Nasal spray pump

Desmopressin may be given orally, intranasally, SC, or IV. The oral dose must be determined for each individual patient and adjusted according to the patient s response to therapy. When the drug is administered nasally, a nasal tube is used for administration. The nasal tube delivery system comes with a flexible calibrated plastic tube called a rhinyle. The solution is drawn into the rhinyle. One end is inserted into the nostril and the patient (if condition allows) blows the other end to deposit solution deep into the nasal cavity. A nasal spray pump may also be used. Most adults require 0.2 mL daily in two divided doses to control diabetes insipidus. The drug may also be administered via the SC route or direct IV injection. 

Before 1 sf dose of new boff le of nasal spray, pump must be activated by holding upright and pumping nozzle 6 times until a faint spray is emitted. 

Recently, a comparison study of deposition pattern of aqueous nasal spray pumps and non-portable nebulizers was published. The obtained controversial results showed a relative standard deviation of 35-80%. This demonstrates the variations in nasal anatomy and physiology from individual to individual. Other stud-ies indicate that differences in the spray performance, i.e., spray angle and particle size distribution, of delivery systems do not necessarily result in different in vivo deposition. 

Suman, J.D. Laube, B.L. Dalby, R. Nasal Nebulizers versus Aqueous Nasal Spray Pumps A Comparison of Deposition in Human Volunteers. Respiratory Drug Delivery VI, Hilton Head Island, SC, May 3-7, 1998 School of Pharmacy of Virginia Commonwealth University, Interpharm Press Buffalo Grove, IL, 1998 211-218. 

Suman, J.D. Laube, B.L. Ta-chun, L. Brouet, G. Dalby, R. In Vitro Tests of Aqueous Nasal Spray Pumps May Not Predict In Vivo Deposition Pattern. Postersession Aerosol Delivery, AAPS New Orleans, LA, Nov 14-18, 1999. 

Cheng YS, Holmes TD, Gao J, Guilmette RA, Li S, Surakitbanham Y, et al. Characterization of nasal spray pumps and deposition pattern in a replica of the human nasal airway. J Aerosol Med 2001 14(2) 267-280. 

Only two antidiuretic peptides are available for clinical use in the United States (1) Vasopressin (synthetic 8-l-arginine vasopressin Pitressin) is available as a sterile aqueous solution it may be administered subcutaneously, intramuscularly, or intranasally. (2) Desmopressin acetate (synthetic l-deamino-8-D-arginine vasopressin DDAVP, others) is available as a sterile aqueous solution packaged for intravenous or subcutaneous injection, in a nasal solution for intranasal administration with either a nasal spray pump or rhinal tube delivery system, and in tablets for oral administration. The therapeutic uses of vasopressin and its congeners can be divided into two main categories according to the type of vasopressin receptor involved. 

Fig. 24.14 Squeeze spray bottle (a) and nasal spray pump (b) for spraying liquid into the nose...

Non-viscous liquids can be sprayed into the nose as an alternative to drops. To aid this type of administration two types of containers are available squeeze spray bottles and nasal spray pumps (see Fig. 24.14). 

The nasal spray pump consists of a pump mechanism with a spray nozzle mounted on a bottle. A dose is sprayed by pressing the pump mechanism. During the first few pump actions only air is delivered from the nozzle as the pump mechanism fills with liquid. The amount of liquid that is sprayed per pump action is independent on the pump force or the liquid level. This results in accurate, reproducible dosing. The bottle needs to be in the upright position when the pump mechanism is released for a new dose to be drawn from the bottle. The nasal spray pump is best used with the patient in the sitting position. 

The nasal spray pump is less vulnerable to microbiological contamination of the spray fluid. 

Nicotine nasal spray is marketed as a pharmacy-only medication in the UK, and is available only by prescription in the USA. The nasal spray was designed to deliver doses of nicotine to the smoker more rapidly than other NRT products. The device is a multidose bottle with a pump that delivers 0.5 mg of nicotine per 50-pL squirt. Each dose consists of two squirts, one to each nostril. Nicotine from the nasal spray is absorbed into the blood more rapidly than from the gum (Schneider et al. 1996). Venous plasma concentrations after a single 1-mg dose range between 5 and 12 ng mL Time to peak plasma concentration (7j ax) with nasal administration is around 11-13 min for 1-mg doses. This rise time is slower than for cigarette delivery (Henningfield et al. 1993), but faster than for the other NRT products. 

Nasacort AQ Before use, prime the nasal spray by pushing down on the actuator until a fine spray appears (5 pumps). If the pump has not been used for more than 14 days, the spray must be reprimed with 1 spray. 

Using detailing and DTCA and sales data for drugs in five therapeutic classes (antidepressants, antihistamines, antihyperlipidemics, nasal sprays, and proton pump inhibitors), Rosenthal et al. (2002) found wide ranges in... 

Prime the pump with 4 sprays or until a fine mist appears before using the nasal spray the first time. Tkfter the first use and if the pump hasn t been used for 3 or more days, prime the pump with 2 sprays or until a fine mist appears... 

