the antimuscarinic and anticholinergic/direct smooth muscle relaxant drugs. However, promising new drugs targeting other receptors are under investigation. There is no FDA-approved drug for stress incontinence or overflow incontinence. Pharmacologic clinical trials for urinary incontinence are no different than pharmacologic trials in other areas. A randomized controlled trial is the best approach for documenting effectiveness and safety. A rigorous trial should include identification of primary and secondary outcomes. The measurement tools of outcomes must be reliable and validated. Preferably, the severity level of urinary incontinence should be established, and measurement of effectiveness must include durability. Not only must side effects be identified, but their impact on the quality of life must be quantified. An exciting area in pharmacologic treatment of urinary incontinence is the method of drug delivery. In addition to sustained release oral medication, the transdermal patch and the intravaginal route are starting to be used in clinical practice. The intravesical route is still in the investigational phase. Pharmacologic research for urinary incontinence is now entering an exciting time because technologic advances are creating new agents with more precise targeting and more sophisticated methods of delivery are being developed and tested.

Adrenergic Antagonists↗
PubMed2004

[Repeated improper intravenous injection of fentanyl from a transdermal system].

We report on a 30 year-old male who misused transdermal fentanyl. He injected the contents of transdermal patches intravenously. Suffering from chronic pain following total hip replacement, he had received a prescription for this drug formulation from his general practitioner. During his stay in a pain clinic he was able to obtain a total of 13 fentanyl patches from other patients or local pharmacies. He became seriously ill with multiple organ dysfunction in the course of an infection of his thigh. After surgical and intensive care treatment he recovered soon, but the hip prosthesis had to be explanted. There are some reports in the literature of misuse of fentanyl patches. The contents may be ingested orally, or they can be inhaled. Aspirated with a syringe the content of fentanyl patches can also be injected intravenously, sometimes resulting in exit-us. Prescribers must be aware of the potential for abuse of fentanyl patches which can be stolen, sold or even removed from dead bodies.

Administration, Cutaneous↗
PubMed2002

Cryoablation of unresectable pancreatic cancer.

BACKGROUND: Most patients with pancreatic cancer are not candidates for curative resection. The goal of this study was to evaluate the safety of an intraoperative ultrasound-guided cryosurgical procedure in a phase I study of unresectable pancreatic cancer. METHODS: From March 1995 to March 1999, 10 cryosurgeries using intraoperative ultrasound were performed on 9 patients with unresectable cancers at laparotomy. Four patients had a concurrent gastrojejunostomy, 2 had a chemical splanchnicectomy, and 1 underwent a concurrent hepatic cryosurgical procedure. RESULTS: There was no intraoperative morbidity or mortality. No patients developed postoperative pancreatitis or fistula. All patients had good pain control postoperatively and were tolerating a regular diet at the time of discharge. Pain control at discharge was achieved with an oral formulation (4/9), transdermal patch (3/9), no pain medication (1/9), and intravenous patient controlled analgesia (1/9). CONCLUSIONS: Ultrasound-guided cryoablation for unresectable pancreatic cancer appears safe and may contribute to improved postoperative pain control. Future studies to determine its therapeutic role in the management of unresectable pancreatic cancer are indicated.

Cryosurgery↗
PubMed2006

A clinical update on female androgen insufficiency--testosterone testing and treatment in women presenting with low sexual desire.

The diagnosis of female androgen deficiency syndrome is suggested by complaints of a diminished sense of well being, persistent unexplained fatigue and decreased sexual desire, sexual receptivity and pleasure in a woman who is oestrogen-replete and in whom no other significant contributing factors can be identified. The diagnosis is supported by the finding of low circulating concentrations of free testosterone. Barriers to its recognition include the non-specificity of the symptoms and methodological problems due to insensitive testosterone assays. Barriers to its treatment include the unavailability of satisfactory forms of testosterone for administration to women and lack of data regarding long-term safety. Although several conditions lead to clear-cut androgen deficiency, such as hypopituitarism, adrenal and ovarian insufficiency, glucocorticoid therapy and use of oral contraceptives and oral oestrogens, it is important for clinicians to recognise that in normal women, androgen levels decline by 50% from the early 20s to the mid 40s, and hence age-related androgen insufficiency may occur in women in their late 30s and 40s, as well as postmenopausally. Satisfactory measurements of free testosterone requires a sensitive and reliable assay for total testosterone, and quantitation of sex hormone binding globulin, from which free testosterone is readily calculated. Adverse effects of testosterone treatment are few if replacement is monitored to achieve physiological circulating testosterone concentrations. Currently, available methods include testosterone implants and testosterone creams, and transdermal patches and sprays are in development.

