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PubMed2005

Determination of fentanyl in human plasma and fentanyl and norfentanyl in human urine using LC-MS/MS.

Fentanyl, a potent analgesic drug, has traditionally been used intravenously in surgical or diagnostic operations. Formulations with fentanyl in oral transmucosal delivery system and in transdermal depot-patch have also been developed against breakthrough pain in cancer patients. In this report, LC-MS/MS methods to determine fentanyl in human plasma as well as fentanyl and its main metabolite, norfentanyl, in human urine are presented together with validation data. The validation ranges were 0.020-10.0 and 0.100-50.0 ng/ml for fentanyl in plasma and urine, respectively, and 0.102-153 ng/ml for norfentanyl in urine. Liquid-liquid extraction of the compounds fentanyl, norfentanyl and the deuterated internal standards, fentanyl-d5 and norfentanyl-d5 from the matrixes was applied and separation was performed on a reversed phase YMC Pro C18-column followed by MS/MS detection with electrospray in positive mode. The inter-assay precision (CV%) was better than 4.8% for fentanyl in plasma and 6.2% and 4.7% for fentanyl and norfentanyl, respectively, in urine. The ruggedness of the methods, selectivity, recovery, effect of dilution and long-term stability of the analytes in plasma and urine were investigated. Effect of haemolysis and stability of fentanyl in blood samples were also studied. The methods have been applied for the determination of fentanyl in plasma samples and fentanyl/norfentanyl in urine samples taken for pharmacokinetic evaluation after a single intra-venous (i.v.) dose of 75 microg fentanyl.

Chromatography, Liquid↗
PubMed1998

Effects of short-term suppression of ovarian hormones on cardiovascular and neuroendocrine reactivity to stress in women.

The present study reduced the levels of ovarian hormones to early postmenopausal levels by a GnRH agonist and evaluated the effects of a temporary suppression of ovarian hormones on premenopausal women's cardiovascular and neuroendocrine responses to laboratory challenges. The stress responses of 24 healthy young women were evaluated during three tasks during the early follicular phase and then after three monthly injections of Lupron, which suppressed their levels of estradiol, FSH, and LH. Thereafter, half the group resumed menstrual cycles (labeled Cycle), and half continued having Lupron injections in combination with transdermal estradiol (labeled Patch) and all were reevaluated a third time. A third group (labeled Control) of 12 women had four monthly injections of Lupron first and then were evaluated the first time. After their cycles resumed, they were reevaluated twice 3 months apart. Results showed that the magnitude of the blood pressure and catecholamine changes declined over the three evaluations, suggesting that the women's stress responses habituated. Although the suppression of ovarian hormone levels led to alterations in ovarian hormones for several months, which were accompanied by typical menopausal symptoms, cardiovascular and neuroendocrine responses to stress did not vary. This study did not test the effects of current estrogen exposure or of long term suppression of ovarian hormones upon cardiovascular and neuroendocrine responses.

Adult↗
PubMed2003

Advancing the field of drug delivery: taking aim at cancer.

Drug delivery systems for cancer therapeutics have now been used by millions of patients and have resulted in the creation of new therapies as well as significantly improving existing ones. Here we discuss a number of the drug delivery systems that have been approved by regulatory authorities and that are currently in clinical use, such as controlled delivery of cancer therapeutics, local chemotherapy, polymer drug conjugates, liposomal systems, and transdermal drug delivery patches. The next generation of "smart" drug delivery approaches such as controlled release microchips are discussed as are some of the future challenges and directions in this field.

Absorbable Implants↗
PubMed1999

Quantitation of 4-oxo-4-(3-pyridyl)butanoic acid and enantiomers of 4-hydroxy-4-(3-pyridyl)butanoic acid in human urine: A substantial pathway of nicotine metabolism.

