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PubMed1980

Chronic treatment with the gonadotropin-releasing hormone agonist D-Ser(TBU)6-EA10-LRH for contraception in women and men.

The stimulatory analogue of luteinizing hormone-releasing hormone (LRH) D-Ser(TBU)6-EA10-LRH was administered subcutaneously (sc) or intranasally to 10 women with amenorrhea and to 44 healthy female and male volunteers. The LRH agonist evoked a pronounced initial release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) but the gonadotropin response decreased during the course of the chronic treatment. Ovulation could not be induced in seven amenorrheic women who were given prolonged treatment with the analogue. In normally ovulating women, ovulation was inhibited during chronic treatment with a daily sc dose of 5 microgram or a daily intranasal dose of 400 microgram. In four healthy men treated with 5 microgram of the LRH agonist daily over 17 weeks basal FSH, LH, and testosterone levels decreased but spermatogenesis and potency were unaffected. The negative effects on testosterone secretion may limit the use of the LRH agonist for male contraception. Chronic intranasal administration of the stimulatory LRH analogue paradoxically inhibited ovulation and proved to be a safe and effective new approach to contraception in women.

Administration, Intranasal↗

PubMed1984

A comparison of an aqueous and a pressurized nasal spray of beclomethasone dipropionate in the management of seasonal rhinitis.

A multi-centre, double-blind, parallel group study was carried out in 38 patients with seasonal rhinitis to compare a new aqueous nasal spray of beclomethasone dipropionate with the conventional pressurized nasal spray. Beclomethasone dipropionate (200 micrograms) was administered twice daily for a treatment period of 2 weeks. Both treatments were found to be equally effective and well tolerated. It is suggested, therefore, that the new aqueous nasal spray provides an alternative method of intranasal administration of the steroid for patients who may prefer an aqueous product.

Administration, Intranasal↗

PubMed1995

Efficacy of a temperature-sensitive Sendai virus vaccine in hamsters.

A temperature-sensitive HVJ-pB strain of parainfluenza type 1 (Sendai) virus was obtained from a persistently virus-infected cell culture. Intranasal inoculation of Syrian hamsters with the HVJ-pB temperature-sensitive mutant resulted in an abortive infection but induced a specific antibody response against Sendai virus without appreciable lesions in the respiratory tract. Prior exposure to the temperature-sensitive mutant protected hamsters from subsequent challenge with virulent wild-type virus. The efficacy of protection became apparent at 5 days after vaccination and lasted for at least 720 days. For practical use of the HVJ-pB vaccine, a single intranasal administration to newborn babies aged over 15 days is recommended.

Administration, Intranasal↗

PubMed1993

[Recent progress in the diagnosis and treatment of diabetes insipidus].

Recent progress in the diagnosis and treatment of diabetes insipidus (DI) is reviewed. Response of plasma vasopressin (AVP) to 5% hypertonic saline can be a new indicator of the capacity of AVP response to osmotic stimuli. Marked progress in the imaging analysis by computed tomography and magnetic resonance imaging (MRI) has made it possible to evaluate hypothalamic-pituitary lesions in detail. Especially, signal intensity on T1-weighted MR image of neurohypophysis is suggested to reflect its function. Sequencing analysis of genes encoding AVP-neurophysin precursor or AVP receptor is expected to be a most useful method for the diagnosis of inherited DI. Intranasal administration of DDAVP (1-deamino-8-D-AVP) is recommended as a standard therapy for DI.

Administration, Intranasal↗

PubMed1996

[A physiological analysis of kidney ion-regulating function in children with enuresis].

Peculiarities of the excretion of ions (Na, K, Ca, Mg) and water were studied in healthy children and children with the nocturnal enuresis, aged 6-15 years. A greater diuresis in the enuretic children is due to an increased excretion of the osmotically active substances including Na and Mg; excretion of K and Ca does nor differ from the control. A new formula is proposed for the quantitative evaluation of the role of different substances in the osmolar clearance. A high correlation is found between the sodium and magnesium excretion and the osmotic free water reabsorption. A single intranasal administration of 1-deamino-8-D-arginine-vasopressin (DDAVP) to the children before their going to bed returned to the norm the sodium and magnesium excretion in the enuretic children. It is suggested that the defect peculiar to this particular pathology is associated with a decrease in the ion reabsorption in the thick ascending Henle loop. The normal level of the ion transport is restored after stimulation of V2-receptors by DDAVP. An explanation is suggested of the mechanism of the increase of diuresis with a simultaneous rise in the osmotically free water reabsorption in children with enuresis.

