|"No Drip" Nasal Sprays: How Different Are They?|
|Written by Donald Riker, PhD|
|Wednesday, 08 December 2010 15:54|
Several branded and store brand manufacturers of nasal decongestant sprays offer consumers a "No Drip" version (Afrin No Drip, Schering; No Drip Nasal Spray, Equate). These products make various claims including: "no drip", "fast", "won't drip down/from your nose or throat", "extra moisturizing", "helps rehydrate", "stays where you spray", "works in seconds", etc. These claims may or may not find claims support, but less obvious is that these alternative formulae may change the bioavailability of the active ingredient.
Not everyone is willing to spray liquids into their noses; more consumers than you might think feel that way. Those that do spray find nasal congestion uncomfortable but nasal sprays are among the most effective and long-acting treatments available without a prescription. They work fast and last all day. These products sidestep some of the side effects of oral decongestants found in many multi-symptom relief products, particluarly for those with hypertension or using Rx drugs. As safe and effective as these products are they have some practical drawbacks.
Practical issues include: spray patterns, drip back, drip forward, bacterial or viral contaminant on reuse, shared use, nasal drying, etc. Two medical issues can occur with regular daily use or overuse: nose bleeds, behavioral dependency, and possible loss of efficacy. Leaving these aside manfacturers have altered their base brand formulae to create "no drip" products. Generally speaking these nasal topical formulae incorporate thickening agents such as microcrystalline cellulose and/or carboxymethylcellulose, glycerin, etc to increase the viscosity of these products. More viscous liquids can be expected to have longer residence time on the nasal mucosa partially due to physical forces that resist nasal cilia clearance.
Claims to decreased "drip rates", reduced clearance, etc may be supportable using simple clearance methods in the nasal passage or subjective perception. However, claims to "rehydration" seem more problematic. "Rehydration" implies cellular dehydration and then cellular rehydration presumably throughout the nasal passages. Each of these seems unlikely and difficult to prove. The same logic applies to "extra moisturizing", possibly a parallel cosmetic claim.
Not so obvious is whether these formulae are "stealth" controlled release products. Formulae that use cellulose or other polymers, traditional components of controlled release systems, can alter the time/action curves of oral, topical, and liquid products. How the efficacy, or topical safety, of these formulae differs from the base formula is anyone's guess. For example, the physical slowing of nasal clilia beat frequency and prolongation of residence time may increase efficacy or topical side effects. However, sequestration and later release of decongestants from the formula matrix may create an unapproved, or "stealth", extended/control release formula; while at the same time other, possibly unsupported, benefits of such a formula are expressed on the label.
A regulatory reading of the OTC Monographs governing consumer drug products suggests that a formula that significantly alters the bioavailablity of an active ingredient should be subject to bioavailability studies such as those published as draft FDA guidelines for nasal products.
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