Androgens↗
PubMed1991

A practical guide to nitrate use.

Nitrate preparations are useful in the treatment of acute and chronic angina, acute and chronic congestive heart failure, and acute myocardial infarction. Development of tolerance is best managed by providing a nitrate-free interval, thus avoiding continuous drug levels. This interval probably should be 10 to 12 hours with use of a transdermal patch. Nitrate treatment of the elderly may require lower doses to avoid hypotension.

Angina Pectoris↗
PubMedDate not supplied

Combining clonidine and nicotine replacement for treatment of nicotine withdrawal.

The U.S. Surgeon General's 1988 report on nicotine addiction has increased the need for the substance abuse treatment community to become more involved in smoking cessation programs. A unique approach to nicotine detoxification has been developed at the Haight Ashbury Free Clinics' Drug Detoxification, Rehabilitation and Aftercare Project. After an evaluation by a physician, a thorough explanation of the treatment plan, and if the patient is interested, a combination of clonidine via the transdermal patch (Catapres-TTS) and of nicotine replacement via nicotine polacrilex (Nicorette) is used. By combining a Nicorette taper with clonidine, the physician can control the rate of nicotine withdrawal (Nicorette) and the extent to which withdrawal symptoms are treated (clonidine). This appears to be an effective, comfortable method for detoxification from cigarettes and nicotine. Its use should prove helpful as an adjunct to a comprehensive smoking cessation program.

Clonidine↗
PubMed2004

Iontophoretic enhancement of timolol across human dermatomed skin in vitro.

The objective of this study was to assess the in vitro the iontophoretic delivery of Timolol across human dermatomed skin in order to determine whether therapeutic doses of this drug can be delivered. Anodal iontophoresis of Timolol was performed by manipulating the donor vehicle and the current density. It was observed that by reducing simultaneously the competitive ions (NaCl) from 8 to 4 g/l and the pH from 7.4 to 4.7, the iontophoretic flux was significantly increased by a factor of 1.5 (669+/-81 microg/cm h). In order to simulate the situation in a transdermal patch, the iontophoretic delivery of Timolol was also studied after adding an artificial porous membrane placed between the Timolol formulation and the human dermatomed skin. No significant difference was observed in the steady state flux across the skin when an artificial membrane was added. Furthermore, a linear relationship was found between current density and steady state flux. These results indicate that the iontophoretic delivery of Timolol can be accurately controlled by the applied current. Assuming a one to one in vitro/in vivo correlation the Timolol transport in vitro results in therapeutic plasma concentrations in humans with very low current densities limiting possible skin irritation.

Administration, Cutaneous↗
PubMed2000

Efficacy of transdermal nicotine in reducing post-cessation weight gain in a Hispanic sample.

This study examined nicotine replacement effects and pre-quit smoking characteristics with respect to post-cessation weight gain in a primarily Mexican-American sample of Hispanic smokers. Hispanic smokers (108) were randomly assigned to receive either nicotine transdermal patch or placebo patch for 10 weeks, during which time smoking status and weight change were measured. The overall weight gain experienced by the successful quitters was greater than that experienced by non-quitters. Differences between quitters and non-quitters were significant for both females (2.0 vs. 0.86 kg; p < 0.05) and for males (2.3 vs. 1.2 kg; p < 0.05) at 6 weeks post-randomization. At the end of the 10-week treatment, only the females showed a significant difference in weight gain between the quitters and non-quitters (2.8 vs. 1.1; p < 0.01). Results of the random effects regression models for quitters indicated that the active group gained weight at a significantly lower rate than the placebo group (p = 0.047) for females, but not for males (p = 0.87). Years of smoking (p = 0.001) but not baseline cigarettes (p = 0.13) were significant predictors of weight for females, but not for males (p = 0.24 and 0.72, respectively). The use of nicotine patch treatment for smoking cessation effectively attenuated weight gain for successful female quitters compared with placebo-treated quitters. Identification of pre-quit smoking characteristics may prove useful in predicting who is most likely to gain weight when quitting smoking.

Administration, Cutaneous↗
PubMed2002

Nicotine effects on alertness and spatial attention in non-smokers.

Nicotine reportedly improves covert orienting of spatial attention, but enhanced alertness may also play a role. The present study explored nicotine effects on measures of spatial attention and alertness in non-smokers. Nicotine was delivered to 17 non-smokers (data from 12 subjects were analyzed) by a 7-mg transdermal patch (one patch in a low-nicotine condition; two patches in a high-nicotine condition). We examined nicotine's effects on spatial attention using a covert orienting task with central, predictive cue stimuli. Nicotine effects on alertness were examined with EEG and subjective questionnaires. Blood was drawn and serum levels of nicotine are reported. Nicotine decreased overall reaction times in the covert orienting task. There was no change in the validity effect, the reaction time difference between validly and invalidly cued targets. However, nicotine significantly improved both EEG and self-rated measures of alertness. We conclude that nicotine increases alertness in non-smokers, but we found no improvement in spatial attention using a covert orienting task.