Administration, Intranasal↗

PubMed1998

A comparative study of pharmacodynamics and bioavailability of 2 different desmopressin nasal sprays.

The antidiuretic effect and pharmacokinetics were investigated in 16 healthy, male overhydrated volunteers after intranasal administration of 20 microg desmopressin. The antidiuretic activity was measured by determination of urine osmolality and diuresis every 15 minutes over a period of 8 hours. Both study preparations were equally effective regarding a rapid onset of activity and a highly reproducible magnitude of effect. Urine osmolalities, analyzed as area under the time curve (AUCosm) and maximum urine osmolalities were similar for both nasal sprays. Urine volume, analyzed as area under the time curve, was raised after treatment with the test preparation. Bioequivalence was assessed for the primary criterion AUCosm by a calculated mean ratio (test/reference) of 102.8% and a 90% confidence interval ranging from 95.4% to 110.8%. Plasma levels of desmopressin, measured by a specific and sensitive radio-immunoassay method, were already detectable 20 minutes after administration. The mean time curves were parallel at different concentration levels. The maximum desmopressin plasma concentrations of both preparations were comparable, showing high interindividual variability. The times of reaching maximum plasma concentrations were similar. Desmopressin bioavailability was increased after treatment with the test preparation (mean ratio of 130.8% and a 90% confidence interval ranging from 109.9% to 155.7%). Both preparations showed a pronounced biological effect with similarly raised urine osmolalities. The detected differences in bioavailability seem to have no direct correlation to the biological response.

Administration, Intranasal↗

PubMed1998

The duration of antidiuretic response of two desmopressin nasal sprays.

The duration of antidiuretic response and pharmacokinetics of desmopressin were investigated in 16 healthy, male overhydrated volunteers after intranasal administration of 20 microg desmopressin (dDAVP). The antidiuretic activity was determined by measuring urine osmolality and diuresis over a period of 24 hours. Both study preparations were equally effective regarding a rapid onset of activity and a highly reproducible extent of effect. Urine osmolalities, analyzed as areas under the time curve (AUCosm) were similar for both nasal sprays. Urine volumes were comparable. Bioequivalence was assessed for the primary criterion AUCosm by a calculated mean ratio (test/reference) of 100.9% (90% confidence interval ranging from 88.0% to 115.6%). Plasma levels of desmopressin, measured by a specific and sensitive radioimmunoassay method, were already detectable 20 minutes after administration. The mean time courses showed a similar shape with increased concentration levels for the test preparation. Consequently maximum desmopressin plasma concentrations were different, showing high interindividual variability. However, the times of reaching maximum plasma concentrations were similar. AUC(0-24h) was significantly raised after treatment with the test preparation (mean ratio of 127.9%; 90% confidence interval ranging from 106.6% to 153.5%). A subanalysis of the 2 reference batches with the two-sided t-test procedure for parallel groups resulted in a mean ratio of 83.1% with a 90% confidence interval ranging from 67.2% to 102.7%. The estimated ratios of the 2 batches of the reference preparation were borderline to the equivalence range. In conclusion, both study preparations had the same pronounced biological effect with different desmopressin bioavailabilities.

Administration, Intranasal↗

PubMed1998

A nontoxic adjuvant for mucosal immunity to pneumococcal surface protein A.

In this study, we demonstrated that pneumococcal surface protein A (PspA) nasally administered with a nontoxic A subunit mutant of cholera toxin (mCT) S61F elicited a protective immune response. Immunization with PspA and mCT elicited higher levels of PspA-specific IgG and IgA Abs in serum and of IgG and IgA anti-PspA Ab-forming cells in spleens, cervical lymph nodes (CLN), and lung tissue when compared to nonimmunized mice. Furthermore, significant PspA-specific IgA Abs were induced in saliva and nasal secretions. These responses were dependent on the use of mCT as a mucosal adjuvant. The PspA-specific Ab responses induced by mCT S61F were comparable with those induced by native CT (nCT). Analysis of cytokine responses showed that nasal PspA plus mCT S61F enhanced the induction of PspA-specific CD4+ T cells producing IL-4 but not IFN-gamma in CLN at both the protein and mRNA levels. Importantly, significant numbers of mice intranasally immunized with PspA plus mCT S61F were protected from lethal challenge with capsular serotype 3 Streptococcus pneumoniae A66. These results show that intranasal administration of PspA together with mCT S61F is an effective mucosal vaccine against pneumococcal infection and induces CD4+ Th2-type cells, which provide help for both mucosal and systemic Ab responses.

