Molecular structure of pseudoephedrine
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Pseudoephedrine is a sympathomimetic amine commonly used as a decongestant. The salts pseudoephedrine hydrochloride and pseudoephedrine sulfate are found in many over-the-counter preparations either as single-ingredient preparations, or more commonly in combination with antihistamines and/or paracetamol/ibuprofen. more...

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This agent is often referred to by consumers as Sudafed, which is the trademark for a common brand of pseudoephedrine hydrochloride. Other brand names include Afrinol, Novafed, and Cenafed.

Unlike antihistamines, which modify the systemic histamine-mediated allergic response, pseudoephedrine only serves to relieve nasal congestion commonly associated with colds or allergies. The advantage of oral pseudoephedrine over topical nasal preparations, such as oxymetazoline, is that it does not cause rebound congestion (rhinitis medicamentosa). However, the disadvantage of oral pseudoephedrine is that it can cause high blood pressure.

Nomenclature

Pseudoephedrine is the International Nonproprietary Name (INN) of the (1S,2S)- diastereomer of ephedrine (which has 1R,2S- configuration). Equivalent names are (+)-pseudoephedrine and D-pseudoephedrine. (Reynolds, 1989)

(-)-Pseudoephedrine or L-pseudoephedrine then designates the enantiomer of pseudoephedrine.

Chemistry

Pseudoephedrine, a phenethylamine, is a structural isomer of the popular weightloss/energy supplement and asthma medication, ephedrine. Ephedrine is an alkaloid extracted from the Ephedra plant, which produces it naturally as a racemic mixture. That is, ephedrine molecules occur as two "mirror images," inasmuch as a pair of hands do (See the article on entantiomers). The pharmacologic properties of each "reflection" often share similarities and differences. The (-) or levorotatory isomer is a very potent sympathomimetic amine and anorectic, thus responsible for the amphetamine-like stimulation that is characteristic of Ephedra products. The (+) or dextrorotatoryisomer, aka pseudoephedrine, is far less potent as a stimulant. However, it retains much of ephedrine's ability to open airways and nasal passages.

Mode of action

Pseudoephedrine is a sympathomimetic amine - that is, its principal mechanism of action relies on its indirect action on the adrenergic receptor system. Whilst it may have weak agonist activity at α- and β-adrenergic receptors, the principal mechanism is to displace noradrenaline from storage vesicles in presynaptic neurons. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the aforementioned postsynaptic adrenergic receptors.

The vasoconstriction that pseudoephedrine produces is believed to be principally an α-adrenergic receptor response. Whilst all sympathomimetic amines, to some extent, have decongestant action; pseudoephedrine shows greater selectivity for the nasal mucosa and a lower affinity for central nervous system (CNS) adrenergic-receptors than other sympathomimetic amines. (+)-(1S,2S)-pseudoephedrine shows far lower CNS activity than other Ephedra alkaloids, ephedrine, and (-)-(1R,2R)-pseudoephedrine.

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Delayed season, children niche impact cough/cold market - cold medicine market - Brief Article - Statistical Data Included
From Drug Store News, 1/15/01

Retailers shouldn't be looking to trim back their cough/cold sets early this year, say illness-tracking experts. In fact, by the middle of next month, things should really start to get interesting.

Because of high rhinovirus activity, the percentage of people sick between February and April should be about 12 percent to 13 percent higher than it was during the same period one year ago, Surveillance Data president Gerald Kress told Drug Store News late last month. Some 200 rhinoviruses--the viruses that cause sore throat, runny nose and cough--make up the common cold family.

According to Kress, another factor to be considered this cough-cold season is influenza and the impact of flu vaccine shortages during the fourth quarter of 2000. "When influenza peaks-which we expect [to happen this month]-- we don't know how many additional people will be sick this year, because [many] did not get a vaccine shot."

As such, Kress suggested that retailers perhaps keep higher inventory levels of OTC cough/cold products during the first quarter--and even into April.