A liquid chromatography-atmospheric pressure chemical ionization-tandem mass spectrometry (LC-APCI-MS/MS) method was developed to analyze human urine for 4-oxo-4-(3-pyridyl)butanoic acid (keto acid) and the enantiomers of 4-hydroxy-4-(3-pyridyl)butanoic acid (hydroxy acid) to test our hypothesis that (S)-hydroxy acid could be a biomarker of metabolic activation of the tobacco-specific carcinogens 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN) while (R)-hydroxy acid would be formed predominantly from nicotine, as indicated by studies with rats. Urine was collected from smokers, and from the same individuals after they had stopped smoking and used a nicotine transdermal system (nicotine patch) for 3 weeks. If (S)-hydroxy acid were a biomarker of NNK and NNN metabolic activation, its levels should be higher in the urine of smokers than in nicotine patch users because tobacco smoke, but not the nicotine patch, contains NNK and NNN. Internal standard, [2,2,3,3,4-D5]hydroxy acid, was added to an aliquot of urine, which was then subjected to solid phase extraction. The eluant containing hydroxy acid was esterified with acidic methanol, followed by treatment with (S)-(-)-alpha-methylbenzyl isocyanate, producing methyl-4(S)- or methyl-4(R)-[(S)-alpha-methylbenzylcarbamoyl]-4-(3-pyridyl)buta noate [(S,S)- or (R,S)-MMPB, respectively]. After HPLC purification, the MMPB diastereomers were separated and quantified by LC-APCI-MS/MS. Mean levels of (S)- and (R)-hydroxy acid were 14.1 +/- 8.0 and 1120 +/- 600 ng/mL, respectively, in smokers during ad lib smoking (n = 18), while the corresponding levels during nicotine patch use (n = 18) were 4.1 +/- 3.3 and 363 +/- 228 ng/mL. The amounts of (S)-hydroxy acid were far higher than could be formed from NNK and NNN, and the total amount of hydroxy acid indicated that it was a substantial urinary metabolite of nicotine, in contrast to results with rats. Therefore, the study was extended to quantify keto acid. This was accomplished by NaBH4 treatment of urine, which converted keto acid to hydroxy acid quantitatively, which was in turn analyzed as described above. Levels of keto acid while subjects were smoking and using the nicotine patch were 228 +/- 129 (n = 8) and 97.5 +/- 80.6 ng/mL (n = 8), respectively. These results indicate that conversion of nicotine to keto acid and hydroxy acid is a substantial metabolic pathway in humans, accounting for an estimated 14% of the nicotine dose. Apparently, keto acid is extensively converted to hydroxy acid in humans, in contrast to the results with rats. (S)-Hydroxy acid in human urine cannot be used as a biomarker of NNK and NNN metabolic activation because it is overwhelmed by the (S)-hydroxy acid formed from nicotine, despite the fact that >98% of the urinary hydroxy acid has the (R)-configuration. These results provide new insights about nicotine metabolism in humans.

Animals↗
PubMed1994

A double-blind, placebo-controlled trial of transdermal fentanyl after abdominal hysterectomy. Analgesic, respiratory, and pharmacokinetic effects.