Adjuvants, Immunologic↗

PubMed1998

Azelastine does not adversely affect aerobic performance.

BACKGROUND: The effect of the treatment of allergic rhinitis with azelastine on physiological indicators of aerobic performance such as VO2 max and ventilatory threshold (VT) were evaluated. The clinical efficacy of azelastine was also established. METHODS EXPERIMENTAL DESIGN: fifteen physically active males with allergic rhinitis or rhinoconjunctivitis were selected as subjects (experimental group, EXP). Fifteen physically active, healthy subjects served as controls. Subjects performed a maximal incremental exercise test on a bicycle ergometer (ramp protocol) before and after a 5-day treatment period. During the 5 days, EXP group subjects were treated with azelastine (intranasal dose of 0.56 mg/day). The following variables were recorded before and after treatment: power output (W), HR (beats.min-1), VO2 (ml.kg-1.min-1), minute ventilation (VE, in 1.min-1), and oxygen pulse (VO2.HR-1, in ml.beat -1). Blood lactate concentrations (mmol.l-1) were also determined using capillary blood samples (25 microliters). RESULTS: No significant difference was found between pre- and post-trial variables in control subjects. However, peak HR values were lower in EXP subjects after treatment with azelastine (190 +/- 6 beats.min-1 pre-treatment vs 186 +/- 56 beats.min-1 post-treatment; p < 0.05). In addition, VE values at the exercise intensity corresponding to VT were higher in EXP after treatment (54.7 +/- 12.8 l.min-1 pre-treatment vs 60.2 +/- 14.6 l.min-1 post-treatment, p < 0.05). CONCLUSIONS: These findings suggest that the intranasal administration of azelastine used for the treatment of allergic symptoms of the upper respiratory tract in physically active subjects, does not seem to adversely affect maximal aerobic capacity or submaximal aerobic performance.

Administration, Intranasal↗

PubMed2000

Acute candidiasis of the oro- and hypopharynx as the result of topical intranasal steroids administration.

Topical nasal steroids have become increasingly popular for the treatment of allergic and other types of rhinitis. However, undesirable local effects of intranasal steroids, such as nasal irritation and burning, crusting and epistaxis are quite common. Candidiasis of the pharyngeal mucosa is a complication, which has not been described so far after treatment of rhinitis with intranasal topical corticosteroids. Between March 1997 and September 1998, we managed to treat successfully three patients with acute erythematous candidiasis of the pharynx, which was the result of the use of intranasal topical steroids. Mechanism, clinical features of acute pharyngeal candidiasis, differential diagnosis and treatment are discussed.

Administration, Intranasal↗

PubMed1993

The sedative effect of intranasal midazolam administration in the dental treatment of patients with mental disabilities. Part 1. The effect of a 0.2 mg/kg dose.

The purpose of this study was to determine the sedative effect of a 0.2 mg/kg dose of midazolam, administered intranasally, prior to performing various restorative dental procedures on a group of mentally disabled patients under local anesthesia and nitrous oxide/oxygen analgesia. Twenty-one patients, aged 4 to 21 years, all of whom had previously exhibited highly combative and resistant behavior toward dental treatment under local anesthesia, were sedated with 0.2 mg/kg midazolam. Only patients assessed as ASA anesthesia status I or II were admitted to the study. After administering the midazolam, each patient was allowed to rest before initiating the dental procedures. Behavioral patterns during the various procedures were rated on a behavioral rating scale of 1-7. Each patient served as his or her own control, comparing behavior with or without intranasal midazolam. The results showed a marked improvement in behavioral patterns after administration of intranasal midazolam. Ratings on a scale of 1-7 were noted as "markedly effective" and "effective" for 69.2% of those patients who received infiltration injection anesthesia, 93.8% under rubber dam, 76.2% during cavity preparation, 84.2% for restoration placement and 87.5% during pulpotomy procedures. The majority of patients were discharged within 150 minutes of intranasal instillation. Further studies are indicated to ascertain the most appropriate dose of intranasally administered midazolam.

Administration, Intranasal↗

PubMed2002

Aminated gelatin as a nasal absorption enhancer for peptide drugs: evaluation of absorption enhancing effect and nasal mucosa perturbation in rats.

