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PubMed1980

Intranasal topical flunisolide therapy in children with seasonal allergic rhinitis.

This study tested the effectiveness of flunisolide in the treatment of children with seasonal allergic rhinitis. Thirty-five children between the ages of 5 and 14 years used an intransal preparation of either flunisolide (200 micrograms/day) or placebo for a 6-week double-blind parallel trial consisting of a 2-week baseline phase and a 4-week treatment phase, conducted during a period of 'high' pollen counts in Adelaide, South Australia. Flunisolide was effective in reducing four symptoms of hay fever: sneezing, stuffy nose, runny nose and eye itch. Sixty-four percent of the flunisolide-treated group and 33% of the placebo-treated group noted substantial or total control of their hay fever symptoms (P < 0.05). The effect of the intranasal administration of flunisolide on the pituitary-adrenal axis was monitored by performing plasma cortisol measurements (a.m. and p.m.) and 24-hr urinary free cortisol excretion studies for each patient. The data confirmed that 200 micrograms/day intranasal flunisolide does not suppress the pituitary-adrenal-axis in this young patient population.

Administration, Intranasal↗

PubMed2004

Nasal route and drug delivery systems.

Nasal drug administration has been used as an alternative route for the systemic availability of drugs restricted to intravenous administration. This is due to the large surface area, porous endothelial membrane, high total blood flow, the avoidance of first-pass metabolism, and ready accessibility. The nasal administration of drugs, including numerous compound, peptide and protein drugs, for systemic medication has been widely investigated in recent years. Drugs are cleared rapidly from the nasal cavity after intranasal administration, resulting in rapid systemic drug absorption. Several approaches are here discussed for increasing the residence time of drug formulations in the nasal cavity, resulting in improved nasal drug absorption. The article highlights the importance and advantages of the drug delivery systems applied via the nasal route, which have bioadhesive properties. Bioadhesive, or more appropriately, mucoadhesive systems have been prepared for both oral and peroral administration in the past. The nasal mucosa presents an ideal site for bioadhesive drug delivery systems. In this review we discuss the effects of microspheres and other bioadhesive drug delivery systems on nasal drug absorption. Drug delivery systems, such as microspheres, liposomes and gels have been demonstrated to have good bioadhesive characteristics and that swell easily when in contact with the nasal mucosa. These drug delivery systems have the ability to control the rate of drug clearance from the nasal cavity as well as protect the drug from enzymatic degradation in nasal secretions. The mechanisms and effectiveness of these drug delivery systems are described in order to guide the development of specific and effective therapies for the future development of peptide preparations and other drugs that otherwise should be administered parenterally. As a consequence, bioavailability and residence time of the drugs that are administered via the nasal route can be increased by bioadhesive drug delivery systems. Although the majority of this work involving the use of microspheres, liposomes and gels is limited to the delivery of macromolecules (e.g., insulin and growth hormone), the general principles involved could be applied to other drug candidates. It must be emphasized that many drugs can be absorbed well if the contact time between formulation and the nasal mucosa is optimized.

Administration, Intranasal↗

PubMed1994

The efficacy of intranasal mupirocin in the prevention of staphylococcal infections: a review of recent experience.

Staphylococcal infections remain an important cause of morbidity and mortality. Methicillin-resistant Staphylococcus aureus (MRSA) present a particular problem because of the costs of treatment and containing outbreaks. The role of nasal carriage of staphylococci in the epidemiology of staphylococcal infection has been recognized for over 30 years. Until recently, eradication of nasal carriage of S. aureus has proved difficult, with a variety of topical and systemic agents yielding poor results with either little discernible effect on nasal carriage or rapid recolonization. Mupirocin is a novel topical antibiotic with excellent antibacterial activity against staphylococci, including MRSA. Intranasal administration of calcium mupirocin has achieved excellent results in the eradication of nasal carriage of S. aureus and producing an associated reduction in S. aureus infection in a variety of clinical settings, including MRSA outbreaks, neonatal nurseries, haemodialysis, cardiothoracic surgery and familial staphylococcal infections. This article reviews the efficacy and safety of intranasal mupirocin in the prevention of staphylococcal infections.

Administration, Intranasal↗

PubMed2006

Attenuated Bordetella pertussis: new live vaccines for intranasal immunisation.