BACKGROUND: A randomized, double-blind, placebo-controlled trial was conducted to assess the analgesic, pharmacokinetic, and clinical respiratory effects of 72-h application of two transdermal fentanyl (TTSF) patch sizes in patients undergoing abdominal hysterectomy. METHODS: TTSF patches releasing 50 micrograms/h (TTSF-50) or 75 micrograms/h (TTSF-75) fentanyl or placebo patches were applied to 120 women 2 h before abdominal hysterectomy under general anesthesia. Postoperatively, all patients had access to supplemental morphine using patient-controlled analgesia pumps. Each patient was attended continuously by a research nurse for 8 h on the night before surgery and for 84 h after patch application. The following data were collected: visual analog scale pain scores, supplementary analgesia, fentanyl plasma concentration (4-h intervals), continuous hemoglobin saturation (pulse oximetry), respiratory pattern (continuous respiratory inductive plethysmography), and adverse effects (nausea, vomiting, pruritus). Data analysis included analysis of variance, Kruskal-Wallis, and chi-squared. P < 0.05 was considered significant. RESULTS: There were no demographic differences among groups. Visual analog scale pain scores were significantly lower for the TTSF-75 group, and supplemental morphine was significantly decreased in the TTSF-75 group in the postanesthesia care unit and for both the TTSF-50 and the TTSF-75 group for 8-48 h postoperatively. Between 5 and 36 h, the TTSF groups had significantly increased abnormal respiratory pattern including apneic episodes (tidal volume of less than 100 ml for more than 15 s) and episodes of slow respiratory rate (less than 8 breaths/min persisting for more than 5 min) and significantly increased requirement for oxygen supplementation. Nine patients in the TTSF groups were withdrawn because of severe respiratory depression compared to none in the placebo group. No significant between-group differences were present in the incidence of nausea, vomiting, or pruritus. Although fentanyl plasma concentration was higher in the TTSF-75 group than in the TTSF-50 group, the differences were not significant. Fentanyl plasma concentration decreased significantly 48 h after patch application. CONCLUSIONS: Application of TTSF patches 2 h preoperatively is associated with moderate supplementary opioid requirements for analgesia in the early postoperative period and ongoing opioid supplementation for at least 72 h. Although good analgesia is the result of this combination therapy, it is associated with a high incidence of respiratory depression requiring intensive monitoring oxygen supplementation, removal of the TTSF patches in approximately 11% of the patients and opioid reversal with naloxone in approximately 8% of the patients.

Administration, Cutaneous↗
PubMed1999

Effects of atropine and scopolamine on bradycardia and emetic symptoms in otoplasty.

OBJECTIVE: To assess the effects of unilateral or bilateral otoplasty on bradycardia and postoperative nausea and vomiting (PONV) and the efficiency of transdermal scopolamine in the prophylaxis of PONV. STUDY DESIGN: Post hoc assessment of the data from a double-blind, randomized study. METHODS: Fifty otoplasty patients were studied; half of them received randomly and in double-blind fashion a transdermal therapeutic system (patch) of scopolamine (TTS-scopolamine) as prophylaxis against PONV before general anesthesia. The placebo group received atropine 10 microg x kg(-1) intravenously during induction. RESULTS: The scopolamine-treated patients suffered more from moderate peroperative bradycardia (8/25; P < .05) than the atropine-treated patients (1/25). Two patients wearing a half of the TTS-scopolamine patch needed intravenous atropine. After unilateral otoplasty, none of the TTS-scopolamine-treated patients and 50% of the atropine-treated patients suffered from PONV. After bilateral operation, the respective incidences were 39% and 81% (P < .01). After unilateral otoplasty no patient needed droperidol, but after bilateral otoplasty, 12 of 19 of the atropine-treated and 4 of 18 (P < .05) of the scopolamine-treated patients needed droperidol. The mean numbers of doses of droperidol were 0.8+/-0.9 and 0.3+/-0.6 (P < .05), respectively. Two additional patients, wearing half of the TTS-scopolamine patch, suffered from mild central anticholinergic syndrome. CONCLUSION: TTS-scopolamine offers effective prophylaxis against PONV (auriculoemetic reflex), but does not protect from bradycardia (auriculocardiac reflex) in otoplasty. Cutting of the TTS-scopolamine patch may lead to undesirable side effects.

Anti-Arrhythmia Agents↗
PubMed1991

Occupational allergic contact dermatitis caused by nitroglycerin.

Irritant contact dermatitis caused by occupational contact with nitroglycerin has been known since the end of the last century. Nitroglycerin is an allergen, and the transdermal drug delivery systems for nitroglycerin recently used to treat angina pectoris have sensitized. 4 patients with allergic contact dermatitis caused by nitroglycerin from explosives are described, and 1 patient who was sensitized by transdermal nitroplaster. On patch testing, dynamite and/or the explosive components nitroglycerin, ethylene glycol dinitrate and dinitrotoluene gave allergic reactions. The following concentrations and vehicles are suggested for patch testing: nitroglycerin 0.5-2% pet., dinitrotoluene and ethylene glycol dinitrate 0.1-0.5% pet. Persons exposed to nitroglycerin at work should try to avoid skin contact by using protective gloves. It is advisable that those who have become allergic to nitroglycerin should wear disposable protective gloves when handling explosives.

