MARCH 2012

Added chewing value

The pharmaceutical industry is experiencing a global rise in generic competition and an important decrease in new molecules, making it increasingly important for companies to look for strategies that enable them to remain competitive and maintain a powerful product portfolio that keeps profitability high.

One of the strategies is to focus on new drug-delivery systems to create new products or reinvent ones already on the market to improve efficacy, consumer appeal and compliance.

Medicated chewing gum (MCG) stands as an opportunity for innovation with new pharma applications already under development. It is a particularly interesting prospect for those companies that look to differentiate their products with a new and attractive format.

Traditionally, medicated chewing gum remained as a niche pharma category due to its complex formulation and manufacturing that uses hot mixing and extrusion procedures involving specific technology and equipment that most pharmaceutical companies are not familiar with.

The use of heat in these processes prevents many active pharmaceutical ingredients (APIs) from being considered due to their sensitivity to high moisture and temperature levels. However, a door has opened with the launch of a new solid-dose excipient developed exclusively to adapt MCG production to pharmaceutical-standard equipment.

Consumer appeal

Many people dislike swallowing regular oral-dosage formats such as tablets or capsules. Chewing gum does not require water intake and has pleasant sensory properties. It also brings a rapid onset of action due to the oral release of the API by the action of chewing. The majority of the API is absorbed orally, bringing faster bioavailability.

Moreover chewing gum has inherent benefits that give extra value to this dosage form:

  • Good for oral health
  • Improves concentration
  • Decreases stress levels
  • Prevents the urge to eat or smoke

All these provide positive synergies to combine with the therapeutic action of an active ingredient to give a great performance and improve compliance for consumers.

How to use Health in Gum®

Health in Gum® is a pharmaceutical excipient produced using proprietary technology by Cafosa (Mars/Wrigley). It is a homogeneous powder that combines gum base and polyols. Health in Gum® allows for formulation and dry mixing with APIs to produce chewing gum through direct compression.

This means that the formulation and production of medicated chewing-gum products is now possible without the need for any extra specific equipment.

It is no longer necessary to use the traditional process involving chewing gum equipment and technology. Health in Gum® fully adapts to oral-dose pharmaceutical manufacturing processes. Some examples of drugs being marketed as medicated chewing gum include the well-known traditional nicotine gums, motion-sickness gum and some digestive and oral-care products.

Now with the use of the latest direct-compression technology, this format and presentation is within reach of the entire pharmaceutical industry, from small local firms to large multinational companies.

Meaning anyone can develop and launch their own medicated chewing gum products with total ease, either as totally new products or as an extension of their current line.

New API research

In a recent internal study, Cafosa measured the in-vitro release of loratadine (a common antihistamine to treat allergies) from a compressed chewing gum using Health in Gum® . For the experiment, the firm used mechanical masticator equipment to determine drug release for MCG, which was officially adopted by European Pharmacopoeia in 2012. The results were very promising and consistent with other studies about loratadine release in chewing gum. This performance introduced a new therapeutic area of interest for this drug-delivery system.

Additional research from external sources brought positive data for Health in Gum® with other APIs that are also good candidates for MCG: cetirizine (an anti-allergy drug) and benzydamine hydrochloride (a local analgesic for sore throats), which demonstrated nearly total release from chewing gum after a standard 30-minute chewing time.