Medicated Chewing Gum (MCG): A Novel Oral Drug Delivery System

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Medicated chewing gums (MCG) have a wide range of applications in health care, including drug delivery and neutraceuticals. These gums are used for the prevention and treatment of motion sickness and dental caries and smoking for cessation. The popularity of medicated chewing gums as drug delivery systems is increasing due to their advantages such as non-invasiveness, easy administration, and faster metabolism through the liver or gut wall. Moreover, the trend of using biodegradable chewing gums is increasing due to a ban on synthetic polymer-based chewing gums in Singapore and other parts of the world.  

Drugs released while chewing can either be absorbed directly into the bloodstream via the buccal membrane or it could be swallowed with saliva and absorbed in the gastrointestinal (GI) tract. As most of the given drug in MCGs gets absorbed, a reduced dose may be required, lowering the chances of side effects. The drug concentration that is absorbed via the GI tract is subjected to the first-pass metabolism unlike those that will be absorbed in the oral cavity. The first-pass metabolism reduces the amount of drug that is eventually absorbed which normally affects the administered dosage. Medicated chewing gums (MCG) is supposed to act as an extended-release dosage form that provides a continuous release of medicine contained.

The formulation of drugs like pain-relieving substances, antiemetics, antifungals, vitamins, nicotine as chewing gum has broadened the dosage format application. Suitability of formulation process and stability of the drug in the dosage form plays a major role in these limitations.

To increase acceptance and promote the widespread use of MCGs, many innovative concepts are emerging with more in the works. A prominent one is the incorporation of more than one drug in single dosage formulations which can effectively reduce polypharmacy, encouraging patient compliance. Also, separation of drug components with different release times as in modified release is possible in certain MCGs.

Manufacturing Process:

  • Conventional/Traditional Method
  • Freezing, grinding and tabletting Method
  • Direct compression Method

Direct compression is more economic and straightforward in terms of good manufacturing practice requirements than other method, the pharmaceutical industry is focusing increasingly on this process. It is suitable when the directly compressible excipients are available. Several problems arise with manufacturing of medicated chewing gums (MCG). Sticking is one of the major problem that arises. To know more about it check the below link on Pharma solution by Dr. Ajay.

https://pharmasolution1.blogspot.com/2020/09/tablet-processing-formulation.html

Quality testing for Medicated Chewing Gum (MCG):

The following important quality control tests are carried out on medicated chewing gums (MCG) but I will only elaborate Drug release test, rest of them are too lengthy so will discuss it later.

  • Content of active ingredient
  • Uniformity of Content
  • Uniformity of weight
  • Tensile strength
  • Organoleptic properties (taste, mouth-feel, colour and odour)
  • Dissolution / Drug release test

In the first apparatus adopted by EP, a defined volume of dissolution medium is shed into mastication chamber, the acidity of medium reaches to pH 6.0 by phosphate buffer and the temperature should be 37°C ± 0.5°C, the piston speed is 60 rpm.

The usual number of chews per minute of a normal person is 60 strokes/min, then a part of MCG or the whole gum is placed into the chamber and the apparatus is set and the procedure is started. The machine is stopped at determined time, the remaining part of the gum is then removed and a sample of dissolution medium is prepared, the content of active agent(s) is determined by a suitable method, after each sampling, dissolution medium could have been replaced by a new and fresh medium so that the dilution factor should be calculated. The content of active agent(s) in the gum residue could be determined too. 

Medicated chewing gums (MCG) represent an example of a specialized tablet type specifically designed to be chewed in the mouth. They must be subjected to a number of tests before they are approved for consumption and marketing.

Factors affecting drug release from MCGs:

A major concern in MCG formulation is controlling how incorporated drugs are released into the body.

There are three major determining factors:

Person-to-person variability:

    Individuals have different chewing habits which affect how quickly and how much drug is released. The European Pharmacopoeia recommends 60 chews/min for adequate drug release.

Process-related:

Formulation process and composition of MCGs also plays a major role. Mixing of active ingredients with hydrophilic or hydrophobic compounds is employed in drug formulation to modify drug release.

Physicochemical properties of drug:

     Drugs with high aqueous solubility are readily soluble in saliva, releasing rapidly and completely from MCG into the oral cavity. While lipid-soluble and slightly water-soluble drugs are released more slowly as they are first released into the gum base then saliva.

    Mechanism of Drug Transport:



Advantages of MCGs:

Fast onset of action due to rapid release of active ingredients in buccal cavity and subsequent absorption in systemic circulation.

  • High bioavailability.
  • Convenience – Does not require water to swallow. Hence can be taken anywhere.
  • High acceptance by children.
  • Both systemic and local effect
  • Fewer side effects
  • Superior ability to carry different APIs.
  • Possibility to evaluate the suitability for different APIs.
  • Stomach does not suffer from any direct contact with high concentrations of active ingredients, thus reducing the risk of intolerance of gastric mucosa,
  • Aspirin, Dimenhydrinate and Caffeine shows faster absorption through MCG than tablets.

Conclusion: 

Medicated chewing gums (MCG) is an excellent drug delivery system for self-medication, as it is convenient and can be administered discreetly without water. It offers several advantages compared to chewable tablets, lozenges and other related formulations. Hence in forth coming years it will become a much more common and popular drug delivery system.

It can be utilized for systemic drug delivery where a rapid onset of action is needed, such as motion sickness, nausea, pain, allergy, infection and hypertension (provided the drug is easily absorbed through the oral mucosa).

Local delivery to tissues of the oral cavity has several applications, including the treatment of toothache, periodontal disease, bacterial and fungal infections, aphthous and dental stomatitis, which require a long period of drug release to the oral cavity. As chewing gum is intended to be retained in the mouth for a long time, the issue of taste-masking remains an important factor in product development, as does the control of drug release from the gum base. The convenience and acceptability of chewing gums, combined with effective sweetening and taste-masking, may lead to improved compliance. Moreover, MCG also benefits from the rewards that are inherent to chewing gum such as oral care, stress relief, improved concentration, and weight management.

Future prospective:

Medicated chewing gum is an advance form of the oral formulation and it develops a dramatic change in the patient suffering from the swallow able disorder and patient that are older in age. Medicated chewing gum are most popular among children, and they easily take the drug like a chocolate, but apart from this medicated chewing gum is suffering from several incompatibility related problems and the most common is physical incompatibility. A lot of research is required on the Medicated chewing gum for the drugs that are suitable for the preparation of the Medicated chewing gum and not have physical incompatibility.

Query:

Ask if you have any Query visit  http://pharmasolution1.blogspot.com, I will revert back to you with a solution. To learn more always visit and connect with Pharma solutions by Dr. Ajay.

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About the Author:

Dr. Ajay Kumar Singh, M.Sc. (Gold Medalist), Ph.D. is the author and founder of “Pharma Solutions by Dr. Ajay”.

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Disclaimer:

Examples used in this article are not meant to be endorsements of any product or technology from the author.

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