Adult↗
PubMed2002

Comparative study to evaluate skin irritation and adhesion of Estradot and Climara in healthy postmenopausal women.

OBJECTIVES: To compare the local tolerability, adhesion and estradiol delivery of a 5-cm(2) transdermal patch (Estradot), Novartis Pharmaceuticals, Basel, Switzerland) and a 12.5-cm(2) patch (Climara, Berlex Laboratories, Wayne, NJ, USA). METHODS: This was an open-label, randomized, intrapatient, comparative study. One hundred healthy postmenopausal women applied the 50 micro g/day 5-cm(2) patch and the 12.5-cm(2) patch concurrently for 7 days; safety and tolerability were assessed. Twelve women continued to apply the 5-cm(2) and 12.5-cm(2) patches separately for 7 days in a two-way cross-over study, to investigate the reproducibility of estradiol delivery. RESULTS: The proportion of subjects with a clinically significant erythema score was higher with the 12.5-cm(2) patch. The 5-cm(2) patch had a significantly lower incidence of very slight erythema than the larger patch (21.4% vs. 32.3%; p = 0.0028). Overall erythema scores were 0.22 and 0.41, respectively. More 5-cm(2) patches had > 90% adherence than the 12.5-cm(2) patches (87.5% vs. 82.0%, not significant) and fewer became detached (0.5% vs. 3.0%). Both the patches showed reproducible delivery of estradiol. CONCLUSION: The 5-cm(2) patch was associated with less skin irritation and better adherence than the 12.5-cm(2) patch, although the majority of the differences were not significant. The 5-cm(2) patch was well tolerated and showed reproducible estradiol delivery, as did the 12.5-cm(2) patch.

Adhesiveness↗
PubMed2001

Clinical correlates of estrogen replacement therapy use and duration of use among medicaid recipients.

Estrogen replacement therapy (ERT) is used not only for the short-term control of menopausal symptoms but long-term for disease prevention. This study examined the influence of selected clinical conditions on the use of ERT and the duration of ERT use among women enrolled in a state Medicaid program. We identified 60,531 women, aged >/=45 years, who were enrolled in Maryland Medicaid continuously for at least 2 of 3 years. ERT use was determined through prescription claims submitted for reimbursement. The presence or risk of selected clinical conditions (e.g., osteoporosis, heart disease, estrogen-sensitive cancers) was determined by screening Medicaid claims files for related diagnoses, procedures, or prescription claims. Multiple logistic regression was used to model ERT use, and proportional hazards regression was used to model duration of use. Fourteen percent of these women filled an ERT prescription, with use varying by age, race, and place of residence. Oral dosage forms were the most popular (80.8%), followed by vaginal cream or ring (22.2%), and transdermal patch (7.3%). In adjusted models, osteoporosis, heart disease, hypertension, hyperlipidemia, diabetes, ovarian cancer, and thromboembolic disease were positively associated and dementia and breast cancer were negatively associated with ERT use. None of these medical conditions predicted the duration of estrogen therapy. Use of ERT was very low among these women despite coverage of prescription medications, and the presence of clinical indications had no influence on the length of therapy among these women despite known benefits for long-term preventive therapy.

Aged↗
PubMed1995

Treatment of nicotine dependence.

Drug and nondrug interventions used in treating nicotine dependence are reviewed. Tobacco use is the leading preventable cause of death in the United States. Risks of smoking-related disease and death decline sharply when smokers quit, but 26% of Americans continue to smoke. Most smokers find it extremely difficult to quit smoking because of their nicotine addiction. Nonpharmacologic interventions used to promote smoking cessation include behavioral therapy, setting a specific date for quitting, receiving advice to quit from a health care professional, follow-up visits to review progress, self-help approaches, group counseling, filtration devices, hypnosis, and acupuncture. The efficacy of these approaches ranges from substantial to almost nil. The only pharmacologic agent with FDA-approved labeling for use in smoking-cessation therapy is nicotine. When used in conjunction with appropriate nonpharmacologic interventions, nicotine-replacement therapy roughly doubles the rate of quitting obtained with placebo. Nicotine-replacement therapies consist of nicotine transdermal (patch) systems and nicotine chewing gum. The nicotine patch is the first-line replacement therapy because it is effective when accompanied by only minimal (as opposed to more intensive) nonpharmacologic interventions and because it is easier to use and comply with than gum. Clonidine, antidepressants, and buspirone require further study to determine what role, if any, they should play in the treatment of nicotine dependence. The stages of smoking cessation are precontemplation, contemplation, action, and maintenance; interventions are selected on the basis of the stage the smoker is in. Nicotine dependence is difficult to treat, but there are aids that boost a smoker's chances of quitting. Nicotine patches and chewing gum offer the most effective pharmacologic options, especially when combined with behavioral interventions and counseling.

