User-Friendly OTC Dosage Forms Deliver Opportunity For Industry

In a guest commentary, Thomas Hein, senior vice president for commercial and regulatory affairs at Hermes Pharma, discusses how user-friendly dosage forms can be utilized by the OTC industry to better meet the demands of patients and consumers. Hermes Pharma, a division of Hermes Arzneimittel GmbH in Germany, works with drug marketers to develop user-friendly formats for OTC drugs and nutritional supplements.

Consumers increasingly are demanding choice and convenience in all areas of their lives, including pharmaceuticals they use. They don’t just want a medicine that works, they want, and expect the pharmaceutical industry to provide solutions targeted to their individual needs and preferences. This poses both a challenge and a significant opportunity for the OTC drug industry; those companies that can rise to it will attract more customers, breeding brand loyalty in the process.

Thomas Hein, senior VP commercial and regulatory affairs for Hermes Pharma, which develops user-friendly formats for OTC drugs and nutritional supplements.

One approach for the industry to consider is the formulation of active pharmaceutical ingredients in user-friendly dosage forms, rather than in traditional tablets and capsules. In many cases, these provide consumers with ease-of-swallowing and additional lifestyle convenience.

The default dosage form for many OTC manufacturers remains solid tablets, which are well-understood, reasonably cost-effective to produce and package, and relatively easy to formulate.

However, a recent survey Hermes Pharma commissioned by market research firm Spiegel Institute Mannheim with more than 2,000 consumers in the US and Germany showed that at least half reported having experienced difficulties swallowing tablets.

Hermes Pharma Survey: More Than 2,000 Consumers, US And Germany

About a third of the consumers described the issue as serious, and the most frequent reasons they cited were tablets/capsules were too big, became stuck in the throat or had an unpleasant taste/odor. Interestingly, these people did not report similar problems swallowing foodstuffs or fluids.

To overcome such difficulties, many of the respondents said they drank vast amounts of water to wash down tablets. Other approaches that can negatively affect the API release profile, bioavailability and medical efficacy include breaking tablets, 32%; crushing and dissolving them in water, 17%; or chewing them, 9%.

The survey also established that providing pharmaceuticals in a hard-to-swallow dosage form has a serious impact on compliance. In fact, 8% resorted to not taking their medication – not only affecting the individual's health but potentially the health care system as a whole.

Consumers expect even more than simply having access to medicines that are easy to swallow (see graph below). Among US survey participants, the next most important characteristics where pleasant flavor/odor, 38%, and easy opening of packaging, 36%, while 34% prioritized "ease of integration into everyday routines."

To me, it is clear that people want the same level of convenience and choice in their OTC products that they are used to from other consumer packaged goods, household appliances and technology, among many others.

Convenience First

Globally, the OTC market is an important and growing source of medicines for patients, as well as revenues for the pharma industry. Rx-to-OTC switches accounted for 19% of OTC sales and 27% of growth over the past five years, according to Consumer Healthcare Products Association data. In fact, without OTC medicines, it is estimated that 60m US consumers wouldn’t seek treatment for their illnesses, according to a 2012 study Booz & Co. conducted for CHPA.

Additionally, market research firm IRI's data show US consumers on average make 26 trips a year to purchase OTC products – a total of 2.9bn retail trips annually, while CHPA research shows consumers on average visit doctors three times a year.

Consumers also want choice and convenience in where and when they buy OTC products. In addition to the 54,000 pharmacies in the US, more than 750,000 retail outlets sell OTC drugs. While OTC channels vary by country, sales generally are increasing in drugstore, supermarket, convenience store, gas station and internet/mail order outlets. Stores still account for the vast majority of OTC drug sales, however for vitamins and dietary supplements, online sales are rather sizeable, according to a 2014 Kline & Co. study.

Factors influencing where people shop for OTC products include geographic proximity, operating hours and product range as well as counselling by trained staff. OTC medicines also provide around-the-clock convenience in health care options for busy families and caregivers.

The power of OTC is delivering the choice and convenience consumers expect in all areas of their lives. This makes a new breed of user-friendly medicines ideally suited to the OTC market.

User-Friendly Medicines, New Opportunities

As already described, many consumers are dissatisfied with the conventional tablets and capsules available to them – and since OTC medicines are available without prescription, consumers are free to vote with their wallets. Medicines that overcome the challenges of inconvenient dosage forms and better meet the needs of consumers are likely to gain more traction in the market.

One approach open to pharmaceutical industry is the formulation of user-friendly dosage forms such as effervescent and chewable tablets, lozenges, instant drinks and orally disintegrating granules. These are designed to be simple to administer and easy to swallow. In addition, they can be formulated in a range of flavors, which, together with effective taste-masking ensures they have a pleasant taste and smell.

Dosage forms that require the addition of water offer an extra hydration benefit, while those that don’t require water are well-suited for "on the go" use, ideal for busy consumers. In this way, OTC customers can escape the restrictions and drawbacks associated with solid tablets and can select the dosage form and flavor that suits them best.

Companies offering user-friendly dosage forms will not only better meet patient needs, but also more effectively differentiate their products in the marketplace and benefit from increased opportunity to build brand loyalty. Dosage forms for the elderly, children, sportspeople or busy professionals also represent potential opportunities to up new market segments for existing brands.

The global OTC market continues to grow, offering a substantial opportunity for the pharmaceutical industry. This puts the patient at the center of their own health care as they make their own treatment decisions based on efficacy and convenience. The challenge consumers have in swallowing conventional tablets and capsules can be eliminated by user-friendly dosage forms, which also integrate better into users’ lives and offer choice. I strongly believe that companies that formulate products as user-friendly dosage forms are better positioned to attract customers and differentiate their brands, creating the opportunity to breed brand loyalty and increase sales.

From the editors of the Tan Sheet