OTC Otrivin Measured-Dose Pump with Moisturizers, Otrivin Nasal Drops, Otrivin Nasal Spray, Otrivin Nasal Spraywith Eucalyptol, Otrivin Nasal Spray with Moisturizers, Otrivin with Measured-Dose Pump Cfiemical Class Imidazoline derivative... 

Dosage form Two versions of Synarel are available Synarel Nasal Solution for Central Precocious Puberty and Synarel Nasal Solution for Endometriosis. They appear to be the same except for package and labeling. Each 0.5 ounce bottle contains 8 ml Synarel Nasal Solution 2mg/ml (as nafarelin base). Each bottle is supplied with a metered spray pump that delivers 200 pg of nafarelin per spray. 

Nasal Sprays Clarity, microbial bioburden, pH, particulate matter, unit spray medication content uniformity, droplet and/or particle size distribution, weight loss, pump delivery, microscopic evaluation of suspensions, particulate matter, extractables, leachables from plastic and elastomeric components of container closure and pump. 

Fill in plastic bottles that are closed with a conventional spray insert or into plastic or glass bottles that are closed with a conventional pump sprayer. In the latter case, pumps with nasal spray inserts are, for example, used that spray about 0.14 mL of solution per actuation. In this manner, 0.14 mg of azelastine hydrochloride is sprayed into the nose per actuation in the form of the solution. 

Atrovent (ipratropium bromide) Nasal Spray 0.03% is a metered-dose, manual-pump spray unit that delivers 21 meg (70, uL ) ipratropium bromide per spray on an anhydrous basis in an isotonic, aqueous solution with pH... 

Nasonex nasal spray, 50 meg is a metered-dose, manual-pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate, calculated on the anhydrous basis, in an aqueous medium containing glycerin, micro-... 

Each milliliter of Afrin Original Nasal Spray and Pump Mist contains oxymetazoline hydrochloride, 0.05%. It also contains benzalkonium chloride, edetate disodium, poly-... 

Tri-Nasal spray is a metered-dose manual-spray pump in an amber polyethylene terephthalate bottle with 0.05% w/v triamcinolone acetonide in a solution containing citric acid, edetate disodium, polyethylene glycol 3350, propy-... 

Nasal 100 ngJrnL spray pump and rhinal tube delivery system Parenteral 4 g/mL solution for injection Oral 0.1, 0.2 mg tablets Follitropin alfa (Gonal-F)... 

Since the introduction of metered-dose inhalers, nasal solutions have increasingly been formulated as nasal sprays. Initially, aerosol-based systems containing chloro-fluorocarbons were employed however, the Montreal Protocol put an end to this. Thereafter, mechanical pumps or actuators were employed to deliver nasal formulations as sprays. These devices, using actuators, can precisely deliver as little as 25 pL and as much as 200 pL of a formulation. However, various factors must be considered in formulating the spray these include viscosity, particle size, and surface tension, all of which may affect the accuracy of the dose administered. 

A nasal spray (isotonic aqueous ipratropium pump) has been used in allergic and non-allergic rhinitis as well as the common cold. The spray caused no systemic adverse effects and only minor infrequent episodes of nasal dryness and epistaxis, which did not interfere with treatment (15,16). 

A wide range of over-the-counter and prescription pharmaceutical products use manually actuated pumps. A common example is the nasal spray container. When the design of these pumps allows contaminated products to be used, the patients and the manufacturer have a problem. This was the case, when palmitic, myristic, stearic, and oleic fatty acids (these are all non-formulation ingredients) were found in a nasal spray product. 

Nasal spray products contain therapeutically active ingredients (drug substances) dissolved or suspended in solutions or mixtures of excipients (e.g., preservatives, viscosity modifiers, emulsifiers, buffering agents) in non-pressurised dispensers that use metering spray pumps. (FDA 1999)... 

AFRIN (DURATION Schering-Plough QJ.S.) Oxymetazoline 0.05% Nasal decongestant BKC, Na2edta, PEG1450, pov, PG, NaP Plastic squeeze bottle Spray pump bottle... 

MIACALCIN nasal spray Novartis (U.S.) Calcitonin-salmon 32 amino acids, Mr = 3527 BKC 0.1 mg/mL, NaCI 8.5 mg/mL, HCI, N2 Glass bottles, screw-on pump 90 pL per actuation... 

Various studies (Bond et al. 1984 Newman et al. 1987a) have found droplet size distributions of aqueous nasal spray products to have mass mean (median) diameter values between 44 and 62 pun. These studies showed that the majority of the dose was deposited locally in the anterior one-third of the nose. The relationship between retention time and viscosity has shown that the addition of various concentrations of methylcellulose (MC) to a metered spray pump containing desmopressin resulted in a dose-related increase in mean particle size from 51 pan (0 percent MC) to 81 pan (0.25 percent MC) to 200 pirn (0.5 percent MC), without a change in mean spray weight. The longest retention time was observed for the 0.25 percent MC solution, which was attributed to its particle size (81 p,m) and not to an increase in viscosity, since a decrease in retention time was observed for the highest viscosity (0.5 percent MC) solution... 

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