Bordetella pertussis, the etiologic agent of whooping cough, is a highly infectious pathogen with a strong capacity to colonize the human respiratory tract. A single infection with virulent B. pertussis induces strong mucosal and systemic humoral and cellular immune responses, as well as long-lasting protection in humans. Therefore, B. pertussis may be a suitable vector for intranasal vaccination against a variety of diseases by a single dose. We showed that intranasally administered recombinant live B. pertussis expressing heterologous antigens induce mucosal immune responses in the respiratory and the genital tracts of mice as well as systemic antibody responses. To consider live B. pertussis for human vaccination, we, therefore, aimed at the development of attenuated strain. Allelic exchange was used to delete the dermonecrotic toxin gene and to replace the pertussis toxin gene by an allele encoding inactive toxin. To reduce the production of tracheal cytotoxin, the ampG gene was over-expressed. After various rounds of homologous recombination, B. pertussis BPZE, affected in the production or activity of three major toxins, was isolated. Histological examinations of infected mice confirmed the strong attenuation of this strain. Nevertheless, it colonized the mouse respiratory tract over a period of roughly 1 month. The level of protection against subsequent challenge with virulent wild-type B. pertussis, induced by a single intranasal administration of BPZE was at least as high as that induced by two injections of commercial acellular vaccine. We conclude that live attenuated B. pertussis may be an attractive vaccine candidate to be administered in a single intranasal dose against whooping cough. Moreover, live recombinant B. pertussis may be used as a vector for intranasal vaccination against a variety of diseases.

Administration, Intranasal↗

PubMed2005

Intranasal delivery of recombinant human growth hormone (somatropin) in sheep using chitosan-based powder formulations.

The effectiveness of chitosan in promoting the intranasal bioavailability of recombinant human growth hormone (hGH) has been evaluated. hGH was formulated with chitosan to produce a powder blend (Formulation A) and granules (Formulation B) for intranasal administration. The in vivo pharmacokinetic performance of the formulations was evaluated in a group of six sheep in a randomised crossover study. A subcutaneous injection of hGH solution was administered as a control. The intranasal and subcutaneous doses of hGH were 0.3 and 0.03 mg/kg, respectively. The intranasal formulations appeared to be well tolerated. Mean bioavailabilities of hGH from Formulations A and B were 14 and 15%, respectively relative to subcutaneous injection. It is concluded that chitosan-based intranasal powder formulations may provide a practical means for non-injectable delivery of hGH and, potentially, other therapeutic protein molecules.

Administration, Intranasal↗

PubMed2004

Nitric oxide modulation of the immune response against cholera toxin-adjuvated ovalbumin administered by the intranasal route.

Here, we studied the effect of aminoguanidine (AG) treatment, a nitric oxide synthase (NOS)-2 inhibitor, during the immune response against intranasal administration of ovalbumin (OVA) mixed with cholera toxin (CT) in BALB/c mice. NOS-2 mRNA was detected by reverse transcription-PCR (RT-PCR) in samples of lungs and turbinates early post-inoculation of the antigen. Animals intranasally treated with AG, showed an increase in the levels of seric specific IgG and IgM. A higher IgG1/IgG2a ratio against OVA was also observed in sera of same animals. Moreover, high levels of specific IgA were detected in samples of pulmonar washings obtained from treated animals. On the contrary, treated animals showed a lower DTH response while splenocytes obtained from the same animals showed a reduced proliferative capability against OVA compared to controls. Finally, RT-PCR analysis showed increased expression of TGF-beta in turbinates, lungs and cells from pulmonar washings obtained from AG treated mice. Taken together, these data suggest a role of nitric oxide (NO) in modulating the primary immune response against intranasal antigens.

Administration, Intranasal↗

PubMed1989

Bioavailability of intranasal metoclopramide.

After intranasal administration of metoclopramide, (5 mg in 0.5 ml sterile water) the maximum plasma concentration of 13.5 +/- 7.3 (mean +/- s.d.) ng ml-1 was achieved. Absolute bioavailability was 50.5 +/- 29.5%, 110 +/- 41 min later. We conclude that the intranasal route does not allow rapid absorption of the drug and is not associated with greater bioavailability than the oral route.

Absorption↗

PubMed1997

[Intranasal application of inactivated influenza virus vaccines].