Adult↗
PubMed1989

Principles of transdermal nitroglycerin administration.

The currently marketed delivery systems for transdermal nitroglycerin (GTN) develop fairly constant GTN plasma concentrations throughout the 24-h application period. This may be associated with tolerance, particularly when higher doses are employed. Because of this problem, a new GTN transdermal delivery system (TDS) has been developed which provides a time-dependent, non-constant drug delivery rate. This system was engineered to provide high GTN plasma concentrations during the first 12h of application which should prevent exercise-induced angina and low nitroglycerin levels during the second 12-h period to prevent tolerance. This GTN TDS with a phasic release profile is described and the in vitro and in vivo release rates and resulting plasma concentrations are contrasted with those of conventional GTN transdermal patches.

Administration, Cutaneous↗
PubMed1988

When does nitrate tolerance develop? What dosages and which intervals are necessary to ensure maintained effectiveness?

To address the issues of tolerance development and its circumvention during long-term treatment with nitrates, several controlled studies have been performed. In patients with coronary artery disease, during long-term treatment with isosorbide dinitrate (ISDN) in sustained-release form at dosages of 20 mg t.i.d., 40 mg t.i.d. and 60 mg t.i.d., both the rate of anginal attacks and the ischaemic reaction to exercise were unaffected. After a marked acute anti-ischaemic effect to 40 mg ISDN in nonsustained-release form, during chronic administration of the same dose four times daily, in association with continuously-high nitrate plasma concentrations, similarly, there were no significant effects. On use of nitroglycerin (NTG) transdermal patches delivering 10 mg, 15 mg and 30 mg per 24 hours, respectively, renewed patch application after 24 hours was not met with the same marked response observed after initial application. Clearly attenuated effects could be seen within 8 to 12 hours. These results show that tolerance development is incurred when the incrementation in plasma concentration after a repeated nitrate dose is of relatively limited magnitude with respect to baseline values. The observation of rapid reversibility of nitrate tolerance lead to the concept of interval treatment which on daily use incorporates a sufficiently long period without nitrate administration. On use of a nitrate-free treatment interval employing a regimen of 20 mg ISDN nonsustained-release form twice daily in the morning and at midday, 120 mg ISDN sustained-release form once daily or 50 or 100 mg isosorbide 5-mononitrate once daily, maintained effectiveness has been documented, as it has also been shown for treatment with NTG patches delivering 10 mg per 24 hours on incorporation of a 12-hour patch-free interval. The currently available patch system with discontinuous NTG delivery does not incur a complete loss of action but a considerable attenuation of its effects indicates the need for further refinements. Thus interval treatment guarantees maintenance of nitrate effects, albeit with the limitation that 24-hour therapeutic coverage is not enabled.

Administration, Cutaneous↗
PubMed2004

Olfactometric and rhinomanometric outcomes in post-menopausal women treated with hormone therapy: a prospective study.

BACKGROUND: The aim of this prospective study was to evaluate the effects of hormone therapy (HT) on olfactory sensitivity in post-menopausal women. METHODS: Forty-six naturally post-menopausal women underwent rhinomanometric and olfactometric measurements to compare nasal airflow resistance values and olfactometric thresholds during the eighth month of HT treatment with baseline levels prior to starting HT. Eighteen women used an oral HT regimen, and twenty-eight women used transdermal patch HT. RESULTS: Rhinomanometric values during HT were statistically differ from those at baseline (P < 0.001). Olfactometric threshold data indicated a higher sensitivity during the HT treatment than at baseline (P < 0.001). Finally, no statistically significant difference was observed among women using oral or patch HT administration on rhinomanometric and olfactometric values. CONCLUSIONS: Our study demonstrates that 8 months of treatment with estrogen and progestogens in HT preparations has an effect on nasal airflow resistance and the olfactory thresholds to odours. We believe that estrogens could influence neuronal plasticity, and the neuronal conduction time into the olfactory system. Our findings confirm that gonadal steroids such as estrogen have an influence on non-genital targets; this relationship might have a beneficial impact on sensorineural communication and emotional behaviour.

Administration, Oral↗