Adult↗
PubMed1985

CL115,347, an analogue of prostaglandin E2. Peripheral circulatory effects of single ascending doses administered transdermally in normal subjects and in patients with Raynaud's phenomenon.

The beneficial effects of intra-arterial or intravenous infusion of the prostanoid products of anachridonic acid, PGE and prostacyclin (PGI2) are well documented. More recently an analogue of PGE2, (CL 115,347, American Cynamid Co.) has become available. This substance is absorbed transdermally from a patch placed on the skin. In a placebo-controlled trial the vasodilatory effect of single incremental dosage, 500 mcg, 1000 mcg and 1500 mcg, was measured in a temperature-/humidity controlled laboratory in normal subjects and in patients with primary and secondary Raynaud's phenomenon. The optimal dosage proved to be 1000 mcg; the effect may last for 84 hours; higher dosage may be associated with a "steal" phenomenon.

Administration, Topical↗
PubMed1997

Prevention of postmenopausal bone loss using tibolone or conventional peroral or transdermal hormone replacement therapy with 17beta-estradiol and dydrogesterone.

Postmenopausal bone loss can be prevented by continuous or intermittent estradiol (E2) administration. Concomitant progestogen therapy is mandatory in nonhysterectomized women to curtail the risk of endometrial hyperplasia or cancer. However, the recurrence of vaginal bleeding induced by sequential progestogen therapy in addition to continuous estrogen administration is one of the reasons for noncompliance to hormone replacement therapy (HRT). Tibolone, a synthetic steroid with simultaneous weak estrogenic, androgenic, and progestational activity, which does not stimulate endometrial proliferation, has recently been proposed for the treatment of climacteric symptoms. To compare the efficacy of conventional oral and transdermal HRT with that of tibolone in the prevention of postmenopausal bone loss, 140 postmenopausal women (age, 52 +/- 0.6 years; median duration of menopause, 3 years) were enrolled in an open 2-year study. Volunteers had been offered a choice between HRT and no therapy (control group, CO). Patients selecting HRT were randomly allocated to one of the following three treatment groups: TIB, tibolone, 2.5 mg/day continuously, orally; PO, peroral E2, 2 mg/day continuously, plus sequential oral dydrogesterone (DYD), 10 mg/day, for 14 days of a 28-day cycle; TTS, transdermal E2 by patch releasing 50 microg/day, plus DYD as above. Bone densitometry of the lumbar spine, upper femur, and whole body was performed using dual-energy X-ray absorptiometry at baseline, and then 6, 12, 18, and 24 months after initiation of therapy. One hundred and fifteen women (82%) completed the 2 years of the study. The dropout rate was similar in each group. Over 2 years, bone preservation was observed in all three treatment groups as compared with controls, without significant differences among treatment regimens. In conclusion, tibolone can be regarded as an alternative to conventional HRT to prevent postmenopausal bone loss.

Absorptiometry, Photon↗
PubMed2006

Methylphenidate transdermal system: In attention-deficit hyperactivity disorder in children.

The methylphenidate transdermal system (MTS) patch is approved by the US FDA for use in children aged 6-12 years with attention-deficit hyperactivity disorder (ADHD). This delivery system permits sustained absorption of the drug through the skin and into the bloodstream. Methylphenidate (MPH) is a CNS agent thought to act on dopamine and noradrenaline (norepinephrine) pathways and thereby blocks the reuptake of these neurotransmitters into the presynaptic neuron. In children with ADHD, MTS patches releasing MPH doses of 10-30 mg over a 9-hour period (12.5-37.5 cm2 patch size) is steadily absorbed, with mean peak plasma concentrations of d-MPH (20-46.5 ng/mL) reached in approximately 8 hours. In well controlled trials in children with ADHD, patients administered MTS patches releasing MPH 10-30 mg over approximately 9 hours showed significantly greater improvements in their ADHD symptoms than placebo recipients. MTS patches are generally well tolerated in paediatric patients with ADHD, with treatment-emergent events being similar in nature to those reported with oral MPH. The majority of adverse events were mild to moderate in intensity.

