Inhalation Spray

Weigh insulin in a clean glass container and dissolve in acid buffer and titrate to a pH of 7 with Tris buffer. 

Add Brij 98 and sodium lauryl sulfate to the insulin solution to form a homogenous solution. 

Lyophilize and suspend dried particles in a non-aqueous suspension medium of ethanol and then charge with hydrofluoroalkane (HFA) 134a. 

Fill the formulation in a pressure-resistant container fitted with a metering valve. 

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Inhalation sprays and aerosols As above As above 0, 6, 12, 24, 36 months... 

NITROGLYCERIN, TRANSLINGUAL At the onset of attack, spray 1 or 2 metered doses onto or under the tongue. No more than 3 metered doses are recommended within 15 minutes. May use prophylactically 5 to 10 minutes prior to activities which might precipitate an acute attack. Do not inhale spray. 

Pregnancy Category D (inhaler, spray, transdermal patch) Category C(gum). Nicotine is contraindicated in women who are or may become pregnant advise patients to use contraceptive measures. 

Patients with cystic fibrosis use aerosol inhaler sprays of the DNA-hydrolyzing enzyme deoxyribonuclease to help reduce the viscosity of mucous secretions, which contain large amounts of DMA arising from destruction of WBCs as they fight lung Infections. 

Spray translingual spray onto or under tongue, do not inhale spray... 

Etofenprox is an insecticide with an action similar to pyrethroids, which act predominantly on the central nervous system. It may be hazardous if swallowed. Do not inhale spray mist. Avoid skin contact wear protective gloves, clean protective clothing and a face mask (surgical type) when handling the product. Wash hands and exposed skin thoroughly after using. 

Stevenson, C. Hastedt, J.E. Lehrman, S.R. Chiang, H.S. Bennett, D.B. Lesikar, D. Yang, B. Gong, D. Cabot, K. Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation. US patent 6,569,406, Aug 7, 2001, Nektar Therapeutics San Carlos, CA. 

Picloram is either a colorless powder or crystalline solid having very low vapor pressure, making inhalation exposure unlikely unless the dust is inhaled. Exposure to picloram occurs mainly through its manufacture and its use as a herbicide in forests. Environmental exposures in humans occur when forest visitors or others not directly involved in spray operations come in contact with spray or sprayed foliage, inhale spray mist, eat plants or animals contaminated with the herbicide, or drink water containing the herbicide. A suggested no-adverse-effect level is 1.05 mg 1. ... 

In the not too distant future, Insulin intake will become even easier. Thanks to a new insulin inhaler, by Generex, insulin injections may become relics of the past. The inhaler sprays insulin out into the mouth like a mist, which coats the membranes of the mouth, throat and tongue. The insulin then passes quickly through the membranes into the bloodstream. The new insulin inhaler is in phase two clinical trials. If all goes well, the Food and Drug Administration could put it on a fast track for approval, making it available on the market in less than two years. 

The clinical efficacy of nasal and inhalation spray drug products is directly dependent on the design, reproducibility, and performance characteristics of the container closure system. 

EXPOSURE ROUTES Inhalation (spray drift in regions surrounding agricultural areas, application of the pesticide) ingestion (contaminated food and drinking water) occupational exposure. 

In the US, two separate guidelines have been developed, one covering both metered dose inhalers (MDIs) and dry powder inhalers (DPIs) and one covering nasal sprays, inhalation solutions, and suspensions and inhalation sprays [22, 23], The guidance on MDIs and DPIs is however still in draft form nearly 10 years after being published for comment one of the unresolved issues is the dose content uniformity requirements which are discussed later in this chapter (Section 16.5.4). There are also other sections which would benefit from further discussion, in particular the number and nature of some of the tests that may be expected on stability. 

Nasal spray Inhalation spray Inhalation solutions and suspensions Metered dose inhaler MDI Dry powder inhaler DPI, device metered Dry powder inhaler DPI, pre-metered Not included Non-pressurized metered dose nasal spray Nasal single use sprays Non-pressurized metered dose inhaler Product for nebuhzation (single and multiple use) Pressurized metered dose nasal sprays Pressurized metered dose inhaler Dry Powder Inhaler, device metered Nasal powders, device metered Dry Powder Inhaler, pre-metered Nasal drops (single and multiple use)... 

Table 16.2 Tests to be considered on stability for nasal sprays, inhalation sprays, and inhalation...

Nasal spray Inhalation spray Inhalation solutions... 

Metered volumes of hquid are similar to those used with pMDls, i.e., around a 100 pL. Volume flow rates through a single nozzle are not sufficient to deliver such liquid volumes during a single breath, and instead the metered volume flows in parallel through about 1,000 identical nozzles to generate the inhaled spray cloud. 

A 44-year-old man, who had had asthma since childhood, and who was taking Franol (ephed-rine hydrochloride 11 mg + phenobarbital 8 mg + theophylline 120 mg) three times a day and using a Brovon inhalant spray (0.5% adrenaline + 0.14% atropine methonitrate + 0.88% papaverine hydrochloride) as required, developed a dilated cardiomyopathy. He had been using the inhaler up to 40 times a day and had done so for 20 years. The inhaler and tablets were withdrawn and he improved with conventional management of asthma and heart failure. 

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