Technological peculiarities for obtaining of medicated chewing gums
A medicated chewing gum (MCG) is a new alternative solid dosage form for oral application, which is used for the delivery of a great number of active pharmaceutical ingredients. Monographs for this dosage form are introduced in the SPhU, European Pharmacopoeia and United States Pharmacopoeia. But to date, domestic manufacturers do not produce preparations in the form of medicated chewing gums. This is primarily due to the complexity of the equipment applied and the absence of appropriate legal documentation for MCG manufacture, which limited the introduction of this dosage form in pharma-ceutical companies of Ukraine. We have analyzed the literature data on the methods of obtaining a medicated chewing gum, as well as the basic technological aspects and the equipment applied have been considered. This allowed us to conclude that with development of compositions for obtaining chewing gums by direct compression Pharmagum® (SPI Pharma, USA) and Health in gum®(Cafosa, Spain) the possibility of production of this dosage form in domestic enterprises has increased and is promising to date. Chemically, they are a mixture of polyols (sorbitol/xylitol/mannitol) and of sugars with gum bases, plasticizers and anti-caking agents. Chewing gums made by these compositions give faster release of drugs than conventional methods owing to lower binding of the medicinal substance with the gum base and can be directly compressed on a conventional tablet machine.
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