Thursday, April 15, 2021

Formulation, Manufacture and Evaluation of Medicated Chewing Gum

by | October 3, 2020 0

Medicated chewing gums (MCGs) are solid or semi-solid, single-dose preparations with a base consisting mainly of tasteless masticatory gums that are intended to be chewed but not swallowed. It is a drug delivery system that contains one or more active ingredients which are released by chewing.

After dissolution or dispersion of the active ingredient(s) in saliva, drugs released from the gum within the oral cavity can act locally, be absorbed via the buccal mucosa, or from the gastrointestinal tract (when swallowed with the saliva).

The use of chewing gum as delivery systems have been promoted for certain peculiar needs. Sugar-free gums have been used to counteract dental caries by stimulation of saliva secretion. This has led to more widespread acceptance of medicated chewing gums.

Medicated gums for delivery of dental products to the oral cavity are marketed in a number of countries, for example, fluoride-containing gums as an alternative to mouthwashes and tablets or chlorhexidine gum for treatment of gingivitis. The potential use of medicated chewing gums for treatment of oral infections has also been reported. MCG is also useful as a delivery system for agents intended for systemic delivery.

This article reviews the fundamentals of medicated chewing gum, historical development, composition, production techniques, quality control tests as well as the advantages and disadvantages of medicated chewing gums as a drug delivery system.

Development and history of medicated chewing gum

Chewing gum is a pleasure that almost everybody enjoys. People have enjoyed chewing gum since ancient times after man experienced the pleasure of chewing a variety of substance. Chewing gum has an ancient history in 50 AD of Greeks sweetening their breath and cleaning their teeth using mastiche, a resin from the bark of mastic tree. Ancient Mayan Indians of Yucatan chewed chicle from the sapodilla tree.

John B. Curtis in 1848, made and marketed the first commercial chewing gum called “THE STATE OF MAINE PURE SPRUCE GUM”. Over time their company (Curtis Chewing Gum Factory) prospered, it was then that Curtis’ son found they need to improve the company and machines, so he developed a machine which mass-produced gums.

During the 1860’s Thomas Adams, a New York Photographer realized the potential market for chewing gum products. He wrapped pieces of pure, flavorless chicle in colored tissue paper, packaged them in boxes, and left them on consignment with numerous drugstore owners. The gum was named Adams New York No.l. Public response to the product was very favorable.

On 28 December 1869, Doctor William F. Semple, a dentist from Mount Vernon, Ohio filed the first patent for chewing gum both as a confection and a pharmaceutical to protect teeth. This product comprises liquorice and rubber dissolved in alcohol and naphtha.

The first medicated chewing gum, Aspergum® containing acetylsalicylic acid was launched in 1924 in the United States of America but its use as a drug delivery system did not gain acceptance as a reliable drug delivery system until 1978 when nicotine chewing gum was released in the market.

The European Pharmacopoeia in 1991 defined the intended use of medicated chewing gum as the local treatment of mouth diseases or for systemic absorption through the oral mucosa or from the gastrointestinal tract.

Although modern chewing gums often consist of synthetic resins, Thomas Adams first manufactured MCGs with natural latex-base and issued the first patent of chewing machine to render chicle kneaded and smooth. Today, advancement in technology and extended know-how have made it possible to develop and manufacture medicated chewing gum with pre-defined properties.

Read Also: Formulation, Manufacture, and Evaluation of Chewable tablets

Composition of medicated chewing gum

Medicated chewing gums are formulated with suitable excipients to enhance chewability, palatability and efficient delivery of the medicament. In addition to the active pharmaceutical ingredient(s), medicated chewing gums contain:

1. Gum base

2. Elastomers

3. Plasticizers

4. Texture agents/ fillers

5. Lipid and Wax

6. Softeners and Emulsifiers.

7. Antioxidants

8. Flavoring agents

9. Sweeteners

10. Colouring agents.

11. Anti-tack agents

12. Anti-caking agents

Equipment used in the manufacture of medicated chewing gum

These include:

  1. Weighing balance
  2. Mixer
  3. Heater
  4. Extruder
  5. Molding machine for chewing gum (e.g., stainless steel popsicle mold, plastic basket injection mold, injection plastic air purifier mold, launch mold and die/tooling, etc.)
  6. Kneading machine/rollers
  7. Cutter

Equipment for quality control and/or performance tests e.g., equipment for testing the content and release rate of active ingredient (dissolution test), friability, hardness, stability, etc.

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