This study was carried out to evaluate the potential of aminated gelatin as a nasal absorption enhancer for peptide drugs. The absorption-enhancing effect was investigated in rats using insulin and fluorescein isothiocyanate-dextran with a molecular weight of 4.4 kDa (FD-4) as model drugs. The absorption of insulin was estimated by measuring the changes in plasma glucose levels following intranasal administration, and that of FD-4 was determined by measuring its plasma concentration after dosing. The hypoglycaemic effect after intranasal administration of insulin with aminated gelatin significantly increased compared with that after intranasal administration of insulin in phosphate buffered saline, indicating that aminated gelatin effectively enhanced the nasal absorption of insulin. In contrast, neither kind of native gelatin (isoelectric point = 5.0 and 9.0) showed any absorption-enhancing effect. The pH of the formulations and the concentration of aminated gelatin were found to affect the hypoglycaemic effect. In addition, aminated gelatin at a concentration of 0.2% significantly enhanced the absorption and the efflux of FD-4 through the rat nasal mucosa. The possible perturbation of aminated gelatin to nasal mucosa was evaluated by measuring the leaching of lactate dehydrogenase (LDH) using an in-situ perfusion rat model. Aminated gelatin presented a concentration-dependent (0.1-0.4%) but relatively small effect on the LDH leaching from the rat nasal epithelial membrane. These results suggest that positively charged aminated gelatin could be a new absorption enhancer for nasal delivery of peptide drugs.

Absorption↗

PubMed1999

Antibody-independent protection against rotavirus infection of mice stimulated by intranasal immunization with chimeric VP4 or VP6 protein.

This study was to determine whether individual rotavirus capsid proteins could stimulate protection against rotavirus shedding in an adult mouse model. BALB/c mice were intranasally or intramuscularly administered purified Escherichia coli-expressed murine rotavirus strain EDIM VP4, VP6, or truncated VP7 (TrVP7) protein fused to the 42.7-kDa maltose-binding protein (MBP). One month after the last immunization, mice were challenged with EDIM and shedding of rotavirus antigen was measured. When three 9-microg doses of one of the three rotavirus proteins fused to MBP were administered intramuscularly with the saponin adjuvant QS-21, serum rotavirus immunoglobulin G (IgG) was induced by each protein. Following EDIM challenge, shedding was significantly (P = 0.02) reduced (i.e., 38%) in MBP::VP6-immunized mice only. Three 9-micrograms doses of chimeric MBP::VP6 or MBP::TrVP7 administered intranasally with attenuated E. coli heat-labile toxin LT(R192G) also induced serum rotavirus IgG, but MBP::VP4 immunization stimulated no detectable rotavirus antibody. No protection against EDIM shedding was observed in the MBP::TrVP7-immunized mice. However, shedding was reduced 93 to 100% following MBP::VP6 inoculation and 56% following MBP::VP4 immunization relative to that of controls (P = <0.001). Substitution of cholera toxin for LT(R192G) as the adjuvant, reduction of the number of doses to 1, and challenge of the mice 3 months after the last immunization did not reduce the level of protection stimulated by intranasal administration of MBP::VP6. When MBP::VP6 was administered intranasally to B-cell-deficient microMt mice that made no rotavirus antibody, shedding was still reduced to <1% of that of controls. These results show that mice can be protected against rotavirus shedding by intranasal administration of individual rotavirus proteins and that this protection can occur independently of rotavirus antibody.

ATP-Binding Cassette Transporters↗

PubMedDate not supplied

Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation.

PURPOSE: The purpose of this retrospective record review of 2- and 3-year-old dental patients receiving intranasal midazolam (INM) was to compare drops vs spray administration to behavioral outcomes observed for agent acceptance during administration and for agent efficacy during parental separation, local anesthesia injection, and delivery of restorative dentistry. METHODS: Temperament and attachment scores based on adaptability and approachability determinants judged by the parent and interactive and Frankl behavior rating scores determined by the operator were used to compare preoperative behavioral characteristics between the 2 groups. The Ohio State Behavioral Rating Scale (OSBRS) and the Frankl behavior rating scale were used to determine intraoperative behavioral outcomes for agent acceptance and efficacy. RESULTS: Analysis of 64 sedation records revealed that the 2 groups had similar preoperative behavioral characteristics. Improvements in the Frankl behavioral rating scores were observed during the sedation, but no statistically significant difference between the drops and spray groups was measured using the OSBRS. For the procedural event of drug administration, however, the spray group demonstrated a statistically significant reduction (P=.025) in aversive behaviors when compared to drops administration as measured by the OSBRS. This finding was observed, even though the volume of spray was greater than used in the drops group. CONCLUSIONS: Spray administration of INM produced significantly less aversive behavior than administering drops in 2- to 3-year-old dental patients of similar behavioral characteristics. The effectiveness of the conscious sedation technique was not influenced by the method of nasal administration. This study suggested that the use of a commercially available atomizer improved patient acceptance of INM administration but did not influence agent efficacy compared to drops administration for 2- to 3-year-old dental patients in an office setting.

