SubscribeThis latest article for Hospital International shows a range of Medical Chewing Gum available from Fertin Pharma.
It is a well-known fact that the right drug delivery system is critical to the success of a pharmaceutical product. A novel drug delivery system creates additional patient benefits that will add new competitive advantages for a drug and, thus, conserve or increase revenue.
People of all cultures chew gum, and a variety of gums and gum-like substances have been enjoyed for thousands of years. The introduction and subsequent success of Nicotine chewing gum in the 1980’s paved the way for a more general acceptance of chewing gum as a drug delivery system. Improved technology and extended know-how, together with the inclusion of medical chewing gum in the European Pharmacopoeia in 1998, have further contributed to the acceptance of this method of drug delivery. Today, medical chewing gum meets the same high quality standards as tablets. Furthermore, it can be formulated to obtain various release profiles of active substances, thus enabling distinct patient group targeting.
In addition to offering competitive marketing advantages, a chewing gum formulation offers a vast number of clinical benefits. As many active substances are buccally absorbed, efficacy can be greatly enhanced due to the associated fast onset of action and high bioavailability. Medical chewing gum also provides a topical effect in the oral cavity and in the throat.
New FDA approved facilities at Fertin Pharma will be up and running by 2004.
From a patient convenience point of view, discreet and easy administration without water promotes higher compliance. Since it can be taken anywhere, a chewing gum formulation is an excellent choice for acute medication. The advantages for children and for patients who find swallowing tablets difficult are obvious.
Fertin Pharma is the world leader in the development of medical chewing gum. This position has been achieved through research not only at Fertin Pharma’s own laboratories in Denmark, but also through many years of close cooperation with researchers and scientists from various hospitals and universities around the world.
Currently, Nicotinell® and NiQuitin® chewing gum--developed and produced for Novartis and GlaxoSmithKline respectively--are the major contributors to Fertin Pharma’s success. The company has shown a remarkable 20% growth per year in the sales of medical chewing gum during the last five years and, due to an expected breakthrough outside the nicotine business, Fertin Pharma’s position on the world market is expected to be markedly strengthened in the years to come. Consequently, the company has invested 50 million USD in new high-tech production facilities, which are currently in the process of FDA approval.
The chewing machine has been accepted in the European Pharmacopoeia as state of the art testing apparatus for release documentation of active substances in medical chewing gum.
The development team at Fertin Pharma possesses know-how and patents for profiling the release of both lipophilic and hydrophilic substances. The company makes use of several different release systems (solubilizers, matrixes, encapsulation techniques, etc.) and combinations of systems to create the optimal release profile for the relevant active substance. This release profile might be very fast or more prolonged (up to 20 minutes) depending upon the product and target patient group. Additional fine-tuning of the profile can be done by placing the active substance in the coating as well as the core.
In order to obtain in vitro release rate results, Fertin Pharma has developed a chewing machine that has been accepted by the European Pharmacopoeia as the state of the art testing apparatus for release documentation of active substances in medical chewing gum.
To succeed in the market, a chewing gum formulation must have a pleasant taste and texture. Most active substances have an unpleasant, bitter, or metallic taste. Since the active substance will be released in the oral cavity and remain there for a longer period of time than is the case with ordinary delivery forms (usual chewing time is 10 to 20 minutes), unique expertise in taste definition, taste masking, and taste modification are essential to the success of a medical chewing gum product. Moreover, there are no official standards for unpleasant taste, so it is necessary to establish information on taste properties for all new active substances.
MediChew® is the registered trademark for Fertin Pharma’s chewing gum technology.
In most cases, it is desirable that the taste fades out when the active substance has been fully released. The release profile of the flavors and sweeteners, therefore, is usually designed to follow the release profile of the active substance.
One of the major challenges for the product developer is that any small adjustment in the amount of active ingredient, flavor, sweetener, or gum base component may lead to changes in several parameters. For example, the addition of extra solubilizer might change not only the release of the active substance, but also gum base texture, taste, and stability of the product. During the development process, therefore, it is necessary to test several parameters related to taste and texture continually. Every active ingredient requires a custom-made gum base.
Fertin Pharma has access to its own gum base production and has established a panel of professional “tasters” who are trained to evaluate organoleptic data related to chewing gum products. During the development process, a taste and sensory profile is compiled from evaluation results of the panel to ensure the best possible taste and texture.
To qualify as a clinically reliable and attractive drug delivery system, chewing gum must meet the same stringent demands as tablets. At Fertin Pharma, the production, quality assurance, and quality control are currently in accordance with cGMP standards and are certified in accordance with ISO9001: 2000. In order to comply with the standards set by the US FDA, new FDA facilities are under construction.
Though chewing gum as a drug delivery system has currently gained wide acceptance only within smoking cessation and oral health care, vast interest in this mode of drug delivery for a wide variety of other indications exists and continues to grow. Clinical trials have confirmed the advantages to be gained by exploiting the effects of chewing gum per se, the convenience of the delivery system, and the possibilities of buccal absorption and local effect. Furthermore, one trial has indicated that chewing gum is possibly a safer drug delivery system for active substances that are susceptible to abuse.
If chewing gum as a drug delivery system is to be employed in additional therapeutic areas, it is important that the delivery form is acceptable to the end users. Clinical trials and market research have proven this to be the case. In the coming years it is very likely that new formulations will enter the market and that chewing gum will become a common drug delivery system.
Contact:
Bo Tandrup, Business Development
btd@fertin.com
Tel: +45 72 15 13 00
MISSION:
Fertin Pharma will perform as a “best in class” partner for product development and the manufacturing of medical chewing gum. Our focus will be on financial performance and benefits for customers, patients, and employees.