"We know we [would] have more people sick in a normal situation," Kress explained. "Now we [can] anticipate a further increase in illness of an unknown proportion based on the vaccination situation."

Of course, the dynamics at play during this year's cough-cold season have been somewhat unique. It is not every season that the cough/cold category is faced with a double whammy: a major withdrawal of phenyl-propanolamine-containing products and flu vaccine shortages in late fall.

However, both issues have since faded. For one thing, vaccine shortages are definitely over. Barbara Reynolds, a spokeswoman for the Centers for Disease Control and Prevention, told Drug Store News late last month that there were about 7 million doses available-a sufficient amount of vaccine for people who want to be vaccinated against influenza. Reynolds said that while there had been about a month delay in the shipment of vaccines, the number of doses now available is about the same as last year.

Luckily, illness patterns have cooperated with the earlier vaccine shortages-which should almost work out to the greater benefit of the public's health. "We are having a slow-starting flu season, which makes all the more reason for people to vaccinate as late as January," Reynolds explained.

Similarly, as the cough/cold season rolls on, retailers and manufacturers don't expect the PPA issue to have much of an impact on the category in 2001- though some say products that never contained PPA have benefited from the removal of those products.

"People who are sick will not walk away from the category--if there is any drop off, it will be minute," said Tim Bland, category manager Drug Emporium. "People may choose to go to their doctor for a prescription, or [perhaps] Sudafed and Tylenol Cold and Flu would be the beneficiaries if people want to find an alternative."

T.J. Higgins, senior director of marketing, Schering-Plough Health Care Products, said the company's Drixoral brand, which is formulated with pseudoephedrine, increased by 20 percent roughly three weeks after the Food and Drug Administration issued its warning against PPA-containing products. The company's Coricidin HBP line--which is decongestant-free and formulated for people with high blood pressure--increased by 50 percent after PPA products were pulled from the shelves, according to Higgins. The line had been growing 15 percent, prior to the PPA issue, he said.

On the other hand, Coricidin D tablets--Schering-Plough's only product that had contained PPA--has been reformulated with pseudoephederine and is expected to hit shelves this month, according to Higgins.

Whether consumers turn to reformulated products or try new brands in 2001, they will have more of a selection to choose from as manufacturers continue to add new products.

Childrens' offerings

However, most of the innovation figures to occur on the children's side of the business--the adult segment is already oversaturated, causing them to be resistant to adding more adult products, explained CVS spokesman Mike DeAngelis. "So suppliers are looking at the children's segment as an opportunity to extend their lines," he said.

Whitehall-Robins spokesman Fran Sullivan said the pediatric category traditionally has outpaced the adult cough/cold category, perhaps owing to the fact that adults are more likely to "tough it out" when they have a cold, but want to provide their children with relief when they are sick.

But mom and dad won't necessarily buy into the category without a green light from the doctor, according to Jon Fiume, vice president of retail operations and natural products at Ritzman Natural Health Pharmacies.

"More pediatricians are recommending these products for children, and the consumer is buying in because they trust their pediatricians," Fiume said.

Whether it is in the pediatric or adult cough/cold market, suppliers agree that innovation is key.

"New products are the lifeblood of the cough/cold category," said Donna Ward, a marketing manager at Bayer.

Bayer's new offering, Aleve Cold & Sinus, is positioned for the relief of pain and nasal congestion, and while Ward explained that there is a growing consumer demand for products indicated for specific relief, there would always be consumers who favor multipurpose products.

One new product trend that seems will continue in OTC cough/cold is natural health's influence on the category, according to Peter Burke, director of marketing, Ricola USA.

"Consumers want a nice balance between the menthol content and other beneficial ingredients. "When a consumer selects a throat drop or a cough drop, their No. 1 priority is effectiveness," said Burke.

COPYRIGHT 2001 Lebhar-Friedman, Inc.
COPYRIGHT 2001 Gale Group

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