Recent concept on the common mucosal immune system gives new direction of influenza vaccine development-mucosal vaccine. Vaccines have to be administered over the mucosal surface (in case of influenza vaccine, intranasal route may be the most suited route) to assure mucosal immunity which is the first hand armament against influenza virus. This article reviews our work on intranasal administration of inactivated influenza virus HA vaccines. Since influenza vaccines are usually given to people who has some degree of immunity due to past infection or immunization, vaccines which have booster effect are preferable. In this context, intranasally administered inactivated influenza HA vaccine was more immunogenic than cold adapted reassortant live influenza virus vaccine, another candidate mucosal influenza virus vaccine, which is now under investigation in the United States.

Administration, Intranasal↗

PubMed1992

Intranasal immunization with bacterial polysaccharide containing liposomes enhances antigen-specific pulmonary secretory antibody response.

Enhancement of bacterial antigen-specific secretory IgA (sIgA) titres in the lungs may enhance resistance to infections, such as pneumonia, occurring at this mucosal surface. To examine this issue, we intranasally administered liposomes containing bacterial polysaccharide antigens from Aerobacter levanicum, Pseudomonas aeruginosa and Streptococcus pneumoniae. In each case, increased titres of bacterial polysaccharide-specific sIgA could be achieved in the lungs following intranasal immunization with antigen encapsulated in liposomes. In comparison with oral immunization, which required high doses of polysaccharide antigen even when coadministered with adjuvant, intranasal administration of liposomes containing polysaccharide antigens achieved a similar pulmonary sIgA response with approximately 1/30 the amount of antigen necessary with oral immunization. In the case of P. aeruginosa, the magnitude of the sIgA response following intranasal immunization was sufficient to significantly reduce mortality from pneumonia produced by this organism. These results demonstrate that liposome-based mucosal immunization strategies can induce increased bacterial polysaccharide antigen-specific sIgA titres in the lung, and reduce susceptibility to pneumonia.

Administration, Intranasal↗

PubMed2002

Comparative pharmacokinetics of single doses of doxylamine succinate following intranasal, oral and intravenous administration in rats.

The intranasal route of administration provides a potential useful way of administering a range of systemic drugs. In order to assess the feasibility of this approach for the treatment of nausea and vomiting, doxylamine succinate was studied in rats for the pharmacokinetics (AUC, C(max), t(max)) following intranasal, oral and intravenous administrations. Subjects (six male Sprague-Dawley rats per time interval for each route of administration) received 2-mg doses of doxylamine succinate orally and I-mg doses intranasally and intravenously, respectively. The various formulations were formulated in isotonic saline (0.9% w/v) at 25 +/- 1 degrees C. Doxylamine succinate concentrations in plasma were determined with a high-performance liquid chromatographic assay and a liquid-liquid extraction procedure. Intranasal and oral bioavailabilities were determined from AUC values relative to those after intravenous dosing. Intranasal bioavailability was greater than that of oral doxylamine succinate (70.8 vs 24.7%). The intranasal and oral routes of administration differed significantly from the intravenous route of administration. Peak plasma concentration (C(max)) was 887.6 ng/ml (S.D. 74.4), 281.4 ng/ml (S.D. 24.6) and 1296.4 ng/ml (S.D. 388.9) for the intranasal, oral and intravenous routes, respectively. The time to achieve C(max) for the intranasal route (t(max)=0.5 h) was faster than for the oral route (t(max)=1.5 h), but no statistically significant differences between the C(max) values were found using 95% confidence intervals. The results of this study show that doxylamine succinate is rapidly and effectively absorbed from the nasal mucosa.

Administration, Intranasal↗

PubMed1989

Management of allergic rhinitis: focus on intranasal agents.

The clinical manifestations of allergic rhinitis are the result of an immune-mediated process after exposure of a sensitized individual to airborne allergens. The primary symptomatology includes nasal congestion, rhinorrhea, nasal and conjunctival pruritus, and sneezing. Principles of management include allergen avoidance, palliative therapy, immunotherapy, and pharmacotherapy. Oral decongestants stimulate alpha-adrenergic receptors in the nasal cavity, resulting in vasoconstriction and decreased edema. Oral antihistamines block histamine1 (H1) receptors, and may relieve rhinorrhea, sneezing, and nasal and conjunctival pruritus. Topical decongestants have a local effect on adrenergic receptors in the nasal mucosa, resulting in rapid, marked vasoconstriction. Intranasal corticosteroids inhibit mediator release from mast cells and basophils, and reduce edema of the nasal mucosa. Dexamethasone sodium phosphate, beclomethasone dipropionate, and flunisolide are currently available for intranasal administration. Cromolyn sodium inhibits allergen-induced degranulation and mediator release from sensitized cells, and is useful primarily as a prophylactic agent. Several agents, including the corticosteroids budesonide and flucortin butylester, the mast cell-stabilizing agent nedocromil sodium, the anticholinergic agent ipratropium bromide, and the H1 receptor antagonist levocabastine are being investigated for intranasal use in the management of allergic rhinitis.