Administration, Cutaneous↗
PubMed2002

Comparison of transdermal administration of fentanyl versus intramuscular administration of butorphanol for analgesia after onychectomy in cats.

OBJECTIVE: To compare postoperative discomfort assessed by subjective pain score and plasma cortisol concentrations in cats undergoing onychectomy that received analgesia by use of transdermal fentanyl (TDF) patches or an i.m. injection of butorphanol. DESIGN: Randomized prospective clinical trial. ANIMALS: 22 client-owned cats weighing 2.2 to 5 kg (4.84 to 11 lb) undergoing onychectomy. PROCEDURE: Researchers were blinded to which cats received a TDF patch (25 microg/h) 18 to 24 hours prior to surgery or an i.m. injection of butorphanol (0.2 mg/kg (0.09 mg/lb]) at the time of sedation, immediately following extubation, and at 4-hour intervals thereafter for 12 hours. Clinical variables, plasma cortisol concentration, and pain scores were evaluated and recorded 24 hours prior to surgery, at extubation, and 2, 4, 8, 12, 24, 36, and 48 hours after surgery. RESULTS: The TDF group had a lower pain score than the butorphanol group only at 8 hours after surgery. Both groups had significantly lower mean plasma cortisol concentrations 0, 24, 36, and 48 hours after surgery, compared with mean plasma cortisol concentrations prior to surgery. No significant differences in appetite or response to handling the feet were observed between the 2 groups. CONCLUSIONS AND CLINICAL RELEVANCE: Our data did not reveal a difference in pain relief between administration of TDF and butorphanol. Plasma cortisol concentrations were not different between groups. Fentanyl appeared to provide equivalent analgesia to butorphanol in cats undergoing onychectomy. The primary advantage of using a TDF patch is that repeated injections are not required.

Administration, Cutaneous↗
PubMedDate not supplied

New strategies in opioid therapy for cancer pain.

BACKGROUND: The last decade has seen a great increase in the range of opioid agents and formulations available for the treatment of chronic pain, raising new clinical questions and options. METHODS: The author conducted an extensive review of the existing medical literature on opioid agents and formulations currently available. RESULTS: Opioids remain the cornerstone of pharmacotherapy for cancer pain. In addition to severity of pain, coexisting disease, response to previous therapy, the drug's pharmacokinetics and available formulations influence the choice of an opioid agent. Short-half-life drugs, such as morphine, hydromorphone, fentanyl, oxycodone, and oxymorphone, are generally favored initially because they are easier to titrate than long-half-life agents. Long-acting controlled-release opioid preparations can lessen the inconvenience of around-the-clock administration of drugs with a short duration of action. In recent years several new formulations have been developed, including controlled-release morphine suppositories and suspensions; controlled-release tablets of oxycodone, hydromorphone, and codeine; and transdermal fentanyl, a patch that allows 3-day dosing and avoids the first-pass effect of the liver. Most patients who receive controlled-release opioids should be provided with a rescue dose of an immediate-release opioid to treat pain that may break through the controlled-release schedule. CONCLUSIONS: Among the important advances in the last decade in the treatment of chronic pain is the realization that the goals of care and the best means of achieving them differ not only among individuals but often for a single patient throughout a long course of care. Physicians must not only be knowledgeable but also flexible in their approach to managing cancer pain. An understanding of the range of opioid agents and the formulations available can allow physicians to maintain the best possible quality of life for their patients with chronic pain.

