Nasal sprays, ingredients

Nasal sprays, inhalants Pharmaceutical ingredients Purified water Manufacturing environment Products As above Loop daily and taps weekly Daily or weekly Routine for products with high water activity Periodic after history is established for product with a low water activity... 

Table 4 Examples of Nasal Spray Products and Ingredients... 

Different consumer needs, whether for infant, child, or adult, varies the concentrations of the active ingredients in a nasal drug formulation. Fig. 4 shows a typical nasal spray system fitted with a snap-on closure. The dispensing system can be adapted to the anatomy of the patient. The actuators for pediatric application are slimmer in their geometry and the dosage volume is reduced (Fig. 5). 

GRAS listed. Accepted as a food additive in Europe. Included in the FDA Inactive Ingredients Guide (IM and IV injections, nasal sprays, oral capsules and tablets, and sublingual, rectal, topical, and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Ganadian List of Acceptable Non-medicinal Ingredients. 

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. 

Menthol is a white, waxy crystalline compound having a strong odor of peppermint. Its main source is oil of peppermint from the plant, Mentha arvensis. It is an ingredient of decongestant ointments and nasal sprays and is also used to flavour toothpaste and cigarettes. 

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)... 

It is stated that nasal sprays have unique characteristics with respect to formulation, container closure system, manufacturing, in-process and final controls and stability. The product must deliver reproducible doses during the whole life of the product. Excipient controls are discussed in the FDA draft guidance in many respects, the chemistry, manufacturing and controls (CMC) standards expected of excipients are starting to approach those required of the active pharmaceutical ingredient (API). 

Bernal, J.L. Del Nozal, M. J. Martin, M.T. Diez-Masa, J.C. Cifuentes, A. Quantitation of active ingredients and excipients in nasal sprays by high-performance liquid chromatography, capUlsiry electrophoresis and UV spectroscopy, J.ChromatogrA., 1998, 823, 423-431. [beclomethasone dipropionate fluticasone dipropionate beclomethasone fluticasone benzalkonium benzalkonium chloride phenylethyl... 

Fill into a spray nasal dispenser with a solution volume of 2 mL. The composition comprises approximately 550 MRC-units active ingredient per milliliter, and the applicator delivers a quantity comprising 55 units per actuation. 

Neo-Synephrine is the active ingredient in some nose sprays used to reduce swelling of nasal membranes. Identify the functional groups in the structure of Neo-Synephrine. 

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