Administration, Intranasal↗

PubMed1996

Intranasal midazolam plasma concentration profile and its effect on anxiety associated with dental procedures.

The objectives of this study were to describe the serum concentration time profile for midazolam following intranasal administration to adult dental surgery patients and to ascertain the effect of midazolam on anxiety. Six female patients received a single 20 mg (0.32 to 0.53 mg/kg) dose of midazolam. Blood samples were collected at 5, 10, 20, 30, 45, and 60 min following dose administration. Midazolam plasma concentrations were determined by gas chromatography. Anxiety was evaluated using a 100-mm visual analogue scale. The maximum concentration of midazolam was reached 25.8 min (range 18 to 35 min) following dose administration. Maximum concentrations were variable. However, there was no relationship between the weight-adjusted dose and maximal concentration. Patients experiencing baseline anxiety exhibited a trend toward reduction in their measured anxiety score (P = 0.06). Plasma concentrations above the hypothesized minimum effective concentration for sedative effects were attained when midazolam was administered intranasally to adult dental patients.

Administration, Intranasal↗

PubMed2004

Effects of recombinant cholera toxin b subunit (rCTB) on cellular immune responses: enhancement of delayed-type hypersensitivity following intranasal co-administration of Mycobacterium bovis-BCG with rCTB.

Recombinant cholera toxin B subunit (rCTB) is a safe and potent mucosal adjuvant. To gain insight into the mechanism underlying the adjuvant effect of rCTB, the effects of rCTB on cell-mediated immune responses of mice and guinea pigs were examined after intranasal administration of Mycobacterium bovis -bacillus Calmette-Guérin (BCG) with and without rCTB. Delayed-type hypersensitivity, for skin reactions in guinea pigs and for footpad swelling reactions in mice, to purified protein derivative (PPD) were enhanced by intranasal co-administration of BCG and rCTB, as compared to giving BCG alone to these animals. Moreover, tumor necrosis factor (TNF)-alpha and interferon (IFN)-gamma production of spleen cells and antigen specific spleen cell proliferation, stimulated with PPD, were enhanced in the presence of rCTB. These results strongly suggest that rCTB enhances cellular as well as humoral immune responses.

Animals↗

PubMed1995

Effects of cocaine on cortisol secretion in humans.

The effects of acute cocaine administration on the pituitary adrenal axis in humans without a history of drug abuse are unknown. The authors studied 12 male volunteers twice in a double-blinded, placebo-controlled, randomized fashion. After intranasal administration of 2 mg/kg cocaine, cortisol levels were significantly higher than after placebo administration. The authors concluded that acute administration of cocaine to humans increases cortisol secretion.

Administration, Intranasal↗

PubMed1996

Induction of measles virus-specific cytotoxic T-cell responses after intranasal immunization with synthetic peptides.

We have investigated the structural requirements for the induction of cytotoxic T-cell responses (CTL) in vivo after intranasal immunization with an immunodominant CTL epitope from the nucleoprotein of measles virus (MV). For the induction of CTL responses, covalent linkage of the CTL epitope to a helper T-cell epitope was required and the orientation of the epitopes influenced the immunogenicity of the CTL epitope. The presence of two copies as compared with one copy of a T-helper epitope, rendered the CTL epitope more immunogenic and resulted in the in vivo induction of MV-specific CTLs without the need for an adjuvant. The role of CTL responses to this epitope in protection after intranasal administration was evaluated in a mouse model against challenge with a neuroadapted strain of MV. Although a decreased mortality in the peptide immunized compared with that in unimmunized mice was observed, the protection achieved was not significant. These findings highlight the importance of the rational design of synthetic immunogens for the induction of CTL responses and the potential of the intranasal route for immunization.

Adjuvants, Immunologic↗

PubMedDate not supplied

A pharmacological approach to the analgesizing mechanism of somatostatin in cluster headache.