Administration, Intranasal↗

PubMed1989

Plasma levels following intranasal and intravenous administration of human interferon-beta to rabbits.

Rabbits were given single doses (2 x 10(6) IU) of human fibroblast interferon (HuIFN-beta) by the following routes of administration: (a) intravenous injection, (b) dropwise intranasal administration of a liquid dosage form, and (c) spraywise intranasal administration of a powder dosage form. Following the intravenous injection, plasma HuIFN-beta concentrations declined rapidly in a biphasic manner in agreement with a two-compartment model, whilst concentrations following the intranasal administrations conformed to a one-compartment model. Maximum plasma levels and the areas under the plasma concentration-time curve (AUC) in response to dose were studied in the case of the spray administration, and found to be proportional to dose. The systemic bioavailability of HuIFN-beta (administered with sodium glycocholate and excipients) via the nasal routes was about 3% of that via the intravenous route. The elimination half-lives did not differ significantly between these two routes of administration.

Administration, Intranasal↗

PubMed1986

Pharmacokinetics in the human of a new synthetic vasopressin and oxytocin uterine antagonist.

The pharmacokinetics in the human of 1-deamino-2-D-Tyr(OEt)-4-Thr-8-Orn-vasotocin (dE-TVT), was studied after iv and intranasal administration in 11 subjects at 12 experiments each route. The plasma concentration of the analogue was analysed by means of an arginine vasopressin antibody, which cross-reacted with dE-TVT to 4.7%. When given intravenously as bolus injection (10 nmol/kg/body weight), the total body clearance amounted to 0.623 +/- 0.099 (SEM) l/h kg and the half-life to 16.2 +/- 2.4 min. After intranasal administration (100 nmol/kg/body weight), the bioavailability was 10.5 +/- 2.9%. Peak concentrations in plasma appeared 2-8 min after iv and 10-45 min after intranasal administration. At the end of an observation period of 2 h measurable amounts in plasma were still found in one of the iv and seven of the intranasal experiments. It is concluded that the moderately long half-life is suitable for the treatment of hospitalized patients in premature labour where promising results with intravenous infusion (50 micrograms/min) of dE-TVT have been obtained. It is still uncertain whether or not the absorption of dE-TVT is sufficient for intranasal administration to out-patients with uterine hyperactivity in late pregnancy and to patients with primary dysmenorrhoea, where significant relief of symptoms were seen after iv administration (10 micrograms/kg body weight).

Administration, Intranasal↗

PubMedDate not supplied

[Clinical evaluation of desmopressin (DDAVP) in diabetes insipidus: solution vs tablets].

Efficacy and tolerability of perorally administered desmopressin were evaluated in 12 adult patients suffering from central diabetes insipidus. According to the results of the study desmopressin should be administered at a higher dosage than 300 micrograms/die to obtain the same antidiuretic effect as with the intranasal administration. No significant changes in body weight, arterial pressure and blood chemistry parameters have been detected over the whole administration period and only some slight side-effects occurred. Oral desmopressin may be considered as an effective alternative to traditional intranasal administration and it may significantly improve patients' compliance.

Administration, Intranasal↗

PubMedDate not supplied

Upper-airway obstruction and prolonged recovery from anesthesia following intranasal clotrimazole administration.

A 16-month-old Labrador retriever was presented for evaluation and treatment of nasal aspergillosis. Intranasal clotrimazole was administered to treat the condition. The dog was anesthetized on two occasions to facilitate drug administration. Following the first treatment, the dog developed mild pharyngitis but no other complications. Inflammation and edema of the pharynx resulted in upper-airway obstruction following the second treatment. Pentobarbital sedation was used to maintain the endotracheal tube until the obstruction was relieved. Recovery following sedation was extremely prolonged. This case illustrates two adverse drug reactions: severe pharyngitis and edema (probably a result of the vehicles present in the clotrimazole formulation) and prolonged recovery (possibly the result of microsomal enzyme inhibition by the clotrimazole).

Administration, Intranasal↗