Analgesics, Opioid↗
PubMed2000

Transdermal formulations of deprenyl: guinea pig and pig models.

The efficacy of many drugs relies on their presence at the site of action over a period of time. The retardation or programmed release capability of the conventional dosage forms like oral and parenteral are limited and toxic and undesired side-effects may occur after their applications. These problems may be solved using transdermal delivery systems. Transdermal systems are aimed for local, or systemic action. In the letter case controlling the rate of delivery or modulating the distribution in the organism. The selection of an adequate biological method of evaluating a new transdermal formulation is a critical point of the development. The in vitro methods can help in the characterization of the different formulas, but without an in vivo disposition study they cannot give relevant information about the expectable therapeutic behavior. We adapted and improved an in vivo test system for the evaluation of new transdermal particulate systems (patches) and liposomes containing deprenyl selegiline as active ingredient. The in vivo evaluation system consists of two steps: 1. Full biodisposition study on guinea pig, using isotope labeled selegiline. 2. Biodisposition studies on domestic pigs including dose, area, surface dependence and comparative bioavailability with traditional dosage forms and application moods. Specific examples of these studies and experimental technology are presented.

Administration, Cutaneous↗
PubMed2002

A mouse model of keratoconjunctivitis sicca.

PURPOSE: To evaluate the effects of pharmacologic inhibition of aqueous tear production and desiccating environmental stress on aqueous tear production, tear clearance, corneal epithelial permeability, and conjunctival epithelial morphology, proliferation, and conjunctival goblet cell differentiation. METHODS: Aqueous tear production was inhibited by applying transdermal scopolamine (scop) patches to the depilated midtail of female MC, CBA mice. Desiccating environmental stress was created by placing mice in a hood with a continuous airflow blower. Aqueous tear production and volume, tear clearance, and corneal barrier function were compared in four experimental groups: untreated control mice, mice placed in the blower hood, mice treated with a scop patch, and mice treated with a scop patch and blower hood (scop patch + blower). Cotton threads were used to evaluate aqueous tear production and volume. Tear clearance was assessed by fluorometric measurement of collected tear fluid 15 minutes after instillation of 1% sodium fluorescein. Corneal epithelial barrier function was assessed by fluorometric measurement of carboxyfluorescein uptake. Conjunctival morphology and goblet cell density were evaluated in stained histologic sections. Conjunctival epithelial proliferation was assessed by bromodeoxyuridine (BrdU) labeling. RESULTS: Significant decreases in cotton thread wetting and tear clearance were observed in mice treated with a scop patch (P < 0.001) or with a scop patch and blower desiccation (P < 0.001), with a greater reduction in tear clearance in the latter group. Significantly increased corneal carboxyfluorescein uptake was noted in the scop patch group compared with untreated mice (P = 0.05) and in the scop patch + blower group compared with all the other groups (P < 0.0001). Changes in conjunctival epithelial morphology and a significant decrease in conjunctival goblet cell density (P < 0.001) were observed in the scop patch + blower group compared with the untreated control group. The number of proliferating conjunctival epithelial cells was significantly greater in the scop patch + blower group. CONCLUSIONS: Pharmacologic inhibition of tear production in mice is accompanied by ocular surface epithelial changes resembling human keratoconjunctivitis sicca (KCS) that are exacerbated by desiccating environmental stress. Cholinergic stimulated tear production appears to be essential for maintaining a healthy ocular surface.

Animals↗
PubMed1987

Comparison of transdermal nitroglycerin therapy with previous long-acting oral or ointment nitrate therapy.

The charts of patients initially treated with long-acting oral or ointment (LAOO) nitrate therapy who subsequently used transdermal nitroglycerin (TNG) patches for the treatment of angina pectoris were reviewed to evaluate patient response, cost-effectiveness, and therapy preference. Fewer hospital admissions and emergency room visits were required during the period of TNG therapy than during the period of LAOO therapy. In addition, more patients reported improvement in angina status during TNG therapy, and a strong patient preference was noted for TNG treatment over the other forms of therapy. The cost analysis showed a trend toward a cost advantage for TNG therapy.