Vasodilation, conjunctival and nasal edema as well as miosis are symptoms associated with cluster headache (CH) attacks. Similar symptomatology is caused by substance P (SP) release from peripheral trigeminal nerve endings. The symptomatic effect of somatostatin (SRIF) during CH attacks was attributed to the inhibition of SP release from trigeminal neurons. This study was designed to evaluate both the vascular effect of SRIF on the dorsal hand vein and SRIF plasma levels prior to and after subcutaneous and intranasal administration in CH patients. A powerful venoconstriction and tachyphylaxis were demonstrated when SRIF was administered both as bolus and infusion. Plasma levels of SRIF in CH sufferers were lower than in control subjects. Subcutaneous and intranasal SRIF administrations induced maximal plasma levels after 5 and 10 min, respectively. These data suggest that SRIF plays an important role during CH attacks; however, its exact mechanism of action is still to be defined.

Analgesia↗

PubMedDate not supplied

Epitalon influences pineal secretion in stress-exposed rats in the daytime.

OBJECTIVES: The content of C-Fos protein was tested in rat pinealocytes in the norm and stress and in case of intranasal administration of Epitalon (Ala-Glu-Asp-Gly), which regulated pineal secretion processes, presumably, via protooncogenes. SETTING: Intact and osmotic-stress-exposed rats were used for the immunohistochemical detection of C-Fos protein. All animals were intranasally administered with Epitalon, the last infusion made in two hours before the biopsy. Simultaneously, light microscopy of the pineal parenchyma was performed in all groups of animals. RESULTS: A slight but significant C-Fos increase was observed only in stress-exposed pinealocytes of rats after intranasal Epitalon infusions. C-Fos was irregularly distributed throughout pineal cells. In stress, the clusters of 5 10 cells containing C-Fos in their cytoplasm were detected. The dilation of capillaries and pericapillary space induced by an osmotic stress was partially reduced by the intranasal infusions of Epitalon. CONCLUSIONS: Tetrapeptide Epitalon is synthesised on the basis of the amino acid composition of pineal peptide extract Epithalamin. Epitalon modulates pineal secretion only under a stress impact but never in the norm. It prevents osmotic-stress-induced pathologic changes in the pineal parenchyma structure. Besides, the physiological activity of Epitalon seems to be mediated by the activation of protooncogenes in pinealocytes.

Administration, Intranasal↗

PubMed1998

Intranasal azelastine. A review of its efficacy in the management of allergic rhinitis.

UNLABELLED: Azelastine, a phthalazinone compound, is a second generation histamine H1 receptor antagonist which has shown clinical efficacy in relieving the symptoms of allergic rhinitis when administered as either an oral or intranasal formulation. It is thought to improve both the early and late phase symptoms of rhinitis through a combination of antihistaminic, antiallergic and anti-inflammatory mechanisms. Symptom improvements are evident as early as 30 minutes, after intranasal administration of azelastine [2 puffs per nostril (0.56mg)] and are apparent for up to 12 hours in patients with seasonal allergic rhinitis (SAR). The effect on nasal blockage is variable: in some studies objective and/or subjective assessment showed a reduction in blockage, whereas in other studies there was no improvement. Intranasal azelastine 1 puff per nostril twice daily is generally as effective as standard doses of other antihistamine agents including intranasal levocabastine and oral cetirizine, ebastine, loratadine and terfenadine at reducing the overall symptoms of rhinitis. The relative efficacies of azelastine and intranasal corticosteroids (beclomethasone and budesonide) remain unclear. However, overall, the corticosteroids tended to improve rhinitis symptoms to a greater extent than the antihistamine. Azelastine was well tolerated in clinical trials and postmarketing surveys. The most frequently reported adverse events were bitter taste, application site irritation and rhinitis. The incidence of sedation did not differ significantly between azelastine and placebo recipients and preliminary report showed cardiovascular parameters were not significantly altered in patients with perennial allergic rhinitis (PAR). CONCLUSION: Twice-daily intranasal azelastine offers an effective and well tolerated alternative to other antihistamine agents currently recommended for the symptomatic relief of mild to severe SAR and PAR in adults and children (aged > or = 12 years in the US; aged > or = 6 years in some European countries including the UK). The rapid onset, confined topical activity and reduced sedation demonstrated by the intranasal formulation of azelastine may offer an advantage over other antihistamine agents, although this has yet to be confirmed.

Administration, Intranasal↗