Administration, Cutaneous↗
PubMed1995

Prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. A prospective randomized study of metoclopramide and transdermal hyoscine.

OBJECTIVE: To compare the antiemetic effects of metoclopramide and hyoscine in patients after laparoscopic cholecystectomy. DESIGN: Prospective, randomised trial. SETTING: University hospital, Sweden. SUBJECTS: 100 consecutive patients median age 49 years (range 21-79) of whom 9 were withdrawn after randomisation. INTERVENTIONS: Patients were randomised to receive either four doses of metoclopramide 10 mg intravenously starting at the induction of anaesthesia (n = 44), or hyoscine transdermally through a patch placed behind the ear at 0600 h on the day of operation (n = 47). MAIN OUTCOME MEASURES: The incidence of nausea and vomiting. RESULTS: Metoclopramide was significantly more effective at preventing both nausea and vomiting (20/44 (45%) compared with 32/47 (68%), p < 0.05, and 10/44 (23%) compared with 21/47 (45%), p < 0.05). Women were significantly more likely to become nauseated than men (46/66 (70%) compared with 5/25 (20%), p < 0.001). Two patients in the metoclopramide group developed dizziness, and one patient in the hyoscine group had a disturbance of vision. About 20% in each group required additional antiemetic treatment. The median hospital stay in both groups for patients who did not develop complications was 2 days. CONCLUSION: There was a high incidence of nausea and vomiting after laparoscopic cholecystectomy even after treatment with metoclopramide. Further measures are indicated, particularly for women.

Administration, Cutaneous↗
PubMed1996

[Physostigmine in treatment of cerebellar ataxia].

Cerebellar ataxias are still a challenging problem for neurologists, and to this day there exists no medical, physiotherapeutic, psychot-erapeutic or surgical therapy which constantly leads to a reduction of ataxic symptoms. In the pathophysiology of cerebellar ataxia a cholinergic defect has often been described. In a double-blind, cross-over study with 14 patients with cerebellar ataxia and an open follow-up, long-term study with 21 patients, the clinical effects of physostigmine capsules in doses up to 10 mg per day were studied. Moreover, a transdermal application (physostigmine patch) was developed, achieving constant physostigmine plasma levels for 24 h. Of 14 patients treated with physostigmine during the double-blind, cross-over study, nine could correctly distinguish between verum and placebo. They all showed small but constant improvements, clearly experienced by the patients. With the physostigmine patch, 12 of 14 patients improved. Thirteen of 14 patients decided to take part in open follow-up studies with physostigmine, and most of them preferred the physostigmine patch as long-term medication. To date, 21 patients with cerebellar ataxia have been treated with physostigmine. As far as we can judge at the end of a treatment period of at least 2 years, the progression of the disease could be stopped in 17 of 21 patients. These patients reported small but constant effects, and none wants to live without the physostigmine patch.

Administration, Cutaneous↗
PubMedDate not supplied

Use of transdermal nicotine systems in a possible suicide attempt.

BACKGROUND: Transdermal drug delivery systems, a relatively recent development, are well accepted by physicians and patients because of reliability and ease of administration. The patch reservoirs, however, contain large quantities of drug, and the potential for considerable toxicity exists if they are used incorrectly. A case is presented of an apparent suicide attempt that involved the use of nicotine transdermal patches. METHODS: This case report involved a patient seen in the emergency department by one of the authors. Data were obtained from the patient's medical record while maintaining confidentiality. RESULTS: The drug overdose was a potentially serious one. The patient recovered fully after an uneventful hospital course. CONCLUSIONS: Transdermal drug delivery systems now deliver many drugs, several of which are quite potent. Intentional or unintentional misuse of the systems can result in toxicity. The physician and pharmacist should carefully instruct each patient in the appropriate use and handling of transdermal drug delivery systems.

Administration, Cutaneous↗